Biosimilars can now be substituted as part of regular formulary maintenance changes, according to CMS' Medicare Advantage and Part D Final Rule for 2025. However, the change could significantly increase patient cost sharing, according to an article on the American Society of Health-System Pharmacists website.
The biosimilar substitution rule would apply to all enrollees, including those taking the reference product prior to the effective date of change. The update is consistent with requests from ASHP to encourage biosimilar adoption. However, "State legislatures will need to move quickly to empower pharmacists to implement substitutions of lower-cost biosimilar products in order to avoid dramatic increases in patient cost sharing from this Medicare policy," Tom Kraus, ASHP vice president of government relations, said in the article.