Optum joins CVS, Cigna in dropping Humira

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Optum Rx will join the other major pharmacy benefit managers and exclude Humira from some formularies.

In a message to providers, Optum said it will exclude Humira and prefer biosimilar options for new patients beginning in 2025.

Existing patients will be able to continue on Humira until the FDA designates biosimilars as interchangeable with Humira, meaning they can be substituted at the pharmacy without consulting the prescriber. The designation is expected in 2025.

In August, Express Scripts, Cigna's PBM, said it will remove Humira from its largest commercial formularies in 2025.

Humira, used to treat rheumatoid arthritis and other inflammatory conditions, is the highest-grossing drug of all time. Biosimilar competitors to the drug can cost less, though the transition has been slow, according to a 2023 report from KFF Health News.

CVS Caremark was the first major PBM to replace Humira with biosimilars from its main formularies. The company dropped Humira from its formularies in April. After instituting the change, 97% of Caremark member prescriptions were switched to a preferred biosimilar, the company said.

[EXTERNAL LINK] - Optum joins CVS, Cigna in dropping Humira

 

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This was part of the 2025 Final Rule.

Contract Year 2025 Medicare Advantage and Part D Final Rule (CMS-4205-F) | CMS

Background

www.cms.gov

More Flexibility to More Quickly Substitute Lower Cost Biosimilar Biological Products for Their Reference Products

CMS is finalizing two changes to provide Part D sponsors with more flexibility to make midyear substitutions of biosimilars for their reference products on their formularies:

• All biosimilars may be substituted as formulary maintenance changes: Part D sponsors may treat formulary substitutions of all biosimilars for their reference products as “maintenance changes” that would not require explicit prior approval by CMS. This option has previously been available only for interchangeable biological products. Part D sponsors previously had to obtain explicit approval prior to substituting biosimilars other than interchangeable biological products, and these substitutions applied only to enrollees who began therapy after the effective date of the change — delaying enrollees’ access to cheaper options. Treating all biosimilar substitutions as maintenance changes means that midyear formulary substitutions of biosimilars for their reference products would apply to all enrollees (including those already taking the reference product prior to the effective date of the change) following a 30-day advance notice to affected enrollees.
• New interchangeable biological products may be immediately substituted: We are finalizing additional flexibility for interchangeable biological products not on the market at the time that Part D sponsors submit their initial formulary for CMS approval. Part D sponsors meeting certain requirements have the additional option to immediately substitute a new interchangeable biological product for a reference product and provide notice of the change to affected enrollees after making such change.

These changes provide Part D sponsors with mechanisms to give enrollees access to equally effective — but potentially more affordable — options sooner than under the current policy. Consistent with the work of the President’s Competition Council, these regulations continue the Biden-Harris Administration's commitment to promoting enhanced access to affordable biosimilar and generic products.