How will the Humira Biosimilars be Covered?

Next year, seven biosimilars of Humira are expected to launch, but leaders from the Biosimilars Forum are concerned not all will make it onto formularies.

Although seven biosimilars to the blockbuster rheumatoid arthritis (RA) drug AbbVie’s Humira (adulimumab) are expected to launch in 2023, they may not be available to patients, according to the Biosimilars Forum, which represents biosimilar manufacturers.

Leaders from the Forum and their member companies are concerned, based on past experiences, that the Humira biosimilars won’t be placed on formularies unless manufacturers are willing to be reimbursed less due to high rebate fee structure.

“The first-to-market biosimilars have been launched in general at a list price 30% lower than the brand,” Juliana M. Reed, executive director of the Biosimilars Forum, told Formulary Watch. “When each new biosimilar is launched, the competition drives down the price even further. Biosimilar developers prefer to have access to formularies at lower list price rather than have to add a high rebate on to the product in order to gain access to the market through PBMs. Forum member companies have experienced this with PBMs.”

Additionally, to ensure coverage for all biosimilars at their launch, it will be important for Centers for Medicare and Medicaid Services to classify the Humira biosimilars as maintenance changes, Reed said.“Without this change in policy, those biosimilars will not be able to be included on formularies until 2024,” she said.

Much of the future of the biosimilars industry depends on whether Humira biosimilars will be placed on formularies as they become available in the U.S. market.

Humira is the best-selling drug globally and currently faces no U.S. competition amid a 470% price increase since it was first launched.

The first biosimilar, Amgen’s Amjevita, is expected to launch in January 2023. The others expected to launch in the second half of the year include: the Merck’s Hadlima, Boehringer Ingelheim’s Cyltezo, Coherus BioSciences’ Yusimry, Viatris’ Hulio, Sandoz’ Hyrimoz, and Pfizer’s Abrilada.

PBMs' payment model has changed since Humira biosimilar manufacturers began developing the drugs, according to Reed. In order to gain exclusive formulary access, PBMs are requiring the lowest net cost, which is calculated using a high rebate from manufacturers.

Representatives for Express Scripts, United Health Group, and Optum did not respond to requests for comment from Formulary Watch.

Reed said CMS and policymakers need to implement a clear and expedited pathway to add all biosimilars to Medicare Part D formularies when they become available.

Related: Biosimilars Can Save Money for Medicare and Beneficiaries

Medicare Part D and its beneficiaries would benefit if all biosimilars are made available and used more often, according to a recent report by the Office of Inspector General (OIG) at the U.S. Department of Health and Human Services. In 2019, biosimilars’ reference products were prescribed about five times more frequently than biosimilars in Part D. But if biosimilars had been used instead, spending on all biosimilars could have been reduced by $84 million, or 18%. Additionally, beneficiaries’ out-of-pocket costs for these drugs could have decreased by $1.8 million or 12%.