CMS Coverage Decision Finalized

Last month, we wrote that MichBio signed on to a letter opposing the Centers for Medicare and Medicaid Services (CMS) unprecedented draft National Coverage Determination (NCD) decision to limit seniors’ access to an entire class of Alzheimer’s drugs. On April 7, CMS released a final decision to limit coverage only to people who receive Aduhelm™ and any future monoclonal antibodies directed against amyloid as part of a clinical trial. This means that future new treatments approved under the FDA’s Accelerated Approval Pathway will have to undergo cumbersome, expensive and time-consuming new trials that will delay and limit access, and will have to wait for CMS bureaucracy to develop the necessary processes and registries.

The industry views the CMS decision as an enormous setback for Alzheimer’s patients and an unprecedented undermining of the FDA’s scientific autonomy and decision making.