Panelists at the GRx+Biosims conference call for increased transparency and policy reforms within pharmacy benefit management (PBM) systems to support accessibility, affordability, and fair competition for adalimumab biosimilars. We discussed. The conference was held in Rockville, Maryland from October 21 to October 23, 2024.
The GRx+Biosims conference was held in Rockville, Maryland from October 21 to October 23, 2024. |Image credit: Daniel – Stock.adobe.com
Moderator Michael Sargent, senior director of policy at the Accessible Medicines Association, opened the discussion on reference adalimumab (Humira) and adalimumab biosimilars by highlighting recent changes in data analysis that have taken into account the impact of dispensing channels. emphasized. He emphasized the connection between vertically integrated specialty pharmacies and large pharmacy benefit managers (PBMs) and the role that private label products can play in increasing the availability and affordability of biosimilars.
Following this, Nick Adolph, Head of U.S. Market Access Strategy at IQVIA Human Data Science Institute, presented the adalimumab State of the Union, highlighting the team’s efforts in commercialization consulting and market access. He compared this to other loss of exclusivity cases involving biologics and small molecules, noting that uptake of adalimumab biosimilars has been relatively slow so far.
Adolph detailed that although Humira maintains a significant market share, there was a sharp increase in the number of applications for adalimumab from March to April 2024, driven primarily by co-branded products. He attributed the recent decline in overall adalimumab volumes to AbbVie’s new product launch, which successfully repurposed patient prescriptions. He also analyzed payer rejection and showed that biosimilars face more NDC blocks and prescribing exclusions than Humira, highlighting major barriers in the biosimilar market.
Adolph then addressed the impact of specialty pharmacies, particularly those associated with large PBMs, on the uptake of adalimumab biosimilars. He cited PBMs like Caremark that have successfully transitioned patients to biosimilars through specialty pharmacies.
“One of them is, if not; of— Biggest takeaways from what we’re seeing with co-branding [of products] This is just the true ability of PBMs to switch and move patients when they really want to. [market] share [to a biosimilar]. It’s like they’ve never fully flexed this muscle, but now we’re seeing the full power of biosimilars in PBMs with a 90% share,” Adolph explained.
Mary Jo Carden, Head of Policy at Sandoz, then discussed the private label biosimilar opportunity and emphasized the importance of transparency in pharmacy benefit management systems. He highlighted the potential impact of policy changes such as the Inflation Control Act on biosimilar adoption and market competition.
Mr. Carden discussed the history of the use of private labels in generic medicines and their potential to accelerate the adoption of biosimilars. He emphasized that for private label biosimilars to be successful, there must be transparency in PBM practices to support fair competition and expand patient access.
“Companies like transparency so we know the rules of the road. And when payment systems are not transparent and very confusing, there are many different ways to reach the same end goal. There are winners and losers without us even knowing it. [everything yet]—This is still being written—Certainly the winner is that biosimilars are gaining recognition. Pharmacies benefit from the adoption of biosimilars. This wasn’t just a few months ago, or even a year ago. Are we exactly where we want to be? No, but there are some adoptions going on right now,” Carden said.
Carden advocated for sensible reforms to ensure fair market access for biosimilars, noting that private label products could grow within the health benefits market, paralleling trends in the pharmacy benefits sector. .
Carden and Adolph discussed the new $2,000 Medicare Part D out-of-pocket cap and the potential to encourage biosimilar use through increased plan and manufacturer liability, making the Inflation Control Act a The potential impact on mirrors became a major focus. This change may incentivize commercial plans to incorporate more biosimilars as a cost control strategy, while Medicare Part D plans may still favor high-rebate originator products. Both panelists emphasized the need for transparency and fair competition for biosimilars to succeed in the market.
Mr. Sargent also touched on the efficiencies that specialty pharmacies bring to dispensing, particularly the efficiencies brought about by Caremark’s recent formulary adjustments that minimize red tape and improve patient access. Mr. Adolph and Mr. Carden discussed the possibility of implementing specialty pharmacy dispensing fees in retail settings to strengthen pharmacy economics and support innovation in both the biologics and generic drug markets.
When Sargent asked about the challenges and opportunities for biosimilars, Adolph and Kaden emphasized the role of private label products in increasing market adoption. They noted the need for transparency within PBMs and considered how interchangeability designations could facilitate biosimilar substitution at the pharmacy level and ultimately improve patient access. They emphasized the need for direct reforms to ensure fair competition and broad access to patients.
Finally, Sargent asked the panelists whether the launch of the adalimumab biosimilar represents hope or real progress for the industry. Both Adolph and Kaden emphasized the importance of continued innovation and competition, saying that despite existing challenges, biosimilars have the potential to significantly reduce costs and increase patient access. expressed optimism. They argued that continued transparency and competitive markets are essential for the sustainable growth of biosimilars in healthcare.
Carden concluded: “These are really common sense reforms. We’re not looking for government oversight, we’re looking for the ability to actually participate in a fair market. We talked about how you can be at a disadvantage in terms of access fees compared to the reference product, which should not be the case, and that you can replace the reference product with a biosimilar on the formulary. is very important.”
References
Adolph N, Carden MJ, Sargent M. Humira biosimilar adoption: a sign of progress or doom? Published at: GRx+Biosims; October 21-23, 2024. Rockville, Maryland.
