Is Biogen Planning to Appeal CMS Aduhelm Reimbursement Decision?

In early April, the U.S. Center for Medicare and Medicaid Services (CMS) implemented its guidance for Biogen's controversial Alzheimer's drug Aduhelm (aducanumab). The guidance significantly limited the drug's availability. CMS had issued the draft notice in January, providing several months of public responses.

The recommendation restricts Aduhelm to reimbursement only if used in a clinical trial, a very unusual move for a drug approved by the U.S. Food and Drug Administration. The agency also applied this guidance to an entire class of beta-amyloid-clearing medicines that have yet to be submitted for approval.

There is speculation that Biogen might appeal the decision.