How Policy Reforms in PBM Systems Could Change the Adalimumab Market

Panelists at the GRx+Biosims conference discussed the need for increased transparency and policy reforms within pharmacy benefit management (PBM) systems to support the accessibility, affordability, and fair competition of adalimumab biosimilars. The conference was held from October 21 to October 23, 2024, in Rockville, Maryland.

Moderator Michael Sargent, senior director of policy at the Association for Accessible Medicines, opened the discussion on reference adalimumab (Humira) and adalimumab biosimilars, highlighting a recent shift in data analysis that now considers the impact of dispensing channels. He emphasized the link between vertically integrated specialty pharmacies and large pharmacy benefit managers (PBMs) and the role that private label products could play in enhancing biosimilar accessibility and affordability.

Following this, Nick Adolph, principal of US Market Access Strategy at the IQVIA Institute for Human Data Science, focused on his team’s work in commercialization consulting and market access, presenting a “state of the union” for adalimumab. He compared it to other loss-of-exclusivity events for biologics and small molecules, noting the relatively slow uptake of adalimumab biosimilars so far.

Adolph detailed a sharp increase in adalimumab claims from March to April 2024, primarily driven by cobranded products, although Humira retains a significant share of the market. He attributed a recent decline in overall adalimumab volume to AbbVie’s new product launches, which have successfully diverted patient prescriptions. He also analyzed payer rejections, showing that biosimilars face more NDC blocks and formulary exclusions than Humira, underscoring a significant barrier in the biosimilar market.

Adolph then addressed the influence of specialty pharmacies, particularly those tied to large PBMs, on adalimumab biosimilar uptake. He cited PBMs like Caremark, which have successfully transitioned patients to biosimilars via their specialty pharmacies.

“One of the—if not the—biggest takeaway from what we're seeing with the cobranding [of products] is just the PBMs’ true ability to, when they really want to, switch the patients over and move [market] share [to a biosimilar]. It's kind of like they've never fully flexed this muscle, but now we're seeing the full power of 90% share for a biosimilar at a PBM,” Adolph explained.

Mary Jo Carden, head of policy at Sandoz, followed with a discussion on the opportunities for private label biosimilars, stressing the importance of transparency in the pharmacy benefit management system. She highlighted the potential impact of policy changes, such as the Inflation Reduction Act, on biosimilar adoption and market competition.

Carden explained the historical use of private labels in generics and their potential to boost biosimilar adoption. She emphasized that for private label biosimilars to succeed, PBM practices need transparency to support fair competition and expand patient access.

“Businesses like transparency, so that we know the rules of the road. And when you don't have transparency in the payment system and it's very chaotic, you do have differing ways to get to the same end goal, and there's winners and there's losers. While we don't know [everything yet]—this is still being written—certainly the winner is that biosimilars are being recognized. There is adoption of biosimilars in the pharmacy benefit. We weren't talking about that that a couple months ago, a year ago. Are we where we want it exactly to be? No, but we do have some adoption right now,” Carden said.

Carden advocated for sensible reforms that would ensure fair market access for biosimilars and noted that private label products might grow within the medical benefit market, paralleling trends in the pharmacy benefit sector.

The Inflation Reduction Act’s potential impact on biosimilars was a key focus, as Carden and Adolph discussed the new $2000 Medicare Part D out-of-pocket cap and its potential to drive biosimilar use by increasing plan and manufacturer liabilities. This change may encourage commercial plans to incorporate more biosimilars as a cost-management strategy, although Medicare Part D plans might still prefer high-rebate originator products. Both panelists underscored the need for transparency and fair competition to enable biosimilar success in the market.

Sargent also touched on the efficiencies specialty pharmacies bring to dispensing, particularly through Caremark’s recent formulary adjustments that have minimized paperwork and improved patient access. Adolph and Carden discussed the possibility of adopting specialty pharmacy dispensing fees in retail settings to enhance pharmacy economics and support innovation in both the biologics and generics markets.

When Sargent asked about the challenges and opportunities for biosimilars, Adolph and Carden highlighted the role of private label products in increasing market adoption. They pointed to the need for transparency within PBMs and considered how interchangeability designations could facilitate biosimilar substitution at the pharmacy level, ultimately improving patient access. Both emphasized the need for straightforward reforms to ensure fair competition and broad access for patients.

In closing, Sargent asked the panelists whether the launch of adalimumab biosimilars represents hope or true progress for the industry. Both Adolph and Carden highlighted the importance of ongoing innovation and competition, expressing optimism that despite existing challenges, biosimilars hold the potential for significant cost savings and increased patient access. They advocated for continued transparency and a competitive marketplace as essential for the sustainable growth of biosimilars in health care.

Carden concluded, "These are really common-sense reforms. We are not asking for government oversight, but really the ability to be in a fair market. We talked about how sometimes biosimilars are disadvantaged related to access fees relative to reference products. Well, that shouldn't be the case, and then being able to replace a reference product with a biosimilar on formularies is critically important.”

References

Adolph N, Carden MJ, Sargent M. Humira biosimilar adoption: hints of progress or signs of doom? Presented at: GRx+Biosims; October 21-23, 2024; Rockville, MD.