PBMs Announce 2023 Coverage Plans for Adalimumab Biosimilars

Prime Therapeutics recently announced its coverage plans for Humira and its biosimilars, which will start coming to the US market in 2023. It’s the latest pharmacy benefit manager (PBM) to make coverage decisions about adalimumab now that the branded product will face competition from multiple biosimilars.

AbbVie’s Humira, which treats multiple inflammatory diseases, had sales that nearly reached $21 billion in 2021. The only more profitable medication that year was Pfizer’s COVID-19 vaccine. But with the first adalimumab biosimilar, Amgen’s Amjevita, launching in January 2023 followed by at least 7 more—including Boehringer Ingelheim’s Cyltezo, which is the only approved adalimumab biosimilar to have interchangeability—Humira’s reign is likely about to come to an end.

In addition to the 8 approved biosimilars, there are another 2 under review with the FDA. One of these biosimilars, AVT02, has an application for interchangeability under review. AVT02 would be the first interchangeable, high-concentration adalimumab biosimilar when it is approved.

In 2023, Prime will recommend Humira biosimilars to sit alongside the reference product in the inflammatory drug class on the preferred drugs list of the formulary.

"Prime actively promotes evidence-based use of biosimilars to deliver the lowest net cost options to clients. In this case, that option may be the brand drug or its competing biosimilars," Dave Schlett, executive vice president and president of PBM solutions for Prime, said in a statement.

Prime is just the latest PBM to announce changes related to adalimumab biosimilars. In early December, Cigna Pharmacy, which manages pharmacy benefits for Cigna, announced it would add adalimumab biosimilars as preferred products on commercial formularies at the same position as Humira.

“Biosimilars hold tremendous promise to improve the affordability of life-changing specialty medications, and this is part of our work to expand access to them and achieve lower costs for the employers and members we serve,” Katy Wong, chief pharmacy officer, Cigna Pharmacy, said in a statement. “By placing biosimilars on our formularies in the same position as Humira, we’re also ensuring that physicians and patients have choice and flexibility as they assess these additional biosimilar therapies.”

Neither Cigna nor Prime said which of the biosimilars they would have available on their formularies.

In November, OptumRx was the first to decide to include Amjevita and 2 other biosimilars on formularies. OptumRx’s CEO Heather Cianfrocco announced the decision at the HLTH2022 meeting. The biosimilars will be available on the Select and Premium formularies, but no information on tiering or utilization management strategies were provided.

Greater use of biosimilars offers the chance for massive savings. A September report from the Association for Accessible Medicines found that FDA-approved generics and biosimilars saved the US health system $373 billion in 2021 alone. According to the report, the biosimilars market is approaching nearly 30% of the overall biologics market and saved patients more than $7 billion in 2021. Not only is the average sales price (ASP) for biosimilars, on average, 50% less than the reference product, but competition from biosimilars has reduced the ASP for reference biologics by an average of 25%.

“Thanks to new biosimilar competition, more patients are receiving the care and medicines that they need,” Craig Burton, executive director of the Biosimilars Council, said in a statement. “But new challenges on the horizon demand attention, including the launch of new pharmacy benefit biosimilars, ongoing gaps in biosimilar adoption, and brand rebate traps that continue to exploit perverse incentives in the health care system. The coming years will be critical to fulfill biosimilars’ promise for patients.”

With 8 or more adalimumab biosimilars ready to enter the US market over the next year, savings from biosimilars are poised to continue growing.

In a study published in the July 2022 issue of The American Journal of Managed Care^®, researchers from RAND Corporation and HHS’ Office of the Assistant Secretary for Planning and Evaluation estimated that savings between 2023 and 2025 from adalimumab biosimilars could reach $19.5 billion or half of the total savings expected from biosimilars through 2021 to 2025.

“We project that biosimilars will lower spending on biologics by $38.4 billion from 2021 to 2025, with the bulk of savings accruing from new downward pressure on reference biologic prices and from new biosimilar entry,” the authors concluded.