CMS proposes allowing Part D plans to switch biologicals to non-interchangeable biosimilars

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On 6 November 2023, the U.S. Centers for Medicare & Medicaid Services (CMS) proposed a new rule to give Medicare Part D plans more flexibility. It has been proposed that biosimilars can now be substituted for the reference biologicals, even if these have not been deemed interchangeable by the US Food and Drug Administration (FDA).

Switching V19A17

At present, reference products can only be substituted at the pharmacy level with interchangeable biosimilars [1]. Current CMS guidance requires Part D plans to obtain physician-led approval prior to substituting a reference biological product with a non-interchangeable biosimilar.  This is deemed an important step in fostering confidence in substitution with biosimilars.

The new plan was outlined in the contract year 2025 Medicare Advantage and Part D policies proposed by CMS on 6 November 2023. This states that the change would apply to all plan enrollees, not only those who begin the therapy after the effective date of the change (as is the case at present). This change will facilitate fast access to cheaper medication options for all enrollees. 

The CMS proposal would permit the Part D plans to treat formulary substitutions of non-interchangeable biosimilars as ‘maintenance changes’ that do not require prior Medicare approval.

US hospital group Premier’s senior vice president of government affairs, Soumi Saha said, 'It has been known for years that biosimilars can improve patient access to medications while saving the US healthcare system billions of dollars, yet anticompetitive practices by vertically integrated payers have put their own profits ahead of lowering drug costs for patients by favouring the reference biologic[al]and lucrative rebates’.

However, Alliance for Safe Biologic Medicines’ Executive Director, Mr Michael Reilly, who served as Associate Deputy Secretary of Health and Services during the development and implementation of the Part D prescription drug benefit, highlighted, 'Substitution of biosimilars by someone other than the prescribing physician is a controversial practice banned in many countries, including nearly all of Western Europe. It is also opposed by the majority of physicians, in the US and worldwide'.

Furthermore, he added, 'Nothing has changed regarding non-interchangeable biosimilars since last year’s CMS Rule. Non-interchangeable [biosimilars] still haven’t met the FDA data requirements for interchangeability and still shouldn’t be substituted by a third party without physician approval. This ill-considered move stands in stark contrast to the opinions of the medical community, the wishes of patients, a decade of substitution policymaking across 50 states, the substitution policies of most advanced nations, and CMS’ own assurances'.

Comments are due on the CMS proposed rule by 5 January 2024.

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1. GaBI Online - Generics and Biosimilars Initiative. FDA issues draft guidance on biosimilars and interchangeable biosimilars labelling []. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Nov 21]. Available from:

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