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JC Scott (00:08):Welcome to the Pharmacy Benefit, a podcast that highlights the role of PBMs and serving millions of patients and consumers throughout the country. I'm JC Scott. November is National Diabetes Month. In 2018, over 34 million people in the United States, roughly 10% of the population were living with some form of diabetes. This can be both health interrupting and life-threatening. And for patients, staying on a medication regime is exceptionally important for managing the condition, which means that the cost of their medication is also exceptionally important.JC Scott (00:40):Unfortunately, cost is increasingly a challenge for many patients with diabetes today. The insulin market has consolidated, which can limit competition and stifle the development of therapeutic alternatives. And that lack of competition is one important factor which can lead to higher list prices. Today's episode focuses specifically on these questions of cost and accessibility and what can be done to help.JC Scott (01:02):Joining me is Amy Bricker, Senior Vice President of Health Services Supply Chain at Express Scripts. Amy is responsible for the company's key relationships and strategic initiatives across the pharmaceutical supply chain. Her work focuses on leveraging partnerships with manufacturers and pharmacies to create value for employers and other health plan clients, and to keep essential medicines like insulin within reach of patients.JC Scott (01:26):From 2016 to 2019, Amy served as a commissioner on the Medicare Payment Advisory Commission or MedPAC, which provides analysis and policy advice on the Medicare program to Congress. And last year, Amy testified at a hearing at the House Energy and Commerce Committee on the rising cost of insulin. Amy, thank you for joining me.Amy Bricker (01:46):Thank you for having me JC.JC Scott (01:49):I thought we could start by talking a little bit about what informs your perspective on the topic we're going to be discussing today. You're a registered pharmacist and you started your career working in a pharmacy. How has that experience with direct patient interaction at the pharmacy counter affected your thinking on supply chain and cost issues?Amy Bricker (02:07):Yeah. Thanks for the question. Yes, I am a registered pharmacist. It's been quite some time since I've practiced, but when I think back about why I chose pharmacy as a profession it really stems from the fact that my younger brother was diagnosed with type 1 diabetes. And I saw firsthand what diabetes could do to not just patients, but my brother, my family, and the toll that that disease can take on an individual.Amy Bricker (02:37):For many they can adapt and they can understand how to manage that disease if given the proper tools and resources and for others, including my brother it was life-altering and continued to be a struggle for him. He was diagnosed at a young age and has lived with diabetes longer than he hasn't. And still as an adult continues to grapple with the disease that there is no cure. And it's a reminder every day that he is a diabetic and that he has to keep that top of mind in all that he does. And so I saw that firsthand and it really shaped the person that I am in my interest in healthcare and specifically in the management of diabetes and in the cost of diabetes.JC Scott (03:22):I didn't know about your personal experience. Thank you for sharing that with us, Amy. And so you were saying that that experience growing up and your brother's condition then inspired you to get into the business of pharmacy, which then obviously led to the work that you're doing.Amy Bricker (03:37):Absolutely did. And it shaped my sister. She's also in the same field. And so I think we saw firsthand what that disease means to patients and the cost is one aspect of it, but the complexity and the fact that while there has been tremendous advancement in that disease, it's a very difficult disease to manage. You don't get days off. You don't get to forget that you're a diabetic, type 1 diabetic that is. You don't get to be careless about it.Amy Bricker (04:10):Or again, just kind of, "Maybe I'll deal with that tomorrow." That's a disease that's always with you. And unfortunately given the little advancement that we've had in a cure towards the disease, we're left with traditional and at times feeling as though an antiquated systems and therapies in order to treat.JC Scott (04:32):That leads me to talk a little bit with you about what's going on in the insulin marketplace today. So insulin itself has humble beginnings, but today's insulin market has become a pretty complicated one. Let's let's start at the beginning, a trio of inventors discovered insulin and then sold their patent to the university of Toronto for about a dollar. And yet about a century later, the average price per month of insulin exceeds $450. And there's still almost no generic or biosimilar competition. What's going on in the insulin market?Amy Bricker (05:02):The healthcare system in the US is a free market for-profit system. And while we've seen with the growing tension on insulin specifically, list price increases moderating in the last couple of years, they haven't declined. And so not only do you have very inflated list prices, but that is only relevant when you think about the proliferation of benefits that anchor back to that list price, where you have high deductible health plans and where you have high co-insurance plans.Amy Bricker (05:40):And so patients unknowingly or unexpectedly are faced with these out-of-pockets that are insurmountable. And the stories that you hear around having to choose between rent or food and insulin is just it's heartbreaking. And so there are a number of things in play here, but not only have list prices continue to soar, we've not seen them decline ever in the history of this system. We have a proliferation of a benefit design that is frankly a failed experiment.JC Scott (06:19):And you raise an important point that patients are exposed to those list prices, right? Either those who may have insurance coverage, but be on a plan who's design is exposing their out-of-pocket costs more to that list price. Or of course for all the people who are uninsured and may not have coverage and have to pay the full cost at the pharmacy counter. I think insulin manufacturers might argue too is that the high price or the price increases we've seen historically are the price of innovation, right? That they would say there's new, more effective insulins on the market. Even though we don't have a cure, the treatment's getting marginally better. And that increase in value, justifies the increase in list price.JC Scott (06:56):As you know, Amy, I came out of the medical technology field and certainly there's innovation going on there for diabetics with continuous glucose monitors and delivery devices that make it easier for patients to live their lives more comfortably. And so I think we all would say absolutely there is value to innovation, but are you seeing that kind of innovation on the pharmaceutical side in terms of the progress of the science that justifies the prices that we're seeing from the manufacturers?Amy Bricker (07:25):Yeah, no, no. Yeah, sitting there on the one hand we're not dealing with pork insulin. There's human insulin so that's progress. If you look at the human insulin those that were entered the market decades ago, they are inexpensive. I think you can get them on-label or off-label for around $25 a vile, but that's going to require that you use a syringe and you pull up a dose and who's carrying around vials and syringes these days?Amy Bricker (07:53):And so, yes, there's been some advancement, advancement with respect to delivery devices, also advancement and the actual chemicals or the actual pharmaceutical itself that it's longer acting and more stable if you will. But there hasn't been incremental advancement in year over year. We've got a few more recent examples of better insulin formulations, more stable formulations. But this is the only area that I can think of pharmaceuticals that is where you pay for and you pay a high price for some new product to the market.Amy Bricker (08:35):You don't see if you look at televisions and the advancement there and they get thinner and they get lighter, you're not paying tens of thousands of dollars more for that. With innovation also comes the ability to create that at a lower price or at a greater value for consumers. And this is an example of we haven't really seen advancement, but we continue to see an increase in costs for those products.JC Scott (09:01):And would you say that some of that directly correlates back to the fact that there's really just three primary manufacturers of insulin today that they're just not that competition in the marketplace that's requiring them to more aggressively compete on both price and innovation?Amy Bricker (09:16):Yeah. I think there's something to that. When you have the ability at some point to bring a lower cost product to the market, are you going to be able to get the market share? Are you going to be able to recoup an investment if you are a biosimilar or a generic product coming to market? That's always something that a manufacturer has to weigh as they're considering entering the market. And you're right. There are three large manufacturers today that hold the entire market and the market share associated.Amy Bricker (09:49):And so what is it that it will take in order to get additional competition and therefore lower priced in the market? I do believe that when you look at the net cost, so here we go talking about the role of a rebate. But when you look at the role that the PBM has played, which essentially is demanding and encouraging competition and therefore additional discounts to plan sponsors. We have seen that the net costs have stabilized and are historically not risen to the extent that list price has, but that's the role of the PBM.Amy Bricker (10:31):Where this falls apart is when you look at the benefit design and when a patient is actually subject to that list price initially part of the plan year that you don't see the full impact of what the PBM has brought and the value that they've delivered to their plan sponsors.JC Scott (10:50):Yeah. And I think that takes me into sort of the next area I wanted to explore, which is your current industry, the PBM industry and what you're able to do to help. And you touch on probably the most important aspect, which is where you can, you're leveraging competition to try and bring those net costs down. For those who hadn't seen it and Amy, I think you saw this research that came out earlier this year from Sante that showed that despite the fact that total gross sales of insulin increased from 22 billion in 2012 to 54 billion in 2019, PBMs held total net sales to only 13 billion during that same time period.JC Scott (11:25):So I think that's a good proof point of the work that you just talked about. I also feel like though that sometimes people don't have good visibility into the full scope of what PBMs do in a case like this and trying to help diabetic patients deal with something like insulin and managing their prescription use.JC Scott (11:44):Can you talk a little bit about what Express Scripts is doing to help Americans living with diabetes not only on the affordability side, but just generally for access to improve health and wellness?Amy Bricker (11:55):Yeah. So we're really proud of the results that we've been able to deliver. Last year through our drug trend report that we publish every year, we cited over 5% decline in spending for diabetic medications for those that were enrolled in our clinical solutions. And so it's a combination of discounts that we're able to get from pharmacies themselves or retailers, but more importantly clinical programs that leverage formularies, that leverage appropriate utilization of product that we're wrapping our arms around these patients to ensure that they're adherent, but that they're also taking the right products for their disease or for the stage of their diabetes.Amy Bricker (12:42):And so we're not only just using those traditional tools of formulary and utilization management, but also diabetes care value program, which is a value-based solution. It ensures that the patient's using the appropriate channel. So where is it most appropriately dispensed, but also leveraging specialists, specialists, pharmacists, and nurses that are able to interact with these patients. Again, many of them maybe being newly diagnosed or those that are out of compliance or that their diabetes isn't under control need the additional attention and it's difficult to get that sometimes from a physician. Some of them are not managed by endocrinologists or specialists. And so they rely heavily on their pharmacist in this case, our therapeutic resource center, pharmacists to ensure that they're getting the best care possible.Amy Bricker (13:38):And so we're doing that through a number of mechanisms, just traditional outreach, but also through you made a comment a moment ago about devices. So that we're connecting to the patient in a way that they want to be communicated with, either through devices or through their glucose monitor or through text messaging. Also talking to their caregivers, if it happens to be a child or an elderly patient that needs additional support in managing their disease. So all of these things together, it's not a one size fits all, but there are traditional ways in which we can help our clients keep costs down and ensure patients have access. And then there are more sophisticated ways that we're learning to do that in collaboration with not just clinicians, but also with manufacturers and with medical device companies.JC Scott (14:32):And I have to imagine that that more holistic approach to care management or condition management that you're taking as a company here in the example of patients who rely on insulin has been acutely more important this year during the COVID pandemic for people who you're worried about making sure they maintain access to supply, that they continue to be adherent even while we're all on and off sheltering plate in place at home and living through the current situation.Amy Bricker (15:00):Absolutely. It's now more important than ever that we keep patients out of the hospital and having to go to the ER because your diabetes is either or your blood sugar is too high or too low, we want to avoid that. We always want to avoid that, but now it can also be a matter of life and death. And we know that patients that have diabetes that are higher risk if they happen to contract COVID-19. And so it's more important than ever that we're using every resource that's available to us to ensure that patients have the care that they need.JC Scott (15:33):Let's talk a little bit about the other important group of key players here and that's policymakers. When we look at the challenges for patients on insulin diabetics, you've got experience with MedPAC, you spend time on Capitol Hill, officially and unofficially. And so I'd welcome your perspective here, maybe to start with something that came out of the administration earlier this year.JC Scott (15:54):CMS announced the Part D Senior Savings Model, which allows Part D plan sponsors to offer a new voluntary Part D plan under which cost sharing for insulin would be limited to $35 a month per beneficiary. Can you just walk us through at a high level of that new model and what it might mean for Part D enrollees next year?Amy Bricker (16:13):Sure. So I'm going to start maybe with the first part of your question. I think there are many things that the industry can do to address insulin prices. And I mentioned this in a prior PCMA forum and it might be surprising to some, but I think that pharmaceutical manufacturers have subsidized the healthcare system for quite some time. They continue to have to fund ever-growing coupon programs. And when you talk to them privately, they say, "These are out of control. I don't know how to stop though, because my competitor isn't going to stop offering a coupon."Amy Bricker (16:57):But it's a program that was initially designed to get around formulary design, which of course we're not in favor of, but with the proliferation of high deductible health plans and percentage copays, they're at an all-time high. And so you have to factor in what are the things that are on the minds of these manufacturers? When of course they're public companies and they have shareholders, they have expenses around 340B. 340B, which was of course intended to be something for those hospitals and health systems that were mainly serving the underserved or those that had no insurance. And the program of course had aspirations of ensuring that those entities were able to continue to serve that population. It's gone out of control.Amy Bricker (17:45):And so we're not seeing our clients or our patients specifically benefiting. You're saying that time's very profitable, health systems benefiting and retail pharmacies benefiting. So in total, there has to be nothing will change unless something changes. We've got to see reform in 340B. I would call for a resetting or elimination of coupons for the entire industry because it's out of control, but yet no one can stop because of fear that their competitors won't.Amy Bricker (18:19):But back to the question that you asked secondly around the CMS' new model that they've proposed for Part D. It's offering insulin limited at $35 a month for those plans that wanted to enroll. This is critical. One in three Medicare beneficiaries today have diabetes, and they've decided cost as a barrier to accessing medications. Both Express Scripts and Cigna intend to participate in this program this year. we think it's critical. It's critical to address the out-of-pocket concerns relative to insulin. And we think it's a great program. And I'm excited to see the results of that.JC Scott (19:01):And I'd like to go back to your comments about the proliferation of coupons. Just for those listening to our conversation who may not have as much background into why our industry may see those as problematic, because I think the going into assumption might be, "What's wrong with a coupon? It helps lower my out-of-pocket costs. I can stay on whatever drug I want to stay on. Isn't that a good thing for me as the patient?" Can you just maybe share a little bit of perspective as to why that creates problems for everyone in a system like that?Amy Bricker (19:33):But there's a couple of things. As I mentioned early on, this was a mechanism for manufacturers who were not on a formulary to continue to have access to patients. And so when you would typically get a message that the product is expensive because it's not on formulary, a coupon would be available to you. Typically, you got those handed out, they were a piece of paper and the doctor gave them to you at first when they prescribe the product to you and you carry it into the pharmacy. And you knew that you were asking for help with your high out-of-pocket.Amy Bricker (20:04):Now it's become automated. It's behind the scenes. Patients don't even know that a coupon is in play. It's applied at the point of sale by the retailer as they are processing the claim. The downside of this is a couple of things. Plan sponsors have no visibility to this. So they don't know that the patient is using a coupon. They've created a benefit design where they've asked patients to contribute some amount towards their healthcare spend. It also is increasing the costs associated with healthcare for pharmaceutical manufacturers. Because many of them again because it's automated are just buying down the patient's out-of-pocket.Amy Bricker (20:50):And so you have this continued proliferation of people going into these benefit designs. They in some cases are not actually exposed to the out-of-pocket that is intended by the plan, but yet the manufacturer is paying that down. This all happens on the commercial side of our benefit. These coupons are not available in government programs, including Medicare and Medicaid. And so there's also a good reason for that and Medicare got this one right.Amy Bricker (21:21):But what it hasn't addressed, the Medicare design has not addressed and has not I think had a resetting if you will, since it actually was created was the fact that list prices now are extremely high on these products, that patient are subject to these high out-of-pocket costs. And depending on what phase the patient is in their benefit, it's just not predictable. And it's something that patients are very confused by. And we need to re-look at specifically with insulin the out-of-pockets that we're asking consumers to pay associated with life-saving and life-sustaining medications.JC Scott (22:05):Thank you for providing that background because I don't think a lot of people connect those dots understand that the plan formulary design is purposeful in the way that you're trying to encourage patients to use equally effective, but cheaper alternatives. And if the coupon is steering the patient to use or stay on a more expensive drug, that's more expensive for everybody in the plan. It doesn't provide the support for the development of the cheaper alternatives. And it really sort of misses the point of the whole plan design.JC Scott (22:33):So thank you for that background, Amy as we wrap up maybe to look forward and ask you to strike a note of optimism. Because we have been struggling for decades with the challenges around insulin. And as you said and especially in recent years with the increases in price, but everybody's focused on it now. So where do you see this going next year, five years down the road? How do you see the marketplace evolving? What's the outlook for diabetic patients on some of these questions?Amy Bricker (23:02):Yep. So as I said a moment ago, nothing is going to change unless something changes. And we've got to encourage the manufacturers who testified alongside me last year who said that they want nothing more than to ensure that patients have access to their therapies at an affordable price. We need to take them up on that. But in order to do that, there has to be something in the market by way of regulation or policymaking that encourages the manufacturers to reset or to lower their list prices for there to be reasonable reform to benefit design, to ensure that the patient is thought first that we're keeping the patient's care top of mind.Amy Bricker (23:46):And as I mentioned before, there needs to be a reform specifically of the Medicare Part D program. The example a moment ago of the $35 insulin in Part D. I'm encouraged by that. And I think we'll learn a lot from the plans that elect to enroll in that offering, and essentially how that translates for patient care and for adherence. And so I think we're making some strides.Amy Bricker (24:16):Of course there is always more to do, but I think there is tremendous common ground that we can reach across the industry here, so we all want the same thing and that's to ensure that patients have the care that they need. And the manufacturers of course want to ensure that they have access to the drugs that they have in the market to treat those diseases.JC Scott (24:35):Well, I'm going to take that as a very optimistic note that you given your professional experience as a pharmacist at the beginning of your career, working now in the PBM industry, your interactions with manufacturers that it's proved positive that there is space for collaboration around the needs of patients on issues like this. Amy, thank you so much for spending time with me today. I really enjoyed the conversation.Amy Bricker (24:56):Thank you, JC. It was a pleasure.JC Scott (24:58):And thank you to everyone for listening. As always, I encourage you to subscribe to the Pharmacy Benefit and download all of our podcast episodes. You can do that on Google Podcasts, Apple Podcasts, Spotify, or wherever you find your favorite podcasts. I'm JC Scott. Thanks for joining me.