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AMCP Podcast Series — Listen Up: Stan Mehr Director of Content Biosimilars Review & Report
Show Notes
Health care expert Fred Goldstein, host of the AMCP Podcast Series — Listen Up! sits down with Stanton Mehr to discuss what is ahead for biosimilars in 2023, including the new adalimumab biosimilar launches and potential ustekinumab introductions. These are the first biosimilar antibodies to become available that will be widely covered under the pharmacy benefit. Payer executives have been anticipating this pivotal juncture and AMCP is helping to prepare pharmacy and medical executives for this opportunity to take advantage of the massive savings anticipated by these new biosimilars.
Stanton Mehr is director of content for Biosimilars Review & Report and President of SM Health Communications. A writer and editor working and reporting on the managed care industry since 1988, he has been an AMCP member for over 25 years and has followed the biosimilar industry since the inception of the BPCIA.
Want to learn more? View AMCP’s Biosimilar resources!
Transcript
[SPEAKERS: Fred Goldstein, Stan Mehr]
Fred Goldstein 00:02
Hello and welcome to the AMCP Podcast Series — Listen Up! as we take a deep dive into the challenges, trends and opportunities in managed care pharmacy, follow the show's social hashtag AMCPListenup. And to learn more about AMCP Visit amcp.org. I'm your host Fred Goldstein. Today our guest is Stan Mehr, director of content at biosimilars review and report. Welcome, Stan.
Stan Mehr 00:27
Thank you, Fred. Glad to be here.
Fred Goldstein 00:29
Yeah, it's a pleasure to have you on. Why don't we start with just a very quick description for maybe some of our audience what is a biosimilar?
Stan Mehr 00:36
Well, very briefly, a biosimilar's, a close, but an exact copy of a biologic or reference product that is expected to produce efficacy and safety outcomes that are equivalent to that biologic. Think of it as a parallel pathway to the generic drug program for small molecule drugs. In the FDA's biosimilar evaluation process, candidates are evaluated in multiple ways against the biologic reference before approval. The specific reason that biosimilars were introduced are solely to increase competition and to lower costs, just like generics
Fred Goldstein 01:10
fascinating. And obviously biosimilars have been a hot topic for the last five years. Why are things culminating now in 2023?
Stan Mehr 01:18
That's a great question and I think a lot of it is is due to anticipation. We have over I think 40 approved biosimilars right now in the US, but not all of them are marketed and one of the most highly anticipated products that are going to reach the market this year, is adalimumab. The reference product is HUMIRA. Now that products racked up more than $20 billion in sales in the US in 2022. Alone. And this anti TNF inhibitor is used to treat several common autoimmune conditions including rheumatoid arthritis, psoriasis, IBD, among others. One biosimilar adalimumab has already been launched in January, and perhaps eight others will enter the market by the end of July. Payers are hoping that net prices will drop quickly yielding multimillion dollar savings for many plans and insurers. There's also another possibility for an initial launch later in this year for biosimilar, Secukinumab, which is a reference product called Stelara. Now, that's the first interleukin product to face biosimilar competition. That product also has over $6 billion in US sales. And the interesting thing is both of these products, the HUMIRA biosimilar and Stelara Biosimilars are all primarily covered under the pharmacy benefit. So although biosimilar insulins have been launched previously, this marks the first time PBMs pharmacy benefit managers will be making coverage decisions for these high cost biosimilar monoclonal antibodies,
Fred Goldstein 02:55
what is AMCP doing in the biosimilars area and how is the organization preparing its members for these new biosimilars this year and beyond?
Stan Mehr 03:02
Well, AMCP has been tracking biosimilars since the first biosimilar filgrastim approval back in 2015. And the Academy has been working on a number of initiatives. realizing the importance of generating real world information, evidence and monitoring for potential effectiveness, or safety issues. AMCP created the BBCIC or the Biologic and Biosimilar Collective Intelligence Consortium, and that's headed by Dr. Cate Lockhart. BBCIC leverages the medical and pharmacy databases of its participating members to generate and analyze scientific evidence on both biologics and biosimilars and emphasizes publishing the results in peer reviewed journals. Dr. Lockhart is the principal investigator of a recently awarded FDA grant which examines the use of real world data to improve the efficiency of regulatory decision making regarding biosimilars and interchangeable biologics. CVS Health Clinical Trial services, which is part of Aetna, and Health Partners Institute, our collaborators on the grant AMCP has also worked with PBMs, payers in the pharmaceutical industry through a 2020 partnership forum, better understand the challenges and gaps associated with biosimilar adoption and successful implementation of coverage. In 2022, more recently, AMCP began initiative that focused on operational readiness to cover biosimilars under the pharmacy benefit. Now, of course, that relates directly to the Humira biosimilar launches. It began with a set of market research interviews with key stakeholders in the presentation of those results at an initial workshop attended by PBM, payer and employer representatives. The overall goal of this project is to develop and disseminate tools and resources that payers and others can use to overcome the practical challenges to implementing pharmacy coverage. Once the P&T committee decides to add biosimilars to its formulary. Some of the opportunities that have been identified with stakeholder education, creation of a biosimilar tracking, tracking device and through the sharing of best practices that includes collaboration amongst stakeholders. Another workshop will be scheduled in the springtime to pressure test some of these new tools and resources on development. Although AMCP has included biosimilar content in its national educational meetings for the 2023 meeting in March AMCP made biosimilars a separate track to address some of the issues that are critical at this time for its members. This includes interchangeability laws and regulations, a payer and PBM panel on biosimilars success stories, expectations for 2023 and sponsored content on specific conditions, for instance, autoimmune diseases or disorders, and how biosimilars will play a growing growing role in these specific conditions.
Fred Goldstein 05:59
So, Stan, what are some of the issues to consider why is it so important when we look at these products to see whether they're under the medical or the pharmacy benefit?
Stan Mehr 06:07
That's a great question too. You know, up to this point in time, the vast use of biosimilars has been under the medical benefits specifically for oncology directed products or support products. And they're typically Buy and Bill type products under the pharmacy benefit. The plans and the PBMs have the ability to make more direct formulary decisions that are going to affect people directly and affect the utilization and the uptake of the biosimilars. And there's a greater opportunity to bring to the fore more of the classic pharmacy benefit tools that have been used in the past with other molecules to try to manage the use of these products and hopefully encourage their use over time. So for instance, it might be a case where you can take advantage of interchangeability, where in the medical benefit. interchangeability has no practical application; under the pharmacy benefit. interchangeability basically means there's the opportunity for automatic substitution, which means automatically substituting for the reference product that is. So we can automatically substitute for another biosimilar, but if we want to switch market share quickly, a substitution will allow folks to do just that,
Fred Goldstein 07:23
Stan, obviously, affordability or cost is a critical issue today, what's at stake for the affordability of pharmaceutical innovation?
Stan Mehr 07:31
Everything. I can't emphasize this enough, when generics first came onto the marketplace, the savings obtained from the generics helped to fund or finance our use and continuing innovation for the first generation of biologics. So if we didn't have the generic drugs come in and gain uptake, we probably wouldn't be able to afford the HUMIRA products, the etanercept products, all the anti TNF inhibitors that are so prevalent today in the treatment of many of these diseases. So creating this competitive pathway for the biologics is critical for supporting the financing of the specialty pharmaceuticals, which now account for more than 50% of the total drug spend. And as we've heard repeatedly and from multiple resources, the costs for individual drug treatments are soaring, several cost over $1 million per year or per treatment cost. So we really do need the infusion of new biosimilars to lower the cost of existing biologics that are off patent in order for us to continue to innovate for these new gene based therapies for life threatening and debilitating conditions. And they're the most obvious example, with price tags for each drug in the millions. How can the US health system afford to keep paying for this level of innovation, we must introduce competition to biologic therapies whose market exclusivity has expired, and some have long expired, the savings being forecast for appropriate biosimilar coverage utilization over the next few years alone may exceed $100 billion.
Fred Goldstein 09:18
This is also an area where perhaps due to these high prices, we're going to begin to see some alternative payment models introduced.
Stan Mehr 09:25
I wouldn't doubt it. Quite frankly, if you're looking at these drugs that are with these very high price tags, and particularly for drugs that are for very rare diseases, there has to be a way to finance the payment for these drugs. Now that simply might be through value based contracting, more adaptive use of such contracting models, higher rebates, but there has to be a sustainable way to produce these these medications and continue to innovate these life saving therapies, while at the same point, not breaking the bank.
Fred Goldstein 09:59
Well, thanks so much, Dan, for joining us.
Stan Mehr 10:02
My pleasure, Fred. Glad to do it. And we're gonna be very excited to keep watching what happens in 2023 with the emergence of these new biosimilar products.
Fred Goldstein 10:13
And thank you for joining us today. If you liked the show, you can find all our episodes at amcp.org/podcast on our show page at HealthcareNOWRadio.com or on your favorite listening platform by searching Healthcare NOW Radio. You can follow our shows social hashtag at AMCPListenup. And don't forget to share, like and follow AMCP. org on LinkedIn, Twitter, Instagram and Facebook. I'm Fred Goldstein for AMCP. Until next time.
About the Hosts
Fred Goldstein is the founder and president of Accountable Health, LLC, a healthcare consulting firm focused on population health, health system redesign, new technologies and analytics. He has over 30 years of experience in population health, disease management, HMO, and hospital operations. Fred is an Instructor at the John D. Bower School of Population Health at the University of Mississippi Medical Center and the editorial Board of the journal Population Health Management.
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