Narrator  00:00

Be inspired, supported, and empowered. This is the Global Healthy Living Foundation, Podcast Network.

Ben Blanc  00:06

You’re listening to “Healthcare Matters,” the podcast that pulls back the curtain to help you make sense of complex health care economics and policy issues. With us is Dr. Robert Popovian, in Washington, D.C. He’s a pharmacist, an economist, and the Chief Science Policy Officer, at the Global Healthy Living Foundation.

Dr. Robert Popovian  00:28

And joining me is my good friend, as always, Ben Blanc, dialing in from the heartland of America, Indianapolis, Indiana, and he is our Associate Director of Digital Production and Engagement. So, Ben, we just concluded the Olympics, and there was a lot of discussion among the athletes about free health care. I’ll bet that, that’s not shocking to you as a Frenchman.

Ben Blanc  00:48

It’s not – The system is definitely different there. First of all, health care is largely state funded, and also the focus on preventive care is really something else. But keep in mind that the French health care system is one of the most expensive one in the world. But every system has its’ perks and its’ quirks, so maybe we’ll focus on the quirks for today’s episode. And we all know it, the health care system, here in the U.S., has  its own set of challenges, one of which is patient steering. So, let’s dive in.

Ben Blanc  01:23

And Robert, today, we have two guests joining us. With us is Lou Tharp, Co-Founder and Executive Director at GHLF. After running a successful international public relations, advertising, and marketing company for nearly 20 years, Lou became a social entrepreneur, in 1999, and co founded Creaky Joints and Global Healthy Living Foundation. Lou is here to share his experience as a fierce advocate and patient. Lou has been on a biologic for the past two years and has personal experience with patient steering. And our second guest is Dr. Anne Sydor, who’s Director of Research Development at GHLF, and if her name rings a bell, that’s probably because Anne has been a frequent guest of the show. At GHLF, Anne helps design and acquire funding for all of our research work. And Anne actually prompted this episode, having recently experienced patient steering related to filing meds for a family member moving away to college. So, definitely lots to talk about in this episode. Speaking of, today, we’ll talk about patient steering, which is a prevalent, yet, often overlooked issue within the U.S. health care system. We’ll explore why it happens, how it affects patients, and what can be done to protect patient rights. And before we begin, let’s clarify what we mean by patient steering. Patient steering refers to the practice where health care providers influence or direct patients towards specific medical services, pharmacies, or providers that they own or have financial agreements with, and, often, without full transparency. So, Robert, have I captured that accurately?

Dr. Robert Popovian  03:01

Somewhat accurate. But today we’re going to concentrate on how pharmacy benefit management companies are really steering patients to their privately owned pharmacies, instead of allowing patients to go, basically, to any independent pharmacy or any pharmacy of their choosing. Same concept, though.

Ben Blanc  03:17

So, Robert, can you explain why PBMs engage in patient steering and the implications of their ownership of specialty pharmacies and use of programs, like accumulators and maximizers.

Dr. Robert Popovian  03:29

So, the reason PBMs steer patients through their own pharmacies is twofold. One is because they own these pharmacies, and they happen to make a lot of money off of these pharmacies, instead of having them go to an independent pharmacy to get their prescriptions. What the FTC report also found, by the way, that when they reimburse pharmacies, these PBMs actually reimburse better for medicines – their own PBM owned pharmacies, than actually the independent pharmacies, again. So, there are multiple reasons why they do this – It’s a financial reason. But there’s also underlying other reasons, because they want to, probably, administer policies such as accumulators and maximizers, which we’ve spoken about multiple times on this podcast. And these programs basically take away the patient assistance program that is given by the biopharmaceutical companies, and then they don’t apply this patient assistance program towards a patient’s out of pocket cost, maximum out of pocket responsibility, or deductible; and hence, they keep the patients in this perpetual deductible phase. At the same time, the pharmacy benefit management companies, when they don’t apply this, they still require the patient to pay for their out of pocket cost responsibility, their maximum out of pocket costs. And so there are two primary reasons for patient steering – is one financial and then for them to be able to administer these type of policies that hurt patients on both ends, 1. patient choice, the 2nd one, patients paying more out of pocket than they have to.

Ben Blanc  04:59

Well, thanks for that detailed explanation, Robert. It’s clear how these practices impact the broader system. Now, turning to our guests, Lou, as someone who has been directly affected, could you describe your experience with patient steering and how it impacted your care?

Lou Tharp  05:15

Sure! Thanks, Ben. Hi, Robert. So, as Ben mentioned, I’m on a biologic, and is, everybody who listens to this podcast, know biologics are not cheap, and the patient copay can be a few $1,000 a month. So, I got a copay card, and actually a debit card too, from the manufacturer. My PBM is CVS Caremark. I have a local pharmacy, which is very close, who I know, who delivers drugs right to the door, so I put through the first prescription with them, CVS Caremark denied it and said I had to go through CVS Caremark. So, what happens here is they force you to go to the pharmacy, as Robert says, of their choice. And this happens to be a pharmacy that Aetna owns, or maybe CVS Caremark owns Aetna. It’s hard to tell anymore, and I got to thinking about this. Ultimately, I whined enough, complained enough, and testified before the Maryland State Legislature and got it changed, and I’m now with the New York Presbyterian Hospital, which is a specialty pharmacy that I like a lot, and also the same organization that my doctor works for. So, here’s what happens: the idea that somebody can force you to go to a specific company to get a service, that a third party has recommended, is just bad business for patients. It’s great business for PBMs, for pharmacy benefit managers and insurers. And the analogy here is that several years ago, insurance companies in the automotive sector used to do this all the time. It was very common, and still is, in some states, that if you get into an accident, you get steered to the body shop that either the insurance company owns, the car insurance company owns, or that they have a relationship with, that provides them with less expensive bills that they have to cover. So, legislatures around the country got tired of this, and they passed a whole series of laws preventing this. Where I live, in New York, and conveniently, where I testified in Maryland, there are laws that prohibit steering, when you have an automobile accident. So, the case that I was able to make to the Maryland State Legislature was, “You already do this for cars. You’ve already passed this law. Therefore, how can you not pass one that protects humans and protects our bodies and our access to medicine?” The bill was voted out of the house, passed, and I’m checking now to see how it fares with the House of Delegates at the Senate, and we’ll know, but we got a very good response. So, the point here is that, states aren’t stupid, and neither are patients. And these kinds of policies come out of health insurance companies all the time, and if you follow the money, they’re always geared toward making more profit for the insurance company. And the minute you start to complain, then legislators meet with the insurance companies, and the insurance companies and the PBMs say, “Well, okay, we’re happy to do that, but we’re going to raise rates.” Now, GHLF has done research, in other areas that show that’s not the case, that, you know in the case of prior authorization, especially. We have worked with state legislators in the past to pass prior authorization laws, step therapy laws, against a chorus of insurance companies and PBMs saying that they’re going to raise rates if this passes. And you know what, they don’t raise the rates, because that’s a whole different hill to climb; that’s an obstacle that’s very difficult to overcome many times, because you have to go through state insurance commissioners and other state bodies. So, that main argument works a lot of times, but in practice, it’s a false argument.

Ben Blanc  08:48

Well, thanks for sharing your experience, Lou. And what’s a bit scary with what you’re saying is that, I mean, you’re obviously well versed in all things health care, and you’re not afraid to call your pharmacy benefit manager, your insurance provider, you’re able to advocate for yourself, and yet it seems like you very often have to push back and to make yourself heard, to get what you need. Anne, I understand you’ve also dealt with patient steering in your family. So, could you detail your family’s experience with patient steering and how it influenced your approach to health care?

Dr. Anne Sydor  09:23

Sure! So, my youngest child just went off to college and is finishing the pediatric portion of his life and shifting from pediatric care to adult care, as well as moving halfway across the country, much to his mother’s dismay, not really – I’m happy for him. But we were trying to set up all of his health care before he left. We talked to his physician about the fact that he was making two transitions, and we wanted to make sure that his medications, that he takes daily, wouldn’t run out, that on top of all the transitions he was making, he wouldn’t have to deal with a shift in how he gets his medicine. So, we asked his physicians to give him 90 day prescriptions, which would get him through, you know, a three month period, and allow him time to set up with new pharmacies and new physicians, where he is now and in the adult health care system. I received the regular message, from my pharmacy, that his prescriptions were ready, and I went to pick them up…and they were 30 day supplies. And he said, “Wait, these are supposed to be 90 day supplies. I know the doctor prescribed 90 day supplies. Why are we not getting the 90 day supplies?” And I was told it had been denied by the insurance company and that I would have to file an appeal. At this point, he’s leaving in a couple of weeks, and the whole point is to make sure he has continuity of care with his medications. So, I called the Pharmacy Benefits line, customer service line, and I asked them why we can’t have the 90 day prescription, and they say, you know, it wasn’t cleared. And I said, “Okay, well, can you check why it wasn’t cleared?” But again, I have to ask these questions every time; I’m not getting information, unless I ask for it. First, I was told I would have to get the doctor to redo the prescription. And I said, “Why? He’s already done a 90 day prescription.” Okay, well, then I guess it has to go through us. And I said to the customer service agent, “Oh, I understand, you’re steering me to your pharmacy, right?” And then, the very nice customer service agent, of course, couldn’t say this to me, and instead said, “Well, I don’t know why it’s happening, but I just know that if you go mail order through us, you’ll get the 90 day prescriptions, and curious what the co pays are.” And these are generic medications; they are not expensive medications, my co pays are low. We arranged to have it mail ordered, and made that choice as a one time exception, because I won’t go through the insurance company’s pharmacy for one major reason, and that is the value that I place on having a pharmacy in my neighborhood. My pharmacist is one of my health care providers; they’ve provided us with vaccinations, they’ve provided us with naloxone, they’ve provided us with all kinds of care, including life saving care, and I need a pharmacist in my neighborhood. As a mother of young children; kids get infections, they need antibiotics, and they need them urgently. I don’t want to wait until they’re mailed, nor do I want to have to drive 10 miles across town to pick up antibiotics, when I’ve got a sick kid. I want a pharmacy in my neighborhood. And so when we talk about the financial incentives, Robert, that you brought up, it’s not just about increasing their profit margins, it’s about the trend in U.S. big business towards monopolies. It’s about the verticalization of health insurance and pharmacies, and it’s about driving the small independent businesses out of business. I might be able to live without a brick and mortar bookstore in my neighborhood, I wish I had one, I miss it, but I can live without it. I can’t live without a pharmacy in my neighborhood; I need my pharmacist, and I need the health care that they provide. And this is why, for me, steering is such a big problem, and why this time we did it, is a one time exception.

Lou Tharp  13:18

Anne brought up some really good points, and there’s one point that I want to take off on that, that she mentioned. When I was under the kind of the Iron Fist of CVS Caremark, I would get my prescription biologic delivered by FedEx. Now, I don’t know how FedEx is in your neighborhood, but in my neighborhood, the FedEx driver, and this has happened before, slows down and throws the box at the end of the driveway. When they really want to take care of you, they stopped the truck and set the box somewhere in the driveway. So, one day, they left it in the weeds and I couldn’t find it. It sat outside in sub freezing weather for a day and a half, and you’re not able to do that with this biologic. So, I had to spend an hour on the phone with CVS Caremark, before I finally got to a pharmacist, who told me how to test the drug and see if it was still good. I’ve had situations where the FedEx driver just leaves a tag on the mailbox saying, ‘We tried to deliver it. You weren’t home.’…and I was home. I’ve had it where they say ‘We need a signature and you weren’t home.’ And so, this caused both delays and what amounted to, in one case, a substandard drug over and over and over again. And the CVS Caremark folks refused to acknowledge this, they refused to understand it. And what it did was give me more ammunition for when I testified before the state legislature in Maryland, and you could see the elected folks, the representatives, and the delegates. You could just see them looking, thinking, ‘How could this possibly be?’ Because they’re not sick, they don’t understand it. And that happens a lot of times, people think they have good insurance until they get sick. People think they have a nice insurance company, they don’t even know what a PBM is, until they get sick, and then they have to put up with this. Actually, it’s overt abuse, because it’s planned abuse of the patient. They put up obstacles that they know you’re going to have to fight, in order just to get your medicine. So, what Anne was saying about a pharmacy in your neighborhood, and as I said, my pharmacy knows me, they deliver the drug, they knock on the door and they call before they come over. It’s a real person, it’s not somebody in a purple uniform throwing a box at me. So, good points, Anne!

Dr. Anne Sydor  15:26

For me it’s also the delivery systems are problematic. It’s also the case, that trying to get around these systems is problematic. So, in my case, we were looking for generic drugs, and it was pretty easy for the customer service rep to just put the prescriptions through a different system, to enter them into their mail order pharmacy, instead of entering it into my local pharmacy and see that it was covered. Again, a clear case of steering; covered under the CVS own ‘mail order pharmacy,’ but not covered under my local pharmacy. And I didn’t have to spend an hour on the phone to speak to a pharmacist. These were simple, generic drugs for people with more severe chronic diseases, taking biologics, taking immunotherapies, taking drugs that have a lot more parameters that you have to meet in terms of the right temperature, the right conditions, and getting them on time. The idea that you would have to spend an hour talking to somebody, just to find out why you can’t get your medication, an hour on hold; I’ve never had to wait an hour at my local pharmacy. I’ve had to wait, sure, I’m one customer among many, but not hours just to be allowed to speak to somebody. And I think that’s another thing, that’s really problematic, about the pharmacy benefit managers and this verticalization of health care, which really is moving more towards a monopoly situation.

Lou Tharp  16:51

Anne, you just did it again – You made me think of something while you were talking. So, the major issue, the second major issue is, you never get to talk to the same person twice at a PBM. They are reading a screen, that contains notes from the last person you spoke with, and that person may be a good note taker, they may be a bad note taker. And so, you wind up starting from the baseline every time you talk to your PBM, and if you go around and around and around with this, and then they put you on hold, and then they transfer you to somebody else. And the idea that you have to listen to ‘push 1, if you’re an idiot, push 3, if you’re a moron, push 3, if you’re impatient,’ they do that, in order to queue you up. And it makes you feel like, “Well, I didn’t have to wait too long, once I got through the phone tree.” Well, the phone tree is part of the call, and so this designed inefficiency, which allows them to hire fewer customer service reps, and this automation, which allows them to push more work on the reps they have by taking notes, is absolutely unacceptable when you compare it to neighborhood pharmacists, who calls you up, and knows your name, and when they call your phone, their name pops up. You talk to them, they say, “Hey, how’s your sharps container? Do you need any alcohol? What’s going on?” And there’s a real connection, “You know, would Wednesday be good to deliver this? How about Thursday?” And so, there’s a huge, huge difference here that extends far beyond the simple idea that what seems like convenience, really isn’t.

Dr. Anne Sydor  18:24

Not just what seems like convenience. What they say, is cost savings for the entire system. For most of this conversation, I’ve been, you know, sticking to my role as a parent, as a community member, you know, as somebody who’s a care partner to young adults. I’ve also done policy research with you, Robert, and we’ve shown that these things they claim are making the system more efficient and saving the system more money, are actually simply transferring costs onto patients, and when laws passed at the state level stop those policies from taking place, as Lou said, they scream and cry, “Oh, your premiums will have to go up if you don’t allow us to shift costs onto you that way, we’ll have to shift them on to you another way.” But we’ve done the research, and we’ve seen that there’s no correlation between increases in insurance rates at the state level, and when states do and don’t pass laws, limiting what insurers can do.

Ben Blanc  19:25

Hearing you both share your stories, really brings to light the personal side of this issue. And Anne, you were just referring to the policy research work that you and Robert have been conducting. We actually have a page on GHLF’s website, where you can find all the relevant information – We built in interactive tools, so you can explore health care premium cost trans, state by state, and you’ll find a lot of other related resources on there as well. You can go to ghlf.org/copay-assistance-protection, and the link to that page will be in the episode description, for this episode. So, Robert, I’m turning to you, because surely there are some actions that can be taken to help patients fight back against patient steering. And my question for you is, what legislative and regulatory measures are being implemented at the state and federal levels to address patient steering and protect patient rights?

Dr. Robert Popovian  20:20

So, on the state level, several states have passed anti steering legislation. That means, that prohibit PBMs from steering patients to their PBM on pharmacies. Texas has done it. I was in Georgia yesterday, at the Georgia Bio Association, and Anne and Lou, you would be happy to see that a lot of people are using our research, to fight back against the accumulators and maximizers, I was told. So, there are states that have passed such legislation; I know Lou also testified in Maryland about this. Now, on a federal level, obviously there’s bipartisan legislation to reform PBMs, and part of that legislation includes anti steering legislation that prohibits PBMs from steering patients to PBM owned pharmacies. But also, most recently, there’s a Senate legislation by Senator Warren of Massachusetts that has authored it, I believe, and in it, it prohibits PBMs from owning pharmacies, and that’s going to be the key here, that will solve a lot of the ills. Because remember, again, going back to the FTC report, one of the major findings of this interim report was that PBMs reimburse differently: Their pharmacies, they reimburse them much better, than the independent pharmacies that there were comparisons. And the whole intent of this is economics, right? It’s to drive out business, drive out the independent pharmacies and anybody that does not affiliated with PBMs, because that way they get to have oligopolies and monopolies in the system, and they’re able to manipulate it much better. So, as we discuss this issue, it’s also important to note that Chairman Comer has called on the PBM executives, to correct their hearing testimony. The PBM executives recently testified at his committee meeting, and they said that they do not steer patients, nor do they manipulate the reimbursement to favor PBM loan pharmacies versus independent pharmacies. And the Chairman has, in a very unusual request, asked them to come on and correct their hearing testimony, because of the FTC report, which has found the exact opposite of those remarks, and he’s giving them an opportunity to basically fix what they said at the hearing, when they were on the ropes. So, this is a very unusual step by the committee chair. Usually the only time you see this is that in criminal activity, when witnesses are provided an opportunity to correct themselves before they’re criminally charged. So, it’ll be interesting to see what the PBM executives do, and we will be dropping the link to the letter that went out from the Chairman Comer to the PBM executives in the show notes.

Ben Blanc  22:49

Right! Well, thanks, Robert. It’s really encouraging to hear about the efforts to address these challenges. And from our discussion today, it’s clear that patient steering significantly impacts individual health care choices and overall costs, and we’ve heard from our two guests, Lou and Anne. They’ve both had to fight back against patient steering. They’ve had to place those calls to their pharmacy benefit manager, their insurance, they’ve had to ask the right questions. So, it’s definitely something we need to make sure that people are aware of and educated about, but I’m not the expert here, so Robert, you have the last word.

Dr. Robert Popovian  23:27

So, first of all, I want to reflect on something that happened to Anne, with regards to, this is a generic med, right? This is not an expensive med, that she was steered towards a PBM old pharmacy. So, the question is, why does this happen? And I know she lives in Pennsylvania, so in fact, there’s legislation in most states, and I think Pennsylvania is one of them, that the PBMs cannot charge the patient more for going through a mail order or their pharmacies, than they go to an independent pharmacy. But this is a perfect example that even though we have legislation in the States, PBMs go ahead and ignore it. And in fact, this issue came up yesterday, at the Georgia Bio meeting, that it is easier for them to ignore these laws and regulations and just pay a fine or have a squeaky wheel, because nobody’s gonna pay attention, unless somebody, like Anne, goes to the State Board of Pharmacy or complains to the consumer protection agency within Pennsylvania. So, that’s a typical example of what PBMs do, is that they just ignore everything, they don’t care. Because at the end of the day, they feel so above the law that even though there’s legislation in the states, there in Pennsylvania, they require probably that 90 days are to be dispensed by anybody, local pharmacy, or mail order, at the same out of pocket cost. They can go ahead and ignore it, because the consumer, the patient, is way overwhelmed and doesn’t have the time and energy to fight them on it. And if they don’t complain and they don’t file with the corporate agencies, these agencies are overwhelmed and they cannot regulate them appropriately. So, having said that, the whole reason for patient steering, is not better patient care. Better patient care is not provided by an unknown, like Lou said, somebody that you call on the line and probably don’t get the same person. And I’ll bet, Lou, that person wasn’t even a pharmacist, but I guarantee you, when you go to your local pharmacy, you will talk to a pharmacist, not somebody who has answered the phone, for the PBM. So, it’s not for better patient care, let’s put that aside. Okay, let’s be honest about it – This is about PBMs wanting to steer patients to their pharmacy for one reason, and one reason only, economics. They’re gonna make more money – If you go to their pharmacy, instead of going to your local independent pharmacy, or local pharmacy of your choosing, rather than theirs. And this has detrimental effects, like how, Lou has talked about it, with regards to quality of the medicine that he’s getting, or what Anne talked about it, with regards to the ability to access the medicine quickly. This has detrimental effects on patient care, but again, it boils down to economics, and it boils down to PBMs having so much power, and they’re such large monopolies, that the only way we can fix this is for legislative efforts, both on the state and the federal level, to really push back on this patient steering, because it is not for better patient care, it is to enrich the PBMs bottom line, period.

Ben Blanc  26:12

Well, thanks for breaking that down for us, Robert. I think that was some very valuable information for our listeners. Anne and Lou, thanks very much for joining us and for sharing your insights.

Ben Blanc  26:25

And that’s it for us. Don’t forget to subscribe to our podcast on Apple podcasts, Spotify, or wherever you might be listening, so you never miss an episode. And if you have a second, help spread the word by rating our podcast, writing a positive review, and sharing with your family and friends – It will help more people like you find us.

Dr. Robert Popovian  26:45

And I want to thank Anne and Lou, that came on our podcast. We always like to hear from patients, especially patients, who have gone through difficult times accessing health care, accessing their medicines, and so on and so forth. But most importantly, if you have questions or thoughts, in our audience, please send it to us – You can email us at [email protected], and you know, if we find something compelling, like we found out about the steering issue from Anne and Lou, we’ll bring you on the podcast, and we’ll interview you because we want to hear from you, and we will feature you on our upcoming podcasts.

Ben Blanc  27:19

And before you go, make sure you take a listen to some of our other great podcasts on the GHLF Podcast Network. You can find all of GHLF’s podcasts at ghlf.org/listen

Ben Blanc  27:31

He’s Dr. Robert Popovian…

Dr. Robert Popovian  27:33

And he’s Ben Blanc. We’ll see you all next time.

Narrator  27:37

Be inspired, supported, and empowered. This is the Global Healthy Living Foundation, Podcast Network.

Narrator  00:00

Be inspired, supported, and empowered. This is the Global Healthy Living Foundation Podcast Network.

Ben Blanc  00:06

You’re listening to “Healthcare Matters,” the podcast that pulls back the curtain, to help you make sense of complex healthcare economics and policy issues. With us, is Dr. Robert Popovian, in Washington, D.C. He’s a pharmacist, and economist, and the Chief Science Policy Officer at the Global Healthy Living Foundation.

Dr. Robert Popovian  00:29

And joining me is my good friend, Ben Blanc, from the heartland of United States, Indianapolis, Indiana. He is our Associate Director of Digital Production and Engagement. So, Ben, have you been following the Paris Olympics?

Ben Blanc  00:36

I have been, yes! I actually even hosted a party for the opening ceremony last week at my house. What sports are you going to be watching, Robert?

Dr. Robert Popovian  00:48

I have been following the soccer, very closely. Football…

Dr. Robert Popovian  00:52

…as the rest of the world refers to, and I have to say it was disappointing. Good for you, as a Frenchman; France beat the United States, in the opening game. But you know, I’m going to be following the traditional sports: swimming, wrestling, boxing; it’s a smorgasbord of different sports that you, typically, don’t see on an average day, in the sports conglomerate in the United States. So, looking forward to these two weeks.

Ben Blanc  00:52

Shocker.

Ben Blanc  01:17

Yeah, agreed. Exciting times, Robert. There’s so much we could talk about in this episode. There’s definitely a lot in the news for the upcoming elections. And perhaps one thing, that flew under the radar, is the recent FTC report on pharmacy benefit managers, commonly known as PBMs. I know you always have a lot to say about PBM. So, without further delay, let’s get started!

Dr. Robert Popovian  01:40

Let’s do it!

Ben Blanc  01:45

So, Robert, you know the drill, I want to start the episode with a number. What if I tell you the number, “80%.” Does that ring any bells?

Dr. Robert Popovian  01:53

Absolutely, it does. And that’s the number that FTC put in its report. And FTC, by the way, stands for Federal Trade Commission. And what FTC said, is that 80% of the retail marketplace in the United States is managed or is, sort of like it’s, an oligopoly of three companies, CVS Health/Caremark, Cigna/Express Scripts, which is the PBM, and United Healthcare/Optum Rx, which is the PBM. So, three large PBMs, and insurers manage 80% of the retail prescriptions, that are processed in the United States.

Ben Blanc  02:27

Well, that’s a great way to introduce to this topic, we’re unpacking a crucial report that the FTC just released in June. The FTC is a U.S. government agency, tasked with promoting consumer protection and eliminating harmful anti competitive business practices. Today, we delve into their findings on PBMs. And this recent report sheds light on how PBMs influenced drug costs and pharmacy operations. Revealing significant impacts on both healthcare providers and consumers. So, Robert, the FTC report highlights an unprecedented level of concentration and vertical integration among major PBMs. Could you explain how this has affected their control over drug access and pricing?

Dr. Robert Popovian  03:14

Well, the vertical integration and the horizontal integration are two different issues. So, the horizontal integration is when, PBMs, pharmacy benefit management companies buy other pharmacy benefit management companies, and they consolidate as such that has been going on for the last two decades, actually, the market has become an oligopoly of three large PBMs, with regards to management of drug benefits, and that’s CVS Health at Caremark, that we talked about, United Healthcare Optim, and Cigna Express Scripts. What has happened in the last five to seven years is that we’ve seen vertical integration. So, in vertical integration is that when the PBMs, or the insurance companies, now are either merging or buying each other out, and that’s what has created, a not only an oligopoly of insurance providers, managing drug benefits, but also the PBMs, consolidating on their own, which has happened over the last two decades. So, what FTC has shown, is that the market concentration is significant. And that in fact, where there used to be multiple PBMs, about two decades ago, functioning in the marketplace, now there’s primarily three PBMs. And the rest of the market is a hodgepodge of smaller PBMs, that are trying to survive. But on the back end, because of this vertical integration, between insurers and PBMs. Now, you’ve seen the health insurance market also consolidate, in these three companies. So, they found that, that by doing such things, as vertical and horizontal integration, PBMs have an over abundance influence on drug pricing, and also affordability, with regards to what they can charge consumers. So, the other thing, Ben, I want to make sure everybody’s clear, is that this is an interim report, that there’s more to come from the FTC. This is the beginning of their investigation into this stuff.

Ben Blanc  04:58

Now, off the cuff: I’m a patient, I should be paying attention to the PBMs I get my drugs from and how do I do that?

Dr. Robert Popovian  05:05

You need to be diligent. And they make it very difficult to be honest with you, it’s much more simpler to find out your provider and the hospital, there’s a medical benefit, then you choose your medical benefit based on whether or not your physician is in network, for example, or the hospital that you want to go is in network. But patients need to do a hell of a lot more work to figure out if their drugs are covered. And they make it extremely difficult for you to figure that out, upfront. They may tell you, for example, this is your out of pocket cost for a generic or brand name drug, but they don’t tell you exactly whether your brand name drug is covered, whether the generic is in a different tier, that your out of pocket will be higher, or even the brand name drug is in a different tier of formulary coverage. So, formulary coverage information is extremely hard to come by. It’s extremely difficult and opaque to figure out. But patients need to do the better due diligence. The reason being is that, Ben, it’s great that you can go to the physician that you want to go to or the hospital; you can be near a hospital that you want to go to in case of emergencies. But as a patient, if you don’t have access to these medicines that are going to help you manage or cure you of the disease, then what’s the point? So, to me, physicians are important, and providers are important, that you need to go to, but if you don’t have the tools and the ability to manage your disease, then everything falls apart. And as a patient, that’s where you need to be concentrating on.

Ben Blanc  06:05

Gotcha. Well, thanks for providing such a clear picture of the overarching influence PBMs have. Now, considering these dynamics, independent pharmacies are crucial to many communities. What does the FTC report reveal about the challenges these pharmacies face due to PBM practices?

Dr. Robert Popovian  06:48

Well, the FTC, sort of like confirms what we’ve all known, which is the PBM business model really undermines the community pharmacies. And it’s unfortunate, because in some cases, FTC also found that the PBMs favored their own pharmacies, because remember, PBMs are not just processing prescriptions and developing formularies. But now they’re in the business of dispensing specialty medicines. But 70% of specialty medicine dispensing today, comes from three specialty pharmacies that aren’t, again, owned by the three largest PBMs. So, because of that reason, is that the FTC found that they are giving better reimbursement, better deals to their own pharmacy, owned pharmacies, than to the independent pharmacies. So, in other words, they’re trying to sort of run them out of business. And this is important then, because last week, there was a hearing in Congress and the three large PBMs were in the hot seat and trying to talk to them. And in one of the sort of retorts between the congressional member and the PBM, the PBM mentioned that no, in fact, they have a great relationship with the independent pharmacies and privately owned pharmacies, and I believe one of the congressional member had to remind the PBM executive that they’re on the road, they can’t lie about the stuff. So, that’s one of the things that, one of the big things, that came out of the FTC, is that they’re undermining the business model of these independent pharmacies and the way they are doing it this through reimbursement differential, that they’re giving to better reimbursement to their pharmacies, with regards to the drug pricing versus the independents. In other words, they’re trying to drive them out of business, so they can capture 100% of the market.

Ben Blanc  08:23

Well, actually, let’s double down on this. You’ve just mentioned it. The FTC report also covers extensively the issue of PBMs owning their own pharmacies. So, what does that tell us about the competitive landscape there? What does it mean for consumer choice and drug pricing?

Dr. Robert Popovian  08:39

Bad! Anytime you have a monopoly or oligopoly, in this case, market competition is set by individual companies. And whenever they have market power, they’re going to increase prices overall. So, it’s bad news for the consumers, but the other thing that we have to talk about, Ben, is that not only they’re setting out prices, and what the consumer ends up paying for, but they’re also developing these formularies. Because remember, PBMs are not just processing prescriptions, they’re developing formulary. So, they’re developing the access that you have to these medicines, and then they determine how much you have to pay for it. In addition, they’re now dispensing these drugs. And we talked about it, how their pharmacies are favored over independent pharmacies. So, overall, what PBMs have become is the judge, the jury, and the prosecutor. They’re basically covered the entire market, through an oligopoly. And that’s what the FTC has confirmed, something that many of us have been talking about over the last several years, if not over a decade, that we need to sort of like parse out and break up these monopolies or oligopolies. What the FTC has confirmed to the report is everything that we’ve been saying has been true. And now we have a government document that we can refer to.

Ben Blanc  09:48

Well now, let’s dive deeper into the specifics of PBM operations and the role of formulary design, so formularies determine which drugs are covered by health plans. How do PBMs use formulary design, to influence which drugs patients can access and at what cost?

Dr. Robert Popovian  10:06

Well, the intent of formularies, initially, was to cover or favor the most cost beneficial intervention in the marketplace. Right. So, formulators with designed to promote generics, for example. What the FTC report found, and actually, this is not nothing new, again, we’ve been talking about this for a long time, including on this podcast, is that formularies have turned into a profit maximizing endeavors. The whole intent of the formulary, through a PBM lens, is to cover the drugs that will bring the best profit to the PBM, the highest margin for the PBM. Therefore, there are cases and FTC has documented that, we’ve documented at GHLF, through our research, where the PBMs favor more expensive medicines, in comparison to a less expensive generic, for example, they favor a brand name drug versus a generic. And the reason being is that the margins are better for them. So, all you hear from the PBM is when you bring this up to them, and you challenge them on this endeavor, and we’ve done it at GHLF, through our research and also through our communications, is their responses, well, the net price is favorable. But you have to always ask as a patient, as a consumer, “net price to whom?” I’m 100% certain that the net price for the premium is better, because they’re making better margins off of it. But that’s not necessarily the case for the consumer and by manipulating formularies. And that’s another thing FTC found, that they favored these more expensive medicines in view of less expensive generics. By favoring these more expensive medicines, the patient ends up paying more out of pocket. Now, the PBM is saving money for themselves, but they’re not passing any of those savings on to the patient. So, therefore, it’s a profit maximizing machine. And the whole premise of formularies has been turned upside down, where instead of favoring the most cost beneficial intervention, what they’re favoring is the one that brings them the best profit.

Ben Blanc  11:55

Well, let’s keep talking about this. Now, rebate negotiations. They’re a key aspect of how PBMs operate. So, what are some concerns raised in the FTC report, regarding PBMs rebate practices? Especially, in relation to generic and biosimilar drugs.

Dr. Robert Popovian  12:12

So, rebate contracting, is the premise that creates all of the misaligned incentives. Because what rebate contracting does is to say, look, I will cover this drug by the pharma company, if you give me 50% rebate back to the PBM. So, let’s say you have two drugs, right? Identical and they can be interchanged. Patients can take one or the other; one drug is priced at $100, but the pharma company agrees to give a kickback or rebate of 50%, back to the PBM. That reduces the price, net price, to $50. For the PBM, the other drug price at $50, grayed out, so there is no rebate, it’s just $50. PBM will always, always, prefer the $100 drug and the 50% rebate, because there’s two reasons why: number one, they never pass 100% of the rebates back to the plan sponsor or the patient, they never do. It’s maybe in the 90 percentile, maybe it’s in the 95/80 percentile. So, they keep a percentage of that. The second reason is that as soon as you get into rebate contracting, there are other things that come up, which is fees, and fees are the ones that have been growing faster. And their profit margins are better, because they never have to share any of the fees with the plan sponsor or the patient. So, in other words, rebate contracting creates misaligned incentives by promoting higher price medicines. In addition, it triggers other type of fees and concessions that pharma companies have to give, that are never ever shared with the plan sponsor or the patient by the PBM. So, rebate contracting, it’s, like, the starting point of all the problems that occur, in the marketplace. Now, there are insurers and companies that don’t use rebate contracting, and they get very favorable pricing and that price is passed directly to the patient, one of them being Kaiser, Kaiser does not use a PBM to negotiate drug prices, does not use rebate contracting to negotiate prices; what they negotiate is a net price and that net price is reflective of what the patient ends up paying.

Ben Blanc  14:10

Yeah, very clear! Now, with rebate practices influencing market dynamics so strongly, what potential reforms or regulatory measures could address these issues to improve drug affordability and pharmacy variability?

Dr. Robert Popovian  14:25

So, first of all, remember when we started, we said this is an interim report. So, there’s more to come. In fact, the FTC mentioned that at the end, that we need to talk about influence on drug prices, higher drug prices, sad things like that, specifically diving more details into that. So, more to come from the FTC. There has also been reports in the media that FTC is preparing to litigate to sue these PBMs, part of this lawsuit will be to break them up or perhaps to create an environment that they cannot do some of the practices that they currently engage in. There’s also ability for congressional activity and there’s been an active discussion, legislatively on the federal level, definitely on the state level, they’ve passed some legislation to regulate it. But we need federal legislation to be able to do three things: number one, to create transparency. That’s the starting point, you know, we need to figure out where every dollar amount that as a concession is given by the pharma company goes to, does it stay as a profit margin for the PBM? Does it go back to the consumer or to the plan sponsor. So, the number one thing is transparency; number two thing, is to really hone in and define: does rebate contracting really influence the marketplace on the formulary design? And number three, is really to be able to say that there needs to be a separation between fees and the price of the medicine. This is the linking thing that everybody talks about. And that’s gotten the most opposition from the PBMs, because they know they make a lot of money. But there’s other things that legislation needs to do, for example, there’s patients theory, should we forbid the PBM, from steering the patient to their PBM own pharmacy? And instead the patient can go to any farms. So, that’s another part of the legislation that needs to be addressed. So, there’s multiple areas that legislatively, we need to address, it’s very detail, we don’t have time to go over every piece. But there’s definitely activity from an FTC standpoint, from a litigation perhaps, and also congressional activity, which legislatively, to sort of curtail, some of the market dominance that has created all this problems in the marketplace.

Ben Blanc  16:26

Well, so my take on this is that there is a need for greater transparency and potential regulatory reforms to ensure that drug prices are fair, and that pharmacies can operate on a level playing field. But Robert, you’re the expert. So, you have the last word.

Dr. Robert Popovian  16:44

The last word is that: this is just the starting point, the transparency is the starting point, but we need to do more. And FTC’s report has shined light to a lot of bad practices that PBMs engage in, not only undermining the marketplace, from regards to patient access and affordability, but how they’re trying to drive out competition from the market and make it more of a monopolistic marketplace, than it is right now. So, the last word is that as consumers, as patient advocates, as employers, we need to advocate for both the FTC to move forward with litigation, but also for active legislation, federally, to curtail these practices. Ben, one of the things that came out at this hearing is that the three largest PBMs have these companies that have put all offshore, they have companies ex U.S., that are called, group purchasing organizations. The question from the Congressional members was, why are these companies in Ireland and Switzerland and not in the United States, and the PBMs didn’t have a good answer. And the reason being they’ve set up these companies offshore is because they anticipate some type of legislative activity or legal activity coming up, and they wanted to protect themselves by setting up these companies offshore.

Ben Blanc  17:57

Well, thanks for breaking that down for us, Robert. To our listeners, don’t forget to subscribe to our podcast on Apple podcasts, Spotify, or wherever you might be listening, so you never miss an episode. And if you have a second, helps spread the word by rating our podcast writing a positive review and sharing with your family and friends. It’ll help more people like you find us.

Dr. Robert Popovian  18:18

And Ben, we’re gonna put the FTC report in the show notes. I assume that everybody can take a look at it. And as always, for our audience. If you have any questions, please send it to us. And even if it’s some suggestion for us to delve into further, with regards to the discussion on PBMs, drug pricing, drug affordability, or any of the other issues that we cover in our podcast, please email us at [email protected]. Please engage with us. We’re always looking for feedback.

Ben Blanc  18:45

And before you go, make sure you take a listen to some of our other great podcasts on the GHLF Podcast Network. You can find all of GHLF’s podcasts at ghlf.org/listen. He’s Dr. Robert Popovian.

Dr. Robert Popovian  18:58

And he’s Ben Blanc. And we’ll see you all next time.

Narrator  19:03

Be inspired, supported, and empowered. This is the Global Healthy Living Foundation Podcast Network.

Narrator  00:00

Be inspired, supported and empowered. This is the Global Healthy Living Foundation Podcast Network.

Ben Blanc  00:10

You’re listening to Healthcare Matters, the podcast that pulls back the curtain to help you make sense of complex healthcare economics and policy issues. With us is Dr. Robert Popovian in Washington DC. He’s a pharmacist, an economist and the Chief Science Policy Officer at the Global Healthy Living Foundation.

Dr. Robert Popovian  00:28

And as always, joining me is my good friend Ben blanc dialing in from heartland of United States, Indianapolis, Indiana, and our associate director of digital production and engagement. So Ben, how was the Indy 500 this last weekend?

Ben Blanc  00:43

Well, this year, the race got a little delayed for a few hours because of the rain. But you know what, it was well worth it. More time to do what French people do best, that is, eat and drink. And you know, just a great day overall. And 33 drivers zoomed by the green flag at the tracks. And we had a repeat winner this year, Joseph Newgarden. he won two years in a row.

Dr. Robert Popovian  01:07

Yeah, I saw that. In fact, something that hasn’t happened in over 20 years. That’s unbelievable. So moving forward, the high speeds of Indianapolis, Indiana and Indy 500. Let’s switch gears and race to the worlds of gene therapy, where precision and advanced technology are also driving major breakthroughs in medicines every day.

Ben Blanc  01:29

Wow, smooth transition there, Robert. And today with us to talk about gene therapy, we have a special guest, Dr. Anne Sydor, who’s one of our colleagues, and is the Director of Research Development and communications at GHLF. So let’s dive in. Thanks for joining us, Anne.

Dr. Anne Sydor  01:49

It’s my pleasure to be here.

Ben Blanc  01:50

So, Anne, you’re no stranger to our listeners. You’ve been on the show before. Could you introduce yourself briefly to those joining us for the first time.

Dr. Anne Sydor  01:58

My name is Anne Sydor, and I am the Director of Research Development at the Global Healthy Living Foundation, which means I help design and find funding for all of our research work. I am also the founder and principal of VT4, which is a consulting agency that helps people with research design and development and also with writing papers on all kinds of scientific topics.

Ben Blanc  02:24

So we always start our episode with a key number that relates to the episodes topic. And today, Robert, that number is 5000. Can you tell us what this numbers means?

Dr. Robert Popovian  02:36

So 5000 is the number of gene therapy trials that are listed in the National Institutes of Health’s database, including an increase of as many new trials incorporating Chimeric Antigen Receptor, CAR T, otherwise known as CAR T cell therapies and human genomic editing studies, that are ongoing. And later on in the episode Anne will talk about where are we with regards to specifically gene therapies and how many and what type of therapies are in the marketplace right now for helping patients get better?

Ben Blanc  03:07

Very clear. Well, actually, let’s start with you, Robert. Could you share what the reasoning was behind your collaborative paper that you wrote with Anne titled, “Value and Pricing Models for Gene Therapy Replacements: The Current State of Affairs.”

Dr. Robert Popovian  03:21

That’s a great question. So first of all, the report was published through the Pioneer Institute where Anna and I collaborated with each other in that level as well in that Institute as well. I’m a visiting Health Policy Fellow there and Anne is a guest expert that we brought on to help us draft the paper and also write and provide her opinion on the topic. So what was the impetus? Frankly, the impetus started for me about a decade ago, when I first got involved in the policy space regarding gene therapies, and a lot of the hyperbole at that time was the price tags of these products that were coming into the market. There was a lot of discussion concerns about the dollar amounts that these products were being introduced at. And frankly, what we decided to do myself, and as well as Dr. Bill Smith, who is our other co author, is to write a paper to sort of level set of how pricing is done, why it’s done this way, the hurdles that gene therapies go through, and specifically also for the audience, that is mostly policy folks, and also individuals who are interested in politics, what is gene therapy, and how does that help patients? And that’s why Anne was so invaluable to the work because she brought on to scientific background of helping us understand better what is gene therapy and how patients are going to benefit from it and some of the hurdles with regards to the research and development.

Ben Blanc  04:44

So many questions. Well, thanks for the insightful background, Robert. Now, Anne, for our listeners who might be new to this field, and also because this topic is a lot to digest, at least for me, could you give us a brief overview of why gene therapy entails and how it works. So what is it exactly?

Dr. Anne Sydor  05:03

Happy to share this a little bit. And this is really where I specialize, is taking very complex scientific topics and communicating them in simple ways. So to be as simple as possible gene therapy is broadly defined as the use or modification of any genetic material to treat disease. Genetic material might be DNA, which is what codes our genes or RNA, which is produced by our genes and translated into proteins. Now, within that broad definition of gene therapy, there are three key types. One introduces or increases the production of a protein with a therapeutic function. And that might be a cancer killing gene or something that activates the immune system. Second is by replacing a dysfunctional gene with a functional copy. And third is by silencing a dysfunctional gene or a gene mutation. So those are the three ways that genetic material can treat disease. The effects can be achieved in multiple ways, we can take cells from a patient, change the DNA within those cells, and then re transplant them back into the patient. That’s the CAR T therapy that Robert just spoke about. We can also introduce gene therapies with a viral vector, which is given as an infusion into the blood or spinal fluid or as an intramuscular injection. And then with RNA therapies, those can be delivered in multiple ways as well, usually through infusion or injection. Our paper focused on gene therapies that replaced dysfunctional genes with viral vectors that are injected, infused, or put into a muscle. We can talk about more than that during this conversation, of course.

Ben Blanc  06:54

Well that’s a great introduction to gene therapy, Anne. Gene therapy 101. So can you expand on that a little bit? And, actually, you’ve just mentioned it briefly. You’ve touched on treatments. So what are some of the gene therapy treatments that are available today? And how are they transforming patient care?

Dr. Anne Sydor  07:10

So there are about 25 gene therapies that have been approved by the Food and Drug Administration. Most of those are cell replacement therapies where a person’s own cells are modified and then reintroduced to that person. About a half dozen are gene replacement therapies where new DNA is being introduced into a person’s cells. And another half dozen, are RNA therapies, where RNA that changes the way DNA is expressed is introduced into a person’s cells.

Ben Blanc  07:47

Yeah, thank you. However, these innovations come at a cost, right? So, Robert, could you explain why gene therapies tend to be so expensive? What are the main factors that contribute to high costs associated with gene therapies?

Dr. Robert Popovian  08:01

Well, that’s a great question. As we started with the discussion, about why we wrote the paper, right? It was the hand wringing about the price of these medicines when they are introduced in the market. So when you start peeling the onion, you realize that the actually most of these gene therapies are a great value, because a lot of these patients are gonna require treatments for life. And a lot of the gene therapies are a cure, not all of them, most of them are cures. And that type of treatment for life costs a lot of money. So when you look at a price of a gene therapy, you have to compare it to what it would cost the patient to be managed throughout their lifetime. But there’s other issues with regards to how the price is set. Number one, most of these gene therapies, if not all of them, are for rare or ultra rare diseases, very few patients are going to benefit from it. But the cost of research and development is significant, and it’s not coming down. And in fact, it’s increasing. And therefore for a company to be able to recoup some of the costs, they have to be able to price a certain level. And remember, when you don’t have enough patients to pass that cost on to, the price per person will be significantly higher, although the overall cost to the system or health system or the government is not significant because there aren’t that many patients. So the second reason why the prices are set. But the third reason and something that Anne always reminds me, is the value that these drugs bring to society. First of all, a lot of them are cures like we talked about. So there’s the value of a cure versus management of the disease long term. Number two, some of these gene therapies are life extending therapies, that means they extend life expectancy for a lot of these patients. So when you look at a patient who without gene therapy may live for example, two years versus now with a gene therapy may live 25, 30 years, there’s a value that that life brings to society that is almost incalculable at times, but we have tried to do that in our paper and talk about that to a certain extent. And also the productivity that that individual brings, you know, it’s not just the value of having that individual live longer, but also, there’s some productivity involved. So because of those reasons, you can’t just look at the price tag of a medicine. What you have to look at is the price of the medicine comparatively to what it would cost to keep the patient alive or even live long enough with other types of treatments, you have to compare it to the cost of recouping of investment that needs to be done by a pharmaceutical company. But most importantly, the value that these individuals now bring if they’re healthy and productive, and as I said, that’s a really big number that is sometimes incalculable. But it’s something that we need to keep an eye on, because if a patient lives longer, and they’re more productive to society, that means that the return on investment is much better. So in other words, policymakers, decision makers, when they just look at the price, they can’t just look at the price. They have to look at what the alternative would be without this type of treatment.

Dr. Robert Popovian  08:34

Yeah, very interesting. And you also mentioned briefly accessibility. And I feel like that’s also another very interesting point. So understanding the cost structures definitely gives us a clearer picture on this, but there is something else, and maybe we should talk about the regulatory hurdles and challenges. Anne, could you tell us what challenges are currently impacting the accessibility of gene therapies, and how might these be addressed?

Dr. Anne Sydor  11:33

Absolutely. And, you know, Robert spoke very coherently about the fact that, you know, when we talk about a human life and the value of human life, that’s really priceless. None of us can put a price tag on that some agencies try to put value on human life with value adjusted years lived or disability adjusted life years, things like that. But that really starts comparing the value of one life to another. And we think that’s really not something that any of us are able to do. We do see that these are Life Extending therapies that are revolutionary. And it’s still new science. And the fact that is new science is really what also adds to the costs. So these are diseases that treat very small numbers of people. Because gene therapy is directed at a mutation in a known gene that causes a disease, it’s only the people with a problem in that specific gene who will benefit from a treatment. So the number of people who would receive a treatment is small. However, the cost of development not only remains high as it does for any drug, the cost of developing gene therapy is much, much higher than the cost of developing or producing a small molecule, for example. So you have to go through clinical trials. And with a rare disease, clinical trials are more expensive, because it’s more difficult to find the people with the disease to enroll in the trial, then you also have to do genetic testing to make sure that they really do have the gene difference that has been targeted. Next, you not only have to develop the gene therapy, you have to develop the delivery mechanism, the viral vector, that is going to be delivered to the patient on. Both the gene therapy, the viral vector, and the two in combination have to be tested for safety and efficacy in current FDA regulations. So that basically triples the complexity of these clinical trials. On top of that we’re producing biological molecules. It’s not like a chemical reaction, where we put a lot of chemicals into a vat, throw them together, dehydrate them and compress that into pills. This gene therapy requires having biological cells, bacteria or other cells, produce genetic material, those cells have to be grown in dishes. And those dishes then have to be harvested. It’s a much more complex manufacturing process that takes a much more highly trained workforce. And on top of that, the FDA requires that all of those processes be finalized before clinical trials even begin. That takes an enormous investment of upfront capital that is impossible to recoup if a particular experimental therapy turns out not to be beneficial. So we have all of these elements that make the research and development of gene therapy significantly more expensive than other treatments. Yet, the regulations for those clinical trials are the same as if we were testing any other biologic or small molecule therapy. So we think that there are ways that the FDA could ease the burden on gene therapy development. For example, by using manufacturing standards rather than having to approve each and every manufacturing process prior to beginning clinical trials. There are several bodies that do best practice manufacturing processes to maintain quality. Those could be adapted. The FDA could also, and has started to, consider platform trials where multiple drugs are being tested, or multiple medications are being tested against one placebo group. Additionally, looking at natural history studies as a control, verses a placebo controlled group. So there are a few things with regulations that could really ease the burden of clinical trials for developing these medications. And finally, again, changing the regulatory model for manufacturing processes would also bring down the price, because that upfront capital investment would become a much lower burden.

Dr. Anne Sydor  12:14

Thank you, Anne, for also placing the spotlight back on the patient here. I think it’s very important. So with these regulatory insights, it seems like there is a need for broader systemic changes. Robert, do you think a new payment model is required in the United States to manage the costs of gene therapies?

Dr. Robert Popovian  16:24

So that’s a great question. So initially, I would say my thinking was always the same as others that, yeah, we do need a new payment model in the United States. But the more I’ve thought about it, and look, there’s been a lot of academic work done on this topic. To MIT, specifically Mark Trusheim, has done a ton of work, great work has been published. But it’s all theoretical. There’s no model that has been developed in the US to pay for these therapies differently than what we have currently going on. So my initial thinking was that, yes, we do need a new payment model in the United States, perhaps with some of these drugs for two reasons. Number one, the costs involved, the person who pays for it, the insurer or to government agency, is not necessarily the one that’s going to benefit long term from it. Because as we know, we have a bifurcated insurance model in United States where everybody under 65 is on some type of commercial insurance versus 65 and older is on Medicare. And plus, on the commercial side, we don’t have consistency that the patient stays with the same insurer throughout their life. They may change around. So the whole thinking was, well, is it fair, for example, for United Health to pay for a gene therapy of a 20 year old, let’s say, and that that will extend the life of that 20 year old well above 65? And then let’s assume that that 20 year old leaves after a year and goes and enrolls with Cigna, for example. And Cigna is now benefiting from this healthy individual coming to them, while United have incurred all the costs. Is it fair? So that’s the number one reason why people are thinking we need a new payment model is that, “how do we have that individual that invest in that gene therapy, also benefit from it long term as the one that is paying for this care?” So that’s the number one reason. The number two reason is that there’s some risk involved, right, with this therapies. As I said, yes, some of them are cures, but some are not necessarily cures, they reduce the burden of the disease. And remember, a lot of these therapies are also relatively new. We don’t know what happens years and years down the line. So should there be some risk associated with these therapies for the biopharmaceutical industry? Who’s developing these things? Should they take on some of the risk? Because at the end of the day, it is an unknown that we’re getting into. My thinking was always that, yes, because of those two reasons, we need a new payment model, and we need to develop one as soon as possible for them to flourish, gene therapies to flourish. Over the years, though, I’ve done a lot of research and thinking about this. And frankly, we already do similar interventions, and we pay for similar interventions to the current model that we have that are high costs, with long term effects, with limited knowledge of what the long term impact is, and they’re high risk, and it’s for small patient populations. I brought this up in the past and I compare gene therapy to something like transplants in the United States. And we had 46,000 transplants done in 2023. In the United States. It was about a 9% increase compared to the previous year. And the argument against that always has been from individuals, “Well, the transplant market is limited, right, it’s limited by the number of organ donations and everything else.” Well, yes and no. It is limited to that effect, but we see that there’s a year over year increase of transplants done in the US and now we’re getting into more non-human organ donation transplants that can expand that market significantly. And if you think about it, it’s a high cost intervention that is born by the individual that the initial payer that may not get the benefit long term, it is an unknown outcome long term about this. And it’s a risky intervention. A lot of transplants fail. In fact, I just had a family member who passed away who had a bone marrow transplant, and he passed away within like three months of that happening. So do we really need a new payment model? Or can we manage this to the current payment model that we have in the US? And my answer is, I don’t know. I was much more confident before looking at the transplant numbers and the way that the transplant market is moving to say, “yes, we do need one.” But now that I’m looking at that market, maybe other things that we do, for example, a hip replacement or a knee replacement that again, somebody bears the cost initially, and then somebody else benefits from it long term as an insurer, has convinced me that perhaps we need to do more thinking about this. That maybe the current payment model is good enough, as Anne said, we modify the R&D development process, we have competition in the market, where it drives down these prices, and then we’ll see if we really do need to change the payment model. But at this point, in my thinking is that it’s an unknown because of other innovations that I’ve mentioned.

Dr. Anne Sydor  21:08

Robert, I think that’s a really great point. And it’s an important and somewhat different way of looking at gene therapy than what I commonly see or hear from people. So when we think about medications, and when we think about gene therapy as medications, we run into problems comparing the pricing models and the payment models, because we’re looking at a one time treatment for a small group of people versus medications for chronic diseases, which get taken day after day, week after week, month after month, and paid for on that basis as well. So the lifetime cost of a treatment taken for years and years and years is not that different from the lifetime cost of the gene therapy. What is different is that it’s the treatment happens once. So when you just compared those one time treatments, not to other medications, but to procedures that are also one time treatments, thinking about gene therapy as akin to a knee replacement or an organ transplant, and comparing how we pay for gene therapy in the same way that we pay for those kinds of one time procedural treatments may really be a way to revolutionize thinking around gene therapy payment. And I’d love to hear what other people have to say about that in the future.

Ben Blanc  22:29

I love how you just opened the floor to finish this episode, Anne. I think it’s actually a really great way to conclude. So thank you, Anne. Thank you, Robert. And sounds like the future of gene therapy is shaped by the pivotal role of innovation and regulation and addressing high costs and regulatory challenges will be crucial. But I’m not the expert, so Robert, you have the last word.

Dr. Robert Popovian  22:52

I want to thank Anne, first of all, for joining us. And last word is that Anne and I would like to bring on somebody in a future podcast to debate us about this new payment model, because I thought her point was brilliant. I think we need to look at this gene therapy as more of a procedure, rather than a therapy, or a treatment, that it’s been coined. And I think this group think about, that we need a completely new payment model to be able to get these type of treatments or procedures to patients is a fallacy. And there’s enough evidence that we do other type of interventions, which are far more risky and unknown outcomes, and we are able to pay for them appropriately and have patients have access to them. So my thinking is, we want to have a debate. Let’s bring those people on on a future podcast, and let’s have a discussion about this. But overall, I have to say that again, going back to my original comment about why this paper was so important for us to write and why Pioneer Institute was interested in that and why Bill, Anne, and I co authored the paper is this whole notion that policymakers just get spooked by the dollar amount that they see. And they need to just step back and compare that dollar amount to the value that these products bring in, the cost savings that they will incur over a lifetime of treatment, and also that, look, at the end of the day, we’re talking about very few people. So the overall cost into the system is miniscule. Yes, the individual incremental costs may be high, but overall cost is going to be significantly lower than a traditional biopharmaceutical.

Ben Blanc  24:27

Well, thanks for breaking that down for us, Robert. And we’ll absolutely keep our listeners updated when we know when part two of this episode will happen. I think that was some very valuable information for our listeners. Anne, thank you so much for joining us and sharing your insight.

Dr. Anne Sydor  24:42

My pleasure.

Ben Blanc  24:44

To our listeners. Don’t forget to subscribe to our podcast on Apple podcasts, Spotify, or wherever you might be listening so you never miss an episode. And if you have a second, help spread the word by rating our podcast, writing a positive review, and sharing with your family and friends. It will help more people like you find us.

Dr. Robert Popovian  25:03

And I want to also mention to our listeners, as always, that if you have any questions, thoughts, suggestions, comments, future topics that you want us to discuss, please send us an email on [email protected]. And you know, as always, we will do our best to address those. And if we see something that is compelling enough, we may even ask you to come and join us on one of our podcasts.

Ben Blanc  25:25

We certainly willA And before you go, make sure you take a listen to some of our other great podcasts on the GHLF Podcast Network. You can find all of GHLF podcasts at ghlf.org/listen. He’s Dr. Robert Popovian.

Dr. Robert Popovian  25:40

And he’s Ben Blanc, and we’ll see you all next time.

Narrator  25:45

Be inspired, supported and empowered. This is the Global Healthy Living Foundation Podcast Network.

Narrator  00:00

Be inspired, supported and empowered. This is the Global Healthy Living Foundation Podcast Network.

Ben Blanc  00:10

You’re listening to Healthcare Matters, the podcast that pulls back the curtain to help you make sense of complex healthcare economics and policy issues. With us is Dr. Robert Popovian in Washington, DC. He’s a pharmacist, an economist, and the Chief Science Policy Officer at the Global Healthy Living Foundation.

Dr. Robert Popovian  00:27

And joining me is my very good friend Ben Blanc from the heartland of America, Indianapolis, Indiana, and our Associate Director of Digital Production and Engagement. Ben, we’re on May 10. This is a special time in Indianapolis, isn’t it?

Ben Blanc  00:42

That’s right, Robert. And actually, I want to remind our listeners that Indianapolis or Indy as we call it is a four season city and something’s always happening. But that’s right. May is a special time of the year here as we’re getting ready for the Indy 500, the largest single day sporting event in the world. And I grew up watching Formula One on the weekends. So to me, this is gold.

Dr. Robert Popovian  01:06

Yeah, I’m more of a football guy, you know, Ben, from our previous episodes, and also a soccer guy, but I’m definitely major events, kind of a person. And today we’re talking about another major event that you and I attended last month, the World Vaccine Congress.

Ben Blanc  01:20

You were a presenter there, and you also moderated a few panels, so lots of learnings to share. Let’s get to it. And as usual, I want to start this episode with a number. And I think a good number is 5000. Can you tell us what this number means, Robert?

Dr. Robert Popovian  01:38

Well, Ben, you and I were there. And we were one of the 5000 people who attended this the number of attendees that were attended the world vaccine Congress. That tells you how important this Congress is to the world of vaccines, over 450 speakers, 300 exhibitors, and all of these people meet over a period of four days to cover everything vaccines from research, immune profiling, clinical trials, manufacturing, access, everything under the moon that you can think of.

Ben Blanc  02:06

That’s right. And it’s also worth mentioning, we’re talking about a crowd made up of professionals from the industry, academia, other nonprofit organizations, and even government.

Dr. Robert Popovian  02:17

That’s right. In fact, we had some representatives and a panel I was on from the government. So yes, they’re definitely represented that’s what makes this an important program and it takes to make the progress go forward on the vaccine space.

Ben Blanc  02:31

Well, let’s dive right into it. So while we were at the World vaccine Congress, we interviewed and by we, I really mean you interviewed a few folks that we work with in the vaccine space.

Dr. Robert Popovian  02:43

That’s right, Ben. And the first person we chatted with was Abby Bownas. So let’s listen to the interview. So, Abby, we’re doing a special podcast for our listeners on Healthcare Matters. And we’re very glad to have you on this podcast. Why are you here? Why are you at the World Vaccine Congress? What are you going to be doing here?

Abby Bownas  03:01

I’m so excited to be here at the World Vaccine Congress, Robert, and today, we’re going to be talking on behalf of the Adult Vaccine Access Coalition, which works to improve access and utilization to adult vaccines, which, unfortunately, are and as your listeners probably know, are far below where they could and should be. And so we’re really trying to think about how we can improve those vaccination rates, and what are the federal and policy opportunities to do so. So I have a panel later today with a number of experts, and we’re gonna be talking about what immunization infrastructure is. That idea of core programming and what all the different components are that really make up that one word that we like to use is infrastructure. Whether that’s the data, and the safety, the actual vaccines, the education, the outreach, all those pieces that fit into infrastructure, and what it takes to maintain that, especially in a post COVID environment, where some of those funds that have been around for the last few years are not going to be as free flowing as they were over the last few years. So that’s our topic of discussion today.

Dr. Robert Popovian  03:58

That is fantastic. Because you know, as our audience knows, adult vaccination all vaccination for all people is a very important issue for us. But we’re definitely not where we need to be as a society. And we’re very happy to have you here at the World Vaccine Congress.

Ben Blanc  04:13

Yeah and talking about not being where we need to be as a society with vaccination. That’s a topic that we’ll hear more about later in the episode. Robert, you also asked Abby, who you’ve known for a long time, to talk about her coalition, ADPC. So let’s hear from Abby about what ADPC stands for. And what she does at the coalition.

Abby Bownas  04:31

So the American Disease Prevention Coalition, or ADPC, has been around for the last few years trying to work to support the role of pharmacists as vaccinators. And what we see is that in different states across the country, while all pharmacists can vaccinate, the rules on how they can do it, and which vaccines, and their authority levels really differs in a major way depending on state by state. So we have a great group of advocates that are working together to really try to support pharmacy vaccination because we believe that when the immunization neighborhood is strong and has all those partners working together, that we’ll be able to boost immunization rates. And so that’s the goal.

Dr. Robert Popovian  05:06

So the question I have for you is twofold, actually. Who are these partners? Because I believe it’s a very broad coalition unlike most coalition’s that you see, it’s a very broad coalition. But secondly is what is the main aspects of the coalition? What is it trying to accomplish? The state federal, what are you engaging in?

Abby Bownas  05:23

Right, so it’s a state based coalition. The pharmacy, when it comes to kind of those authorities on how pharmacists vaccinate, the rules are actually made state by state. Interestingly, over the last couple of years when the pandemic was happening, HHS and the federal government actually created a broad acknowledgement of the need for pharmacists to vaccinate, and so there were temporary provisions put in place, and they’re actually still happening until the end of this year. That really allowed pharmacists across the whole country to operate and vaccinate. And so in this time, before that happens, we are trying to make sure that all states get their laws basically up to date now, so that that can continue once those prep act provisions expire at the end of this year. You had also asked about coalition partners, and we are lucky enough to have representatives from pharmacists and pharmacies across the country at the table. We have some of the vaccine makers and innovators that work on vaccines. We also have some additional patient groups, Global Healthy Living Foundation being one of them. And so we’re really lucky to have a broad group of I think organizations that really just represent the value of pharmacists, but also just the value of having all partners that can vaccinate out there helping to improve access.

Dr. Robert Popovian  06:36

And you know, at Global Healthy Living Foundation, we’re agnostic. We want our patients to be immunized as any way they can, but if they prefer going to a pharmacy by a pharmacist or pharmacy technician to be immunized, or go to a physician’s office, that’s a great thing. But the reality is that we need to make access broad.

Abby Bownas  06:53

And I think that’s a core component of this, right. And the idea is, wherever you are that it becomes the easy choice for that person to make a decision. A lot of doctors offices don’t stock or carry the vaccines, we want to make that easier for them to do so. But at the same time, if that physician’s office is making a strong recommendation to get vaccinated, the person can then go to the pharmacy and access that vaccine. So it’s a really nice, I think, collaboration between all the providers to make sure that we are vaccinating.

Dr. Robert Popovian  07:21

That’s right. Abby, thank you so much for joining us.

Abby Bownas  07:24

Thank you.

Ben Blanc  07:24

It’s so interesting what Abby is sharing here. And access was actually a topic on everyone’s mind at the Congress this year, right? It’s a broad subject, but that’s definitely something that all the different actors who are part of the World Vaccine Congress debated, discussed and formulated suggestions about. So now the topic of policy barriers reminds me of an interview that you had with Dr. Thomas Acciani.

Dr. Robert Popovian  07:48

So yes, we spoke with Tommy who was on one of the panels that I was participating in. And the topic was, “How do we tackle the first combined flu, COVID, and RSV season?” Alongside Tommy, there was a CDC colleague that was there, and the National Foundation of Infectious Diseases. Obviously, Tommy works for GSK. He’s the director of U.S. vaccine policy. So let’s listen to his interview. So we are here at the World vaccine Congress. And we’re here with Dr. Thomas Acciani. So Tommy, tell us, what do you do at GSK, and why are you here at the conference?

Dr. Tom Acciani  08:23

So I lead up the US vaccine policy work at GSK. I’ve been at GSK for just a little over a year. Prior to that I worked for HHS and the United States government doing health care policy. And prior to that I was a research scientist for 15 years. But why we’re here at the World Vaccine Congress is kind of just a highlight some of the big policy barriers that exist, that we’re just trying to tear down with our public-private partnerships to basically just increase patient access. So that’s really ultimately what it was.

Dr. Robert Popovian  08:46

What has stood out to you in this Congress since you’ve been here today.

Dr. Tom Acciani  08:50

Yeah it’s, I think, actually your quote that rang true. I think the hardest was this Byzantine like system that we have. And we put up these policy barriers for no reason, and we just need to take them down, and we’re trying to work with that. We’re trying to work with the United States government. We’re trying to work with our advocates to kind of do this to kind of highlight all of that. But ultimately, I think the the thing we need to focus on is that there should be no wrong door to immunizations when it comes to vaccinations in this country. So wherever you have an activated patient that should be able to get administered a vaccine right then and there.

Dr. Robert Popovian  09:17

Terrific. Thank you so much, Tommy, for joining us.

Dr. Tom Acciani  09:19

Thank you very much for having me.

Ben Blanc  09:20

Well, great interview, Robert. So talking about barriers and access to vaccines, vaccine reimbursement plays a role here. Robert, you held a presentation where you presented GHLF ‘s work over the past few years in the vaccine space, which was titled, “Medicaid Reimbursement in the Pharmacy Space.” Do you want to tell us a little bit about that, and then we can listen to some of the excerpts from your presentation?

Dr. Robert Popovian  09:42

Sure. GHLF, we’ve done an array of studies over the years regarding immunization access. We’ve concentrated on immunization access in low income communities, we’ve looked at where patients actually get immunized, which is overwhelmingly in the pharmacies these days by pharmacists being the immunizers. But this latest study what we did and we presented the data at the World Vaccine Congress was looking at whether or not there’s a correlation between reimbursement and vaccine uptake. And we use Medicaid Reimbursement for flu vaccine as the example that we studied. And we looked at both the pharmacy reimbursement as well as physician office reimbursement. We did the analysis, and statistically speaking, there was a positive correlation in reimbursement and vaccine uptake or immunization at pharmacies, not necessarily a statistical correlation on the physician offices, even though there was a higher level uptake as reimbursement went on in that space as well. But the moral of the story is that look, Medicaid especially the reimbursement is woefully low. And if we are serious about helping low income patients, helping diverse communities, because you know, and I’ve spoken about this, majority of Medicaid patients they’re overpopulated by racial and ethnic minorities. If we’re serious about DEI and all these things, then we need to also be able to reimburse pharmacies and physicians at a higher level in that space to equal to what they get reimbursed, for example, on Medicare Part, and that there is definitely going to help with vaccine uptake, which will then help these communities stay healthier.

Ben Blanc  11:14

Well, thanks for that overview, Robert. And now let’s hear in more details what you had to say at the World Vaccine Congress.

Dr. Robert Popovian  11:20

So today I’m going to talk about background findings from the latest research that we’ve done, specifically the one that has to do with Medicaid reimbursement. And it’s not just for pharmacy, we’ve also looked at the same study Medicaid reimbursement for physicians. And then talk about policy research that we’re doing, and then the future research that’s going to come out in 2024, and what we’re planning on doing in 2025. So our work at GHLF really started about three years ago, and one of our first initiatives, my areas of interest after I left Pfizer, I was there for about 20 plus years doing government affairs work and policy work was to look at what is the vaccine access for patients in low income communities. And why low income communities? Because as you all know, low income communities are over represented by minorities, and therefore it’s an equity access for underserved populations. So we took a look at it and this study was published two years ago in the Journal of American Pharmacists Association, looked at access to pharmacy versus physician offices that immunize. We use data from NCPDP, as well as CMS to be able to identify these locations. And what we found out is that in low income communities, there’s better access for pharmacies and physician offices that immunize. But this access gets even more significant when you take into hours of operation, take into consideration hours of operation, and the ability to also administer the vaccine for Medicare patients and has to do with the billing issue that goes on in the Part D space. Why is this important is because low income patients generally don’t have the ability to take off time from work during the middle of the day to go see a physician to get their vaccine administered. Therefore, having access at the pharmacy level is much more prudent and better for them. That was the first study that we did. Then the second study I was interested in doing and we found a partner in IQVIA, the human data sciences to partner with us at Global Healthy Living Foundation, and we decided to look at where are patients, adult patients getting their vaccines, specifically post pandemic? We published this paper in 2023. In, as I said, in a collaborative effort with IQVIA, it was an IQVIA paper with the GHLF being a co-author. And what we found is that overwhelmingly post pandemic almost entirely the adult immunization was taking place in the pharmacy level about 90%. And I know that a lot of the spike happened post COVID because the COVID vaccine was being administered in the pharmacy. And the most recent example is the RSV vaccine, over 80% of the RSV vaccines were administered in a pharmacy this last season and my anticipation that this is going to continue for adults in the foreseeable future unless we do some policy changes that hopefully we will get into in our discussion in the panel. The other thing we looked at was racial differences. What we found out is that minorities are actually more often going to a pharmacy which sort of confirmed for us what we have found out from our previous study that they’re going to a pharmacy much more often to get their immunization than white patients, so Hispanics and Asians by far, but there’s still an uptick of black Americans who would rather go to a pharmacy, and this confirms a lot of the studies that have been in the past. So the next study we decided to do is the most recent one that we published a couple of months ago and had to do with reimbursement for pharmacy and physician offices regarding Medicaid patients. Why do we pick Medicaid? Why do we pick flu? Its because flu, number one, is universally being provided both in physician offices and in pharmacies, right? So that’s the number one thing. Medicaid because it impacts low income communities and we have very good data that we were able to get from the state programs that you know, we found out that what Is the Medicaid reimbursement level and we were able to correlate it with uptake in certain states. So we wanted to look at whether or not reimbursement level impacts uptake. Now, this is nothing new. There’s been data out there for awhile that shows that patients when you provide better reimbursement, vaccination uptake improves. And this happened in the pediatric patients, and you see that the Medicaid patients are lagging behind either commercial or Medicare with regards to flu vaccination. So again, we were trying to look at is that what happens if there’s better reimbursement both and physician offices and for pharmacies regarding immunization going up or down in flu vaccine. Visually, its very obvious there’s an uptick. You see, there’s a trend that goes upwards with regards to reimbursement. So reimbursement increases, uptake increases or immunization increases. But us being economists, the three economists who wrote this paper, we had to do the statistical part of it to see if there’s a statistical correlation to it. And what we found out is that there was a trend for physician offices, but not statistically significant. But there’s definitely a statistical correlation between pharmacy reimbursement and improvement in vaccine uptake in Medicaid populations. The interesting part is that physician offices, there was a trend, it wasn’t statistically significant. But still, there’s a trend that if you improve reimbursement uptake, increases in physician offices as well. And this has significant implications from a policy perspective, because we’re talking about Medicaid patients, who are underserved, who have lower immunization rate than the commercial and Medicare patients that one of the policy solutions that we can provide as a community, as a society is to improve reimbursement in that space. The interesting part that also came up with me with regards to this study was that not all Medicaid programs in the states reimburse pharmacies to administer flu, but four or five of them are out there that don’t allow patients who have Medicaid to go to a pharmacy to receive their flu vaccination, which to me is a bad idea, considering all the other data we’ve looked at with regards to access in low income communities and where adult patients want to go get their vaccines and everything else. So, those were just studies that were interesting to us, because it’s sort of a journey, as I said, and the policy recommendation is that, you know, state should provide pharmacists immunization authority similar to what physicians have. We need to come up with a better scheme than just low balling either physicians or pharmacies about administering a vaccine and, well, our recommendation is, frankly, to go up to the Medicare level and what we anticipate seeing is that there will be an improvement in vaccination level. So to conclude our future research, as I mentioned, we’re doing we just published a paper that you just saw in April 2024. Yesterday, it came out with a press release. We have a podcast that has been done Healthcare Matters is a podcast that I talk about a lot of the policy issues. About 50% of time its vaccine related. The other 50% is PBM related, so if you have an interest in drug pricing and PBMs, listen to the podcast. You’ll learn a lot or hopefully you’ll disagree with some of the stuff I have to say. The other thing that we’re doing is that we’re publishing a paper later this year with regards to immunization challenges uptake challenges patients are facing. So GHLF is primarily made up of adult patients with chronic diseases that are immunocompromised. So we surveyed about 1000 plus of our patients to see what are the challenges that they face regarding vaccine uptake getting the vaccine. So think about it, these are all immunocompromised patients, these are all chronic disease patients, so for them, there should not be any barriers, right? They should walk in, they should be eligible for any of the vaccines that are out there for them, they should not have any out of pocket cost reimbursement. Interestingly, about 20% of the people who we surveyed had significant challenges accessing their vaccine. Part of it has to do because the pharmacist or the physician was confused about age requirements and whether or not immunocompromised patients qualify to getting that vaccine. So this has to go back to we need to do a hell of a lot of education with healthcare professionals to get them around to understanding what are the exemptions that we put with regards to recommendations or stuff like that. The second part had to do with reimbursement, actually. A lot of patients told us that they showed up at the physician or pharmacy and they had to pay up front for the vaccine and then get reimbursed for it even though their net out of pocket costs would have been zero. How many people can imagine showing up at a pharmacy or physician has put up like $120, $150 and then didn’t get reimbursed. A lot of people walked away. About 10% of the total 1000 people that we surveyed, they just walked away. And remember, these are patients who are immunocompromised, adult patients who are pro vaccine, and they’re very motivated to get their vaccine. So having 100 patients just walk away from whatever vaccine they needed, It’s something that we’re going to look into more with the survey and we’re going to publish some of the results.

Ben Blanc  19:56

Well, those were select segments of your presentation that you gave at the World vaccine Congress and you also moderated a few panels with several guests. Lots of learnings, I wonder if you could share with our listeners your main learnings from the World Vaccine Congress.

Dr. Robert Popovian  20:10

So Ben, I mean, it’s always exciting to be at this meeting, and you learn a lot about vaccines. And you hear a lot about vaccines that have been developed or being developed in the infectious diseases. But what stood out to me was all the vaccine research that’s being done in areas other than infectious diseases. For example, there’s a ton of research being done on oncology vaccines or other types of chronic diseases that is super exciting. And that’s, I think, the future of vaccines. It’s not just about respiratory illness or infectious diseases, but all of these other types of ailments that patients suffer from that vaccine development may be a lifesaver or improve the quality of life or extend life. So our audience needs to keep an eye on this, we need to keep an eye on this because that’s the future research that’s coming. It far exceeds just the respiratory space and the infectious disease space.

Ben Blanc  21:00

Well, I liked that word that you use, Robert, lifesaver, I think that sums it all. So thanks so much for breaking that down for us. And I think that was some very valuable information for our listeners. And to our listeners, don’t forget to subscribe to our podcast on Apple podcasts, Spotify, or wherever you might be listening, so you never miss an episode. And if you have a second help spread the word by rating our podcast, writing a positive review and sharing with your friends and family. It’ll help more people like you find us.

Dr. Robert Popovian  21:30

And as always, if you have any questions, comments, thoughts, please send it our way. Our email address is [email protected]. And you know, we’re always looking for good ideas, so Ben and I scour through the emails and usually find one or two things that we want to talk about. And guess what if we can reach out to you and perhaps we can bring you on as a guest on our podcast.

Ben Blanc  21:52

And before you go, make sure to listen to some of the other great podcasts on the GHLF Podcast Network. You can find all of GHLF’s podcasts at ghlf.org/listen. He’s Dr. Robert Popovian.

Dr. Robert Popovian  22:04

And he’s Ben Blanc, and we’ll see you all next time.

Narrator  22:09

Be inspired, supported and empowered. This is the Global Healthy Living Foundation Podcast Network.

Narrator  00:00

Be inspired, supported and empowered. This is the Global Healthy Living Foundation Podcast Network.

Ben Blanc  00:06

You’re listening to Healthcare Matters, the podcast that pulls back the curtain to help you make sense of complex healthcare, economics and policy issues. I’m Ben Blanc, Associate Director of Digital Production and Engagement at the Global Healthy Living Foundation.

Dr. Robert Popovian  00:23

And I’m Dr. Robert Popovian, the Chief Science Policy Officer at GHLF.

Ben Blanc  00:27

And Robert and I are bringing you a special live episode from the World Vaccine Congress here in Washington, DC. Robert, I’ve actually already seen you moderating and presenting a couple of panels today.

Dr. Robert Popovian  00:39

That’s right. And not only the panels were exciting to hear, but it’s mostly the research that we’ve done at GHLF, partnering with organizations like IQVIA that we presented on, so it’s our own data that we were talking about today.

Ben Blanc  00:53

Well, it’s been a packed day. So let’s get to it!

Dr. Robert Popovian  00:59

Ben, you know, you mentioned to me that this is the first time you’ve been at the World Vaccine Congress. So can you explain for our listeners, what is World Vaccine Congress?

Ben Blanc  01:09

Absolutely. And as you can see, around us, the World Vaccine Congress is actually a really big event in Washington, DC. And I think it’s actually the largest and the most established Congress in the US.

Dr. Robert Popovian  01:20

That is absolutely true, Ben.

Ben Blanc  01:22

So it’s a really large gathering that’s dedicated to research and development and strategic partnering for the global vaccine industry. So across four days, the Congress covers everything vaccines from research, immune profiling, and clinical trials to manufacturing and access. And we’re here with professionals from the industry, academia, other non-profit organizations and government to discuss vaccine related challenges and successes. So Robert, let me ask you this: Why are we, the Global Healthy Living Foundation, here at the Global Vaccine Congress?

Dr. Robert Popovian  01:57

So we were invited to speak at this conference, you know, they asked me to come and present our latest data that we’ve published. You know, in fact, yesterday morning we released our latest paper on vaccines. It has to do with estimating the economic and human costs related to a lot of the regulations and barriers that occur in the state level that prohibit the patients to go to their favorite site to get the vaccine, which is their community pharmacy. But besides that, we’ve done multiple other papers and research in the last two – three years that we’re presenting here. And then I’m going to be moderating a panel. And I’m going to be on another panel talking about, again, as I mentioned before, it’s all the research that we’ve done in the last two – three years regarding vaccines and vaccine access and healthcare costs and vaccine availability. So we’re very excited to be here, Ben. And you know, it is a privilege and an honor to be asked as a patient organization to be here and present our data. So Ben, again, I want to go back to my original thoughts that this is the first time you’ve been here. So what is your immediate impression? What is the first thing comes to mind when you talk about World Vaccine Congress?

Ben Blanc  03:01

Well, I’m glad you asked. I think first of all, I’m really impressed by the amount of people that are here. A lot of people that are here either to present their own findings or attending presentations like yours. And it’s just amazing to see so many different stakeholders come together. Also, I feel like the World Vaccine Congress is an excellent platform for organizations like GHLF to share our work. I mean, Robert, you just mentioned it. There was a report that was released last month by IQVIA and GHLF, and you are able to present those findings today. We just released another study, just yesterday; you’re going to be able to talk about those findings. So yeah, for GHLF, I feel like this is a really great opportunity. And actually to talk about this, we have Seth Ginsberg live with us, the President and Founder of GHLF. Hi, Seth! Thanks for joining us today. And we’re seeing a really good mix of stakeholders here at the Global Vaccine Congress. So Seth, my question to you is as the President of GHLF, how do you see the role of organizations like ours playing their part in the vaccine world?

Seth Ginsberg  04:03

Well, first of all, it’s great to be here. And thanks for the opportunity to talk for a few minutes about the importance of vaccine advocacy and the need to have patients involved in the conversations. World Vaccine Congress is super important and a really important gathering of so many different people, and it’s amazing for GHLF to be right in the middle of it all because we’re folks living with chronic diseases and with chronic conditions, many of which are either immune compromising or require medicines that make you immune compromised. Vaccines play an even more important role in ensuring that we stay healthy and protected because we’re more susceptible to things that are out there that are preventable. GHLF sits at a very special place here in this situation and our role is to literally be in the middle of the patient and their families and the health care providers and the policymakers and the regulators and the insurers and the public, as well as our pharmacists and the places that we get our prescriptions as well as our vaccines. And so the importance of improving access to all of these folks, especially the healthcare providers and the pharmacists, is incredibly important so that everybody has a shared understanding and all of us can be on the same page with respect to improving access to vaccines, ensuring we minimize barriers, and we give patients what they deserve: the healthiest life possible, the happiest life possible. And vaccines play an incredibly important role in that, so that, together, we can live our best lives and be our healthiest selves and prevent those headaches and steer clear of those problems from vaccine preventable illness.

Ben Blanc  05:52

Well said. Thanks, Seth. And now to conclude this episode. I’m turning to you, Robert. What is next for GHLF regarding vaccine policy and economic research?

Dr. Robert Popovian  06:02

So great question. So as I mentioned, we’ve presented plenty of data here over the last three years. We’ve done four different studies in vaccines, it has to do with vaccine access, vaccine reimbursement, vaccine availability in low income communities, immunization in low income communities, which you know, Ben, low income communities are over represented by minorities. So it’s more of an equity issue of getting vaccines in the arms of poor patients or underserved populations. But what’s coming for us is a couple of other research that we’re going to be completing in 2024. One has to do with regards to the interaction and access availability of these vaccines, and the meddling that’s being done by the pharmacy benefit management companies. Unfortunately, PBMs are looking at the vaccine marketplace as a profit center now, and they’re trying to meddle in like they have done with other biopharmaceuticals. And it’s going to create some chaos and unintended consequences or intended consequences, based on the PBM schemes. And then the second study that we’re going to complete is a survey of about 1000 patients that we did and looked at what are the barriers that they face as adult immunocompromised patients with chronic diseases in the field. Why aren’t they able to get the vaccines that they need? So we’re going to publish that survey and we have very interesting findings. We’ve done some of the initial analysis and there’s some interesting findings that we’re going to learn from that survey.

Ben Blanc  07:26

Thanks, Robert. That’s amazing. Thank you, Seth. And that’s it for our special episode of Healthcare Matters from the World Vaccine Congress in Washington DC. You already know, but don’t forget to subscribe to our podcast on Apple Podcasts, Spotify, or wherever you might be listening so you never miss an episode. And if you have a second help spread the word by rating our podcast, writing a positive review, and sharing with your family and friends. It will help more people like you find us. He’s Dr. Robert Popovian.

Dr. Robert Popovian  07:54

And his Mr. Ben Blanc. Great to have you been at the World Vaccine Congress!

Ben Blanc  07:59

And great to see you!

Narrator  08:02

Be inspired, supported and empowered. This is the Global Healthy Living Foundation Podcast Network.

Narrator  00:00

Be inspired, supported and empowered. This is the Global Healthy Living Foundation Podcast Network.

Ben Blanc  00:06

You’re listening to Healthcare Matters, the podcast that pulls back the curtain to help you make sense of complex healthcare, economics and policy issues. I’m Ben Blanc, Associate Director of Digital Production and Engagement at the Global Healthy Living Foundation.

Dr. Robert Popovian  00:23

And I’m Dr. Robert Popovian, the Chief Science Policy Officer at GHLF.

Ben Blanc  00:27

And Robert and I are bringing you a special live episode from the World Vaccine Congress here in Washington, DC. Robert, I’ve actually already seen you moderating and presenting a couple of panels today.

Dr. Robert Popovian  00:39

That’s right. And not only the panels were exciting to hear, but it’s mostly the research that we’ve done at GHLF, partnering with organizations like IQVIA that we presented on, so it’s our own data that we were talking about today.

Ben Blanc  00:53

Well, it’s been a packed day. So let’s get to it!

Dr. Robert Popovian  00:59

Ben, you know, you mentioned to me that this is the first time you’ve been at the World Vaccine Congress. So can you explain for our listeners, what is World Vaccine Congress?

Ben Blanc  01:09

Absolutely. And as you can see, around us, the World Vaccine Congress is actually a really big event in Washington, DC. And I think it’s actually the largest and the most established Congress in the US.

Dr. Robert Popovian  01:20

That is absolutely true, Ben.

Ben Blanc  01:22

So it’s a really large gathering that’s dedicated to research and development and strategic partnering for the global vaccine industry. So across four days, the Congress covers everything vaccines from research, immune profiling, and clinical trials to manufacturing and access. And we’re here with professionals from the industry, academia, other non-profit organizations and government to discuss vaccine related challenges and successes. So Robert, let me ask you this: Why are we, the Global Healthy Living Foundation, here at the Global Vaccine Congress?

Dr. Robert Popovian  01:57

So we were invited to speak at this conference, you know, they asked me to come and present our latest data that we’ve published. You know, in fact, yesterday morning we released our latest paper on vaccines. It has to do with estimating the economic and human costs related to a lot of the regulations and barriers that occur in the state level that prohibit the patients to go to their favorite site to get the vaccine, which is their community pharmacy. But besides that, we’ve done multiple other papers and research in the last two – three years that we’re presenting here. And then I’m going to be moderating a panel. And I’m going to be on another panel talking about, again, as I mentioned before, it’s all the research that we’ve done in the last two – three years regarding vaccines and vaccine access and healthcare costs and vaccine availability. So we’re very excited to be here, Ben. And you know, it is a privilege and an honor to be asked as a patient organization to be here and present our data. So Ben, again, I want to go back to my original thoughts that this is the first time you’ve been here. So what is your immediate impression? What is the first thing comes to mind when you talk about World Vaccine Congress?

Ben Blanc  03:01

Well, I’m glad you asked. I think first of all, I’m really impressed by the amount of people that are here. A lot of people that are here either to present their own findings or attending presentations like yours. And it’s just amazing to see so many different stakeholders come together. Also, I feel like the World Vaccine Congress is an excellent platform for organizations like GHLF to share our work. I mean, Robert, you just mentioned it. There was a report that was released last month by IQVIA and GHLF, and you are able to present those findings today. We just released another study, just yesterday; you’re going to be able to talk about those findings. So yeah, for GHLF, I feel like this is a really great opportunity. And actually to talk about this, we have Seth Ginsberg live with us, the President and Founder of GHLF. Hi, Seth! Thanks for joining us today. And we’re seeing a really good mix of stakeholders here at the Global Vaccine Congress. So Seth, my question to you is as the President of GHLF, how do you see the role of organizations like ours playing their part in the vaccine world?

Seth Ginsberg  04:03

Well, first of all, it’s great to be here. And thanks for the opportunity to talk for a few minutes about the importance of vaccine advocacy and the need to have patients involved in the conversations. World Vaccine Congress is super important and a really important gathering of so many different people, and it’s amazing for GHLF to be right in the middle of it all because we’re folks living with chronic diseases and with chronic conditions, many of which are either immune compromising or require medicines that make you immune compromised. Vaccines play an even more important role in ensuring that we stay healthy and protected because we’re more susceptible to things that are out there that are preventable. GHLF sits at a very special place here in this situation and our role is to literally be in the middle of the patient and their families and the health care providers and the policymakers and the regulators and the insurers and the public, as well as our pharmacists and the places that we get our prescriptions as well as our vaccines. And so the importance of improving access to all of these folks, especially the healthcare providers and the pharmacists, is incredibly important so that everybody has a shared understanding and all of us can be on the same page with respect to improving access to vaccines, ensuring we minimize barriers, and we give patients what they deserve: the healthiest life possible, the happiest life possible. And vaccines play an incredibly important role in that, so that, together, we can live our best lives and be our healthiest selves and prevent those headaches and steer clear of those problems from vaccine preventable illness.

Ben Blanc  05:52

Well said. Thanks, Seth. And now to conclude this episode. I’m turning to you, Robert. What is next for GHLF regarding vaccine policy and economic research?

Dr. Robert Popovian  06:02

So great question. So as I mentioned, we’ve presented plenty of data here over the last three years. We’ve done four different studies in vaccines, it has to do with vaccine access, vaccine reimbursement, vaccine availability in low income communities, immunization in low income communities, which you know, Ben, low income communities are over represented by minorities. So it’s more of an equity issue of getting vaccines in the arms of poor patients or underserved populations. But what’s coming for us is a couple of other research that we’re going to be completing in 2024. One has to do with regards to the interaction and access availability of these vaccines, and the meddling that’s being done by the pharmacy benefit management companies. Unfortunately, PBMs are looking at the vaccine marketplace as a profit center now, and they’re trying to meddle in like they have done with other biopharmaceuticals. And it’s going to create some chaos and unintended consequences or intended consequences, based on the PBM schemes. And then the second study that we’re going to complete is a survey of about 1000 patients that we did and looked at what are the barriers that they face as adult immunocompromised patients with chronic diseases in the field. Why aren’t they able to get the vaccines that they need? So we’re going to publish that survey and we have very interesting findings. We’ve done some of the initial analysis and there’s some interesting findings that we’re going to learn from that survey.

Ben Blanc  07:26

Thanks, Robert. That’s amazing. Thank you, Seth. And that’s it for our special episode of Healthcare Matters from the World Vaccine Congress in Washington DC. You already know, but don’t forget to subscribe to our podcast on Apple Podcasts, Spotify, or wherever you might be listening so you never miss an episode. And if you have a second help spread the word by rating our podcast, writing a positive review, and sharing with your family and friends. It will help more people like you find us. He’s Dr. Robert Popovian.

Dr. Robert Popovian  07:54

And his Mr. Ben Blanc. Great to have you been at the World Vaccine Congress!

Ben Blanc  07:59

And great to see you!

Narrator  08:02

Be inspired, supported and empowered. This is the Global Healthy Living Foundation Podcast Network.

The transcript will be made available soon.

Narrator  00:00

Be inspired, supported and empowered. This is the Global Healthy Living Foundation Podcast Network.

Ben Blanc  00:10

You’re listening to Healthcare Matters the podcast that pulls back the curtain to help you make sense of complex healthcare, economics and policy issues. With us is Dr. Robert Popovian in Washington DC. He’s a pharmacist, an economist, and the Chief Science Policy Officer at the Global Healthy Living Foundation.

Dr. Robert Popovian  00:29

And joining me is my good friend Ben Blanc, dialing in from Indianapolis, Indiana, who is our Manager of Programs and Special Projects at Global Healthy Living Foundation. Ben is doing double duty today he is going to be joining me as my co-host as we start our season five, episode one. He has been a great producer, and he will be the co-host. You may catch a hint of his sophistication in the air or some type of “je ne sais quoi” as they say, as Ben is originally from France. So you know, Ben this year, a lot going on in Europe. We have the Euros in Germany. We have also a big year in France, the Olympic Games this summer. So are you going to be visiting your homeland?

Ben Blanc  00:29

Hmm, well, let me think Robert, paying double for flights, Paris will be packed inflated prices for everything. Yeah, I think I’ll stay home and watch the games on TV.

Dr. Robert Popovian  01:21

That’s probably a safe bet and start watching on TV. Speaking of global events like Olympic, health and safety especially in these days are top importance, much like topics we always tackle here on Healthcare Matters podcast. And for today’s episode, we have a very special guest Vibhu Tewary who is a researcher and he’s the Project Director at the IQVIA Institute for Human Data Sciences and we’ve collaborated on multiple occasions on research initiatives and papers. So I welcome Vibhu on our podcast, episode one, season five. Vibhu, welcome you know, I want you to give some background for our audience about what you do with IQVIA and also your academic background. Take it away.

Vibhu Tewary  02:06

Thank you, Robert. It’s a pleasure to be here. Robery as you mentioned, I’m a Project Director at the IQVIA Institute. I’ve been working with the IQVIA Institute for a couple of years, the IQVIA Institute is a small part of the broader IQVIA organization with the objective of using the data assets that IQVIA has to contribute to public health discussions, public policy discussions, with a view to have an impact for patients and other stakeholders in the overall health system. Prior to being with the IQVIA Institute, I was in the broader IQVIA as part of the consulting team. Before that, I went to Duke University for my MBA with the focus on healthcare management. However, public health public policy has always been close to my heart. Prior to any of this, I used to work in India at a policy think tank looking at rural education, rural health care. So all of these topics are really, really interesting, really, really close to my heart, and I’m looking forward to diving into them. So really happy and honored to be here and looking forward to the conversation.

Ben Blanc  03:03

Well, welcome aboard Vibhu and Robert, you know how it goes. We always start the episode with a number and today that number is 13, $13 to be exact. Can you tell us the significance there? And yes, it relates to today’s episode.

Dr. Robert Popovian  03:19

So Vibhu and I worked on the study that we’re going to discuss today on the podcast, which basically demonstrated that a $13 increase in pharmacy reimbursement for adult flu vaccination was associated with nearly a six percentage point surge in state vaccination rate for Medicaid fee for service covered adults. And this is important because that’s the crux of what we found and this is what we’re going to be discussing today on the episode.

Ben Blanc  03:44

Well, I’m sure you’ll be telling us all about this report that you two co-authored, but before we get into it, let’s start this episode with a little bit of background. In 2023, GHLF and IQVIA Institute for Human Data Science released a paper that evaluated where adult patients in the US received their immunizations before and after the pandemic. Vibhu, I’m turning to you with my first question, what are the main findings of that 2023 paper? And by the way, I read the report and it seems like the number 90% really stands out.

Vibhu Tewary  04:21

Yeah, thanks, Ben. So I think as you mentioned, the objective of that research was we wanted to understand where are adults in the US getting their vaccine? Is it at pharmacies, is it at non-pharmacy settings, like medical centers? And to do this, we looked at the iqvia prescription and medical claims data, we can tag that on the basis of whether the claim came from a pharmacy setting or not. We looked at this data starting from 2018. We went up all the way to middle of 2022. And what we find is that overall across all vaccines that we looked at for adults, a large majority of the administration took place at pharmacies, in particular during the pandemic so 2020,2021, we saw a steep increase in vaccine administration at pharmacies. This is driven by a number of factors. If you look at the COVID vaccine, the 90% number that you mentioned comes into play. So more than 90% of COVID-19 vaccinations for adults were provided through pharmacies in both 2021 and 2022, if you exclude the temporary and government public health site. Now this trend holds even if you analyze the data by race, gender, income level, it’s still all above 90%. This isn’t just true for COVID-19 vaccine. Even your shingles vaccine sees a similar trend with a large majority of the administration taking place at pharmacies across all of the years that we looked at. The flu vaccine is interesting, around 60% of the vaccination during flu season takes place at pharmacies. Another interesting trend that we noted was between 2018 and 2020, there are increases in flu vaccine uptake. But all of those increases pretty much are happening at the pharmacy level, the flu vaccine administration at the non-pharmacy level is pretty much remaining stable. I think all of these findings, they highlight the importance of pharmacies, the role they’re playing in adult vaccination, and really shed a light on the crucial importance of these pharmacists.

Ben Blanc  06:12

Gotcha. Well, thanks for the overview, Vibhu. Robert, do you have anything to add? And actually considering these findings, could you share your thoughts on the policy implications and barriers that are relevant to the findings?

Dr. Robert Popovian  06:24

Yeah, absolutely. You know, and barriers are significant at some states, not as significant in other states. As many of our audience knows practice of medicine or practice of pharmacy is governed by state law. It’s not governed by federal law. And when we looked at the data that we published with IQVIA, at GHLF, we quickly realized that what we need to do is harmonize, expand, enhance state laws to allow pharmacists to immunize more, especially for adult patients. And the reason being is that that’s where patients prefer to go to, and that’s where the vaccination is happening. But you know, currently, that environment is a complete mess. As I said, every state is different. There are multiple states that don’t allow all the vaccines to be administered by the pharmacist for adult patients, which is a sad truth. And we need to do a better job of fixing those. But the reality is that patients want to go to a pharmacy, they’re more accessible, they’re more relevant and in low income communities, especially compared to physician offices where patients can go after hours, and especially for patients who are working hourly jobs that they cannot take off from those jobs in middle of the day to visit a physician, the pharmacies are open after hours. And frankly, there’s evidence that economically, it’s less expensive to immunize at a pharmacy than it is at a physician’s office. So all of these things are policy implications that policymakers need to take into consideration, especially on the state level, as I said, because that’s who governs practice of pharmacy and allows for immunization to take place by a pharmacist at the pharmacy.

Ben Blanc  08:00

Very clear. Well, now that we have all this background, let’s talk about our most recent co-authored report, which again, is a joint effort between IQVIA Institute for Human Data Science and GHLF. The report just came out in February, and I’ll sum it up for our audience before we dive in. Simply put the paper found a direct link between pharmacy reimbursement and flu vaccination rates among Medicaid covered adults. So of course, understanding the motivation behind a study is crucial. Robert, could you share what drove us to undertake this particular piece of research?

Dr. Robert Popovian  08:36

So it was interesting because the previous research that was done and Vibhu and I had a long discussion about this, was mostly done on surveys, right of physicians or pharmacists. And basically the studies went and asked the physicians like if you get paid more, are you going to vaccinate more? Obviously, physicians would say yes, but there was no empirical data to really support from a research perspective, if that’s true that whether or not higher reimbursement rates drives uptake of flu or any type of adult vaccination. There’s some literature that was published previously on pediatrics, where better reimbursement rates on the pediatric side does improve pediatric vaccination uptake. So what we wanted to do is duplicate that study on the adult space and really to get away from the survey stuff that was done either by other organizations that have published in the reports and really get into solid data to support whether or not reimbursement increase will impact uptake of flu vaccines. And we chose the Medicaid population primarily because, you know, the Medicaid population is underserved. We know that it’s over represented by minorities. So if you’re interested in, you know, equity and inclusion, you want to improve care in the Medicaid population, because there’s a lot more racial and ethnic minorities in the Medicaid patients. And then we chose flu because flu is something that everybody is, you know, recommended to get it’s not one of those vaccines that’s age specific, everybody should get a flu vaccine. And so those are the inputs that we really talked about and motivated us to get into the study and try to see if there is a correlation.

Ben Blanc  10:15

Alright, now that we know why this paper came to be Vibhu, could you walk us through the data and methodology that were employed in this report?

Vibhu Tewary  10:24

Yeah. Thanks, Ben. So basically, to understand this relationship, you need two broad sets of data points. One is what is the vaccine uptake for the Medicaid population? And then the other piece of it is what are the reimbursement rates for that same population, we again looked at IQVIA prescription and medical claims data, particularly for the Medicaid fee for service population. And we’re able to mark out in terms of the entire population that’s there in the IQVIA data, how many of them are actually getting their flu vaccine, we looked at this for the 2020 to 2023 flu season. That at a state level gives us a percentage. So for each state, what percentage of their Medicaid fee for service adult population is actually getting the flu vaccine. Then we looked at what is the reimbursement rate in each of theses states from the same set of patients. And by reimbursement rate, we mean, how much was reimbursed for the vaccines supply, if there’s additional reimbursement for vaccine administration, how much was reimbursed. And from that we subtract out cost of the vaccine itself. We did this both for pharmacies, as well as office based physicians. So for each state, we ended up with a number. Now that we have both of these numbers, we want to compare the two to be able to do that we set up a multiple regression model where we look at our dependent variable, which is the vaccine uptake rate and have the reimbursement rate as one of our independent variables along with other variables at a state level. So we looked at state per capita income, state education level, other factors that might be impacting within the Medicaid population, how many people are actually getting the flu vaccine. Looking at this data, I think as we started off right at the start, what we find is a $13 increase in the reimbursement rate would lead to a six percentage point increase in the overall flu vaccination in this specific population. I think it’s interesting also, just to highlight why did we choose 13. Thirteen is the difference between the average reimbursement rate, which is around $12 or so based on a calculation across states and the highest reimbursement rate, which is $25 or so for that why we were looking at that $13 number. Again, I think there’s also a lot of other factors that come into play in terms of what raises the vaccination rate. But this research, clearly, with data highlighted, there is an important link here between reimbursement for pharmacies and for the adult vaccination uptake. So I think it again highlights that important role that pharmacies are playing.

Ben Blanc  12:53

Yeah, thanks for breaking down all that information for us. And I know the findings are compelling. So Vibhu, you had to prep a slide presenting the key findings of this report, what would your bullet points be?

Vibhu Tewary  13:05

I think the main the top line message here is if you increase reimbursement rates for Medicaid population, you will see an increase in the overall vaccine uptake. That’s what the research is showing. Specifically, if you increase it by $13, research shows that it would increase by six percentage points. Those are the main takeaways. If I had to add another bullet point, we looked at this by gender, by race, and in general, the results hold irrespective of gender, irrespective of race. So this is consistent across the board.

Ben Blanc  13:38

Yeah, that’s very clear. Now, every study has implications that extend beyond the data, right. So, Robert, from your perspective, what are the policy implications of these findings?

Dr. Robert Popovian  13:50

Well, the policy implications are that if you increase the reimbursement rate, you’re gonna get better uptake in Medicaid patient population for regards to specifically on flu vaccine, but my belief is probably other vaccines. And this is important, as I was mentioning earlier on, you know, Medicaid populations, minorities, racial and ethnic minorities are over represented in those patients. So if you’re serious as a society to you know, reduce health disparities and improve equity and access and all those other things, then you need to be serious about improving reimbursement. And one of the things I want to give some observation on is that from a policy perspective, you know, Medicare is a good barometer, right? Medicare reimbursement is much higher than Medicaid reimbursement on average across all the states. And one of the policies that we discussed and we’d recommend is that perhaps the Medicaid reimbursement should equal Medicare reimbursement. There’s no reason why patients who are poor and indigent and are again over represented by racial and ethnic minorities should get lower reimbursement for vaccines at pharmacy, which clearly will demonstrate a better uptake than Medicare patients, our seniors. So yeah, that’s the main policy issue. But you know, this is another area of focus of trying to remove a barrier and improve access uptake in especially in a very vulnerable patient population, underserved patient population.

Ben Blanc  15:15

Yeah, that’s very insightful. Thanks, Robert. Are there any other areas or topics that can potentially be evaluated for future research? Who wants to go first? Vibhu should we start with you?

Vibhu Tewary  15:28

I think there’s quite a bit of research still to be understood here and to ensure that adult vaccines are reaching the right populations. I mean, in my head, there’s two broad categories of research. One is to understand the role of the pharmacist and any challenges and blockages there that can be in terms of you know, do they have the right data to be able to make decisions for specific patients. Even for our current research, I would be curious to see as states change their reimbursement rate, what is the impact that they’re having? So continuing to focus on that. Are they appropriately supplied with the vaccines? And then the other side is understanding other factors that impact adult vaccination. So what is happening with the patient’s side, are they appropriately informed regarding the importance of these vaccines and where they can get it? Is it reaching vulnerable populations? And can that be insured for health equity? So there’s, there’s two broad sets of discussions here, all of it, I think there is data out there that can help shed light on it, and needs to be looked at in more detail.

Ben Blanc  16:30

And what about you, Robert? I’m sure you also have an opinion on this.

Dr. Robert Popovian  16:34

Yeah. I mean, we are in midst of doing a survey actually, of Global Healthy Living Foundation patients, all of them have chronic disease, almost all of them are immunocompromised, and trying to see what are the blockage points for them regarding vaccines? Are they getting denied, whether it’s at the physician’s office or a pharmacy with regards to having access to a vaccine? And then what are the reasons for that denial? Is it because out of pocket costs, which shouldn’t be right, because of Affordable Care Act, you know, the Inflation Reduction Act should have taken all of those things away, and patients should not have any out of pocket costs. But we still see some instances where patients are being charged upfront for the vaccine and the way that the benefit design is set up, and then they have to go get reimbursed, which is, as you know, well, and throughout our podcasts, we talked about any kind of out of pocket cost that is significant, patients are not going to take the medicine or get the vaccine and are going to walk out of that institution or that pharmacy without their therapy. So that’s one of the areas that we’re going to focus on. And then another thing Vibhu and I have talked about, is this whole shared clinical decision making and the impact that’s had. It’s policy position that CDC has taken over the years for adult vaccines especially and what is the impact of that policy on vaccine uptake in adults? Is it good, bad, indifferent, we’re going to hopefully have an opportunity to look at that in the next 12 months or so.

Ben Blanc  17:59

Yeah, thanks, Robert. And a heads up to our audience, we’ll be dropping all the links to the papers we’ve been talking about in the show notes, so make sure to check them out. And as we wrap up today’s discussion, do either of you have any final thoughts about the joint research conducted?

Dr. Robert Popovian  18:17

Let me say that at GHLF, you know, I’m personally thankful for Vibhu for his partnership. The GHLF and IQVIA Human Data Sciences organization have done a lot of good work for patients. And that’s the thing that I have come to realize partnering with Vibhu is that the both organizations are focused on patient and patient access, that’s the most important thing. If we can do research, not for the sake of doing research, but meaningful research that’s going to improve that access point, then we should be partnering up and working together. And we’re open to further collaboration between the two organizations and even beyond bringing other partners

Vibhu Tewary  18:54

I would just echo that I think both the types of research we’ve discussed here have been really, really intellectually interesting questions, but they have a direct impact on the patient. And it’s honestly been a pleasure to work with the GHLF team on these projects and on these pieces of research and see the impact that they can make. Some of the research that Robert is mentioning, I think we’re very excited to continue this partnership. And if the other stakeholders that are relevant and interested, I think we’re always open for other partnerships moving forward as well.

Ben Blanc  19:23

Thank you both. That’s all we’ve got for today. So thanks again, so much Vibhu for joining us. And Robert, as always, you have the last word. So what sticks with you from today’s episode?

Dr. Robert Popovian  19:34

Well, you’re a pretty good co-host, how’s that Ben? But you know, what sticks with me is that the value of research and data is sometimes underappreciated. And we sometimes talk about policy issues from an emotional standpoint or, you know, we want to bring up examples, but when you have data, then you can really drive down policy change in the United States and that’s very important. And I also want to thank Vibhu for joining our podcasts you know, season five, episode one, so you’re going to be front and center, Vibhu and we look forward to having you in other podcasts in the near future.

Vibhu Tewary  20:08

Thank you, Robert. It’s been a pleasure.

Ben Blanc  20:11

Well, thanks for breaking that down for us, Robert. I think that was some very valuable information for our listeners. And speaking of our listeners, don’t forget to subscribe to our podcast on Apple, Spotify or wherever you might be listening so you never miss an episode. And if you have a second, help spread the word by rating our podcast, writing a positive review, and sharing with your family and friends. It will help more people like you find us.

Dr. Robert Popovian  20:36

If you have any questions, thoughts, suggestions, as always, you can email us at [email protected].

Ben Blanc  20:43

And before you go, make sure you take a listen to some of our other great podcasts on the GHLF Podcast Network. You can find all of GHLF’s podcasts at ghlf.org/listen. He’s Dr. Robert Popovian.

Dr. Robert Popovian  20:56

And he’s Ben Blanc and you will not find him in Paris this summer. I will see you all next time.

Narrator  21:03

Be inspired, supported and empowered. This is the Global Healthy Living Foundation Podcast Network.

Narrator  00:00

Be inspired, supported and empowered. This is the Global Healthy Living Foundation Podcast Network.

Conner Mertens  00:10

You’re listening to Healthcare Matters, the podcast that pulls back the curtain to help you make sense of complex healthcare economics and policy issues. As always, we’re joined by Dr. Robert Popovian. Tuning in from Washington DC, he’s a pharmacist, and economist and the Chief Science Policy Officer at the Global Healthy Living Foundation.

Dr. Robert Popovian  00:27

And joining me is my good friend Conner Mertens, in Seattle, my co-host and our Patient Advocate and Community Outreach Manager, and this episode is a special one for us at Healthcare Matters and for you our listeners because this is Conner’s last episode, he is moving on to bigger and better things in life. And Conner this has been an exceptional run you know, we’re concluding our fourth season and the podcast will continue on without you.

Conner Mertens  00:54

Show must go on, show must go on. Robert, keep it going.

Dr. Robert Popovian  00:56

Hey, look, I grew up in Hollywood, California, the show always goes on. But in the meantime, for our last episode, I have a number in my mind, which is 35 percent. What does that mean for you?

Conner Mertens  01:11

I think we talked about it last episode but all the upheaval in Seattle, I think 35 percent’s, the chance that the Seahawks pick a good coach for the next season. But that might be a little high, I could be a little optimistic there.

Dr. Robert Popovian  01:21

As an alumnus of University of Southern California still breaks my heart that they pushed Pete Carroll out the door and he didn’t want to leave and it’s going to be interesting to see what Seattle does. But no, so 35 percent is the percentage by which the list price of a generic version of the Flovent, which is a very popular inhaler for patients with asthma is cheaper compared to the brand version. And what happened is that GSK, which is the company that makes Flovent, decided that they were going to pull the brand drug from the market and introduce a generic version of it at 35 percent discount. And guess what, then this was covered in Wall Street Journal article that came out earlier this year, the major PBMs are refusing to cover the generic version, even though it’s 35 percent cheaper. So, it’s a great transition to today’s topic of misaligned incentives, as we’ve discussed, and this is a great example of the misaligned incentives that exists with the PBMs and in our market access and our biopharmaceutical access market.

Conner Mertens  02:21

Well, Robert it feels fitting that for our last episode together, we’re going to be talking PBM shenanigans, as always. This is a topic that we cover extensively because there are so many practices that are shady and detrimental to patients. So it’s only fitting that we’re on a familiar topic, The article in the Wall Street Journal got a lot of attention in social media, actually, can you tell us a little bit more about what happened?

Dr. Robert Popovian  02:41

Again, it got a lot of attention, because at the end of the day, a pharma company decided that they had enough of playing the rebate game that we’ve discussed in the past with the PBMs. They said, you know what, we’re going to remove this drug from the market from a brand perspective, it’s called Flovent, as I said, it’s a very popular drug that’s used a lot by asthmatics. Oh, we’re going to introduce a generic version to our manufacturing facility, so no differences between this drug and the brand name drug, and we’re going to introduce it into the market at 35 percent discount. So that’s great, list price discount. And what happened is that for some odd reason, not odd, obviously, we’ve talked about these misaligned incentives. PBMs, that have decided that they’re not going to cover this generic version. Why, and this is why a lot of things came out in the social media is because it is not as profitable for the PBM to cover the generic version compared to the brand version. And that’s where the misaligned incentives come into play.

Dr. Robert Popovian  02:41

So, how do rebate systems affect drug formularies and patient access to medications?

Dr. Robert Popovian  02:41

Well, the way they affect it is that the higher the rebate, the more incentive it is for the PBM to cover the medicines. So they like having these higher price branded drugs, which provide huge rebates and fees and concessions to them, which by the way, they don’t pass all of it back to the employer and almost none of it back to the patient and they keep that as profit. And therefore it causes misaligned incentives where they prefer those type of environment and this Flovent example is the perfect scenario that was laid out in the open to this Wall Street Journal article that demonstrates how rebates and fees and everything collected really dictates what they are willing to cover. They’re more willing to cover expensive medicines, because that’s more profitable to them than inexpensive, generic drugs that are cheaper for the patient.

Conner Mertens  04:36

Well, again, these are topics that we’ve covered extensively before passing on concessions to patients. GHLF, we’ve talked about this for several years concerning formulary exclusions, is that kind of the same discussion we’re having now?

Dr. Robert Popovian  04:49

Yeah it is. That’s why drugs get excluded from formulary, because we talked to the PBM and the PBM excuses that look, the net cost of the brand name drug is less than the net cost of the generic drug because I was getting a lot of rebates and fees and concessions from the pharma companies. But the question becomes the net price for whom? Perhaps the net price is cheaper for the PBM but because they keep majority of those concessions, and especially the fees, almost all of the fees that they collect, and pass almost none of it back to either the employer or very little of it, and then 100 percent, they’re not passing any of it back to the patient, it is less expensive to them. But that’s not what we’re here for, we’re here for patients saving money, employers having benefit designs that they can afford. And instead, what the PBMs are doing is creating an environment where they’re excluding medicines for no other reasons, because they’re not as profitable to them than the lower priced alternatives that have been introduced in the market.

Conner Mertens  05:49

As we start looking at different solutions. I’m thinking about the news about Eli Lilly directly selling to consumers that weight loss product, right? And is this direct to consumer model, is that something that’s worth pursuing for patients or for the pharmaceutical industry?

Dr. Robert Popovian  06:05

It is, and it’s not a new model. I mean, Conner, when I was at Pfizer, we tried to sell, directly sell the smoking cessation, drug Chantix to the consumers to a similar model that Eli Lilly that has proposed for this weight loss drug. And it didn’t work, because I don’t think the environment was ready for it. This was about a decade ago. But I think we’re ready now to have this type of conversations about direct consumer purchasing of drugs. And we’ve seen the model work, right? In the last couple of years, there’s been a lot of discussions about patients bypassing insurance, especially for generic drugs and going directly and paying cash at certain pharmacies that are willing to say sell these drugs at a much lower price to the patient in a cash base than compared to what it would cost them to utilize their insurance card. And the most recent example is the Mark Cuban pharmacy that has gotten a lot of media attention. But that model has been around for a while Costco has been doing it, Walmart has been doing it. There’s a lot of independent pharmacies like blueberry pharmacy has been doing it and there’s the freedom pharmacy in Ohio, these pharmacies have been thriving and helping patients save 1,000s and 1,000s and 1,000s of dollars by bypassing their insurance and purchasing it directly from pharmacies. It’s not just what Eli Lilly is doing, just going directly in selling the product to the patient. But also this model has been growing in the last few years, especially in the generic market. But you know, we need to go beyond that, Conner. There has to be a different thought process about perhaps the pharma companies should start directly selling to certain health providers. And it’s not a new concept, the largest insurer in this country in the largest state that we have, in California, Kaiser Permanente buys directly from pharma company. They bypass the middleman with regards to wholesalers and things and they take inventory of the drug from the pharma company. And they have warehouses that they place these medicines and have direct contracting with them without going through a PBM. And the same model can be explored with other type of large institutions that are willing to purchase directly from pharma companies, bypassing a lot of the middlemen and are able to then lower those prices, both the pharma company will make more money and guess what the end user, the institution will pay a lower price. So everybody, it’s a win win situation, lower prices for the institution and higher margins or better profit for the pharma company, and they bypass the middleman. And that’s my thought is that that’s another area that needs to be explored. Why can’t a Texas oncology that serves about 50 percent of patients in Texas, the second largest state in the country bypass all of the middleman directly purchase oncology drugs from the biopharma companies. The third thing is pharma companies now need to explore directly selling their drugs to employers, there are big employers out there like Walmart, and Walgreens. And you know, they’re sitting out there and they have the wit to be able to purchase these drugs bypass, everybody else, bypass the insurance companies, bypass the PBMs, and really acquire these medicines for their employees at a significant discount. I know those models are being tested and have been tested and PBMs when they get a wind of them, they threaten the pharma company that if they pursue any kind of direct selling to employers, that they will remove all their products from the PBM formularies. And that threat is real, because they have a lot of, as we’ve talked about a lot of wit and bandwidth and might in the marketplace. So, there’s a lot of different ways to pursue this. I think the Lilly example is great, it’s nothing novel. I think other companies like Pfizer, I mentioned has tried it, but we need to do this direct to consumer, direct to employer, direct to provider models to bypass all of this infrastructure unnecessary who’s profiting from all of this and really going to the endpoint consumer.

Conner Mertens  10:01

Yeah, I mean, it sounds like this is a model that the direct to consumer has the potential to be beneficial financially for patients and the biopharmaceutical industry, would that mean that only people opposed to this would be who? The PBMs?

Conner Mertens  10:15

Yeah, and PBMs are opposed to it. I mean, they hate the cash-based pharmacies for generics, right? And their opposition is somewhat hollow, because they’re claiming, well, you know, we are losing touch with our patients, because we don’t manage them clinically now, because we don’t have access to whether or not they went and got the medicine from their cash-based pharmacy and we don’t have that in their records. That’s baloney. To me, that needs to be resolved because you as a PBM, as an insurer, has to provide better patient care, but not to the detriment of patients overpaying for the generic medicines and trying to find a better deal at Costco or Walmart or at the Cuban pharmacy or at the freedom pharmacy, you should not be penalizing them, overpay for the generics because your excuses now that I need to capture that drug because I need to have it in the portfolio of the medicines that they’re taking. Figure out a way. Remember, you’re not only paying for their drugs, but you’re providing health insurance now, because as we know, we’ve talked about it in this episodes, PBMs own insurance companies, this vertical integration has happened. So, guess what it is in your incentive to capture that so figure out a way to do it. But don’t penalize patients by having them, making them pay more by using their insurance card.

Conner Mertens  11:30

Well, I guess one of my last questions is what other areas can biopharmaceutical companies consider regarding direct selling, I wonder, and maybe this is a shot in the dark, would this sort of model have any impact on things like innovation or expanding access?

Dr. Robert Popovian  11:44

Well, expanding access, definitely, we’ve seen this right. If pharma companies are able to sell directly to patients, the access improves, if they are able to bypass for example, and sell directly to a health system, they will lower prices, therefore access will be better. We talked about some of those models. At the end of the day, every model that needs to be pursued is that whether or not we cut out more middlemen from the model and go directly to the consumer. And this thing has happened as we discussed, Eli Lilly trying to do it with this weight loss drugs. Pfizer tried to do it with the smoking cessation medicines, generic drugs you hear every day, patients are saving 1,000s of dollars by going and directly paying cash at the pharmacy. So we need to pursue those models. And it’s not only in the pharmaceutical business, Conner, I don’t know if you’ve heard the term direct primary care? But this is a group of primary care physicians who are telling consumers and believe me, they’re growing in number that if you come to me and pay me directly, instead of going through your insurance, I will save you money long term, your insurance costs, and you will have unlimited access to me. The direct primary care is another concept that needs to be galvanized. And we need to pursue that because patients are saving money and getting better care instead of going through the insurance bureaucracy.

Conner Mertens  13:05

I’ll tell you what, Robert, that’s a pretty thorough conversation. Is there anything else you want to add to the conversation?

Dr. Robert Popovian  13:09

No, I mean, look, the Wall Street Journal article was great because one of the top newspapers read covered this issue of misaligned incentives, how a 35 percent cheaper medicine is being denied. Patients are being denied of it. And remember, Conner patient out-of-pocket costs, especially if you have a deductible or coinsurance which we all do, is based on the retail price. So, patients would have saved money with this generic Flovent. But because PBMs are not profiting as much by covering the generic Flovent instead of the brand name drug, they’re refusing and they’ve removed it from the formulary. To the detriment of patients saving money, but more importantly, to the detriment of patient health care. There are patients, 1000’s, millions of patients who are on Flovent who today are unable to access that through their insurance model. So Conner, you’re a dear friend, I can’t thank you enough for your excellent collaboration on these podcasts. These podcasts would not have been as successful without you. You’ve been an amazing partner, co-host, a friend, I want to thank you so much. I’m going to miss talking about Seattle sports with you and needling you about all of the sport teams that make the wrong decisions in the upper Northwest. But I’m going to give you the last word this time Conner.

Conner Mertens  14:27

Yeah, thanks, Robert. I guess on this topic, specifically put a little bow on it, when we talk about these models, we just got to be trying to find ways to make healthcare better, and more accessible, and cheaper for patients. And things like this, these formulary exclusions, and lack of passing on of incentives, these directly get in the way of that. Any way we can find some extra money for patients and make their lives a little easier, I think we’re all in on. But I can’t thank you enough for the time on this podcast, Robert, our time working together. You’ve been incredible colleague, incredible friend, being able to talk the failures and successes in sports, or Taylor Swift talks, and just all things health care, it’s been a pleasure. And I’ve just been a sponge here, you’re absolutely brilliant. And I think what makes this podcast so easy is I’m learning along with the rest of our audience, so it’s been something special. And don’t worry, I’m gonna stay subscribed, I’m gonna be tuned in for whoever fills the seat and sits behind this microphone, because there’s always gonna be more to learn about and more policy and more healthcare to inform our communities about and at the end of the day, I’m never going to stop fighting for patients. I’m proud of the work we’ve done, and specifically the conversations that we’ve had here. So thank you, Robert. And a special thank you to our audience. Without you, none of this would be possible. And you’re the reason we do what we do. Robert is gonna be back for more enlightening episodes next season. In the meantime, do what I did, don’t forget to subscribe to our podcast on Apple, Spotify, or wherever you might be listening, so you never miss an episode. And if you have a second, spread the word by rating our podcast, writing one of those positive reviews, and sharing with your friends and family, it’ll help more people like you find us.

Dr. Robert Popovian  15:55

And if you have any questions as Conner mentioned, we’re going to continue to season five relatively soon here because we have some papers coming out from GHLF that we would like to talk about on this podcast. So if you have any questions, thoughts, comments, suggestions, please send it our way at [email protected]

Conner Mertens  16:13

And before you go, make sure to take a listen to some of the other great podcasts on the GHLF Podcast Network. You can find all of GHLF’s podcasts at [email protected]/listen, as always, he’s Dr. Robert Popovian.

Dr. Robert Popovian  16:25

And he’s Conner Mertens. See y’all next time.

Narrator  16:30

Be inspired, supported and empowered. This is the Global Healthy Living Foundation Podcast Network.

Narrator  00:00

Be inspired, supported and empowered. This is the Global Healthy Living Foundation Podcast Network.

Conner Mertens  00:10

You’re listening to Healthcare Matters, the podcast that pulls back the curtain to help you make sense of complex healthcare economics and policy issues with us, as always, is Dr. Robert Popovian, joining us from Washington DC. He’s a pharmacist, he’s an economist, and he’s the Chief Science Policy Officer at the Global Healthy Living Foundation.

Dr. Robert Popovian  00:27

And joining me is my good friend, Conner Mertens, in Seattle, Washington, my co-host and our Patient Advocate and Community Outreach Manager. Conner, interesting times, no more Pete Carroll in the sidelines of the Seattle Seahawks. What’s going on?

Conner Mertens  00:41

It’s been a weird weird month for Seattle sports and Seattle football specifically, hasn’t it?

Dr. Robert Popovian  00:46

Absolutely. For the entire college and NFL landscape.

Conner Mertens  00:49

Exactly.

Dr. Robert Popovian  00:50

So Conner, let’s start this episode, I have an important number I want to share with you and that number is 2.9 million. What does that mean to you? I’ll give you a hint. It has to do with the COVID infection. And it’s probably a number you haven’t heard in the news yet, because the study just came out earlier this year.

Conner Mertens  01:11

2.9 million has to do with COVID. I’m gonna go with the amount of sourdough that was made during the pandemic. That was everyone’s thing, right? Everyone was making sourdough.

Dr. Robert Popovian  01:19

That is true. We were all home and waiting to get out of the house and nothing else to do but cook. So, no, the 2.9 million actually, you know, I was part of this research that was released by the Progressive Policy Institute. It was a paper written by myself, Michael Mandel, who was the Chief Economist for PPI and Wayne Weingarten, who’s the Chief Economist for the Pacific Research Institute. So I was one of the three authors, some of our audience knows anyways, I’m a Senior Health Policy Fellow at Progressive Policy Institute, besides being the Chief Science Policy Officer at Global Healthy Living Foundation, and you know, the 2.9 million was really the fatalities that were avoided due to the rapid development of the vaccine. We did some nuanced actually analysis in this paper that we came up with about 3.3 million because we estimated not only the rapid development, but the efficacy rate as well as getting the shot into the arms of the patients. So yeah, 2.9 to 3.3 million is the number of fatalities that was avoided because we were able to as a country as an industry with biopharmaceutical industry to develop and distribute this vaccine for COVID-19.

Conner Mertens  02:28

Well, I mean, it sounds like this is a pretty complex study, a lot of big numbers, a lot of moving parts. Can you just give us a brief summary of what these findings were?

Dr. Robert Popovian  02:36

Well, yeah, it was written by three economists, so I assume it was complex. But I have to say, even though it was written by three economists, it was written by Policy Institute, it’s a very good, easy read, and I would encourage everybody to visit the show notes, and we will put a tag to the paper. But let’s summarize like what did we find in our paper, we estimated that between 2.9 and 3.3 million fatalities have been avoided because of this rapid development and distribution of the vaccine. 12.5 million hospitalizations have been avoided, which is significant, because not everybody ended up dying, but a lot of people were hospitalized. So because of this rapid development of the vaccine 12.5 million hospitalizations were avoided. We saved as an economy in the US $500 billion and that’s primarily because of the avoided hospitalizations. And you know, we had very moderate estimations of what the cost of those hospitalizations were and $500 billion was saved because of its development. But there are a couple other things that we looked at, we looked at specifically at boosters, because that’s a big issue. Now, latest boosters out not too many people are getting boosted up. But it’s out there, we estimated that patients who don’t get boosters, and the ones that get repeated boosters, and there’s everybody else who falls somewhere in between probably, there’s 6.2 times more greater fatality rate for patients who avoid the boosters who are not getting any of the boosters. So, your likelihood is about 6.2 times more to die from COVID If you’re not being boosted up. And finally, one of the things that we estimated we looked at specifically what age group the boosters benefits the most both economically and from a efficacy standpoint.

Conner Mertens  04:18

Well, 500 billion, that’s nothing to shake your fist at, that’s a lot of money. And and we’ve talked about on the show before that vaccines are if not the most effective preventative treatment for healthcare, keeping people out of the most cost effective rather way for keeping people out of the hospital. So you just kind of started to allude to it but who’s benefiting and who benefited because we’re looking retrospectively most from the development of the COVID vaccine?

Dr. Robert Popovian  04:43

Without a doubt our study shows and other studies have demonstrated the same it’s really based on age, age is a very big factor of who benefits from immunization and it’s not something new. It’s not something shocking, but because we’ve seen the same similar data with flu and pneumococcal another type of immunization generally is the elderly. It’s the people who have multiple chronic diseases or immunocompromised, who benefit the most from immunization, both from an efficacy standpoint with regards to outcomes. But also from an economic standpoint, we can save significant amount of money when you look at 60 and older patients who are being provided the vaccine compared to lower age brackets. But you know, it’s not a surprise to anyone that older people benefit the most from immunization.

Conner Mertens  05:31

And one of the hot topics during COVID. And controversial in some regards, is the idea of herd immunity or natural immunity. And I’m curious if you could tell us a little bit more about did your research show us anything about that? And what does that mean for vaccinations?

Dr. Robert Popovian  05:47

We did use it as an assumption in our study and the assumption has been proven correct, since the COVID infection came about in 2020, that herd immunity is equally as efficacious as the immunization. Having said that, and that was one of the assumptions that we did in the modeling in our study and are looking at in the paper. Having said that, Conner, we’ve talked about this before in our podcasts for any individual, you, myself, Ben, to gain natural immunity, we have to go through the disease. So you technically have to get sick to gain that immunity versus with immunization, you bypass that illness. And with that illness also comes potential fatality or hospitalization. So yes, theoretically, without a doubt, data confirms that if you’re getting natural immunity to getting sick, yes, it is as efficacious as getting the vaccine. But what people don’t want to talk about who are anti-vaxxers, or don’t want it to be is the thing that you have to get sick to get that natural immunity, and you have to go through the sickness and take the risk of a fatality or a hospitalization before coming out at the back end, having gained this natural immunity, which is then equal with vaccination. And that’s what vaccinations generally do, you avoid that illness, you avoid the potential bad outcome, and you get to the back end, having gained immunity towards a very deadly disease.

Conner Mertens  07:11

And when we talk about the financial ramifications of that, and why we always talk about how vaccinations are the most cost effective preventative tool that we have. If somebody goes through the sickness and they end up in the hospital, then those are bills that add up and those are costs that add up whereas it costs pennies on the dollar to make these vaccines that can prevent the treatment and bypass and get straight to that immunity. I’m curious, what about long term COVID? You didn’t really talk about long term COVID and it’s research did you? Was that something that came up?

Dr. Robert Popovian  07:39

We didn’t look at long term COVID in this paper, because there’s a lot of like data that’s coming out on long term COVID. And there’s a lot of controversy, but a recent study that just came out and you know, it was shared with us by one of our colleagues has to do with boosters and long COVID. And what the study finds is that patients who have been boosted and immunize fully, technically have a lower incidence of long COVID even if they get infection because remember, with vaccination, you still get infected from time to time you get flu vaccine, you may still end up with the flu, but the severity of illness is not as much. And the same thing has been found out with COVID is that with long COVID, if you’ve been boosted regularly, and you’ve received your regular vaccination for COVID, the chances of long COVID is much lower than patients who have not been regularly boosted or did not receive any of the original vaccination schedule. So again, we didn’t look at it in our study that was published. But there’s other studies have recently come out was shared with us has to do with boosters, and also that there’s a correlation between patients who have been boosted and the lower incidence of long COVID.

Conner Mertens  08:47

Well, let’s bring it back to our patients and the community that we work with here, the Global Healthy Living Foundation, how do we protect patients that think that the vaccine doesn’t work as well? Like how can we help them?

Dr. Robert Popovian  08:58

Oh, boy. So…

Conner Mertens  08:59

Loaded question.

Dr. Robert Popovian  09:00

Loaded question, because it’s not a policy solution, Conner, in my opinion, and we like talking policy here and data and legislation all the time. But this is not a policy issue. I think with vaccines, we need to go back to the basics. But what we’ve seen in the over the last couple of years, this past year specifically, is that immunization rate for even adults, even older adults has dropped in the United States. There’s this hesitancy about vaccines, there’s this apprehension by patients to be immunized. And we almost need to go back to the basics of ensuring, teaching, advocating for vaccination because the last thing you want to do, especially the troubling numbers are within the older adults that are not only not getting there, perhaps their COVID boosters, but they’re also not getting their flu vaccine and that’s troubling or pneumococcal vaccine and that’s what we need to start doing is going back to the basics, really talking to patients, talking to them, not mandating stuff, not wagging our fingers, but talking to them, and educating them on the benefits of the immunization. And hopefully, this podcast and our efforts at GHLF will go a long way to be able to do that. And it’s with a sad heart that I have to say this because, again, you’ve heard me say it a million times, you just said that vaccines are the most cost effective intervention ever developed in healthcare. And we’ve almost lost our way in the last few years about what the benefits are and we need to go back to the basics.

Conner Mertens  10:29

I think you’ll be happy to hear I had a doctor’s appointment Tuesday this week, and I got four different vaccines, and my arm is feeling pretty sore today. But it’s nice having that peace of mind. You said it earlier. We love to talk policy here. So I guess then my last question has to be about based on your findings, are there policy recommendations we could propose for future health strategies, especially in light of new variants and the needs for boosters that are constantly evolving?

Dr. Robert Popovian  10:52

I think the strategy needs to be we need to be prepared, because I don’t think people saw COVID coming. We were not well prepared as a country. Thankfully, the private sector stood up and was able to get the immunizations out and treatments out quickly. And it’s not only the vaccines, but also the oral antivirals, the antibody therapies are available for patients. I think we need to be more prepared, there’s going to be more breakouts, we had a very rough respiratory season, this last year, everybody I knew was sick, I got sick, even though I had my flu vaccine, and I had my COVID vaccine, I didn’t have flu, nor COVID, it was something else. So, we need to be on our toes, we need to be aware of these things that are circulating around. And a lot of times we take that for granted, I can tell you and from a policy perspective, we need to be better prepared, better funded for types of outbreaks that we’re gonna be facing. And it’s not just COVID or flu or pneumococcal it’s other things that are coming that we don’t even know about.

Conner Mertens  11:51

Well, Robert, you know how we do things around here, I’m gonna make sure you get the last word. But you know, what I take away is this was a very thorough study, and we learned a lot of really good things. Not only did we save millions of lives through this proven effective vaccine, but we saved a lot of money too. And that’s taxpayer money and that’s out of pocket money. That’s $500 billion, that could be used for other things. So keep getting the vaccine, keep funding vaccine research. And we’ll continue to see these live saved and this money saved. But let’s make sure you get the last word. What do you think?

Dr. Robert Popovian  12:20

No, wihtout a doubt, I mean, what you said was perfect, right? We saved lives through the rapid vaccine development, and also not only the development, but getting shots in the arms, right? We save a lot of money and because of that, and we can’t lose sight of that. And we cannot go back to the days that we were really hesitant about immunization because COVID is one infection, there are many other infections out there. And we need to protect our patients, especially our most vulnerable patients who happen to be elderly or immunocompromised.

Conner Mertens  12:51

As always, thanks for breaking that down for us, Robert, I think there’s some very valuable information in there for our listeners. And to our listeners, don’t forget to subscribe to our podcast on Apple, Spotify, or wherever you might be listening so you never miss an episode, if you have a second helps spread the word by rating our podcast, writing a positive review, and sharing with your friends and family, it’ll help more people like you find us.

Dr. Robert Popovian  13:11

If you have any questions, thoughts, suggestions, comments, please send it to us via email to [email protected]. We want to hear from you and in fact, you may be featured on one of our upcoming episodes like we’ve done with other guests.

Conner Mertens  13:25

And before you go make sure to take a listen to some of the other great podcasts on the GHLF Podcast Network. You can find all of GHLF’s podcasts at ghlf.org/listen. As always, he’s Dr. Robert Popovian.

Dr. Robert Popovian  13:37

And he’s Conner Mertens, see you all next time.

Narrator  13:41

Be inspired, supported and empowered. This is the Global Healthy Living Foundation Podcast Network.

Narrator  00:00

Be inspired, supported and empowered. This is the Global Healthy Living Foundation Podcast Network.

Conner Mertens  00:10

You’re listening to Healthcare Matters, the podcast that pulls back the curtain to help you make sense of complex healthcare economics and policy issues. With us, as always, is Dr. Robert Popovian, joining us from Washington DC. He’s a pharmacist, economist, and the Chief Science Policy Officer at the Global Healthy Living Foundation. We’re also joined today by patient advocate Catherine Hicks.

Dr. Robert Popovian  00:30

And joining me is my good friend, as always Conner Mertens, from Seattle, Washington. My co-host and our Patient Advocate and Community Outreach Manager. Today, as he mentioned, we have a very special guest, Catherine Hicks, who will be joining us. But before we get started, Conner, as always, I’m going to ask you for a number. I’m going to put the number out 57%. What do you think that’s about?

Conner Mertens  00:53

Seahawks chances of winning the Super Bowl this year, baby? A solid 57?

Dr. Robert Popovian  00:57

Oh, my goodness. Okay, well, good. I want Pete to win another Super Bowl. So for sure, I will be supporting the Seahawks, but no. 57% is actually the percentage of formulary exclusions that have questionable clinical and/or economic benefits for patients through Express Scripts for 2023. So we have done a webinar recently, and we discussed this number in detail, but that is it. 57% is actually the percentage of questionable economic and clinical benefit exclusions for patients that have occurred in 2023 for Express Scripts.

Conner Mertens  01:39

So it sounds like today we’re gonna be talking about formulary exclusions, Robert. And there’s you said a lot of fancy big words there. So you’re gonna have to help us break that down. What in a nutshell, is a formulary exclusion?

Dr. Robert Popovian  01:50

So formulary exclusions very simply, the pharmacy benefit management company or the insurer, in some cases, decides that they’re going to exclude a drug from the formulary and provide patients with very little choice. They either have to be switched to a different product, they may have to take a different product that has a different formulation, or in some cases, unfortunately, Conner patients are out of luck. There is no other alternative. So they may exclude drugs that provide zero alternatives on the formulary for the patient.

Conner Mertens  02:20

Well, let’s get Catherine into this conversation nice and early. Catherine, why don’t you introduce yourself, tell us a little bit about who you are and how you’re impacted by these formulary exclusions.

Catherine Hicks  02:30

My name is Catherine and I live in San Francisco, California and I was diagnosed with juvenile idiopathic arthritis as a child and it has persisted into adulthood. In addition, I have epilepsy, as well, diagnosed in childhood and formulary exclusions have been something I fought my entire adult life. There’s always been a struggle to get the proper medication for me. And after being in medically induced remission for about eight years, I had to switch insurance and they excluded the medication I was on. And during that time of why we were fighting and appealing it, I got severely ill and ended up being hospitalized with kidney infection, a very severe kidney infection that briefly dipped into sepsis. My body really didn’t know what to do being taken off that medication with no taper or and no change. So it really went into acute crisis. And I was in the hospital for about 10 days. But it took about three months to actually fully recover to be able to get back on my medications once we had gone through the process of appeals and fighting with them. And during that time, my rheumatory arthritis severely attacked my spine and I have long term spinal damage from that.

Conner Mertens  03:36

Thank you so much for sharing all that. That’s just a face and a story behind what these sometimes complicated words mean – “formulary exclusions.” What do you wish that folks who are in decision making, the ability to make decisions that impact patient care, what do you wish that they knew?

Catherine Hicks  03:50

That their decisions have impacts on large groups of people. Now my medication is not only used for my type of disease, but other autoimmune diseases as well. So there are hundreds of thousands of people that could potentially be affected by your decisions. We’re not a bottom line, we’re not a profit center for you. We are actually people who are trying to live with diseases that affect us every day. And when you make these decisions without our input, without our notice, and you take away the ability to care from the doctors, you really can impact someone’s life for the long term. I have long term spinal damage from this and I’m gonna be dealing with for the rest of my life that will probably eventually require major surgeries. So when you think you’re saving people money by excluding drugs, what you’re really doing is just shifting the money to more severe care that it’s going to be needed. More hospitalizations, more severe things, especially in my case where this damaged to my spine, I’m looking at fusions or disc replacements, probably in the next five to ten years, that’s going to cost you a lot more than taking care of my drug would have. And you also put the burden of proof to a large degree on the patient and the doctor and that also takes away from doctor’s care. Meaning at times the doctors have to be dealing with your paperwork, is also you’re taking away from caring for the patients in the way that they need to be taken care of. So the long term patients suffer in a lot of different ways than just not getting their medications.

Conner Mertens  05:07

Well, thanks for sharing all that. Catherine. I know it’s tough. But as you know, it’s important to share these stories, because it’s the only way that folks really know the impact.

Catherine Hicks  05:14

And that’s why I’m here. And that’s why I do the advocacy work I do. I’m very open on social media about my disease and stuff. And a lot of people just don’t know. They just don’t know about people like me, because you looked at me, I don’t look sick. You know, that’s typical. You don’t look sick with the chronic illness community. And so that is why I do the advocacy work. I do.

Conner Mertens  05:33

Definitely and we’re grateful that you do it. So Robert, like we said, Catherine is really a personal story, and not just a number. But let’s talk some numbers now. There’s definitely some research and studies that I know that you’ve been a part of, and that you talk about, can we dive into some of that research?

Dr. Robert Popovian  05:48

Happy to Conner. You’re absolutely right. So Global Healthy Living Foundation did the original research in 2022, which was published in the Health Science Journal, which was a peer reviewed publication. In it, we evaluated the 2020 to Express Scripts formulary, and we basically evaluated based on the criteria I gave you, whether or not these exclusions are clinically or economically beneficial for patients. And we found that 46% 47% of those exclusions were not clinically beneficial or economically beneficial. In 2023, we’ve re assessed the 2023 formula by ESI. And what we learned is that the exclusions, number one have increased. And number two, what has happened is that the clinically questionable and economically questionable exclusions have increased to 57%. So no more than half of those exclusions really don’t benefit the patient. In addition, we did a separate study that we looked at specifically three drug classes. And Catherine’s comments were very interesting, because there’s a patient behind each of these exclusions. And we wanted to quantify in these three drug classes, which we looked at, which were the anticoagulant drug class, the migraine drug class, and the psoriasis drug class, atopical psoriasis drug class. Of how many people are impacted, and how many of them would have a negative consequence, if one of those drugs was excluded from the formulary. And again, we did the analysis. And guess what, in both cases, in all three disease cases, actually it’s millions of people, not only millions get impacted, but significantly more important, millions are going to have adverse events, they’re going to have adverse outcomes. And both of these studies, by the way, in 2023, have already been completed. Both of them have been submitted to pre-publication website. What a period publication website is that it’s not been yet peer reviewed, but that we are confident enough about the results, and that we’ve submitted it for everybody to see the results to provide us feedback. Because it’s important to get this information out as soon as possible. We just can’t wait for the editorial timeline of journals to be able to get this information out. But having said that, pre-publication websites also allow you to then submit the publication for peer reviewed publication. And that’s what our intent is. Now we’re preparing both of the manuscripts to be published in a peer reviewed journal, we’re going to submit them into multiple journals and see which ones pick it up. But for now, they’re available, they will be in the shownotes, both the links for people to be able to go take a look at them on their own and judge the data on their own merits. And both of those publications have links to my email directly ghlf.org. And you can question some comments to me. But basically, that’s where we are with the research. And Conner, it’s important to get this information out as soon as possible and educate patients. One of the things I’ve learned from Catherine and listening to her is that, number one, you need to be your own advocate in the healthcare system. And then to lean on friends, family, and anyone that will help you to be able to navigate this treacherous healthcare system that we have in the United States, has been really not a patient friendly one.

Catherine Hicks  09:06

And I can speak to that a little more, kind of my own experiences on that. The thing I would say is, being your own advocate is always what I would recommend. But there’s so many things in chronic illness that definitely make that a hard thing to say. I mean, I’ve been on the phone recently, non-formulary exclusion issue with something else, where I was on the phone for 17 hours with an insurance company. So you know, I think it’s one of those things that can be exhausting. But the thing that I would say is you can always educate yourself. And the thing I would say primarily, is educate yourself on those appeal processes. Because in that 17 hours of being on the phone dealing with a pharmacy issue, I was told things that contradicted each other in polar opposite ways. So educating yourself in what an appeal process looks like. Even if you’re not the one doing it, is foremost the first thing I would tell you to do, and it’s really hard to find that information as a patient. With that appeal process, you’ll get a denial letter in the mail and they’ll say that you have 30 days to appeal, but they don’t tell you what they’re doing once you’ve appealed. And you have to dig for that, I had to dig for that for about two days before I found it on BlueShield’s website. So I would say that’s the first thing you want to do. I would say, if you have a great relationship with your doctor, let your doctor do it. You know, that’s their job, they have the insight into how that works. But a lot of people don’t have that ability to have a good relationship with their doctor. I’m blessed. I live in a town with, in an area with lots of great options for rheumatology. There’s rheumatology research done here, I have some of the top notch doctors in my reach. But I know not everyone is like that. And so if you don’t have that, you don’t have the ability, sometimes patients will say, “I just can’t do this.” But I had relied on friends when I was in the hospital. My best friend was with me for that entire 10 days. And she was the one asking the doctors who were coming in what’s going on. She was the one phoning my doctor on my behalf. So there are always people and if nothing else, you can reach out to a person in your patient community.

Conner Mertens  10:55

So Robert, last question, what what are the alternatives to this? How do we combat this? I know that we’ve been taking these studies and research that you’ve mentioned to the state capitals and to DC and we’re trying to get these in front of the right people. But what’s the alternative to formulary exclusions, that are going to allow patients to get this continuum of care that’s so necessary.

Dr. Robert Popovian  11:12

Unfortuntanately, unlike like accumulators, or maximizers or rebate reform or passed through concessions to patients, there isn’t an active legislation currently in the marketplace in legislative efforts, both on the state and the federal side that sort of prohibits these type of exclusions. And the reason that it’s not because it’s been really well hidden by the insurers and the PBMs. And nobody has done anything with regards to really shining light on the issue. So what we’re doing at GHLF is the first step, which is really studying it, demonstrating the harm it does to patients, capturing stories such as Katherine’s in the public domain. And my hope is that patient organizations, provider organizations, you know, consumer groups, employers, will then get together and formulate some type of a legislative policy effort to prohibit this type of activity. This is an egregious activity that flies under the radar. It’s commonly done with drugs that a lot of patients may not even know about. And because there aren’t that many patients that get affected. But still, as I mentioned, in my talk in the beginning, every exclusion includes a patient. And every exclusion should be taken seriously and every exclusion should be evaluated and judged based on its merits. So right now, nothing, but my hope is that it will take on some type of a legislative policy angle in the near future as we get more and more information out there.

Conner Mertens  12:43

So Robert, as we talked about all the time, I’ll make sure you get the last word in here. But what I really take away from this podcast episode is formula exclusions are just another one of those tools really holding back patients. And not just holding them back, but doing active harm. And we’re really trying to step up and make sure the world knows and that decision makers know Catherine’s story, and the story of millions of other patients that these exclusions truly, truly harm them. And we have to be taking a closer look at how we can prevent the harm being done to patients. But what’s on your mind, let’s make sure you get the last word.

Dr. Robert Popovian  13:12

So Conner, I’m gonna follow up with a couple of things you just mentioned. Number one exclusions harm patients. Exclusions of drugs formularies, of the three largest formularies of optim, CVS Health and Express Scripts are increasing year over year. Between last several years there’s about a 34% annual increase in number of exclusions. That’s number one. Number two, from our studies at Global Healthy Living Foundation, we have basically discovered that not all of these exclusions are clinically or economically beneficial to patients. Some of them make sense, you’re excluding a brand name drug for generic, specifically, like a Lipitor brand is excluded for a tour of a statin generic, that’s fine. But what we’re finding is that more than 50% of these exclusions are not economically or clinically beneficial for patients. And number three, and most importantly, and as I mentioned, every patient gets impacted. A lot of patients get impacted. Number of patients impacted, and number of patients that potentially can have adverse events from this formula switching is significant. It’s in the millions. It’s not in the 1000s. It’s in the millions. And even in a drug class that is not commonly used. Like anti-coagulants is not something a lot of people take. Even in that drug class, millions of people are impacted with exclusions, and the number of people with adverse events or adverse outcomes are in the millions. So something to pay attention to. And we hope that everybody goes and reads our research that we’ve done and we will be publishing. But it’s in pre-publication server, as I mentioned, and please let us know what you think.

Conner Mertens  14:47

Well, as always, thanks for breaking that down for us, Robert. And if folks want to learn more about formula exclusions, be sure to check out our show notes where we’ll have the link to our recent webinar where Robert breaks all this down. And don’t forget to subscribe to our podcasts on Apple, Spotify, or wherever you might be listening, so you never miss an episode. If you have a second, help spread the word by rating our podcast, writing one of those positive reviews, and sharing it with your friends and family. It’s going to help more people like you find us.

Dr. Robert Popovian  15:11

And if you have any questions, thoughts, or suggestions for us, you can send us an email at [email protected]. And we may have you on one of our podcasts. I mean, that’s how we got Catherine to come on and talk about her experience. And by the way, I want to thank you, Catherine, for doing this.

Conner Mertens  15:26

And before you go, make sure to take a listen to some of our other great podcasts on the GHLF Podcast Network. You can find all of GHLF podcasts ghlf.org/listen, she’s Catherine Hicks, and he’s Dr. Robert Popovian.

Dr. Robert Popovian  15:39

And he’s Conner Mertens, see you all next time.

Narrator  15:43

Be inspired, supported and empowered. This is the Global Healthy Living Foundation Podcast Network.

Narrator  00:00

Be inspired, supported and empowered. This is the Global Healthy Living Foundation Podcast Network.

Conner Mertens  00:06

You’re listening to Healthcare Matters, the podcast that pulls back the curtain to help you make sense of complex healthcare, economics and policy issues. Joining us, as always is Dr. Robert Popovian tuning in from Washington, DC. He’s a pharmacist, an economist and the Chief Science Policy Officer at the Global Healthy Living Foundation.

Dr. Robert Popovian  00:27

And joining me is my good friend, Conner Mertens, from Seattle, Washington, my co-host and our patient advocate and community outreach manager who does an outstanding job working with our patients. So Conner to start this episode, I have an important number as always, for you, and I would like to share the number 30%. Does that ring a bell for you? It’s a number you may have read in the news lately, perhaps?

Conner Mertens  00:50

I mean, I think October is about 30%, scarier and spookier when there’s a Friday the 13th. So something along that line?

Dr. Robert Popovian  00:59

No, but I have to say it’s sadly it has to do with drug shortages that in the United States, drug shortages increased by nearly 30%, between 2021 and 2022, according to a report commissioned by the Senate earlier this year, and this is an excellent transition to get into our topic for today.

Conner Mertens  01:23

That’s interesting. You mentioned that Robert, this drug shortage, because I’m not just hearing from patients in the US about it. I’m hearing from our international patients as well. I don’t think it’s something that we’re just seeing here. But you’ve been, for the past several weeks, attending and spoken at several national conferences. What are the top three topics that are commonly coming up on these presentations?

Dr. Robert Popovian  01:43

So not surprisingly, you know, Conner, you and I have talked about this, we’ve had guests over to talk about these issues in the last few episodes that we’ve done. Not surprisingly, the number one thing you hear about drug pricing specifically about inflation Reduction Act and the impact on drug prices. The second thing, obviously, as always, you hear probably more than anybody else at GHLF, because you get calls from patients, has to do with healthcare affordability, and patient’s concerns about health care being affordable for them. But surprisingly to me, in these last few conferences, I attended one last week that had to do with cancer. It was a cancer conference that I spoke at. This week, I was at a cardiovascular conference. And in both of these conferences, the topic that came up was drug shortages. And it seems to be an epidemic of drug shortages that are going on. But I’ve been involved in this space for a while. So I have some my own thoughts. And it was interesting to hear that from the attendees basically.

Conner Mertens  02:41

Yeah, I mean, obviously, we’ve discussed these topics of drug pricing and the IRA, the inflation Reduction Act, and just healthcare affordability generally in previous episodes. But we haven’t addressed this issue of drug shortages yet. Why don’t we dive into that topic? Can you just kind of break down for our audience what drug shortages are?

Dr. Robert Popovian  02:58

Yeah, so it’s nothing new. First of all, we’ve been dealing with drug shortages, at least since I’ve been aware of it for the last two decades, if not longer. But I think he the ebbs and flows over time. We sort of get a handle on them. And then the drug shortages spike again. And it has to do commonly with concerns that patients and providers have. And they reach out to, for example, congressional members, and they look into it more closely. But it seems to me, Conner, that there’s been a rash of drug shortages or various type of drugs in the last few months. And that’s why Senate basically commissioned this report. And we were able to quote that 30% From but there’s been also hearings on the hill. And there’s a lot of concerns, obviously.

Conner Mertens  03:42

What kind of drugs are we seeing that are most commonly impacted, Robert? I’ve heard of Ozempic, and maybe some cancer drugs, some chemo drugs, what are we seeing?

Dr. Robert Popovian  03:50

So we’re seeing it all over the map? I mean, traditionally, the shortage has has been in the sterile injectable space. Right? So we’re talking about drugs that are manufacturing is very complex. They’re injected into patients, and we hadn’t seen it much in the cancer or chemotherapy space, except for pediatric patients a while ago, which I first got involved in this topic. But you’re right, and there are different issues. Right, Ozempic, it’s not a manufacturing issue, it’s more a demand issue that’s going on. A lot of people are demanding it and the manufacturers are trying to supply that as soon as possible. In the other cases with the chemotherapy drugs, it’s another issue with regards to distribution of this drug evenly across different markets. But with the sterile injectables like normal saline and things like that, that has to do with directly with manufacturing, where there has been issues with regards to where manufacturing has dropped. And there are reasons for that so.

Conner Mertens  04:43

Well, I mean, let’s get into that. What are the reasons for these shortages?

Dr. Robert Popovian  04:46

Yeah, primarily is economics. Frankly, Conner, the number one reason for many of these shortages, not ozempic related, has to do with economics. It has to do with regards to complexity of these drugs being manufactured. And we have a good thing going in the United States where we have a very robust as you know, we’ve talked about this on this podcast, a good generic industry. But what the generic industry has done also, with regards to sterile injectable of these very complex drugs is push these generic medicines that have been around for a long time, their price is so low that the manufacturers are technically not making any money. So what happens, they end up like dropping out and stop manufacturing those drugs. And that also is for primarily economic reasons. It’s just not making any money off of them. So they stopped manufacturing them, and then you end up having a shortage. But that has to do with that part of the drug. The other reasons are what I alluded to, which are cancer chemotherapy drugs, is the distribution. Majority of that shortage issue with cancer chemotherapy drugs that we’ve seen has happened in community oncology centers, and not necessarily in large oncology practices and not practices, but hospitals like Sloan Kettering. And the reason being is that there’s uneven distribution of those drugs. These large institutions overbuy and suppliers probably send them a lot more. And what happens is that the community oncologist who doesn’t treat as many patients may end up having a shortage. And then the third reason-so we have economics, we have uneven distribution. The third reason is really reliance on raw materials. We’ve been far too long relied on China for raw materials. And we’ve seen a rash of shortages on antibiotics that we typically take for granted, you know, all of us get antibiotics for various colds and ailments. And we’ve seen a rash of those shortages. And that has to do with raw materials. There’s been a disruption in the supply chain of getting these raw materials out of China and too much reliance on China actually. So that needs to be addressed. So there’s different reasons why we’re seeing these different shortages in different therapeutic categories.

Conner Mertens  06:49

I think one of the questions that we always like to get into on this podcast is how does this impact patients? And I mean, you’re a pharmacist. So you clearly have first hand knowledge of this. What are the consequences for patient care with the shortages?

Dr. Robert Popovian  07:01

Well the consequences can be severe, right? Let me give you my personal example of shortage. My daughter had a respiratory infection a few months ago, and we went to the physician, the physician prescribed some antibiotics, it’s typical antibiotic you would get for respiratory infection, I’m talking about amoxicillin. And I ended up going to the pharmacy to pick it up. And the pharmacist said, we don’t have it. And that was unheard of right? You would never walk into a pharmacy and not be able to get amoxicillin. And she said, you know, “We’re backordered for less few days.” And she said, “Come back tomorrow.” And the consequence for patients is delaying care. Now, this was a respiratory infection, it was important to treat the infection, obviously, antibiotic is important, I was able to go to a different pharmacy and get it. But imagine now, if a patient shows up for their chemo treatment, and there’s a shortage of the chemo drug. Or worse, if it’s some type of a cardiovascular disease. These things have consequences for patients if they are not able to acquire these drugs on a timely manner. So patient care does suffer and there could be delay in care and delaying care as you know, Conner leads to bad outcomes for patients.

Conner Mertens  08:09

And as you mentioned before, this isn’t a new issue, right? Like you’ve dealt with this, and you’ve seen this happen in the past.

Dr. Robert Popovian  08:16

Yeah. And it’s not. And really, we’ve seen it ebb and flow over years. I personally saw it intensely come up about a dozen years ago. I had just moved to DC actually and there was a lot of hearings and everything else regarding drug shortages that had to do with cancer chemotherapy drug for pediatric patients, actually. Which is even scarier, right? We’re talking about little children who require that kind of therapy. And you know, as I mentioned, I mean, economy drives a lot of it. We’ve suppressed prices so much in the United States that some of these manufacturers of specialty sterile injectables, they just don’t make enough money. So they just get out of the market. And they say we can’t make any money so we’re not going to supply then you’re ending up with shortages because of that. So that’s one reason the other reasons are, you know, we discussed too much reliance on China. Maybe regulatory issues. So there are solutions that we can suggest that can fix the problem.

Conner Mertens  09:08

Well, then let’s get into them. What are the solutions that you suggest? How can we combat these shortages and make sure that patients are getting a continuum of care and not missing out?

Dr. Robert Popovian  09:16

So Conner, one of the things that we need to do is really rethink about our pricing policies in United States. If you think about the Inflation Reduction Act, technically, we’ve put a ceiling on certain drugs now, right? Because there’s going to be a price setting for certain medicines. And maybe it is time for us to think about a floor for prices that yeah, it’s great that we have this robust generic market where 90% of prescriptions written in the United States are generics. But because of this competitive landscape, have we suppress prices so far down that some manufacturers drop out because they can’t make any money? Or worse, let’s let’s say if FDA walks into a manufacturing facility and closes it up because of safety concern, then the supply chain just completely gets obliterated and that drug doesn’t exist. So what I’m saying one of the solutions may be for us as a society to think about, a floor for prices. That certain prices for certain medicines should not be dropping so far down, that it makes it non-lucrative for these manufacturers to stay in the game. There are different mechanism and levers that we can do that through government policy, that we can fix it. The other thing is what President Trump did, and definitely President Biden has followed through is to create policies that we’re less reliant on China on not only manufacturing, but these raw materials and things like that, that we are able to procure these things from other countries rather than just China. Because, again, we saw with the pandemic, as soon as the supply chain broke off, we ended up having shortages of these drugs. The third thing is regulatory. But you know, make sure that the FDA is walking in and closing a facility that there’s a plan in place well in advance to be able to make sure that there’s no shortage of the medicine because of that action. And in a non-related pharma side, think about what happened with baby formulas, right? A manufacturing facility that was supplying almost 80% of the supply for baby formulas in the United States. You know, the FDA rightfully went in, shut it down. But because of that we had massive shortage of baby formula. Remember, people were like importing baby formula from Canada and European countries, because there was significant shortages. And lastly, I think it’s the uneven distribution that we talked about, especially with the chemotherapy drugs. I really think that’s more of a distribution issue than manufacturing shortage issue. It’s hard because a lot of wholesalers, they sell these large volumes of these medicines to institutions that see a lot of patients. And what happens because the uneven distribution affects community oncologists that are not seeing as many patients, but do see patients that require these medicines. So how do we make sure that there’s no shortages for those type of practices?

Conner Mertens  11:55

Well as always, thanks for breaking that down for us, Robert. You know, we’re going to make sure you get the last word in here. But what I’m taking away is these drug shortages, they’re preventable issue. And ultimately, the patients are the ones who suffer. And the folks that are vulnerable already are going to have serious problems with their continuum of care if these drug shortages aren’t dealt with, but let’s hear what you got to say.

Dr. Robert Popovian  12:14

No, you’re absolutely right. I’m gonna use a quote from a great American James Carville. You know him is from Louisiana. And he quoted the phrases, “The economy is stupid,” during the Clinton administration. And I’m going to say the same thing is the economics of the generic drug pricing in this country that are causing a lot of the problems with the drug shortages. Yes, there’s regulatory issues we need to address we need to address the uneven distribution. We need to make sure we are not reliant on other countries. But the bottom line is that majority of the shortages are caused by the way that we’ve set up the pricing policies in the United States with regards generic. Especially with regards to generic sterile injectable, these complex medicines that are very expensive and difficult to make. And unless we address the economics of it, we’re going to continuously go through this ebbs and flows of shortages.

Conner Mertens  13:02

I couldn’t agree more. Robert, thanks for breaking that down for us. And thank you to our listeners for tuning in to another episode of Healthcare Matters. Don’t forget to subscribe to our podcast on Apple, Spotify or wherever you might be listening so you never miss an episode. And if you have a second helps spread the word by rating our podcast, writing one of those positive reviews and sharing it with your friends and family. It’ll help more people like you, find us

Dr. Robert Popovian  13:22

If you have any questions, thoughts or suggestions, as always, please reach out to us. You can send us an email at [email protected]. As I mentioned earlier in the podcast episode, the reason we discussed the drug shortage issues because it kept coming up in various meetings and settings that I was involved in. So we may use some of your thoughts and ideas in future episodes. Actually, if you’re willing to come on, we will have you and host you on our podcast right, Conner?

Conner Mertens  13:50

Absolutely, Robert. And before you go, be sure to take a listen to some of our other great podcasts on the GHLF Podcast Network. You can find all of GHLF’s podcasts ghlf.org/Listen. As always, he’s Dr. Robert Popovian.

Dr. Robert Popovian  14:03

And here’s my good friend Conner Mertens. See you all next time.

Narrator  14:08

Be inspired, supported and empowered. This is the global Healthy Living Foundation Podcast Network.

Narrator  00:00

Be inspired, supported and empowered. This is the Global Healthy Living Foundation Podcast Network.

Conner Mertens  00:06

You’re listening to Healthcare Matters. The podcast that pulls back the curtain to help you make sense of complex healthcare economics, and policy issues. As always, we’re joined by my partner in crime, Dr. Robert Popovian. Joining us from Washington, DC. He’s a pharmacist, economist, and the Chief Science Policy Officer at the Global Healthy Living Foundation.

Dr. Robert Popovian  00:27

And joining me is my good friend as always Conner Mertens, from Seattle, Washington. He’s my co-host and our patient advocate and community manager at Global Healthy Living Foundation. He does an outstanding job working everyday with patients to meet their needs, answer the questions. And Conner you know the drill, we start off every episode with me giving you a number and the number for this episode is 2,000. And when I say 2,000, what does that mean to you?

Conner Mertens  00:56

I don’t know much about 2,000. But I’m going to take a shot and tell you that 20 million is probably the amount of hearts broken when we found out Taylor Swift and Travis Kelce are starting to become an item.

Dr. Robert Popovian  01:06

You know what I’ll take the over on that one, to be honest with you, I think, probably move 200 million or something. But no $2,000 is the cap that was implemented to the inflation Reduction Act that applies for patients on Medicare Part D. So their prescription drug benefit program. Which means that patients for the first time in Medicare Part D have actually an out of pocket cap, that means they will not be required to spend more than that. And in fact, Conner, you know, one of the secrets was that Part D of the health benefit plan for prescription drugs was the only health benefit plan, either into commercial insurance or even the government insurance that did not have a cap until the Inflation Reduction Act was passed.

Conner Mertens  01:50

So today, we’re gonna be talking the Inflation Reduction Act, which is a topic we’ve covered before on this show and is covered last week on a really good episode of The Health Advocates and other great podcasts in the GHLF Podcast Network. We’re definitely going to dive in and get some updates on it since there has been some updates since our last discussion. Robert, what are the big wins and misses for patients, concerning the IRA?

Dr. Robert Popovian  02:12

So Conner, you know, with any large legislation, Inflation Reduction Act was a huge piece of legislation that passed last year, there’s always benefits and risks for patient and specifically when it comes to biopharmaceuticals. You know, the benefits, without a doubt, we just talked about it – the $2,000 annual cap that patients are going to have with regards to out of pocket cost exposure. They’re not going to be required to pay more than, that this is the first time that Part D, as I mentioned has a cap for patients. The second part of the benefit is that unlike other parts of the insurance model, whether it’s commercial insurance, or Part B as in boy, Part D required patients or seniors to pay an out of pocket costs for vaccines. And because of the Inflation Reduction Act that out of pocket cost is not zero. So just like other adults, or kids that enjoy insurance to other government type of insurance plans or private insurance, seniors are not going to have to be paying anything out of pocket. And the third thing is really the insulin cap. And I know we’ve talked about this in one of our previous episodes when we talked about IRA and insulin cap of $35. Really, what has happened over the last year we have talked about in previous episodes is that the three insulin manufacturers in the United States, Sanofi, Novo Nordisk, and Lilly have decided that they’re going to have a cap of $35 for all patients, not just Medicare patients, which Inflation Reduction Act does. So in essence, what the IRA has done is taken what the manufacturers are going to do for everyone and codified into law for seniors. And the risks, what’s going to happen to patients? Well, I want to talk about what the Genentech CEO said, which is, you know, as a company that decided to delay a molecule that was intended for treatment of ovarian cancer, this is a drug that they’re investigating, and they’re hoping to bring to the market and apply for FDA, you know, evaluation, and they’re going to delay it because ovarian cancer is not a large market. And they’re going to see whether or not the drug actually worked for lung cancer and prostate cancer, two of the larger cancers. And the reason being is now is because of due to the Inflation Reduction Act, as soon as a drug gets approved by the FDA, the clock starts ticking with regards to the timeline that the government then can get into negotiating or set prices. And therefore pharma companies are reluctant to bring out molecules or drugs that are for small population. So this is going to hurt these patients who have rare diseases or ultra rare diseases, because they want to see if these drugs work for larger patient populations, that they can sell more of it. And therefore, it’s an unintended consequence of this law, that it’s going to have some negative effect for patients who are suffering because pharma companies, because of this law, and the way it’s set up, have to wait until to see if the drug works for larger populations before they bring it to the market. So that’s been the major negative thing, is the impact on innovation and access to medicines for patients. But, you know, as always, the risks and benefits are patient.

Conner Mertens  05:14

Yeah, so it’s something that we again discussed on our last episode regarding the Inflation Reduction Act was the unintended consequences that we see in R&D, the research and development of these drugs. So what are the other unintended consequences of the implementation of the Inflation Reduction Act?

Dr. Robert Popovian  05:30

So couple of things that actually we didn’t really discuss on our episodes, and I’m not sure if we’ve discussed it in any of our podcasts is that one of the other things that Inflation Reduction Act did is that they kept how much insurance companies, or pharmacy benefit management companies can increase the premiums. And because of that notion that they cannot increase premiums, because of the issue that now they have caps on how much they can charge patients, which is a good thing, both of those. And because they no longer, part of the benefit design, was that they cannot pass the cost to the government that they used to for the super expensive patient. There’s a possibility, it’s very good possibility, and it’s probably going to happen, is that they’re going to start ratcheting down to benefit itself. What does that mean for the average patient? Is that you may see more step therapy and prior authorization, and even removal of drugs, like exclusion of drugs from formularies, because the incentive is going to be for them to really ratchet down the benefit, because they’re not going to be able to either pass the cost to the government, they can’t charge the patients anymore, and they can’t increase the premiums, which are three great things for patients. But that’s another unintended consequence that you can basically foresee coming.

Conner Mertens  06:41

Yeah, I mean, step therapy and formulary exclusions are certainly topics that we’ve covered extensively, as well, and the consequences of that have on patient care and their health overall. Robert, what are the good parts of the IRA? How is this helping patients?

Dr. Robert Popovian  06:55

Well, definitely, you know, the cap, the annual cap, the vaccine zeroing out, and also the insulin cap that is going to be codified into law. One of the things that has come up Conner, we talk about what’s new, is that two weeks ago, CMS – Center for Medicare and Medicaid Services – published the initial list of drugs to be negotiated. And there were some surprises actually in that list. And we should discuss that and put our take into it.

Conner Mertens  07:21

Definitely. That was something that we didn’t have the last time we discussed the Inflation Reduction Act was this list of medications that CMS was going to release. So what are your thoughts on it? Is it a good list? Bad list? Ugly list? What are we thinking?

Dr. Robert Popovian  07:33

I think it’s a 50/50. To be honest with you, there’s some not so surprises on the list of drugs that are going to be negotiated or price set by the government. These are expensive medicines that are being sold to many patients and their high cost spending drugs for Medicare. But it was interesting that they also put in four drugs on the list, three of them being small molecules that actually lose their patent life prior to the publication of the date of the price, which is going to be January 1, 2026. Which sort of doesn’t make sense because you know, this, as soon as products lose their patent and generic molecule, especially small molecules are introduced in the market, not like biosimilars, the market collapses, and these prices of these drugs, bought them out at 90% reduction. So it was interesting to see that there were three small molecules that are going to lose their patents prior to the enforcement of the price on the January 1, 2026, that are going to be going off patent. So in essence, it doesn’t make sense what they are on the list. The fourth medicine actually is a biologic, Stelara, that already has a biosimilar that’s been approved by the Food and Drug Administration. And it’s supposed to come out in 2025. So again, this drug is going to have competition. So again, it doesn’t make sense, because remember, the premise of this law was that we’re going to look at drugs that have no generic competition, that they don’t have any biosimilar competition, and we’re going to basically start price setting them. And in essence, the initial list released sort of violates the essence of what this law was supposed to be doing. So those were the surprises to me. And then the other thing, Conner, they did bypass couple of oncology drugs that are high cost medicines that should have been included on the list. And that was surprising in a way that they didn’t include them. Now, you could think about it that they perhaps wanted to bypass oncology medicines, but that’s not the case because a couple of other oncology medicines were included on the list.

Conner Mertens  09:31

So we talked about the benefits and the risks for patients with this IRA. But what are the biggest misses? How does this just flat out come up short?

Dr. Robert Popovian  09:40

You know, Conner, we’ve talked about this on multiple episodes. The biggest issue with the way that the market is for pharmaceuticals, the way that PBMs and insurers sort of take advantage or scheme the market, is that when drugs are negotiated, and there’s significant rebates and concessions given by pharma companies, none of those rebates and concessions get passed back to the patient at the pharmacy counter. That means when you and I, and Ben our producer or anyone else shows up to the pharmacy and picks up a medicine, if that medicine has been negotiated, the price of that medicine has been negotiated to be significantly lower than what the retail price of that medicine is. We don’t get to benefit from that. So if we have a coinsurance or deductible, we have to pay these inflated retail prices, instead of the significantly lower negotiated prices that can be about 40 50 60 70% less than the retail price. And that was the biggest miss. They could have done it. They didn’t do it. Patients would have significantly saved money at the pharmacy counter. And I have to say, I blame both the previous administration and the current administration that they have not addressed this issue. Pharmaceuticals are the only benefit in the healthcare marketplace. And our listeners have heard me say this multiple times, is the only benefit in the marketplace, when a patient shows up and has a deductible or coinsurance, they’re paying that deductible coinsurance based on an inflated retail price instead of a negotiated price in every other segment of the healthcare system. We know that Ben is having some dental issues. When he shows up to his dentist’s office based on the negotiated, he pays his deductible or coinsurance based on a negotiated price. That doesn’t happen in the pharmaceutical, somehow PBMs, and insurers have bamboozled the government and the employers and both administrations have dropped the ball and are not helping out patients at the pharmacy counter.

Conner Mertens  11:31

Well, as always, thanks for breaking that down for us, Robert. I know that this is going to be a continually evolving issue and topic that we’ll keep everyone and our listeners up to date on because it is ever-changing and it is important. It impacts folks lives and daily in the healthcare system. You know, I really take away from this is obviously, there’s some good and some bad. But we really should be concerned about things like research and development and the production of emerging treatments and therapies that can be impacted by the Inflation Reduction Act. Just my two cents. But you know how it goes around here, Robert, we’ll make sure you get the last word. What do you think?

Dr. Robert Popovian  12:05

No, your two cents are really good two cents actually. And I have to say whether you believe Congressional Budget Office, or you believe any of the private analysis that has been done, Inflation Reduction Act will have a negative impact on innovation in this country. Uh, you know, the answer to that question has been answered both by the government agencies as well as private consulting firms. Now the issue is, to what extent? And how does this impact our patients in the Global Healthy Living Foundation and otherwise, that really need these innovative medicines. And that’s to be seen. It’s an unknown. And we will see this law play out for the next few years as we go through the process. But Conner, you deal with our patients every day. And I know the first and foremost thing on their mind is that, is there hope for me to be able to either cure or manage my illness? And is that in the current model? Do we have anything currently or is it in the future? And the future is the one that looks really murky at this time.

Conner Mertens  13:05

Well, thanks for breaking that down for us, Robert. I think there’s definitely some valuable information in there for all of our listeners. And to our listeners, don’t forget to subscribe to our podcasts on Apple, Spotify, or wherever you might be listening, so you’ll never miss an episode. If you have a second help spread the word by rating our podcast, writing one of those positive reviews and sharing it with your friends and family. It’ll help people like you find us.

Dr. Robert Popovian  13:28

If you have any questions, thoughts or suggestions for us, you can send us an email at [email protected]. And we’re always looking for new material, new questions. In fact, Conner our podcast with Shilpa, last time we did it for regarding her journey about getting her vaccine, has gotten a tremendous amount of feedback in social media. A lot of people have sort of empathized with what she has gone through. And how that came about is that you know, we got a note from Shilpa that said, “This is what happened to me,” and we invited her to come on the podcast. So please send us your thoughts. And if we see something compelling, we will definitely discuss it. But we may even have you come on board and talk to us about it. So please do contact us.

Conner Mertens  14:12

And before you go, make sure to take a listen to some of our other great podcasts on the GHLF Podcast Network like “The Health Advocates,” which covers the IRA in their last episode. You can find all of GHLF’s podcasts at ghlf.org/listen. As always, he’s Dr. Robert Popovian.

Dr. Robert Popovian  14:28

And he’s my good friend, Conner Mertens. We’ll see you all next time.

Narrator  14:33

Be inspired, supported and empowered. This is the global Healthy Living Foundation Podcast Network.

Narrator  00:00

Be inspired, supported and empowered. This is the Global Healthy Living Foundation Podcast Network

Conner Mertens  00:10

You’re listening to Healthcare Matters, the podcast that pulls back the curtain to help you make sense of complex healthcare economics and policy issues. With us, as always, is the incomparable Dr. Robert Popovian joining us from Washington, DC. You know, he’s a pharmacist, he’s an economist, and he’s the Chief Science Policy Officer at the Global Healthy Living Foundation.

Dr. Robert Popovian  00:29

And joining me is my good friend, Conner Mertens, from Seattle, Washington, my co-host and our numero uno, community outreach manager and patient advocate extraordinaire.

Conner Mertens  00:39

Robert, I’m really excited to be back and we have a special guest today my good friend and colleague, the brilliant Shilpa and we’re gonna get right into this episode.

Dr. Robert Popovian  00:53

So yes, let’s welcome our dear colleague, Dr. Shilpa Venkatachalam. Welcome aboard Shilpa. Why don’t you briefly introduce yourself and tell us what you do at Global Health in foundation?

Dr. Shilpa Venkatachalam  01:05

Sure. And thank you, Robert and Conner for having me as a guest today. So my name is Shilpa Venkatachalam. I am the Director of Patient centered research and ethical oversight at the Global Healthy Living Foundation, where we do what’s called patient centered research. And that means we bring the patient voice to the table in all the research that we do. I’m also someone who lives with rheumatoid arthritis. I was diagnosed in 2017. So quite a few years back, but not that long. And I’ve of course, cycled through several medications for my own treatment. I’ve gone through a diagnosis, a misdiagnosis and then back to another diagnosis. So again, it’s very nice to be part of this conversation.

Dr. Robert Popovian  01:49

So I would like to make it clear to our audience Shilpa is here today, not to talk about her job, and she does great work at GHLF. But she’s here today as a patient who has a very interesting story to tell regarding the real life trials and tribulations patients go through in certain states with regards to acquiring vaccines. So Shilpa tell us what happened, because you and I have talked about this, and you’ve explained it to me, and I would love our audience to hear it from you firsthand.

Dr. Shilpa Venkatachalam  02:16

Sure, goodness, every time I have to talk about this, I really get fired up because it was one of, I don’t want to see the worst experiences, but close to it. So as you know, with conditions like rheumatoid arthritis, there’s an increased risk of contracting infections. This is an established fact. But my story today, Robert, is not really about the availability of vaccines or the need to take them, especially if like me, you’re living with a chronic condition, chronic underlying condition, you’re taking medications that may suppress your immunity. Today, my story, and I’m really eager to share it, and so thank you for having me, again, is about how, despite the availability of these vaccines, many of us who actually need it are unable to get it because of the many system level barriers. And you can see already my emotion is starting to pick up because I just relived this entire thing every time I’m retelling the story. So you know, as a patient, it’s really frustrating enough to have to deal with chronic pain, to have to deal with chronic fatigue, doctor’s appointments, X-rays, imaging, bloodwork, medications. And then on top of all that, when you have to deal with roadblocks over and over again, to get something that you need, that your doctor has recommended to you, that guidelines have recommended. It’s really actually quite demeaning, frustrating, a waste of time, and discouraging when you’re not able to get it. So let me give you an example. I had to recently get the shingles vaccine, and I’m talking about the Shingrix not the Zostavax. Because I initiated a certain treatment for my rheumatoid arthritis. And I just want to say I’ve been through this before. So it’s not the first time I’ve tried to access Shingrix. I gave up last time because of all the roadblocks. So this time, I was determined as hell to find a way to get that vaccine because I needed it. And I was also plain fed up because I knew what was coming. So there’s sort of a mix of emotions. And this medication in particular, that I was supposed to start for my rheumatoid arthritis, it increases the risk of shingles for those on it. And hence the recommendation is to get the Shingrix vaccine before you start the medication. And I want to say this at the start. I’m not pointing fingers at anyone. Everyone in this play that I’m about to talk to you about was wanting to help, right? They all wanted to help. But the problem is that every time I tried to get access to the vaccine, there was always a roadblock. So I don’t know how much in detail you want me to go into my story but honestly, if I don’t go into the detail, you might not be able to grasp the gravity here. So I was advised to get the vaccine. And so off I went to the pharmacy to get it, right? I hadn’t started my new rheumatoid arthritis medication because I wanted to get the vaccine at first. So I went to the pharmacy, and I got told at the pharmacy, it’s not possible, you’re not 50, we can’t give it to you. You’re not eligible is what they told me. They said, the system and by the system, I’m guessing they meant the computer pointed out that you’re not 50. And hence, there is no eligibility and so we can’t administer it to you, is was what I was told. And I was thinking, “Well, my RA is not going to wait until I’m 50 to progress.” So I tried to explain to them that I had rheumatoid arthritis, that I was immune compromised because of the medications I was taking, and that I was eligible to get the Shingrix, and in fact, my doctor had recommended it. I explained this to them over and over again and they understood. And they said, “We understand what you’re saying, but we’re not able to administer it to you.” Fine. I called my doctor’s office. And they said they’ll send a note and a prescription. But actually the pharmacy said, “No, ask your doctors to send us a prescription.” So they did. The pharmacy got a hold of the prescription. Initially, they insisted that the prescription had not come through, but it eventually did. They got the prescription and now that they had the prescription, I was thinking, “Okay, great, all sorted. Let me go back.” So I went back to the pharmacy, and I asked them, “You know, you have the prescription now can you give me the vaccine?” And they said, “Well, we have the prescription, we can give you the vial, but we can’t administer the vaccine to you.” So it’s like, hang on. So how am I supposed to? And I asked them, I said, “How am I supposed to give the vaccine to myself?” And they said, “We’re really sorry, the system is not allowing us to administer it to you. Maybe ask your doctor or another clinic or a hospital to give it to you.” At this point, I’m thinking, “Fine, just stay calm, and go to the next steps.” I called up about five or six different clinics, each clinic told me they can’t administer a vaccine from outside, within their facility. So I called up the hospital where I was being treated for my own care, spoke to my team, they found out from their nurse practitioners, and they got a notification from the hospital that they could not administer the vaccine for the same reason, that this was an outside vaccine that was being brought into their property. So now I’m thinking, “Okay, I have the vial, I have the injection, I have people who know how to give a vaccine, and yet I can’t get the vaccine.” That’s how frustrating and unbelievable this whole thing is. So I called again, I called everyone again, the pharmacy, the hospitals, the clinics, my doctors, my care provider team. And again, everyone’s trying to help and see what’s going on, and why I’m not able to be given this vaccine. Eventually, honestly, I don’t know what happened eventually. But at one point, the pharmacy called me and said, you can come we can give you the vaccine. And that’s how it all happened. I just want to say before I stop, that all these delays, I mean, it’s one thing that the vaccine, you know, I spent hours and weeks – I’m not kidding – weeks to get this vaccine that I should have got very easily. And all these delays with the vaccinations meant delays to initiate my treatment for my rheumatoid arthritis. And so I went into flare after flare, I was put on opioids, I was put on painkillers, to control my pain, I was not able to sleep, I was not able to work. I was frustrated, I was under a lot of mental and emotional distress because I had to travel back home to India in a few weeks. And I couldn’t without the vaccine because I couldn’t start my medication. And seeing all this, everyone my family, my friends, were all frustrated because they were seeing what I was going through. So that’s my story in a nutshell and I’m sorry to go into so much detail about it.

Conner Mertens  08:39

No, no Shilpa thank you so much for sharing. That really does sound like some sort of horror story and completely unfair. And you know, it sounds like at times, we make it more difficult as opposed to less difficult for patients to acquire vaccines in the United States, especially something like this, which is so clearly needed for you. And while it’s also delaying your care, can you expand on that a little bit more?

Dr. Shilpa Venkatachalam  09:01

Sure. And I really I couldn’t agree more, especially after having gone through this. And I’m, you know, as a researcher, I’m someone who works on vaccines and the importance of vaccines. But after this experience and my previous experience accessing the Shingrix, having vaccines available is one thing. But there is no use having something in stock, and then having multiple barriers to accessing what’s in stock. I was absolutely shocked that getting a highly effective preventative medicine, a vaccine, wasn’t easy or quick. You know, I expected that I would walk into a pharmacy, get vaccinated and then move on to the next step, which is to start my treatment. Because we get told over and over again, research tells us don’t delay your treatment, right? Your outcomes are going to be worse if you delay your treatment. So I was doing everything right as a patient could. And I was working the system here trying to get that vaccine. Trying to stop the medication, which is what we constantly tell patients. Navigating insurance to gain access to the medication that my body needed at that point, right? I was doing everything I could. What I realized, eventually after many weeks of fighting, and again, I’m not fighting against one person, I’m not saying this is one person’s fault. In fact, what I realized was, this wasn’t a person related fault at all. I began to see how many ways my frustration as a patient running around in circles was in vain. Because it isn’t that people involved don’t want to help. If it was one person, you can solve that problem. But here, it’s a system level fault. We live in a healthcare system that is severely fractured. And that poses a barrier at every step of the way to the patient. It’s not the onus of the patient to spend hours, weeks trying to get access to something that they should be given. And then we talk about vaccine hesitancy. We have no right to talk about vaccine hesitancy when we make it so difficult at every step of the way to our patients to gain access to what they need. So every attempt falls like a house of cards. And we have to start all over again. And at some point, honestly, it’s easier to just give up, and I was close to doing that too.

Conner Mertens  11:10

Yeah, Shilpa, thank you so much for being so candid and honest with your experience and I’m just so sorry that you had to go through all that. And Robert, you know, we talked about vaccines on the show often, were very pro-vaccine and understand its importance, like Shilpa mentioned, as a preventative care technique. So another thing that we discussed is what can we do about it? What is the solution here to make sure patients don’t have to go through this hell that Shilpa went through, of all these hurdles that are currently in place to get this preventative, care such as immunization.

Dr. Robert Popovian  11:38

So Conner I mean, Shilpa’s story is not unique, but it is self-reflecting of the problems that we’ve talked about on this podcast for many, many months or years actually, about why do we make it so hard for patients to access the most cost-effective intervention in the medicine which is vaccination. And Shilpa ran into several things on her way to acquiring the vaccine. And one of the first things is that she lives in the state of New York. So in the state of New York, pharmacists are not allowed to administer all FDA and CDC recommended vaccines and, or CDC recommended vaccines. They have to go about only administering vaccines that are on a list that is put out by the state. Now there are several states in the United States that love pharmacists. As soon as the vaccine is FDA approved and/or CDC recommended to administer those vaccines. New York happens to be not one of them. So hence starting the problem, starts with the state level requirements regarding regulation of who, and at what point can they, and what vaccine can they administer to the patient. So in the State of New York patients such as Shilpa, if they’re 19 years and older and immunocompromised, pharmacists, is allowed to administer the shingles vaccine to them. That’s a CDC recommendation. And it is one of the listed drugs that the state of New York has put on the list and the pharmacists can administer. What the problem was when Shilpa showed up to the pharmacy, is that the second barrier occurred, which is the pharmacist could not administer the vaccine because there was no way they can justify or confirm that she was immunocompromised. She was probably taking a medicine, most likely a specialty medicine, that was probably being handled through a specialty pharmacy. And if you go to a different pharmacy, they don’t have access to those medication information. So this is the second barrier that Shilpa ran into that we, and she alluded to it, is a fractured system. We have a system that the patient’s information instead of being with the patient is housed within different entities such as a physician’s office, a pharmacy, a different pharmacy, a specialty pharmacy, a hospital setting. So a pharmacist, Shilpa showed up – they can confirm her age, but they couldn’t confirm that she was in fact immunocompromised because they couldn’t confirm that medication that she was taking causes patients to be immunocompromised. So that was the second barrier. So now we have laws and regulations that restrict access to vaccines for patients, that’s the first step. And New York is not unique. And then you have an additional barrier that, because of the lack of information or transferability of the information, access of information between healthcare professionals, they can’t go about to even provide the vaccine when the patient is not only eligible but requires that vaccine. So both of those issues have to be resolved before we get to a point that individuals such as Shilpa, and this is very important, because Shilpa is a educated healthcare consumer. She works for a not-for-profit, dealing with healthcare issues – a patient advocacy organization. She has done health services research all her career. So she is an educated consumer and she needed the vaccine and she put up with it and she went through the bureaucracy and fought through it and finally got it despite the frustration. 99.9% of patients out there similar to Shilpa are not educated consumers. And they would soon as give up, rather than go through all of the hurdles that she went out, to be able to conquer, to be able to get the vaccine that was necessary for her.

Conner Mertens  15:21

And, Robert, this is not something new. We’ve been dealing with these battles forever. And I think about, before we even heard what COVID was, being in Albany and doing some advocacy in New York, and seeing the anti-vaccine protesters. And there’s also the thing, you know, the idea of vaccine hesitancy is something that is fair and something to discuss. But putting all that aside, who is against vaccine access, rather than the vaccines themselves?

Dr. Robert Popovian  15:45

So publicly? I mean, nobody’s against vaccine access, right? Even the anti-vaccine groups, they’re not saying “We’re against the access to vaccines.” What they’re saying is that, “Vaccines don’t work. You shouldn’t be taking it.” That’s a different issue and there are misinformed individuals out there, frankly. So who’s against vaccine? Nobody publicly about the access. But privately, you know, you have legislation in the state houses to expand pharmacist’s ability to immunize, you all of a sudden see state medical societies and certain other entities vehemently opposing it. And the reason they oppose it, on the surface is nonsensical, because they claim that administering a vaccine is something that physicians should be only doing, or only certain vaccines pharmacists can administer. And it is nonsensical because frankly, administering a vaccine is based on a recommendation by CDC or an FDA labeled indication. It has nothing to do whether to diagnose a patient. You don’t diagnose a patient to administer them the vaccine. So it’s not about diagnosis. So who’s against it publicly, no one. Privately, mostly the state med societies who are fighting vehemently to deny expansion of the scope of, or ability of the pharmacist to immunize patients. And as I said, the premise should be that, at the end of the day, we should be all about access to vaccines. And the reason being – and Conner, you and I have talked about this. Some of the research that GHLF has done, pharmacies, especially in low-income communities, and especially for seniors who live in low-income communities, are far more accessible than physician offices. First of all, you don’t need an appointment to get to one but physically, they are more accessible because of the hours of operation and the geography that they’re located in. So by denying the pharmacist’s ability to immunize, on-par with their physician colleagues is just ridiculous. And it’s backward thinking by these states that refuse to do so or promote that type of ideology. And to add to the whole mess, our research showed that the state of New York for low-income communities and seniors living in low-income communities, has far better access, significantly better than the average state for pharmacies than physician offices. So when people talk about access, and they talk about equity, and they talk about administering it, and social determinants of health, and all these other things, including health disparities, they talk a good game publicly, but whenever it comes privately, their actions, especially in support of legislative efforts, that does not allow scope of practice for pharmacies or pharmacists, to expand and be the same as physicians for immunizing patients, says a lot more which is very sad and disheartening and you end up in situations such as Shilpa. Now Shilpa’s situation also had to do with transfer of information, that’s another thing and another topic. But at GHLF, our belief is that patient’s own their data and their information and they should be able to share it with any healthcare professional they choose to. As I said, unfortunately, in this country patient data, patient healthcare data, is commonly hijacked by various institutions, including pharmacies and physician offices, and hospitals. And they vehemently guard that information and instead of information that should be owned by the patient, is owned by entities who then utilize this for various reasons. Some good some not so good. So Shilpa, do you have any words of wisdom for our audience? Besides reaching out to GHLF and our colleagues such as Conner for patients support. I mean, I know you were probably gonna say, your word of wisdom is going to be don’t give up. But any practical things that you can share with our audience?

Dr. Shilpa Venkatachalam  19:41

Sure, um, I don’t know if they’re words of wisdom, or words of encouragement. But also I just want to, before I come to that, I just wanted to say that it was really insightful to listen to what you were saying, Robert. Because every time someone told me, “It’s the system,” I really didn’t understand what that meant. And then when you explained that there are issues around transfer of data. And for example, the pharmacy couldn’t even see that I’m immune compromised and that I’m on a specialty medication, which I am. Now I understand what it means when someone tells you, “It’s the system that’s not allowing us.” So thank you for that. Words of encouragement: Yes, I will start by saying, “Don’t give up.” Easier said than done. You know, one shouldn’t really have to fight to get a vaccine. That onus is not on the patient. But sometimes the only way is to advocate for yourself. And not just advocate for yourself, but advocate loud and make some noise. The reason I’m speaking about this so ferociously, and I’ll continue to do so, and I know there are others who have spoken and I hope more will join my voice here, and other people’s voices, because we want the healthcare system to know patients like me. We want the healthcare system to know what is happening. Next time, when we talk about vaccine hesitancy, and by we I mean our society, let’s not forget why some people don’t get vaccinated. It’s the responsibility of the society to make healthcare easy to access. Especially for those of us who are dealing with underlying conditions. If it becomes this hard every time, I will give up on getting a vaccine, eventually. I will throw up my hands and give up. You know, we all have enough issues to fight with. We don’t need another one. Especially not one that has an easy solution. So yeah, my words of wisdom, or words of encouragement: don’t give up reach out to Global Healthy Living Foundation, and patient advocacy organizations like us. We will help you, we will support you. And I think the main thing here is to make the chorus louder so that something will change at the policy level.

Conner Mertens  21:40

Certainly some words of wisdom and truly and honestly, thank you so much for joining us and sharing so candidly the experience that you’ve had trying to get this shingles vaccine, Shilpa and you’re welcome back anytime. Gonna make sure as always, Robert, you get the last word in but what I know is that more access, not less to immunization and vaccines is, not only the most cost effective preventative treatment, but it’s just essential for overall health. And quite frankly, it’s malpractice having all these hurdles in place for patients access these treatments. You know, as Shilpa said we can’t talk about anti-vaccine folks, or vaccine hesitancy until we address accessibility issues. But like I said, let’s make sure you get the last word. What’s your biggest takeaway from Shilpa’s journey here?

Dr. Robert Popovian  22:20

The biggest takeaway is that, don’t give up, number one. But most importantly, our position at GHLF is very clear. Pharmacists, who are the most accessible healthcare professional in the community, should be able to administer vaccines on-par, similar to what their physician colleagues are able to. Therefore they need to be able to administer any FDA approved and/or CDC recommended vaccine for adult patients, period. We don’t need more stories such as Shilpa’s, because she may have persevered, many others don’t. So please join us in advocating that every patient have access to immunization in the pharmacy. Because at the end of the day, as Conner said, and as I’ve said many times, it is the most cost beneficial intervention in health care that we have today.

Conner Mertens  23:10

I couldn’t agree more. Thanks for all that, Robert. And and again, thank you Shilpa for sharing your experience as a patient with us.

Dr. Shilpa Venkatachalam  23:16

Thanks very much for allowing me to share this. And as Robert said, I hope changes are coming. And I hope those changes are changes that make it easier for patients to access vaccines.

Conner Mertens  23:28

Thank you, Shilpa. And to our listeners, thanks for tuning in. Don’t forget to subscribe to our podcasts on Apple, Spotify, or wherever you might be listening, so you never miss an episode. If you have a second, helps spread the word by rating our podcast, giving us one of those positive reviews, and sharing with your friends and family. It’ll help more people like you find us.

Dr. Robert Popovian  23:44

If you have any questions, thoughts or suggestions, you can always send us an email at [email protected]. And we always are looking for new ideas and we may include you or feature your question in one of our upcoming episodes.

Conner Mertens  23:59

And before you run, make sure to take a listen to some of our other great podcasts on the GHLF Podcast Network. You can find all GHLF podcasts at ghlf.org/isten. As always, he’s Dr. Robert Popovian.

Dr. Robert Popovian  24:10

And he’s my good colleague, Conner Mertens. See you all next time.

Narrator  24:17

Be inspired, supported and empowered. This is the global Healthy Living Foundation Podcast Network.

Healthcare Deception: Exposing Copay Accumulator and Maximizer Schemes

Narrator  00:00

Be inspired, supported and empowered. This is the Global Healthy Living Foundation Podcast Network.

Conner Mertens  00:10

You’re listening to Healthcare Matters, the podcast that pulls back the curtain to help you make sense of complex healthcare economics and policy issues. With us, as always, is Dr. Robert Popovian. Joining us from Washington DC, he’s a pharmacist, economist, and the Chief Science Policy Officer at the Global Healthy Living Foundation.

Dr. Robert Popovian  00:27

And joining me is my good friend, Conner Mertens from Seattle, Washington, my co-host, and our Community Outreach Manager and Patient Advocate extraordinaire. And that’s not all. Today, we are also joined by JP Summers, our Patient Advocate and Community Outreach Manager as well at Global Healthy Living Foundation who not only works for GHLF, but she happens to be a chronic disease patient herself. And today we have a very special episode, and we’re going to talk about this important topic that JP is going to explain to us from a GHLF perspective, but also more importantly from a patient perspective.

Conner Mertens  01:00

Yeah, we’re actually recording this episode right after you yourself and JP and some of our other GHLF colleagues are finishing up a great—like a really, really informative—webinar that we’re going to tell you a little bit more about in a moment.

Dr. Robert Popovian  01:12

Thank you Conner, it was a great webinar. And I would highly suggest that people go ahead and listen to it. It’s going to be posted on YouTube, various other channels. We’re going to have it in the show notes for you to be able to follow and see where you can see the webinar if you missed it. But we have a lot to discuss today here, and we want to definitely talk about webinar. But Conner, as always, I’m going to throw out a number to you. And the number today is 19.

Conner Mertens  01:37

Oh gosh, Robert 19. I’m watching a lot of the World Cup right now. 19 is Crystal Dunn for the US Women’s National Team?

Dr. Robert Popovian  01:44

I believe she may be, but that’s not what we’re gonna be talking today, even though Women’s World Cup is a very interesting topic. No. 19 is the 19 states that have passed legislation to protect patients against predatory sort of policies that have been implemented by the pharmacy benefit management companies and insurers called accumulators and maximizers. And these states ban those type of policies and protect patients.

Conner Mertens  02:11

Alright, Robert, I guess meat and potatoes: what is a copay accumulator adjuster?

Dr. Robert Popovian  02:16

Okay, so a copay accumulator is when patient assistance is provided by manufacturer, a drug manufacturer, to the patient. And the patient is able to use this patient assistance to cover their out-of-pocket costs. And before accumulators were being implemented or maximizers were being implemented, patients would show up to the pharmacy, utilize that assistance, pay for two out of pocket costs, and that out of pocket cost payment would apply to their deductible or to their maximum out of pocket costs requirements. Through the implementation of these schemes called accumulators, now none of that amount of patient assistance applies to the patient’s deductible or maximum out of pocket costs. So in essence, what they’ve done is to steal the patient assistance from the patient to pad their bottomline—these are the insurers and the pharmacy benefit management companies—and keep the patient in what I consider a perpetual deductible phase that unless they pay the deductible out of their own pocket, they’re not going to be able to meet it. So in essence, they’re basically profiting from this program, and they’re double dipping. They’re not only using the patient assistance program from manufacturer as profit, but they’re mandating that the patient then has to pay for their own out-of-pocket costs, which in the past was not the case. They were able to meet the deductible to these patient assistance programs.

Conner Mertens  03:38

Yeah, I mean, that’s what it kind of sounded like when you were describing is double dipping. That’s, that’s kind of the perfect way to describe it. So does this kind of look like in practice, and I think we should throw to JP in a second to hear what her perspective is as a patient, but let’s say your deductibles $1,000 and you get some copay assistance program through the manufacturer that gives you, you know, $500 coupon for your medications. Does this mean that that $500 coupon is not going to count towards your $1,000 deductible and you’re still working towards that $1,000?

Dr. Robert Popovian  04:08

That is exactly it Conner. I couldn’t have explained that any better. What happens is that that dollar amount that comes from a manufacturer never applies to the deductible and therefore you as a patient have to pay for it out of pocket from your own pocket. So now we’re gonna go to JP, and I want JP for you to talk about your own personal experience. Obviously, you work for GHLF. You work with our patient community every day. But more importantly, you’re a patient yourself. And I want you to tell the story of how accumulators as a policy implemented by the pharmacy benefit management company and insurance have impacted you

JP Summers  04:45

Sure. Yes as a patient, my first, first experience with copay accumulator happened after I was diagnosed with chronic migraine and I had tried several medications. Nothing seemed to really help. My neurologist suggested a treatment that was actually his specialty treatment. Got help with the copay with assistance patient program. You know, everything seemed okay. And then few months later all of a sudden it went to go pick up my prescription and was told the amount changed, which I was surprised because, again, I had this assistance. How is that even possible? So then I made phone calls. And by the time I got answers, I realized that it was under the patient accumulator program. And at that point, I didn’t know much about it. So of course, doing research, I learned even more, got upset. And then when my son, who also was diagnosed with chronic migraine,  had the same situation happened with his treatment, all of a sudden, now we were faced with, you know, a huge dollar amount for prescriptions. And I made the decision, which was really a dangerous decision. You should never stop taking medications, especially if it’s something that helps you to live a better quality of life. But financially speaking, we were a one income household at the time, because I was not working. And we had other members of our family that relied on things. So again, I decided not to take my medication so I could afford his, and never in my life did I ever think that I had to choose a loved one’s health over mine. No one should be in this situation. No one should ever have to choose another one’s health over theirs. But I made that decision. And when you go through something like that, it’s not just a financial burden. It’s emotional and mental. Because again, this is not something you should have to worry about. You should be able to take your medication that helps you to function, that helps you to be a parent to your children. And it just was a hard situation that not just myself but my family went through at that time, and I would never wish that on anyone. And when these situations happen, patients often have to sacrifice something in order to get those treatments or they don’t get the treatments because they can’t afford it.

Conner Mertens  06:53

Well thanks for sharing all that, JP. I know that that’s a really important story, and I know that you find value in telling these stories because as we’ve seen, advocacy has the power to create change, and your stories have the power to create change. I know you’ve been involved with a few different Advocacy Days around the country around this issue. Can you tell us a little bit more about that?

JP Summers  07:11

Sure. Yes, Conner. So in my situation, being with GHLF, I had the opportunity to do Advocacy Days, but also because of my dual residency, I had opportunies to testify in Texas. I spoke at a press conference in Wisconsin, and being able to share the story again was impactful on so many levels because again, it’s something that my family went through, but also to raise awareness. And as I’m telling this story to people in the position to help make that change, I feel that again my voice can be very impactful, as well as everyone else on the coalition’s that were there to help share their stories. But when Texas, again, was in the middle of making the decision on whether to pass the bill, I was sharing my story. And sometimes it can be difficult. But again, I do it because I want to help other people. And I was so thankful for the opportunity to be able to speak in front of those lawmakers. And thankfully, our efforts with GHLF on our side and the other coalition’s Texas was able to pass that bill.

Conner Mertens  08:15

I mean, that’s great. And like we were saying it’s a testament to your ability to humanize these issues, which is so important when it comes to advocacy. So thanks for sharing your story JP. But in that same vein, Robert, we see legislation all over the country and federally about copay accumulator gestures. I personally live in a state where I’m protected by that, by copay accumulator bans in Washington state. But we also did some Advocacy Days in Oregon and California this year where they don’t have those protections. And one of the things that kept coming up was this idea that copay accumulator adjuster bans will raise premiums. And I know that you’ve done a lot of work and along with many others in our organization have done a lot of work to kind of prove this myth wrong. Can you tell us a little bit more about what GHLF and yourself and our other colleagues have found around this idea of rising premiums in the face of copay accumulator bands?

Dr. Robert Popovian  09:05

So the short answer to that question, Conner, is it’s absolutely false. We looked at it for the last two years. We obviously released a tool that is available to anyone for free to go and take a look at it. And what we found last year is that there was no statistical differences between states that had passed the bands and the states that had not passed the bands, or even within the state whether or not the ban itself had an impact on premium increases. So what the narrative that the PBMs and insurers are providing everyone is absolutely false about this type of legislation. Now 2023 we’ve re released an updated tool with better visuals as well as, you know, updated the number of states obviously. In Washington state, Conner you live there as you mentioned, you are protected. They passed it last year. Texas that’s where JP lives, you know she is protected now because the legislation was passed this year. I live in Virginia. Virginia was one of the first states to pass legislation to protect patients. Ben, our producer, lives in Indiana, which is not being provided help yet, you know, hopefully next. He’s not protected yet. But you know, large and small states, Texas, we’re talking about Oklahoma or Virginia had passed this legislation to protect patients, versus if you look at there are blue states that have passed it—New York and Illinois. So this is not a partisan issue. This is not a small or big state issue. We have states like Texas and New York passing legislation to protect patients. If you think about it, they’re polar opposites from a political standpoint, but they found a commonality of protecting patients at the end of the day. And that’s what matters. At this time, I would like Ben, our producer, to also put in a clip from our webinar because Anne Sydor, Dr. Anne Sydor, who is a good colleague of ours, does a great job of explaining about the tool and how it can be used—the website and everything else—and also where the data came from, as well as another colleague of ours, an economist, Esteban Rivera, is going to be able to explain how we did the statistical analysis. So please, listen.

Dr. Anne Sydor 11:09

Thank you so much for the introduction, Robert. The data for this analysis comes from the Healthcare Information Exchange database, which is a repository of all premiums for the ACA plan and can be used really as a proxy for how insurance premiums have changed from year to year. So this is a publicly available database. Anyone can go and look at this data. It is a large amount. There are dozens and dozens of insurance programs from state to state, what we’ve done is we’ve taken the average premium for each of the metal tiers. So there are different levels of insurance, bronze, silver, gold. We’ve taken the average for each of those tiers for each state in a given year. And we looked at how states compare from one to the next. We’ve also looked at how states with bans on accumulators compare to states without bans on accumulators. So when we look at this website, again, this information all comes from the Healthcare Information Exchange. We also have terms defined. A lot of people aren’t sure whether or not they have an accumulator or a maximizer in their health insurance policy. Accumulators and maximizers affect patient assistance programs. If a patient has a $1,000 deductible, and they get $500 in the form of coupons or copay assistance or any other assistance to afford expensive specialty brand name medications, that $500 that they pay with a coupon used to go towards their deductible. With an accumulator or a maximizer policy, that no longer happens. They say the $500 from the assistance program, but instead of having $500 left in their deductible, they still have $1,000 to pay. Now, when we come down and we look at this graph, what you see that’s really important is the shape of these lines. The blue states might be a little bit higher. The orange states might be a little bit lower, but the rate of change, the rate at which insurance premiums go up or down, is the same in both blue and orange states.

Esteban Rivera 13:29

So the question here is did enacting legislation cause a statistically significant increase in premium prices when comparing that to potential increases to previous prices? I’ll explain why the answer is no to that question using an example. When analyzing prices in 2022 in a specific state that passed legislation in 2021, one needs to take into consideration what previous prices were in that state and how it compares to the overall averages. No matter the selection of the state in this example, the ANOVA test shows and proves that there is no significant statistical relationship between the passing of legislation on an increase in premium pricing. One way I like to think about that is that this year’s price is dependent on all the previous year’s prices. So averages were already increasing over time and that is the key factor to pay attention to here.

Dr. Anne Sydor 14:23

And the truth is no matter what we call it, whether we call it coupons or copay cards or patient assistance programs, whether it’s a subsidy, whatever it is, it’s a mechanism for an organization whether it’s a pharmaceutical company or a charitable organization. It’s a mechanism for them to cover the costs that the patient would pay, the share of the drug cost the share of the prescription that would be borne by the patient and family.

Conner Mertens  14:52

Just some amazing information from our colleagues at GHLF really breaking down this issue of copay accumulator adjusters. Gonna let you get your last word, Robert, but I really, really learned about this. It’s just a myth. The people opposing copay accumulator adjusters, the powers that be, pushed this narrative that that we’re going to see this these rising premiums and that’s just not the case. And it’s amazing the work that you and other folks have done in GHLF to show this in a very visually appealing way but also just a very open and transparent way where all the data is sourced and available. So yeah, it’s just a credit to all around to you folks for digging into this and making sure that this information is out there. What do you say, Robert, what’s the last word?

Dr. Robert Popovian  15:29

The last word is that we’ve passed in 19 states, and we need to pass in the rest of the states to protect patients. We need to pass federal legislation because you know, state laws don’t govern every state insurance plan. Therefore, we need federal regulation and federal legislation. There’s a federal bill that is pending in Congress. As advocacy organizations, whether it’s patient advocacy, provider advocacy, employer advocacy, we have to all come together to be able to protect because all of us at some point in our life will be patient, I guarantee you that. As a pharmacist, I can tell you 100% for sure you will be a patient at some point in your life. And you will need that protection from the predatory schemes of the PBMs and the insurers.

Conner Mertens  16:12

I couldn’t agree with you more. Thanks for that, Robert, and thank you to JP summers for joining us on this episode, again. Happy to have you back anytime. Big thank you to the other folks involved in this copay accumulator work, Esteban Rivera, Anne Sydor, and just countless other people doing work behind the scenes at GHLF. It’s really impressive what they’ve been able to churn out. And for our listeners, don’t forget to subscribe to our podcasts on Apple, Spotify, or wherever you might be listening so you never miss an episode. And if you have a second, help spread the word by rating our podcast, writing a positive review, and sharing with your family and friends. And help more people like you find us

Dr. Robert Popovian  16:45

If you have any questions, thoughts, suggestions, comments, anything, any ideas for future shows, please send it to us via email at [email protected] We always look at them, and hopefully we will pick up some ideas that we can run the future podcasts about.

Conner Mertens  17:01

For more information on copay accumulator adjustors, please visit ghlf.org/copay-assistance-protection. And that’s a little long, so be sure to check out the link in the notes as always. He’s Dr. Robert Popovian,

Dr. Robert Popovian  17:14

And he’s Conner Mertens. See you all next time.

Narrator  17:18

Be inspired, supported, and empowered. This is the Global Healthy Living Foundation Podcast Network.

Narrator  00:00

Be inspired, supported and empowered. This is the Global Healthy Living Foundation Podcast Network.

Conner Mertens  00:10

You’re listening to Healthcare Matters, the podcast that pulls back the curtain to help you make sense of complex healthcare economics and policy issues. With us as always is my partner in crime Dr. Robert Popovian, tuning in from Washington, DC. He’s a pharmacist. He’s an economist. And he’s the Chief Science Policy Officer at the Global Healthy Living Foundation.

Dr. Robert Popovian  00:28

And joining me today is my good friend, Conner Mertens, from Seattle, Washington, my co host, and our patient advocate and community outreach manager at GHLF. Conner, today we have a special guests, David Balat. We’re gonna dive right into his episode. But before we start, as always, I’m going to ask you a question. So Conner, if I asked you what the number 41% represents, what do you say?

Conner Mertens  00:52

I actually know this one. We were just talking about this, and I just read about it. It has to do with the healthcare debt, right?

Dr. Robert Popovian  00:57

Unfortunately, that’s correct. The main cause of bankruptcy remaining constant over the years in the US is job loss and medical expenses. It was recently reported that 41% of US citizens carry some sort of medical debt and even worse, 24% are considering bankruptcy to solve the medical debt issues. So this is an excellent transition to our guest who is an expert on all things related to healthcare financing, specifically on hospital issues and hospitalization costs and today’s hot topics. So let’s get started.

Dr. Robert Popovian  01:34

So we’ve discussed the topic of transparency on this podcast multiple occasions, specifically focusing on drug price transparency. And today we’re going to explore a bit further, but specifically, we’re going to look at a lack of transparency in the hospital pricing and hospital costs and how it impacts patients. With us today is my good friend, someone I’ve known for many years, David Balat. Welcome to Healthcare Matters, David.

David Balat  01:58

Thank you for having me, Robert.

Dr. Robert Popovian  02:00

Excellent. David, you and I have known each other a long time. You have a robust background in healthcare. You’re the founder of the Healthcare Finance Specialists, and you work in the hospital marketplace for a long time. Why don’t you give our audience a little bit of an introduction. Let us know about what you’re doing in the past, present, and what you plan on doing in the near future.

David Balat  02:20

Wonderful, I appreciate it. And thank you both for having me, Conner, I appreciate the opportunity as well. You know, I grew up in the hospitals. I had aspirations of becoming a physician and worked in hospitals as soon as I was able to have a job. And work just about in every department throughout various types of hospitals as well, community, rural, academic, you name it. And I really gravitated more towards the administrative side of it, as opposed to the clinical. And so that’s where I got my education and really hit the ground running as soon as I finished with my postgraduate work. And have been a healthcare executive and hospital CEO for nearly 20 years before moving into public policy and have worked with different administrations, have continued to still work with lawmakers at both the federal and state level in various states by helping them understand how healthcare really works. Because there are a lot of folks out there that are experts or specialists of sorts that really have not worked in the industry. So I feel that like folks like Robert and myself and people who have actually gotten their hands dirty offer a different perspective to those individuals, to those people making decisions and their staff on how things really work. And I’ve gotten back into it, started my consulting firm, again, Healthcare Finance Specialists, and I’m working with independent practices. I’m working with employers. I’m working with as many people as I can, different organizations, to help them understand how you can access affordable, high quality health care regardless of where you are in this country. And one of the projects that I’m excited about is my partnership with the joint venture between Lasso Health and Walmart Health. And they’re offering a very robust telemedicine project, or product I should say, that will address medical care, urgent care and talk therapy for the price points that are as low as $20 a month per person and $40 for an entire family. They’re getting into the drug business, the art, the prescription drug business, rolling that out here very shortly. And then next year, we’re looking at addressing lab cost and surgery costs and a number of other areas that affect everybody and how we can get upfront pricing for those individuals, for those organizations that are the ones ultimately paying for healthcare.

Conner Mertens  04:35

I mean that’s amazing, David. Definitely a thorough resume as Robert mentioned. But, as another thing Robert mentioned, we discussed the topic of transparency often on this show. It’s something that’s so foundational to the work that we think can improve healthcare. Especially we talk about how lack of price transparency for medicines reduces competition and ultimately hurts patients, and then they overpay for life saving therapies and even discussions about transparency in the 340 B program. Can you please discuss the lack of transparency in hospital pricing?

David Balat  05:03

Yeah, so let’s go back to the last administration. I was in, in the White House in the time that they were working on the executive order under the Trump administration to, to roll out the Hospital Price Transparency Rule. And I was very happy to see the Biden administration continue in that effort. It was one of the few executive orders that wasn’t rescinded. So that’s been a positive. The hospital industry, the American Hospital Association, fought this rule tooth and nail, sued it to the highest court and they lost at every level, which we were very, very pleased with. One of the main arguments was people don’t really care—people won’t use price transparency. And you know, honestly, that, that may be the case, but it’s just been so hard to access that it hasn’t been used because it’s not available.

Dr. Robert Popovian  05:43

So David, we talked about patients—the impact on patients on drug price transparency and spending. You just alluded to how the administration, both Trump and Biden administration, have championed the for the hospital transparency. What are the employers doing? Because, you know, sometimes in healthcare, it’s almost like the silent majority, but what are they doing? Are they fighting for transparency? Are they not? I mean, you’re starting to work with them more directly now in your new position. So what are you seeing?

David Balat  06:13

You know, they’re in a tough spot because if you go into business and you start a company, you don’t expect that you’re number two or number three or your number four budget line item is healthcare benefits. Everybody is getting into the business of health care. That’s not their expertise. It’s not what they know. They’re just trying to perform the business that they got into. So it’s not something that they pay a lot of attention to. They’re thinking the insurance company or their third party administrator will will do the job for them. But the problem with that is given the amount of money that they’re putting out every month, every year, it’s something that they’re now really having to pay more attention to. Even more so, if you’re a self funded plan—it is your legal duty. You’re a fiduciary under the law, under ERISA, to make sure that those dollars are being used at their best and highest use. Now, let’s just say for those that aren’t self funded, let’s just say an employer is just fully insured and all they’re doing is paying the premiums every month, it still behooves them to get involved in price transparency because the high cost of healthcare in hospitals across the board is making it so that people are avoiding getting the care that they need. And if they get sicker, they’re losing more work. And it’s bad for the employers as well that way. So it’s important regardless of the way that they’re providing this benefit. But you’re exactly right. They’re an important piece. If they were engaged in this fight more so than they are today, we wouldn’t need Washington or state governments to be involved. It would get done because of the market.

Dr. Robert Popovian  07:35

Terrific. I don’t disagree with you. I completely agree. I think in a lot of ways if employers were more engaged on this issue, but it is difficult. And I—they are in a hard place because they’re not in the business of healthcare during the business of manufacturing, I don’t know, tires or clothing, right? So they’re not, they didn’t get into those businesses to manage healthcare for their employees.

David Balat  07:55

Right. I just wanted to address one other point about the price transparency and where people are getting it wrong. Some of the arguments against transparency are, well, if I’m in the back of an ambulance and I’m being headed to the hospital because of an accident or a cardiovascular event, I’m not going to call and ask about the price. That’s true. That’s exactly right. Nor should you. But nearly 80% of all healthcare services are elective. They’re scheduled. So we’re talking about those things that you can anticipate and that you have time to deal with.

Dr. Robert Popovian  08:26

You’re so right. I mean, every time I’ve been in meetings, when issue of hospital price transparency has come up, you get this apoplectic response from the hospital executives and they bring up that extreme example, right? If you’re in a car accident, you’re not going to go look for pricing, you’re just going to go to the closest emergency room or to hospital for treatment. But there are a lot of services, including, for example, maternal care that can be planned ahead of time, and patients can make better choices if they had the information. But let me ask you something, because this is something that always comes up. Do you believe that patients can save money if there was truly hospital price transparency in the marketplace?

David Balat  09:09

Sure, let me give you a really easy example. Well, before I give you the example, let me just give you some statistics. The average deductible is between $5000 and $6,000 in this country. 60% of all Americans have less than $1,000 in their savings account. Now if I have an order for a CAT scan, and I have, and let’s just say I have insurance. And there are two hospitals that are in my network, both relatively close to my home. And I can call up and say I need a CT of the head without contrast. Hospital A is part of a system. They’re able to leverage their market power and they’re able to secure higher rates from the insurance company. Let’s just say for my insurance, they’re able to get $2,000 for that CAT scan. Hospital B is maybe one or two hospitals. They don’t have that leverage. They’re not able to negotiate. Same CT, the same equipment, probably the same radiologist reading it, they’re able to get a contract for $1,000. With that knowledge and given the fact that I have a deductible of $5,000. So this is all out of my own pocket. I’m a cash payer, because where am I gonna go? That is an example of knowing the price in advance, being able to secure that information. It betters me financially, betters my family financially, and I’m able to have peace of mind. And frankly, it’s given me an agency in the process, which most people don’t feel that they have when shopping for healthcare. If a doctor gives you an order and says go to this place, you go to this place. You have it done and then you hope for a bill that’s reasonable.

Dr. Robert Popovian  10:31

Terrific example. Great example. Let me move a little bit back to another topic that I’ve always talked about: consumerism and healthcare. When I say those words, consumers and healthcare, what is the first thought that comes to your mind?

David Balat  10:45

Well, I immediately think, what is the contrast? So I have to think of what the contrast is to consumerism. The contrast is government run health care, much like the VA, or what we’re seeing in Canada, or the NHS. There’s a lot of rationing, there’s a lot of being told what you can and cannot have, depending on what condition you’re in, or what age you are. Consumerism on the other hand, again, gives agency. It gives a sense of control to the individual. It gives them the ability to find the product that they want, the service that they want, at the price that they need. That’s what consumerism is. Unfortunately we don’t have true consumerism in healthcare yet. But that’s the direction we would rather move into as opposed to the contrast.

Conner Mertens  11:26

Thanks for clearing all that up for us. I’m super curious, since I work really closely with our patient community. I guess my question is a little bit of follow up to that. How do you think that these things that you and Robert are discussing about consumerism in healthcare will benefit patients?

David Balat  11:40

Well, it’s just like I said. It’ll, it gives them a sense of being in charge, and it gives them peace of mind. Many people don’t get the care that they need because of a fear of what it’ll cost. Now, affordability and high quality is not just a theory. It’s not a pie in the sky kind of idea right now. It’s happening, much like what I discussed that’s happening between Lasso Health and Walmart Health and their joint venture. If you look at Surgery Center of Oklahoma—you can go to their website, and if there’s an ear tube removal that you know that your child needs to have, you can go to their website, and it’ll give you the price up front for the facility, the doctor and the anesthesia. It’s an all-in bundled price. That’s the direction that transparency really should be going in the future. Right now, it’s unbundled. There are a lot of different codes. It’s confusing. It’s difficult to ascertain what that price will be for this procedure or that procedure, but at some point in the future, I do think that we’ll be moving in the direction of having prices that are consistent with a procedure type. Now there will be some variation because people come in with different risk acuities, different risk factors, which could make the surgery end up going much longer, which would therefore result in a different, more expensive price, which  behooves us all to stay as healthy as we possibly can. But that’s the direction that we’re moving in, I think, for healthcare, because the thing that we should all fear is having the government be in charge of healthcare. We see what they’re doing with trying to control drug pricing, and that’s not going very well at all. And in fact, they may be harming the development and innovation of medications, not just in our country, but across the world.

Conner Mertens  13:11

All right, David, let’s go back to bankruptcies. Can you just give us an idea of why this is all happening so much in the US? Who are the major players involved in that?

David Balat  13:18

That’s a multifaceted response to that. It’s not a simple question. But one of the things that is under a lot of scrutiny right now are the nature of what charity care is that is provided by tax exempt or nonprofit hospitals, I prefer tax exempt. Many under federal rules, nonprofit hospitals are required to provide community benefit. That doesn’t necessarily mean charity care, or reduction in the charges for what services are offered. And in fact, we did a research study on the hospitals in the state of Texas, and we saw that it was relatively even between for profits and nonprofits in how much charity care was given. But many of the nonprofits will say, “Well, we provide education and we provide a number of different tools that fall under our community benefit requirements.” Most other companies would call that marketing. So their billboards, their kiosks and affair or whatever the case may be. They’re providing information to try to get you to see their doctor have come in and use their services. That’s not as much community benefit, as far as I’m concerned, as it is just a marketing effort. So I think that there are, there needs to be some changes to the definitions, federal law, and then maybe even a look at the state level for how charity care can be provided to benefit these patients that would be close to the benefit that they receive and not having to pay taxes.

Conner Mertens  14:34

Yeah. Thanks, David, for sharing all that insider knowledge. And on this podcast, we have a tradition. Robert, you know, you got the last word.

Dr. Robert Popovian  14:40

Well, I have to say, I mean, David definitely is an expert on the hospital side. I’m an economist, and I have to tell you in every other segment of the healthcare system, transparency—price transparency—always creates competition and lowers prices and lowers costs and lower spending. Somehow or another the insurance industry, the pharmacy benefit management companies, and the minions and the economists and the minions that they pay off have sort of bamboozled everyone to think that transparency will hurt the healthcare system, that in fact, transparency will drive up costs and drive up spending and drive up utilization. And it’s utter nonsense. You know, we need more transparency. We need more consumerism in healthcare, whether it’s in the hospital services or in drug pricing and drug spending. The only people that are going to benefit from this is the consumer, the actual payers who pay for healthcare in the United States, the taxpayers, the patients. And the people who try to protect and create a opacity in pricing and transparency and basically fight transparency are the ones that are benefiting handsomely from the current model, which are primarily the insurers and the pharmacy benefit management companies. So thank you, David. I want to give my personal thanks for coming on our podcast.

Conner Mertens  16:02

Well yeah, thanks David. Thanks Robert, for breaking that down for us. I think that was quite a look behind the curtain. Definitely some valuable information for our listeners in there. And to our listeners, don’t forget to subscribe to our podcasts on Apple, Spotify, or wherever you might be listening so you never miss an episode. If you have a second help spread the word by rating the podcast, writing a positive review, and sharing with your friends and family, and help more people like you find us.

Dr. Robert Popovian  16:23

If you have any questions, thoughts or suggestions, as always, you can send it to us on email at [email protected]. And we always are looking for new ideas and we may include you or feature your question in one of our upcoming episodes.

Conner Mertens  16:38

And before you go, make sure to take a look at some of our other great podcasts on the GHLF Podcast Network. And you can find all of GHLF’s podcasts at ghlf.org/listen. As always, he’s Dr. Robert Popovian.

Dr. Robert Popovian  16:51

And he’s Conner Mertens. We’ll see you all next time.

Narrator  16:55

Be inspired, supported and empowered. This is the Global Healthy Living Foundation Podcast Network.

Narrator  00:00

Be inspired, supported and empowered. This is the global Healthy Living Foundation Podcast Network.

Conner Mertens  00:10

You’re listening to Healthcare Matters, the podcast that pulls back the curtain to help you make sense of complex healthcare economics and policy issues. With us, as always is Dr. Robert Popovian. Joining us from Washington, DC, he’s a pharmacist. He’s an economist, and he’s the Chief Science Policy Officer at the Global Healthy Living Foundation.

Dr. Robert Popovian  00:28

And joining me is my good friend, Conner Mertens, from Seattle, Washington, my co host, and our community outreach manager and patient advocate extraordinaire. Today, we have a special episode, we are joined by our government affairs lead, Corey Greenblatt, and also by JP Summers [who’s] been JP on our podcast before. She is our patient advocacy savant, and also happens to be a chronic disease patient herself. So we’ve cooked up a special episode for today and Conner you’ll also be on the hot seat.

Conner Mertens  00:59

That’s right. I’m really excited. We had a really fun summer getting around the states and with JP, Cory, and I behind the mic, I have a feeling you’re gonna want to hear everything about this advocacy tour.

Dr. Robert Popovian  01:09

That’s right. Lots to discuss. You guys had a busy summer. And I have a bunch of questions for the three of you. But just before we get started, Conner, what does the number eight stand for?

Conner Mertens  01:20

You know, I usually don’t really answer but this time I do. That is, you know, the amount of states we’ve been able to go to on our GHLF road trip this summer to make sure that patients voices are being heard at the state legislative level.

Dr. Robert Popovian  01:31

Exactly. And that’s excellent work. So let’s light this candle. Let’s get started. So my first question is for you, Cory, you are our government affairs lead the global Healthy Living Foundation. So Cory, what compelled you put together this tour? Conner, you and JP went on this tour of the states and you obviously work on the federal level as well. But what made you decide to do this this year? I know that it’s been difficult to do this type of work post pandemic. And then also comment on how was the reception from the policymakers that you visited with?

Corey Greenblatt  02:09

Yeah happy to talk about that. And really happy to be here, Robert, thanks for having me. And JP on to talk. So to answer your first question: What compelled us to put together a tour? I think It’s a combination of a few things. As you mentioned, during the pandemic, we weren’t really able to get out to the states in the way that we used to prior to the pandemic where we would maybe do a couple of these trips every year. And in its place, the pandemic gave us an opportunity to continue to meet with legislators in a virtual setting, which gave us the opportunity to meet with people in more states than we had previously done. So in taking that in 2023, we said, how can we meet with more states, bring patients to these states and get our voice and get active in more places like we used to. With more states opening up to be in person again than they previously had been, we thought that there was an opportunity for us to bring the patient voice out in a couple of different key areas. And to answer your second question: What the response was from policymakers? It was overwhelmingly positive. I think one of the things that we realized through these trips was that patients walk into a door of a legislators office and more so than anyone else, they walk in with a net positive rating before they say a word. That’s because policymakers and staffers understand the toll that it takes for patients to be there and speak to them and share their stories and what they’ve gone through to have to be able to share these stories. And so before a word comes out of our mouths, they’re thanking the patients that we’re there with just for being able to show up and share their experience. So it gives us an opportunity as a patient organization, working with the patients we do to really gain a lot of key support for certain pieces of legislation across the country. And I think we were able to do that.

Dr. Robert Popovian  03:58

Cory, thank you so much. I mean, I’ve observed your work firsthand. On the federal level, you and I work together, and I think you do a terrific job. And I’m not surprised that the reception was so overwhelmingly positive from policymakers. So my next question is for Conner, actually. Conner, besides policymakers, we were able to also communicate with some patient advocacy organizations, patient groups, and also provider groups at some point. So tell us more about what are they telling you those groups that you interacted with in the state tours? What were the challenges that they are facing?

Conner Mertens  04:31

Thanks, Robert. I think that one of the best things that we do here, and something that we always strive to do is coalition build. And so when we get into the states, we try to find who’s already on the ground, who’s got their finger on the pulse of the health care industry in these states so we can be most effective, and more voices combined can have a greater impact. One thing that I was really proud of, actually, with our patient groups that we started working with, was how often the tool that we developed at GHLF, you know, was used. And this was the tool that was able to demonstrate to-date, that there’s no statistically significant change in the rates of health insurance premium increases after we see passage of state laws requiring that patients assistance funds will have to count towards, you know, the policyholders deductible or out of pocket maximum payments. So a big focus about access challenges we heard from our colleagues in patient groups, are copay accumulator adjusters, and that’s something that across the board, we’re seeing legislation pop up all over the country to try and fight these practices. The challenge is, is every state has their own different legislative agenda, they have their own different schedules. And It’s just always a challenge to figure out what is most needed for patients in each state and how to most effectively advocate for this type of legislation.

Dr. Robert Popovian  05:43

Thank you, Conner. So JP, next questions for you. And you have been on this podcast before. You play a very unique role at Global Healthy Living Foundation where you work as a Patient Advocacy Coordinator or manager, as well as you are a patient yourself. And in your eyes, what was the reception from a patient perspective? We heard Cory, what Cory said. And I completely agree. I think when patient groups walked in, there’s a great deal of credibility, but you walk in as not only a patient group representative, but also a patient. So What was the reception and in the state level, when you did direct outreach?

JP Summers  06:17

It was a great reception. You know, I have been in advocacy for about eight years. And I can honestly say that this was the first time of doing meetings in a row, that I noticed that we were getting asked question after question. I could see that the aid or the representative was writing down notes. And to me as a patient, that means they’re invested. When they ask those questions, when they’re taking notes-they are invested, not only in your time, but you. And I just was so amazed at again, walking in, like Cory was saying, we’re walking in, and they were thanking us for being there. And then again, after sharing our stories, they were asking questions, and I just felt that I belonged there. That we weren’t just another appointment, that we were actually worth their time.

Dr. Robert Popovian  07:08

JP, that for me is music to my ears, because that’s one of the things that we’ve strived for right? For decades is to get the patient, an actual patient voice heard. Not only those that represent patients. So Cory, I’m going to come back to you just like many of us at Global Healthy Living Foundation, the list of issues that you cover is unbelievable. There’s a lot of policy issues that we work on and try to discuss these topics with policymakers and other organizations and other individuals. What would you say, in your opinion, was the main policy topics that repeatedly came on in these discussions with the policymakers or anyone else that you were working with on the state level in these tours?

Corey Greenblatt  07:53

Yeah. And Robert, you’re flattering me. I’m blushing right behind here. But I think some of the key issues that we talk about a lot are and I’m sure you mentioned it, and I know you mentioned it many times on your podcast or copay accumulator adjusters, copay assistance. Copay accumulator adjuster bans are probably the most common bill that we are advocating for at the state level right now. In part because we feel we are coming at this with expert evidence based on our organization’s reporting and your own reporting, and our accumulator tool, that we’re able to talk about these laws in a way that many other patient groups can’t. And when we are able to bring patients like JP and many of the other patients we worked with, as well, to these meetings and talk about this issue. There is a palpable feeling in the room. And there is a true effect when we’re able to actually get the impact of these accumulators through to staff members, and what the outcomes of the research has kind of shown to prove that these laws should be passed. Beyond them, beyond copay, accumulator adjuster laws, many of the bills fit into PBM, pharmacy benefit manager, transparency laws. So things like “share the savings” laws or rebate reforms. Ways that would decrease costs for patients, while also increasing transparency on the PBM industry are things that we’ve been very conscious of as well through our work both as an individual organization and with many of our coalition partners, as well. I could go on and on about the issues, but really, those were kind of our key focuses this year.

Dr. Robert Popovian  09:23

Thanks, Cory. I mean, you’re aware of this, but you’ve probably already seen it this morning, I got a note about Senate Finance introducing legislation, federal legislation, regarding the de-linking fees that the PBMs charge from the retail price of the medicines. We’ve talked about this repeatedly on our podcast, how it’s a misaligned incentive, because it basically promotes utilization of more expensive medicines. And this is going to be the first step I believe to doing a lot of that PBM transparency and PBM work that you’ve spearheaded for GHLF in the state level, so kudos to you, good work. So JP, I’m gonna come back to you for the next question. You obviously worked through GHLF to help patients every day, patients such as yourself. And you know, I know that you’ve been active in couple of states minimum, that I know of, Wisconsin, you testified in that state regarding banning accumulators. And in Texas, you wrote an opinion editorial that was picked up by multiple channels actually, in the state level. Can you give us another specific example that you’ve worked with, or the same, or elaborate on the work you did in Wisconsin and Texas as a GHLF representative and as a patient representative,

JP Summers  10:35

So when I go to testify, or when I’m writing an article, you know, doing the advocacy days, I feel empowered. I feel like I have some control over my health, even though most of the times my symptoms are debilitating, just having a voice. And again, whether It’s through written testimonial, in person, you know-meeting with different representatives from each state that I live in, I still feel that It’s important to share my story and raise awareness. But I know that the patients that come with us, the patients that participate on these advocacy days. I know they feel the same, we have conversations in between meetings, even before we prep, we do you know, kind of go over their stories, and we speak with them. And I hear all the time, whether It’s just through passing when we’re going from meeting to meeting, or I get a text or email to saying thank you for allowing me to share my story. And again, a lot of them are chronically ill, and they’re going through the same thing I am, they’re having good days, they’re having bad days, and they just feel that their condition has taken away so much from them, but to be able to speak about your situation, to be able to share your experiences, I know It’s very empowering. And they all feel confident again in themselves. And that’s something that most people will think that maybe sharing your story can be painful at times. But really, to be honest, I find it so empowering. I feel better mentally and emotionally, maybe not physically, because I’m not, you know, again, may not be feeling well in that way. But just to have that feeling that I just took a piece of my former life back because I shared my story. It’s just a wonderful feeling. And I know that those patients feel it because they’ve told me several times.

Dr. Robert Popovian  12:16

That’s terrific. We’re so happy to have you and also discuss this topic with you. So Conner, last question for you. You talk to a lot of patient groups and Corey and JP talked about some of the policy topics that they’ve covered in their discussions, anything else came up in your work in the state level with any other policy issue that was sort of hot and heavy that you were dealing with?

Conner Mertens  12:38

You know, when we talk to patients, there’s a lot of other issues besides the ones that we’ve been able to talk about today. Some of those ones are just high health care costs, expensive medications, which we cover extensively on this show is- and actually our last episode, go check it out was about you know, the new drug pricing paradigm that we’re on the cusp of and that’s just a common everyday thing that folks living with chronic disease have to deal with, are high and expensive medication costs, high health care costs, out of pocket expenses. Another thing that we hear about is these soft costs. The ones that may not necessarily be able to be covered by insurance, such as transportation expenses, or home modifications, or caregiver expenses, lost wages, there’s a lot of ways that chronic disease impacts patients outside of what we’re working on at the legislative level. And then the other one that’s just very topical is we’ve been seeing a rolling back of accessibility and accommodations that rolled out during COVID that really benefited a lot of folks living with chronic disease. It made getting back into work a lot easier. And so you know, there’s a lot of things that are constantly facing patients. And here at GHLF we’re always trying to track those down and and do the best that we can to help patients not have to experience them. Right, Robert?

Dr. Robert Popovian  13:50

Thank you. Thank you, Conner. Yes, absolutely. And I want to give each one of you one last opportunity to give us one takeaway you had from this tour that you’ve done in the state level. So Conner, let’s start with you, actually, and give us one takeaway. Quick.

Conner Mertens  14:04

Great, yeah, nice to share the spotlight with some other folks now. Yeah, for me, what was really impactful was the amount of times you’d walk into a legislative office with one of our patient advocates and, you know, working alongside our patient advocates, and then hearing from lawmakers hearing from their aides that this was the first time they’d spoken to a patient about these issues. And that’s a double edged sword where it’s disappointing that these patients, or that the lawmakers are not hearing directly from patients as often as they should and how these laws can impact their lives. But it does give us a sense of pride that we’re making sure that wherever decisions are being made about patients, that their voices are being raised, and they’re being heard. You know, and I’m sure JP will talk more about it, but just the pride that we have in being able to validate our patient community in these places is really rewarding and I look forward to continuing to do it with a great gang that we have on this podcast today.

Dr. Robert Popovian  14:12

Excellent. Let’s go to you JP then. What do you think, what is your one takeaway from these meetings?

JP Summers  14:56

I am so glad that we are doing these advocacy days because we are getting the opportunity to visit these different capitals and put ourselves out there as an organization, but also bringing patients and again, we are investing in ourselves. And we are helping to raise awareness. And it’s just a great thing. It’s a great thing that we are doing. Again, I feel very fortunate to be able to attend these meetings and to be able to speak with a patient, they are equally as excited as I am to be able to do these meetings in person.

Dr. Robert Popovian  15:29

Thank you, JP. And Cory, one last take?

Corey Greenblatt  15:32

One of the biggest takeaways from this is that PBMs are now a known actor in the healthcare industry. We don’t spend our first 10 minutes of our meetings anymore explaining what role pharmacy benefit managers play in drug pricing and formulary exclusions and all of these things. Staff members, legislators know them. For the most part, they understand that these are for-profit companies that are making decisions that continue to make them profits and not necessarily benefit patients. And so we’re able to spend the rest of the meeting focusing on the issue at hand, not necessarily the actors that are taking part in these issues.

Dr. Robert Popovian  16:12

Well, Cory, I have one thing to say, ‘amen.’ Because It’s taken decades, correct. I mean, you and I have been at this for a long time.

Corey Greenblatt  16:19

Oh, yeah. It’s really nice that now we can walk into these meetings. And we can kind of say, “Okay, so here’s PBMs.” And immediately see the staff members go, “Okay, bad guys. Got it.”

Dr. Robert Popovian  16:32

So with that said, I want to thank all three of you for joining us, Conner and I on this podcast.

Conner Mertens  16:39

Well, Robert, just because we got some new friends on the podcast today doesn’t mean we’re changing things up. Let’s make sure you get the last word in there. What’s your biggest takeaway from hearing about the adventures of GHLF on the road?

Dr. Robert Popovian  16:48

Yeah, the GHLF road trip. That’s interesting. So I would say the one big takeaway I have is that, you know, at GHLF, we do extraordinary amount of research, both on clinical research and also policy and economic research. But without being able to communicate those results, those findings, effectively, especially with policymakers, patients, and providers, there’s no point of doing that work. And what my take away is, that the work you all do, that three of you did over the summer, visiting with policymakers, patients, providers, anybody who is interested in these topics, is that you gave us a venue to be able to share the exciting work that we’re doing at GHLF. And be able to promote the solutions that we provide that improve access for patients. So kudos to all three of you. Thank you for doing this. And you know, as always, Conner, you and I will be back on the next podcast but I want to specifically thank JP and Cory, for joining us today.

Conner Mertens  17:48

You’re welcome back anytime, folks. Thanks for joining us. Thank you to our listeners, we’ve got plenty more coming your way this season. So don’t forget to subscribe to our podcast on Apple, Spotify, or wherever you might be listening, so you never miss an episode. If you have a second helps spread the word by rating our podcast, writing one of those positive reviews and sharing with your friends and family. It’ll help more people like you find us.

Dr. Robert Popovian  18:11

If you have any questions, comments, thoughts, suggestions, anything. You can send us an email at [email protected]. And who knows, you know, Conner and I go through those every day, every week. And we may include some of those topics in our next podcast or try to answer some of your questions that you may have.

Conner Mertens  18:30

And before you go, make sure to take a listen to some of our other great podcasts on the GHLF Podcast Network. You can find all those GLHF Podcasts at GHLF.org/listen. Well, thanks again to JP and Corey for joining us. As always, he’s Dr. Robert Popovian.

Dr. Robert Popovian  18:45

And he is Conner Mertens. We’ll see you all next time.

Narrator  18:50

Be inspired, supported and empowered. This is the global Healthy Living Foundation Podcast Network.

Narrator  00:00

Be inspired, supported and empowered. This is the Global Healthy Living Foundation Podcast Network.

Conner Mertens  00:10

You’re listening to Healthcare Matters, the podcast that pulls back the curtain to help you make sense of complex healthcare, economics and policy issues. With us as always, as my partner in crime Dr. Robert Popovian, tuning in from Washington, DC. He’s a pharmacist, economist, and the Chief Science Policy Officer at the Global Healthy Living Foundation.

Dr. Robert Popovian  00:28

And joining me is my good friend, Conner Mertens, from Seattle, Washington, my co host and our patient advocate and community outreach manager. Welcome back Conner fourth season episode one, let’s get started.

Conner Mertens  00:40

The time has flown by – four seasons, lots of topics were covered throughout our first three seasons. So thank you for sticking with us. And we’re so eager to get started on this new season with you all. And while we’ve been away, there’s been a few changes in the biopharmaceutical marketplace.

Dr. Robert Popovian  00:53

That’s right, lots to talk about. And actually Conner, as always we do in our podcast, we start off with giving you a percentage. So for this episode, what do you think of the percentage 85% might represent?

Conner Mertens  01:09

85% is usually the odds of the Mariners absolutely devastating me late in the season.

Dr. Robert Popovian  01:14

Good guess and I think that may happen this year, but what we’re talking about is a discount. And yesterday, we found out that the HUMIRA biosimilar is going to be available on cost plus pharmacy, the Mark Cuban’s pharmacy for 85% discount of the retail price, about $600 at dose, which is significant savings, but we’re gonna get into more of this discussion later on our episode.

Conner Mertens  01:46

Well Robbet Let’s get after it. I know that we’ve been away for a while and got a lot of catching up to do. So today we’re gonna be talking about drug pricing and some shifts in that.

Dr. Robert Popovian  01:54

Yeah, exactly Conner. And since we’ve been away some major shifts in the drug pricing paradigm have taken place. And that’s what we want to discuss today and what the implications are what’s causing it number one, but what are the implications of those changes for patients?

Conner Mertens  02:09

So what new news is there regarding the biopharmaceutical marketplace?

Dr. Robert Popovian  02:14

So the biggest news was that the three insulin producers in this country, Eli Lilly, Novo, Nordisk, and Sanofi have decided to significantly drop the prices of insulin in the US market and cap the price at $35 across the board, which is significant, because you know, the price reduction is almost like about an 80% reduction in price. And really what it does, it kills the net to retail price bubble that is being taken advantage of by the pharmacy benefit management companies as they are getting a lot of that margin as profit and keeping it as profit. So This is good for patients. This was tremendous amount of news that came out, but there’s more obviously,

Conner Mertens  02:57

Yeah. And you and your colleagues at the Progressive Policy Institute wrote an interesting paper about the shift in the drug pricing paradigm in the US. Can you tell us a little bit more about that?

Dr. Robert Popovian  03:07

Yeah. So we talked about how the insulin prices were dropped. But there’s more to it because we also have an example that happened earlier this year, where Johnson and Johnson decided to sell one of their brand products directly to consumers through the again, the cost plus pharmacy, the Mark Cuban’s pharmacy, at about a 55 to 60% discount compared to the retail price that’s offered through the insurance companies. So again, what we discussed is that there’s significant pressure in the marketplace for pharma companies to rethink their pricing methodology. And that’s what we want to discuss today.

Conner Mertens  03:41

So I guess the next question is, why did the insulin manufacturers do what they did here?

Dr. Robert Popovian  03:46

That’s a great question. And that’s what we cover in the paper that we wrote with the my colleagues, Michael Mandel and Aaron Delaney from the Progressive Policy Institute, where we basically decipher that there are four pressure points that are taking place for biopharma companies to really rethink their pricing model. Number one is for insulin and specifically there was a lot of insulin legislation, specific legislation for insulin and diabetics, and also litigation that’s taking place both on the state and federal level. And I think that was one pressure point of that came about to sort of have the, these biopharma companies rethink their pricing methodology and instead of rewarding pharmacy benefit management companies, directly pass the savings to the patients. The number two thing is really the Inflation Reduction Act. The Inflation Reduction Act is coming fast and furious, and a lot of pharma companies are thinking about what the implications are for those products that are going to be sort of price set by the CMS and one of the remedies of those price setting is to drop out or that list is really to reduce your price significantly and drop out because the sales are going to be impacted and then CMS then has to reevaluate which drug ends up on that list to set a price. The third issue is a little bit inside baseball. But I believe It’s even a more of a impetus for pharma companies to rethink their pricing methodology, which is the removal of the cap for the average manufacturer price for Medicaid rebates. And you know, this cap has existed and the removal and, this is very interesting, the removal of this cap is going to create an environment where biopharma companies are going to have to pay Medicaid to cover their drugs. And you know, Conner let that sink in, I mean, not get paid by Medicaid, but actually pay Medicaid to cover their medicines. So the only remedy for that, again, is significantly to reduce your prices. And this impacts a lot of brand products that are older, that have been around for a while and if taken massive price increases over time, and the only remedy that I believe exists is for these companies to reduce their prices and not have to be impacted by This A and P cap removal of the rebates. And finally, I mean, It’s really an external environmental issue, which is the FTC investigation. I think the FTC investigation going on into practices, the pharmacy benefit management companies, is going to give some cover for industry not to like really worry about what the implications are if they really changed their pricing methodology. And because of the scrutiny that’s happening on the PBMs, both on the FTC and also congressional level, and on the state level, that pharma companies can be brave and really redo the pricing thought process and help patients out. So those are the four points that we believe are going to create an environment that we’re going to see significant shift in the pricing methodology of the biopharma companies.

Conner Mertens  06:44

So before this, what role did the PBMs and you know, state Medicaid programs play in inflating these drug prices? How have the new list prices addressed this issue?

Dr. Robert Popovian  06:54

Well, the role that they played really has to do with rebate contracting, and it’s not as much the Medicaid programs rather than the rebate contract and methodology, which is favored by the pharmacy benefit management companies. When you have a rebate, which is technically a kickback. The impetus is for the drugs to be higher price and more kickback going to the pharmacy benefit management company, which reduces the net price, they end up paying the biopharma companies. And this net to retail price bubble has grown significantly into hundreds of billions of dollars. And what has happened over time is that every time a biopharma company sells a brand name drug, on average, 50 cents, or 50% of it, goes back to the supply chain, where there’s the pharmacy benefit management company and insurer primarily, but also the wholesaler to pharmacies, the providers, the physicians, the hospitals, and so on. And what the pharmacy benefit management companies have thought about is that, why are we doing this rebate contracting or protecting this rebate contracting model, which we get only 50% of the benefit, but we get the 100% of the blowback politically because of these high prices. So the rebate contract model has really driven this higher price models to be favored by the pharmacy benefit management companies. And what people don’t understand is that when you have higher prices, and higher kickbacks, even if the PBM passes on a significant percentage of it, let’s say back to the employer, or whoever the plan sponsor, they still benefit more from having that methodology because they keep a percentage of it, and of the rebates and also a significant portion, if not all of the fees and everything else that they charge. So that’s what’s driven this whole premise of higher prices in the marketplace and what the insulin manufacturers did by dropping their price, they really exposed this environment where higher list prices were only benefiting one entity and one entity only, which was the pharmacy benefit management companies.

Conner Mertens  08:54

So are there are other examples of how drug pricing is evolving here in the US. Can you give us any other examples aside from our insulin discussion?

Dr. Robert Popovian  09:02

Yeah, absolutely. I mean, I mentioned that Johnson and Johnson decided to sell one of its brand products directly to consumers through the cost plus pharmacy model, which is the Mark Cuban’s model that sells cash based pharmaceuticals directly to the patient and they’ve discounted that drug by about 60%. And that’s significant, but there was even more significant news yesterday and we can talk about that with regards to what happened with the HUMIRA biosimilars.

Conner Mertens  09:27

Let’s dive into that more biosimilars are starting to be introduced into the US marketplace. What did we hear yesterday?

Dr. Robert Popovian  09:33

Right, so the retail biosimilar market is increasingly evolving, and it’s going to evolve even significantly more this year. Humira, the largest selling biopharmaceutical in the US with sales of upwards of $20 billion dollars annually. It’s going to get significant competition in the marketplace through these biosimilars. And the first biosimilar was introduced by Amgen in the market and has gotten very little traction because again, and it’s been priced lower than the HUMIRA and as we discussed PBMs prefer to higher price/higher rebate products. But what happened yesterday is another biopharma company that is developing a HUMIRA biosimilar Coherus decided to sell its biosimilars directly through cost plus pharmacy at 85% discount. So in effect they set up a ceiling for the price of this biosimilar now, and there is no floor because the interesting part is going to be how this drives other companies to reprice their biosimilars, and including Abbvie, to reprice their HUMIRA. Interesting part about this whole issue is that how the pharmacy benefit management companies and PCMA, which is the trade organization for the PBMs, is going to try to spin the whole thing about why they’re covering the higher price alternative compared to the lower price now that we know it 85% Discount Coherus product. This is going to be fascinating information coming out in the next two to three weeks to see how they respond with spinning and their PR departments are price-spinning this thing like crazy trying to come up with reasons why they’re covering the more expensive medicine.

Conner Mertens  11:11

Well, I guess that leads me to my next question, which is who stands to benefit and lose from these changes? Like how are patients expected to benefit from these reforms? And what impact will it have on the PBMs and others who you know, are going to benefit from a high list price and the rebate.

Dr. Robert Popovian  11:27

The biggest losers from lower list prices are the pharmacy benefit management companies, without a doubt. I don’t care anybody who wants to say otherwise, they are the biggest losers, because they’re no longer going to be able to collect those humongous rebates that they were doing, right, because now that the list price has dropped significantly, the rebates are gonna go away, or they’re gonna be significantly lower. The biggest winners are to patients. We’ve discussed this issue on numerous occasions on our podcast. When a patient shows up to a pharmacy counter. And if they have a deductible or a coinsurance, their deductible, or coinsurance is based on the inflated retail price that they end up paying, not the net price that’s been negotiated on their behalf by the PBM. So what’s going to happen with these lower prices now is when a patient shows up to the retail pharmacy, at the counter, and they have a coinsurance or deductible, they’re going to be paying it based on these lower retail prices that have been introduced, whether it’s through the insulin manufacturers, or these biosimilars. And that’s going to be leading to tremendous amount of savings for patients. This is significant patients, and patients only are going to benefit from this. And one of the things that we need to do is encourage our patient population, our listeners to go in and even ask for more companies to be brave and really rethink their pricing methodology and reduce their prices so they can benefit and this is tremendous news for patients.

Conner Mertens  12:52

All right, Robert, we’ve been doing this for four seasons. So I’m going to make sure you get the last word in here. But you know, I think that this is a really exciting thing for patients. You know, the shift that we’ve seen with the insulin has exposed the dirty dark secrets of the drug pricing industry. Ultimately, this new paradigm is the unintended, but welcome result of lots of legislative and regulatory and market pressures that have been exerted on the biopharmaceutical industry, from patient advocates and folks that are just trying to get patients easier access to medications. But as always, let’s make sure you get the last word, Robert, what do you think?

Dr. Robert Popovian  13:23

No, I agree with you, Conner. I think making things uncomfortable for the players in the marketplace, to the benefit of patients is what we strive for. And if PBMs are losing money and losing profits, that’s not a bad thing for patients, trust me. At the end of the day, the only person that is going to be the biggest loser is the pharmacy benefit management company, because they’re going to make less money and less profits. The biggest winners are the patients because they’re going to show up to the pharmacy counter and pay less for their medicines. And that’s what we want in the marketplace. Enough with the distortions, enough with the gamesmanship, patients need to benefit and this is unbelievable news. And I’m so happy that Eli Lilly, Novo Nordisk, Sanofi, coherus J&J, all these companies that are producing biosimilars that are brave enough to rethink the pricing paradigm. Started with insulins, we’re getting into the autoimmune disorder drugs. This is great news for patients. Let’s continue doing this. Let’s put the pressure on the system to the benefit of patients. And we’re going to get two things out of this: one, less profits were PBMs, and more money in the pockets of the patients.

Conner Mertens  14:32

Thanks for breaking it down for us, Robert. I know that there’s some really valuable information in there for our listeners, and like you said, this is an important topic that folks should be up to date on and should know what they’re talking about. Speaking of information, we are on our fourth season of Healthcare Matters. And I hope that you take your chance to go back and listen to the first three seasons – a lot of valuable information in there. So don’t forget to subscribe to our podcast on Apple, Spotify or wherever you might be listening so you never miss an episode. If you have a second helps spread the word by rating our podcast, writing a positive review, and sharing with your friends and family. It will help more people like you, find us.

Dr. Robert Popovian  15:03

So we’re starting season four. If you have any questions, thoughts, suggestions, ideas, you can send it our way, please email us at [email protected]. And if it’s an interesting topic, and it’s an interesting question, you may be featured on our upcoming episodes. We’re trying to be much more user friendly, as they say this season. And we’re going to include a lot more external guests. In fact, we are planning on having, Ben has already arranged our producer to bring on Corey and JP and Conner to talk about their tour of the States and what has happened in the first half of the year in the state legislative efforts. So stay tuned.

Conner Mertens  15:42

That’s right. I’m really excited to cover our state advocacy efforts in our next episode. And lastly, before you go, make sure to listen to some of our other great podcasts on the GHLF Podcast Network. You can find all of those podcasts at ghlf.org/listen. As always, he’s Dr. Robert Popovian.

Dr. Robert Popovian  15:58

And here’s my partner in crime, Conner Mertens and welcome back, Ben. We’ll see you all next time.

Narrator  16:04

Be inspired, supported and empowered. This is the Global Healthy Living Foundation Podcast Network.

Narrator  00:00

Be inspired, supported and empowered. This is the Global Healthy Living Foundation Podcast Network.

Conner Mertens  00:06

You’re listening to Healthcare Matters, the podcast that pulls back the curtain to help you make sense of complex healthcare economics and policy issues.  I’m Conner Mertens, Patient Advocate and Community Outreach Manager at the Global Healthy Living Foundation. Today, we’re excited to bring you a special compilation episode of Healthcare Matters, featuring select informative and engaging segments from past episodes recorded with my co-host, Dr. Robert Popovian, the Chief Science Policy Officer at GHLF. While we’re currently on a brief hiatus, we’re hard at work preparing for the return of our show in May, where we’ll continue breaking down the complexities of healthcare economics and policy, providing you with the insights you need to better understand the healthcare landscape. As we reflect on the great conversations we’ve had in our past episodes, we’re reminded of just how important it is to make these discussions accessible to everyone. So, in this episode, we’ll be revisiting some past segments that highlight key issues, trends, and solutions in the ever-changing world of healthcare. Let’s get after it.

Conner Mertens  01:06

To kick off this compilation episode, let’s dive headfirst in the world of drug formulary exclusions. Why don’t we start with what it means? What is a drug formulary exclusion?

Dr. Robert Popovian  01:16

So Conner, drug formulary exclusions are when a pharmacy benefit manager or an insurer decides to exclude medicines that have been on formulary for many decades or years or months and replace them with alternatives such as generics or other drugs that have similar capabilities. But the problem with the exclusions is that it impacts patients and that’s what we’re here to talk about, what is the impact on patients?

Conner Mertens  01:42

Robert, maybe tell me a little bit more about who implements these, and how they benefit from it.

Dr. Robert Popovian  01:47

So the pharmacy benefit managers or the insurers are the ones that implement them and they exclude these medicines from the formularies. And the benefit truly goes to the pharmacy benefit managers, because by excluding certain type of medicines from formularies that patients are taking, they’re able to extract even more concessions from the pharmacy by pharmaceutical companies. And at the same time, they’re able to cut their costs. But the question is, what is the impact on the patient?

Conner Mertens  02:16

So obviously, we work with folks living with chronic disease. It sounds like they’re really going to be impacted by these formulary exclusions.

Dr. Robert Popovian  02:24

Exactly. And that’s been the problem for years. So this is not a new phenomenon. This has been going on for over a decade now when exclusions have been happening. And it’s like clockwork, when the fall comes, football season starts, formulary exclusions take place and the announcements come out of these three large pharmacy benefit management companies which are Optum, CVS Health and Express Scripts. And every year more and more drugs are being excluded from these formularies. The problem is that nobody knows what happens to these patients. Nobody knows if a patient that is stable on these therapies ends up in a hospital, becomes non adherent to their therapy. And it’s an unfortunate situation because they put the patient and their provider in a very difficult situation because they end up changing and meddling into what is best for the patient and the best care. And the worst part, Conner, to me is that they do not have any mechanisms of going back and seeing what are the consequences of their actions. In fact, they probably don’t want to see what the consequences of their actions are. What they do is that they push this back on the patients and their providers to manage.

Conner Mertens  03:36

So just to clarify a little bit more, if a patient is steady on a medication that’s working for them, and their formulary changes, they can be kicked off that medication? What happens then if these are essential for quality of life or day to day living for patients?

Dr. Robert Popovian  03:50

You’re right, that’s what exactly happens. A patient is stable on a drug that they may have been on for a year, decades, months. And because of this exclusion now, this product is no longer available for them. What has happened is that the patient ends up going to their provider, a physician, a pharmacist, a nurse practitioner, and has to be now put on a new therapy with unknown consequences. And that’s the problem, because who’s going to bear the burden of the risk of these type of formulary exclusions, it’s certainly not the pharmacy benefit management company, or the insurer. They’re pushing this risk back on to patients by having poor quality of life or side effects or not having their disease managed appropriately. And they’re pushing this burden on their providers, to the pharmacists, to the nurse practitioner, to the physician to the physician assistant to manage these things. They are the ones that are culpable for all of the activity, but they bear none of the risks.

Conner Mertens  04:51

And in bearing none of the risk, it’s also sounds the only thing that’s being taken into account here is a bottom line, and not the drugs efficacy or side effects or outcomes or the doctor’s treatment plans. So ultimately, the care of a patient is being taken away from the doctor just because of some moving numbers in drug names on a formulary. Is that right?

Dr. Robert Popovian  05:10

Exactly. I mean, the reason that they’re excluding these medicines, as I started to say in the beginning of this podcast is because they can then garner more concessions by pharmaceutical companies, and they get all the benefit of the cost savings of the bigger concessions and all the other stuff. And then they push the risk upon the patient and providers to manage that risk. And it is an unfortunate situation. And the least they can do is ensure that patients are not falling through the cracks. And in fact, their care is not being undermined, through their policies.

Conner Mertens  05:49

So aside from educating folks on all sides of the healthcare system, the patients, the providers, our doctors, what’s being done about this practice, who’s protecting these patients from these life changing exclusionaries?

Dr. Robert Popovian  06:01

Nothing really has been done on the federal side. And that’s the unfortunate place. As I said, this is an annual event that takes place, everybody looks at the numbers, the numbers keep growing of the exclusions, and we just go on to the next year and the year after that, but nobody knows what happens to these patients. So is there some action that can be taken, absolutely. There is some action that can be taken to prohibit this type of practice, or at least for the minimum, to mandate that the pharmacy benefit management companies and insurers that are doing and implementing such policies are held accountable. And that’s through finding out what happens to the patient after these exclusions take place. Maybe nothing happens to the patient, and that’s a good thing. But if it does, then who bears the risk? And we don’t know that because nobody wants to take that responsibility.

Conner Mertens  06:53

And let’s switch gears up to our mailbag episode where we took listener questions and did our best to answer them. We did get a great question from Jennifer. She says: “I’ve been listening to various news outlets touting the Mark Cuban Cost Plus Pharmacy, is this a new pharmacy concept?

Dr. Robert Popovian  07:07

Well, Jennifer, to answer your question in a short way: no. Mark Cuban’s Cost Plus Pharmacy is definitely getting a lot of media attention and in fact, I was on a call with a reporter from the Rheumatologist Journal talking about this venture. There are other entities who have been well established for many years doing this type of pharmacy service, which is primarily providing pharmaceuticals and mainly the generic formulation, in a cash manner to patients. And that means patients walk in and pay cash instead of using their insurance cards, and they are saving tons and tons of money. So the benefit of having though somebody like Mark Cuban is that he does possess a huge megaphone. Everybody knows who he is. He has a nightly show called Shark Tank, I believe. And he does get a lot of attention. So I believe what he’s doing is great for this whole environment, because what he’s doing is raising the awareness that patients have alternatives, that they don’t have to use their insurance card always to save money. And in fact, in some cases, and or most cases with generic medicines, they can walk into these pharmacies that offer cash prices for the generics, in fact all pharmacies do, but these are specific pharmacies that are just offering cash prices for pharmaceuticals that are generics and they can save a lot of money.

Conner Mertens  08:29

So I guess another question I have for you, Robert, is is this, you know… a new pharmacy concept? Has this been around for a while?

Dr. Robert Popovian  08:35

No, it’s not new. As I said, other entities have been doing this for a while. I mean, the largest being Costco. We all know about Costco. We go there to get a lot of our foods and you know, diapers and paper towels and everything else but they have a pharmacy within Costco and Costco Pharmacy has been very focused on cash paying patients who come in to purchase their pharmaceuticals. And in fact, a huge percentage of their business in the pharmacy is still cash-based business. So they’ve been doing it for many, many, many years. It’s just that, you know, they don’t have the visibility Conner, as you know, of somebody like Mark Cuban who is able to get this word out much more effectively than they would. And you there are other smaller players that are community based pharmacy like Freedom Pharmacy, Blueberry Pharmacy that provide these type of services in specific locations, which again is the same exact concept: Patient walks-in, doesn’t use their insurance card. In fact, they save money by paying cash and these pharmacies are thriving, and the patients are saving money. And that’s what we want, right, Conner for our patients?

Conner Mertens  09:39

We were also joined by our colleague Zoe Rothblatt, who was able to shed some light on the patient perspective and help us out with some important questions.

Zoe Rothblatt  09:46

Hi, it’s Zoe, thanks so much for having me on. I have a question for you, Robert. You know, I’ve had fellow patients tell me that they’re thinking about going on a biosimilar instead of the brand name biologic that they’re currently on and they asked me if biosimilars are safe. And they ultimately wonder if their condition is going to get worse if they use a biosimilar. We get this question a lot and as a professional, what’s your response to those patients?

Dr. Robert Popovian  10:14

Hi, Zoe, first and foremost, so good to hear from you. Second, I would say you need to talk to your healthcare professional that’s managing your care. Whether it’s your physician, your pharmacist, your nurse, your nurse practitioner, your physician assistant, whoever you’re going to that is providing you the care that is the first person that you should approach about these questions. They can provide the best answers because they know exactly what you’re going through as a patient. The second thing is more of an academic answer, which is I will give to anybody that asks: Biosimilars are absolutely safe and absolutely as effective as the brand biologics. FDA has approved these medicines, they go through rigorous research and development process. It takes several years, several 100 millions of dollars to be able to bring these drugs to the market. There is a lot of science that goes behind it, there’s a lot of regulation, there’s a lot of scrutiny, there’s nothing to be worried about these drugs. As a patient, you’re gonna get the same response as on a brand biologic. Now the big question for patients and patients like yourself is that, if you’re willing to do this right, to switch to a biosimilar, the question you should be asking, it’s not really from your healthcare professional, or your pharmacist or anybody else, but from your insurance company is that whether you’re or not, going to get those savings passed on to you directly at the point of sale, instead of being hoarded by the PBMs and insurers. So that’s the one that I’m always concerned about. And at GHLF we’re always concerned about is that: Will the patient benefit from something like this rather than the insurance company and PBMs pocketing the difference in savings and taking it as profit?

Conner Mertens  11:57

And a big thank you to Zoe for helping us out with that episode. And as always, Robert crushed that answer. But to wrap up this compilation episode, let’s take a look at our advice for patients. We always try to consider how we can address these issues we’ve discussed today with our patient community. The first thing that we are going to suggest is you talk to your doctor and figure out what’s the best course of options for you. You know the second thing is to be educated, find reputable sources, and I think that that’s a really important piece right now in the age of misinformation is to find things that are actually true and peer reviewed. And trust the scientists and listen to the scientists. And then you know, find community find folks that are going through the same thing that you are and talk honestly and openly with them. You know, these things, these hesitations they shouldn’t be treated as you know, we shouldn’t ostracize people for asking questions and feeling nervous about these things. Robert, what do you think?

Dr. Robert Popovian  12:43

So one more thing I would say is tune-in and listen to the podcasts that are put together by Global Healthy Living Foundation. I mean, we do the Healthcare Matters podcast. But we have several other podcasts in our podcast network that talk about specific disease areas. We have somebody who focuses on psoriasis and somebody who focuses on migraines and pain. So dial in and listen to our podcasts, we provide a great deal of information and we try to bring down the level of discussion to a patient level, because that is important, right? We’re not trying to, here in these podcasts, convince healthcare professionals or we’re not trying to demonstrate that we can go toe to toe with an academician. What we’re trying to do is convey information to the everyday patient who’s looking for answers. And that’s our audience. And that’s what we take very seriously. And we do this with every single podcast that Global Healthy Living Foundation puts together.

Conner Mertens  13:39

I strongly encourage folks to go check out the 50-State Network one of GHLF’s advocacy arms and get involved that way. Sign up, tell us your story and work with us to elevate the stories. We’ll give you a megaphone. We’ll make sure that legislators and folks that are at the tables of power and the powers that be that they’re going to hear your experience and hear you out for how their decisions impact your life, your care and your health. But ultimately, just take that step, be loud take up space, you deserve to be heard.

Conner Mertens  14:12

Thanks for listening. That was a lot of valuable information that Robert broke down for us and we have many more great discussions to come so stay tuned for our next episode. As always, don’t forget to subscribe to our podcast on Apple, Spotify, or wherever you might be listening so you never miss an episode. You can also find our podcast on YouTube. We’re everywhere. And if you have a second help spread the word by rating our podcast, writing a positive review and sharing with your friends and family, it will help more people like you find us. I’m Conner Mertens. We’ll see you next time.

Narrator  14:41

Be inspired, supported and empowered. This is the Global Healthy Living Foundation Podcast Network.

Narrator  00:00

Be inspired, supported and empowered. This is the Global Healthy Living Foundation Podcast Network.

Conner Mertens  00:10

You’re listening to Healthcare Matters, the podcast that pulls back the curtain to help you make sense of complex health care economics and policy issues. As always, we’re joined by Dr. Robert Popovian, tuning in from Washington, DC. He’s a pharmacist, he’s an economist, and he’s the Chief Science Policy Officer at the Global Healthy Living Foundation.

Dr. Robert Popovian  00:28

And joining me is my good friend, Conner Mertens, from Seattle, Washington, my co-host, and our Patient Advocate and Community Outreach Manager.

Conner Mertens  00:37

And a big thank you to you, our listeners for tuning in all season. We’re a bit sad, because this is going to be our last episode of the season. But don’t worry, we’ll be back in May with a brand new season to give you a full recap on the state legislative sessions and then other legislative priorities.

Dr. Robert Popovian  00:50

That’s right, we’re gonna make sure that we recap the legislative sessions sometime in mid-May, and we will release a shorter compilation of episodes so you don’t miss us too much. So Conner, let’s get right into it.

Dr. Robert Popovian  01:04

Today, I’m going to ask you what you think of the percentage 80. What does 80% mean to you?

Conner Mertens  01:12

We got our numbers again… Um, 80% sounds like the cost increase I’m paying for my inflated Thai dinners.

Dr. Robert Popovian  01:20

Close, but no. 80% is the percentage of retail prescriptions that the three largest PBMs manage in the United States. So the three largest PBMs, Express Scripts, CVS Health, and Optum, manage 80% of the prescriptions in the retail space in the United States.

Conner Mertens  01:43

Well, Robert, it sounds like today, we’re going to jump in, and kind of dive deeper on a topic that we’ve discussed many times and something that we think is essential to making health care better for folks. And that’s the issue around transparency. Recently, you co-authored an article in National Review. I mean, I think the title says it all but it’s: “Transparency Laws Are the First Step in Creating a More Sustainable Health Care System”. And like I said, this is nothing new. We’ve talked about this, and it spreads across so many other issues in health care, this idea of transparency. And you know, on the state level, we hear states implementing transparency laws, or at least trying to. Now there’s chatter that federal policymakers are interested in passing similar legislation. What can you tell us, Robert?

Dr. Robert Popovian  02:23

Well, first and foremost, the reason I authored a paper is because frankly, if you don’t have transparency in the marketplace, and you don’t have accurate collection of information and data, you’re going to make poor policy decisions. So that’s what enticed me to write this article because first and foremost, we need data… appropriate data. And that’s going to come through transparency, and transparency laws that are passed for us to be able to collect that information, and be able to then come up with policy solutions that actually address the data points that we see are not helping out first and foremost, the patients. So that’s what encouraged me to write it. But from a federal standpoint, yes, you are right. I mean, states have dabbled into the issue of transparency for a while, I talked about it in the article that I co-authored with Catherine Windels. And now federal policymakers are starting to dabble into it and dip their toes into the issue of transparency on the federal level. And both the House and the Senate have sort of sent out smoke signals that they’re interested into getting into the space.

Conner Mertens  03:29

I guess the next question is, can you explain to our audience what policymakers are trying to accomplish? What’s… you know… We’ve we’ve identified this problem, but what are they doing to solve it?

Dr. Robert Popovian  03:38

Well, first and foremost, they’re trying to figure out what is the accounting, right? Where’s the money going to? So you spend over $500 billion in pharmaceutical spending in the United States, a great percentage of that over 40%, some people say even closer to 50%, is somewhat given back as revenue to what we call as middlemen. Which primarily 90% of the middleman happens to be the pharmacy benefit managers. So what the federal government wants to do is that of that 40% of that $500 billion that is pushed back into the system, because that’s the concessions, rebates, fees that the pharmaceutical industry ends up paying. What percentage of that money is kept by the PBMs as profit? What percentage of that money is passed back to the employers, the patients and the government, whether state or federal. And that’s what the policymakers are trying to accomplish, it’s to get an accounting of almost where’s the money flow going? And that’s what they’re trying to accomplish on the federal level. They’ve tried to do some of that on the state level.

Conner Mertens  04:46

Yeah, there’s a lot of ambiguity and like we said, just a lack of transparency overall. What would you say is the government’s stance? What are government agencies saying and doing regarding transparency with these PBMs?

Dr. Robert Popovian  04:56

Well, the agencies, I mean, first and foremost, the federal government from a congressional standpoint, both the Senate Finance and the House Ways and Means as well as other committees within the house, have an interest in looking at this. So that’s been their point of view, let’s go into transparency. But It’s not just Congress. The FTC has also sent out information and requested information regarding transparency. And the reason being is that all of these entities feel that there’s incomplete information. So congressional budget office for years has, you know, tried to model how much of the money is being pushed back to the federal government from the PBMs. Whether it’s primarily in the Medicare Part D space. But what they end up doing is doing it based on modeling data and not actual data. And the actual data that they do receive from the PBM is incomplete data. Because what they’ve done through regulations, they just asked the PBMs to provide them the numbers regarding rebates. But as our audience knows, and we’ve discussed this many, many times on our podcast, the concessions are more than just rebate, right? We are talking rebates, discounts, fees, which have been increasing significantly more than rebates have. And also remember, back when Medicare Part D was implemented, and CBO started collecting this information or mandating this information from the PBMs, we didn’t really have specialty medicines, as many of them, and PBMs did not own specialty pharmacies. But in the last five, six years, they’ve acquired a lot of these specialty pharmacies. So not only do the pharmacy benefit management companies, the three largest PBMs, Express Scripts, CVS Health and Optum, control processing of the prescriptions, 80% of them, that happen in the United States, but they also are involved in the dispensing. So close to 40% of specialty pharmacy dispensing goes through these three large PBMs again, because they own the pharmacies, so not only they manage benefit design, they control, you know, access to medicines, to formularies. But now they also manage dispensing. And there’s a lot of fees and money that flows through the pharmaceutical industry to these specialty pharmacies, because they require pharmaceutical industry to pay exorbitant fees for them to dispense their medicines from these pharmacies. So the Congress is interested in knowing what is going on. And they want to have a complete picture and not what CBO has for years pointed to as rebates. Because as we know, now, rebates are an incomplete number of concessions that end up in the hands of the PBMs from the pharmaceutical industry.

Conner Mertens  07:47

Absolutely. And I think something that we’ve noticed recently, at least anecdotally, is impasse advocacy, when we would go to DC and we would work with lawmakers there. It took a lot of time to explain what a PBM is, what step therapy is, you know, all these issues, what are transparency issues. But we’ve noticed recently that folks are catching on. A lot of the aides in the offices and a lot of the lawmakers themselves now they actually know what these insidious practices are and what they are. So we’re spending a lot less time just trying to explain it, and more time trying to fix it, which is a good problem. But I’m curious, who would be opposed to this legislation? And what’s their opposition based on?

Dr. Robert Popovian  08:24

Well, it’s primarily been the pharmacy benefit management companies and insurers who were opposed to this. Their primary opposition is that any kind of transparency will not allow them to negotiate prices lower or lower pharmacy spending, which is nonsensical argument because there’s ample data that’s available in many parts of the marketplace that demonstrates that transparency, in fact, lowers prices, lowers pharmacy spending, lowers prices of pharmaceuticals. And also one thing that they don’t want to tell policymakers is that one of the largest insurers in this country, which happens to be Kaiser Permanente, which is the by the way, the number one insurer in the state of California, our most populous state in the Union. It happens to use zero PBM for negotiation of drug prices. And in addition, they refuse to negotiate based on rebates. They negotiate based on net price. That’s all they want to know, what is the net price to me, and they don’t care about rebates, and they don’t use a PBM to do any of those negotiations. So the model is very successful, and successfully lowers prices and costs for Kaiser Permanente. It can be done for the rest of the country. It could basically take us back to where we are negotiating based on net prices instead of having this secret rebate dollar amount that flows back into fees and everything else, the concessions that flow back to the pharmacy benefit management companies. From the pharmaceutical industry, and majority of the time, those dollar amounts don’t end up in the hands of the real payers in the United States, which happen to be the patients, first and foremost, employers, and to a certain extent the government, both state and federal government.

Conner Mertens  10:12

You mentioned successful models. And I’m curious, what is the potential impact on patients when we have these positive models? And what’s the impact on patients when we don’t have transparency?

Dr. Robert Popovian  10:22

Well, the boogeyman argument that PBMs always use regarding transparency, besides their inability then to lower prices and control costs, which we know is nonsense, is that… well, if you don’t collect all these rebates, and we go away from rebate contracting, to what Kaiser does, which is net price contracting, what you will end up doing is putting pressure on premiums, because they argue that some of these rebate dollars go back to support premiums, that lower overall healthcare costs premiums. Again, a nonsensical argument, because if Kaiser Permanente one of the largest insurers in this country, the largest insurer in the state of California, is able to negotiate based on net prices and keep their premiums low, as low as anybody else in the marketplace, then what is the point of having this backwards way of doing business? So again, their arguments fall flat because the data doesn’t support it. If somebody is paying less for something, then why do you need to increase premiums? Premium support is unnecessary if in fact, you’re collecting multi billions of dollars of drug concessions from biopharmaceutical industry and passing on only a percentage of that back to the actual payers.

Conner Mertens  11:41

So I guess the next logical question is, what else can policymakers do? Or what are policymakers doing to create this transparency that’s obviously needed regarding drug pricing and spending.

Dr. Robert Popovian  11:52

So what policymakers should be doing, they’re not there yet, with regards to their thought processes, another point that we made in the opinion editorial, which is they need to force biopharmaceutical industry to come clean. They need to mandate that biopharmaceutical industry demonstrates or calculates how much price pressure does rebate contracting put on them to increase their prices. We just recently saw only two weeks ago that Eli Lilly decided to cut their prices. They went down to a net price of $35 for their insulin. Basically, they reduced the price by 70-80%. Why, because now no longer they’re gonna give rebates back to the PBMs. So instead of the PBMs benefiting from this contracting agreements, the patients are going to benefit from it. So the insulin price went up from $120, $130, $140 to $35. That’s significant. And that’s what Congress needs to do is put pressure on the biopharmaceutical industry to come clean and demonstrate how much pricing pressure is rebate contracting putting on them. And it’s not just rebate contracting, all the fees, and all the fees they have to pay to the specialty pharmacies that are owned by the PBMs that will not cover the medicine unless those fees are paid for. So pharma industry needs to come clean. And also pharma industry needs to start changing their vernacular. For far too long, the industry has protected the PBM business model by referring to them as quote, unquote, payers. We’ve discussed this many, many times, again, on our podcast, the true payers in this marketplace, in the healthcare marketplace are not PBMs, and they’re not insurers, they’re middlemen. They pass the money from one side to the other and keep a percentage of this profit for themselves. The true payers are the patients, the federal and state governments to a certain extent, and the employers. So that’s another thing Congress can do, is really come clean and put pressure on the biopharmaceutical industry to become more transparent about that too.

Conner Mertens  13:51

Well, we’re going to make sure you get the last word, Robert, but this conversation of transparency is intertwined with so many of the other conversations that we have when we’re talking about patients and making sure that they have the best benefits and pricing. Transparency is the floor, we have to start there. And we can’t change the policies. And we can’t change the legislation until we know where and how this money is moving around. But let’s make sure you get the last word. What are you thinking?

Dr. Robert Popovian  14:18

No, I’m thinking exactly the same thing you said. Unless we have accurate data, we make poor policy decisions. And the issue of transparency, and what Congress is trying to do and what the states have tried to do is, first and foremost, get the information correct. Stop doing modeling work, or guesswork or take the words of the PBMs like CBO has done for many, many years as to what percentage they keep. Stop getting incomplete information through laws and regulations that you’ve written. In fact, get the right information, get all of the information and then start peeling the onion and making policies that make sense that actually are going to help patients instead of making poor policy decisions based on incomplete information or misinformation that you’ve been doing for many, many years.

Conner Mertens  15:11

Well, as always, thanks for breaking that down for us, Robert. I think there’s definitely some valuable information in there for our listeners, and hopefully for lawmakers too! And what a great end to the third season. To our listeners, we’ll be back in May, so you won’t miss us too much. In the meantime, we’ll be releasing a few compilation episodes, so make sure you stay tuned in. And don’t forget to subscribe to our podcasts on Apple, Spotify, or wherever you might be listening. We’ve got a bunch of episodes for you listen to while we’re on hiatus. So make sure you catch up on seasons one through three. And if you have a second help spread the word by rating our podcast writing a positive review, and sharing with your friends and family. It’ll help more people like you find us.

Dr. Robert Popovian  15:46

Just because we’re going on hiatus for a few weeks doesn’t mean that we’re not going to be checking our emails. So please send us your comments, emails, audio clips, anything that you want us to talk about to [email protected] and we will try to answer all your questions and maybe feature some of those topics in our new season coming up,our season four in fact, Conner!

Conner Mertens  16:09

Four seasons! Yeah, Robert, time flies. And before you go, make sure you take a listen to some of our other great podcasts on the GHLF Podcast Network. You can find all those at ghlf.org/listen. As always, he’s Dr. Robert Popovian.

Dr. Robert Popovian  16:22

And he’s Conner Mertens. We’ll see you all in a few weeks.

Narrator  16:27

Be inspired, supported and empowered. This is the Global Healthy Living Foundation Podcast Network.

Narrator  00:00

Be inspired, supported and empowered. This is the Global Healthy Living Foundation Podcast Network.

Conner Mertens  00:10

You’re listening to Healthcare Matters. The podcast that pulls back the curtain to help you make sense of complex healthcare economics and policy issues. As always, we’re joined by Dr. Robert Popovian, tuning in from Washington, DC. He’s a pharmacist. He’s an economist, and he’s the Chief Science Policy Officer at the Global Healthy Living Foundation.

Dr. Robert Popovian  00:28

And joining me is my good friend, Conner Mertens, from Seattle, Washington, my co host, and our patient advocate and community outreach manager.

Conner Mertens  00:36

And today, Robert, we’re gonna be joined by our friend and fellow colleague JP Summers, who, like me, is a patient advocate and community outreach manager at the Global Healthy Living Foundation. She was recently in Wisconsin to support a bipartisan legislation aimed at ensuring copay assistance programs benefit patients instead of insurance companies. But we’ll get into that in a few minutes here.

Dr. Robert Popovian  00:56

We’re so glad to have her join us. She will tell us more about her trip to Wisconsin, and more importantly, provide us with a patient perspective of why such regulations or policies are toxic to the patients. So today, Conner, I want to ask you a number like we always start our podcast with and the number I have in mind is number 16. And don’t tell me It’s your favorite football player Joe Montana’s Number

Conner Mertens  01:25

No, even better: it’s my number. I was 16 in high school, middle school, college. So I think It’s time to retire that number. So if your answer is that 16 is the number we should be retiring, then you’re probably right.

Dr. Robert Popovian  01:37

Well, the 16 number should be retired considering your prowess in the football field. But I was more thinking about that there are 16 states that have passed legislation protecting patient assistance programs to this day. And in fact, New York State is the latest one that passed and why JP is here today with us is because she was out in Wisconsin trying to advocate for passage of that similar law in the state of Wisconsin,

Conner Mertens  02:03

And hopefully Wisconsin will be number 17 on that list. So Robert, today we’re going to be talking about patient assistance programs and out of pocket costs in copay assistance. Is that is that kind of what I’m getting?

Dr. Robert Popovian  02:14

Yes, definitely. We’re gonna get to delve into that and specifically discuss how and why are patients being taken advantage of by insurance companies and pharmacy benefit management companies.

Conner Mertens  02:25

Let’s dive in. Robert, let’s just start with the basic question, what are patient assistance programs?

Dr. Robert Popovian  02:30

So patient assistance programs came about probably about two decades ago, and they were primarily meant to help patients who were uninsured, who couldn’t afford their drugs, and they needed some assistance from the biopharmaceutical industry to pay for those medicines. They’ve evolved into a much more complex and Byzantine system, because [the] majority of the patients now that get care or patient assistance from the biopharmaceutical industry are actually fully insured and fully employed individuals, It’s just happens that their benefit design and insurance model creates an environment that they can’t afford their medicines, and hence, they have to reach out to either biopharmaceutical industry or foundations for additional support.

Conner Mertens  03:12

So where are we at right now with out of pocket costs? Are they increasing? Are they kind of staying the same? What are we seeing for these out of pocket costs for patients right now.

Dr. Robert Popovian  03:21

So we’ve talked about this actually Conner, in the past in one of our podcasts, and you know, on average, out of pocket costs for patients, the average patient has been going down into United States for pharmaceuticals, they spend less in out of pocket costs for drugs today than let’s say 10 years ago, or 20 years ago. But that’s an average. And you gotta be careful with averages. Because what happens is that there is a group of patients who are clearly being harmed by the current policies. And the reason, by the way, that the averages have been going down is primarily because, you know, 90 plus percent of prescriptions in the United States are generics, and generics are super affordable for patients. And there are other issues with the generic market that we’ve delved into in the past, but currently, the average out of pocket cost for an individual patient does go down, but that’s not the case for certain patients, which are being harmed.

Conner Mertens  04:10

Yeah and Robert, you mentioned those specific patients that are feeling a little bit more pain in the pocketbook. But can you tell us a bit more why these groups of patients are struggling more than you know what you said, which is the average is going down?

Dr. Robert Popovian  04:22

So there are two reasons. Number one: these patients require probably brand name medicines that don’t have generic… products available in the marketplace and those drugs are expensive and they’re becoming more and more expensive as we get into more rare disease biologic type of therapies. Their second reason is frankly, because of benefit design changes. 10 years ago, [the] number one way patients paid for their pharmaceuticals was through co pays co pays our flat amounts. That patient walks into the pharmacy, they know exactly what their co pays for their drug, they pay that copay, and they walk out. Over the last 10 years, benefit design for drugs has shifted to more coinsurance, which is a percentage of the retail price of the medicine, and also deductibles, which is also based on the retail price of the medicine. So that’s why they’re feeling the pain more, this select group of patients, because they get into an environment that they require these very expensive medicines, while the benefit design has shifted and has put more pressure on them through payment of coinsurance and deductible, which are based on these inflated retail prices, which, by the way, the insurers and the PBMs don’t pay. They negotiate significant rebates and discounts and fees from these pharmaceutical companies. And unfortunately, they don’t share any of that with the patients

Conner Mertens  05:37

Well we are throwing around a lot of big words in there, but two things that I think we should probably hash out a little more are: what do we mean when we’re talking about accumulators and maximizers?

Dr. Robert Popovian  05:46

So these are programs that came about maybe four or five years ago. And what they do in a very brief way of explaining them is that they require that any kind of patient assistance program that comes from the biopharmaceutical industry could not be applied to the patient’s deductible or maximum requirements for their out of pocket costs. So in other words, the money that the pharmaceutical industry provides to the patient to help support their out of pocket cost is collected by the PBM, and then in addition, then the PBM goes back to the patient and collects even more money to meet the deductible of that medicine or the coinsurance of that medicine. And It’s become a point that they’re double dipping, they’re stealing the money from the patients that the pharmaceutical industry has sort of provided them to help afford their medicines. And at same time, they force the patient to again pay for their medicines, and they have to pay for it until they meet their deductible or their out of pocket costs maximum.

Conner Mertens  06:46

Yeah, I mean, it really sounds like patients are being taken advantage of here.

Dr. Robert Popovian  06:50

Exactly, and that’s the bottom line is that these insurers and the PBMs are double dipping, and not only extorting money from the patients that was meant for the patients, that was designed to help patients for their out of pocket costs, but then they’re going back to that same patient and [they’re] still collecting more money from them directly.

Conner Mertens  07:09

Well, Robert, you know, we always like to get into the policy and the legislation and what’s being done about these issues that we raised on these podcasts. And at the top of the show, we discussed that lots of states were taking actions. So what are states doing? And how are these laws coming about?

Dr. Robert Popovian  07:23

So these laws are primarily being promoted to patient advocates, and patient advocacy groups and provider groups that are concerned about this extortion by PBMs, and insurers of the patients. And what these laws do is that they’re very clear. They mandate that any kind of out of pocket costs provided by the patient to meet their deductible or their coinsurance or their copay, or their out of pocket maximum has to count towards their deductible, period. You know, so any kind of support from any entity that the patient gets has to count towards the patient’s deductible. And as we’d discussed, 16 states have passed, and we’re gonna have JP come on a little bit later and talk about what they’re trying to do in Wisconsin, which is the same thing.

Conner Mertens  08:06

Well, we know and we ourselves are one of those patient advocacy groups that push for these kinds of reforms. But I’ve got to imagine that the pushback is probably coming from where? Are we talking from insurers and PBMs?

Dr. Robert Popovian  08:17

Clearly, I mean, It’s coming from insurers and PBMs because this is a profit model for them. You know, they’re double dipping, and this is a revenue source that they capture as profit. So they have criticized these laws that have passed in the states that they will force an increase in premiums, the insurance premiums in those states. Fortunately, as always, in our organization, at Global Healthy Living Foundation, we’re very forward thinking. So we’ve created a tool which is available to anyone, It’s on our website on ghlf.org, you can Google it and find it, that anyone can go {use] policymakers, patients, patient advocates, providers, insurers, even PBMs. They can go and take a look at and look at premiums in the states that have passed this legislation versus premiums in the states that have not passed the legislation. What they’ll see is that there’s absolutely no difference in premiums between the states that have passed and the states that have not passed. We’ve done statistical analysis, and to date of all the 16 states that have passed this legislation, their premiums have not gone up nor gone down either post-passage of this legislation, statistically, or [are] there any differences between the states that have passed it and the states that have not passed this. So in essence, Conner, what the insurers and the PBMs are criticizing these laws about which is, “Well, if you pass them they’re going to increase the premiums, the health insurance premiums,” is absolutely not true. The data does not support the rhetoric and as always, we have the data. The data was captured through governmental agency-provided information through the Johnson and Johnson Foundation, actually, that provides a website that has all of the premiums, and we were able to analyze this information and put it on the website which is available, again, to anyone who’s interested, and they can go look at every single state that has passed their insurance premiums and compare it to the states that have not passed it. And they will see exactly what we are discussing right now. There are absolutely no differences, and there are absolutely no statistical differences between those.

Conner Mertens  10:17

And don’t forget, you can find the link to that tool in our show notes. Well, It’s good to hear that there’s some states that are passing laws to protect patients from these harmful practices. And one of those that we’re hoping to add to the list is Wisconsin. You know, we have a local celebrity here, JP. JP Summers is one of our colleagues, and she recently spent some time representing GHLF but more importantly, patients and the patient community with policymakers in Wisconsin who are interested in helping out patients and institute patient protection laws to ensure that patient assistance programs are not going to be stolen by insurers and PBMs, like we discussed, but thank you so much for joining us, JP.

JP Summers  10:52

Yes, yes. It’s great to be here.

Conner Mertens  10:54

Yeah. So you yourself are a patient living with some conditions, and also a patient advocate. What’s it like to have both those roles?

JP Summers  11:02

Well, it’s a very important role, both of them, actually, becaus,e you know, when you go through the process of seeking help, getting medical assitance and then finding a treatment, and then how do you go on from that point: it’s the whole process, but at the same time, it helped me to become the advocate I am today, because had I not gone through that whole experience, then I wouldn’t know what to look for what to be actively involved in when it came to pushing issues.

Dr. Robert Popovian  11:30

So JP, first of all, thank you for coming on. From your perspective, how would you think the law will help a patient such as yourself? You know, I’m sure you’ve experienced this getting patient assistance from the biopharmaceutical industry.

JP Summers  11:44

Yes, Robert. And the number one thing is it would not put any unnecessary financial situation onto the patient. I have been there. I have shown up to pick up my prescription and all of a sudden the price that I was paying before tripled. And to me, when you’re living with several chronic illnesses to have your medication suddenly change is really unexpected, and it puts you in a financial situation where you have to make decisions and very tough ones that that.

Conner Mertens  12:10

So how was it JP? How was, how was advocating in Wisconsin? What was the mood? Are folks excited? Are lawmakers and stakeholders, are they listening? Is there hope for Wisconsin being another one of those states to pass along these protections?

JP Summers  12:23

I feel that there is. There was a lot of positive things being said there were several patients besides myself there to advocate, to share their personal stories. But what really caught my attention was the press. They were very involved. They were asking questions, and that tells me that they’re invested in what we’re looking to do in Wisconsin.

Dr. Robert Popovian  12:43

So one benefit is that, Connor and JP, looking at the map right now, this is truly a bipartisan issue, because you’re seeing states like New York pass it, which are truly blue states. And then you see states like Louisiana and Oklahoma pass it, which are truly red states. So I believe that there’s an opportunity to in every state to pass this patient protection law, and we’re so happy JP that you were there advocating for patients, representing GHLF. And also one quick question: did the issue of the tool come up that we’ve developed at GHLF in any of your meetings there?

JP Summers  13:19

Well, I mentioned it in my press conference, when I was sharing my personal story. I did mention that, you know, we have this tool that is on our website. So it was mentioned during that time. But anytime I’m speaking with someone, I do tell them to check our website because we have great resources, but especially this one in particular.

Conner Mertens  13:41

JP, thank you so much for a) going to Wisconsin, making your voice heard and standing up for patients and b) for coming on with us. We love to have you and you know, you’re welcome back anytime.

JP Summers  13:51

Great. Yes, I enjoyed it. And I’m sure there will be more to come. Some very exciting things happening and also in other states that I will be participating in. So yes, thank you for having me.

Dr. Robert Popovian  14:01

So just to echo what Conner said, JP, you’re always welcome to come on. We love having patients perspectives heard on this podcast. And please, when you go, and yourself too, if you have any thoughts about policy issues, economic issues that are impacting patients, if you have questions, or you hear things, let us know. I mean, we would love to talk about those issues on our podcast here.

JP Summers  14:23

Definitely. And like I said, there are some things that are coming up that I’ll be participating in, and I’m sure there’s going to be a lot of information that I can share with the both of you.

Conner Mertens  14:32

Looking forward to JP, we’ll see you soon. Nothing changed in this time. Robert, I’m gonna make sure you get the last word. But I think that it’s great for us to have JP on, to get the patient perspective of how these policies can really negatively impact patients. And it’s good to hear that things are happening on the state level. There can always be more but we need to be making laws that are protecting patients, increasing visibility, and at the end of the day, making sure that patients are getting the most benefits from these programs that are designed to benefit them and not the insurers and PBMs.

Dr. Robert Popovian  15:03

That’s right, Conner. I mean, at the end of the day, we are here at GHLF trying to advocate for patients but we’re also here on behalf of GHLF to develop tools and opportunities to demonstrate how patients are being taken advantage of, but more importantly, how we can protect patients from being taken advantage of by insurers, and by the pharmacy benefit managers specifically. And this is one area that we’ve spent a lot of time and resources and we are hoping that people, individuals, policymakers, as I said, providers, patients, patient advocacy groups, go to our website, take a look at it, get educated, because this is important, we’ve passed it in 16 states, but there’s 34 states left that need to pass this law. And in addition, state laws can only go so far and we need to introduce legislation federally to protect all the ERISA plan type patients that are not granted the protections from a state level and have to have federal legislation passed for them.

Conner Mertens  16:08

As always, thanks for breaking that down for us, Robert. I think there’s some very valuable information in there for our listeners. And thanks to JP, for joining us today and bringing your patient and advocate perspective to such an important conversation for patients. Don’t forget to subscribe to our podcasts on Apple, Spotify, or wherever you might be listening, so you’ll never miss an episode. And now you can actually find our podcasts on YouTube. We’re literally everywhere. And if you have a second help spread the word by rating our podcast, writing a positive review and sharing with your friends and family. It’ll help more people like you find us.

Dr. Robert Popovian  16:38

You can also send us an email or audio clip to [email protected]. And we want to hear from you. We want to hear your ideas. We want to hear your questions, and as I mentioned to JP, especially from patients. We want to hear what your questions are and how we may help you at GHLF to be better patient advocates.

Conner Mertens  16:58

And before you go make sure you take a listen to some of our other great podcasts on the GHLF Podcast Network. You can find all of GHLF’s podcasts at ghlf.org/listen. He’s Dr. Robert Popovian.

Dr. Robert Popovian  17:10

And he’s Conner Mertens.

JP Summers  17:11

And I’m JP Summers.

Dr. Robert Popovian  17:12

We’ll see you all next time.

Narrator  17:15

Be inspired, supported and empowered. This is the Global Healthy Living Foundation Podcast Network.

Narrator  00:00

Be inspired, supported and empowered. This is the Global Healthy Living Foundation Podcast Network.

Conner Mertens  00:10

You’re listening to Healthcare Matters, the podcast that pulls back the curtain to help you make sense of complex health care economics and policy issues. As always, we’re joined by Dr. Robert Popovian, tuning in from Washington, D.C. He’s a pharmacist, he’s an economist, and he’s the Chief Science Policy Officer at the Global Healthy Living Foundation.

Dr. Robert Popovian  00:28

And joining me is my good friend, Conner Mertens, from Seattle, Washington, my co-host and our Patient Advocate and Community Outreach Manager

Conner Mertens  00:37

And we got a super duper special guest today, Robert, we will be joined later in the episode by Zoe Rothblatt. Zoe is our Associate Director of Community Outreach at GHLF, who also happens to be my partner in crime on another podcast of ours; Breaking Down Biosimilars. And as an advocate and patient herself she’s going to be bringing the patient perspective to our conversation, which we know is super important. So we’re excited to have Zoe on.

Dr. Robert Popovian  01:00

Absolutely, we’re very glad that she can join us and I think you actually just gave away our topic for today Conner…

Conner Mertens  01:07

Spoiler!

Dr. Robert Popovian  01:07

… Today we’ll be talking about biosimilars.

Dr. Robert Popovian  01:13

So Conner, let’s get into the episode. What does the number 21 billion mean to you?

Conner Mertens  01:21

You and your numbers Robert… 21 billion sounds like the budget I’m gonna give myself for takeout this year.

Dr. Robert Popovian  01:27

Oh my God. We need to start talking about managing costs here, Conner. But no, no, with all seriousness, according to Amgen’s most recent Biosimilar Trends Report, biosimilars have saved the U.S. healthcare system roughly $21 billion over the past six years.

Conner Mertens  01:45

That was 21 billion with a B, right?

Dr. Robert Popovian  01:47

Absolutely, sir.

Conner Mertens  01:49

That’s a lot of Thai. That’s a lot of takeout… And that’s a perfect transition. I know that Biosimilars are going to be front and center, we talk about them often at the Global Healthy Living Foundation. But why is 2023 a crucial year for the biosimilars?

Dr. Robert Popovian  02:01

Well 2023 is when we’re going to see the introduction of a biosimilar for Humira. So why is this important? Because Humira is the largest selling all-time biopharmaceutical in the world. It generates about $20 billion in sales annually in the U.S. only, and this is going to be interesting to see because not only biosimilars are going to be introduced in 2023, but there’s going to be multiple biosimilars of Humira introduced this year. So that is why it’s a crucial year to look at what is the impact of introducing competition to the marketplace. Are we going to see lower prices? Are we going to see lower costs for patients? Those are all the questions that we’re going to have to face in the next 12 months.

Conner Mertens  02:49

And I think that, you know, two questions that kind of go hand in hand are what have we learned from biosimilars so far when they’ve been introduced into the market? And more importantly, how do they compare to their biologic versions?

Dr. Robert Popovian  03:03

So let’s talk about the market first, and then we can talk about the actual safety, efficacy, purity of these medicines. So for a marketplace, the data is very clear. Every time a biosimilar has been introduced into the market, the prices of the originator biosimilar drops, but not only the price of the original biosimilar gets reduced, but also the competitors the biosimilars themselves. And the reason we know this is because in the last six years when biosimilars have been introduced, most of them have been physician administered drugs, and we do have transparency in the net prices of these medicines. These medicine prices are published by CMS, and they’re called average sales prices, which is the net price or as close to the net price that you can get in this marketplace. And what we’ve seen is that every time a biosimilar gets introduced, net prices of these medicines get dropped, employers, government, patients end up paying less for these medicines. So competition definitely has worked. It reduces prices, and it creates savings for the health system, for the patients, for the employers for the government, and most importantly, it improves access for all of our patients.

Conner Mertens  04:17

Well, the other thing about these biosimilars is, as you can find out on our other show, Breaking Down Biosimilars, that they work the same. These drugs are, in all essence, essentially the same drugs, the efficacy, the safety, and more importantly, we’ve seen the success of these biosimilars across other marketplaces in Europe and in Canada. And then we’ve seen how successful and more accessible it’s made these drugs. So how will patients in the U.S. benefit from these Humira biosimilar introductions to our marketplace?

Dr. Robert Popovian  04:49

So that’s the million dollar question that’s to be determined.

Conner Mertens  04:52

The $21 billion question?

Dr. Robert Popovian  04:54

Yeah, that’s a very good point. So the reason for that is because unlike the physician-administered or provider-administered biosimilars, the Humira biosimilar is a self-administered drug, and it’s provided through the pharmacy benefit. The pharmacy benefit, unlike the provider-administered drugs, doesn’t function under average sales price, which is the net price that we discussed. And remember, a patient’s coinsurance and deductible is always based on the physician-administered drugs based on average sales price. So they do benefit from all of the rebates and concessions. On the other hand, the patient-administered medicines, which are governed through the pharmacy benefit, those negotiations, those rebates, those concessions never end up in the hands of the patients. They’re absorbed as profits by the Pharmacy Benefit Management companies or PBMs. And in the pharmacy benefit side or the self-administered drug side, patients end up paying their coinsurance and deductible based on the average wholesale price or better said, the retail price of these medicines. So my guess is, and a lot of policymakers have said the same thing, and economists, that you will not see a drop in the average wholesale price of the Humira nor a significant difference in the biosimilars when they’re introduced in the marketplace. However, there will be fierce competition on the back end with regards to rebate contracting, where significant rebates and concessions and fees are going to be passed on to the PBMs and insurers for the coverage of these medicines, both the Humira and the biosimilars. However, because of the way benefit design is set up, on the pharmacy benefit side, patients are not going to see those savings, and they’re not going to basically benefit from any of the concessions, they increase concessions, rebates, fees, everything else that is provided by the biopharmaceutical company to the PBMs and to the insurers.

Conner Mertens  06:53

So Robert, as you mentioned, once the PBMs get involved, there starts to be a need to kind of look a little deeper about where’s the money going, where’s the money coming from. So I’m wondering if the patient won’t benefit directly, then who’s going to benefit from the biosimilar introductions into the market.

Dr. Robert Popovian  07:08

So who will benefit is the PBM, and the PBM’s bottom line, and the PBM shareholders, and it will be captured as profit by these insurers and the PBMs. Now, the assumption is that some of that may, and I have to underline that “may”, and capitalize it, be passed back on to the employers or to the government at some form of premium support. But that’s an unknown because we don’t have transparency on the pharmacy benefit management side regarding the pharmacy benefit design, unlike the transparency that currently exists in the physician-administered medicines. So we know there will be savings, there will be significant savings, there will be fierce competition, these biopharmaceutical companies are going to give a lot of rebates and fees and concessions to be able to get coverage from these PBMs on their formularies. But unfortunately, because of the opacity of the way, contracting is done on the pharmacy benefit side, we’re never going to know what those numbers are, and we’re never going to know how much of it is captured as profit by the PBMs, and how much of it may at some point be passed back on to the employers or to the government as premium support. We certainly know – and this is very important for our patients – that none of it is going to be passed back on to the patient at the point of sale.

Conner Mertens  08:27

Now, it’s 2023, I hear a lot of mays, and maybes, and potentiallys, how long until we can see meaningful reduction in the list price of these drugs?

Dr. Robert Popovian  08:38

So it depends. It depends on how much are these biosimilar companies willing to drop their price, their average wholesale price or the retail price, and how much is the policy community: the economists, patient advocacy groups, the provider groups, and also the media, are willing to put public pressure on the PBMs and insurers to do the right thing, and cover the lowest listed price or the drug that has the lowest list price instead of covering the one that has a very high list price but provides the PBMs rebates and concessions to be covered. So again, we may see it. I’m hoping that we will see it, that some biopharmaceutical company that is developing biosimilars is brave enough to come out and slash its average wholesale price or retail price significantly, and draw attention from policymakers, and patient advocacy groups, and patients, and providers, and for us to put pressure on the PBMs to do the right thing. I’m just extremely skeptical at this time.

Conner Mertens  09:41

I think it’s a good time for us to bring in a patient perspective. You know, we’re getting a little in the weeds here, but I’m curious how this will impact everyday patient. So with that, it’s time for our special guest, Zoe Rothblatt tuning from Nashville, Tennessee. You already know, she’s an expert, she’s an advocate, she’s somebody that uses biologics and the co-host of another great podcast you might have heard of called Breaking Down Biosimilars. Thanks for joining us, Zoe.

Zoe Rothblatt  10:07

Hi, Conner, hi Robert, thank you so much for having me on. I’ve enjoyed listening to your conversation so far, and I mean, I’m just like cracking up in the background. You make a topic like biosimilars so fun and with so much levity, so I’m really excited to be here with you both. So yeah; hi listeners of Healthcare Matters. I’m Zoe Rothblatt, and like you heard, I co-host Breaking Down Biosimilars with Conner. I live with spondyloarthritis and Crohn’s disease, so I’ve been on biologics for about five years now. So yeah, I mean, I’m really interested in biosimilars, and learning more about them, and especially personally as someone who might end up being switched on one. So I’d love to share with you guys my thoughts as a patient unless you have some specific questions for me.

Conner Mertens  10:53

Oh, I totally do. And you actually kind of set me up perfectly. You said you might be switched to one of these biologics. My question is: will patients be switched without their knowledge? Because that’s… you know, when we talk about collaborative care, that has to be an important conversation with your doctor. Right?

Zoe Rothblatt  11:08

Exactly. It’s so important to have conversations with your doctor and be on the same page. And that’s just one level of it. And then with something like medications, you know, you guys were mentioning all the stakeholders before. Oftentimes, insurance, PBMs, these other groups are coming in and they’re part of that process. So the communication that you have with your doctor can get interfered sometimes. You just mentioned step therapy, that’s an example of when someone else interferes. So the question of whether patients will be switched without knowledge is a little bit nuanced. I’m sure Robert can touch on this but there’s this concept of interchangeability and I believe one of the biosimilars coming out this year for Humira has interchangeable status. So what this means, it’s similar in the generic sense for pills where, you know, your doctor prescribes, let’s say, an antibiotic and then you go to the pharmacy and you pick it up and you get a generic version, that would be an interchangeable. In the case of biosimilars what they do is a similar thing, and a biosimilar is replaced for your biologic. Otherwise, I mean, you would see this information. So It’s always great as an advocate to double check what your prescription says, but it could be a little surprising, which is scary, but otherwise, your provider will likely not be notified. And you may not have much say in the matter, unfortunately, but you’ll definitely be able to have conversations with your doctor. Robert, did I get that right?

Dr. Robert Popovian  12:29

You absolutely got it beautifully. And Zoe one thing is that, the good part is, if you are substituted for a biosimilar and you’re currently on a brand name drug, by law pharmacists are required to inform you upfront about the substitution. And this is similar to the laws that we have regarding generics. So as a pharmacist, even if I substitute you from a brand name to a generic drug and small molecule, I am legally obligated to let you know prior to the substitution. Because there is no such thing as an auto substitution. This is something that everybody gets wrong. Only a few health plans and few Medicaid programs have mandatory substitution. Majority of time your benefit design is what dictates whether or not a pharmacist may substitute, but that’s also a “may”, you could still acquire a brand name drug but the differential in out of pocket costs is so significant, as you know, with small molecules with generics and brand name drugs, that most patients choose to go with the generic. And in this case, you will be informed as a patient by the pharmacist, if you are switched to the biosimilar. And also, it’s important to note that whether or not it has an interchangeable designation or not, the pharmacist still has to inform your provider at some point that you have been substituted. The only difference between interchangeable biosimilar and non interchangeable biosimilar is that the pharmacist does not have to get the authorization upfront from the provider if it’s interchangeable. If it doesn’t have that interchangeability designation, all they do is basically call the provider to get the authorization upfront. So that’s the only difference. But the safety and efficacy and purity of all these drugs is exemplary, the FDA has approved these medicines, as Ben our producer knows and having lived in France for many years, these biosimilars have been available for Humira for almost a decade. So we have a lot of safety data regarding these medicines. So as a patient, I would just follow the direction, and the best thing you said, which is talk to your provider, got to your pharmacists, and your physician to make sure they’re doing the right thing for you.

Zoe Rothblatt  14:33

Yeah, I totally agree. Knowledge is so much power when you live with a chronic condition that often, you know, your disease, it feels like it’s controlling you, and I always feel like a way to take some of that power back is through knowledge, and just learning more about my condition. And it’s interesting with biosimilars because when I first heard of them, I had that uncomfortable feeling that many patients have where it’s like: my number one priority is feeling good, and that’s how I feel on the drug that I have now. I’ve been on it, this one, the Humira for a year now, and I feel good and you know it’s nerve wracking to say; I’m going to switch my plan and maybe not have the same results. And I guess I first learned about biosimilars a few years ago, and slowly but surely after learning more about them, that like… initial hesitation, and yucky feeling has gone away, because like you said, the FDA has approved this drugs, there’s rigorous testing on efficacy and safety. They’ve been around in other countries for a long time. And if you asked me a few years ago, if I would be comfortable switching, I probably would have said maybe not. And now I would say: “yeah, I’ll try it.” I’ve learned a lot about it. And I’ve taken some of that power back from the unknown and had conversations. Actually when Conner and I started the podcast, I brought it up to my doctor and her face lit up because she said not many patients ask about biosimilars. And I just think it’s so important to proactively be having conversations with your doctor, whether it’s about biosimilars, or other medications or other different tests just so you’re… you’re equipped with knowledge before the time comes. And if it does happen, you feel a little bit better, and it’s not like the rug’s being pulled out from under you.

Dr. Robert Popovian  16:10

So as a health care professional, I will tell you; knowledge is power, and never give up the knowledge, and be brave enough to ask the question from your providers. They are there to help you. And if they’re not answering your questions and not helping you through this journey, it is time for a new provider, unfortunately,

Zoe Rothblatt  16:29

100% Especially because a chronic condition is chronic, right? You’re gonna live with it. It’s lifelong, probably. So you need a partner in care because, you know, you can’t just be settling for sub optimal care, be annoyed every time you go see your doctor because this is your everyday well being. And I heard you guys both talking about costs a lot in the beginning. And I think that it’s not so clear how biosimilars will affect costs for patients. But I do know, I’ve heard from patients that a big concern is: will biosimilars have the same type of support programs that biologics do? And from what I’ve seen from biosimilars so far is that they do, but it’s definitely important to one; talk to your doctor about what supports are out there, but two; you know, when you google your drug name, you can often find different support programs. And it seems like biosimilars are getting the same kinds of programs that biologics do which is really comforting as a patient. I use it for, you know, copay support when I was learning how to do injections. They had amazing injection training videos. You know, the injection pen for biosimilars might look different than biologics, it might take you a little bit of time to get comfortable with that injection, and it feels like the supports are there, which is really important to patients.

Conner Mertens  17:41

Zoe, my friend, thank you so much for joining us. Your perspective is absolutely brilliant. You brought so much life to this conversation. And we’re lucky to have you, and you’re welcome back anytime.

Zoe Rothblatt  17:50

Thank you both for having me on. This was a lot of fun. And thank you for talking about such an important topic that’s really relevant right now to patients. And I hope people listen to this, and feel more confident in their health care decisions and treatment decisions going forward. And also Conner, what do you think I should say next?

Conner Mertens  18:09

I think this is a great opportunity to plug a podcast I’ve heard of once or twice…

Zoe Rothblatt  18:14

You read my mind; Everyone check out Breaking Down Biosimilars for all you need to know about biosimilars, and the kinds of decisions and questions that go into them, their approval process, and so much more. Thanks, guys.

Conner Mertens  18:27

Well, I learned a lot in the short amount of time. Zoe is absolutely brilliant. But really, I’m just excited that biosimilars are finally being introduced into the market in the U.S. And while there are a lot of question marks, I think that this is a big positive step, and we’re going to see a positive impact on patients. And like you’ve said, the competition will only help create more opportunities for patients to have access. But let’s make sure you get that last word. What do you think, Robert?

Dr. Robert Popovian  18:51

So, thank you so much for joining us. First of all. Number two, Conner, you’re absolutely right. I think there will be significant competition in 2023 for Humira through the biosimilar introductions. Perhaps maybe, maybe not, patients will save directly from all the concessions and everything else, we don’t know that yet. I don’t suppose they will. But one thing we do know is that, whenever competition comes into the market access improves for patients. So that is the silver lining that we have to hang on to that competition will always improve access. And that’s what we’re all about. We want better access for our patients.

Conner Mertens  19:31

Well Robert, thanks for breaking down biosimilars for us.

Dr. Robert Popovian  19:35

You’re welcome.

Conner Mertens  19:36

And thank you again, Zoe for joining us, and to you for tuning in. Don’t forget to subscribe to our podcast on Apple, Spotify, or wherever you might be listening so you never miss an episode. You can also find our podcasts on YouTube. We’re literally everywhere. And if you have a second help spread the word by rating our podcast, writing a positive review, and sharing with your friends and family. It’ll help more people like you find us.

Dr. Robert Popovian  19:57

You can also send us an email or audioclip to [email protected]. And as always, you may be featured on one of our upcoming episodes. But please do send in your comments and questions because that will help us tailor our podcasts based on your needs as patients.

Conner Mertens  20:15

As always, he’s Dr. Robert Popovian.

Zoe Rothblatt  20:17

I’m Zoe Rothblatt.

Dr. Robert Popovian  20:18

and he’s Conner Mertens, and we’ll see you all next time.

Narrator  20:23

Be inspired, supported and empowered. This is the Global Healthy Living Foundation Podcast Network.

Narrator  00:00

Be inspired, supported and empowered. This is the Global Healthy Living Foundation Podcast Network.

Conner Mertens  00:10

You’re listening to Healthcare Matters, the podcast that pulls back the curtain to help you make sense of complex health care economics, and policy issues. As always joining us is Dr. Robert Popovian from Washington, D.C. He’s a pharmacist, economist and the Chief Science Policy Officer at the Global Healthy Living Foundation.

Dr. Robert Popovian  00:27

And joining me is my good friend Conner Mertens. Happy New Year, Conner! Happy New Year to all of our listeners. Conner is my co-host and our ‘numero uno’ Patient Advocate and Community Outreach Manager at the Global Healthy Living Foundation.

Conner Mertens  00:41

And thank you for tuning in and listening. We’re eager to start this new year with you all and there’s a lot to discuss in 2023. We find ourselves starting the new year in the midst of a ‘tripledemic’ which I think you know a little bit about Robert, and we have a new Congress. A lot, a lot to discuss!

Dr. Robert Popovian  00:56

Yes, lots to discuss. And my household was inflicted by the triple pandemic during the holidays. We came down with RSV, flu and COVID!

Conner Mertens  01:07

Bunch of overachievers at the Popovian house, huh?

Dr. Robert Popovian  01:09

That’s right. That’s right. We wanted to make sure we completely covered the entire pandemic as it existed. So we have a special episode today, Conner, we’re going to talk about specifically a report that came out this morning. It’s a collaborative report between IQVIA Data Sciences and Global Healthy Living Foundation and to my recollection, this is probably the first time IQVIA has partnered up with a patient advocacy group to put out a report such as this. And in that report, one number stands out. So when I say 90% to you, Conner, what does that represent?

Conner Mertens  01:42

I mean, I would probably say 90% is the amount of college football fans that fell asleep during that national championship game.

Dr. Robert Popovian  01:49

That’s a very good guess, actually. And it’s definitely not the winning percentage of Russell Wilson. But no, the 90% is that 90% of the U.S. population lives within a five-mile radius of a retail pharmacy. And that’s an important issue that we’re going to be discussing today, and we’re going to concentrate on the findings from the report.

Conner Mertens  02:15

So it sounds like today, we’re gonna be digging into this report put out by IQVIA, and you might have to remind us who that is, and Global Healthy Living Foundation, which is where we work. But it sounds like we’re gonna be digging into pharmacies and their impact on community and health in general. Can you kind of just give us a brief overview of who this partner is that we’re releasing this report with?

Dr. Robert Popovian  02:35

So IQVIA Data Sciences is probably the number one data sciences company in the health care field. Not just pharmaceutical, but in health care they have been around for a very long time. And myself, a lot of the health policy researchers, health economics researchers, use their data to do a lot of our analysis and talk about trends in health care and health care utilization, health care pricing, healthcare costs. And I have to say, I’m always indebted to them, because they do have a lot of data and they were very gracious in being able to partner with us and share some of this data with us, and we conducted the analysis in partnership with them.

Conner Mertens  03:13

So before we do dive in and start dissecting kind of what the results are, what’s kind of the premise of this? Why did this partnership come about for this study?

Dr. Robert Popovian  03:22

That’s a great question. So the partnership came about because last year GHLF, independently through a grant to ADPC, which is the American Disease Prevention Coalition, was able to do a study that was published in the American Journal of Pharmacy. And in that report, in that study, what we analyzed is the access to pharmacies versus physician offices in low income communities. We wanted to investigate: do patients who live in poor communities, do they have better access to pharmacies or to physician offices regarding immunization? And what we found was, and we’ve covered this information in our previous podcast, is that without a doubt, and overwhelmingly, patients who are poor and live in poor neighborhoods have far better access to pharmacies than to physician offices when it comes to getting their vaccines. Especially the adult patients and senior patients.

Conner Mertens  04:17

And so what are the results of this follow up study? What are those telling us?

Dr. Robert Popovian  04:21

So what we wanted to do is, the next iteration of that, was to really look at what the trends have been since the pandemic, right. So what has happened over time since the pandemic took place? Has the behavior of patients regarding vaccination changed? Are they going more to pharmacies? Are they sticking out with physicians? What are the trend utilization of vaccines over time? Have they significantly changed since the pandemic? You know, for the good or the bad, vaccines have been front and center since 2020? End of 2020, right? When the first vaccines were approved and came into the marketplace, or even before that and what we wanted to do, GHLF and IQVIA wanted to do, look at these trends, and that’s what the report is all about. It’s to look at trend lines of where do adults go to get their vaccines after the pandemic took place?

Conner Mertens  05:11

And so what what are the results? Tell us. What does that mean for patients, especially patients in low income communities?

Dr. Robert Popovian  05:17

That’s great question. So what the trends tell us is that overwhelmingly adult patients received their vaccines in a pharmacy after the pandemic took place. Now majority of that reasoning is because after the second quarter of 2021, you know, when we had those universal sites that patients were going and those went away, and pharmacy really became the main institution where patients were getting their COVID vaccine, overwhelmingly, what we saw is that the shift in the vaccination site of patients away from what we call non-pharmacy medical centers to pharmacy with regards to immunization. Now, majority of this, again, was driven by the COVID vaccine. But we also saw some trends where there was an increased flu vaccination in the pharmacies in the last two flu cycles. For example, we saw a moderate increase in HPV for adult patients. You know, so what overall the report says is that if you look at post-pandemic, especially after second quarter of 2021, where vaccines became front and center, adult patients were getting their vaccines in a pharmacy. Now, the question is why, and how do we maintain this access point?

Conner Mertens  06:30

Well, and obviously we understand the importance of adult vaccination and getting those rates up. But what about pediatric patients? What about pediatric vaccinations? Does this report cover anything in that regard?

Dr. Robert Popovian  06:42

We specifically looked at pediatrics from a flu perspective. And yes, there was some increase in pediatric patients for flu vaccines, that patients who were kids were being taken to a pharmacy to receive their flu vaccines, but it was still overwhelmingly that vaccination for pediatric patients was provided in a physician’s office or a provider’s office. The opposite was the COVID vaccine. For pediatric patients COVID vaccine was overwhelmingly being provided in a pharmacy.

Conner Mertens  07:11

I think another important piece of this is something that we’ve covered before and an issue that’s very important to us as patient advocates around the issue of equity in health care. And if we’re learning these things about accessibility in lower income communities, what are the implications of that? Can you kind of just elaborate on the findings in parallels to health equity?

Dr. Robert Popovian  07:31

Absolutely, like we did in the first study that we published last year, which looked at really low income communities. In this study, we looked at race and ethnicity differences, what was the patterns of utilization of pharmacy as a center for immunization for adults, for Latino patients versus Asian patients, versus Black patients. And what we saw is that overwhelmingly Asian patients, and Latino patients prefer a pharmacy over white patients in receiving their vaccination as adults, and Black Americans are a little bit lower than white Americans in receiving their vaccine in a pharmacy. So regarding our minority communities, Latinos and Asians prefer to go into a pharmacy and have received their vaccination in a pharmacy compared to the white patients.

Conner Mertens  08:16

Well, I guess the natural follow up question then is, what are the implications of all those results?

Dr. Robert Popovian  08:20

The implications is that we all know that minorities, whether they’re racial minorities, or ethnic minorities, they have a very limited access to health care compared to white Americans. And what we see is that two out of the three, the Asians and the Latinos prefer going to a pharmacy to receive vaccines. So what it means is that if we want to maintain access for patients who are minorities, we need to ensure that pharmacies, pharmacists and pharmacy technicians at some point are able to administer all the vaccines that a physician, for example, or a provider can administer in their office. That is critical. In some states, we do a great job of addressing that. In some states, patients can walk into a pharmacy or physician’s office and a pharmacist is able to administer the same vaccines to the adult patient as a physician may. But in majority of states, that’s not the case. There’s restrictions, access restrictions that either patient has to get a prescription or there’s only a certain number of vaccines that the pharmacist may administer to the patient, which really hinders the ability of these communities that really suffered from an equitable access to health care to really gain and almost become equals to the white communities who have better access to physician services.

Conner Mertens  09:42

Well, I’m glad that you brought that up, Robert, because obviously, one of the things we try to dive into here is policy and legislative solutions to these problems. So you kind of touched on it there, but what are the other proposed policy recommendations that GHLF and IQVIA are putting forward in response to this research?

Dr. Robert Popovian  09:58

So the number one, and most important one, is obviously that pharmacies, pharmacists and pharmacy technicians should have the capability of immunizing adults in the same ability than their physician colleagues or their provider  colleagues or other provider colleagues health care professionals may have, so they are able to administer all FDA approved and/or ACIP recommended vaccines. So that’s number one. Number two is that we need to improve reimbursement levels for vaccination administration. This is especially important because the reimbursement levels both for physicians and other providers and pharmacists is absolutely horrendous when it comes to the Medicaid program. And we need to encourage these pharmacists to be able to provide the services, and physicians to provide services and make them whole from a monetary standpoint, so they’re able to provide these vaccines to the patients. So number two is better reimbursement, especially in the Medicaid services. And number three is that we need to make sure that when there is approvals of vaccines by the FDA that ACIP quickly acts and makes a decision about recommending these vaccines for two reasons: number one, because most healthcare professionals including pharmacists, and physicians are not willing to provide a vaccine even though it’s FDA approved, which you know, they should be able to, but they may not want to. And number two is because of reimbursements. A lot of health insurers and government programs will not reimburse unless an ACIP recommendation is provided for a vaccine. And the last piece, which is the PREP Act and all of the declarations that have happened, which have expanded the authority of the pharmacists to immunize patients. We recommend that PREP Act should be codified into law and made permanent, and not only permanent from a federal level but permanent on the state level. As we’ve discussed previously, Conner, practice of pharmacy, practice of medicine, or practice of optometry or dentistry is governed by state law. So a federal law and its declarations is important and it should be made permanent. But it should be codified into state law because that’s who governs the practices of medicine, pharmacy, optometry and so on.

Conner Mertens  12:08

Well, as always, Robert, that is thorough, but I’m definitely walking away knowing a little bit more about pharmacies and accessibility issues. And I always want to make sure you get the last word but you know, I’m kind of taken away from this about how the COVID-19 pandemic really led to an increase in the role that pharmacies are going to play in overall health and immunization access and processes. And something that we constantly preach here is making sure that we’re meeting patients where they are. And so when we discuss accessibility issues, especially for folks that are in the marginalized communities, then we have to be looking at data like this, and meeting those patients, like I said, where they’re at, but tell me what you think, Robert, what should we take away?

Dr. Robert Popovian  12:45

Conner, I couldn’t agree more. So the pandemic was horrible, the pandemic continues to be horrible. You know, we still are losing Americans every day to this terrible disease. But certain good things came out of it, which is we learned that there’s access problems, but those access problems can be addressed. Where patients prefer to go get their health care services? And one is immunization, and patients, clearly based on our data shows that patients want to go to a pharmacy to get their immunization, especially adult patients. So one of the things we cannot do is roll back any kind of sort of freedoms and ability for patients to choose during the pandemic. We can’t roll those back. As you said, marginalized communities, ethnic communities, racial communities, low income communities, all suffer from access to health care, so we need to make access easier, not worse for them. And the data from what we published last year with regards to local income communities and the data that we’re just gonna release, the report that just came out this morning, clearly demonstrates patients prefer and have better access to pharmacies regarding immunizations. So lawmakers, policymakers, if you really want to address the equity issue in health care, you need to start looking at pharmacy as a point where patients receive their immunization and that’s the starting point. But immunization is one of the areas that we focused on. One of the last things I would ask our audience to do is read the report. We’re going to tag the link to this podcast. We’re also going to link last year’s study that was published in the Journal of American Pharmacists Association. Please read those studies. They’re important pieces of work and they built into the evidence of how we can address equity, where patients want to get their care, and why is it important for us to be able to have… what are the policy solutions that are important for us to pursue, to make our healthcare system more equitable among everyone?

Conner Mertens  14:42

Well, as always, thanks for breaking that down for us, Robert. I think that was some very valuable information for our listeners, and I hope that they all go and check out this report. And don’t forget to subscribe to our podcast on Apple, Spotify, or wherever you might be listening, so you never miss an episode. And if you have a second help spread the word by rating our podcast, writing one of those positive reviews and sharing with your friends and family it will help more people like you find us

Dr. Robert Popovian  15:04

And I want to wish everyone a Happy New Year. We’re glad that we’re back talking to you all. Please send your comments, emails, questions to us. We’re very willing to listen to you and address anything that you may have for us, and in fact, send ideas for topics for us to discuss in this podcast. You can reach us via email or send an audio clip if you want to [email protected] and guess what, we may feature you in one of our upcoming episodes.

Conner Mertens  15:36

And before you go, make sure to take a listen to some of our other great podcasts on the GHLF network. You can find all of GHLF’s podcasts at ghlf.org/listen. Robert Popovian, my friend, thank you so much.

Dr. Robert Popovian  15:49

And thank you Conner. We’re very excited to be back and kicking off the new year with our first episode of the year and we will see you all next time.

Narrator  15:59

Be inspired, supported and empowered. This is the Global Healthy Living Foundation Podcast Network.

Narrator  00:00

Be inspired, supported and empowered. This is the Global Healthy Living Foundation Podcast Network.

Conner Mertens  00:10

You’re listening to Healthcare Matters the podcast that pulls back the curtain to help you make sense of complex health care economics and policy issues. With us as always is Dr. Robert Popovian joining us from Washington DC. He’s a pharmacist, economist and the Chief Science Policy Officer at the Global Healthy Living Foundation.

Dr. Robert Popovian  00:27

And joining me is my good friend, Conner Mertens, from Seattle, Washington, my co-host and our Patient Advocate and Community Outreach Manager.

Conner Mertens  00:35

And today Robert we’re also joined by Ben Blanc dialing in from Indianapolis. He’s our producer and happens to be Manager of Programs and Special Projects at GHLF.

Ben Blanc  00:45

Well, hi Conner, hi Robert! Thanks for letting me be part of your dynamic duo for this episode. I’m a fan! Now I know you guys like to talk about American football but today we’re in the middle of the World Cup so I’ll just say this: “Go team France!” France has already won two World Cups, right? And we’re leading group D. Team USA is not doing too bad either. But we’re recording this before the knockout stage. France is set to play against Poland and the U.S. will be facing the Netherlands. We’ll see what happens this weekend. So who’s headed to the finals? Any projections?

Conner Mertens  01:19

Listen, you got a lot to be excited about in France with Mbappé. That guy is absolutely on a tear. But obviously, we know that that the Yanks are going to come in from the U.S. and bring home the championship. Let’s go! It’s time for U.S.!

Dr. Robert Popovian  01:34

Well, welcome aboard, Ben. We need all the help we can get today because we’ve put together a special mailbag episode for our listeners. And for all of you to know, we came up with this episode after all three of us were listening to the Brady Bros which is the Brady brothers getting together and they do a ‘mailbag episode’ once in a while, and we thought that would be a cool idea to do this with our listeners.

Ben Blanc  01:55

That’s right, Robert. And today, our listeners will be the ones asking all the questions! Now, let’s get into this episode. We’ve been hearing from our listeners and one thing that came up multiple times is the need for more transparency. So I thought it would be great to start with the following question from Jennifer. And I’m sure, Robert, you’ll explain to our listeners what transparency has to do with her question. She says, I’ve been listening to various news outlets touting the Mark Cuban Cost Plus Pharmacy. Is this a new pharmacy concept?

Dr. Robert Popovian  02:29

Well, Jennifer, to answer your question in a short way: no. Mark Cuban’s Cost Plus Pharmacy is definitely getting a lot of media attention and in fact, I was on a call with a reporter from the Rheumatologist Journal talking about this venture. There are other entities who have been well established for many years doing this type of pharmacy service, which is primarily providing pharmaceuticals and mainly the generic formulation, in a cash manner to patients. And that means patients walk in and pay cash instead of using their insurance cards, and they are saving tons and tons of money. So the benefit of having though somebody like Mark Cuban is that he does possess a huge megaphone. Everybody knows who he is. He has a nightly show called Shark Tank, I believe. And he does get a lot of attention. So I believe what he’s doing is great for this whole environment, because what he’s doing is raising the awareness that patients have alternatives, that they don’t have to use their insurance card always to save money. And in fact, in some cases, and or most cases with generic medicines, they can walk into these pharmacies that offer cash prices for the generics, in fact all pharmacies do, but these are specific pharmacies that are just offering cash prices for pharmaceuticals that are generics and they can save a lot of money.

Conner Mertens  03:51

Yeah. And that’s actually… I’m glad that that’s one of our first questions because that is super topical. I think over Thanksgiving dinner, this is something that my brother brought up. My brother is not a patient, but to Robert’s point what’s great is that there’s somebody who has a big megaphone and a giant platform who’s bringing attention to these issues of you know, affordability of our medications, and doing his best to provide some sort of alternative, like you said. So I guess another question I have for you, Robert, is is this, you know… a new pharmacy concept? Has this been around for a while?

Dr. Robert Popovian  04:19

No, it’s not new. As I said, other entities have been doing this for a while. I mean, the largest being Costco. We all know about Costco. We go there to get a lot of our foods and you know, diapers and paper towels and everything else but they have a pharmacy within Costco and Costco Pharmacy has been very focused on cash paying patients who come in to purchase their pharmaceuticals. And in fact, a huge percentage of their business in the pharmacy is still cash-based business. So they’ve been doing it for many, many, many years. It’s just that, you know, they don’t have the visibility Conner, as you know, of somebody like Mark Cuban who is able to get this word out much more effectively than they would. And you there are other smaller players that are community based pharmacy like Freedom Pharmacy, Blueberry Pharmacy that provide these type of services in specific locations, which again is the same exact concept: Patient walks-in, doesn’t use their insurance card. In fact, they save money by paying cash and these pharmacies are thriving, and the patients are saving money. And that’s what we want, right, Conner for our patients?

Ben Blanc  05:23

Yeah well, people need to hear this. There are alternatives. There are ways to pay less for your medicine. All right. So another topic that has to do with transparency is PBMs. You guys have talked about it a few times on the podcast and Ali sent us the following question: “I hear that PBMs use the rebates to lower premiums. Is that true? Is that the reason why they don’t want to share their rebates with patients?”

Dr. Robert Popovian  05:47

So in a short way, the answer is yes. Theoretically the longer way of answering this question is no, they don’t really use this to lower premiums. They say that publicly, they say that to policymakers who are trying to investigate them, to FTC they say that too. But the reality is that nobody knows. And that’s because there’s such a lack of transparency. There’s billions and billions and billions of dollars collected and form of rebates and fees and concessions from the pharma industry that patients do not benefit from. And not only they don’t benefit from directly, but because of this whole opacity secretive way of how they collect this money, nobody knows how much of that money goes back, for example, if in fact, they do help lower premiums. So conceptually, yes, that’s what they say and potentially, that’s what it does, lower premiums, but to what effect, we have no idea. And I know Conner, we always get questions of why am I going to the pharmacy, and then I’m paying these exorbitant prices while I know insurance companies are negotiating billions of dollars of rebates and savings from pharma industry.

Conner Mertens  06:58

Well, we’re no strangers to PBMs and kind of the harmful practices that they participate in and I’m always glad when people are asking these questions. But obviously, the solution to this is making sure that these rebates and these concessions are being passed along to the patients at the point of sale, rather than all this back room sort of: “Oh, well, we’re giving you concessions,” without being able to prove it. And something that we talk about constantly, constantly, constantly in broken record is the need for transparency. Who knows, they could be doing this to lower premiums, but we don’t know. And until that happens, we’re going to keep looking out for patients and ensuring that they have the most accessible and quality medications.

Ben Blanc  07:36

Yeah, that makes sense. Looks like there’s still a lot of progress to be made in that area.

Dr. Robert Popovian  07:41

Absolutely Ben. And it starts with transparency. If we know exactly where this money is going, then we’ll have a better idea of whether or not the patients are saving the money or it’s going towards premium support, or most likely, what is happening is, profitability by the insurers and PBMs.

Ben Blanc  07:58

All right, well, that’s sending a message loud and clear to our legislators out there. Transparency. That’s what we need. Now switching gears a bit to bring up another hot topic. It’s winter time and there’s a resurgence in oral viruses. You know, we’ve talked about COVID. We’ve talked about the flu. Albert has a question about vaccination. Let’s take Albert’s question next. He writes: “Thanks, Conner and Robert for a great podcast. My question is in regards to vaccination. You’re very pro vaccines. But I have heard from health care professionals that natural immunity is far better than vaccination. Is that true?

Dr. Robert Popovian  08:32

So the question that you’re asking is something that comes up often, right? These are individuals who have been infected, for example, with COVID or flu, and they’re like: “Well, I have the antibodies, now why do I need to get the vaccine? And the question is not really whether or not you should be getting the vaccine. The question is whether or not you should risk getting really sick or perhaps dying. And by taking the vaccine, you’re avoiding that journey as a patient, right? So you can always wait to get sick and develop natural immunity. But if I was a patient, and I am a patient, I rather get the vaccine, get a mild sort of like immune response, but know that I’m protected instead of risking that I will get sick and then the outcome is an unknown. And depending on your clinical background, that outcome may be mortality, which is not something that patients should risk. So to answer your question, perhaps natural immunity is better but why risk it as a patient. That’s what I tell people. And Conner, I know you get this question all the time for our patients that call in.

Conner Mertens  09:38

Yeah. And what I think that the answer has to be is that community health has to be multi pronged attack. You know, we can’t just focus on herd immunity, natural immunity, we can’t just focus on masks, we can’t just focus on vaccines. It has to be a collection of all these things coming together in order to decrease the… you know the effects of these diseases that are running around and especially this winter. We’re seeing this convergence of RSV, flu and COVID, at any one time, I know at least three or four people that are sick right now and kids are ending up in the ICU. So yeah, I think that it’s a fair question and we never fault the question, and there is a lot of benefits to natural immunity. But let’s do it all, let’s make sure that we’re mitigating all these different transmission methods and providing all the best care and and again, providing as many mitigation strategies as we can to get through this winter.

Dr. Robert Popovian  10:26

So one thing that also is important to us and the Global Healthy Living Foundation, we represent chronic disease patients who are primarily immunocompromised, and at times, they cannot take the vaccine for a variety of reasons. So we depend on other individuals to be vaccinated and be protected. So they can go through these hard times during the winter season without being exposed to the infection. So that’s another concept that you need to think about whenever you’re deciding to get immunized or not is that you know, there are other individuals that may not be able to take the vaccine or the vaccine is not effective. For example, there’s evidence that patients with blood cancer, for example, the vaccine doesn’t work for. So even if they get the vaccine, they don’t create immunity. So we need to protect and think about not only ourselves, but us as a community, because at the end of the day, we’re trying to interact with people and we don’t know who you’re interacting with, and there are patients who may be immunocompromised, or that the vaccine is not effective.

Ben Blanc  11:25

But actually, since you’re talking about our community GHLF’s Community, Conner, I have a question for you. As a Patient Advocate and Community Outreach Manager at GHLF, how have you addressed those issues with our patient community?

Conner Mertens  11:38

Well, always the first thing that we we’re going to suggest is you talk to your doctor and figure out what’s the best course of options for you. You know the second thing is to be educated, find reputable sources. And I think that that’s a really important piece right now in the age of misinformation is to find things that are actually true and peer reviewed, and trust the scientists and listen to the scientist. And then you know, find community find folks that are going through the same thing that you are and talk honestly and openly with them. You know, these things, these hesitations they shouldn’t be treated as you know, we shouldn’t ostracize people for asking questions and feeling nervous about these things. What we should do is be encouraging them, giving them the education information for them to make the right choice, which is to follow the science and get vaccinated or listen again, like I said, listen to what their doctor has to say. Robert, what do you think?

Dr. Robert Popovian  12:22

So one more thing I would say is tune-in and listen to the podcasts that are put together by Global Healthy Living Foundation. I mean, we do the Healthcare Matters podcast. But we have several other podcasts in our podcast network that talk about specific disease areas. We have somebody who focuses on psoriasis and somebody who focuses on migraines and pain. So dial in and listen to our podcasts, we provide a great deal of information and we try to bring down the level of discussion to a patient level, because that is important, right? We’re not trying to, here in these podcasts, convince healthcare professionals or we’re not trying to demonstrate that we can go toe to toe with an academician. What we’re trying to do is convey information to the everyday patient who’s looking for answers. And that’s our audience. And that’s what we take very seriously. And we do this with every single podcast that Global Healthy Living Foundation puts together.

Ben Blanc  13:18

And should we add that at GHLF we’re also advocating on behalf of the patients, but we’re also providing them resources and helping them to be their own advocates, right? So how can people get involved and become advocates?

Conner Mertens  13:32

I strongly encourage folks to go check out the 50-State Network one of GHLF’s advocacy arms and get involved that way. Sign up, tell us your story and work with us to elevate the stories. We’ll give you a megaphone. We’ll make sure that legislators and folks that are at the tables of power and the powers that be that they’re going to hear your experience and hear you out for how their decisions impact your life, your care and your health. But ultimately, just take that step, be loud take up space, you deserve to be heard.

Ben Blanc  13:59

Well, said Conner. And finally we’ll hear from our good friend and colleague, Zoe Rothblatt. She’s the Associate Director of Community Outreach at GHLF. And she’s also the co-host of other GHLF podcasts, including The Health Advocates and also Breaking Down Biosimilars with you Conner actually.

Conner Mertens  14:17

Yeah, I’ve heard her.

Ben Blanc  14:19

So let’s listen to her question now.

Zoe Rothblatt  14:20

Hi, it’s Zoe, thanks so much for having me on. I have a question for you, Robert. You know, I’ve had fellow patients tell me that they’re thinking about going on a biosimilar instead of the brand name biologic that they’re currently on and they asked me if biosimilars are safe. And they ultimately wonder if their condition is going to get worse if they use a biosimilar. We get this question a lot and as a professional, what’s your response to those patients?

Dr. Robert Popovian  14:48

Hi, Zoe, first and foremost, so good to hear from you. Second, I would say you need to talk to your healthcare professional that’s managing your care. Whether it’s your physician, your pharmacist, your nurse, your nurse practitioner, your physician assistant, whoever you’re going to that is providing you the care that is the first person that you should approach about these questions. They can provide the best answers because they know exactly what you’re going through as a patient. The second thing is more of an academic answer, which is I will give to anybody that asks: Biosimilars are absolutely safe and absolutely as effective as the brand biologics. FDA has approved these medicines, they go through rigorous research and development process. It takes several years, several 100 millions of dollars to be able to bring these drugs to the market. There is a lot of science that goes behind it, there’s a lot of regulation, there’s a lot of scrutiny, there’s nothing to be worried about these drugs. As a patient, you’re gonna get the same response as on a brand biologic. Now the big question for patients and patients like yourself is that, if you’re willing to do this right, to switch to a biosimilar, the question you should be asking, it’s not really from your healthcare professional, or your pharmacist or anybody else, but from your insurance company is that whether you’re or not, going to get those savings passed on to you directly at the point of sale, instead of being hoarded by the PBMs and insurers. So that’s the one that I’m always concerned about. And at GHLF we’re always concerned about is that: Will the patient benefit from something like this rather than the insurance company and PBMs pocketing the difference in savings and taking it as profit?

Ben Blanc  16:31

Well, thank you Zoe for sending your question. And thanks, Robert. As usual, it was very clear. Thanks for breaking down all that information for us. And thanks a lot to the two of you. We talk a lot behind the scenes, of course, but it was really nice to be able to have this conversation on air with you guys.

Conner Mertens  16:46

Thanks for coming. Ben, I really had a blast with you today. And I can’t imagine this will be the last time we have you on air. It’s always great to hear directly from our audience, and we hope to continue hearing from you.  As always, Robert, we want to make sure you get the last word in here. What do you think?

Dr. Robert Popovian  17:03

Number one, we picked up something from The Brady Bunch crew, which is to do this mailbag episode. Number two, Ben, thank you for joining us. And number three, please, as patients reach out to us, we are here to help you. Our telephone lines are open, our emails work really well. We get text messages all the time. And Conner needs to be really busy because that’s his number one job, which is to take your calls and talk to you and help you out in your journey as a patient and we’re all here to support you. So don’t be shy pick up the phone, we’re here.

Conner Mertens  17:36

And don’t forget to subscribe to our podcast on Apple, Spotify or wherever you may be listening so you’ll never miss an episode. And if you have a second, help to spread the word by rating our podcast, writing one of those awesome positive reviews, and sharing with your friends and family. It’ll help more people like you find us

Dr. Robert Popovian  17:51

And you can also send an email or audio clip similar to what Zoe did to [email protected] and you might be featured in one of our upcoming episodes just like we did today. We love being challenged by all of your questions. And before we go make sure you listen to some of our other great podcasts that we mentioned on our podcast today.

Conner Mertens  18:15

Great point Robert! Shameless self-promotion here but we mentioned earlier along with my friend and colleague Zoe we host the podcast Breaking Down Biosimilars. We explain what biosimilars are, how they get approved, their potential savings and the promises that they hold for the future. And remember, you can find all of GHLF’s podcasts at ghlf.org/listen. As always, he’s Dr. Robert Popovian.

Dr. Robert Popovian  18:38

And he’s Conner Mertens. We’ll see you all next time. Go Trojans, Go USA.

Narrator  18:44

Be inspired, supported and empowered. This is the Global Healthy Living Foundation Podcast Network.

Narrator  00:00

Be inspired, supported and empowered. This is the Global Healthy Living Foundation Podcast Network.

Conner Mertens  00:10

You’re listening to Healthcare Matters, the podcast that pulls back the curtain to help you make sense of complex health care economics and policy issues. With us, as always, is Dr. Robert Popovian joining us from Washington DC. He’s a pharmacist, economist, and the Chief Science Policy Officer at the Global Healthy Living Foundation.

Dr. Robert Popovian  00:28

And joining me is my good friend, Conner Mertens, from Seattle, Washington, my co-host and our Patient Advocate and Community Outreach Manager. Yes, and I’m going to be the first one to admit it: Seattle Seahawks are in first place for the NFC West. Unbelievable!

Conner Mertens  00:42

All the way to the Super Bowl Robert, all the way to the Super Bowl! And thank you for listening to us, and for all the positive feedback. Let’s start with a listener comment. This one comes from James C. who writes: “Thanks for bringing some clarity to the mountain of health information out there.”

Dr. Robert Popovian  00:56

Keep the feedback coming. And as always make sure you spread the word by rating our podcast or writing an honest positive review. We really appreciate it. And we want to be the first ones to tell you that our next episode is going to be a ‘mailbag episode’, where we’re going to ask you, all our listeners, to send in questions to us. And we’re going to try to address as many questions as we can. And our esteemed producer Ben Blanc is going to be moderating that session between Conner and I.

Conner Mertens  01:22

We’re really looking forward to this mailbag episode. So to participate, make sure you send your question to [email protected] and you might be featured in our next episode.

Dr. Robert Popovian  01:31

So now let’s get into this week’s episode Conner. So Conner, today we’re taping this podcast on November 8, which is election day. So let’s start the discussion with me asking you a question: What the states of Oklahoma, Georgia, Illinois and Washington have in common?

Conner Mertens  01:54

Like you said, it’s election day, my brain’s a little mush right now. So I’m gonna guess that’s our ideal college football playoff scenario. I see why you got Washington State in there: Go Cougs

Dr. Robert Popovian  02:03

Maybe not this year, you know, the Oklahoma is struggling, Washington state is doing okay, and Georgia definitely will be there. But no, these four states are the states that have passed accumulator or maximiser bans. That means to protect patients of out-of-pocket costs, this legislation was passed in these states to allow any kind of a patient assistance program that comes from anywhere, whether it comes from the pharmaceutical industry, foundations, and so on and so forth, to count towards a patient’s deductible or their out-of-pocket requirements. So that’s what the commonality is.

Conner Mertens  02:41

Okay, Robert, that makes sense. So in this episode, we’re gonna be diving into kind of what’s on the horizon, potentially, to look forward to legislatively after these elections. Obviously, we’re kind of taking stabs in the dark, we’re not really sure what’s going to happen tonight. But as you were mentioning offline, issues for patients don’t go away despite who’s sitting in office. So why don’t we get into this? What are some issues that we’re thinking about federally that patients should pay attention to this year?

Dr. Robert Popovian  03:03

Okay, well, we need to continue Conner helping patients without out-of-pocket spending, right. There was some stuff that was done through Congress for Medicare patients that helped them, you know, cap their out-of-pocket costs for Medicare Part D, as well as zeroing out-of-pocket costs for vaccines for elderly. But now we need to hep everyone, right? So one of the main issues that we need to revisit is why can’t patients benefit from multi-billion dollars of concessions that are given by the pharmaceutical industry to the PBMs, and the insurers at the point of sale when they go to a pharmacy? And that’s one of the things that we need to start thinking about is: how do we help the patients with those things?

Conner Mertens  03:46

A good place to start then, Robert, is can we remind folks what is a PBM? And what is a pharmacy benefit manager and why are they being the beneficiaries from these rebates rather than who you would think which it would be the patients themselves?

Dr. Robert Popovian  04:00

So Conner, PBMs or pharmacy benefit management companies are multinational organizations that set up benefit design and negotiate on behalf of patients and employers with pharmaceutical industry to create coverage decisions for drugs. These companies negotiate multibillion dollar contracts in concessions and rebates and fees and everything else, and unlike any other segment of the healthcare system where the insurers negotiate with hospitals or physicians or optometrists or dentists, and that the patient directly benefits from those negotiated prices in the pharmaceutical industry, in the biopharmaceutical market, all of the concessions are primarily being pocketed by PBMs and insurers and very little if any money is passed back directly to the patient at the point of sale when they show up to the pharmacy counter.

Conner Mertens  04:50

So a priority of this next Congress has to be you know, that two-pronged piece which is passing along, you know, these concessions in the rebate savings but also transparency, right? Like, we don’t know what’s happening, or these PBMs aren’t required to be transparent about the way that they do their drug pricing. Are these two ways? Are there other things happening in Congress now that we can look forward to? Or is this something that they’re gonna have to pick up the mantle and get started, you know, recreate the wheel?

Dr. Robert Popovian  05:17

I think Congress has been talking about transparency for a long time, and you bring up a good point. I mean, without transparency, we don’t even know what the exact numbers are, right? One of the questions that always comes up, what is the price of a medicine? Well, the price of the medicine is whatever the sticker price is. But that’s not what the insurers and the pharmacy benefit management companies, employers, or anyone else pays, it’s primarily the person who’s uninsured walks into a pharmacy, and that’s the person who pays that price. So first and foremost, we need to figure out how much money is collected by these entities from the biopharmaceutical industry and how much of it flows back to the employer, to the government or to the patient, which is the most important recipient here, right? And has the Congress done anything meaningful to create transparency in this marketplace? Not necessarily. There’s obviously investigations being conducted by the FTC, in this topic of how much money is being pocketed by PBMs, and insurers and the model… the entire insurance model that currently exists. But currently, on the federal level, we have very little impetus or any kind of legislative effort to create this transparency that needs to occur first.

Conner Mertens  06:24

So to the many, many members of Congress that tune in to our podcast, we want them to know that: Get to work on these transparency laws. What are some other ways that we can be addressing, you know, biopharmaceutical company pricing,

Dr. Robert Popovian  06:36

I think one of the best ways to do on the federal side is to create an environment whereby pharmaceutical industry has a stake also in the outcomes of these drugs, right. So instead of just setting a price, getting paid for it, they need to make sure that these drugs work in the patients. And there are methodologies like outcome-based contracting that need to be implemented with certain classes of drugs to make sure as I say, always, that the pharmaceutical gets to provide the necessary outcome that it has promised. And if it doesn’t provide the necessary outcome, then they cannot be paid for that medicine. So those are the type of things to keep the pharmaceutical industries feet to the fire and make sure that they are providing medicines that will provide benefits to patients, and those benefits can be captured, and then they will be reimbursed accordingly.

Conner Mertens  07:30

One thing that we’ve discussed before is, you know, what these laws and this legislation can do to innovation in the marketplace and around new drugs and therapies. What can our next Congress do to maintain and ensure we continue to have innovation in the medical fields while still making sure that patients are going to benefit better?

Dr. Robert Popovian  07:51

I think, as I said, you need to make sure that the flow of money is known of where the money is collected and where it goes. Because then you can decide whether or not the villain is the pharmaceutical industry, or the Pharmacy Benefit Management company or the insurance company, or perhaps the employer who’s not sharing these savings with the patient at the point of sale. That’s the number one thing, the second thing that they can do is to ensure that the pharmaceutical industry is healthy, and the marketplace is healthy so that when crisis like the COVID pandemic happens, they’re able to step up and bring innovative medicines into the market quickly to be able to then manage diseases that we may not even know about that this time.

Conner Mertens  08:32

Well, there’s always work to be done on the federal level but I’m curious, what do you think our priorities that we’ll see at the state level… Obviously 50 different states, 50 different legislatures, 50 different priorities, systems of Medicaid, Medicare… I know I’m asking a very broad, but what do you think state legislatures should be focusing on fighting for this next session?

Dr. Robert Popovian  08:51

Right. So on the state level, that’s where the action is usually right, Conner? You and I have experienced this and what we’ve seen in the state level is number one: the rules of transparency is much more applicable. There’s multiple states that have passed legislation that require transparency about how much money is collected by the insurers and the PBMs funded by pharmaceutical industry and how much is passed back on to the plan’s sponsor or to patients, State of Texas comes to mind. There are states such as California that have mandated to see what is the spending towards premiums that occurs for biopharmaceuticals. So that’s another thing. But the most important thing is the question that we started with, right? The states of Oklahoma, Georgia, Illinois and Washington and several other states that have passed bans on maximizers and accumulators. These are programs that do not allow patients to benefit from any of the patient assistance programs because what the PBM does is that it does not allow to these programs for this money that comes from the patient’s assistance program from the biopharmaceutical industry to apply to the patient’s deductible or to their out-of-pocket costs requirements. Most importantly, though, we need to look further along so certain states, including state of Texas, have passed laws regarding prohibition on steering patients. And what is patient steering: is that when a Pharmacy Benefit Management company requires a patient to go to their PBM pharmacy, and by doing so, they’re making sure that they capture all of the concessions and all of the stuff that they get from the biopharmaceutical industry. And let me tell you, they don’t pass all of that back to the plan’s sponsor. Anti-steering legislation, such as the one that passed in the state of Texas allows the patient to go to any specialty pharmacy that they want to in the state and does not mandate them to go to the PBM own specialty pharmacy. Remember, 80% of specialty pharmacy ownership is through Pharmacy Benefit Management companies, and that’s important. So they not only control the retail marketplace, which is the pharmacy, you and I go into and walk in and get our prescriptions, but they control the specialty pharmacy marketplace, which is far more lucrative with regards to all of the concessions, like rebates and fees, because that’s where the dollar amounts exist. That’s where the brand name medicines live. So Conner, what about you? I mean, you talk to our patients every day, what do you hear that they want to see changed come this new Congress, or this new era of governorships in the both the state level and the federal level? What do you hear from our patients?

Conner Mertens  11:31

Yeah, I mean, luckily, I think you truly do have your finger on the pulse, because I’m hearing a lot of the same issues that you’ve brought up today. Obviously, you can get a little more niche than some of our patients, but what we’re hearing is they just want cheaper medications, they want to be able to get access to their doctors quicker, they just want better and more accessible healthcare. And quite frankly, I’m glad that you know, you’re here, and we’re here to dig into how that happens in the background, but ultimately, they don’t care how it happens. These are their lives that politicians are playing with, and at the end of the day, they just want to be able to have a healthy life that isn’t going to cost them their life savings. So that’s I think, kind of what I’ve been hearing across the board.

Dr. Robert Popovian  12:11

And Conner, I couldn’t say it better. Because when we think about politics and patients, and you know, we have a rule in our podcast, right? Health care is bipartisan, access to health care is a bipartisan issue. Trust me, cancer doesn’t care if you’re Republican or a Democrat. Access to medicines, and the way the medicine works for a patient is irrespective of your political leaning. Therefore, all of these things that we just talked about are a continuation of things that we need to fight for, as an organization, and to people like you who work with our patients directly. Because at the end of the day, whether it’s a Republican Congress, or a Democratic Congress or Senate, or a governorship, it doesn’t matter, because the patient issues of trying to get healthier, to be kept healthy, and to be able to access medicines, and physicians and hospitals, is the same. And both parties have a responsibility to patients to be able to get them better, quicker, faster, healthier. And unfortunately, that’s not the way we view health care in our political ecosystem. And that’s a shame, and it’s to the detriment of the patients.

Conner Mertens  13:20

Well, Robert, that’s a hell of a last word. Thanks for breaking it down for us. I think that’s some very valuable information for folks in this next upcoming year with a lot of uncertainty in politics. At least they got you!

Dr. Robert Popovian  13:31

Well, they have us. They have you, they have me, they have Ben, who’s producing this podcast and they have Global Healthy Living Foundation and everybody who works in GHLF. But at the end of the day, it takes a village and at some point it doesn’t mean anything if you’re a libertarian, or conservative or liberal or a Democrat or a Republican, you are going to get sick, I have news for you. And at that point, you’re not going to care about politics, all you’re going to care about as a patient is to get better. And as a health care professional, who has worked with patients in the past, all we care about as health care professionals is to help those patients get better. And that’s where we need to focus our attention now.

Conner Mertens  14:19

Well, again, thanks for breaking that down for us, Robert. And to our listeners, don’t forget to subscribe to our podcasts on Apple, Spotify, or wherever you might be listening so that you’ll never miss an episode. If you have a minute help spread the word by rating our podcast, writing a positive review and sharing with your friends and family. It will help more more people like you find us

Dr. Robert Popovian  14:36

And to our listeners, don’t forget, we have our mailbag episode coming up next. So please send all your questions. And if you don’t want to send a question, send an audio clip to [email protected]. And we will try to answer as many questions as we can. And we’re going to get Ben involved and he’s going to come on and he’s going to moderate this session and we’re going to have a hell of an episode and you’re going to have fun with this. Okay, Conner, so before we head out, I want to make sure that all of our listeners know about the other great podcasts on the GHLF Podcast Network.

Conner Mertens  15:08

That’s right, actually in the last episode of Talking Head Pain, our colleague, Joe Coe, is joined by Michelle Tracy. She’s an advocate, a writer, and also migraine patient who has been very open about her journey with migraine and mental health on social media. If you haven’t done it already, make sure to give it a listen. That’s a really good series. And remember you can find all these GHLF podcasts at ghlf.org/listen.

Dr. Robert Popovian  15:30

And you know, Conner, that episode actually I have listened to and one of the things that reminds me of is that: please voice your opinion, please let us know how we can help. GHLF is here to help patients and if you need help reach out to us. We are able to help you out and we will do so as any way we can.

Conner Mertens  15:51

Well said Robert. Well, thanks for tuning in. As always, he’s Dr. Robert Popovian.

Dr. Robert Popovian  15:55

And he’s Conner Mertens. We’ll see you all next time.

Narrator  15:59

Be inspired, supported and empowered. This is the Global Healthy Living Foundation Podcast Network.

Narrator  00:00

Be inspired, supported and empowered. This is the Global Healthy Living Foundation Podcast Network.

Conner Mertens  00:10

You’re listening to Healthcare Matters, the podcast that pulls back the curtain to help you make sense of complex health care economics and policy issues. With us, as always, is Dr. Robert Popovian joining us from Washington DC. You know, he’s a pharmacist, he’s an economist, and he’s the Chief Science Policy Officer at the Global Healthy Living Foundation.

Dr. Robert Popovian  00:28

And joining me is my good friend, Conner Mertens, as always, my co-host and our ‘numero uno’ Patient Advocate and Community Outreach Manager at the Global Healthy Living Foundation.

Conner Mertens  00:40

Thank you for listening to us, and for all the positive feedback. Let’s start with a listener comment. This one’s from Sean P. who wrote: “Very informational podcast. I learned a lot!”

Dr. Robert Popovian  00:49

Please keep the feedback coming. And as always make sure to spread the word by rating our podcasts or writing an honest positive review. We’d really appreciate it. So Conner, let’s get into this week’s episode. What does the number 2,566 mean to you?

Conner Mertens  01:07

I like that we’re doing this new theme of numbers at the beginning of our podcast, but this one rings no bells. But sounds pretty specific. What’s 2566 mean to you, Robert?

Dr. Robert Popovian  01:16

Well, those are the number of Americans who passed away unfortunately from COVID in the last seven days.

Conner Mertens  01:22

That’s seven days…

Dr. Robert Popovian  01:24

Yes. So we lost 2,566 Americans.

Conner Mertens  01:32

Well, Robert, sounds like today we’ll be talking about COVID. And with that, let’s dive in. Can you tell me more about this number? What does that say about where we’re at in the pandemic? We’re definitely skipping over the question of are we over this pandemic, because the answer is no. What do we need to know about where we’re at in the pandemic right now?

Dr. Robert Popovian  01:47

So where we are, is that we are trying to get people vaccinated. We’re trying to get people healthy, if they are not vaccinated, or even if they are and they have breakthrough disease, through oral antiviral therapy, or antibody therapy. And that’s where we are. We’re trying to manage a disease that is going to be with us for quite a while. And that’s what we’re going to talk about today is that what is the new stuff that’s coming out for COVID-19 with regards to new information about the vaccines, the therapies, and how we may ask patients to work with us on getting themselves better care.

Conner Mertens  02:24

So we can see that the rollout of the vaccines and therapies has undeniably helped curb death and hospitalization rates and governments are exploring how to manage COVID going forward. But that number you said 2566 is still a number. Those are all people, those are all real lives that we’re losing every week from this disease. So the question is, what’s next?

Dr. Robert Popovian  02:46

What’s next is really for us to be able to come to grips that, you know, we’re going to have vaccines. These vaccines are going to have tremendous efficacy in reducing hospitalizations and deaths. But there are also some limitations, right. What we’ve learned is that mutations have come up with COVID. And there’s new variants that are coming out. So we’re gonna have to get boosters. But then the reality is that Conner, there are certain patients who cannot be vaccinated or the vaccines don’t work for them. Specifically, the blood cancer patients or patients for a variety of other reasons who are not going to get the vaccine. So it’s not just about the vaccines, but how do we move forward as a community, as researchers, as patient advocates, as healthcare professionals in providing care to those individuals through either antiviral therapy that’s out there, antibody therapy that needs to be out there, and as efficacious if not more than oral antivirals, and how do we ensure that those therapies get to the patients in a timely manner?

Conner Mertens  03:46

Okay, so let’s start with the antibody treatments. You know, we constantly hear about this idea of herd immunity or natural immunity, what are the benefits of these antibody treatments?  Why can’t we rely on these natural immunities?

Dr. Robert Popovian  04:01

So natural immunity is great, right? Don’t get me wrong. I mean, eventually, we want to get to a point that we have herd immunity, we have natural immunity, you know, and I get a lot of questions from people who come up to me and say: “Look, I’ve had COVID, you know, I developed antibodies. So do I really need to get vaccinated?” And my answer is very simple. I say, yes, you’ve had COVID, you’re fortunate enough to be talking to me at this point, because there’s a lot of people who are not so fortunate and have passed away. So you can take the chance of getting sick, developing natural immunity through antibody development in your body, or you can get the vaccine to ensure that you’re not going to end up dying. And that’s the case here, is that the antibodies, the natural immunity antibodies are important, but they’re not really realistic if you want to reduce the burden of illness and possible mortality. Now, the antibody treatments themselves have a lot of potential because they’re not only about treatments. Antibodies that have been developed are also for developing immunity treatment and prevention eventually. So those are treatments that are available currently in the market, although not to the extent that we have the vaccines and the reason being, and we can talk about the challenges that they have, that they haven’t been able to be coming out into the marketplace as quickly and as efficiently as the vaccines and the oral antiviral therapies have.

Conner Mertens  05:27

So let’s go there. What do you think is causing that? What is, in your opinion, the biggest hurdle to bringing these new treatments to the market, if we’re seeing so much success with them?

Dr. Robert Popovian  05:37

I think it has to do and it’s not a thing, I believe, it is the Food and Drug Administration. They’re under the impression that you need to develop these antibodies. They know they’re important therapies, but they want to follow a path that you have to go through with regards to an approval process that is probably outdated. Because by the time that you do the clinical trials and everything else, we’ve moved on to a new mutation. So what the Food and Drug Administration needs to do is really go back to the drawing board and rethink about what the approval process for these antibody therapy should be. We’ve seen how flexible they are with the vaccines, right. This new bivalent, that came out recently, they didn’t even do clinical trials, they did primarily, you know, in vitro studies to get it approved. And I think that they need to really start rethinking about the approval process of these antibody therapies. Because clearly we know even though the vaccines are super important, and super efficacious, there’s just a group of people who is not going to get vaccinated, and a group of people who, like my friend who I just ran into a couple of days ago who is in remission from leukemia, that the vaccines are not going to work for. So we need therapies for those individuals.

Conner Mertens  06:51

Well, something that’s been coming up a lot recently, Robert, have been some studies that folks in our patient community are reading about in Wall Street Journal and other places about some BCG and flu vaccines and how they would be used for COVID. What can we tell them about these studies and about these new treatments? Is this something that we should keep our eye on? Should they be worried? Or is this what we’ve been talking about this whole podcast, which is just another advancement and another tool to fight this disease?

Dr. Robert Popovian  07:20

So as always, science evolves, right. We talk about that in our podcasts all the time. And in case of BCG, it’s interesting. BCG vaccine has been around for decades. In fact, I may be the only one among the three of us, you, me and our producer, Ben, who probably got the BCG vaccine because of where I was born and raised. So BCG vaccine is for tuberculosis. And the reason that I got it is because I’m from a country that has a very high prevalence of tuberculosis. When I moved to the United States, we don’t give that vaccine anymore here, because there’s low risk of infection. There’s some variable efficacy against adult pulmonary tuberculosis and potential vaccine interference with skin test, which is very important because we do do skin tests to monitor for tuberculosis breakout in this country. So BCG has shown some potential, there was a study that was done that got a great deal of coverage. Wall Street Journal covered it, New York Times covered it. And we did get a lot of questions. I got a lot of questions personally from individuals, and it has some broad protection levels with regards to respiratory infections. This should not be a surprise. More studies need to be done to confirm. It was a small study that was done of patients who were tested who got the BCG vaccine versus placebo and development of the COVID. But at this point, Conner, what I tell patients who approach me, or what we should tell the individuals who approach you, is that stay tuned, more data is going to be done. We need more information. But no, this is not potentially something that you should be running out and trying to get the BCG vaccine as a patient. We have other vaccines available for COVID. And we have treatments and as I said, we need to develop more antibody therapies. But at this time, as always, it’s good data and science evolves. And we’ll see where this takes us. There may be some potential for it.

Conner Mertens  09:09

You know, and Robert, I think one of the silver linings that we can take away from this pandemic was so much time, money, research and development was put towards finding a cure and medical advancements. And we’re seeing those pop up in a lot of different places that the research and some of the technologies that have really been studied and advanced during this pandemic. They’re finding new uses, and we’re finding ways that they can treat other things. Can you tell us a little bit more about that?

Dr. Robert Popovian  09:33

I couldn’t agree more. I mean, it’s one of the very few silver linings, right, that there’s been a real emphasis in looking into infectious diseases more as a research environment. It’s also the development of the mRNA platform, because as we’ve discussed in this podcast, the mRNA platform has been around for a long time, but it didn’t have any usage, practical usage, for treatments or vaccines or anything else until the breakout that we’ve had. So there’s definitely been the evolution of science that we’ve seen. And this is good for patients, and this is good for our patients, right? Because the more focus is made into new therapies, new areas of research and everything else, this helps patients who, unfortunately are going to need these therapies long term. And you know, although our organization focuses on chronic diseases, primarily, we are very much a vaccine patient advocacy group, and not only a vaccine patient advocacy group, but you know, infectious disease patient advocacy groups, so things like vaccines and antibody therapies and oral antivirals are super important for our patient population, because inherently chronic disease patients are immunocompromised, and they will need a lot of different therapies for help.

Conner Mertens  10:42

Yeah, Robert, you’re talking about how we’re trying to make these therapies and these vaccines more accessible to folks. And one question that comes up is, I’ve recently learned that a large portion of the adult population has some sort of needle phobia. And I think we all are scared of needles as kids, too. So how, what are some other options that are available for folks that like, you’re seeing earlier, maybe unwilling or unable, or in this case, just a little nervous about this mechanism of administration?

Dr. Robert Popovian  11:08

So that’s a great question. So you know, it’s a little bit of an unknown, but there’s a good percentage of adults who are needle phobic. So if you’re… you have needle phobia, it’s going to be hard for you to get the vaccine, or it’s going to be hard for you to get the antibody therapies because they’re infusions right, or I mean injections. So there are alternatives that have been worked on. And one of the things that, you know, we were discussing prior to starting a podcast is potentially nasal administration of the vaccine through nasal route. And, you know, it’s great, they’re working on it, and you know, they’re going to come out with it. And we do have administration of the flu vaccine through the nasal passage. But that doesn’t mean that we should stop. And we should continue to research in those areas. Because as I mentioned, there’s a good percentage of adults who have needle phobia. So it is a good thing. Again, one of the silver lining is that we’re going to continuously invest in this type of research opportunities.

Conner Mertens  12:01

Insightful, as always, and I want to make sure you get the last word, Robert, but you know, what I’m kind of taking away from this conversation is we’re seeing some waning of this pandemic, it’s certainly not over. And if we don’t continue our mitigation strategies, we could be in for a rough winter. But there are a lot of advancements that are coming along, and really helping patients and helping folks speed this disease and keep folks out of the hospital. But there’s a lot of red tape involved that is slowing down some of this advancement that we’re seeing, you know, that’s just my take. What do you think, Robert?

Dr. Robert Popovian  12:32

Similar, I mean, you know, we have a pandemic that sort of goes through peaks and troughs, right, so we’re at the trough right now. We don’t know what’s going to happen with the winter months coming on upon us, we already see that there’s going to be some harsh flu season. That’s another thing that we need to remind our listeners, go get your flu vaccine, don’t forget about that one. So we are at a trough with COVID, but that doesn’t mean we stop the research. That doesn’t mean that we take off our foot from the gas pedal. It’s important for us to continue to research but not only in the vaccine and promotion of the vaccine, but also understand that new research needs to be done in oral antiviral therapies, in antibody therapies that are going to be so critical. And most importantly, what you said at the end, which is the red tape, it’s the bureaucracy that we cannot go back to. You know, especially when it comes from the Food and Drug Administration. They need to understand that these antibody therapies are critical. I think the administration does. I think Congress understands those things. But the FDA needs to change the way they’re looking at the research and how that should be completed and to get approvals for these medicines or emergency authorizations. Because they’re going to be critical for a certain segment of the patient population for whatever reason that the vaccine either is not going to work or they’re not willing to take the immunization, the vaccination, that we do need those opportunities for those patients to be taken care of.

Conner Mertens  13:58

Well, as always, thanks for breaking that down for us and for the update Robert. I know that our listeners really care about where we’re at with this COVID pandemic, so I know they’re gonna like this one. Some really valuable information for our listeners. And to our listeners, don’t forget to subscribe to our podcast on Apple, Spotify, or wherever you might be listening so you never miss an episode. And if you have a second help spread the word by rating our podcast, writing a positive review and sharing with your friends and family, it’ll help more people like you find us.

Dr. Robert Popovian  14:25

And I have to say Conner, I’ve gotten a lot of good feedback about the last two podcasts that we did. One specifically related to how patients can save money by paying cash for their generics and also the 340B one we did last go round. A lot of good feedback. And for our audience, if you want to send us an email or an audio clip, please send it to [email protected] and you might be featured in one of our upcoming episodes. And before we go make sure you take a listen to some of our other great podcasts on the GHLF Podcast Network.

Conner Mertens  14:59

That’s a great point, Robert. Actually in last week’s episode of The Health Advocates, our friends and colleagues, Steven Newmark and Zoe Rothblatt discuss vaccine skepticism, which you know, it’s a worrisome trend that goes beyond COVID-19. But very applicable to our conversation today. If you haven’t done already, make sure to give it a listen. And remember, you can find all of GHLF’s podcasts at GHLF.org/listen. He’s Dr. Robert Popovian.

Dr. Robert Popovian  15:24

And he’s Conner Mertens. We’ll see you all next time.

Narrator  15:28

Be inspired, supported and empowered. This is the Global Healthy Living Foundation Podcast Network.

Narrator  00:00

Be inspired, supported and empowered. This is the Global Healthy Living Foundation Podcast Network.

Conner Mertens  00:10

You’re listening to Healthcare Matters, the podcast that pulls back the curtain to help you make sense of complex healthcare economics and policy issues. As always, we’re joined by Dr. Robert Popovian tuning in from Washington DC. He’s a pharmacist, he’s an economist, and he’s Chief Science Policy Officer at the Global Healthy Living Foundation.

Dr. Robert Popovian  00:29

And joining me is my good friend, Conner Mertens in Seattle, my co-host and our Patient Advocate and Community Outreach Manager. And I’m looking at Conner, he’s wearing every single item that he owns from Washington State University Cougars. Why is that Conner?

Conner Mertens  00:43

Big game this weekend! We have to embarrass your USC Trojans and had to rep. I noticed you’re wearing some of your gear too.

Dr. Robert Popovian  00:50

That is correct. It is big game and we will see what happens over the weekend.

Conner Mertens  00:55

Go Cougs, go Mariners, go Seahawks. It’s all about Washington this weekend. Thanks for listening to us, and for all the positive feedback. Let’s start with a listener comment. This one comes from Susan M. who writes: “Thanks for breaking down all the healthcare news for us.”

Dr. Robert Popovian  01:08

Thank you, Susan! Keep the feedback coming as always, and make sure to spread the word by rating our podcast or writing an honest positive review. We really appreciate it. Now let’s get into this episode. Conner, what does the number 38,000 mean to you?

Conner Mertens  01:24

38,000… I’m gonna go with: this is your mileage plan this year, you’re flying coast to coast. That’s how many miles you’ve logged for flights?

Dr. Robert Popovian  01:31

Well, Conner, not quite because my wife will dispute the 38,000 number. I have flown a hell of a lot more this year. But I have to say 38,000 is the number of contract pharmacies that are in the United States that are eligible for the 340B program discount. 340B program is a federal program. We’re going to talk about it today and talk about how it impacts patient, what is the good, the bad and the ugly, as we always talk about with regards to various programs instituted in this country.

Conner Mertens  02:04

Yeah, I mean, I’ve heard a lot about 340B but I’m still learning because it’s quite complicated. And just the name itself sounds complicated and confusing: 340B. So obviously, we’re gonna be diving into that. Tell us more about this number you brought up ‘38,000’ and just the 340B program in general. I know there’s a big ask, can you tell us: what are you talking about? What is it 340B?

Dr. Robert Popovian  02:25

So 340B is a program that was instituted in the early 2000s. And the purpose of the program was that the federal government wanted to help institutions. These are hospitals, clinics that take care of overwhelming number of uninsured or underinsured patients and because of that, they were providing a lot of free care. And so they instituted this program to allow these institutions to receive significant discounts for their drugs by pharmaceutical companies. And it’s a very worthwhile program, it really has helped institutions such as the LA County USC, where I trained under when I was in training in the mid 90s. I would say 80% of the people walking through the doors of that hospital were uninsured, and the hospital was taking care of them and without any qualms that they were ever going to get paid. So the federal government basically put together this program to help these types of hospitals and clinics and other entities that really take care of these patients that don’t have adequate insurance or they are  uninsured, and to help them recoup some of the costs that they incur when they provide care. So it’s a very worthwhile program. It’s been something that was absolutely necessary when it was instituted.

Conner Mertens  03:44

Right, so right off the bat, it sounds like 340B is something that should be helping patients and its designation and its inception was all based in trying to help underserved populations. So why then are we seeing some issues around it? Why are pharmaceutical companies trying to alter or change this program?

Dr. Robert Popovian  04:04

Well, as always, with any program that gets instituted, whether it’s by state, federal government, by private sector, it doesn’t matter. It requires continuous evaluation. And what has happened with this program, like many other programs that we’ve seen, it has drifted from its original intent, which was truly to help these hospitals, these clinics that provide care to uninsured to receive these huge discounts. What has happened since its inception, and remember, there were also some other massive policy changes that took place in the United States, right? We had the passage of the Affordable Care Act that has definitely increased the number of insured in this country and has dropped significantly the number of uninsured that receive care. So because of these changes, what has happened is that the program has drifted where it has become the second largest federal program after Medicare Part D regarding biopharmaceuticals and what has happened is that there’s been an insatiable growth in the number of covered entities, that means institutions, hospitals, clinics that are eligible for 340B discounts. But more importantly, and more, I would say, poorly, the expansion, the significant expansion of for-profit pharmacies that are considered contract pharmacies that are now eligible for these discounts as well. And that’s been the one area that biopharmaceutical industry has asked Congress and HERSA, which is the overseer of the 340B program to take a look at because it just doesn’t make sense. And let me put the 38,000 number of contract pharmacies in context for you, Conner, in the United States, we have at most about 80,000 pharmacies. These are retail pharmacies, clinics, so on and so forth, that serve patients. 38,000, 39,000 almost, are eligible for this 340B discount, which is primarily meant for uninsured patients. There’s no way in the United States that one; we have 50% of our population, which is uninsured; nor is it a possibility that 50% of our population is low income. So on the surface, it looks like there’s some abuse going on. And that is what is taking place. And what is taking place is that these contract pharmacies who become eligible because of very loose criteria buy these drugs at significant discount meant for poor patients, and insured patients and underinsured patients, and then utilize these drugs with commercial patients or Medicare patients that are significantly paid better, so their margins have grown exponentially.

Conner Mertens  06:39

So theoretically speaking, this law, the 340B program was meant to encourage hospitals to re-invest, you know, in their in their local communities where there might not be enough resources for health care for underserved populations. So obviously, that’s just theoretical, where are we seeing the shortcomings? Why is this being abused or potentially being abused?

Dr. Robert Popovian  06:58

So that’s a great question, because that’s another part of the problem. So currently, there are no criteria for these institutions that receive these 340B discounts to re-invest and provide, for example, charity care. Certain hospitals, I can tell you, do a fantastic job. They provide enormous amount of charity care, and they utilize these resources that they’ve gained through these discounts to provide back to the community. Other hospitals and other institutions are not doing the same. So one of the things that needs to happen, besides the issue of contract pharmacies and the exponential growth in that area is ‘should we set up a standard for hospitals that are eligible for 340B discounts that they have to meet certain charitable contribution towards communities, and those needs to be standardized as federal law’. So then we know that if this hospital or this clinic is receiving these discounts, then they need to provide an X amount of charity care, and they need to report that back to the federal government. So that’s also another area that needs to be explored. But Conner, I want to go back and talk a little bit about the contract pharmacies and why this is impacting patients. And it’s not just about them receiving these cheaper drugs, and then selling at a much higher margins to insured patients or patients who are receiving federal government insurance through Medicare. The problem is that not only it’s a profit maximizing scheme, but also it impacts the premiums, because at the end of the day, what has happened is that as these institutions are overpaying for these medicines, and pharmaceutical industry is selling it at a much lower price. What ends up happening is the pharmaceutical companies for them to recoup this ever increasing discount has had to increase their prices. So who bears that cost is really patients who are in commercial insurance who have copays coinsurance, or deductibles.

Conner Mertens  08:49

And Robert, you know, one theme that we constantly thread through all of our discussions is this need for transparency in our health system, and especially when there’s these big blank checks being written. And, you know, like you said, it’s going to impact the patient. What are we seeing in terms of transparency around this law?

Dr. Robert Popovian  09:09

So very little, and actually, it’s a bipartisan effort has been called for that there needs to be more transparency because Conner, one other thing I want to point our audience to is an article that came out two weeks ago in New York Times, over the weekend, and it demonstrated how this program is really being used to enrich the institution and poor people are being taken advantage of. So what was happening is that is this institution in Richmond, Virginia, which is eligible for 340B discounts was utilizing that population to get those discounts, purchase those products, but then at same time, as we talked about, instead of providing more care in that community, they were shutting down services. So in essence, they were getting these huge discounts that they were transferring it and profiting from as an institution, and instead of increasing the charitable or services in the poor community, what they were doing is expanding their footprint and their services in more affluent communities outside that where the hospital was located that was eligible for that discount.

Conner Mertens  10:12

Robert, when we talk legislatively, I think that’s a really important question here is: Is this law salvageable? Is this something that we should just cut our ties with and move on? Or can we make this something that is true to what its intended value was, which is to help underserved communities?

Dr. Robert Popovian  10:27

Absolutely salvageable, and it’s important to salvage this law! Because it’s a super important law for hospitals and institutions that provide care to uninsured, low-income communities. So where do we go from here? How do we salvage this law? And there are several policy options that we have in place. One is transparency, and making sure that the discounts and the savings that are gained by these institutions, by these pharmacies are actually used for the patients who are eligible for it. So instead of the discount necessarily following the institution, perhaps the discount should follow the patient, in this case. Number two, should we institute like we talked about standards of charity level care for hospitals, clinics, contract pharmacies that become eligible for this type of discount? We don’t have one, should there be a mandate that they provide X percentage of their revenue towards charity care that they have then report back to the federal government? So that’s number two. Number three, is that do we really start looking at the location of these contract pharmacies? So the contract pharmacy issue has become a lightning rod, because a lot of these eligible institutions, for example in California, have hundreds of contract pharmacies and a very significant percentage of those contract pharmacies do not happen to be in the state of California. They are spread across the country, they’re all over the map. They could be all the way in New York and Maine and Puerto Rico. So the question from a policymaker standpoint that we need to ask is that: Why does an institution in Southern California or Northern California that is serving poor low-income patients that are generally not traveling or sedentary, why is there a need to have a contract pharmacy in the state of Maine serving those patients for that institution?

Conner Mertens  12:20

Well, Robert, this 340B stuff is dense, and it’s niche. And it’s very, like a lot of the other topics we discuss, it’s not easy to understand and I want to make sure that you’re getting the last word. But you know, what I’ve kind of learned about this 340B program is that it has a lot of potential to be good, but the problem is the ambiguity and lack of regulation has essentially allowed for kind of like a bastardization of the program that was made to help underserved communities. But it’s been turned around, and now it’s just a way again, to make money at the expense of patients. How does that sound Robert?

Dr. Robert Popovian  12:53

Conner, I couldn’t have said it better and frankly, I’m going to push this to you, because you’re the individual who talks to our patients. You and your colleagues that work directly with our patients, you need to take all of the stuff that we talked about today, you know, everything that I said, the policy solution and really translate for the patients to become advocates for this program to be preserved with the changes that we are recommending. Because these changes are reasonable, this will help everyone to preserve a very important federal program that serves an important mission, which is to provide significant discounts to institutions that serve poor people. But for it to be preserved, some changes need to occur and it’s really you and your colleagues that need to communicate this with our patients.

Conner Mertens  13:43

Well, as always, Robert, that was thorough. Still got a little bit learning to do because this is complex stuff. But I think that’s some very valuable information for our listeners, and I know that they’re gonna walk away a little bit more knowledgeable. And to our listeners, don’t forget to subscribe to our podcast on Apple, Spotify, or wherever you may be listening so you never miss an episode. And if you have a second help spread the word by rating our podcast, writing a positive review and sharing with your friends and family. It will help more people like you find us.

Dr. Robert Popovian  14:11

And you can also send us an email or audio clip to [email protected] and you might be featured in one of our upcoming episodes. And before we go, make sure you take a listen to some of our other great podcasts on the GHLF Podcast Network.

Conner Mertens  14:29

That’s a good point Robert, there are quite a few in our podcast network. We have a bunch of great podcasts that focus on a wide range of conditions and other important issues to our patient community. You can find all of GHLF’s podcasts at ghlf.org/listen. I’m gonna go ahead and suggest a few: Talking Head Pain, The Health Advocates, Getting Clear on Psoriasis, The Gout Show. There’s already a ton of episodes, a few seasons, you’ll get lost in that library for a while so make sure you go give them a listen. And thank you for tuning in. As always, he’s Dr. Robert Popovian.

Dr. Robert Popovian  15:01

And he’s Conner Mertens. We’ll see you all next time. Fight on!

Conner Mertens  15:04

Go Cougs!

Narrator  15:06

Be inspired supported and empowered this is the Global Healthy Living Foundation Podcast Network

Narrator  00:00

Be inspired, supported and empowered. This is the Global Healthy Living Foundation Podcast Network.

Conner Mertens  00:10

You’re listening to Healthcare Matters, the podcast that pulls back the curtain to help you make sense of complex healthcare economics and policy issues. With us, as always, is Dr. Robert Popovian joining us from our nation’s capital. He’s a pharmacist, he’s an economist, and he’s Chief Science Policy Officer at the Global Healthy Living Foundation.

Dr. Robert Popovian  00:28

And joining me is my good friend, as always, Conner Mertens, in Seattle, my co-host and our Patient Advocate and Community Outreach Manager. And Conner before we get started, these are heady times in the state of Washington! The Huskies, and the Cougars are undefeated. And I’ve circled October 8 in my calendar, where Cougars are going to visit Coliseum. And you and I are going to have probably some side conversations on that.

Conner Mertens  00:51

You better watch out, the Cougars are making a run for it this year! I’m not used to us having a good football team. So I’m really kind of just holding my breath until the other shoe drops. Well, thanks for listening to us. We received some great feedback on our last episode, The Inflation Reduction Act: the Good, the Bad, and the Ugly- What’s in It For Patients. It seems like it really touched a hot topic, make sure you have a listen if you’ve missed it.

Dr. Robert Popovian  01:11

So keep the feedback coming and make sure you spread the word by rating our podcast or writing a positive review. We always appreciate those. Now let’s get into this week’s episode. Conner does the number 92% mean anything to you?

Conner Mertens  01:27

Um, let’s see here. 92%. That’s the amount of Seattle homeowners that also own a dog and a Tesla?

Dr. Robert Popovian  01:36

Well, no. 92% is actually the percentage of prescriptions in the United States that are filled as generics. So 8% of prescriptions in the United States when you go to a pharmacy and you receive your drug or brand-name medicines, and 92% of the time, those prescriptions are generic formulation. So today, Conner we’ll be talking about why are our patients overpaying for their generics. Remember, generics are supposed to be very low cost alternatives to brand-name medicines, but you’d be surprised to hear what’s going on here. And I know you have a personal example that has happened to you recently, when you went to a pharmacy to pick-up a prescription for your father.

Conner Mertens  02:17

Well, we’re going to be talking about out-of-pocket costs, then it sounds like. And like you mentioned, I personally, I went to the pharmacy recently, casual day, pick-up a prescription for my dad and that copay was ridiculously expensive. And I was pretty lucky that the pharmacist actually went out of their way to offer me to pay for it in cash and it was wildly cheaper. Robert, isn’t the entire point of insurance to lower healthcare costs? How often is this the case that medications can be cheaper paying for it in cash rather than through my insurance?

Dr. Robert Popovian  02:45

Well, more often than you think, and this is why there’s been an uptick of individuals who are bypassing insurance and actually paying for prescription drugs, and sometimes for health care expenses in cash rather than using their insurance model. You know, I was on a call Conner recently with a friend of mine who owns two pharmacies in the state of Ohio. He has his traditional pharmacy where they take insurance, you know, where you go in and you pick up a prescription, use your insurance card, you pay a copay or coinsurance or deductible, and right next door, he has a pharmacy specifically just for cash-paying patients. So that pharmacy does not take any insurance, any type of third party insurance, and all day offers patients to pay in cash. And he recently gave me an example of a patient that walked into his pharmacy. This patient was going to get a 90-day supply of a medicine and his exact copay was going to be $56.87. Well, this pharmacist said: “Look, I don’t want to tell you what to do, but this is your copay based on your insurance design, but if you want to pay it in cash, right next door is our other pharmacy that offers the same medicine at the same quantity, same drug, at a cash price”, and guess what the cash price was? It was $14.75, significantly lower than he would have paid if he had used his insurance.

Conner Mertens  04:02

I think that the front and center question then Robert becomes why? Why is it that paying for cash is cheaper sometimes than using our insurance which is designed to make healthcare costs cheaper?

Dr. Robert Popovian  04:13

So Conner, the reason this happens is because of a term called ‘spread pricing’. Spread pricing is a phenomenon that generally happens in the generic space. And this is when an insurance company charges an employer significantly more than what they reimburse a pharmacy and they keep the spread as a benefit or a profit. The pharmacy benefit management company or insurance company keeps that as a benefit or profit to themselves. Because of this reason. And because outpatient costs for patients such as a deductible coinsurance, or copayment is due to the inflated numbers, patients end up paying significantly more most often in the generic space.

Conner Mertens  04:56

And how often would you say that this is happening to individual patients versus government entities or employers or other people that nature?

Dr. Robert Popovian  05:04

That’s a great question! So as always, we refer back to published information, right, because this is a podcast that we try to talk about policy issues but with facts, to help patients understand where these things are coming from. So there are two studies that were published by the University of Southern California, the Schaeffer Institute. The first study looked at how often do patients overpay when they walk into a pharmacy for a generic medicine, if they use their insurance card versus if they had paid it in cash. And what they found out in a one year period, looking at data, that patients over 25% of the time when they were acquiring a medicine, and even a little bit higher when they were acquiring a generic medicine, were overpaying if they use their insurance card versus that they had paid in cash. So in other words, that copay or deductible or coinsurance would have been significantly higher than if they would have just paid in cash. Now, move forward, how often and by how much does the government overpay or the employers overpay? Well, there’s a second study that Schaeffer did utilizing Costco. And in that case, what they did is to compare how much does the federal government would have paid if they would have paid the cash prices by Costco versus how much did they reimburse the insurance companies for that same prescription, same volume, same drugs, same amount dispensed. And what they found out is that over a two year period, the Medicare program overpaid by $4.5 billion. So in other words, it would have been cheaper for the federal program to have acquired these medicines in cash at Costco and just provided all the Medicare patients with Costco benefits, and this had to do with the top 200 generics, then to go through the insurance model that currently exists. What happens to that $4.5 billion, that’s pure profit for the PBMs and the insurers.

Conner Mertens  06:58

Just to refresh our memory, the PBMs these pharmacy benefit managers, can you remind us what they are, or why they exist, besides to frustrate us as as policy experts?

Dr. Robert Popovian  07:07

Pharmacy benefit management companies are really middleman. They’re not payers. Insurers and pharmacy benefit managers are not payers. The two payers in the healthcare system in the United States are patients or employers and to a certain extent is the federal government and state governments. Although, you can argue that ultimately, we pay for that too, because they tax us for those benefits. So it’s really the consumer, the patient and the employer, because they subsidize most of it. So what the pharmacy benefit managers do, they manage the benefit for the pharmacy, but they have corrupted that so much to a point that many times, and it’s not very few people, patients end up overpaying for their prescription drugs when they’re using their pharmacy benefit rather than if they have paid in cash. And if you think about it, this goes against the whole premise of insurance, right? The whole premise of having insurance is to get the best deal. Then if you’re not getting the best deal, then what is the point of insurance?

Conner Mertens  08:03

And there just seems to be so many intermediaries that patients have to go through when trying to get their medications and everyone’s got their hand in the pot and everyone wants a little bit of that money that’s coming in.

Dr. Robert Popovian  08:14

That is absolutely true. And there’s many more intermediaries than just the insurance companies and the pharmacy management companies. But if you think about it, for the lion’s share of what gets captured in the middleman territory, the lion’s share goes to those two entities the PBMs and insurers. The rest of it gets divvied up, a very small percentage gets divvied up between hospitals, physicians, pharmacies, wholesalers and other entities that exist.

Conner Mertens  08:42

It just all sounds so confusing, to be honest, Robert, and I’m supposed to be, like I said, supposed to be an expert at this. But what can folks do when buying medicine to help lower those costs? What  should they be thinking about?

Dr. Robert Popovian  08:53

I wouldn’t say just medicines. Conner, I’ll give you my personal example, just like this happened to you with that prescription. So my daughter, it had nothing to do with prescription drugs, my daughter required a MRI. So she went through the insurance first, she called the MRI center that she was referred to, and her out of pocket costs with insurance would have been $500. So if we’d utilized the insurance that we currently have, we would have had to pay $500 out of pocket for an MRI. I told her why don’t you call different MRI centers and also call back the same one you were referred to and say I have no insurance. How much is this going to be if I paid for it in cash? Well, the cash price ranged between $300 and $350. In other words, it would have been cheaper for her to get cash price than would have gone through the insurance and if she used the insurance, we would, she would have overpaid between $200 and $250.

Conner Mertens  09:49

I think another really good piece of advice is, and you’ll love this as a pharmacist, is talk to your pharmacist. One of the easiest questions you can ask is the one that I asked which is: Is this the best price for my medicine? Is their generic or lower cost options? You know, there are so many ways to find cheaper medications now, as more of these cash systems are being introduced into the market.

Dr. Robert Popovian  10:10

You’re absolutely correct. And as patients, this is the thing that I would say to you Conner, we need to become better consumers of health care. We are patients, but we need to become also consumers just like the way we consume anything. We need to become better at it. And we need to ask questions. And my tip really is: if a patient is looking, the first thing they should do if they have a prescription in their hand, and it’s for generic, is to look up what that cash price would be if they went to Costco, or Walmart, or Amazon or ro.com, any of these pharmacies and figure that out first, before they go to the pharmacy and actually try to use their insurance to pay for that prescription. So that would be my ultimate tip, the same thing that I did with my daughter to say, before we go through this road of using our insurance to pay for the MRI, once you call around for a couple of other places, including the same place you were refered to and get the cash price for that MRI. So as patients we need to become better consumers.

Conner Mertens  11:09

I think that patients in America are forced to become better consumers because they’re living in such a convoluted and complex healthcare system. But you know, one of the other questions that I think that we like to address here is what if anything is being done about this legislatively or in government? I think that I saw something about the FTC, Federal Trade Commission, is stepping up and finally looking into these practices, these PBMs.

Dr. Robert Popovian  11:32

FTC is certainly looking into this. And this is a bipartisan effort by the FTC. All the commissioners voted in favor of looking at how does this impact out of pocket costs for patients for prescription drugs and some of the practices that the PBMs get involved in. But more importantly, just this week, it was announced that Centene, an insurer has settled with the state of Texas for over $100 million in fines because the state of Texas proved that Centene overcharged them for the prescriptions. Now, this is not the only settlement. Other states have settled as well with the same insurer. The state of Ohio did it I believe, last year or earlier this year. They settled on that. Multiple state lawsuits are going on. So there’s a trend here where insurers and the pharmacy benefit management companies that are hired by these insurance are being held accountable by the state governments. But you’re absolutely right. We need to be better consumers. And we need federal agencies like the FTC, to really take a closer look at some of these practices, because they are truly hurting patients. And Conner, you know, we need to make sure that this information gets conveyed back to our patients at the Global Healthy Living Foundation.

Conner Mertens  12:48

Well, as always, Robert, I want to make sure you get the last word in here, but when I think about our discussion, what it really boils down to is: Americans are paying way too much for generic drugs due to a payment system that is manipulated by pharmacy benefit managers. How did I do on that?

Dr. Robert Popovian  13:04

You are correct. It’s unfortunate that a promise of generics is being undermined by the pharmacy benefit management companies. And I would say Conner, we talk a lot here in this podcast about brand name drugs, rebates, why aren’t patients getting the benefit of rebates at the point of sale? We in fact talked about it in our last podcast, the truth is about the rebates, and this is something that we mentioned earlier on our podcast, is that rebates affect about 8% of the prescriptions. Those are brand name prescriptions, not a lot of people take those medicines. You know, we talked about how 92% of prescriptions in United States are generics that are filled. And in fact, that percentage is even higher if a generic is available for brand name drug. So to me whether or not patients get the benefit of the rebate contracted and the negotiated prices on the brand name medicines is important, and it impacts patients and we need to address that. And at GHLF, we are addressing that issue. But to me, the generic issue and the overpayment for generics by patients is far more nefarious. Because what this practice does is directly impact patients over paying out of pocket. And yes, the dollar amounts are not equal to the brand name drugs. The numbers are small. But because the volume is so high, there’s a bit more exposure to patients to overpay because of these type of practices for the generic medicines. And remember, all of us take generic medicines, not all of us take brand name medicines. So therefore, it is even more important for patients to be better consumers in that space. And as we said, we need to start taking charge and whenever we have a question, ask your pharmacist, or better yet, before you even walk to a pharmacy look up those cash prices. Those entities that we mentioned, Costco.com provides this free of charge on their website. You can go to Walmart, Amazon, any of those websites and get that information before you walk into a pharmacy and figure out what that payment would be if you use your insurance card.

Conner Mertens  15:09

Well, as always, Robert that was thorough. Thanks for breaking it down for us. I think there’s some very valuable information for our listeners. Don’t forget to subscribe to our podcast on Apple, Spotify or wherever you may be listening so you never miss an episode. And if you have a second, help spread the word by rating our podcast, writing a positive review and sharing with your friends and family and help more people like you find us.

Dr. Robert Popovian  15:30

You can also send us an email or an audio clip to [email protected]. Our producer Ben is always looking for those so we can improve the production of our podcasts. And guess what, he may decide to feature you in one of our upcoming episodes! And before we go, make sure you all also listen to some of our great other podcasts that are on the GHLF Podcast Network.

Conner Mertens  15:55

That’s a great point, Robert! We got a lot of really good podcasts in our network. Our friends and colleagues Steven Newmark and Zoe Rothblatt are back with season five of The Health Advocates! In the most recent episodes, you’ll get a full update on where we’re at with COVID, methotrexate access issues, as well as a great conversation about IBD. It’s a very informational podcast. So make sure to go and give them a listen. And remember, you can find all of GHLF’s podcasts at ghlf.org/listen. As always, he’s Dr. Robert Popovian.

Dr. Robert Popovian  16:25

And he’s Conner Mertens, the gentleman who talks to patients. We’ll see you all next time.

Narrator  16:31

Be inspired, supported and empowered. This is the global Healthy Living Foundation Podcast Network.

Narrator  00:00

Be inspired, supported, and empowered. This is the Global Healthy Living Foundation Podcast Network.

Conner Mertens  00:06

You’re listening to Healthcare Matters, the podcast that pulls back the curtain to help you make sense of complex healthcare economics and policy issues. With us, as always, is the incomparable Dr. Robert Popovian, joining us from our nation’s capital in Washington D.C. He’s a pharmacist, economist and the Chief Science Policy Officer at the Global Healthy Living Foundation.

Dr. Robert Popovian  00:30

And joining me is my good friend, Conner Mertens in Seattle, my co-host and our Patient Advocate and Community Outreach Manager and an individual who today is contemplating what life will be all about without having the MVP quarterback residing in Denver.

Conner Mertens  00:46

I’ve given up all hope on the Seahawks, we’re all in on the Mariners now! Denver can have him, they can have him, we’re moving on!

Dr. Robert Popovian  00:52

So we’re happy to be back for a third season Conner! There’s so much more we want to share with our audience, our patients, our advocates, our policymakers, everybody who listens to our podcast!

Conner Mertens  01:03

And thank you for listening to us over these past few seasons, and for all the supportive feedback. Now, let’s take a look at one of your comments. Henry writes: “you guys do such a great job helping people like me understand complicated healthcare issues. Thanks so much.” That’s what it’s all about, right Robert?

Dr. Robert Popovian  01:17

It’s always great to hear from our listeners. That’s without a doubt my favorite part of this podcast. So let’s get into our next episode. Conner, what if I told you the number 2,000? What does that mean to you?

Conner Mertens  01:29

Well, now that you got me thinking about the Mariners that was one of the last times we went to the playoffs.

Dr. Robert Popovian  01:34

True. That is a true case. And you know, you should be proud of that. However, today we’re talking about the Inflation Reduction Act, and the number 2,000 has a very special meaning.

Conner Mertens  01:50

So Robert, today we’re talking about the Inflation Reduction Act. Let’s get into it! What is this $2,000 you’re talking about? How does that relate to the Inflation Reduction Act?

Dr. Robert Popovian  01:58

So it’s actually really good news for our seniors, right. So the $2,000 is a cap that was instituted in the Medicare Part D program. So for the first time, our seniors are going to have a cap on out of pocket cost expenditures for their drugs. Before this, there was no cap, there was unlimited exposure. And the $2,000 is the maximum that they will be liable for annually for their expenditures out of pocket.

Conner Mertens  02:26

Well here, you know, we like to talk about the good parts, the bad parts, and the ugly parts, maybe the parts that could be better about health care policy and economics. So when it comes to the Inflation Reduction Act, it certainly sounds like there are some positive things for patients, but certainly some things that could be done better. This $2,000 cap, it sounds amazing for seniors, can you tell us more about why this specifically helps seniors?

Dr. Robert Popovian  02:48

It allows them to have certainty. Right before this, when there was no cap, seniors would have unlimited exposure for out of pocket costs for their drugs. So similarly to what we see in the commercial side, so the insurance plans that you and I have Conner, for the first time in the Medicare Part D program, seniors have certainty. They will not be spending any more than $2,000 per year for their prescription drugs out of pocket.

Conner Mertens  03:13

Which you know, $2,000 still is nothing to shake our head at. That’s certainly a burden financially for a lot of folks. But this is definitely, like you said, a step in the right direction and finally some certainty about what seniors can expect in their health care benefits. What else can we say that the IRA has done that’s really helping folks?

Dr. Robert Popovian  03:32

Well, for the immediate future, starting next year, seniors will not have any out of pocket costs for any of the vaccines that they receive through the Medicare Part D program. That is significant! We know when seniors have an out of pocket cost for the vaccines, there’s a great deal of abandonment at the pharmacy level. So when they show up to the pharmacy to get their vaccines, and if there’s an out of pocket cost associated with it, the seniors generally walk away. So having this law pass and now they have zero exposure to out of pocket costs for their vaccines. This is super important, because as you well know, not only vaccines are the most cost beneficial intervention in the healthcare system, but they’re very important for our elderly. Because, as we’ve seen in the COVID pandemic, they were the ones that were most affected, and the ones that the vaccine helped the most.

Conner Mertens  04:21

And just to mention that it was disproportionately affecting, you know, ethnic and racial minorities and folks from low income communities. So these changes in Medicare Part D for vaccines can be, you know, save some lives, genuinely save some lives!

Dr. Robert Popovian  04:23

That is true.

Conner Mertens  04:37

Robert, a lot of the legislation packed into the bill, this Inflation Reduction Act, are themes that we’ve discussed before. Themes about transparency and passing along savings to patients. Can you tell us what this bill could do better?

Dr. Robert Popovian  04:50

So that’s a good question, right? Just like any other legislation, there’s the good, the bad and the ugly of it. So the bad and the ugly parts are really that patients are still not going to get the savings procured on their behalf by the PBMs at the point of sale, so when they show up to a pharmacy and they have a co-insurance or deductible, they will still have to pay those co-insurance or deductible based on the retail price of the medicine instead of the negotiated price that has been done on their behalf by the Pharmacy Benefit Management company. In fact, the federal government through this legislation had the opportunity to address this and they did not do so. And that’s one of the biggest problems that I foresee that they didn’t address. In addition, I would say the other disturbing part is that, as you well know, Conner, and the Global Healthy Living Foundation has done a study on this and we published it in the Health Science Journal. Annually, the number of drugs being excluded from national formularies has been increasing. And this was an opportunity for the federal government to address this issue. We know that a lot of times these exclusions are okay, you know, because their brand name is being excluded compared to a comparable generic. But in 50% of the cases, these exclusions are either therapeutic substitutions or in some cases, exclusions involve a generic medicine, which is substantially cheaper in favor of a brand drug. And that’s where the seniors are going to get hurt. Because at the end of the day, as we discussed, they’re still being exposed to the retail price of the medicines, and not the negotiated price. And therefore, if a Pharmacy Benefit Management company decides to exclude the generic in favor of a brand, when a patient shows up to the pharmacy, and they have a co-insurance or deductible, they have to pay it based on the full retail price.

Conner Mertens  06:43

So currently there are hundreds of these medications that are excluded from national PBM formularies. Is there any sort of clinical or economic justification for it? Or is this just all trying to line some pockets?

Dr. Robert Popovian  06:55

So that’s a great question, Conner. Our study that we published through the Global Healthy Living Foundation demonstrated that, as I’ve mentioned, 50% of the time, it’s actually justified from both an economic and a clinical perspective. 50% of the time, formularies are excluding drugs, such as a brand name drug that has an equivalent generic in the marketplace, which is substantially cheaper. So it makes absolute sense. But it’s the other 50% that is problematic, because the other 50% involves excluding drugs that don’t have a generic equivalent. So sort of like they depend on a different molecule that they assume will have the same efficacy and safety profile for the patient. In other words, they’re playing doctor through formularies because they’re forcing physicians to make clinical judgments that may not be the best choice for the patient. But in addition, there are cases as I mentioned, that formularies exclude generic medicines, which is again, substantially cheaper in favor of brand name medicines. And the sole purpose of that is to line the pockets of the PBMs by covering higher priced, higher rebated drugs. And this is the unfortunate part about the Inflation Reduction Act. We had an opportunity to address this issue legislatively and codify it into law and make sure that this does not happen. And this was a miss, frankly.

Conner Mertens  08:15

So clearly, we could say that they could have done a little bit better there. Were there any pieces of this that stood out to you as just being plain bad policy?

Dr. Robert Popovian  08:23

So yes, and it has to do with impact on innovation. So the Congressional Budget Office put out a report before the passage of the bill and the signage of the bill that, in fact, about 15 fewer drugs will be introduced into the market over the next 30 years because of the passage of this law. So a bipartisan group of analysts, which Congress depends upon, came up with this number. It’s not a partisan issue. It’s not a Republican or a Democrat number. Now, there are private entities that have done similar analysis using different assumptions. Because remember, Conner, these are all based on assumptions, correct. And they’ve done the analysis to show that up to 60 drugs may not be introduced in the marketplace in the next 30 years. But the question is this: which drugs are not going to get introduced? And my fear is that the more uncertain disease areas, where there’s less certainty about the research, are the ones that pharma companies are going to be pulling back from. So disease areas such as Alzheimer’s, where we haven’t had any effective therapies, disease areas that are not as well reimbursed are going to be the ones that are pulled back from. So that’s the fear. It’s not necessarily that the numbers are going to be exactly right. Whether it’s 15 or 60. We don’t know. We know it’s going to be impacted. But the bigger question is, which classes of medicines which disease areas are going to be impacted? And in my opinion, what’s going to happen is that the pharmaceutical industry is going to pull back in areas of research that are less certain, such as Alzheimer’s.

Conner Mertens  09:58

Alright, Robert, well you get your red marker. What’s something that you wish this bill did and was missing out on?

Dr. Robert Popovian  10:05

What I wished the bill did, and going back to our part that was missing is 1. address the issue of formulary exclusions, and number 2. to have patients benefit from the negotiated prices at the point of sale at the pharmacy. This is unbelievably unfair for patients. And this happens both in Medicare and the commercial insurance companies, with commercial plans. When you and I show up to a physician’s office, or an optometrist or a dentist or a hospital, even when we have a co-insurance or a deductible, we pay those based on a negotiated price that’s been done on our behalf by the insurance company. In case of pharmaceuticals, which is the only entity in the healthcare system, patients do not benefit from those negotiations. So when you and I show up to the pharmacy counter, and we have a deductible or co-insurance whether we are Medicare patient or a privately insured patient, we end up paying based on the full retail price of that drug, which as you and I have discussed in the past, is extremely inflated, because all of the kickbacks and the rebates and the fees that have to go back into the system. Remember, on average 50% of every dollar sold for pharmaceuticals in the US, 50%, so 50 cents out of every dollar, goes back to the supply chain, primarily to the Pharmacy Benefit Management companies and insurers. And they hoard that money instead of passing it back to the patient at the point of sale. And that’s what I would have changed. Those two issues, which is formulary exclusions and the issue of not passing the savings at the point of sale to the patient are supremely important.

Conner Mertens  11:52

And even outside of the Inflation Reduction Act. These are policies that we’ve been preaching for years, you know. And so I truly think it’s what you said, we really missed an opportunity but unfortunately, with the way and speed that federal legislation moves around health care, I almost feel kind of a take what I can get mentality.

Dr. Robert Popovian  12:11

That is not a bad mentality to have. And in fact, our producer Ben mentioned it to me something that is, look, there are some good stuff in here. And absolutely, he’s correct. Zeroing out the out-of-pocket costs for vaccines for seniors, extremely important; Capping out-of-pocket costs at $2,000, extremely important! Those are two huge wins for patients. Patients who are burdened with out-of-pocket costs, and are unable to pay for them. Were there misses? Absolutely. Are there ugly parts of this legislation? Without a doubt. But as Ben always mentions to me, don’t forget the good stuff. So Conner, you and I have to always remember the good stuff and talk about it.

Conner Mertens  12:54

You know, we just like to break it down for our patients. And like you said, whether it’s good, bad or ugly, we want to make sure that you all are informed. Well, Robert, today I kind of figured out something that is very thematic with any legislation is that we kind of take the good with the bad, that’s never black and white, that we could always do better. And unfortunately, the one constant is that we’re coming up short for patients. But as always, I want to make sure you get the last word. This isn’t changing from the first two seasons.

Dr. Robert Popovian  13:22

Conner everything in healthcare comes with the good and the bad. But at the end of the day, at the Global Healthy Living Foundation, and the work you do especially, because you work with patients every day, is for us to support patients. And as long as our North Star is the patient, and the benefits that the patient can get, whether it’s short term, medium, or long term, then that’s a win for us. With this legislation there are absolute wins for patients, but there are absolute misses as well. So what we need to do as an organization, what you need to do as an individual who communicates with patients every day, is to constantly go back and make sure those misses are addressed in future legislative efforts, whether it’s in the federal level, or in the state level. And that’s the message that we need to carry.

Conner Mertens  14:15

As always, thanks for breaking that down for us, Robert. I think that was some very valuable information for our listeners and very topical. Don’t forget to subscribe to our podcast on Apple, Spotify, or wherever you might be listening so you never miss an episode. And if you have a second, help spread the word by rating our podcast, writing a positive review and sharing with your friends and family. It’ll help more people, like you, find us.

Dr. Robert Popovian  14:37

And Conner speaking of our listeners, you can also send us an email or audio clip to [email protected] and you might be featured in one of our upcoming episodes. And before you go, make sure you take a listen to some of our other great podcasts on the GHLF Podcast Network.

Conner Mertens  14:56

Yeah, that’s a good point, Robert. Right now, I’m listening to Talking Head Pain with host Joe Coe and it’s one of my must-listens. As a migraine patient and advocate himself, Joe does a fantastic job sharing what living with migraine is really all about. You can find all of GHLF’s podcasts at ghlf.org/listen. As always, he’s Dr. Robert Popovian.

Dr. Robert Popovian  15:16

And he’s Conner Mertens, the individual who talks to the patients actually in our organization. We’ll see you all next time.

Narrator  15:24

Be inspired, supported and empowered. This is the Global Healthy Living Foundation Podcast Network.

Narrator  00:00

Be inspired, supported, and empowered. This is the Global Healthy Living Foundation Podcast Network.

Robert Popovian  00:10

Patients in low income communities, especially seniors living in low income communities, deserve better access to healthcare.

Conner Mertens  00:21

Welcome back to Healthcare Matters, the podcast that pulls back the curtain to help you make sense of complex healthcare economics and policy issues. As always, I’m joined by Dr. Robert Popovian in Washington DC. He’s a Pharmacist and Economist and Chief Science Policy Officer with the Global Healthy Living Foundation.

Robert Popovian  00:38

And across the country in Seattle, Washington, he’s my good friend, Conner Mertens, Patient Advocate and Community Outreach Manager at the Global Healthy Living Foundation and the number one resource patients have when they have questions about their access issues that they can reach out to.

Conner Mertens  00:52

Robert, can you believe it? We’re coming to the end of season two of Healthcare Matters. We have covered a lot of ground and a lot of topics.

Robert Popovian  00:59

Yeah, we were newbies last year. And I have to say Conner, our audience has been very generous with us and have listened and followed us and has provided us a lot of good feedback. And hopefully we’ve improved our podcast over this period of time. Before we get started, Conner is going to share with us some of the other great podcasts that are on the Global Healthy Living Foundation Podcast Network, as well as some audience feedback.

Conner Mertens  01:24

First, you’re gonna want to check out Getting Clear On Psoriasis with David Brandt. It’s a podcast series about what it takes to live better with psoriasis, from the experts who treat it and the patients who live with it. We have a ton of great podcasts and you can find them all at ghlf.org/listen. Alright, let’s take a look at a comment from one of our listeners. David writes, “I think the way Conner and Robert interact is terrific. Well done.” I guess Robert’s alright.

Robert Popovian  01:47

Well, I have to say, we’ve gotten used to each other like married couple. So it takes a while but wrapping up season two, it seems like we’re in a good cadence.

Conner Mertens  01:55

And thanks for your review. We invite you too, to go to Apple Podcasts and write a positive review and one of those honest five star ratings. We know how honest you are. And wherever you’re listening, Apple, Spotify or the rest, click that subscribe button so you’ll never miss an episode. So Robert, this week, we’ll be chatting about a study that you were one of the researchers on. We learned that based on the results, lower income families had greater access to pharmacies than physician practices, which indicates that pharmacies can play a really valuable role in expanding immunization access and other access. But I think that’s the start of a larger conversation about accessibility in healthcare in lower income communities. You worked on this, Robert, tell us what you think what stood out to you as most compelling from this research.

Robert Popovian  02:37

I’ve always been interested in the topic of equity in healthcare. One area that most often gets overlooked is access to healthcare in low income communities. So this was a way for me to really investigate, where do we stand for patients that really are struggling for access to healthcare.

Conner Mertens  02:55

And, Robert, when we’re talking about this idea of access, what does that kind of mean? And how do we improve that access?

Robert Popovian  03:00

Remember, low income patients have access issues to start with. They’re further away from quality hospitals, further away from quality healthcare. And pharmacies can be a hub for them to be able to access that type of care without having to travel miles away to get that same attention. The other important thing is that they are hourly wage earners with multiple jobs that really makes it difficult for them to access care on typical workday hours. These patients may not only value but prefer access during lunch hours, after work, and on weekends more than they value during access during the typical workday

Conner Mertens  03:37

That speaks the idea that there is no such thing as a nine to five sickness. I remember growing up with four boys in my house, we had a few many after hours trips to the clinic, to the ER when somebody got punted off the couch and needed some stitches. The costs were high to access these clinics.

Robert Popovian  03:55

Well Conner, boys will be boys, but I have two girls. And our typical routine on weekends when they were growing up and they were very much younger was that the ear pain and the earache started usually around 5:30-6pm on a Saturday, where there was no access to a pediatrician, no access to a physician’s office, or an urgent care center. And that’s why we ended up in the emergency room. We need better methods of getting patient care without having to step into a hospital setting as the only choice that patients have.

Conner Mertens  04:28

Yeah, like we said, sicknesses and earaches and infections they don’t have the nine to five Monday through Friday. So we need to talk about that ability to access these emergency services or even preventative services like you started to get into which is immunization or specialists, rheumatologists. How do we improve that access?

Robert Popovian  04:46

One of the simplest way is to make sure that all healthcare professionals are practicing at the top of their license. That means providing the care that they’ve been trained for. Unfortunately, in the United States that’s not what we see every day. Partially, that has to do with licensure issues. There’s concerns about interstate license provisions with regards to physicians, pharmacists, and nurses and therapists and so on. And the second part is because we have this model that the patient has to literally walk in to a hospital setting or a clinic or physician’s office for that individual to make money, they’re very protective of having to have that patient coming in to get their service at that site. Instead, we need to have a different payment model that provides payments to physicians, nurses, pharmacists, hospitals, to keep patients out of those settings, and provide them the care that they have the best access to without having to go through all the hoops.

Conner Mertens  05:41

Does insurance equate access?

Robert Popovian  05:43

Not really, no, it doesn’t. And that’s a fallacy that has been propagated for many decades in United States, that if you provide insurance to patients, all of a sudden access improves, that’s not the same. You need to have insurance because you need to have coverage for patients to be able to afford payment for health care services. But at the same time, if you don’t improve the access side, which is allow patients to access health care in variety of setting and variety of different times, like we’ve discussed, you’re basically defeating the whole expansion of insurance as a model. And there’s data that supports that. In fact, in the state of Oregon, they did a study right after the Affordable Care Act was passed. And Oregon was one of the first states that expanded Medicaid. And the assumption was, as we expand Medicaid and provide insurance coverage for all of these uninsured patients, these patients instead of ending up in the emergency room, they will go and get their care in physician offices and so on and so forth. Because you know, as they go to the hospital, the care is free, and they don’t get charged for it. So that was the assumption. What they found out is that in fact, with the expansion of Medicaid, not only the emergency room visits didn’t decrease, they actually increased now that patients had insurance. Why? Because again, you didn’t address the access issue. Remember, who was being expanded on Medicaid? It was mostly poor, low income individuals who couldn’t afford insurance, and now they had access to insurance. These are the same individuals that are hourly wage earners. And they just don’t have the capacity to go and visit with a physician during normal workday hours. So they ended up again going to the emergency room. So they’re not the same. Insurance and access are two different issues. And we need to address both if we want to provide better patient care.

Conner Mertens  07:30

What does it look like in practice for expanding access? Does it mean allowing pharmacists to do sutures, to do stitches? What does it look like for a patient day to day, a change in access?

Robert Popovian  07:42

Pharmacists, physicians and nurses need to work collaboratively to be able to provide patient care and each one has a skill set that is very unique, and they need to be maximized. So physicians to me are the best diagnosticians. They should be the ones that diagnose the patient. I don’t think any other healthcare professional actually trained or is able to diagnose as well as a physician does ailments. Nurses instead are trained extremely well in managing chronic care. So somebody has diabetes or hypertension, and they require management over long periods of time, they’re probably best suited. Pharmacists, on the other hand, are best suited to managing drug therapy. And this is the thing that falls apart because they are not provided the tools to be able to really manage patients drug therapies, and also not provided the financial incentives to do so. I think each entity within the healthcare professional ecosystem has a very valuable skill set. Unfortunately, we’re not maximizing that skill set.

Conner Mertens  08:43

Robert, let’s get back to that study. What was most surprising to you about your findings?

Robert Popovian  08:47

What stood out for me is that two states, New York and Pennsylvania, had far better access to pharmacies than physician offices for patients in low income communities. Also have the most restrictive laws that do not allow pharmacists to administer immunizations for adult patients as other states do. I truly believe that these parties out there that are against the expansion of the authority are doing a great disservice to their patients and undermining equitable access to vaccines in our most vulnerable populations.

Conner Mertens  09:20

Well, I’ll tell you what, Robert, I think that the biggest part of this is we just need to find ways to make health care more accessible. And at the end of the day, that’s always been foundational to the work that we do at the Global Healthy Living Foundation, is how do we make healthcare better and more accessible for folks living with chronic diseases or just the general healthcare system? We need to figure out where are folks slipping between the cracks and how do we fill those cracks. For two seasons, we’ve made sure you get the last word and that’s not changing today, buddy. What do you think folks should take away from your research?

Robert Popovian  09:49

Patients in low income communities, especially seniors living in low income communities, deserve better access to health care. In the United States, we have an under vaccination conundrum for adult patients. Implementing policies by federal and state governments that expand pharmacies or pharmacists ability to provide more health care services could help increase vaccination access to such patients. These policies including granting pharmacists nationwide authority, similar to their physician colleagues, to administer all vaccines approved or authorized by the Food and Drug Administration and vaccines recommended by the Advisory Committee on Immunization Practices, is going to be key for us to improve their care.

Conner Mertens  10:33

With that, season two is a wrap. I really, really appreciate the last two seasons we’ve had with you, Robert. I’ve learned way too much. My head hurts almost every time we’re done talking, but hopefully did a service for patients and broke down some of these really complex topics and made it a little more digestible.

Robert Popovian  10:48

And I have to tell you, Conner, you’ve been a terrific partner. Your work is what I considered the most important part of what the Global Healthy Living Foundation does everyday, which is communicate with our patients and help them out to navigate this complex healthcare system that we currently live under.

Conner Mertens  11:04

Thanks for sticking with us these last two seasons. And thanks for listening to Healthcare Matters, a podcast that pulls back the curtain helping you make sense of complex healthcare economics and policy issues. As always, we invite you to go to Apple Podcasts and leave one of those honest, five star ratings and a positive review. It’ll help more people like you find us and wherever you’re listening, Apple, Spotify or the rest make sure to click that subscribe button so you never miss an episode. Last time this season, he’s Dr. Robert Popovian.

Robert Popovian  11:31

And he’s Conner Mertens. We’ll see you next season.

Narrator  11:35

Be inspired, supported, and empowered. This is the Global Healthy Living Foundation Podcast Network.

Narrator  00:00

Be inspired, supported, and empowered. This is the Global Healthy Living Foundation Podcast Network.

Robert Popovian  00:08

Biosimilars are drugs that are safe, effective, less expensive. Patients are saving money and the system is saving money. So what we need to do is introduce policies in the marketplace that really enhance adoption of biosimilars.

Conner Mertens  00:23

Welcome back to Healthcare Matters, the podcast that pulls back the curtain to help you make sense of complex healthcare economics and policy issues. As always, I’m joined by Dr. Robert Popovian from Washington, DC. He’s a pharmacist, he’s an economist, and he’s Chief Science Policy Officer at the Global Healthy Living Foundation,

Robert Popovian  00:41

And across the country in Seattle, Washington, he’s Connor Mertens, Patient Advocate and Community Outreach Manager at the Global Healthy Living Foundation. And I would be remissed to say, congratulations Conner. Sounders beat the Pumas for CONCACAF Champions League.

Sports Announcer  00:59

Long awaited Champions League nirvana.

Robert Popovian  01:07

Kudos, I mean first MLS team to win the Champions League.

Conner Mertens  01:11

Immortality, that’s what we’re seeing here in Seattle. It’s exciting time. Well, we received plenty of feedback from our last episode of why are drugs so expensive for seniors.

Robert Popovian  01:22

And two of our listeners blamed it on what they call the greed in the pharmaceutical industry. And they blame both the pharmaceutical companies and the pharmacy benefit management companies in creating an environment that really hurts seniors.

Conner Mertens  01:36

And as we know, that’s only part of the full story. So if you missed that episode, make sure to check it out. Thanks for your comments. We invite you to go to Apple Podcasts and write a positive review and leave one of those honest five star ratings. And wherever you’re listening, whether it’s Apple or Spotify or the rest, make sure you click that subscribe button so you’ll never miss an episode.

Robert Popovian  01:55

So Conner, let’s get into this week’s episode and it’s a topic that is very dear and near to my heart and I know it’s near and dear to your heart because you’ve done a lot of work in this space and it’s biosimilars.

Conner Mertens  02:07

Well Robert, as you know here at GHLF we really like our biosimilars, we like to talk about them. In fact, folks who go check out Breaking Down Biosimilars. I know one of the hosts, he’s pretty knowledgeable on the subject, it’s me, along with my co-host, Zoe Rothblatt. We break down everything you need to know about biosimilars. But today, we’re gonna chat and maybe condense a whole series and do an episode and see where we go. So on that note, Robert, what is a biosimilar?

Robert Popovian  02:32

So a biosimilar is a generic version of a branded biologic that has been developed by various pharmaceutical companies. And it has been approved by the Food and Drug Administration to be equally as safe, effective, and patients can use these medicines instead of the brand biologics. And what we’ve seen in the marketplace is that there’s been a great deal of uptake with these medicines.

Conner Mertens  02:58

Let’s pause there, I think, little more definitions might be necessary. What is a biologic? I mean, what’s a generic biologic? What are those two words mean together?

Robert Popovian  03:07

Unlike small molecules that are synthesized in a laboratory and are developed in a test tube almost, biologics come from live organisms, and it’s the process that is very important, because what ends up being is that the process creates the biologic medicine. And a biosimilar, as we explained, is a generic version of that biologic drug.

Conner Mertens  03:31

So overall, biosimilars are a great thing because they offer more options for patients. What do you think is the biggest reason folks would rather use a biosimilar rather than a biologic?

Robert Popovian  03:43

It gives them more options, but the most important reason that they will use a biosimilar versus a originator biologic, or brand biologic, is because they’re less expensive. And we are at a place in our healthcare system that patients are suffering because of outrageous out of pocket costs instituted because of poor benefit designed by pharmacy benefit management companies. And we need the tools to be able to reduce that out of pocket costs. And one way to do so is through the utilization of lower priced alternatives. And the biosimilars are lower priced alternative to the brand biologics.

Conner Mertens  04:20

We’re not really seeing much usage of biosimilars in US markets. But we are seeing it internationally. Why is that?

Robert Popovian  04:28

The European market had about a 10 year head start to the US market with regards to introduction of biosimilars. And frankly, we didn’t get serious about biosimilar until the Affordable Care Act came into place and part of the Affordable Care Act was to pass the Biologics Price Competition and Innovations Act, otherwise known as BPCIA. And that sort of paved the way for biosimilars to become a reality in the US market. In essence, the biosimilar market didn’t start in the US as the first biosimilar was introduced in 2015-2016 timeframe. And since then what we’ve seen is that there’s been a great deal of uptake in certain biosimilars, but not all of them. However, it is important to note that the market is moving forward and we are seeing better penetration every day.

Conner Mertens  05:25

One thing that I find interesting is that each state has different laws about how biosimilars can be substituted for their reference biologic if a prescription comes into a pharmacy, what should folks do if they have concerns about that?

Robert Popovian  05:38

What I will tell patients is that the Food and Drug Administration has approved biosimilars and has found biosimilars to be of equal safety, efficacy, and purity. What the state laws do is that it allows pharmacists to substitute a biosimilar for a brand biologic, and it allows the pharmacist to substitute without having to inform the healthcare professional that has prescribed it, if the biosimilar has been designated as as interchangeable. Even if the biosimilar is not interchangeable, or it had does not have the designation of interchangeability, the pharmacist may still substitute, the only thing they have to do is to call the physician and get authorization or the provider authorization in advance. In either case, whether it is a biosimilar that is substituting the brand biologic or generic medicine that is substituting a brand medicine, the patients have to be informed by the pharmacist when that takes place.

Conner Mertens  06:38

A question that I remember that stuck out to me from our production during Breaking Down Biosimilars was from one of our patient advocates Kerry, who was asking, if the efficacy is still there, the effectiveness is all there, why are they so much cheaper?

Robert Popovian  06:53

They’re cheaper because of the way that they’ve been developed regarding the process within the FDA. This process is less cumbersome, and therefore, pharma companies were able to bring these medicines out much quicker and with less cost. Therefore they’re priced at a much lower level than the brand biologics. The question is, how do patients save money? Because that’s what’s important for patients is how much they are paying out of pocket. What we’ve seen since the introduction of biosimilars in the market is two things. Number one, we’ve seen a price reduction of the brand biologics, so even the presence of a biosimilar forces brand biologics to reduce their prices. We’ve also seen that as multiple biosimilars come into the market for the same product, there’s also price reduction into biosimilars. So market competition does in fact work. So how does patient benefit from that? When a patient has a deductible or co-insurance, which is based on the price of a drug, they will end up paying less for biosimilar because it is lower priced than a brand biologic, because it’s a percentage of that medicines price based on co-insurance or the deductible is the full retail price. So anytime there’s a lower cost alternative, like biosimilar patients will save money.

Conner Mertens  08:16

Can we chalk this slow process of getting biosimilars into the US market up to classic red tape? Or are there arguments, are there folks that are against these entering the market?

Robert Popovian  08:28

Well, there’s been several barriers that have been erected for the biosimilar adoption in the US market. First and foremost has been the rebate contracting issue. Pharmacy benefit management companies prefer higher priced higher rebated drugs because they keep a percentage of that rebate, and all of the fees that are associated with rebate contracting. The second barrier is this misrepresentation by certain parties that competition doesn’t work. And that in fact, why are we introducing products in the market where we know that they’re not going to lower prices. We now have evidence that biosimilars are saving quite a bit of money. In 2020 biosimilars saved $7.9 billion, more than triple the 2.5 billion that they had saved in 2019. Meanwhile, biosimilars have created about $238 million, on average in annual out of pocket cost savings for patients. These are significant issues. The final barrier is really a regulatory malaise. The Food and Drug Administration has not done a good job of expediting and interpreting policies that will help bring these products quickly into the marketplace. Also, they’ve misinterpreted certain things or created barriers falsely. Like for example, FDA adopted the final policy that the strength of an injectable biologic product is based on both the total content of the drug substance and the concentration of the drug substance. The FDA changed the regulatory rules regarding biosimilar strength versus potency which created a lot of chaos in the marketplace. Most clinicians like myself will say that yes in certain therapeutic classes or certain medicines concentration is important. But in this case with biosimilars concentration is irrelevant.

Conner Mertens  10:14

Here’s what I know, biosimilars are safe and effective, they drive down costs for patients. They’ve been successful domestically and abroad. And we should be doing a lot more to invest in these and make sure that they’re introduced into the market. But as always, Robert, I want to make sure you get the last word. What’s in the future for biosimilars?

Robert Popovian  10:33

Conner, I couldn’t have said it better and you really brought all the points I was going to make, which is these are drugs that are safe, effective, less expensive, patients are saving money and the system is saving money. So what we need to do is introduce policies in the marketplace that really enhance adoption of biosimilars. Whether it is to call out practices such as rebate contracting that creates barriers or to ensure that the Food and Drug Administration is really on the ball and is able to provide regulatory guidance and also doesn’t misinterpret information that is going to create barriers for introduction of biosimilars. We are seeing a very successful market growing, and at the end of the day, patients are saving money. And we need to continuously support that because that’s what we’re about at Global Healthy Living Foundation. Unless a patient is saving money, then what is the point of doing these things?

Conner Mertens  11:35

I mean, as always, Robert, you hit it right on the head. Thanks for breaking that down for us. I think folks are really going to take something away from this episode.

Robert Popovian  11:41

We would love to hear from you. Please send your email or an audio clip to [email protected]

Conner Mertens  11:50

And thanks for listening to Healthcare Matters, the podcast that pulls back the curtain to help you make sense of complex healthcare economics and policy issues. We always invite you to go to Apple Podcasts and leave an honest five star rating and write a positive review. It’ll help people like you find people like us. And wherever you’re listening, whether it’s Apple, Spotify or the rest, make sure to click that subscribe button so you’ll never miss an episode. As always, he’s Dr. Robert Popovian.

Robert Popovian  12:15

And he’s Conner Mertens.

Conner Mertens  12:17

Always go Sounders, baby. We’ll see you next time.

Narrator  12:23

Be inspired, supported, and empowered. This is the Global Healthy Living Foundation Podcast Network.

Narrator  00:00

Be inspired, supported, and empowered. This is the Global Healthy Living Foundation Podcast Network.

Robert Popovian  00:09

We tend to cover everything cheap, which is basically the generic medicines and everything else. And when patients require more expensive drugs, brand name drugs, or biologics, and so on and so forth, the coverage becomes less and less. That means they’re exposed to those prices more and more, which makes absolutely no sense because it goes against the premise of what insurance should be.

Conner Mertens  00:34

Welcome back to Healthcare Matters, the podcast that pulls back the curtain to help you make sense of complex healthcare economics and policy issues. As always, I’m joined by my partner in crime, Dr. Robert Popovian, joining us from our nation’s capitol. He’s a Pharmacist, Economist, and the Chief Science Policy Officer at Global Healthy Living Foundation,

Robert Popovian  00:53

And across the country in Seattle, Washington, he’s Conner Mertens, Patient Advocate and Community Outreach Manager at the Global Healthy Living Foundation. And the individual who has been tasked with finding the next starting quarterback for the Seattle Seahawks.

Conner Mertens  01:08

I think I got a better shot bringing down drug prices than finding a good quarterback for us at this point. But as we get into season two of this podcast, we’ve been covering even more ground on what you need to know about healthcare economics and policies.

Robert Popovian  01:23

But before we get started, as always, we want to be sure for you to take a listen to the other great podcasts on the GHLF Podcast Network.

Conner Mertens  01:32

And right now, Talking Head Pain with Joe Coe is a must listen. As a migraine patient and advocate himself, Joe truly brings to light what living with migraine is really all about. And you can find all these podcasts at ghlf.org/listen. Alright, let’s take a look at one of the comments from our listeners. Laura says that, “Healthcare Matters Part One and Part Two of non-medical switching made it easy to focus and learn about the topic. They do a good job defining complex topics.”

Robert Popovian  01:59

We appreciate the comment, Laura. And you know, this is why we do this podcast is to help patients understand and humanize the entire policy and economics issues that we continuously face as either patient, healthcare providers, or as consumers of the healthcare system. Thank you, Laura. And please keep the comments coming.

Conner Mertens  02:20

We invite you too, to go to Apple Podcasts and write a positive review and leave an honest five star rating. And wherever you’re listening, Apple, Spotify or the rest, click that subscribe button so you’ll never miss an episode. Well, Robert, we were going to talk about international versus domestic US pricing of drugs, but while we were talking off air with our producer, they brought up something that I think is very important, and something that a lot of folks deal with in their day to day and actually is very related to drug pricing. What did our producer, Ted, tell us, Robert?

Robert Popovian  02:52

Well, Ted was very interesting, because we were talking about doing a segment, as you said on international versus domestic drug prices, and we will do this in the future episode, but he brought up the conundrum that his parents are in. Mary, his mother, basically pays $200 every month for a single pill to be taken for a heart disease that she has. And Ted was very genuinely concerned and was asking us specifically, why are patients paying so much out of pocket, especially patients who are on Medicare and fixed income and cannot afford these pills? And these are life savings medicines that they need to take on a regular basis.

Conner Mertens  03:33

Well, let’s get into it. I don’t want to ask too broad of a question, Robert, but why are they paying so much for medications on a fixed income and supposedly supposed to be given concessions?

Robert Popovian  03:43

There are several reasons. Let’s start with benefit design, which is very unique in the Medicare program. And in this case, it forces patients at some part of their plan year to be in a doughnut hole. And oftentimes that doughnut hole requires them to pay the full cost of the medicine. So first and foremost, it’s a benefit design issue, which is very unique to Medicare that you oftentimes don’t see in insurance plans that are provided to employers.

Conner Mertens  04:12

I mean, everyone knows kind of the the Medicare Part A, B, C, what do those all have to do with this?

Robert Popovian  04:16

Medicare Part A really provides hospital services. They cover the hospital costs incurred by the Medicare patient. Part B is designed to provide outpatient services. Like this is when a patient will visit their physician or the physician assistant or nurse practitioner, and that’s what’s covered to Part B. Part D Medicare is the prescription drug coverage and it’s the newest part of Medicare that was implemented in the mid 2000s. And this is the part that really is very different than what you see in typical insurance design models where patients go in and out of a what we call a deductible phase where they are fully exposed to the cost of the medicine. And, frankly, Conner, this issue has to be addressed. It’s a bipartisan supported initiative to address this issue. Unfortunately, it was added as part of the Built Back Better initiative that President Biden and the Democrats introduced. And because that legislation had so many other issues, it did not go through the Senate, although it did pass the House. And what we need to do is revisit this in the Senate level and make sure that we fix the benefit design, which is very unique to the Medicare benefit. Another thing that I think is interesting about Medicare, Medicaid, is what is the relationship that they have with copay cards or patient assistance program? Patient assistance programs, provided by the biopharmaceutical industry, are forbidden to be provided to any kind of Medicare or Medicaid recipient, which interestingly makes very little sense. Because if anything, those are the patients that are the higher consumers of medicines that are sicker and generally need the patient assistance programs, rather than the employer population, population that gets their health insurance through the employers, or they buy it individually in the marketplace. That is forbidden by the federal government because of an Anti-Kickback Statute. And this is something that Congress needs to address regarding patient assistance program that is not available to these patients.

Conner Mertens  06:26

So the discussion we’re kind of having right now is federally speaking, right? Are different rules and regulations at the state level that that can be kind of modeled after?

Robert Popovian  06:34

Not really because most of the program is geared towards to CMS on the federal level. So Medicare is definitely a federal program. Medicaid is a state program, but is really governed to Center for Medicare and Medicaid Services, CMS, and really those rules are the ones that prohibit these patient assistance programs that are provided by by pharmaceutical industry to go directly to the patient. But Conner, it goes beyond that. When you start peeling the onion, on how coverage for pharmaceuticals is versus hospital services or physician services, you’d notice that we are woefully wrong in the way we’ve designed benefits in the biopharmaceutical space, and comparatively to the hospital services or physician services. The best way to put it in a layman’s term is that in the pharmaceutical space, regarding benefit design, is that we tend to cover everything cheap, which is basically your generic medicines and everything else. And when patients require more expensive drugs, brand name drugs, or biologics, and so on and so forth, the coverage becomes less and less. That means they’re exposed to those prices more and more, which makes absolutely no sense because it goes against the premise of what insurance should be. Insurance is typically to protect patients against therapies or interventions or needs that are less frequent. And instead, what we’ve done in the biopharmaceutical space, is that we cover inexpensive generics, which most people take, but we expose patients when it comes down to brand name medicines or biologics or anything that is very expensive.

Conner Mertens  08:23

So Robert, I think that kind of starts to explain why Mary’s paying so much out of pocket.

Robert Popovian  08:29

Exactly. Most likely, like you and I, Conner, when we take a generic medicine and we go through our insurance companies, we pay very little. And then when we need these brand name medicines, which very few people do because again, only 10% of the prescriptions filled in the retail space, in the pharmacy space, are brand name medicines. Patients are fully exposed to the cost of those drugs.

Conner Mertens  08:52

Robert, at this point, it kind of seems like those that are most in need are having to pay the most. And I think that those who are paying the most price in more than one way are folks living with chronic disease and the elder population. What can we do to see this change? Is there anything on the books? Are we working on any federal legislation in the moment?

Robert Popovian  09:10

Not at the moment. We try. And you’re absolutely right, people like Mary are exposed to higher prices for a variety of reasons as benefit design that we discussed. But we also have an issue with regards to these brand name medicines that biopharmaceuticals put out in the market. They generally go through a very convoluted and opaque contracting mechanism with these pharmacy benefit management companies and insurers. What the biopharmaceutical companies do is that they provide significant concessions in form of rebates, discounts, fees, and everything else that goes through these pharmacy benefit management companies and insurers. And unfortunately, none of that trickles back to the consumer at the point of sale. That means Mary when she shows up at pharmacy and requires this brand new medicine, which is priced, let’s say at a retail price of about $10,000. The reality is that the pharmacy benefit management company and insurers probably paying around 4, maybe 3000, for that drug. So the $7,000 savings over a year period, let’s say it’s a total of one year, doesn’t get passed back to Mary when she shows up at the pharmacy counter to pay for her medicine.

Conner Mertens  10:26

And, Robert, you know that as patient advocates, we’re always trying to elevate the voices of those who aren’t heard. So why is it that there’s not a lot of progress being made in this space? Who’s advocating for this population that’s at risk and spending so much on their healthcare?

Robert Popovian  10:42

Unfortunately, not many. And this is the consequences of the system that we have currently, which is seniors, our most vulnerable patient population, don’t really have a constituency out there lobbying on their behalf. And one organization, unfortunately, which is AARP, that is supposed to be looking out for seniors and lobbying on their behalf, is really conflicted, because they have a partnership with one of the three large PBMs, pharmacy benefit management companies, to promote their senior drug program. So in essence, AARP is conflicted out of this, because they are essentially a pharmacy benefit management company on their own because they make a great deal of revenue from maintaining the current model, which is peddle through insurers and PBMs.

Conner Mertens  11:31

Well, thanks for breaking that down for us, Robert. And I know at the end of each episode, we like to give you the last word, but I think this time, you should give the last word to Mary. What can we tell Mary to put her mind at ease or offer a little hope for some change and a little more affordable, life saving medication?

Robert Popovian  11:46

Well, Mary and her son Ted can become advocates for change, first and foremost. And that’s the hope because people know what the problems are. Basically, that we have a backwards benefit design in Medicare, we have a Medicare benefit design that is not truly an insurance design, and it creates loopholes that force patients into significant out of pocket costs. Also, none of these concessions and everything else that has been negotiated on her behalf gets passed back to them. So we know the problems, Mary, we know the problems, Ted. What you need to become is become advocates, and educate yourself and know that as we have exposed these problems, the only way we’re going to change these things is through legislation. And guess what? Seniors vote. And your vote counts. So you need to show up to the ballot box and support individuals, and specifically individuals who that are aligned with policies that will support and protect seniors.

Conner Mertens  12:50

Make your voice heard. Don’t be quiet.

Robert Popovian  12:52

Exactly.

Conner Mertens  12:53

That’s great advice, Robert. Thanks for listening to Healthcare Matters, a podcast that pulls back the curtain to help you make sense of complex healthcare economics and policy issues. As always, we invite you to go to Apple Podcasts and leave one of those honest five star ratings and write a positive review while you’re there. It’ll help people like you find people like us. And wherever you’re listening, Apple, Spotify or the rest, click that subscribe button so you’ll never miss an episode. He’s Dr. Robert Popovian.

Robert Popovian  13:20

And he’s Conner Mertens. And I want to provide my own thanks to Mary and for Ted, for bring their story to us for us to be able to discuss. We will see you all next time.

Narrator  13:32

Be inspired, supported, and empowered. This is the Global Healthy Living Foundation Podcast Network.

Narrator  00:00

Be inspired, supported, and empowered. This is the Global Healthy Living Foundation Podcast Network.

Robert Popovian  00:11

Non-medical switching is basically substituting one molecule for another for the sole purposes of an economic outcome that is favorable to the insurer or the pharmacy benefit management company because none of these non-medical switchings take place because it’s beneficial to the patient.

Conner Mertens  00:30

Welcome back to Healthcare Matters, the podcast that pulls back the curtain to help you make sense of complex healthcare economics and policy issues. As always, I’m joined by my partner in crime, Dr. Robert Popovian, joining us from Washington DC. He’s a pharmacist, an economist, and Chief Science Policy Officer at the Global Healthy Living Foundation

Robert Popovian  00:48

And across the country in Seattle, Washington. He’s Conner Mertens, Patient Advocate and Community Outreach Manager at the Global Healthy Living Foundation.

Conner Mertens  00:57

As we get into season two of this podcast, we’ll be covering even more ground on what you need to know about healthcare economics and policies.

Robert Popovian  01:04

But before we get started, we want to be sure you take a listen to the other great podcasts on the Global Healthy Living Foundation Podcast Network.

Conner Mertens  01:13

Right, and one of those podcasts is The Health Advocates with Steven Newmark and Zoe Rothblatt. They break down major health news of the week and help you make sense of all of it.

Robert Popovian  01:21

Conner, you and Zoe cohosted Breaking Down Biosimilars. It really helps people, patients understand the role of biosimilars, what they’re about, what role they play in healthcare now and in the future.

Conner Mertens  01:33

And you can find all those at ghlf.org/listen. Alright, let’s take a look at a comment from one of our listeners. David writes, “With all the news we hear about COVID, I thought the episode stating the successes and faults of the FDA was very important.” Thanks for your review. And we invite you too to go to Apple Podcasts and write a positive review, and leave an honest five star rating. And wherever you’re listening, Apple, Spotify or the rest, make sure to click that subscribe button so you’ll never miss an episode. Imagine being on a prescription medication that’s working for your chronic disease, and then being forced by your insurance company to change for no medical reason at all. And now imagine that chronic disease is a mental health condition and think about the tremendous impact that that can have on patients. So in this week’s episode, we’re going to go over the terminology. And then in next week’s episode, we will learn how non-medical switching hurts patients who live with these mental health conditions.

Robert Popovian  02:27

We’ve covered this concept of non-medical switching in past episodes. But we’re going to devote two more to dive deeper into this concept so we can learn ways to advocate against it, and hear how it impacts people who suffer from mental health conditions.

Conner Mertens  02:42

And Robert, I’m sure that you have a lot to share about the topic. So let’s dive in. Can you tell me what’s non-medical switching?

Robert Popovian  02:47

To better understand what non-medical switching means for patients suffering with chronic medical conditions, we need to define what is generic substitution, and what is therapeutic substitution. Generic substitution is really simple. It’s substituting a brand name medicine generic drug, and generally, they’re medicine that have been approved by the FDA to be compatible and are significantly less expensive. And oftentimes, a patient is switched from a brand name medicine to a generic medicine.

Conner Mertens  03:22

It’s pretty important to make sure we distinguish substitution in this case versus switching. Whereas when a patient goes through a generic substitution, the medications are going to continue to be as effective and they’re going to continue to be what they’re essentially taking before it. Is that right?

Robert Popovian  03:35

You’re absolutely right. The medications have the same exact active ingredients. There is no difference. The second question is what is therapeutic substitution and what is non-medical switching, which are slightly different topics. Therapeutic substitution is when a product gets substituted with another drug that are totally two different molecules. But therapeutic substitutions sometimes are clinically justified. And the reason they’re clinically justified is because most of the time therapeutic substitutions take place when pharmacy and therapeutic committees meet. These are committees made up of physicians, pharmacists, they sit around and they discuss whether or not they should carry one drug versus another. Hospitals have limited inventory space, and they can’t carry every single drug. So they have to make some judgment calls about which drugs they carry in the pharmacy versus the ones that they don’t. And in that case, they get into a discussion about therapeutic substitution, which clinically is justified but it is a discussion and a decision that’s made between a pharmacist and a physician sitting in a committee and really dealing with clinical issues.

Conner Mertens  04:43

Okay, so that makes sense what generic substitutions and therapeutic substitutions are and these may not, but potentially can, impact patient care and the continuation of their care. But what makes it different from non-medical switching?

Robert Popovian  04:55

Well, non-medical switching is solely for the purposes of an entity like an insurer or a pharmacy benefit manager to make more money, and it’s to the detriment of the patient. And that’s the distinction. Non-medical switching is basically substituting one molecule for another for the sole purposes of an economic outcome that is favorable to the insurer or the pharmacy benefit management company, because we know that none of these non-medical switchings take place because it’s beneficial to the patient. It really benefits the bottom line of this pharmacy benefit management companies and insurance companies. And it’s really a significant burden on patients because these entities are not looking out for the betterment of the patient outcome, but rather to their bottom line, and patients are often not provided adequate notice of the changes and physicians and providers have not provided the adequate notice of these changes that take place during a plan year.

Conner Mertens  05:55

Like you’re saying, folks can be taken off without any notice. In a similar vein, they’re not given transparency. And that’s a theme that we constantly bring up on this show is the need for more transparency in the healthcare system. And the folks can be taken off of their therapies and their drugs without any explanation. And folks are left scratching their heads and often times it’s impacting their wallet, which I can’t tell you how many times it was last week, I was speaking to a patient who mentioned that halfway through the year their medication changed, and they’ve been on it for about four or five years at this point. And it was really helping them. They tried a bunch of medications in the past that had negative side effects. And it really wasn’t the right option for them. And they finally found a treatment that worked. And after five years this formulary changed and they weren’t going to stop taking their life saving medications. And suddenly they were out of pocket costs in the thousands of dollars where before there was covered by their insurer. And so many detrimental impacts to these patients, they may be less likely to take the medication, they may be less likely to afford groceries or rent when they have to pay for life saving medications. And those are really tough positions to put patients in when they inexplicably are kicked off of the coverage for a life saving medication.

Robert Popovian  07:04

It’s not just the exclusion of the drug from the formulary that then forces the physician or provider to change the therapy for the patient. The product can still be covered, but they can be moved to a different tier so increases the out of pocket costs, for example for the patient, and they end up suffering and end up in a road that you just discussed, which is all of a sudden they can’t afford the medicine and even if they can afford it, they have to cut back in other areas, amenities that they need. And the other thing that this non-medical switching doesn’t really take into consideration is that when you switch any patient from any therapy, and you put them on a totally different molecule and force that because of financial gain for your institution, what you end up doing is that you’re forcing the patient now to go back to the physician or the provider, get maybe additional tests, they have to go probably be adjusted under new therapy if that therapy is good for them. And those are all burdens and costs that the patient incurs. And these pharmacy benefit management companies that make these decisions blindly. They really don’t care about all the consequences that they’re forcing upon patients. These patients end up not taking their medicines, or if they are taking their medicines, then they have to basically cut back on other amenities like we discussed.

Conner Mertens  08:22

This sounds like a pretty common theme that we hear where the bottom line of a corporation is more important than the health of the folks that they’re serving. It’s really devastating. I do know that there are some states that see the harm in this and that have passed legislation.

Robert Popovian  08:36

Well, there are states, you’re absolutely correct, that have passed legislation that forbids the pharmacy benefit management company or the insurer to make any kind of formulary changes during the plan year. So during that one year plan year that the patient is sort of enrolled in that plan, and those bills are really good legislative efforts that have been put into books. Unfortunately, what happens is that they’re not retrospective a lot of time, and they don’t go back and fix problems that occurred before the passage of those legislations. They’re still patients who are vulnerable to this type of activity. And it’s important to note that those patients that have suffered in the past are not getting the remedy that they need through this type of legislation. The other thing that is important to note here is that patient protection through the Affordable Care Act prohibits certain health plans from making these mid year sort of switches, these non-medical substitutions. Unfortunately, ACA requirements is neither complied nor regulated and a lot of insurers basically thumbed their nose and move on and pharmacy benifit management companies thumbed their nose at ACA, Affordable Care Act, and they do whatever they want to do, and there’s nobody trying to regulate or force them to comply with that.

Conner Mertens  09:58

This all sounds very concerning, Robert. But what are the numbers telling us of how much this impact patients lives?

Robert Popovian  10:04

Well, there’s several studies that have been done. One that I often refer to is a study that was done in 2019 by Alliance for Patient Access that showed that nearly 60% of patients who experienced this non-medical switching reported a complication as a result of their medication change. That’s significant. 6 out of 10 patients are ending up having some issues that they have to go back to their physicians, or god forbid, they have to be hospitalized because they stopped taking their medication, was not the right medication, or they become nonadherent because they were forced to pay a higher out of pocket cost. It’s important to know these things. And it is important to always remember that non-medical switching is all about reducing insurer and pharmacy benifit manager short term costs to the detriment of the patient.

Conner Mertens  10:52

But as always, Robert, let’s make sure you get the last word.

Robert Popovian  10:54

The last word is that patients need to become very cognizant of that, that this is a possibility. This non-medical switching can happen to them. And it can happen to them unbeknownst to them, because it can be done in a cloak and dagger manner by the pharmacy benefit management company during the plan year when they’re enrolled in the plan. And they’ve sort of signed up to something and now the changes completely. It’s like going and studying for an exam for chemistry, and all of a sudden you show up to the exam and the exam is about physics, or algebra, or economics. That’s what patients need to be very cognizant of, that this can happen to them. And they need to be vigilant, and they need to work with their healthcare providers to make sure this does not happen to them. And they need to make sure that they appeal the processes to make sure that they’re staying on the therapies that is the best therapy for them. Thank you for listening, we hope you guys all learned something from this episode. I have two requests. Number one, please tune in for our second episode on non-medical switching because we’re going to focus on patients who suffer from mental health issues. And the second request I have from you is to go back and listen to season one. We’ve done several episodes that sort of touched on this issue of non-medical switching because it will give you better context of where we’re going with this policy issue and how we can defeat the insurers and the pharmacy benefit managers and not allow them to take advantage of us as patients and as healthcare professionals. Please send your emails or all your clips to [email protected]. We would love to hear from you. We’re always anticipating what you will say in our reviews.

Conner Mertens  12:52

Thanks again for listening to Healthcare Matters, a podcast that pulls back the curtain to help you make sense of complex healthcare economics and policy issues. As always, we invite you to go to Apple Podcasts and leave one of those awesome honest five star ratings and write a positive review. We read them all and they really inform our content here at Healthcare Matters. It’s going to help people like you find people like us. And don’t forget that wherever you’re listening, Apple, Spotify, or the rest, click that subscribe button so you’ll never miss an episode. He’s Dr. Robert Popovian.

Robert Popovian  13:22

And he’s Conner Mertens, and we’ll see you all next episode.

Conner Mertens  13:29

This episode is made possible with support from AbbVie, sponsor of the Global Healthy Living Foundation.

Narrator  13:37

Be inspired, supported, and empowered. This is the Global Healthy Living Foundation Podcast Network.

Narrator  00:00

Be inspired, supported, and empowered. This is the Global Healthy Living Foundation Podcast Network.

Robert Popovian  00:11

Non-medical switching is basically substituting one molecule for another for the sole purposes of an economic outcome that is favorable to the insurer or the pharmacy benefit management company because none of these non-medical switchings take place because it’s beneficial to the patient.

Conner Mertens  00:30

Welcome back to Healthcare Matters, the podcast that pulls back the curtain to help you make sense of complex healthcare economics and policy issues. As always, I’m joined by my partner in crime, Dr. Robert Popovian, joining us from Washington DC. He’s a pharmacist, an economist, and Chief Science Policy Officer at the Global Healthy Living Foundation

Robert Popovian  00:48

And across the country in Seattle, Washington. He’s Conner Mertens, Patient Advocate and Community Outreach Manager at the Global Healthy Living Foundation.

Conner Mertens  00:57

As we get into season two of this podcast, we’ll be covering even more ground on what you need to know about healthcare economics and policies.

Robert Popovian  01:04

But before we get started, we want to be sure you take a listen to the other great podcasts on the Global Healthy Living Foundation Podcast Network.

Conner Mertens  01:13

Right, and one of those podcasts is The Health Advocates with Steven Newmark and Zoe Rothblatt. They break down major health news of the week and help you make sense of all of it.

Robert Popovian  01:21

Conner, you and Zoe cohosted Breaking Down Biosimilars. It really helps people, patients understand the role of biosimilars, what they’re about, what role they play in healthcare now and in the future.

Conner Mertens  01:33

And you can find all those at ghlf.org/listen. Alright, let’s take a look at a comment from one of our listeners. David writes, “With all the news we hear about COVID, I thought the episode stating the successes and faults of the FDA was very important.” Thanks for your review. And we invite you too to go to Apple Podcasts and write a positive review, and leave an honest five star rating. And wherever you’re listening, Apple, Spotify or the rest, make sure to click that subscribe button so you’ll never miss an episode. Imagine being on a prescription medication that’s working for your chronic disease, and then being forced by your insurance company to change for no medical reason at all. And now imagine that chronic disease is a mental health condition and think about the tremendous impact that that can have on patients. So in this week’s episode, we’re going to go over the terminology. And then in next week’s episode, we will learn how non-medical switching hurts patients who live with these mental health conditions.

Robert Popovian  02:27

We’ve covered this concept of non-medical switching in past episodes. But we’re going to devote two more to dive deeper into this concept so we can learn ways to advocate against it, and hear how it impacts people who suffer from mental health conditions.

Conner Mertens  02:42

And Robert, I’m sure that you have a lot to share about the topic. So let’s dive in. Can you tell me what’s non-medical switching?

Robert Popovian  02:47

To better understand what non-medical switching means for patients suffering with chronic medical conditions, we need to define what is generic substitution, and what is therapeutic substitution. Generic substitution is really simple. It’s substituting a brand name medicine generic drug, and generally, they’re medicine that have been approved by the FDA to be compatible and are significantly less expensive. And oftentimes, a patient is switched from a brand name medicine to a generic medicine.

Conner Mertens  03:22

It’s pretty important to make sure we distinguish substitution in this case versus switching. Whereas when a patient goes through a generic substitution, the medications are going to continue to be as effective and they’re going to continue to be what they’re essentially taking before it. Is that right?

Robert Popovian  03:35

You’re absolutely right. The medications have the same exact active ingredients. There is no difference. The second question is what is therapeutic substitution and what is non-medical switching, which are slightly different topics. Therapeutic substitution is when a product gets substituted with another drug that are totally two different molecules. But therapeutic substitutions sometimes are clinically justified. And the reason they’re clinically justified is because most of the time therapeutic substitutions take place when pharmacy and therapeutic committees meet. These are committees made up of physicians, pharmacists, they sit around and they discuss whether or not they should carry one drug versus another. Hospitals have limited inventory space, and they can’t carry every single drug. So they have to make some judgment calls about which drugs they carry in the pharmacy versus the ones that they don’t. And in that case, they get into a discussion about therapeutic substitution, which clinically is justified but it is a discussion and a decision that’s made between a pharmacist and a physician sitting in a committee and really dealing with clinical issues.

Conner Mertens  04:43

Okay, so that makes sense what generic substitutions and therapeutic substitutions are and these may not, but potentially can, impact patient care and the continuation of their care. But what makes it different from non-medical switching?

Robert Popovian  04:55

Well, non-medical switching is solely for the purposes of an entity like an insurer or a pharmacy benefit manager to make more money, and it’s to the detriment of the patient. And that’s the distinction. Non-medical switching is basically substituting one molecule for another for the sole purposes of an economic outcome that is favorable to the insurer or the pharmacy benefit management company, because we know that none of these non-medical switchings take place because it’s beneficial to the patient. It really benefits the bottom line of this pharmacy benefit management companies and insurance companies. And it’s really a significant burden on patients because these entities are not looking out for the betterment of the patient outcome, but rather to their bottom line, and patients are often not provided adequate notice of the changes and physicians and providers have not provided the adequate notice of these changes that take place during a plan year.

Conner Mertens  05:55

Like you’re saying, folks can be taken off without any notice. In a similar vein, they’re not given transparency. And that’s a theme that we constantly bring up on this show is the need for more transparency in the healthcare system. And the folks can be taken off of their therapies and their drugs without any explanation. And folks are left scratching their heads and often times it’s impacting their wallet, which I can’t tell you how many times it was last week, I was speaking to a patient who mentioned that halfway through the year their medication changed, and they’ve been on it for about four or five years at this point. And it was really helping them. They tried a bunch of medications in the past that had negative side effects. And it really wasn’t the right option for them. And they finally found a treatment that worked. And after five years this formulary changed and they weren’t going to stop taking their life saving medications. And suddenly they were out of pocket costs in the thousands of dollars where before there was covered by their insurer. And so many detrimental impacts to these patients, they may be less likely to take the medication, they may be less likely to afford groceries or rent when they have to pay for life saving medications. And those are really tough positions to put patients in when they inexplicably are kicked off of the coverage for a life saving medication.

Robert Popovian  07:04

It’s not just the exclusion of the drug from the formulary that then forces the physician or provider to change the therapy for the patient. The product can still be covered, but they can be moved to a different tier so increases the out of pocket costs, for example for the patient, and they end up suffering and end up in a road that you just discussed, which is all of a sudden they can’t afford the medicine and even if they can afford it, they have to cut back in other areas, amenities that they need. And the other thing that this non-medical switching doesn’t really take into consideration is that when you switch any patient from any therapy, and you put them on a totally different molecule and force that because of financial gain for your institution, what you end up doing is that you’re forcing the patient now to go back to the physician or the provider, get maybe additional tests, they have to go probably be adjusted under new therapy if that therapy is good for them. And those are all burdens and costs that the patient incurs. And these pharmacy benefit management companies that make these decisions blindly. They really don’t care about all the consequences that they’re forcing upon patients. These patients end up not taking their medicines, or if they are taking their medicines, then they have to basically cut back on other amenities like we discussed.

Conner Mertens  08:22

This sounds like a pretty common theme that we hear where the bottom line of a corporation is more important than the health of the folks that they’re serving. It’s really devastating. I do know that there are some states that see the harm in this and that have passed legislation.

Robert Popovian  08:36

Well, there are states, you’re absolutely correct, that have passed legislation that forbids the pharmacy benefit management company or the insurer to make any kind of formulary changes during the plan year. So during that one year plan year that the patient is sort of enrolled in that plan, and those bills are really good legislative efforts that have been put into books. Unfortunately, what happens is that they’re not retrospective a lot of time, and they don’t go back and fix problems that occurred before the passage of those legislations. They’re still patients who are vulnerable to this type of activity. And it’s important to note that those patients that have suffered in the past are not getting the remedy that they need through this type of legislation. The other thing that is important to note here is that patient protection through the Affordable Care Act prohibits certain health plans from making these mid year sort of switches, these non-medical substitutions. Unfortunately, ACA requirements is neither complied nor regulated and a lot of insurers basically thumbed their nose and move on and pharmacy benifit management companies thumbed their nose at ACA, Affordable Care Act, and they do whatever they want to do, and there’s nobody trying to regulate or force them to comply with that.

Conner Mertens  09:58

This all sounds very concerning, Robert. But what are the numbers telling us of how much this impact patients lives?

Robert Popovian  10:04

Well, there’s several studies that have been done. One that I often refer to is a study that was done in 2019 by Alliance for Patient Access that showed that nearly 60% of patients who experienced this non-medical switching reported a complication as a result of their medication change. That’s significant. 6 out of 10 patients are ending up having some issues that they have to go back to their physicians, or god forbid, they have to be hospitalized because they stopped taking their medication, was not the right medication, or they become nonadherent because they were forced to pay a higher out of pocket cost. It’s important to know these things. And it is important to always remember that non-medical switching is all about reducing insurer and pharmacy benifit manager short term costs to the detriment of the patient.

Conner Mertens  10:52

But as always, Robert, let’s make sure you get the last word.

Robert Popovian  10:54

The last word is that patients need to become very cognizant of that, that this is a possibility. This non-medical switching can happen to them. And it can happen to them unbeknownst to them, because it can be done in a cloak and dagger manner by the pharmacy benefit management company during the plan year when they’re enrolled in the plan. And they’ve sort of signed up to something and now the changes completely. It’s like going and studying for an exam for chemistry, and all of a sudden you show up to the exam and the exam is about physics, or algebra, or economics. That’s what patients need to be very cognizant of, that this can happen to them. And they need to be vigilant, and they need to work with their healthcare providers to make sure this does not happen to them. And they need to make sure that they appeal the processes to make sure that they’re staying on the therapies that is the best therapy for them. Thank you for listening, we hope you guys all learned something from this episode. I have two requests. Number one, please tune in for our second episode on non-medical switching because we’re going to focus on patients who suffer from mental health issues. And the second request I have from you is to go back and listen to season one. We’ve done several episodes that sort of touched on this issue of non-medical switching because it will give you better context of where we’re going with this policy issue and how we can defeat the insurers and the pharmacy benefit managers and not allow them to take advantage of us as patients and as healthcare professionals. Please send your emails or all your clips to [email protected]. We would love to hear from you. We’re always anticipating what you will say in our reviews.

Conner Mertens  12:52

Thanks again for listening to Healthcare Matters, a podcast that pulls back the curtain to help you make sense of complex healthcare economics and policy issues. As always, we invite you to go to Apple Podcasts and leave one of those awesome honest five star ratings and write a positive review. We read them all and they really inform our content here at Healthcare Matters. It’s going to help people like you find people like us. And don’t forget that wherever you’re listening, Apple, Spotify, or the rest, click that subscribe button so you’ll never miss an episode. He’s Dr. Robert Popovian.

Robert Popovian  13:22

And he’s Conner Mertens, and we’ll see you all next episode.

Conner Mertens  13:29

This episode is made possible with support from AbbVie, sponsor of the Global Healthy Living Foundation.

Narrator  13:37

Be inspired, supported, and empowered. This is the Global Healthy Living Foundation Podcast Network.

Narrator  00:00

Be inspired, supported, and empowered. This is the Global Healthy Living Foundation Podcast Network.

Robert Popovian  00:06

Data in healthcare has never been meant to be static. We need to provide even greater scrutiny concerning these models and how they’re applied and they make coverage decisions for life saving biopharmaceuticals.

Conner Mertens  00:27

Welcome back to Healthcare Matters, the podcast that pulls back the curtain to help you make sense of complex healthcare economics and policy issues. As always, he’s Dr. Robert Popovian, joining us from Washington DC, a pharmacist, economist and Chief Science Policy Officer at the Global Healthy Living Foundation.

Robert Popovian  00:44

And across the country in Seattle, Washington, he’s Conner Mertens, Patient Advocate and Community Outreach Manager at the Global Healthy Living Foundation. And by the way, he’s also waiting for his refund for his season tickets for the Seattle Mariners since there’s not going to be a baseball season as of today.

Conner Mertens  01:00

So as we get into Season Two of the podcast, we’re going to be covering even more ground than season one, and what you need to know about healthcare economics and policies.

Robert Popovian  01:09

Before we get started, we want to make sure that you take a listen to the other great podcasts on the GHLF Podcast Network.

Conner Mertens  01:17

And there’s a lot of great ones to check out. And if you haven’t checked it out already, Talking Head Pain with Joe Coe is a podcast that confronts head pain head on. And as a migraine Patient Advocate, Joe knows the power of speaking up and being proactive when managing his complex neurological conditions.

Robert Popovian  01:31

Please go to ghlf.org/listen, and listen to all of the podcasts that are now being managed through Global Healthy Living Foundation.

Conner Mertens  01:41

Great. And with that, let’s take a look at a comment from one of our listeners. This week, Barbara writes, “I enjoyed your episode about prior authorization and how insurance companies deny patients the medications their doctors prescribed. I’m glad this important information is out there for more patients to hear.” Thanks for your review. We invite you too to go to Apple Podcasts and write a positive review and leave an honest five star rating. And wherever you’re listening, whether it’s Apple, Spotify, or the rest, click on that subscribe button so you’ll never miss an episode.

Robert Popovian  02:08

Let’s start with this week’s episode now.

Conner Mertens  02:13

So Robert, this week, we’re going to be talking about these organizations that can have global influence, really, when it comes to patient care and access. And I was curious if you want to start us off, tell us what we should know about these kinds of organizations. What are they called? What do they do?

Robert Popovian  02:25

Conner, these organizations exist in almost every country. In the US we have an organization called ICER. In UK, United Kingdom, there’s an organization called NICE. In Canada, there’s Canadian Agency for Drug and Technology and Health. All these organizations are basically trying to define a value and insert value as a component into models so that they may analyze appropriateness of payment for biopharmaceuticals. And they have even tried to sell these analytics to audiences with promises of substantial savings. In fact, in some of the cases like in the United Kingdom with NICE, whatever recommendation NICE provides, National Health Services, which is the agency that provides healthcare in the United Kingdom, will follow their recommendations. And it is important to know about these groups because they’re trying to define value and insert value into the healthcare system. But there are problems with that.

Conner Mertens  03:24

So let’s start there. How do these folks define value? What’s wrong with defining value when it comes to medications, therapies, and treatments in the marketplace?

Robert Popovian  03:32

There’s nothing wrong and in fact, if you look back, these organizations are utilizing legitimate analytical tools developed by economists and economic analysis such as QALYs, for example, cost effectiveness, budget impact analysis are important, and they’ve been used in the past for defining whether or not certain interventions should occur. However, these analytical techniques were never meant to be applied as an ultimate arbiter of whether medicine is worth paying for. And that’s the problem of how these things are being applied. In addition, just in the scope of defining value, if you put yourself on a patient’s journey, a patient who has chronic disease or an acute disease may have multiple chronic diseases and acute diseases. It is as hard for it to be defined as a single value proposition. But then in addition to the entire disease area, you have to note that the patients are dealing with socioeconomic issues, health disparities issues, and those need to be also inserted. But the inherent problem with these organizations instituting value model for patients is that if the patient doesn’t fit the profile, they’re denied the therapy that may help them manage or cure their disease. Just as no individual health is average, no individual’s life choice and values are average and that’s the problem.

Conner Mertens  04:55

So it sounds like they’re using legitimate tools but in a misleading or narrow way, is that kind of an oversimplification of it?

Robert Popovian  05:01

These are legitimate tools. They’ve been used by economists for many decades and years. And we even use it in our household. You judge whether or not to spend something or another. But what the problem is that a lot of these institutions have been given the carte blanche to be able to use these findings to make specific decisions on coverage decisions.

Conner Mertens  05:23

So when it comes to like, ICER, here in the US, what happens if a drug ends up on one of their proverbial lists? What is the repercussion of that for patients?

Robert Popovian  05:31

If they find that the product doesn’t meet the standard level of quality, for example, a lot of institutions can use that data to deny coverage. Now, fortunately, in the United States, we don’t have a mandate similar to United Kingdom. But the whole purpose of ICER is to be able to convince people for them to become the arbiter of this decision making. And that’s the problem. And in the US, we’re not there yet. The information can be used by insurers, by the pharmacy benefit management companies, or by the government. But what ICER is striving towards is to become another organization such as NICE, United Kingdom, where they utilize the data without any kind of questioning and to utilize the data to make coverage decisions.

Conner Mertens  06:17

From year to year, can medications move to and from these lists? And then what happens to patients that are stable in their health on one of these medications?

Robert Popovian  06:26

Absolutely, they can, because these reports are static. And data in healthcare has never been meant to be static. There’s absolutely ways that patients can be denied care after they’ve been on a chronic therapy, because at some point, that product may not fit the model of an ICER that will qualify to be cost effective.

Conner Mertens  06:49

Well, to me, Robert, it sounds like going back to what we said earlier, there is legitimacy here. There is a need for us to find and to determine value in therapies and medications. But the way that it’s being done now is only limiting and narrows what patients have access to and what we strive for in our mission statement as the Global Healthy Living Foundation is to always make sure that patients have the most access to therapies and medications possible. But as always want to make sure you get the last word in here, what should folks know about these regulatory or suggestive organizations?

Robert Popovian  07:20

Conner, there are already concerns about the methodology of some of these research techniques, right? Because we know for example, they are legitimate research techniques. But defining quality, for example, it’s a very difficult situation, especially for a patient who may have multiple diseases. Let’s talk about methodology and ability to be able to come up with the right number. That by itself is problematic. But the bigger problem is that these tools were never intended to be utilized for coverage decisions. And that’s the bigger problem with that. How are they going to be applied in making coverage decisions for patients who are in need of these therapies? We need to provide even greater scrutiny concerning these models and how they’re applied and they make coverage decisions for life saving biopharmaceuticals. And regarding the application, these things were never meant to be the sole arbiter. Most economists who use these types of tools only use it as a guidepost and not the only data point with regards to making decisions. Thank you, everyone for listening to our podcast. We sincerely hope that you’ve learned something. We’d love to hear from you. Please send an email or an audio clip to [email protected].

Conner Mertens  08:47

Thanks for listening to Healthcare Matters, a podcast that pulls back the curtain to help you make sense of complex healthcare economics and policy issues. We invite you to go to Apple Podcasts, leave an honest five star rating and write a positive review and help more people like you find people like us. And wherever you’re listening, Apple, Spotify or the rest, click that subscribe button so you’ll never miss an episode. As always, he’s Dr. Robert Popovian.

Robert Popovian  09:10

And he’s Conner Mertens. Hope to see you guys all next time.

Narrator  09:17

Be inspired, supported, and empowered. This is the Global Healthy Living Foundation Podcast Network.

Narrator  00:00

Be inspired, supported, and empowered. This is the Global Healthy Living Foundation Podcast Network.

Robert Popovian  00:11

The patient is the one that is going to get stuck in the middle. And at some point they’re going to suffer both financially and also, in a way, to be able to get care that is necessary to them.

Conner Mertens  00:24

Welcome back to Healthcare Matters, the podcast that pulls back the curtain to help you make sense of complex healthcare economics and policy issues. He’s Dr. Robert Popovian, in Washington, DC, pharmacist, economist and Chief Science Policy Officer at the Global Healthy Living Foundation.

Robert Popovian  00:39

And across the country in Seattle, Washington, he’s Conner Mertens, one of our Patient Advocates and Community Outreach Managers at the Global Healthy Living Foundation.

Conner Mertens  00:50

And you know, as we get into Season Two of the podcast, we’ve been covering even more ground than before on everything you need to know about healthcare economics and policies.

Robert Popovian  00:58

But before we get started, it is so important for us to make sure that you’re also listening to the other great podcasts on the Global Healthy Living Foundation Podcast Network.

Conner Mertens  01:08

Right. And you have a lot of options out there. But this week, you can check out a new podcast called Getting Clear on Psoriasis with David Brandt. It’s a podcast series about what it takes to live better with psoriasis from experts who treat it to the patients who live with it.

Robert Popovian  01:23

And you can find them all at the ghlf.org/listen.

Conner Mertens  01:27

All right. Well, let’s take a look at one of the comments from our listeners. Rick Shigaki on LinkedIn says about our episode where we were discussing personalized versus precision medicine, “A very well done podcast, examining the synergy of combining personalized medicine with precision medicine.” Thanks for your review, Rick. We invite you too to go to Apple Podcasts and write a positive review and leave an honest five star rating. And wherever you’re listening, Apple or Spotify, click that subscribe button so you never miss an episode.

Robert Popovian  01:57

Terrific, Conner. How about we get into this week’s episode.

Conner Mertens  02:00

Let’s get after it.  Today, we’re going to be talking about copay accumulator adjuster programs. I know it’s a mouthful, but actually, I saw a statistic that said about 80% of commercial health plans have these sort of programs in them. Many people don’t know about them. Many people have heard of them, but don’t know what it means. yet. So many people are affected by these. Robert, give us the breakdown. What is an accumulator adjuster program?

Robert Popovian  02:25

So it’s a great question. And not only the offering exists among insurers and the pharmacy benefit managers, but the employers more and more are picking them up and putting them in their benefit design. So what is the accumulator program? It’s really a program that has been designed to keep the patient perpetually in the deductible phase. So when we have typical insurance, right Conner, you and I have insurance that we have a deductible that we have to meet before the insurance starts paying for it. That deductible phase commonly requires an out of pocket cost that the patient has to pay. You and I paid for it. And then we get out of that phase and the insurance kicks in and starts paying for our medicines. So the accumulate program prohibits any patient assistance program dollars that come from biopharmaceutical industry to apply to that deductible match.

Conner Mertens  03:17

What kind of things don’t count towards? Are we talking about like copay assistance cards? How is this impacting patients negatively before we keep going?

Robert Popovian  03:24

Right, patient assistance program are broad, right? So they’re copay assistance cards, there’s coupons, any kind of a direct help from the pharmaceutical industry that comes towards the patient to be able to afford their drugs. So any of those dollar amounts don’t count toward the deductible. So in effect, it keeps the patient continuously in this deductible phase when they have to continuously pay for this out of pocket costs, whether it’s coming through their pocket, or through these patient assistance programs that the pharmaceutical industry is providing.

Conner Mertens  03:53

So these coupons or copay assistance cards can help with the cost of the drug up front, but it’s still costing patients in the back end with a deductible. Is that right? Or am I reading that wrong?

Robert Popovian  04:04

You’re correct. So they defray the cost of the out of pocket. But it used to be a time prior to these accumulator programs that these out of pocket assistance programs, these patients assistance program, would count towards the deductible, would get the patient out of the deductible phase, and that’s when the insurance would kick in. And then the insurance company would cover the cost. Now, because the patient stays perpetually in this deductible phase, because none of these patients assistance programs are counting towards any of their deductibles, they’re forced to stay in this phase, and therefore the insurance basically never ends up paying for any of their meds.

Conner Mertens  04:39

Well, I mean that that leads to my next question is, why do these programs even exist? They must benefit somebody and I’m assuming it’s got to be the PBMs, the insurers, and like you said now more commonly, the employer, but how does it benefit these groups?

Robert Popovian  04:52

The benefits of this because it keeps the patient from reaching their deductible amount and therefore when the insurance doesn’t kick in that means the insurance company and the pharmacy benefit management company are off the hook. And they don’t have to pay for that medicine. Where in the past were these patient assistance programs would count towards the deductible, the patient would meet those obligations, the dollar amount obligations, and after that the insurance company or the pharmacy benefit manager was on the hook to be able to cover for these meds. So in essence, this is a benefit for the pharmacy benefit management companies and insurers and to some effect, you mentioned the employers, because they no longer are exposed to paying for these meds.

Conner Mertens  05:32

Who’s most affected by copay accumulator adjuster programs. It has to be the folks that are spending exorbitant amounts on their drugs already?

Robert Popovian  05:40

Sure, the patients are but the question is how are they being impacted? Are they being impacted because are they discontinuing their meds because the patient assistance program and pharmaceutical industry provides usually have caps. There’s a certain amount they only provide. So are they being hurt because they meet the certain threshold and the pharma company no longer provides any more patient assistance program? Or are they indirectly being affected because of other issues with regards to out of pocket costs? So there’s two ways that they can be affected. And yes, the patient is the one that is going to get stuck in the middle. And at some point, they’re going to suffer both financially and also in a way to be able to get care that is necessary to them.

Conner Mertens  06:24

Do you think that patients living with chronic disease are disproportionately affected by these sorts of practices?

Robert Popovian  06:29

Yes. And the reason why is because of the chronic disease, you’re paying over a longer period of time than an acute disease. But no matter what a patient is affected, whether they have chronic or acute disease, because at the end of the day, when they are staying in the deductible phase, the pharma company will continuously support them through their patient assistance programs. They’re never going to turn the patient away. And that’s why you’re seeing exorbitant amount of money being spent through this patient assistance program by the pharma companies. So if I needed more support, the biopharmaceutical industry will keep feeding me the coupons, or copay cards to be able to afford my medicine, even though it was basically keeping me in the deductible phase constantly. But there’s an indirect effect on the patients. And that’s what I was alluding to. In the past, when the patient met their deductible amount, at that point, they would go to see, for example, their physician or be hospitalized or would need  an MRI or a CT scan, and those things would have already met their deductible phase so patient wouldn’t have to pay anything out of pocket for them. But now because they’re staying in this deductible phase constantly, even though they’re not being hampered from getting their drugs, because the patient assistance program keeps fueling, providing money to them to be able to afford it. When they show up to the physician’s office or being hospitalized or needing an MRI, they have to pay out of pocket. And therefore they may be foregoing other treatments. So that’s what my point was, perhaps directly they’re not discontinuing their medicines. There’s more to chronic care therapy than just pharmaceuticals. There’s other things that patients need, they need to go see their docs, they need to get testing, sometimes get hospitalized. And those are the things that indirectly the patients no longer are able to afford, and may forego which may impact their outcomes.

Conner Mertens  08:18

Right, and patients that are exposed to those sky high out of pocket costs face threats to their financial security, but also their physical well being. We do know that any barrier to access medication leads to lack of adherence to that, you know, and it’s never the patient’s fault if they can’t afford their drugs or medications. We have to figure out ways to make these drugs more affordable, which I think is a good next question. One thing that we always like to talk about is what’s being done politically. I know that there’s nearly a dozen states maybe more have taken action to limit or outright prohibit these practices. What else is being done? Is there anything done federally about this?

Robert Popovian  08:53

Unfortunately, federally, no. And CMS took a pass at it. Initially, they tried to prohibit copay accumulator programs in the government Part D Medicare program for pharmaceuticals. But they actually reverse that and said that, no, we believe that if any plan wants to adopt copay accumulators they may do so. That’s the federal point of view. On the state level, as usual, and you know this because we work quite a bit in Global Healthy Living Foundation with states, we have the 50 State Network that we have very close relationship with both our patients in the state level, but also policymakers on the state level. And what we have done is that through Global Healthy Living Foundation and other patient organizations have been able to successfully pass copay accumulator bans in certain states that they cannot be applied for that state population. And that’s very important because by banning these copay accumulators, in effect, we’re helping a group of patients that are receiving their insurance and their insurance is being controlled by the state rather than federally which is a whole other issue.

Conner Mertens  09:58

That’s a large portion of patients that are going to be impacted by this.

Robert Popovian  10:02

They are but they leave out two large groups of people that are not being covered by this type of bans. One is patients who get Medicare benefits through Part D, because that’s a federal program. And also the ERISA plans that are not regulated by state law, because they’re self funded insurers, insurance plans, that are funded by the employers, and they’re not governed by state law, and therefore these type of bans do not affect them. In effect, yes, we are helping some patients but not all patients. And remember, Conner, a lot of people who have chronic diseases are generally older. So if Medicare is not being impacted, and accumulator bans are going on and accumulators are being adopted in those programs, it’s a problem, because they’re the ones who are the high utilizers of these medicines. And again, I have to say, and this is very important, there is no evidence that the patients start discontinuing their therapies because of accumulators. And the reason being is that pharma companies will never let the patients fall through the cracks. They keep feeding this beast of patient assistance programs. It’s the indirect medical services that get impacted. And with chronic disease, as I mentioned, there’s more to management of a chronic disease than a pharmaceutical. It’s all these other services that patients require.

Conner Mertens  11:21

Right. And in that same vein, Robert, I read that there’s anecdotal data showing there’s not really evidence these bans in the states are raising premiums. Is that right?

Robert Popovian  11:30

That is actually something I’ve also been privy to, and I’ve looked at it very carefully. And GHLF, Global Healthy Living Foundation, is going to take up a study that we’re going to look at what is the impact of these accumulators in the states with regards to premiums, because it’s important to note if premiums are not being impacted, then what’s the point of not passing these bans and making sure that the patients are provided the security that they need?

Conner Mertens  11:55

Well, you know, Robert, what I’m gonna take away from this is that we really got to protect patients from high out of pocket costs. And one way to do that is by requiring health plans to credit all payments made by or on behalf of patients towards patient deductibles and out of pocket maximums. And that’s not happening with these copay accumulator adjusters. But as always want to make sure you get the last word in here, what what should folks take away?

Robert Popovian  12:16

You’re absolutely correct, Conner. What you just observed is that patients are being hurt, not necessarily the way we anticipate them to be hurt, which is they’re discontinuing their therapy because of this accumulator adjuster programs. But rather, they’re being hurt because unlike being able to go and being able to afford an MRI or seeing their physician or when they’re hospitalized, they may be foregoing those services. And as I mentioned, there’s more to management of a chronic disease than just a biopharmaceutical, we still need these other services to come together to help the patients. Conner and I really hope that you’ve learned something from this episode. It’s always our goal to be able to help you understand healthcare policy matters that may be complex. We’d love to hear from you, as always. Please send your emails or audio clip to [email protected]

Conner Mertens  13:21

Thanks for listening to Healthcare Matters, a podcast that pulls back the curtain to help you make sense of complex healthcare economics and policy issues. As always, we invite you to go to Apple Podcasts and leave one of those honest five star ratings and write a positive review. It’s going to help people like you find people like us. And wherever you’re listening, whether it’s Apple, Spotify, or the rest, click that subscribe button so you’ll never miss an episode. He’s Dr. Robert Popovian.

Robert Popovian  13:45

And he’s Conner Mertens, our Patient Advocacy Manager who helps our patients every day. We hope to see you next time.

Narrator  13:55

Be inspired, supported, and empowered. This is the Global Healthy Living Foundation Podcast Network.

Narrator  00:00

Be inspired, supported, and empowered. This is the Global Healthy Living Foundation Podcast Network.

Robert Popovian  00:09

It is important for us to have multiple therapies even within those classes to make sure that patients have choice and physicians, pharmacists, nurses have choices to make that can then appropriately treat the patient.

Conner Mertens  00:25

Welcome back to Healthcare Matters, the podcast that pulls back the curtain to help you make sense of complex healthcare economics and policy issues. He’s Dr. Robert Popovian, joining us from Washington, DC. A Pharmacist, Economist and Chief Science Policy Officer at the Global Healthy Living Foundation.

Robert Popovian  00:41

And across the country in Seattle, Washington,  he’s Conner Mertens, Patient Advocate and Community Outreach Manager at the Global Healthy Living Foundation.

Conner Mertens  00:50

And listen, we covered a lot of ground in our first season and we’re glad you’re here for the start of the second season.

Robert Popovian  00:55

But before we get started, we want to make sure you take a listen to all of the brilliant podcasts on the Global Healthy Living Foundation Podcast Network.

Conner Mertens  01:04

Right, like The Health Advocates with Steven Newmark and Zoe Rothblatt, our good friends, where they break down major health news of the week and try to help you make sense of it.

Robert Popovian  01:13

And Conner, you and Zoe cohost Breaking Down Biosimilars, which I was actually one of the guest speakers on it, a podcast that helps us understand the role of biosimilars play in our healthcare system now and in the future.

Conner Mertens  01:26

And you can find all of these at GHLF.org/listen. All right, let’s take a look at some of the comments from our listeners. Elisa C. from Twitter says, “This was a great podcast, I listened to it three times.” Thanks for your review. We invite you to go to Apple Podcasts and write a positive review and leave an honest five star rating. And wherever you’re listening, whether it’s Apple, Spotify, or the rest, click that subscribe button so you never miss an episode.

Robert Popovian  01:52

Excellent. Before we get into this episode, Conner, we should mention that this is a follow up to our past episode that we talked about vaccines on the COVID infection. And we’re going to have a little bit of a different discussion today. So let’s get started on this.

Conner Mertens  02:07

We’ve talked a lot about the vaccines. And everyone here agrees that everyone should be on top of those vaccines and it’s one of the best ways to end this pandemic. But today, we’re going to be discussing the treatments that are available for COVID. And one of the things that has brought the death rate down of this disease compared to the beginning of the pandemic has been our ability to continually find new and effective therapies to treat COVID once a patient has got it. And the ability to wean out those treatments that don’t work. So Robert, big picture, what do we know about the current available COVID treatments?

Robert Popovian  02:38

Before we even get into the treatments, Conner, it’s important for us to realize that we’ve learned some stuff from this pandemic, right. So first, we’ve learned that it’s far better to do prevention than treatment. We want to have everybody vaccinated. But in some cases, people are just not going to get vaccinated, not everybody is going to be able to get the vaccine for a variety of medical reasons, whether it’s medical concerns, religious exemption, or simply needle phobia. So we do need treatments, because we know despite everybody getting the vaccine, or most people getting the vaccine, we have breakthrough disease that we need treatments for. So what do we know? Well, currently, there are some treatments that have been authorized by the Food and Drug Administration. And it is important for us to educate our patients through you, through Global Healthy Living Foundation of what they are, but most importantly, to have a discussion with their clinicians, their physicians, their pharmacists about what their options may be.

Conner Mertens  03:38

Robert, can you tell us a little bit about how these treatments work? Obviously, I’m sure there’s some differences and whatnot. But is there a general mode of treatment that that has been most effective,

Robert Popovian  03:49

Not most effective, I would say, Conner. But I would say there are two types of therapies that are available in the market currently. One are the antibodies that are injected into the patient, and they can be provided in a pharmacy or through a physician’s office. And then there are two antivirals that have been authorized by the FDA for the treatment of COVID infection and all of those therapies are authorized. None of them are fully approved by the FDA, but they are treatments that are available for patients. Again, we should always fall back and make sure that we were vaccinated and fully vaccinated. But there are going to be cases that we cannot be vaccinated or that there’s breakthrough disease. So we should have options for those patients.

Conner Mertens  04:34

One of these questions that I have is will these treatments stay effective? You know, even as the virus itself changes? This Omicron variant looks a lot different than the Delta one did.

Robert Popovian  04:45

Conner, that’s an excellent question. Many of our listeners don’t know but my background, actually, when I was trained as a pharmacist is infectious diseases and one of the things we learned is that bacteria and viruses either develop resistence or mutate over time. And not every antibiotic works on every bacterial infection, not every antiviral is going to work on every bacterial infection. So we do need choices in this environment, because even if a therapy has been authorized, and it works currently on a viral infection or a bacterial infection, in this case COVID being a viral infection, eventually they may stop working or may not work on, as you mentioned, a variant of the COVID infection, which is in this case, Omicron. So it is important for us to have multiple therapies, even within those classes, to make sure that patients have choice and physicians, pharmacists, nurses have choices to make that can then appropriately treat the patient.

Conner Mertens  05:45

What are some of the drawbacks or concerns about these treatments?

Robert Popovian  05:48

We’ve seen recently right from the Food and Drug Administration, where they withdrew the authorization for a couple of the antibodies that were made available in the marketplace. And the Food and Drug Administration looked at the data, and they concluded that none of the data coming from laboratory experiments showed that any of the antibodies that had received Early Use Authorization had any activity against Omicron. And hence, what they decided is that look, we’re going to withdraw the authorization and instead of revoking it, what they said is that in the future, as we know, we’ve seen with this virus, it mutates over time, over and over again that in fact, if this antibodies do show activity for future mutations, that we will reinstate the authorization based on laboratory data or data that will come back to us. That was a very important thing. So with the antivirals, the oral antivirals, they have been tested against the Omicron variant. And both of them have shown activity so far in laboratory. And that’s why the FDA has left the authorizations in place. But you know, that’s the one of the biggest things is that science evolves, as we’ve spoken in the past on this podcast. And it is important for us to evolve our treatment choices as science evolves, and not to think that you’re going to basically stay in a static formation and not have to make changes potentially.

Conner Mertens  07:15

With all the flack that the FDA gets, I think that this is a good example of the process working. Something we thought worked didn’t so it was pulled until science shows otherwise, that’s what we’re going to act. But I am curious, where are these treatments developed? Were they developed specifically for COVID? Or did we get these through other means, like what we’ve talked about with the mRNA vaccine?

Robert Popovian  07:35

That’s a great question. Let me actually step back, Conner, and address the FDA comment that you made, which I thought it was brilliant, because I do agree with you 100%. Look, FDA as a regulatory agency, a bureaucratic agency in the United States gets a lot of flack. Sometimes rightfully so. They’re at times ambiguous, slow to act. But in this case, they should be applauded. They are following the science. What they said is that, look, these two antibodies that are been authorized are not showing any kind of an activity towards the current variants that is infecting about 99% of the infections are Omicron that are coming back. So what is the purpose of having these patients being treated with these antibody therapies? But let me address your second question, which is, are these new therapies that we’re talking about, especially the oral ones, are they really new? Or have we known about it? So the most promising therapeutic mechanism of action today appears to be the protease inhibitors that are being tested and researched.  Protease inhibitors reduce the viral load by blocking the function of the essential viral protease enzyme required by the viruses to replicate. So they stop replication of these viruses. Protease inhibitors actually may trigger something in you, Conner, right, and remember, why have we used protease inhibitors in the past? And well, we have, they are very well studied and understood and are currently used effectively in treating HIV, hepatitis C infections. So we do have history of using protease inhibitors for antiviral infections. And now this platform, similar to mRNA, which was around again, we talked about it in the last podcast for decades, has been found to work for the COVID infection. And really, to answer your question, no, these are not brand new technologies. They’re platform that have been developed for other types of infections, but they’re being utilized or re-engineered for treatment of COVID.

Conner Mertens  09:30

Looking back, and we all know hindsight is 2020, but what did we learn from the COVID vaccines that we can apply to the treatments to it to make it better, more accessible, etc, etc.?

Robert Popovian  09:40

Conner, we have learned certain things, right. And I’m hoping that we will be able to replicate them and we are replicating them in the treatment arena. In the US government was enabled the world’s most effective shield against the worst COVID-19 by investing early and aggressively in multiple vaccines. As the pandemic becomes an endemic, similar efforts need to be sought out for therapeutic entrants in the marketplace, whether they’re antibodies or antivirals, which will enable additional wins not only for the US population, but globally as well. And that’s very important because remember, Conner, vaccines are terrific, without a doubt. And that should be the first choice. But they’re also hard to manage and handle because they require refrigeration and too hard to transport. But oral therapy, especially antivirals can be transported very simply and provided to a global population. So it is important for the US government to step up and do the same things that they did for the vaccines, which is very aggressive regulatory work, which they’ve done, but also like investment, both in the research part but also in procurement, which they have done some and also investing in manufacturing that should be done in the US. The US government needs to step up and do some of that stuff and they’re doing it and they’re doing it probably not to the extent that they did with the vaccines, but it should be done much more aggressively both for the antivirals and the antibody therapies.

Conner Mertens  11:13

And especially when we think about this thing is going to get under control eventually, but it’s not going to go away. We’ll still be dealing with it like we deal with influenza. We’re going to have to continually evolve these therapies and vaccines to make sure that we’re on top of it and hopefully preventing something like a four year or three year long pandemic from happening again.

Robert Popovian  11:31

You’re absolutely correct. That’s why we need treatments. We need vaccines to prevent but we need treatments because the reality is, as we spoke earlier on the podcast, not everybody’s going to get vaccinated for a variety of reasons. Personal choice, religious exemption, needle phobia, which is very common in adults, especially, that people don’t take into considerations. I believe, and I’m quoting Jim Cramer from CNBC, that these drugs, these therapies could be the atomic bomb that we once and for all, get rid of this infection and go back to normalcy, and it’s the game changer, in my opinion.

Conner Mertens  12:08

Well, as always, Robert, I want to make sure that you get the last word in here. Tell folks what they should take away from this episode.

Robert Popovian  12:14

Hope, number one. We have vaccines that can help you prevent. Please get vaccinated, first and foremost. If you cannot get vaccinated know that there are treatments out there, whether they’re antibody therapies or oral therapies, antiviral therapies that will help you as a patient. Hope, because pharma companies, pharmaceutical industry, the biopharmaceutical industry, the government, the Food and Drug Administration are working tirelessly to bring these kinds of therapies to you and make it accessible, as accessible as possible. And finally, hope, because I believe with having vaccines, with having therapies that work, we will one day, get rid of this epidemic and go back to our normal life. So three hopes, and I want to conclude that, be patient, we will get through this. It’s just going to take time, but everybody’s working on it. We sincerely hope that you learned something too. We love to hear from you. Send your email, or an audio clip to [email protected].

Conner Mertens  13:28

Thanks for listening to Healthcare Matters, the podcast that pulls back the curtain to help you make sense of complex healthcare economics and policy issues. As always, we invite you to go to Apple Podcasts and leave one of those honest five star ratings and write a positive review. It’s gonna help people like you find people like us. And wherever you’re listening, make sure to hit that subscribe button so you never miss an episode. He’s Dr. Robert Popovian.

Robert Popovian  13:52

And he’s Conner Mertens. As always, please talk to your physician, pharmacist, your nurse. They have better answers than any of us will. But if you need more information, please reach out to Global Healthy Living Foundation and talk to individuals like Conner, who are waiting to be able to help you out. We’ll see you all next time.

Narrator  14:16

Be inspired, supported, and empowered. This is the Global Healthy Living Foundation Podcast Network.

Narrator  00:00

Be inspired, supported, and empowered. This is the Global Healthy Living Foundation Podcast Network.

Robert Popovian  00:10

They’re helping us every day, they’re reducing hospitalizations and mortality, and don’t kid yourself, the chances of you being hospitalized or dying from COVID is much greater if you are not vaccinated. The data is very clear on that, and it has held up throughout this last 12 months.

Conner Mertens  00:31

Welcome back to Healthcare Matters, the podcast that pulls back the curtain to help you make sense of complex healthcare economics and policy issues. He’s Dr. Robert Popovian, joining us from our nation’s capital, a Pharmacist, Economist and Chief Science Policy Officer at the Global Healthy Living Foundation.

Robert Popovian  00:48

And as always across the country from Seattle, Washington, he’s Connor Mertens, one of our very finest Patient Advocates and Community Outreach Managers at the Global Healthy Living Foundation.

Conner Mertens  00:59

And listen, we’re glad you’re here for the start of season two of Healthcare Matters.

Robert Popovian  01:02

And we are really happy that you are joining us and one thing that has helped us was your feedback. We want to hear from you. And it is important for us to hear from you because it helps us hone our podcast to meet your demands. So we want to start each episode with feedback from our listeners.

Conner Mertens  01:21

Right and this week, our review comes from Mason B on Twitter who writes, “Binging the new Healthcare Matters podcasts on this otherwise painfully boring drive thru South Georgia. But low-key it’s super good and crazy informative. Everyone should go listen to it.” Couldn’t agree more Mason, thanks for your review. We invite you to go to Apple Podcasts and write a positive review and leave an honest five star rating. And wherever you’re listening, Apple, Spotify or the rest, click the subscribe button so you never miss an episode.

Robert Popovian  01:48

I love that feedback. Conner, let’s get into this week’s episode.

Conner Mertens  01:54

Robert, this week, we’re going to circle back to a topic we’ve already covered.  We want to hear a little bit more about vaccines. Specifically, what is the difference between Early Use Authorization and FDA Approval in the US market?

Robert Popovian  02:06

Early Use Authorization is a designation by the Food and Drug Administration that has been around for a long time. It is basically FDA’s version of saying that this product is still under investigation but we feel that it has enough data to support the early use by patients because the benefits supersede the risk of taking this drug, and that there’s an environment that we need this. We’ve seen a lot of discussion about Early Use Authorization and FDA Approval during this last couple of years because the initial vaccines that have been approved have actually were approved through the Early Use Authorization designation rather than the full approval. Currently in the marketplace, the only vaccine for COVID-19 that has been fully approved is the Pfizer vaccine. And the Moderna, and the Johnson and Johnson vaccine are still under Early Use Authorization but they’re being evaluated by the FDA.

Conner Mertens  03:02

And we’ve seen how effective these vaccines have been at saving lives and preventing serious illness and disease progression with this virus. What are some of the other things that are utilization? What’s this Novavax that I’ve heard about?

Robert Popovian  03:15

So Novavax is a pharmaceutical company that is developing, what I consider to be, the third vaccine in this marketplace with a different mechanism of action. It has yet to get either Early Use Authorization or approval from the FDA. But I know that the FDA is reviewing its dossier and the data to see how they may judge based on what’s currently available in the market.

Conner Mertens  03:40

What are the differences in the way that these vaccines work? Because I know the vaccines from growing up that have live cultures in them, then there’s the new technologies are relatively new that’s probably been popularized or discussed more recently, which is the mRNA vaccines. What are we seeing with these Novavax and Pfizer and all these other vaccines?

Robert Popovian  03:59

So let’s start with the first two that were approved, which is the Pfizer and the Moderna vaccines for COVID infection. The mechanism of action how they work is really through the mRNA platform. Now, mRNA platform has been around for decades and investigators and researchers have been looking into this platform to develop variety of different therapeutics. The COVID-19 vaccines were really the first time that this platform was able to successfully bring a product into the marketplace. So what is the mechanism of action of the mRNA COVID vaccines? Well, the vaccine delivers a tiny piece of genetic code from the SARS-COVID 2 virus to the host cells in the body, essentially giving those cells instructions or blueprints for making copies of the Spike Proteins.

Conner Mertens  04:49

And this is just a code, this isn’t the actual COVID virus?

Robert Popovian  04:53

That’s right. And what happens that these spikes do the work of penetrating and infecting the host cells and these proteins stimulate an immune response producing antibodies and developing memory cells that will recognize and respond if the body is infected with the actual virus. So in other words, it sends a genetic signal that creates the spike protein that then develops the antibodies for defeating the disease.

Conner Mertens  05:18

And how does that differ from some of these other vaccines that are in the marketplace now?

Robert Popovian  05:23

Good question. So the next one approved after Moderna and Pfizer was the Johnson and Johnson vaccine. And that one is considered a carrier vaccine. What is the carrier vaccine? It’s when scientists engineer harmless adenovirus virus as a shell to carry genetic code to the spike protein on the cell. The shell and the code don’t make you sick, but once the code is inside the cell, the cells produce a spike protein that creates antibodies and memory cells that protects us against the COVID-19 virus. The last one is really the Novavax one that has not yet been approved as we discussed or authorized for use, but that one is considered an adjuvant.

Conner Mertens  06:04

What’s an adjuvant? Come on, that’s a big word.

Robert Popovian  06:07

So protein adjuvant is really it contains the spike protein of the Coronavirus itself but formulated as a nanoparticle, which cannot cause disease. This is much more similar to what you mentioned ,Conner, earlier, which is the typical, you know, the less potent virus given to the patient so they can create antibodies for themselves and then hence be protected against the disease. And when the vaccine is injected, this stimulates the immune system to produce antibodies and T Cell immune responses. So in other words, I think what you were referring to earlier on, of which of these vaccines is really similar to what you remember as a child receiving, is more the Novavax vaccine that’s being developed currently.

Conner Mertens  06:50

Robert, you can see how this gets confusing to some people, because there’s so many different mechanisms and technologies and how do we know which one’s the right one for me, there’s a million questions we can ask. And the other piece of this is that we’ve seen the miles of red tape it takes for drugs and therapies to be approved. This one seemed to happen record pace. Well, how do we put people’s minds at ease that things were done right, and then these are vaccines that we can trust?

Robert Popovian  07:13

So first and foremost, you need to educate yourself and utilize the resources that are coming from sources that you do trust. So those sources happen to be, in my opinion, the Food and Drug Administration data and information from the Center for Disease Control, and the most importantly, and something that we adhere to at Global Healthy Living Foundation, anytime anyone has questions about their therapies, you should always first approach your healthcare professional that you are working with. It’s either your physician, your pharmacist, your nurse practitioner, your nurse and ask them. The reason being is that they know more about you than any other bureaucratic system in this country. And they can answer the question and tailor it to meet your needs as an individual patient. And this is something that Global Healthy Living Foundation lives by every day. We believe that tailored, customized therapies are important to patients, but so is information that is tailored and customized for the needs of that patient and you work on this every single day. You deal with our patients that you come across, and I think that that’s the best advice that we can give them. Look, people have a lot of questions. Without a doubt these vaccines were approved in a record time. But there was also very unusual circumstances where this country was going through. We were, and the world was going through I shouldn’t say just the United States the entire global community was going through. And the other thing that we have to realize is that when we went through these mechanism of action, like I mentioned with the mRNA, this platform and has been investigated for decades. It wasn’t something new that was thrown out for people to look at. People were investigating this platform for a variety of other disease areas, including infectious diseases. It just happened that they had to accelerate a lot of these therapies and these investigations. And in addition, you have to realize the regulatory body of this country, the Food and Drug Administration, was fully focused on defeating the COVID-19 virus. And when you have the complete attention of a bureaucratic body like an FDA, you are going to be able to move things along much quicker than possibly in normal circumstances.

Conner Mertens  09:27

Right, not to mention the fact that so much of the world’s money and resources and scientists and willpower was dedicated to finding this vaccine. I think that’s a perfect explanation for why we were able to get these vaccines in record time and why they’ve been so effective.

Robert Popovian  09:44

Conner, it was all hands on deck, right. It was an unusual circumstance, something that none of us had experienced in our lifetime, possibly multiple lifetimes, and hope not to experience it again in any lifetimes preceding us. At the end of the day, you’re absolutely right. It was all hands on deck, we needed to get this thing done. We had some tools in our toolbox that we reached out to and we were very fortunate that those tools worked and we were able to get ourselves into a place that, actually, we have therapies. Now, we have vaccines and hopefully one of our next episode, we talk about actual treatments of COVID-19, not just vaccines that prevent COVID-19.

Conner Mertens  10:25

I’m excited to dive into the topic about therapies rather than the prevention aspect of it, because that’s a very interesting conversation that’s had a lot of mixed reviews over the last year or two and a lot of skepticism and questions. I think the most common thread that we can put throughout this pandemic has been questions and misinformation. So, we’re always happy to help provide some of that good information. Speaking of that good information. What should folks take away from this episode, Robert?

Robert Popovian  10:48

Number one, there’s multiple ways that vaccines work. There’s not one mechanism of action. Three different vaccines that are available in the market in the US currently, that have two different mechanism of action. A third one is being developed by Novavax that hopefully will come out into the market soon. Number two, if you have questions, there’s good data with the Food and Drug Administration, and with the Center for Disease Control, but there’s better data with your healthcare professional. They know you the best. And we at GHLF believe in that the sanctity of the patient, provider patient healthcare professional relationship, and they’re going to be the ones that help you the most navigating this information. Obviously, as a patient organization we’re out there. We have individuals, like Conner, who are communicating with our patients every day, that we can help out. But for you to have the best tailored answer for your needs, reach out to your healthcare professional that you’ve worked with. So that’s the number two. And the number three thing is that don’t fret. Vaccines are out there. They’re helping us every day. They’re reducing hospitalizations, and mortality and don’t kid yourself. The chances of you being hospitalized or dying from COVID is much greater if you are not vaccinated. The data is very clear on that. And it has held up throughout this last 12 months. The most important thing is that the vaccines are out there to help you. But there are other therapies. So tune in on our next episode to learn about treatments for COVID vaccine and not just about vaccines themselves.

Conner Mertens  12:26

Yeah, and at the end of the day, I think a good lesson that I want to take away from this is talk to your doctors. Trust the vaccine, trust your doctor, trust your pharmacist, trust Dr. Robert Popovian, don’t trust your uncle on Facebook, and go get vaccinated so we can get out of this thing. I mean, get back to some semblance of normalcy soon.

Robert Popovian  12:49

We hope you guys learned something from this episode. We would love to hear from you. Send your email or audio clip to [email protected]. We want to hear from you. It is important for us to capture your feedback because that makes us better at delivering information to you as patients as consumers of healthcare professionals.

Conner Mertens  13:14

And thanks for tuning in to Healthcare Matters, a podcast that pulls back the curtain to help you make sense of complex healthcare economics and policy issues. We invite you to go to Apple Podcasts and leave an honest five star rating and write a positive review. It’ll help more people like you find us and wherever you’re listening, Apple or Spotify or wherever, click that subscribe button so you never miss an episode. He’s Dr. Robert Popovian.

Robert Popovian  13:40

And he’s Conner Mertens, please join us for our next episode.

Narrator  13:48

Be inspired, supported, and empowered. This is the Global Healthy Living Foundation Podcast Network.

Narrator  00:00

Be inspired, supported and empowered. This is the Global Healthy Living Foundation Podcast Network.

Robert Popovian  00:12

The researchers concluded that statin therapy which is used everyday by patients toward lowering their cholesterol reduced deaths by 40,000. There were 60,000 fewer hospitalizations and heart attacks and 22,000 fewer hospitalizations for strokes.

Conner Mertens  00:30

Welcome back to a new season of Healthcare Matters, the podcast that pulls back the curtain to help you make sense of complex healthcare economics and policy issues. He’s Dr. Robert Popovian joining us from Washington D.C., a pharmacist economist and Chief Science Policy Officer at the Global Healthy Living Foundation.

Robert Popovian  00:48

And across the country in Seattle, Washington, he’s my good friend, Conner Mertens, Patient Advocate and Community Outreach Manager at the Global Healthy Living Foundation.

Conner Mertens  00:58

Well, Robert, we covered a lot of ground in our first season. And as we start the new year, we’re glad you’re here too for the start of season two.

Robert Popovian  01:05

We sure are and one thing that has helped us was your feedback that we like to share to start each episode with.

Conner Mertens  01:12

Well, Robert, let’s get to this week’s review then. DRP writes, if you want to learn about how economic and policy issues impact you as an individual or patient, listen to these podcasts. Thanks for your review, we invite you too to go to Apple Podcasts and write a positive review and leave an honest five star rating. And wherever you’re listening, Apple, Spotify or wherever, click the subscribe button so you never miss an episode.

Robert Popovian  01:33

Excellent. Let’s get into this episode then.

Conner Mertens  01:39

So Robert, can we talk about how biopharmaceutical companies go about developing their drugs and how they find their value in those drugs? What are the three most important steps in the development of a drug and the evaluation of the value of that drug?

Robert Popovian  01:54

Stage one is when pharmacists discover and develop a molecule. Companies spend billions of dollars comparing the novel medicine to the standard of care or treatments.

Conner Mertens  02:04

Okay, so that’s stage one, what would stage to be in that process?

Robert Popovian  02:07

So stage two is really when the investigation of the patient outcomes comes into play. And a lot of times we have to utilize what we call clinical surrogate markers, because we cannot see the true outcome for that patient. For example, if the biopharmaceutical companies developing a medicine for treatment of hypertension, it takes years to see the effect. Therefore, they need to utilize surrogate markers like level of blood pressure to evaluate the patient. And that’s the second stage that comes into play. In some instances with certain disease areas, it is easier to look at mortality and morbidity during that time period. But in most chronic diseases, as you will know, Conner, the evaluation will depend on surrogate markers.

Conner Mertens  02:52

Right, because a lot of times with chronic disease, those symptoms present over time, and they’re exactly what they sound like chronic. So we can’t expect to see overnight results from these drugs and therefore collecting the data on the efficacy and value of it. You can’t do that overnight, you need time to create that data. Right?

Robert Popovian  03:09

Exactly. The final stage is stage three, which is when researchers are able to observe and appraise the long term value of these medicines.

Conner Mertens  03:17

Yeah, Robert, when we’re considering the cost and value of innovative pharmaceuticals, what makes time so important to that?

Robert Popovian  03:23

Well, time is a finite commodity in the biopharmaceutical ecosystem, and it is defined by patent life. And as such, there’s only limited opportunity for medicine to realize a financial return that will fund future research endeavors. So time becomes a point that the true value needs to be assessed, but it’s a finite commodity. Hence value of some of these drugs will occur years down the line, for example,

Conner Mertens  03:50

Well, before we get too far into the process of it, I think it’s going to be important for us to define value for our listeners today. What definition are we gonna be working off for the word value?

Robert Popovian  03:59

That’s a great question. Value is not only defined as a medicine having long term positive economic consequences, but also social and human benefits, such as improvements in quality of life and productivity of a patient. The focus is oftentimes on the former, which is the economic benefit and few times on the latter, which is the patient benefits.

Conner Mertens  04:18

Right Robert, and it takes a while for those patient benefits to start coming to fruition. We don’t see especially in chronic patients with chronic disease, they don’t see the results overnight from using these medications. Is that right?

Robert Popovian  04:29

That is true. Also, the societal value takes even longer. For example, in a study published in 2012, a year after the most prescribed statin lost its patent exclusivity, researchers concluded that statin therapy which is used everyday by patients toward lowering their cholesterol reduced deaths by 40,000. There were 60,000 fewer hospitalizations and heart attacks and 22,000 fewer hospitalizations for strokes in 2008. But this is important because it occurred a year after the most prescribed statin went off patent. So the true value was not published and didn’t become publicly acknowledged until a year after the product was basically lost its exclusivity.

Conner Mertens  05:14

So I guess let’s dive into that a little bit more is when these patents and what does that mean for these drugs? What does that mean for innovation?

Robert Popovian  05:21

Excellent question, because when patents end, the value of these medicines don’t end and the value continues in perpetuity, you know, we don’t stop using these medicines just because they’re off patent, they become generic. So they become biosimilars. And in fact, their utilization may increase over time. But the value is absolutely important to evaluate because another example that I always use with patients is the treatment of chronic myelogenous leukemia, CML, which is a type of a cancer, a blood cancer. It used to be that the survival time after diagnosis of CML was basically between three to five years at the time of diagnosis. Today, because of the innovation to these new therapies, the tyrosine kinase inhibitors, in one study published in 2011, patients achieved stable response and had an overall survival rate of 95.2% after eight years, which is similar to having regular life expectancy in the general population. So these medicines over time, provide demonstrable value that cannot be captured during the patent life. But it’s important for society as these products lose patents and they become generics and biosimilars, the value continues in perpetuity.

Conner Mertens  06:34

Okay, so when we’re talking about time and biopharmaceutical research, how does that evolve? How does that come about? Is there like a set process for that?

Robert Popovian  06:43

Yeah, there’s a set process. And a lot of that process is to going through regulatory approval process, which takes time, and rightfully so because we want to make sure that these medicines are safe and effective. And they’re going to basically provide the endpoint result for the patients that are promised. But again, because of this reason, we don’t see the true value of these medicines until years down the road. And unfortunately, the other problem besides time is the access to data that limits our ability to evaluate the value of these medicines. And we sometimes rely on decades old data to really see what happened to the patient while they were taking the medicine. And in the era of Twitter and Snapchat, where we have real time access to statistics regarding our social media activity, we still rely on older information to determine the prognosis or the most precarious commodity which is our health.

Conner Mertens  07:39

So Robert, today, we really discussed the concept of value, and especially time when it comes to biopharmaceutical production. But as always, we want to make sure you get the last word and kind of tell us what should we take away from this.

Robert Popovian  07:51

Conner, no one disagrees that we have a moral obligation to evaluate the price and cost of innovative biopharmaceuticals in the sphere of overall costs. There’s no doubt about it, we need to do that as a society. We all know that a small number of patients are under tremendous amount of financial pressure like never before. We’ve seen this, and there’s been opportunities for Congress to address that and we’ve talked about it in our previous podcasts. However, we need to put the price of the medicines to the long term value they deliver years later. And that’s going to be the challenge for our policymakers, is that how do we evaluate value when there’s the commodity of time, which is a very short supply, and not to lose sight of that as we’re making decisions about what drugs should be covered, what drugs should be paid for, and who should have access to those medicines?

Conner Mertens  08:39

Well, and really, that’s the challenge that I see when I’m working with patients. The benefit of these therapies is really comes from the long haul, and it’s rare that you see, you know, an overnight shift. So as Robert said, time is a very important and valuable thing, especially when you’re living with chronic disease.

Robert Popovian  08:55

Conner, that was a perfect reflection of how patients feel about their chronic diseases and the value of time. Well, we hope you learned something too. We’d love to hear from you. Send your email or an audio clip to [email protected]

Conner Mertens  09:17

And thanks for listening to Healthcare Matters, the podcast that pulls back the curtain to help you make sense of complex healthcare economics and policy issues. And we invite you to go to Apple Podcasts and leave an honest five star rating and write a positive review. It’s going to help people like you, find people like us. And wherever you’re listening, Apple, Spotify or anywhere, click that subscribe button so you never miss an episode. As always, he’s Dr. Robert Popovian.

Robert Popovian  09:41

And he’s Conner Mertens. See you all next time.

Narrator  09:46

Be inspired, supported and empowered. This is the Global Healthy Living Foundation Podcast Network.

Narrator  00:00

Be inspired, supported and empowered. This is the Global Healthy Living Foundation Podcast Network.

Robert Popovian  00:06

Some estimates say that we spend more on administrative burden in the US marketplace than actually pay for pharmaceuticals in the US market, which is astounding to me.

Conner Mertens  00:21

Welcome to Healthcare Matters, the podcast that pulls back the curtain to help you make sense of complex healthcare economics and policy issues. He’s Dr. Robert Popovian and joining us from Washington DC. He’s a pharmacist, he’s an economist, and he’s Chief Science Policy Officer at Global Healthy Living Foundation,

Robert Popovian  00:37

And across the country in Seattle, Washington, he’s Conner Mertens, a very good friend of mine, who’s a Patient Advocate and Community Outreach Manager at Global Healthy Living Foundation.

Conner Mertens  0:46

And if you’re tuning in, you know, our goal is to help simplify the complexities and healthcare economics and policy issues for you the listener. So Robert, as we start the series, it’s always exciting to read listener comments and feedback. You ready?

Robert Popovian  :57

Absolutely. This is my favorite part of the podcast to hear what other [eople to say.

Conner Mertens  01:01

Feedback this week comes from Alslas2 who writes, wonderful, what a great listen, short, concise to the point. That feedback is good.

Robert Popovian  01:10

Absolutely. We want to make it quick. We want to make it understandable for patients and individuals who listened to it to take away something important from every podcast.

Conner Mertens  01:20

Again, that review is from Alslas2. Thanks for your review. We invite all of our listeners to go to Apple Podcasts and leave an honest five star rating and a positive review. Don’t forget that wherever you are, hit that subscribe button so you never miss an episode.

Robert Popovian  01:33

So Connor, let’s start with the episode.

Conner Mertens  01:38

This week, Robert, we’re picking up on a conversation from last week, which is what is the Build Back Better plan for patients. We kind of discussed what it meant, what it does and what it’s lacking. And I always think it’s important for us to address the question of what can be done about it. How can this be better for patients? I think we should start off with that. What do you think can be done about this legislation to make it better for patients?

Robert Popovian  02:00

Thanks, Connor. That’s a great question. Commonly as policy wonks and economists, when we sit around, we complain about things and the wrong policy solutions or legislative opportunities. But we seldom do is provide input about how policymakers can do things better to improve the patient’s experience, and ability to pay for their pharmaceuticals. So in this episode, what we’re going to do, we talked about last week was, what does Build Back Better do to help patients and some of the shortcomings. But in this week’s episode, we’re going to concentrate on what can be done as part of Build Back Better or separately to really help patients when they show up to their pharmacy in their next visit to pick up their medicines. So one of the things that we want to talk about is, for example, what the federal policymakers should have done is to outlaw rebate contracting in the marketplace for pharmaceuticals. Rebate contracting has many issues with it. It creates misaligned incentives in the market where more expensive drugs are preferred over less expensive medicines, which is not intuitive because at the end of the day, the whole purpose of having an insurer, insurance card or a pharmacy benefit manager overlooking your insurance, your pharmacy benefits, is to cover the less expensive medicines first. But for the minimum, what they should have done if they couldn’t outlaw the rebate contracting model is taken all of the rebates, concessions, fees, everything that is collected by pharmaceutical industry, by the pharmacy benefit managers, and the insures and pass that back to the patient at the point of sale when a patient has a coinsurance or deductible for the medicine that they’re paying for.

Conner Mertens  3:50

And I think that this is especially important in the instances when we’re talking about Medicare. QWhat else can be done about Medicare, you know, something that constantly comes up and I think we’ve mentioned last week, was about letting Medicare negotiate prices. It’s a wildly popular and bipartisan idea.

Robert Popovian  04:06

Yeah, I think negotiation is fine. We just have to be worried about what the consequences of that negotiation would be with regards to the impact on research and development, introduction of new therapies in the marketplace and access to the current therapies that are available. In addition, we need to be honest about it. Negotiation is not going to lead to lower out of pocket costs for patients in any way, shape, or form. In fact, it’s a false promise. What Medicare should have done, in fact that they didn’t do it Build Back Better and we talked about it a little bit is to create a better model where they have audit rights of the pharmacy benefit management and insurance companies books to be able to say what is the amount of concessions, fees, rebates that they collect from the biopharmaceutical industry and what percentage of that is being passed back to the plan sponsor, whether it’s the government, employer or directly to the patient. It is just mind boggling how the largest payer of biopharmaceuticals in this country, the federal government, has no audit rights, and oftentimes relies on faulty data, which are dated, or is based on estimates, or based on worse, testimonies of PBM or insurer, pharmacy manager or insurer executives, and they rely on those type of data points to make these massive policy decisions. So that was a big mess here that the federal government didn’t mandate audit rights of the books of the pharmacy benefit management companies and insurers to see where the money flow is going. But again, what we need to do is keep our eyes on the balll. We need to help patients and what would have helped patients is to be able to make sure that they get all of the concessions that is gained on their behalf through negotiation with the biopharmaceutical companies at the point of sale, when they show up to the pharmacy counter the next time to have to pick up the medicine.

Conner Mertens  06:06

And I think that when we discuss things about audit rights, and then the ability to even check on the transparency in the supply chain. This is something that should be done in the bill and things like outcomes based reimbursements for medicines or mandating pharma explains their pricing structures. What are some other ways that can be done to increase the transparency?

Robert Popovian  06:26

Connor, you’re absolutely right, that’s another missed opportunity with regards to the pharmaceutical industry and keeping their feet to the fire to make sure that when they bring products into the market, they deliver the outcomes that is promised to the patients. So one of the ways that Build Back Better would have been better, in fact, was to institute what is called outcomes based contracting or mandate outcomes based contracting for certain medicines that rely on outcomes for patients that may be questionable, or perhaps outcomes that are very unique. And these medicines cost a lot of money and the only way they should be reimbursed, if they deliver the outcomes that was basically promised to the market when the product was brought and marketed for patients. So that’s one opportunity. The second opportunity is really to have pharma companies explain their pricing model in a transparent manner. For some odd reason, we’ve created cottage industry after cottage industry of trying to estimate what the net price of the drug is. While we know that the pharmaceutical industry is the best proponent of how they brought the product and how they priced it. And for some odd reason, they’re not able or unwilling to explain their pricing models transparently in a marketplace and hence they create these cottage industries, such as Institute for Clinical and Economics Research, ICER, or ASR Health or IQVIA, which end up estimating all of these net expenditures, instead of coming out publicly and saying, look, I priced the medicine as x and this is why I priced the medicine as x, let me explain it to you and do it in a very analytical fashion rather than just bunch of rhetoric and words. Those are two missed opportunities that would have helped the marketplace, would have kept the by pharmaceutical industries feet to the fire and ensure that we have a better understanding how products are not only priced but that they deliver the outcomes that they have promised to the patients.

Conner Mertens  08:32

When we’re talking about focusing on outcomes rather than bottom lines, I think that it’s super important for us to wade into discussions of admin burdens, and that includes step therapy or non medical switching formulary exclusions, all topics that we’ve covered in past episodes, don’t forget to check them out, leave a five star rating. But I think that this bill should include some more admin, lightening the load for admin as far as prohibiting non medical switching or formula exclusions. What do you think?

Robert Popovian  8:58

That’s a third miss, right. So you brought up another thing that this legislation doesn’t address, which is the burden of, administrative burden in the United States, which is exorbitant. In fact, some estimates say that we spend more on administrative burden in the US marketplace than actually pay for pharmaceuticals in the US market, which is astounding to me. Again, there are ways to reduce the burden to create more transparency when policies such as non therapeutic switching or therapeutic substitution are in place or to create transparency of why formularies for some odd reason, are covering more expensive brand name drugs instead of the same generic that is available. In fact, in some cases, an authorized generic which is manufactured by the same brand company. These are the type of things that would help create a better marketplace not only to be able to create some transparency and understanding of how, which medicines are covered, but it is also important for us to be able to reduce the burden of administration of healthcare benefits, which costs billions of dollars. And it’s unnecessary cost that doesn’t provide any kind of help for patients or improves the patient’s health.

Conner Mertens  10:15

So right now, there are other pieces of legislation that do impact some of these issues, we brought up the Safe Step Act can combat step therapy, or the No Surprises Act and things like that. But what I think the Build Back Better plan misses is the ability to do it in a sweeping manner that would impact a lot of folks at one time. And a topic we discussed a lot is the ability of federal legislation to impact more patients than is on the state level. But I think it is important for us, as you mentioned, maybe in the last episode, where there are state models for a lot of these things that we should be looking to. Robert, I really appreciate us diving into what should be done. What do you want folks to walk away with?

Robert Popovian  10:52

Connor, a few things. Number one, Build Back Better plan has some good parts, but it misses the main point, which is to help patients with their out of pocket spending when they show up to the pharmacy the next day after it passes through legislation. There are better ways to help patients with their out of pocket cost reduction that we are trying to propose through Build Back Better. One way would be to eliminate rebate contracting or for the minimum to make sure that all of the rebates, concessions and fees are passed back to the patient at the point of sale at the pharmacy counter when they are about to pick up their prescription. Two, what we should have done through Build Back Better is institute policies such as outcomes based reimbursement or better transparency on how drugs are priced. And instead, we didn’t do that. We walked away from it and that was a big miss. And the third big miss, frankly, is what we talked about, which is reduction and administrative burden in the US marketplace. Our healthcare professionals, our healthcare system is burdened with huge impact through these type of administrative issues. And unless we address that, we’re not going to be able to reduce healthcare costs meaningfully in the United States. So the three things that we would promote and propose that needs to be done to really help patients create better transparency, provide audit rights for the government and finally, to reduce the administrative burden on healthcare professionals are things that would have meaningfully helped the health care system. We hope you learned something too. We’d love to hear from you about the Build Back Better plan and how it should be improved. Send your emails to Healthcare Matters at GHLG dot org. Or better yet, include a short video or audio clip.

Conner Mertens  12:46

And who knows, whatever you share may be included in our listener feedback portions in future episodes. Thanks for listening to Healthcare Matters, the podcast that pulls back the curtain to help you make sense of complex healthcare economics and policy issues. And don’t forget, if you like this episode, or love this episode, please go to Apple Podcasts and leave an honest five star rating and positive review. And wherever you’re listening, don’t forget to click the subscribe button so you never miss an episode. As always, he’s Dr. Robert Popovian.

Robert Popovian  13:14

And he’s Conner Mertens, sitting there in Seattle, Washington thinking, when is the NFL season going to be over? See you all next time.

Narrator  13:25

Be inspired, supported and empowered. This is the Global Healthy Living Foundation Podcast Network.

Narrator  00:00

Be inspired, supported and empowered. This is the Global Healthy Living Foundation Podcast Network.

Robert Popovian  00:10

It is a major issue for consumers. Everyday patients, through any fault of their own, are not able to afford their medicines. And it does cause some complications down the road if they’re not taking their medicines because of this outrageous out of pocket cost that they have to pay.

Conner Mertens  00:28

Welcome to Healthcare Matters, a podcast that pulls back the curtain to help you make sense of complex healthcare economics and policy issues. As always, I’m joined today by my partner in crime, Dr. Robert Popovian, joining us from Washington DC. He’s a pharmacist, economist and Chief Science Policy Officer at the Global Healthy Living Foundation.

Robert Popovian  00:47

And across the country in Seattle, Washington, he’s my good friend, Conner Mertens, Patient Advocate and Community Outreach Manager at the Global Healthy Living Foundation.

Conner Mertens  00:56

And our goal is to help simplify the complexities in healthcare economics and policy issues for you the listener. So Robert, as we start this new series, it’s always exciting to read the listener feedback in the comments. You’re ready for one?

Robert Popovian  01:08

Absolutely. Let’s do it.

Conner Mertens  01:10

First, our feedback comes from obvious MTA fan, “Tickets please!” writes, smart people and much needed, this is how you talk about healthcare. Finally a way to understand things better. And again, that review is from “Tickets please!” Thanks for your review. And we invite all of our listeners to go to Apple Podcasts and leave an honest five star rating and a positive review. And don’t forget, wherever you’re listening, click that subscribe button so you never miss an episode.

Robert Popovian  01:36

Terrific. Let’s get into this episode then.

Conner Mertens  01:42

So Robert, today, we’re going to be chatting about something that is quite topical. Let’s talk about the Build Back Better plan. It’s been kind of up against the ropes since its inception with a multi trillion dollar original price tag. It has a ton that can truly help people everyday folks. Why don’t you tell us, what are the good things about this bill that can help patients?

Robert Popovian  02:02

Well, it does three things, two of them specifically for patients and another one, which is a positive sign for the entire industry. Number one, it caps out of pocket costs for Medicare Part D patients at $2,000 per year. And this is important because, Conner, as we’ve discussed in the past episodes, Medicare Part D is the only insurance entity probably throughout the country that doesn’t have a cap for out of pocket costs for patients. You and I have private insurance and we all have caps for our out of pocket costs for both our healthcare services and our biopharmaceuticals and Medicare Part D is an anomaly and this is going to be fixed through this legislation. The second thing it does that also is going to help patients, specifically patients who have diabetes and are insulin dependent, is going to allow to have a cap on insulin out of pocket costs. Now there’s some discussion about whether the cap number is really a good number or bad but there is a cap now, so patients are not going to be overly exposed to out of pocket costs as they have been in the past. And finally, it does the third thing, which is good for the system, it starts introduction of some type of reporting transparency, that the pharmacy benefit managers and the insurers have to provide how much dollars they sort of like, recoup from the industry in form of rebates, and concessions and fees and everything else which is going to create a little bit less opaqueness of the system, as currently we have it and create a little bit more transparency, which is sorely needed in this marketplace.

Conner Mertens  03:37

But an everyday patient, how would this bill’s passage affect their everyday? What would that look like?

Robert Popovian  03:42

Well, that’s going to be the challenge here, Conner, I think if you’re a Medicare Part D recipient, now you have some certainty that you’re not going to exceed a certain dollar amount per year for out of pocket costs for your biopharmaceuticals. If you’re an insulin dependent diabetic, now you have a mechanism that there’s going to be some caps placed on your out of pocket costs for your insulin, which as you well know they need that medicine to stay alive. But unfortunately, what it doesn’t do, it doesn’t provide immediate relief for patients who show up to the pharmacy after the legislation has passed in form of lowering their out of pocket costs. And that’s the one thing that I think most patients will tell you is the one that bothers them the most. The patients really care about what they pay out of their pocket when they show up to the pharmacy counter. And this legislation does not address that. And that’s the key here because unless we are able to address that issue, a lot of the other components of the legislation really fall apart. For example, if you look at Kaiser Health Care Foundation, they’ve done surveys over the years of asking patients what they believe about government intervening in drug pricing in form of negotiation. And overwhelmingly it had bipartisan support. When you ask consumers who do the polls, they tell Kaiser Healthcare Foundation that yes, in fact, they do want government intervention in drug price negotiation as a way of intervening. And it’s a bipartisan support, by the way. Unfortunately, what Kaiser Healthcare Foundation and a lot of the other outlets don’t cover is the second, third and fourth question that is commonly asked in the same survey, because what the consumers that take the survey point out to overwhelmingly is that the only reason the government should intervene in any type of drug pricing negotiation or any kind of drug pricing management is if it helps the patients immediately when they show up to the pharmacy counter. That means don’t do anything, unless you’re going to help me as a patient when tomorrow I go to Joe’s Pharmacy and have to pick up my prescription. The second thing that the consumers tell us clearly, is that don’t mess around with the research and development model as it exists. As consumers, they still want to have new medicines come into the market. And they don’t want any kind of impediment that’s going to discourage investment in that portion. And finally, what they tell us also is that if you’re going to intervene, you better make sure that my access to the current medicines I’m taking is not going to be curtailed. That means there’s not going to be situations where formularies or pharmacy benefit managers and insurers are going to start restricting access to the drugs that I am on currently. So yes, this bill does some good things. It doesn’t go far enough to help patients when they show up the next day at the pharmacy counter. That’s the one thing that patients really want is savings out of their pocket immediately after the passage of this legislation. But this legislation is not going to do that for them.

Conner Mertens  06:52

We must have been reading the same article because I was seeing some of those same points where somewhere around 70- 78% of Americans think the government ought to do more in intervention of health care plans. And following up to your point of folks wanting to see the immediate changes to the skyrocketing costs of medications. 44% of patients report skipping filling prescriptions because of their high costs. And we know better than most that when folks aren’t adhering to their medications, they can have severe consequences to their short term and long term health. So you started to dig into the parts that don’t go far enough. And we started to talk a little bit about transparency. I’m wondering, does this bill address better data keeping that can help with the transparency?

Robert Popovian  07:36

Not necessarily. I mean, it introduces this concept, but I would venture to argue that states have better transparency bills or legislation that has been intact for a few years. And in fact, the federal government should be following those states, including the state of California, which has published data for the last three years from pharmacy benefit management companies and insurers with regards to what is the impact of spending on drugs, on premiums and specifically, what is the impact of rebates and everything else on premium. So I said it’s starting, but it’s unfinished, I want to say one more thing out. Out of pocket costs is a major issue for consumers. Everyday patients through any fault of their own, are not able to afford their medicines, and it does cause some complications down the road if they’re not taking their medicines because of this outrageous out of pocket cost that they have to pay. So that should be priority number one for anyone, whether it’s a policymaker, and a healthcare professional, or an insurer or pharmacy benefit manager or a patient group to address because unless we address that everything else falls apart.

Conner Mertens  08:47

And, Robert, you mentioned something earlier that I think I want to dive into a little bit more, which was the potential of this impacting innovation in the marketplace and this kind of boogeyman that that we hear about, is this something that holds water? Or is this something that we should be worried about and taking into account when considering this bill?

Robert Popovian  09:03

Conner, I think it’s a given that if legislation as constructed currently passes, that it is going to impact research and development and introduction of new therapies in the marketplace. The data is very much solid. And it comes from the Congressional Budget Office. It comes from research done by congressional staff. It comes from private sector research has been done that in fact, this legislation, as is constructed will impact research and development. So we are going to have fewer medicines coming to the market in the next decade or two decades. The argument boils down to, what is the real impact. That means are we talking about 10 drugs, are we talking about 20 drugs or we’re talking about 30 drugs over 12 months, 36 months, so on and so forth. Without a doubt this bill is going to have a negative impact as investment is going to go down from the pharmaceutical industry with regards to new research and development and new products coming to the market. The only argument here, or the only discussion or disagreement, is what is the real impact. What we’ve seen from both congressional staff Congressional Budget Office, CBO, as well as the private sector that the range is between 10 new introductions of new therapies all the way to 30 to 60 over the next couple of decades. What does this mean to patients? Well, it depends. Because as revenue shrinks and ability to invest in new therapies goes down, the pharma companies, biopharmaceutical companies, are going to be hindered to invest in areas of unknown impact. What does that mean, is that they’re going to invest less in areas that there’s more uncertainty, whether or not they’re going to have successful medicines coming out in the marketplace. So you will see a lot more investment in areas of oncology, perhaps, and therapeutics that are known versus maybe investment in neurology or Alzheimer’s, areas that have been fraught with failures of new medicines coming out. So that’s another thing that consumers, patients should take into consideration because the data is very clear. And it’s not data coming from one entity. It’s coming from multiple entities that really have no way of biasing the information. The only a matter of question is not the impact of R&D but what is the level of impact.

Conner Mertens  11:23

Well, thanks for parsing through that with me, Robert, I’m really excited to dig into part two of this episode, which you can catch next week, which will be answering the questions, what should be done about this? And before we get to that episode, I want to make sure you get the last word in here, Robert, what do you think?

Robert Popovian  11:36

Conner, we need to help patients with our out of pocket costs. That’s why they want government to intervene and sort of get involved in the drug pricing discussion. The problem is that this legislation solves some of the issues, but also leaves a lot of unknowns, and also doesn’t solve the major problem for consumers which is, when I show up to the next day, at again Joe’s Pharmacy, am I going to pay less out of my pocket for my drugs, and that is not going to be the case, and consumers are going to become frustrated, as they’re going to realize they’re not saving any money out of pocket. There’s definitely impact on research and development that’s going to happen. It’s just a matter of what the number is, not whether or not it’s going to impact research and development. But more importantly, the other thing that it doesn’t do, which alluded to, it does create some transparency, but doesn’t go all the way. I would have hoped that the government, as the largest payer would have instituted within this legislation, laws and regulations that mandates that PBMs and insurers open up their books completely and provide audit rights to the federal government, because federal government, at the end of the day is the largest purchaser of biopharmaceuticals in the United States. So it’s a glass half full, but we need to do better. And we need to do better because patients are being harmed. And that’s what we care about and we need to take care of our patients. We hope you learned something too. We’d love to hear from you about the Build Back Better legislative plan and the impact on biopharmaceuticals access for patients and out of pocket costs. Send your emails to Healthcare Matters at GHLF dot org. Or better yet included a short video or audio clip.

Conner Mertens  13:28

And who knows whatever you share may be included in our listener feedback portion of future episodes. Thanks for listening to Healthcare Matters, a podcast that pulls back the curtain to help you make sense of complex healthcare economics and policy issues. And if you liked this episode, please go to Apple Podcasts and leave an honest five star rating and a positive review. Wherever you’re listening. Don’t forget to click the subscribe button so you never miss an episode. As always, he’s Dr. Robert Popovian.

Robert Popovian  13:55

And he’s Conner Mertens, the number one Patient Advocate in this country. See you all next time.

Narrator  14:01

Be inspired, supported and empowered. This is the Global Healthy Living Foundation Podcast Network.

Narrator  00:00

Be inspired, supported and empowered. This is the Global Healthy Living Foundation Podcast Network.

Robert Popovian  00:10

There is some action that can be taken to prohibit this type of practice, or at least for the minimum, to mandate that pharmacy benefit management companies and insurers that are doing and implementing such policies are held accountable.

Conner Mertens  00:28

Welcome to Healthcare Matters, a podcast that pulls back the curtain to help you make sense of complex healthcare, economics and policy issues. He’s Dr. Robert Popovian, joining us from Washington DC, a pharmacist, economist and Chief Science Policy Officer at the Global Healthy Living Foundation.

Robert Popovian  00:45

And across the country in Seattle, Washington. He’s Conner Mertens, Patient Advocate and Community Outreach Manager at the Global Healthy Living Foundation.

Conner Mertens  00:54

Thanks for tuning in. You know our goal here is to help simplify the complexities in our very complex healthcare economics and policy system. So Robert, as we start this new series, it’s always exciting to hear our listener comments. Are you ready for that?

Robert Popovian  01:08

Absolutely. Let’s do it.

Conner Mertens  01:09

Alright, so some listener feedback from Kmeg P, who writes insightful podcasts, very easy to listen to and easily digestible for individuals who are looking for a tutorial on policy and economic issues that impact patients. Will definitely be tuning in and again. Thanks for your review and thanks for listening. We invite all of our listeners to go to Apple Podcasts and leave an honest five star rating and a positive review. And wherever you’re listening, make sure to click the subscribe button so you never miss an episode.

Robert Popovian  02:00

Excellent. Let’s get into this episode now.

Conner Mertens  02:04

Well, today, Robert, I’m really excited to dive headfirst into the world of drug formulary exclusions. Why don’t we just start with what does it mean, what is a drug formulary exclusion?

Robert Popovian  02:13

So Conner, drug formulary exclusions are when a pharmacy benefit manager or an insurer decides to exclude medicines that have been on formulary for many decades or years or months and replace them with alternatives such as generics or other drugs that have similar capabilities. But the problem with the exclusions is that it impacts patients and that’s what we’re here to talk about, what is the impact on patients?

Conner Mertens  02:40

Robert, maybe tell me a little bit more about who implements these, and how they benefit from it.

Robert Popovian  02:45

So the pharmacy benefit managers or the insurers are the ones that implement them and they exclude these medicines from the formularies. And the benefit truly goes to the pharmacy benefit managers, because by excluding certain type of medicines from formularies that patients are taking, they’re able to extract even more concessions from the pharmacy by pharmaceutical companies. And at the same time, they’re able to cut their costs. But the question is, what is the impact on the patient?

Conner Mertens  03:14

And I think that we can start to parse through that by asking what kinds of drugs are most likely to be excluded from formularies?

Robert Popovian  03:21

All kinds of drugs. I mean, if you look at the most recent exclusions that have been promoted by either Optum pharmacy benefit management company, or ESI, which is Express Scripts, pharmacy benefit manager company, they include almost all types of classes on medicines, so there are specialty drugs such as cancer drugs, or drugs for treatment of hepatitis C, all the way to drugs that are relevant for treatment of diabetes, such as certain insulin products.

Conner Mertens  03:50

So obviously, we work with folks living with chronic disease, it sounds like they’re going to be really impacted by these formulary exclusions.

Robert Popovian  03:57

Exactly. And that’s been the problem for years. So this is not a new phenomenon. This has been going on for over a decade now when exclusions have been happening. And it’s like clockwork, when the fall comes, football season starts, formulary exclusions take place and the announcements come out of these three large pharmacy benefit management companies which are Optum, CVS Health and Express Scripts. And every year more and more drugs are being excluded from these formularies. The problem is that nobody knows what happens to these patients. Nobody knows if a patient that is stable on these therapies ends up in a hospital, becomes non adherent to their therapy. And it’s an unfortunate situation because they put the patient and their provider in a very difficult situation because they end up changing and meddling into what is best for the patient and the best care. And the worst part, Conner, to me is that they do not have any mechanisms of going back and seeing what are the consequences of their actions. In fact, they probably don’t want to see what the consequences of their actions are. What they do is that they push this back on the patients and their providers to manage.

Conner Mertens  05:09

So just to clarify a little bit more, if a patient is steady on a medication that’s working for them, and their formulary changes, they can be kicked off that medication? What happens then if these are essential for quality of life or day to day living for patients?

Robert Popovian  05:22

You’re right, that’s what exactly happens. A patient is stable on a drug that they may have been on for a year, decades, months. And because of this exclusion now, this product is no longer available for them. What has happened is that the patient ends up going to their provider, a physician, a pharmacist, a nurse practitioner, and has to be now put on a new therapy with unknown consequences. And that’s the problem, because who’s going to bear the burden of the risk of these type of formulary exclusions, it’s certainly not the pharmacy benefit management company, or the insurer. They’re pushing this risk back on to patients by having poor quality of life or side effects or not having their disease managed appropriately. And they’re pushing this burden on their providers, to the pharmacists, to the nurse practitioner, to the physician to the physician assistant to manage these things. They are the ones that are culpable for all of the activity, but they bear none of the risks

Conner Mertens  06:28

And in bearing none of the risk, it’s also sounds the only thing that’s being taken into account here is a bottom line, and not the drugs efficacy or side effects or outcomes or the doctor’s treatment plans. So ultimately, the care of a patient is being taken away from the doctor just because of some moving numbers in drug names on a formulary. Is that right?

Robert Popovian  06:48

Exactly. I mean, the reason that they’re excluding these medicines, as I started to say in the beginning of this podcast is because they can then garner more concessions by pharmaceutical companies, and they get all the benefit of the cost savings of the bigger concessions and all the other stuff. And then they push the risk upon the patient and providers to manage that risk. And it is an unfortunate situation. And the least they can do is ensure that patients are not falling through the cracks. And in fact, their care is not being undermined, through their policies.

Conner Mertens  07:26

From my understanding these exclusions put out by PBMs are less mandatory and more suggestions. So why do plan sponsors tend to listen to these suggestions? I think you’re starting to get into that, what’s the incentive for them to follow these guidelines?

Robert Popovian  07:42

There’s two reasons that the plan sponsors go along: one because they do get some of those concessions that come back to the pharmacy benefit managers and the insurers. They pass some of those concessions back to the plan sponsor, whether it’s the insurer or the employer. But more often than not, the reasons that plan sponsor, especially employers go along with this type of policies, is because they don’t know any better. They are expecting the experts within the pharmacy benefit management companies and insurers to do the right thing, and to help care for their employees. And more often than not, that’s not the case. And unfortunately, they need to become much more wise and start asking questions. But it’s not just the employees, it’s the government because this happens within the government side too, right, with Medicare Part D plans, and so on and so forth. So everybody needs to be more transparent, ask more questions, be more vigilant and push the pharmacy benefit management companies and insurers to explain why are they taking such actions that are so drastic, that are going to compromise the patient’s care.

Conner Mertens  08:48

So aside from educating folks on all sides of the healthcare system, the patients, the providers, our doctors, what’s being done about this practice, who’s protecting these patients from these life changing exclusionaries?

Robert Popovian  09:00

Nothing really has been done on the federal side. And that’s the unfortunate place. As I said, this is an annual event that takes place, everybody looks at the numbers, the numbers keep growing of the exclusions, and we just go on to the next year and the year after that, but nobody knows what happens to these patients. So is there some action that can be taken, absolutely. There is some action that can be taken to prohibit this type of practice, or at least for the minimum, to mandate that the pharmacy benefit management companies and insurers that are doing and implementing such policies are held accountable. And that’s through finding out what happens to the patient after these exclusions take place. Maybe nothing happens to the patient, and that’s a good thing. But if it does, then who bears the risk? And we don’t know that because nobody wants to take that responsibility.

Conner Mertens  09:51

You know, for me, this is something patients face all the time with some sort of certainty like death, taxes, formulary exclusions and probably the Mariners missing playoffs, but this practice needs to be made more well known, and we need to figure out ways to educate folks about it. But as always, I want to make sure you get the last word in your Robert, what what should folks know about this?

Robert Popovian  10:26

It is about time for policymakers, patients, employers, the government to keep these pharmacy benefit management companies and insurers accountable. And to make sure that practices like formulary exclusions that are done on an annual basis, again, have some type of a mechanism that we can follow through to ensure that the patients are not being harmed. Instead, what we keep doing is that we look the other way, and we have no idea what happens to the patient. And all of the burden is then passed on to them, to their caregivers, and to the healthcare professionals that take care of them. And this is a very unfortunate situation. So education and action by people who need to step up and keep the pharmacy benefit management companies and insurers accountable for these practices, which for far too long have been going on. And all we have done is turn the other way. We hope you learned something too from this podcast. We’d love to hear from you about forumlary exclusions and the burden that are placed on patients and their healthcare professionals that take care of them. Send your email to HealthcareMatters at GHLF dot org. Or better yet, include a short video or audio clip.

Conner Mertens  12:18

And if you’ve had experience with formulary exclusions, let us know and who knows, whatever you share may be included in our listener feedback portion of future episodes. Thanks for listening to Healthcare Matters, a podcast that pulls back the curtain to help you make sense of complex healthcare economics and policy issues. If you like this episode, go to Apple Podcasts and leave an honest five star rating and a positive review. And wherever you’re listening, don’t forget to click the subscribe button so you never miss an episode. As always, he’s Robert Popovian.

Robert Popovian  12:50

And he’s Conner Mertens, the most frustrated Mariners fan. We’ll see you next time.

12:58

Be inspired, supported and empowered. This is the Global Healthy Living Foundation Podcast Network.

Narrator  00:00

Be inspired, supported and empowered. This is the Global Healthy Living Foundation Podcast Network.

Robert Popovian  00:10

So one cannot exist without the other. But the most important thing is that it allows us to be able to really concentrated on the patient and bring the specific drug to the patient, which is the right drug to the right patient at the right time.

Conner Mertens  00:29

Welcome to Healthcare Matters, the podcast that pulls back the curtain to help you make sense of complex healthcare economics and policy issues. He’s Dr. Robert Popovian, joining us from Washington, DC, pharmacist, economist and the Chief Science Policy Officer at the Global Healthy Living Foundation

Robert Popovian  00:45

Across the country in Seattle, Washington, he’s Conner Mertens, Patient Advocate and Community Outreach Manager at Global Healthy Living Foundation.

Conner Mertens  00:53

And listen, our goal is to help simplify the complexities in healthcare economics and policy issues for you. So Robert, as we start this new series, it’s always exciting to hearing from the listeners, you’re ready to read a listener comment?

Robert Popovian  01:05

Absolutely. Let’s get to it.

Conner Mertens  01:07

But first, Alex Gic writes, this is a great podcast that is quick hitting and spot on, easy to follow with all the excess technical terminology. That’s what we try to do, right Robert?

Robert Popovian  01:17

Absolutely. That’s what we try to do to make it easy and make it short, so people understand and they can become advocates for themselves.

Conner Mertens  01:26

And again, that review is from Alex Gic. Thanks for tuning in. We invite all of our listeners to go to Apple Podcasts and leave one of those honest five star ratings and a positive review. And wherever you’re listening, click the subscribe button so you never miss an episode.

Robert Popovian  01:40

Terrific. Let’s get into this episode.

Conner Mertens  01:44

Robert, you wrote about a very important distinction in healthcare, one that I often hear from our patients talk about, but even I’m a little clueless. We often hear about precision and personalized medicine. And maybe I’ve been guilty of using it interchangeably myself. Can you tell us what is personalized medicine? We’ll start there.

Robert Popovian  02:03

Hey, Conner, it’s not uncommon for individuals to mix up the two definitions. And I’ll tell you why. Because they’re so much intertwined concepts that go along with precision and personalized medicine. So what is personalized medicine? Let’s start with that. Personalized medicine has happened every day as physicians, pharmacists, nurses practice healthcare. And this is when a healthcare professional looks at the patient and really decides what is the best way to care for that individual, as an individual. And this is very important because everybody has different needs. Let’s say for example, you need a blood pressure medicine. A physician may choose among a vast array of medicines that they have available to them, but they can take a look at you and see okay, well Conner, for example, is a younger person who works full time, he doesn’t have time to worry about taking the medicine three times a day. So what I may want to do is prescribe something that is once a day for him to increase the opportunity of him being more compliant with his medicine, his or her medicine. And in this case, this is not different, for example, arthritic patient who may have so severe of arthritis that is not capable of infusing their medicine on their own injecting themselves with their therapies and instead requires an oral therapy to be given to them. So personalized medicines have happened for a very long period of time, we’ve been doing personalized medicine for everyone and physicians, healthcare professionals have been practicing this by individualizing the cares of the patient based on their needs.

Conner Mertens  03:33

Seems like every doctor should be practicing personalized medicine, it’s the most important way to make sure that care is focused on the patient and not some other arbitrary treatment plan. How does this differ from precision medicine?

Robert Popovian  03:47

I do agree that everybody should be personalizing their medicine and the care they give their patients. Unfortunately, there’s a lot of times that due to unbeknown circumstances out of the control the healthcare professional actually, that is caring for that patient that a lot of times the care that they provide to the patient becomes cookie cutter and that’s because of all of these middle people like insurers and everybody else who wants to intervene into the practice of medicine. Now let’s go back to the second question you asked which is the Precision Medicine. What is precision medicine? Well precision medicine is the principle that describes how genetic information about a person’s disease is being used to diagnose or treat an illness. It is also an approach to discovery and development of new medicines, which integrates genetic information that helps researchers understand which particular subgroup of patients will most likely benefit from this treatment. My background as a pharmacologist is infectious diseases and I worked a lot with antibiotics on antibiograms. We used to use antibograms to identify which antibiotic would work best for the patient based on the sensitivity of that medicine to the bacteria that they may have. So it’s been going on for a while, but the true evolution of precision medicine came about about half a decade or so when we were able to sequence the human genome, giving us a better understanding and underlying disease in such areas as oncology and immunology. And the more we found out about cancer as a disease in the genome, and the more we learned about tumors, we were able to find that each tumor has its own genetic makeup. And in some companies, greater than half of the investigational medicines today are coupled with specifically bringing products in that treat a specific mutation of a genome that then treats the cancer itself. And it relies on this type of therapy. And that’s why we call it precision medicine, because it’s precisely affects that disease in that patient instead of being like a scattershot.

Conner Mertens  05:48

Right, and like you mentioned earlier, especially folks living with chronic disease, these are very important phrases and topics for them. And I’ve certainly fallen into the trap of using these phrases interchangeably myself. Robert, why is the distinction important? Why is it so important to patients to know what one means and the other means?

Robert Popovian  06:06

The reason it’s important because they’re also intertwined, because you have to do precision medicine but you also have to bring the personalized level of medicine to the patient. As I was explaining, you know, even though it’s very important to pick the right medicine for patient to precision therapy, but if that person therapy is not going to be able to be taken by that patient, because for example, what we just talked about, if it’s arthritic patients who cannot inject themselves, and they require oral therapy, then you need to basically change the course and use something different that will fit the best needs of that patient. So one cannot exist without the other. But the most important thing is that it allows us to be able to really concentrate on the patient and bring the specific drug to the patient, which is the right drug to the right patient at the right time. And that’s why they need to work cohesively together as partnerships between precision medicine and personalized medicine to really take care of patients on an individual basis.

Conner Mertens  07:05

All right, Robert, thanks to you we’re all experts on precision and personalized medicine. Tell us what is the importance of personalized and precision medicine? What are the positive benefits of doctors using these tactics?

Robert Popovian  07:17

It’s to stop treating patients as homogeneous individuals and become heterogeneous. Each individual is very different. And that’s why physicians and scientists and pharmacists and everybody else has to look at an individual patient and be able to treat them. The fortunate part is that there’s more and more investment going both in personalized medicine and precision medicine. A few years ago, we passed the 21st Century Cures Bill that incentivize even more development of precision medicine and ability to bring more of those types of therapies into the marketplace. Now it is up to the healthcare professionals to be able to take those medicines that are precisely used for certain diseases and apply them to the patients that really need them on a personalized level. And that’s what’s the most important thing is to be able to work symbiotically between the two concepts and bring the best care to that patient.

Conner Mertens  08:06

In the work that we do being patient advocates or a pharmacist, we’re always trying to find better health outcomes for patients. How can precision and personalized medicine improve the health outcomes for patients?

Robert Popovian  08:17

It’s through education, so that you can pick the right drug for that patient and provide them the right care at the right time. Without that ability to do that what you’re doing is basically providing a cookie cutter solution to an individual. We know that each individual is very different. I may be the same as a human being as anybody else in my age group, but I have different needs and different wants, from what I need. And my genomics are all different. And I’ve may be affected by therapies differently. So each individual has to be done. And patients should require their healthcare professionals to think about it from that perspective. So not only give them the precision type medicines to treat their disease, but also treat them as an individual to make sure that they get the best care.

Conner Mertens 9:05

Well, as always, thanks, Robert. You know, I’m not going to be using precision or personalized very interchangeably anymore. As always, I want to make sure you get the last word. What’s your patients Know?

Robert Popovian  09:10

Understanding the differences between precision and personalized medicine will bring about a transformation in practice medicine, which is very important for patients. This moves us away from one size fits all in treating serious diseases. especially chronic diseases. Supporting policies that advance these two concepts would bringing life saving therapies for patients waiting for the next cure in the deadly diseases that they face. We hope you learned something too. We’d love to hear from you. Share your ideas about precision and personalized medicine that your healthcare professional may have talked to you about or provided you and send us an email and better yet, including a short video or audio clip at healthcare matters at GHLF dot org.

Conner Mertens  9:58

Don’t forget to subscribe to us on Apple Podcasts, Spotify, or wherever you get your podcasts. If you’d like the podcast, don’t forget to leave us a review, it really helps people like you find the show. Thanks for listening to the Healthcare Matters podcast, part of the family of podcasts from the Global Healthy Living Foundation. He’s Dr. Robert Popovian.

Robert Popovian  10:16

And he’s Conner Mertens, see you all next time.

Narrator  10:20

Be inspired, supported and empowered. This is the Global Healthy Living Foundation Podcast Network.

Narrator  00:00

Be inspired, supported and empowered. This is the Global Healthy Living Foundation Podcast Network.

Robert Popovian  00:12

Although this is not illegal, it is somewhat unethical, because again, it’s blurring the lines between medical practice and insurance coverage.

Conner Mertens  00:23

Welcome to the Healthcare Matters podcast, a podcast that pulls back the curtain to help you make sense of complex healthcare economics and policy issues. As always, I’m joined by the always informed Dr. Robert Popovian. Joining us from California, he’s a pharmacist and economist and the Chief Science Policy Officer at GHLF.

Robert Popovian  00:39

And up the coast in Seattle, Washington is my partner, the incomparable, Conner Mertens, who is an outstanding Patient Advocate and Community Outreach Manager who works also at Global Healthy Living Foundation.

Conner Mertens  00:51

As you know, you’re joining us, our big purpose to help you understand to simplify the complexities in the healthcare, economics and policy issues. These things are affecting you and patients all around the country every day. Robert is the expert. In fact, he’s one of the few people who studied and published both clinical and policy related economic analysis on these important issues.

Robert Popovian  01:10

And you know what, Conner does much more important thing than I do, which is brings it to the human level, as he helps people with chronic diseases be more understood by loved ones, and everyone, elected officials, policymakers, employers, government, and so on.

Conner Mertens  01:28

Robert, this week, we have a really interesting topic, I want to chat about some harmful practices, providers do that kind of blur the line between medical practice and insurance coverage, in fact, maybe a little bit of malpractice. One thing that providers are doing are offering incentives, cash incentives or otherwise for patients to switch medications or switch treatment plans. How can this be a harmful practice?

Robert Popovian  01:52

Well, in general, it starts blurring the lines between medical practice and insurance coverage. And that’s not what we want for patients. Most recently was related to the insurance company Cigna, where they sent solicitations to providers, physicians primarily, to switch patients from one medicine to another, and the patient will receive the $500 debit card if they agree to an alternative payment treatment. Uniformly any patient on this medication is enticed to switch if they are stable on their current treatment. Disturbingly, this attempt to lure patients by providing them with a one time payment blurs the line between insurance coverage and medical practice.

Conner Mertens  02:31

Robert, what is driving these decisions for these providers to offer incentives?

Robert Popovian  02:36

It’s really making money. In the United States, we’ve had this rousse that formularies, which are basically a list of medications that the insurance company chooses to cover, are devised based on clinical data and have been peddled for far too long, that they are actually based on medical data. This latest scheme is another reminder that we have a broken system that takes advantage of the most vulnerable patients. Because what the insurance companies do is by peddling this type of incentives, what they’re doing is they’re pading their own bottom line. Because by switching these patients to a different drug, they’re going to make more money off of rebates, fees and everything else that they collect from the pharmaceutical industry.

Conner Mertens  03:17

Yeah, I think about the patient who might be a little bit behind on rent, and then all of a sudden, they’re offered $500 to try a new medication that their doctor’s telling them to do. It gets you a little worried for those that are underserved and maybe their vulnerabilities. What are the negative outcomes for patients who go through this, we know the importance of adherence to treatments and adherence to medications? What are the negative outcomes?

Robert Popovian  03:40

Well, you hit a right on the head, it’s medication adherence, that’s the number one thing that we need to make sure because if a medication is not taken by the patient, any incentives in the marketplace that would create non adherence, which we know they would, in this case with peddling this scheme will negatively affect the patient because ultimately, the patient will stop taking their medicine for one reason or another. I’ll give you an example. Let’s say if you receive this incentive for the debit card, and unknowingly you ask your physician to switch you and you are switched because a physician wants to do what’s right for you and is also concerned about your out of pocket costs and everything else related to your pharmaceuticals. When he’s switching you, you don’t know what the effect of this medicine is going to be. Remember, this is a brand new medicine. This is not a generic substitution or a biosimilar substitution, which are practically the same drugs. These are drugs that perhaps have the same effectiveness within the therapeutic area, but they’re not the exact drugs. So by you being switched, you may have negative consequences, such as side effects or lack of efficacy. And you may end up back in the hospital, back in the physician’s office or you may stop taking your medicines period. And that’s not what we want for patients to happen. We want to make sure that they’re adherent with their therapy

Conner Mertens  05:04

We’re talking about patients that live with chronic disease, especially patients that live with chronic disease. Having a stable medication that works for you is vital to everyday success and getting through your day. When we think about an abrupt change to a medication that you’re already stable on, $500 incentive can be added up pretty quickly in ER costs when the medication doesn’t work for you, or negative health outcomes down the line. Is that something that you see?

Robert Popovian  05:29

Exactly, that’s what you will end up seeing. And at the end of the day, if you’re really serious about helping patients, instead of doing these gimmicky type of incentives that are one time payments, why don’t you set up a system that’s going to help patients save money over a long period of time, over time that they’re going to be under therapies, what the PBMs, the pharmacy benefit managers, and insurers do is they continuously peddle this data that the average per capita out of pocket spending for biopharmaceutical has dropped and that is a true data point that they use. Unfortunately, averages are deceiving. As patients who are older, under or uninsured or are living with complex diseases, folks that GHLF sort of represents and you work with every day, find that they are significantly burdened with the out of pocket costs. So instead of doing this gimmicky stuff, which is maybe a one time windfall, without unknown consequences, why don’t we change the system, where all of the rebates and fees and discounts that have been negotiated on the behalf of the patients are directly passed to the patient at the point of sale. Currently, the model doesn’t work because when the patient shows up in the pharmacy counter, their out of pocket costs when they have a coinsurance or deductible is based on the retail price of a medicine, which is an inflated price. It’s not the price that the insurer pays, or the pharmacy benefit manager pays. And he ended up paying significantly more out of pocket than they should. And insurers know this because they’ve done their own studies that demonstrate that they certainly are able to do this, if they’re willing to pass on the savings at the point of sale to the patient. In one study that Optum, which is part of United Healthcare did, patients would save an average of $130 per prescription. That’s a lot of money over a 12 month period, far more than a $500 debit card, which is a one time windfall for the patient.

Conner Mertens  07:27

And I think that we’re getting into the nitty gritty here. And this is really important to me, as you know, I think it’s super important for us to identify what the problem is. But the next step is how do we fix it? And how do we combat it? So Robert, how can we combat these practice, what’s being done currently to curb these practices?

Robert Popovian  07:42

It’s education. It’s not a legal issue to entice patients to be switched from one drug to another. And this enticement is going directly to the patient as a windfall. There is no denying that we need to address the healthcare costs dilemma also with these patients, because they are burdened with the out of pocket costs. But it’s a small number of folks that are hurting, who are on specific type of medicines. And for many patients, they cannot ignore this $500 because it pays for rent food and car payment, and it’s impossible for them to ignore it. However, although this is not illegal, it is somewhat unethical, because again, it’s blurring the lines between medical practice and insurance coverage.

Conner Mertens  08:26

Fffectively taking out the attention to effectiveness in the treatment.

Robert Popovian  08:32

Exactly. Well, it’s taking that out. And it’s obliterating the patient and provider relationship, and it’s providing the wrong policy solution. Nobody denies we need to help these patients. But this is not the way to do it. There are better ways to do it. That will save them significantly more money from their out of pocket costs, and at the end of the day, would not put them in a difficult position where they have to ask their physician or pharmacist or any other provider to make a clinical judgment that they may not foresee to be in the best interest of the patient.

Conner Mertens  09:13

That’s fascinating, Robert, and as always, it seems a lot of this boils down to transparency in the system and making sure that patients are put first. As always, I love getting your perspective as the last word here. What do you think patients needs to know?

Robert Popovian  09:18

Well, they need to be educated, number one, and the education starts with making sure they understand that for far too long, insurers and the pharmacy benefit managers have peddled this idea that formularies which are the list of drugs that are covered are being covered based on price and medical efficacy. That is not the case. They’re being covered because they provide higher number of dollars in rebates and fees to the insurers and the pharmacy benefit managers. So that’s number one is education. The number two thing is to advocate and patients need to do this because every patient is an advocate and they need to be an advocate for the system and for themselves. To advocate to change the model where instead of the insurers and the pharmacy benefit managers pocketing all of the savings that they get through concessions, rebates, discounts, fees from the pharmaceutical industry. And instead of pocketing that, or at least pocketing a huge percentage of that, to pass all of that along to the patient at the point of sale when they show up at the pharmacy counter. We do this for every other segment of the healthcare system. And you’ve heard me say this several times, you show up to your dentist, you show up to your optometrist, your physician’s office, your payment for your coinsurance or deductible is based on price that’s been negotiated on your behalf by the insurer. That is not the case for biopharmaceuticals. When you show up in the pharmacy counter, and you have a coinsurance or deductible. Your payment is based on an inflated retail price of medicine that no one pays in the marketplace unless you’re uninsured. And certainly the pharmacy benefit managers and insurers don’t pay that price. We hope that you learned something too. We’d love to hear from you send your email to Healthcare Matters at GHLF dot org. Or better yet, include a short video or audio clip.

Conner Mertens  11:24

And who knows, whatever you share may be included in our listener feedback portion of future episodes. Thanks for listening to Healthcare Matters, a podcast that pulls back the curtain to help you make sense of complex healthcare, economic and policy issues. If you like this episode, please go to Apple Podcasts and leave an honest five star rating and a positive review. And wherever you’re listening, click the subscribe button so you never miss an episode. He’s Dr. Robert Popovian.

Robert Popovian  11:50

And he’s Conner Mertens. We’ll see you all next time.

Narrator  11:55

Be inspired, supported and empowered. This is the Global Healthy Living Foundation Podcast Network.

SUMMARY KEYWORDS

patients, transparency, healthcare, pharmacy benefit managers, conner, information, coinsurance, healthcare system, policy, report, federal government, robert, form, benefit, bidding, network, state, federal level, important, impact

SPEAKERS

Conner Mertens, Narrator, Robert Popovian

Narrator  00:00

Be inspired, supported and empowered. This is the Global Healthy Living Foundation Podcast Network.

Robert Popovian  00:11

It is just disturbing that the federal government, the largest payer of health care in the United States, does not have audit rights to go in, open up the ledgers of the pharmacy benefit managers, see where the money is going.

Conner Mertens  00:29

Welcome to Healthcare Matters, a podcast that pulls back the curtain to help you make sense of complex healthcare economics and policy issues. He’s Dr. Robert Popovian joining us from our nation’s capitol, a pharmacist, economist and Chief Science Policy Officer at the Global Healthy Living Foundation.

Robert Popovian  00:45

And across the country in Seattle, Washington. He is Conner Mertens, Patient Advocate and Community Outreach Manager at Global Healthy Living Foundation.

Conner Mertens  00:53

Our goal is to help simplify the complexities in healthcare economics and policy issues for you the listener. First, we have some listener feedback from Apple Podcasts, “User 2001OABC” writes, we need this excellent take on COVID and the topics we want to hear. That review is from “User2001OABC.” Thanks for your review. We invite all our listeners to go to Apple Podcasts and leave an honest five star rating and a positive review. And wherever you’re listening, don’t forget to click the subscribe button so you never miss an episode.

Robert Popovian  01:24

Hey, Conner, let’s get into this episode.

Conner Mertens  01:28

Thanks, Robert. Today we’re going to talk about something that comes up all the time. This is a recurring theme in all of our conversations and across the healthcare in general. That’s the lack of transparency in our healthcare systems. So many questions boiled down to this need for more transparency. Why am I denied coverage? Why am I forced to take a drug B over drug A? Why are some of these drugs discounted and others aren’t? These questions go on and on. So Robert, talk to me about transparency. Why is it so important?

Robert Popovian  01:54

Well, transparency is really the backbone of the healthcare system, because patients are being asked to carry more and more the burden of out of pocket costs whether it comes to hospital expenditures, their insurance premiums, their pharmaceuticals, and they need to know exactly what is it that they’re going to pay out of pocket before they walk into a pharmacy to a physician’s office, for a hospital admission. I understand there are areas that we’re never going to be able to predict, for example, if you have an accident and you have to end up in an emergency room, perhaps you’re not going to be able to get the exact price or the out of pocket cost that you have to pay. But there are many instances that patients would benefit with better transparency in the marketplace where it provides them the information they need to make appropriate choices for themselves.

Conner Mertens  02:45

I think we have to start at the beginning of this question. And that is, who is benefiting most from this ambiguity and secrecy? And then who’s most impacted?

Robert Popovian  02:53

Well, it’s impacting the patient. It’s impacting the government, both the federal and state level and it’s impacting employers. Those are the three entities that really are paying for the healthcare in the United States. They’re the true payers, it’s not the insurers, it’s not the pharmacy benefit manager. It’s those three other entities that are being disadvantaged by this lack of transparency. It is well known that lack of transparency in healthcare has led to massive and inappropriate profiteering by all kinds of actors, and primarily the insurers and the pharmacy benefit managers to the detriment of the true payers. Without a transparent health system, patients can be harmed when they decide to enroll in an insurance plan that contains for example, large deductibles or coinsurance. Such harm has been fallen upon patients because they don’t know and can’t estimate in advance their out of pocket costs due to lack of transparency.

Conner Mertens  03:47

Robert, my econ professor might not describe me as the most well versed in economics. So why don’t you help me understand, what about the people who say that too much transparency undermines the competitive marketplace?

Robert Popovian  03:58

That’s a great question, because I’m an economist, as you all know, Conner and I do believe that economic environment where individuals are bidding against one another in a blinded manner, economic theory 101 states that you will bid lower and it will suppress pricing. For example, if you and I are bidding for a television set, and we do not know what is the price that we’re bidding on, we will always bid the higher or lower, and if something is we’re trying to get a lower price, it will be lower ultimately because we’re going to be, bid against each other and the blind bidding does help that but what I’m talking about regarding transparency is something different. It is information that the patients require to make more constructive choices. It is information that the employers require to basically make better benefit decisions for their employees. It is the information that the federal government needs to make policy decisions. Conner I cannot tell you how many reports have come out of the Congressional Budget Office or the congressional staff that are intended to promote massive changes in our healthcare system from a policy perspective. Unfortunately, all of these reports have been derived from meaningless, outdated estimations of data instead of real world information. And one of the things that I see over and over again the government do, is that either their complacency or their inability to ask for this data. After all, the federal government in the US healthcare system is one of the largest payors, whether it comes to pharmaceuticals or hospital expenditures or physician expenditures or other provider expenditures. It is mind boggling how they do not have audit rights of to see how much money is gained or transferred between entities in the market. So they can come up with appropriate analysis when they’re suggesting policy changes that is going to impact all of us.

Conner Mertens  06:01

Robert, that’s a perfect segue because my next question is, what legislatively is being done federally to promote transparency?

Robert Popovian  06:09

Federally, not much is being done. But fortunately, states as usual, have taken the step forward to be able to introduce various types of legislation to create a more transparent environment. For example, in the state of Georgia in 2020, House Bill 946, and House Bill 323 passed and it required, for example, that the pharmacy benefit managers could not steer prescriptions for the sake of profiteering and they had to report how much money they were making in the form of concessions from the pharmaceutical industry and report back this information to the state government. Now, we need something similar on federal level, but the states are really where the action is. Another example that is in Texas, legislation was signed this year by Governor Abbott, that prohibited benefit managers from steering patients to their own pharmacies. So for example, Connor, if you’re a CVS patient, that you get your pharmacy benefits through CVS Health, this law prohibits CVS to tell you that you’re mandated to pick up your specialty medicines, for example, your arthritis drug, or your cancer drug from a specific CVS owned pharmacy. And that is very important, because that creates choice. And it creates competition in the marketplace. And those are the two things that we need. And it provides ability for the state government to step in and say, we need better understanding of where these patients are going. And also the flow of money. That’s the next step that the state’s going to have to do.

Conner Mertens  07:54

Obviously, it’s very important to do work on the state level. But that sounds really incremental, what’s going to be the most effective way to impact the most patients?

Robert Popovian  08:04

Well, definitely federal law and the federal law to me, it’s going to be difficult to do, except for one thing that where we can start with is really to ask for transparency in information. Currently, if you look at for example, a congressional staff put out a report on drug pricing negotiation. If you peel back the onion and looked at that report, you realize that they’re using data from 2016. And not only data, but estimations based on sort of testimonials that the pharmacy benefit managers have provided them, instead of real world information, instead of real world data. It is just disturbing that the federal government, the largest payer of healthcare in the United States, does not have audit rights to go in, open up the ledgers of the pharmacy benefit managers, see where the money is going, whether or not all the concessions have been transferred to the federal government or not in the form of rebates, fees, discounts, any and all, every single penny, and then to have more updated information because as you know, Conner, healthcare is very dynamic, especially in the pharmaceutical space. Pharmaceutical expenditures go up and down all the time. And the reason that is is because unlike any other segment of the healthcare system, pharmaceuticals have generics introductions, or biosimilar introductions that plummet the prices of these medicines significantly. And because of that, you have to look at this information more in a real time fashion over periods of time, long periods of time to see trends. Unfortunately, again, they don’t either have access to this information or they don’t require these pharmacy benefit managers to provide them this information in a transparent manner. And this prohibits them from coming up with reports, analysis that then can be used to really shift the policy discussion in the federal level. So for me, and to answer your question about the federal level, is to start with getting information out that is accurate and updated, and not rely on outdated information that is based on testimonials from the pharmacy benefit managers.

Conner Mertens  10:16

There’s a few different pieces of legislation working their way ever slowly, as always, through the federal level, the No Surprises Act, the Safe Step Act. And a lot of these really do focus on this principle of transparency. Do you think that there is hope for finally for us to see some change?

Robert Popovian  10:34

I believe there is. The surprise billing legislation that you’re referring is very important. It’s something that every patient has experienced, surprise bills, when they end up going to hospitals to see a physician, it happened to me. Several years ago, I required a procedure. And I picked a specialist through my network that I can go to when I ended up going to the specialist which was in my network. This physician used a anesthesiologist who was out of network to provide me the anesthesia. And what ended up happening is that when I went home about a month later, I got a bill from the insurance companies saying to me that although my gastroenterologist was within network, my anesthesiologist was considered out of network and I was responsible for the full payment for that anesthesia. Of course, in this case, the insurance company stood by me, and did not let that happen. But that had to do because I wasn’t aware of it. Nowhere it was written, that I not only had to pick the specialist, who was doing the procedure, that I was also unaware that there was going to be any anesthesiologist that was going to provide any kind of procedure at that time to me, and that that individual was out of network. So yes, the surprise billing thing is important. But Connor, the most important thing is that we continuously strive for more and better information for patients, whether it’s in pricing, whether it’s information, so they can make more educated decisions. And not only for the patients for this to happen, but the employers and the federal government.

Conner Mertens  12:13

As always Robert, I’m learning more every day. But I want you to get the last word in, what should folks know about transparency in the US healthcare system?

Robert Popovian  12:21

Conner, at a time when we’re asking patients to carry more of the burden of the healthcare costs, whether it comes in form of deductibles, coinsurance, where it’s an unknown, when we’re asking patients to choose new health plans, for example, we need to provide them the information up front, we need to provide them the information regarding to, is their medicine available on the formulary of an insurance plan that they’re picking. Is their physician in network, is their hospital in network before they sign up for those insurance plans. We’re also asking them to remember, carry a lot more burden of whether it comes in form of deductibles and coinsurance. And we need to provide them that information upfront to them so they can make more educated guesses. So for example, I know your sister just had a baby. And I’m pretty certain that she probably had some type of a coinsurance involved in her delivery. Having a baby is something you can plan for. Wouldn’t it have been very good for her to know exactly upfront whether her gynecologist she wanted to use was in network? Wouldn’t it have  been very good for her to know what her out of pocket was, cost was for going for example, to the hospital down the street or a hospital three blocks away? Those are the type of information I’m talking about that will help patients. Yes, there are instances we need to make urgent decisions. For example, if there’s a car crash, obviously, you’re not going to shop around for an emergency room. But there’s plenty of healthcare interventions, in addition to healthcare decisions that we make regarding our insurance, that having that information up front is very useful. In addition, information just doesn’t end with having information about pricing. It’s information about utilization and spending and all these things that the federal government is using to make, again, massive policy decisions. So wouldn’t it be a good idea, that information is real time and available to them in entirety instead of in bits and pieces, and in form of testimonies or estimations? Look, it is time for this country to move forward with actionable policies that will help reduce healthcare costs. The ideal, most often synonymous with success of such policies is the principle of transparency.

Conner Mertens  14:47

We can’t deny that an informed patient is a healthier patient. And these ideas of transparency in our healthcare system are essential if we want to bring down costs and make a more informed patient.

Robert Popovian  14:58

We hope that you learned something too. We’d love to hear from you about transparency, and what is the impact on patients and why is it important to you. Send your email to healthcare matters at GHLF dot org. Or better yet, include a short video or audio clip.

Conner Mertens  15:14

And who knows, whatever you share may be included in our listener feedback portion of future episodes. Thanks for listening to Healthcare Matters, a podcast that pulls back the curtain to help you make sense of complex healthcare, economic and policy issues. If you liked this episode, please go to Apple Podcasts and leave an honest five star rating and a positive review. And wherever you’re listening, click the subscribe button so you never miss an episode. He’s Dr. Robert Popovian.

Robert Popovian  15:41

And he’s Conner Mertens. We’ll see you all next time.

Narrator  15:46

Be inspired, supported and empowered. This is the Global Healthy Living Foundation Podcast Network.

SPEAKERS
Conner Mertens, Narrator, Robert Popovian

Narrator  00:00
Be inspired, supported and empowered. This is the Global Healthy Living Foundation Podcast Network.

Robert Popovian  00:10
It is time for us to support our seniors by updating the Medicare Part D benefit design to give our most vulnerable population the same protections that the rest of us benefit from everyday.

Conner Mertens  00:24
Welcome to Healthcare Matters, a podcast that pulls back the curtain to help you make sense of complex healthcare economics and policy issues. He’s Dr. Robert Popovian joining me from LA, a pharmacist, economist and Chief Science Policy Officer at the Global Healthy Living Foundation.

Robert Popovian  00:40
And up to coast in Seattle, Washington, the gentlemen who’s waiting by the minute to see when Russell Wilson will come back to playing, he’s Connor Mertens, Patient Advocate and Community Outreach Manager at Global Healthy Living Foundation.

Conner Mertens  00:54
And I’ll give a begrudging “Go Hawks.” And as you know, our goal here is to help simplify the complexities in healthcare economics and policy issues for you. But first, we have some listener feedback. Say Shy Away writes, “breaks through the noise and confusion, great podcasts that breaks down in bite sized pieces the history of vaccines and the importance of them.” That’s what we try to do.

Robert Popovian  01:16
That’s right, Connor. You know, vaccines are one of the most cost beneficial interventions in the healthcare system. There’s no question of the value they bring to our society. Unfortunately, there are barriers that impede access to vaccines. Today, in this episode, we’re going to get into one of those issues. And hopefully you’ll understand exactly what we’re talking about.

Conner Mertens  01:39
And that review is from Say Sha Way. Thanks for your review. We invite all of our listeners to go to Apple Podcasts and leave a very honest five star rating and a positive review. And wherever you’re listening, don’t forget to click that subscribe button so you never miss an episode.

Robert Popovian  01:53
Terrific, Connor, let’s get into this one.

Conner Mertens  01:58
In this week’s episode, we’re talking about how benefit design and Medicare exasperates vaccine access inequity. And I guess, Robert, the first question I have is, what is benefit design?

Robert Popovian  02:08
So benefit design is, every health insurance policy, whether it’s governed through the government, through the private sector, has some type of a design that allows patients to have access to certain hospitals, certain physicians, certain pharmaceuticals at different payment levels, and that’s what’s considered a benefit design. The design of your benefits that you received as healthcare from either your employer through the government or some other entity.

Conner Mertens  02:35
I think benefits is a loaded word. We know that there’s tons of wasteful spending in healthcare, oftentimes to the detriment of patients. In what ways do we see wasteful spending and how does it impact vaccine care?

Robert Popovian  02:45
So Connor, it’s no secret that there’s a lot of waste in healthcare. In fact, we waste approximately $400 billion, if not more on healthcare waste every year. And that has to do with administrative burden because we are non compliant with our meds for a variety of reasons. We waste a lot of money, but one thing we know and that is undisputable is the high value that vaccines bring. So basically, any type of a restriction, or any type of a policy that reduces the access to vaccination, most definitely will negatively impact patients and will increase this wasteful spending that we’ve been talking about. So vaccines should be regarded, and an are regarded as the most cost beneficial intervention in healthcare. And unfortunately for Medicare, counterintuitively, the current cost sharing policies discourage our most vulnerable patient population, our seniors from accessing those vaccines.

Conner Mertens  03:43
Who is most impacted by these vaccine policies and economics? Is it seniors, the folks that are receiving Medicare Part D benefits?

Robert Popovian  03:51
That’s a great question. So the vaccines are divided into two categories for seniors through Medicare. There’s the vaccines that are administered to the Part B as in boy program that seniors have great access to and there’s very little out of pocket costs involved in it, if any, so patients can show up, for seniors and get their vaccines, for example, flu and pneumococcal vaccine are in those categories. Unfortunately, most of the new vaccines, except for COVID now, that are being developed will be coming out under the Medicare Part D as in dog benefit for seniors. And in that case, there’s a co payment or some type of an out of pocket cost associated with that, which is very unusual, because if you think about it, the most private insurance plans that are done through the Affordable Care Act provide coverage for vaccines without any out of pocket costs for patients. So in effect, by not addressing the out of pocket cost issue in Medicare Part D, we’re disenfranchising or discouraging the use of these vaccines, which are the most important intervention by our seniors. That is the problem. What we see is that the population that requires the vaccines the most, maybe discouraged to use it the most as well.

Conner Mertens  05:09
What’s the evidence that this is happening, that folks are inhibited or discouraged from getting the vaccine or the care that they need?

Robert Popovian  05:15
A new study that just came out from IQVIA basically quantified what is going on in Medicare Part D regarding vaccine access and affordability. In the study, IQVIA researched patients or looked at patients who showed up to the pharmacy, the insurance plan had already approved them getting the vaccine, there was no impediment of prioritization, there was an approval already that took place. And when they were provided choice of paying out of pocket, many of them basically abandoned and refused to take the vaccine in that case. So for example, the abandonment rate more than doubled if there was a $10 versus $125 out of pocket cost for patients, so about 164% increase. And this is because seniors are extremely price sensitive. This is the only area in the healthcare that we currently have, because ACA plans have protections, most commercial plans allow vaccines to be had, without any out of pocket costs. The Medicare Part D is the only one that the senior patient that shows up to the pharmacy may have an out of pocket cost may be as little as $10. But it could be the full cost of the vaccine, which could be in the hundreds of dollars. So that’s why we need to address this issue.

Conner Mertens  06:33
And it can’t just be our seniors. Are other communities impacted by these out of pocket costs for vaccines.

Robert Popovian  06:39
Well interesting you should ask. The research that IQVIA also looked into what happens to the same senior populations when you start segmenting them between White, Hispanic or Black. And what they found is that the abandon rate if the vaccine was priced between out of pocket costs was priced between $10 and $40, the White patients amendment rate was 28%, compared to 44% For Hispanics, and 42% for Black patients. Research has basically estimated that eliminating out of pocket costs would increase fill rates for Hispanic and Black patients to the tune of over 90%. What we need to do is that because those populations are even more price sensitive, we need to take into consideration what is the impact of this out of pocket costs to our minority communities.

Conner Mertens  07:29
And as a result, by removing these out of pocket costs, we could see adherence to these vaccines go up as well?

Robert Popovian  07:36
Yes, eliminating them in the study showed that it would improve vaccine uptake in those specific populations by over 90%. So without a doubt, removing out of pocket costs for vaccines will improve adherence. But important to note here. This is not for patients who showed up to the pharmacy and abandoned their vaccines because the insurance company had refused payment for it. This is actually the insurance company had already approved them being administered the vaccine, but there was some out of pocket costs associated with it. That’s why it’s so important to eliminate out of pocket costs for the vaccines in Part D, period. Because any type of an out of pocket cost there’s some sensitivity where the patients will not take their vaccines.

Conner Mertens  08:17
And not only that, this will increase better positive health outcomes by eliminating these.

Robert Popovian  08:22
Without a doubt. Vaccines are regarded as I said, one of the most cost beneficial interventions in the healthcare system. And the best way to provide reduced burden of illness in certain disease areas is through vaccination. And that’s why it is so important for us to improve the access to vaccines for our seniors.

Conner Mertens  08:42
Well, you know, around here we like to get our legislation on. So is anything being done legislatively about this?

Robert Popovian  08:48
Yes. In fact, there’s something on the federal level, HR 1978, which is called the Protecting Seniors Through Immunization Act is being debated right now in Congress. And this Act will remove out of pocket costs for Part D vaccines for seniors. And there’s been also analysis done on that legislation. And it shows that yes, costs will go up, obviously, because the government will have to absorb some of the cost of out of pocket costs. But it’s minuscule compared to what it will happen if the patients stopped taking their vaccines. Please, as patients write to your congressman or support HR 1978, which is Protecting Seniors Through Immunization Act.

Conner Mertens  09:30
Well, Robert, it sounds like right now, some of the most vulnerable are some of the most disadvantaged at this point. And when it comes to vaccine access and adherence, and a really powerful way to combat that is by eliminating these out of pocket costs, especially for Medicare Part D. I’m curious and as always, we want to hear and give you the last word. What do you think folks should take away from this discussion?

Robert Popovian  09:50
Connor, vaccines provide a fiscally responsible and clinically proven path towards for all of us to survive the current and future epidemics until new therapies are discovered. They may even become the preferred treatment option for chronic diseases like Alzheimer’s or Parkinson’s. Potential for abuse is non existent, because you’re not going to get the vaccine unless you need it, right? It’s not something that people are going to abuse. In fact, the primary problem with vaccination is underutilization, which is being caused by some of these policy or benefit design issues like we’ve discussed on Medicare Part D. It is time for us to support our seniors by updating the Medicare Part D benefit design to give our most vulnerable population the same protections that the rest of us benefit from everyday. We hope that you learned something too, from this episode. We’d love to hear from you about how all of us can change policy and support policies that will improve access to vaccines for our most vulnerable patients, our seniors, our treasured seniors, so please send your emails to Healthcare Matters at GHL dot org. Better yet, including a short video or an audio clip.

Conner Mertens  11:05
And who knows, whatever you share may be included in our listener feedback portion in future episodes. Thanks for listening to Healthcare Matters, a podcast that pulls back the curtain to help you make sense of complex healthcare economics and policy issues. If you like this episode, please go to Apple Podcasts and leave an honest five star rating and a positive review. And wherever you’re listening, don’t forget to click the subscribe button so you never miss an episode. He’s Dr. Robert Popovian.

Robert Popovian  11:31
and he’s Conor Mertens. We’ll see you all next time.

Narrator  11:35
Be inspired, supported and empowered. This is the Global Healthy Living Foundation Podcast Network.

SUMMARY KEYWORDS

patients, healthcare professional, therapy, robert, formulary, insurers, healthcare, policy, medicine, conner, pbms, fail, healthy living, curtail, legislation, tik tok, step, employers, providers, change

SPEAKERS

Conner Mertens, Narrator, Robert Popovian

Narrator  00:00

Be inspired, supported and empowered. This is the Global Healthy Living Foundation, Podcast Network.

Robert Popovian  00:10

Anything that we do from a policy perspective and this is the mantra of Global Healthy Living Foundation, policies, legislations, anything that passes, the patient has to directly benefit from them.

Conner Mertens  00:25

Welcome to Healthcare Matters, a podcast that pulls back the curtain to help you make sense of complex healthcare economics and policy issues. He’s Dr. Robert Popovian, joining me from LA. And you know, he’s a pharmacist economist and Chief Science Policy Officer with us at GHLF.

Robert Popovian  00:42

And up to coast for me in Seattle, Washington. He’s Conner Mertens, Patient Advocate and Community Outreach manager at Global Healthy Living Foundation.

Conner Mertens  00:51

As you know, our goal here is to help simplify the complexities in healthcare, economics and policy issues for you. So Robert, as we start this new series, it’s exciting to read a listener comment. You’re ready?

Robert Popovian  01:02

Absolutely. Let’s do it.

Conner Mertens  01:03

Bobby JW writes, “taking the politics out of patient care, yes, we need unbiased discussions of the issues so we patients can be more informed when it comes to advocacy, eager to hear more episodes.” That’s what it’s all about Robert, right?

Robert Popovian  01:17

Absolutely. We need to take the politics out of healthcare. Because as I mentioned before, no way you know how, when you show up to get your treatment, or pick up your prescription or see a physician, they ask you about your politics before they take care of you, or pharmacist provides you the medicine?

Conner Mertens  01:38

Well, let’s get into it, Robert. Today we’re going to chat about step therapy for a myriad of reasons step therapy or fail first protocols mandate that a patient ought to fail on one or more drugs that the provider did not select for them effectively deprioritizing the disease management decisions made by providers and their patients, and putting it in the hands of insurers and formularies right off the bat. That just sounds problematic. Robert, can you tell us why this practice is harmful for patients?

Robert Popovian  02:04

The bigger question is, why are people doing it and it’s just to save money, it’s not for better care. It’s primarily intended to save money for the insurers and the pharmacy benefit managers. It is problematic for patients because what is failing, is failing, ending up in the hospital is failing, patient dying, is failing patient having a side effect or not get appropriate treatment, and not have a cure to their disease that has never been defined. And it’s unfortunate that we put the patients in a very awkward situation where they have to go and try therapies that have not been recommended to them by their healthcare professional, and instead have to follow a formulary that was designed as an aggregate all of all the data instead of getting the medicine that was chosen for them by their physician or healthcare professional.

Conner Mertens  02:55

So are these decisions that are directly impacting a patient’s treatment, continuation of care, and overall health outcomes being influenced by someone whose motivation is their health above all else, or like you said, a bottom line.

Robert Popovian  03:08

It is the bottom line. Over the last dozen years we’ve tried as a patient community, the provider community, the pharmaceutical industry, the policymakers, employers, to a certain extent, have tried to curtail these type of activities and policies, either by changing regulations in the States or introducing legislation that would either curtail or prohibit these types of practices. Unfortunately, there’s more to be done. But this is absolutely about the bottom line. It has nothing to do with better patient care. If it has to do with better patient care, insurers and the pharmacy benefit managers will do a better job of explaining why are they doing these things, because at the end of the day, failing on a medicine is not a pleasant experience for the patient.

Conner Mertens  03:59

But unfortunately, as a patient advocate, I hear far too often patients horror stories of a fail first system. And to put into perspective, I think people need to realize what this looks like, every day, a patient could be stable on the same medication long term. And as a formulary changes, they’re forced to restart and maybe start taking a medication that has sent them to the hospital in the past or has had negative health outcomes, and they’re not gonna be able to get the drug that is prescribed and that has the most benefit to them until they fail again on those drugs. Is that right, Robert?

Robert Popovian  04:34

That is absolutely correct. And it has nothing to do with formulary changing only a patient can be employed by a individual company, and they change jobs and they change insurance companies and they have to start from the beginning and utilizing drugs that probably they have had issues with in the past and continue to do that type of rhythmic treatment until they get back to the therapy that was probably working for them. And that’s one of the myriad of problems with step therapy, that we’ve seen that patients end up having to go back and utilize the medicines that probably at some point in their therapies they’ve tried. But now they have to go back and try it again, because of these changes, whether it’s the formulary, like you mentioned, or they change in their employment status.

Conner Mertens  05:23

So I have to imagine when patients aren’t subjected to step therapy, there’s got to be a better adherence to their drug treatment plans, is that something that we see,

Robert Popovian  05:31

that is absolutely true, I mean, study, after study has shown that any disruption into treatment of patients with chronic diseases ends up basically having patients become non compliant, which is non adherent and not take their medicines as prescribed by the healthcare professional. So for example, it could be as simple as changing the pill color, and when a color of the pill changes that you have been on for many, many, many years, patients do become non compliant. So it’s even worse when you are stable on a therapy. And then you change an employer or a formulary changes. And you have to go through these therapies from the beginning. Let’s start from the start here. Fail first, really is designed to save money. And if it’s designed to save money, let’s be transparent about it. And instead of trying to couch it as a way of better medical care for patients.

Conner Mertens  06:28

What is being done about this legislatively? What can we see progress in curtailing these obviously insidious practices?

Robert Popovian  06:38

For the last dozen years, we’ve tried to pass regulations and legislations in various states. And now there’s actually talk of doing a federal legislation to be able to either manage or curtail or eliminate step therapy from the healthcare system. What has happened over time is that as these legislations have passed, we’ve paid little attention as a community of patients, providers, pharma companies, employers, on how those regulations have been written. And at that point, what we found all the majority of states 29 of them have passed some form of legislation at some point. Regarding step therapy, what we found is that the impact has been minimal. And what we need to do is do a better job of not only passing this legislation, but then going back and ensuring that the regulations that are written to sort of put those in place are also adhere to, but we’re doing a better job. I think the paper that was published by Global Healthy Living Foundation shed some light on it, and the data doesn’t lie that the job is well done from passing legislation. But what we need to do is better job of providing impetus for regulation. And that’s going to be the key here. As we move forward, we have to make sure that as we introduce these bills in the state level, and on the federal level, that we do a better job of keeping the regulator’s feet to the fire, to ensure that they are adhered to by the insurers and the pharmacy benefit managers. And we will get there. I have no doubt about it. It’s just that at this point, we’ve done a lot of activity, but not necessarily activity that fully benefits the patients at this point.

Conner Mertens  08:22

Well, I’m ready to go. Robert, I’m calling my congresspersons office tomorrow. What am I telling them? I’ve heard of this safe step back. Can you tell us more about that?

Robert Popovian  08:29

Go on what you should tell them is that look, there are instances that step therapy may be necessary policy, when, for example, there’s a bipolar generic or biosimilar, that can be utilized instead of therapy, like a brand name medicine, which will save money not only for the patient, but for the healthcare system, to directly lowering out of pocket costs. And that’s the key here, because anything that we do from a policy perspective, and this is the mantra of Global Healthy Living Foundation, policies, legislations, anything that passes, the patient has to directly benefit from them. So is in fact step therapy for switching patients from a brand name medicine to a biosimilar or generic works out well, and the patient is saving money, then we’re all for it. But that is the seldom the case, most often it is forcing the patients to try therapies that either have not worked for them in the past or have not been chosen for them by their healthcare professional. And that’s the thing that we need to look out for.

Conner Mertens  09:32

I really appreciate it in your Op Ed, you pointed out so eloquently that healthcare professionals take the oath of do first do no harm. We don’t get that same oath from the folks who are drawing up these formularies and deciding what is and isn’t covered. I think we should be leaving those decisions up to our doctors. What do you think?

Robert Popovian  09:49

That is absolutely true. I mean, every healthcare professional takes a oath to make sure that we do not do harm first. It is to help patients out and that is the mantra and the oath that GHLF has taken that the patient should benefit from any and all policies that are instituted in the healthcare environment. Insurers and PBMs and their clinical staff have never explained what it means to fail. Should a patient suffer from worsening disease symptoms or side effects or maybe to be hospitalized Is that considered a failure? Insurers and PBMs also unnecessarily demand that providers justify every single intervention to utilize through mounds of paperwork isn’t a time to make sure that insurers and PBMs provide the similar level of evidence for their step therapy policies and the fail first policies, and also take the same oath that every single healthcare professional has taken. And institutions like Global Healthy Living Foundation live everyday by which is first do no harm, and ensure that the patient benefits first.

Conner Mertens  10:53

As always, I want to make sure you get the last word in here. I’ve certainly learned that common thread in many of our conversations is the increased need for transparency. In all the levels of the health care process. What do you think patients should take away?

Robert Popovian  11:07

Look, the folks out there should know that we as Global Healthy Living Foundation, healthcare professionals, such as myself, employers, and most policymakers are on their side, we are fighting for them every day, to get better access to their medicines. It is important for us as a society as a community to go back to the states and now on the federal level, especially and fight for what you said and more transparent, more enforceable laws that help more patients, particularly those with chronic diseases who rely on stable, affordable access to medicines prescribed by their health care professionals. Remember, the intent is to help patients. And remember, the oath is first do no harm. At the end of the day patient is the most important thing for everyone. And we need to continue to fight for them.

Conner Mertens  12:07

And as always, we hope you were able to take something away from this conversation as well. And we’d love to hear from you. Please share ideas with us and email us at healthcare matters at GHLF dot org. And who knows, whatever you share may be included in our listener feedback portion in future episodes. Send us your videos, your audio clips, thoughts. What are the kids into these days, Robert, is it Tik Tok?

Robert Popovian  12:30

Tik Tok, Snapchat. Things that I’m not on. Let’s put it this way. I’m on Twitter and LinkedIn.

Conner Mertens  12:39

Robert, I’m excited to see your Tik Tok dances showing up soon.

Robert Popovian  12:42

Well, if you see me dancing on Tik Tok, it will be the day that we’ve introduced meaningful legislation to help patients and I will do that Tik Tok dance for you Conner.

Conner Mertens  12:55

Thanks for listening to Healthcare Matters, a podcast that pulls back the curtain to help you make sense of complex healthcare economics and policy issues. If you liked this episode, please go to Apple Podcasts and leave an honest five star rating and a positive review. And wherever you’re listening, don’t forget to click the subscribe button so you never miss an episode. He’s Dr. Robert Popovian.

Robert Popovian  13:15

He’s Conner Mertens. See you all next time.

Narrator  13:19

Be inspired, supported and empowered. This is the Global Healthy Living Foundation Podcast Network.

SUMMARY KEYWORDS

patients, robert, conner, bipartisan, biopharmaceutical industry, pocket costs, pharmaceuticals, pharmacy benefit managers, bipartisan support, president biden, insurers, policy, rebates, pocket, generics, medicines, expenditures, drugs, high, costs

SPEAKERS

Conner Mertens, Narrator, Robert Popovian

Narrator  00:00

Be inspired, supported and empowered. This is the Global Healthy Living Foundation Podcast Network.

Robert Popovian  00:09

Bipartisan initiatives are extremely important in healthcare, because at the end of the day, no physician, patient chart, the hospital admissions record ever asks you about your political platform before you get treatment. And I truly believe that there is a bipartisan opportunity here.

Conner Mertens  00:32

Welcome to the Healthcare Matters podcast, a podcast that pulls back the curtain to help you make sense of complex healthcare economics and policy issues. He’s Dr. Robert Popovian in Washington, DC, a pharmacist, economist and Chief Science Policy Officer at GHLF.

Robert Popovian  00:47

And across the country in Seattle, Washington. He is Conner Mertens, Patient Advocate and Community Outreach Manager at GHLF.

Conner Mertens  00:55

And the big reason we’re here, the big reason you’re here is to learn a little bit more about healthcare and economics and policy that’s around you. Robert’s the expert. In fact, he’s one of the few people who’s studied and published both clinical and policy related economic analysis.

Robert Popovian  01:10

And you know what, Conner brings it all to the human level as he helps people with chronic disease be more understood by loved ones and elected officials.

Conner Mertens  01:20

Now that you know a little bit about who we are, and why we’re here, I just really want to dive into this topic with you, Robert. Recently, you wrote about President Biden’s bipartisan opportunity to reduce patient costs. That’s such a hot button topic and something that does have bipartisan support. President Biden’s in position to make real substantive change for patients. And we’ve heard a lot of calls from both sides of the aisle to enact reform, or at least make costs a little more affordable for patients. And so I guess my first question has to be, has he been able to accomplish that so far in this early point in administration?

Robert Popovian  01:53

That’s a great question Conner. So far, President Biden has just announced what he believes is the real framework of what he thinks should happen with regards to reducing pharmaceutical expenditures in the United States. Unfortunately, most of the stuff that he’s proposing does not impact patients out of pocket costs. And that’s something that I believe he believes that he will have to do in the next iteration of bringing policies to the marketplace as to how to help patients lower their expenditures and out of pocket costs for biopharmaceuticals. Bipartisan initiatives are extremely important in healthcare, because at the end of the day, no physician, patient chart, a hospital admission’s record ever asks you about your political platform before you get treatment. Therefore, we need bipartisanship in the healthcare arena. And I do believe that President Biden will eventually get to a point that will be able to produce bipartisan efforts to really help patients and their out of pocket costs.

Conner Mertens  02:58

It feels like we haven’t been making meaningful progress. What’s the holdup, Robert, why is it so hard to get it done?

Robert Popovian  03:03

It’s a complex issue. I mean, this is not something that has happened overnight. So let me give you an example for why we are in the situation we are in. Hospital expenditures in 2019 was $1.2 trillion dollars, which is about three times more spending than pharmaceuticals in the US marketplace. However, patient’s out of pocket spending on drugs in 2019 was $54 billion, which was about 50% higher than out of pocket spending for hospital care. This does not make sense because remember, pharmaceuticals are the one entity in healthcare system that if used appropriately, and if patients have appropriate access to, will prevent more expensive interventions such as hospitalizations, and ending up in the emergency room or physician’s office. We are where we are. But we know we have the leadership, and we should have bipartisan leadership to be able to help patients out.

Conner Mertens  04:01

Robert, I feel like there’s so few bipartisan success stories that we hear coming out of politics. It’s just so elusive now to find agreement on anything, how can we do it? How can we reach that bipartisan agreement?

Robert Popovian  04:12

I think that’s the rhetoric that comes out of the political arms. But if you look at unpeel the onion and look inside, there’s a lot of commonality between the two political parties of what should be done. Now we just need the political will to make it happen. For example, there’s bipartisan support on both sides of the aisle that we do need to cap out of pocket costs for Medicare Part D enrollees. Medicare Part D is the only entity within the Medicare system where patients have unlimited financial exposure to cost of care. And there’s bipartisan support for that. There’s also bipartisan support that patients should directly benefit from all of the concessions that have been gained by the insurers or the pharmacy benefit managers through negotiation with the pharmaceutical industry.

Conner Mertens  05:04

Wait, Robert, who’s benefiting at this point from all those concessions?

Robert Popovian  05:07

It’s directly going to the insurers and the pharmacy benefit managers, the patients are not benefiting from it. So these companies are negotiating on behalf of the patients. But instead of sending back or sharing the savings with the patient, they instead pocket that as profitability most of the time. And we’re not talking about a trivial number here in 2019, there was over $175 billion, or approximately 40% of the gross domestic biopharmaceutical spend that was gained by insurers on pharmacy benefit managers collected by pharmacy benefit managers and insurers in form of rebates and fees from the biopharmaceutical industry. And zero number goes back to the patient.

Conner Mertens  05:50

Robert, did you say billion with a B?

Robert Popovian  05:53

Yes, billion with a B. And I want to point people to a study that my co author and I did Wayne Winegarden from the Pacific Research Institute, that we looked at the issue of what happens if Medicare basically takes the money that has been negotiated on the patient’s behalf, and instead of having the insurance and the PBMs pocket the money go directly to the patient. And we found that based on our modeling, that eliminating the rebate contracting and passing all of the concessions to the Medicare Part D enrollees, leads to lower overall healthcare expenditures and patient out of pocket costs. The lower part expenditures is because, Conner, what happens when patients can afford their drugs, they stay on their drugs, they’re more compliant with their medicines, and they end up having healthier lives and not ending up in the emergency room or hospitalizations, which is significantly higher in expenditures.

Conner Mertens  06:56

Robert, I guess a good question then becomes where have we seen successful policy change in regards to this? Is there somewhere we can model this after where we’ve been able to bring costs down for patients?

Robert Popovian  07:07

We’ve seen this in the space of, by pharmaceuticals, by generics, authorized generics or Biosimilars are available, when they’re made available to these patients, patients spend less money and they’re more compliant with their medicines. Except again, this is another bipartisan effort that has been going on, is that we need to eliminate possibility of rigging the system where the pharmacy benefit managers and insurers end up covering more expensive brand name drugs because they make more money off of rebates and fees, and instead they need to promote generics and biosimilar usage and authorized generic usage. This is not happening in the marketplace, because the current model benefits the middlemen, these pharmacy benefit managers and insurers for collecting all of these rebates and fees and pocketing them and therefore they really like covering brand name medicines with higher prices and high rebates and fees instead of lower cost alternatives like generics, authorized generics or biosimilars.

Conner Mertens  08:10

You know, Robert, it almost sounds like patients are getting issued a coupon and then whatever savings they get from that coupon just gets bumped back to the manufacturer, like I’m going to the grocery store, and I get $5 off my laundry detergent, and Tide is the one that’s walking away with the $5.

Robert Popovian  08:26

You’re right. This is the problem with pharmaceuticals. Unlike any other segment of the healthcare system, whether it’s the hospital, the physician, the dentist, the optometrist, when you walk into those offices and demand service as a patient, and you utilize your insurance card. When you have a coinsurance or deductible, your out of pocket cost is based on a negotiated price that has been done on your behalf by the insurance company in that case, except for pharmaceuticals. Pharmaceuticals is the only entity in the marketplace, where patients walk into a pharmacy, they utilize their insurance card. And when they have a deductible or coinsurance, their deductible and coinsurance is based on inflated retail prices that PBM, the pharmacy benefit manager nor the insurer ends up paying for therefore it’s just unfair. These concessions have been done on behalf of the patients, and the patient should benefit directly from them.

Conner Mertens  09:24

We’ve been talking a lot about what can be done legislatively to affect change and lower these costs. But I think it’s only a fair question. The lawmakers aren’t the only ones on the hook for high prices for patients. How do we hold pharmacy benefit managers and the insurers accountable?

Robert Popovian  09:38

Well, we need to hold everyone accountable, including the biopharmaceutical industry. We need to ensure that if savings are gained through negotiations with the biopharmaceutical industry, that the patients directly benefit from it, and instead they’re not pocketed by the insurers or the pharmacy benefit managers especially on the Medicare side. Regarding by pharmaceutical industry, President Biden and this is again, bipartisan support for this, should encourage new payment models such as payments for outcomes or guarantees that tie medicines to medicine’s value. In other words regarding biopharmaceutical industry, if the drug doesn’t work, you don’t get paid for it, we need to basically institute those types of policies to hold them accountable as well.

Conner Mertens  10:24

Well, as always, Robert, I really appreciate you taking the time to talk with us and make sense of what doesn’t make sense. I was wondering if you could give us the last word. What’s one thing that folks should take away from this discussion?

Robert Popovian  10:35

Well, what patients need to do is encourage their policymakers to work together to be able to reduce their out of pocket costs. Out of pocket costs for pharmaceuticals, on average, is manageable. It’s actually decreasing year over year, except a small percentage of patients that are taking the brunt of the problem. And those are the patients that require drugs that probably are not available in generic formulation. And what patients need to do is encourage legislators to work in a bipartisan manner to make sure when drugs that are brand name drugs and have high rebates and high fees that have been negotiated on their behalf, are directly passed back to the patient at the point of sale, instead of being pocketed by the insurers and the pharmacy benefit managers. Look, we need to meaningfully reduce out of pocket costs for patients, especially patients who are suffering from this. Not everybody is, but a small number are and we cannot forget about them, and we cannot leave them behind. So Connor, I have a question for you. What do you think patients should take away from this podcast?

Conner Mertens  11:47

Listen, I think that so many of our issues in the system boil down to transparency, a lot of the things that you’ve been mentioning are shady practices done behind closed doors. And I think we have to answer the question who’s benefiting from it, who’s losing here. And at the end of the day, unfortunately, patients are losing. We can be doing a heck of a lot more to make sure that patients are cared for. Is that right, Robert?

Robert Popovian  12:09

And I truly believe that there’s a bipartisan opportunity here. Patients are waiting, and we need to help them out. They no longer can go on the way things are as currently set up. We hope that you learned something too from this episode. We’d love to hear from you. Please share your ideas about what you think the bipartisan opportunities are to lower out of pocket costs for patients, this is an important issue for all of you, and send us an email and better yet, including a short video or audio clip and send it to Healthcare Matters at @ GHLF dot org.

Conner Mertens  12:52

I mean, how short are we talking here, Robert?

Robert Popovian  12:55

Look, don’t worry. We have good editors that help us out. And who knows whatever you share, maybe included in our listener feedback portion of future episodes.

Conner Mertens  13:06

As always, Robert, thanks for bringing your expertise, your wisdom, it makes my job a lot easier, or a lot harder, depending on who you ask.

Robert Popovian  13:13

And frankly, Conner without you and reaching out to our patient population, we will be nowhere near resolving some of these issues. So great job.

Conner Mertens  13:22

Well, that’s it for us. Thanks for listening to Healthcare Matters podcast, a podcast that pulls back the curtain to help you make sense of complex healthcare economics and policy issues. He’s Robert Popovian.

Robert Popovian  13:32

And he’s Conner Mertens, see you guys next time.

Narrator  13:38

Be inspired, supported and empowered. This is the Global Healthy Living Foundation Podcast Network.

SUMMARY KEYWORDS

vaccines, mandates, politicized, healthcare professionals, developing, robert, pandemic, people, technology, patients, conner, healthcare, pharmacist, diseases, anti vaxxers, infectious diseases, flu vaccine, misinformation, communities, herd immunity

SPEAKERS

Conner Mertens, Narrator, Robert Popovian

Narrator  00:00

Be inspired, supported and empowered. This is the Global Healthy Living Foundation Podcast Network.

Robert Popovian  00:11

We’re developing vaccines not only for infectious diseases, but we’re developing vaccines for oncology, cancer, Alzheimer’s, Parkinson’s disease, HIV/AIDS. So if we are going to be so hesitant about vaccines, we’re not going to be able to defeat some of these long term chronic illnesses that affect people.

Conner Mertens  00:32

Welcome to the Healthcare Matters podcast, the podcast that pulls back the curtain to help you make sense of complex healthcare, economics and policy issues. He’s Dr. Robert Popovian, joining us from Los Angeles, California, a pharmacist, economist and Chief Science Policy Officer at GHLF.

Robert Popovian  00:48

And he’s Conner Mertens, up the coast for me in Seattle, Washington, he’s the Patient Advocate, Community Outreach Manager at Global Healthy Living Foundation. Thanks for joining us, as you know, our purpose, the big reason we’re here and have a podcast is to help simplify the complexities in our healthcare, economics and policy issues that affect you and the patients and everyone around you. Robert’s the expert, in fact he’s one of the few people who has studied and published both clinical and policy related economic analysis. So you know he knows what he’s talking about.  And you know what, Conner brings it down to the human level, as he helps people with chronic disease be more understood by loved ones and policymakers.

Conner Mertens  01:31

Now that you know who we are, and why we’re here, we’re going to dive straight into today’s topic. Robert, something that’s so topical and so important for us to talk about are the COVID-19 vaccines, it seems like everyone’s talking about it, not enough people are getting it. I think it’s such an important and interesting topic, because every time we get a vaccine, it seems life expectancy goes up. They’ve been mandated in the military, in schools for generations. We’ll get to mandates later, but we’ve seen many diseases come and go, polio, measles, etc, etc. And while COVID vaccine is in air quotes, new technology, it isn’t. Robert, tell us why we should take the COVID vaccine and why we should trust it.

Robert Popovian  02:08

Well, first of all, it’s a miracle that the biopharmaceutical industry was able to get this medicine out as quickly as possibly that they could. And they had the attention of the policymakers, the Food and Drug Administration, to be able to do this. This was not a singular effort by just the biopharmaceutical industry. It takes a village to get the product out. And it’s a critical vaccine because it is hopefully going to get us out of the pandemic and going back to normal life, as we knew it before the COVID 19 pandemic hit us. So it is critical for everybody to take it because one of the things that people forget is that COVID-19, just like flu and other infectious diseases are communicable diseases. So we all have to be vaccinated, the ones that we can. There are obviously individuals that cannot, because of the immunity issues that they may have, and so on, so forth. But all of us that are capable of taking the vaccine, we need to get it. So then hence we can develop the herd immunity that protects all of us, especially the vulnerable patients, which are the elderly, and the younger patients, or people who are immunocompromised.

Conner Mertens  03:22

So what do you say to the people who are concerned that this was developed so quickly? This technology has been around for a while, can you tell us a little bit more about that?

Robert Popovian  03:30

That’s true, Connor, mRNA technology is nothing new. Scientists have been working on this technology for a long time, in a variety of different therapeutic areas, including cancer therapy, it’s just that the application for treatment as utilized as a vaccine for infectious diseases was not the one that they were looking into. So the technology, the baseline technology of mRNA has been around. And we were able to basically utilize that platform to then develop the COVID-19 vaccine. So although it was done expeditiously, unbelievably fast, again, the baseline understanding of the technology and the scientific understanding of how it will work in the human body has been being studied for decades. And in fact, when the COVID-19 vaccine was authorized by the Food and Drug Administration late last year, my comments publicly were more like this is a justification of the platform itself rather than the vaccine on its own. We’re going to be able to use this mRNA technology platform for future diseases, in infections and other types of diseases. And in fact, multiple companies are now working on vaccines using this type of platform. The good news is we have a new way of developing medicines for both infectious disease vaccines and also vaccines related to chronic diseases or oncology and so on and so forth. So it’s nothing new that we were looking at but this was the breakthrough we needed to justify the platform itself.

Conner Mertens  05:04

Absolutely. I think it’s a very important distinction that we have to make between folks that are vaccine hesitant and those that are pure anti vaxxers. Being skeptical of a health system that has done harm in the past is fair. And like we were saying that the onus should be on the medical community to bridge those gaps. But that’s very different than someone who thinks a vaccine has a microchip in it. The problem is the same. But the motivations are completely different. How do we reach these communities where they’re at?

Robert Popovian  05:30

You’re absolutely right. So first of all, let’s step back, what do COVID vaccine and these new vaccines have done is that they’ve revealed once again, that there’s a significant vaccine hesitancy and resistance among Americans, as you’ve said. And there are two different issues. There’s the anti vaxxers, that have traditionally been anti vaccination to start with that we need to be able to somehow corral and educate and make them understand that the benefits of the vaccines brings to society. And then there are individuals that are truly hesitant about vaccinations, whether it has to do because of past experiences that they’ve had through vaccination in different patient populations, or because they’re just skeptical, because remember, this is a new science, and they need to be educated as well. So we need to distinguish those two entities, and be able to educate them and bring them along to make them understand the value of immunizations, and herd immunity, and so on and so forth. And all of us will benefit if they come along with us. Now, having said, that politicizing the vaccine issue like it has been done in the past, is the biggest mistake that we’ve made. Because the more we politicize whether we publicize on the right, or on the left, we make things worse. And these people do not want to be politicized. They want to be heard. And they want to have a legitimate conversation. And the best people, Connor, and you know this, because you work with patients everyday, are the healthcare professionals. They’re the most trusted entity. These people don’t want to hear it from a government official, or from a institution, or some agency that is faceless and nameless. They want to hear it from their own healthcare professionals. So it is the opportunity that healthcare professionals, whether it’s a physician, a pharmacist, a nurse, that we need to step forward, and take on this mandate, and really get engaged and help patients understand and make sure that it no longer gets politicized as it has in the last few months.

Conner Mertens  07:45

I think you’re absolutely right. The way that things have been politicized has really been a detriment to public health. Science doesn’t care what letters next to your name when you’re voting in a booth. I’m curious, Robert, how does the reaction to the COVID vaccine compare historically to other vaccines? Again, we mentioned polio earlier, I think that was reveled when it was discovered and widely celebrated. Did we see same outrage and up in arms fighting for past vaccines?

Robert Popovian  08:12

No, we haven’t. But there’s been a building institutional sort of hesitancy and resistance to vaccines built over time in the last few decades. Part of it has to do because there’s been some bad experiences by certain communities, and specifically communities of color in the United States about vaccines and the vaccine research issue. So they have legitimate concerns and that need to be addressed. The other thing has to do with that there’s so much more social media today and misinformation that you see out there about vaccines in general. And I allude to the fact that one of the main issues that was brought up for vaccine resistance or anti vaxxers used is a safety concern. And all of those safety concerns that came up about 10, 20, 25 years ago, have been put to bed and scientifically been found to be nonsense. Unfortunately, what has happened is that you still continue to see the same rhetoric come up over and over again. Again, I have to go back to the issue that we as healthcare professionals, and I consider myself one as being a pharmacist, we need to work with individuals that you represent, Conner, who are the patients, and really help them understand that this is the best way for us to step forward.

Conner Mertens  09:34

I think it’s a very important point. And we are the most informed generation, we have every answer we could ever imagine at our fingertips. And yet, we’re here, we’re at this point. What are the long term consequences, Robert, that you can see associated with these misinformation and what we’re seeing now?

Robert Popovian  09:50

And this is why Merrill Matthews, Dr. Matthews, and I wrote this Op Ed on “The Hill,” is that the vaccines are the future of healthcare. We’re developing that vaccines not only for infectious diseases, but we’re developing vaccines for oncology cancer. We’re developing vaccines for Alzheimer’s, we’re developing vaccines for Parkinson’s disease, HIV/AIDS. So if we are going to be so hesitant about vaccines, we’re not going to be able to defeat some of these long term chronic illnesses that affect people. Look, as a medical community, we’ve done a good job, we’ve empahsized, you know prevention with regards to exercise and lifestyle changes, but no amount of exercise and lifestyle change is going to prevent us from getting a tetanus or chickenpox or COVID, or polio or shingles. We need to have these medicines and we are developing future medicines based on the platforms that we discussed with whether it’s the mRNA platform, or just vaccines in general. If we don’t get this right, not only there are consequences about us not being able to get out of this pandemic currently, we’re going to suffer as a society long term because we’re not going to be able to then get the benefit of these newer therapies that are being developed in different disease areas, not just infectious diseases.

Conner Mertens  11:10

Well Robert, as you know, we like to talk policy. And I know this is a tough question. But when does it become necessity that we implement mandates? Is that the right answer here? What can we do to curb this and keep it from coming back?

Robert Popovian  11:25

We have mandates right now in this country for immunization for children. If you want to attend school, public school, but most private schools go along with it too, because my both of my daughters went to private school when they were younger and they both had to have all their vaccines done. We do have mandates. So it’s nothing new that we’re trying to say, Oh, well, mandates have never worked or mandates don’t exist. That is not true. We do have mandates and vaccines now. We’ve sort of skirted the issue on the adult population. And the interesting part is that we don’t have a good knowledge base about the data. For example, flu vaccine, which is something that’s recommended for all the way through from the age of six months to senior patients, we sort of poo poo that, and a lot of individuals under the age of 65 don’t get the flu vaccine. Yet, the year before the pandemic occurred, we had over 60,000 deaths just from flu. So imagine if you had taken the flu vaccine and imagine all the excuses about how the flu vaccine is not as effective. Let’s say the flu vaccine is only 30% efffective, right? And you had 60,000 deaths, you would have prevented 18,000 deaths that year. That’s how we need to think about adult vaccination. We need to have some parameters without first, and educating them and saying, Okay, we get it. Not every vaccine is effective because that’s what you hear a lot externally. But just in case of flu, which we know it’s not the most efficacious vaccine, it would have possibly prevented 18,000 deaths in the United States. In my opinion, we have had mandates, we have mandates for pediatric patients, whether or not we should have mandates in the adult population, I think it’s first let’s get through the education and make sure that people understand and put it in context of what it will happen to you if you don’t have one. And then let’s get into a discussion about how you make sure that the most vulnerable patients in this country are not exposed to infections. And that’s the only way for all of us to get immunized. And for us to have herd immunity.

Conner Mertens  13:33

As you mentioned, we’re on the cusp of some major breakthroughs because of the technology that has been cultivated during this COVID 19 pandemic and the subsequent rush to find a vaccine. The entire world scientific community focused on this technology and there’s so much to look forward to. And it really is heartbreaking when the misinformation is spread and folks lose their lives because of it. What’s your last word? What are we going to tell folks to take away from this episode?

Robert Popovian  13:59

Look, what I’m going to tell folks is that, talk to you healthcare professional, talk to your pharmacist, they’re the most accessible one, right, you can walk into any pharmacy without an appointment and talk to a pharmacist about immunization. Make sure you have all the facts from a healthcare professional, not from Twitter, not from Facebook, not from Snapchat, Tik Tok videos, they should be listening to their healthcare professionals. Also organizations like Global Healthy Living Foundation that get their information from healthcare professionals. Don’t just say no without having all of the answers to your questions. The second thing I would say is that future vaccines may be our best preventive medicine option for long feared diseases. They may even become the preferred treatment option. Let’s hope that we won’t be politicizing vaccines in general, like what we’ve done with the COVID-19 vaccine, because that will be the detriment to all of us long term as a society. And remember, one last thing, the least effective vaccine is the one a person refuses to take. We don’t take the vaccine, we don’t get the benefit. We don’t get the benefit. We suffer from it. Thank you for listening, we’d love to hear from you about the COVID-19 vaccines, vaccines in general, send your emails to Healthcare Matters at GHLF dot.org. Or better yet, including short video or an audio clip for us.

Conner Mertens  15:26

And who knows, whatever you say may be included in future listener feedback portions. Thanks for listening to Healthcare Matters, the podcast that pulls back the curtain to help you make sense of complex healthcare economics and policy issues. If you like this episode, give us a rating and write a review on Apple Podcasts, it’ll help more people like you find us. He’s Dr. Robert Popovian.

Robert Popovian  15:48

And he’s Conner Mertens, see you all next time.

15:53

Be inspired, supported and empowered. This is the Global Healthy Living Foundation Podcast Network.