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.