BRIEF—Medicare begins formal process for Aduhelm coverage

The Centers for Medicare and Medicaid Services (CMS) has begun the formal process to determine whether and to what extent Biogen's recently-approved Alzheimer's disease drug Aduhelm (aducanumab) will be covered through Medicare.

The National Coverage Determination (NCD) analysis will determine a national policy for the coverage of treatments of this type, including future options should they be approved.

After an extensive review process, including comments from the public, the CMS is expected to reach a final decision within nine months.

There is an ongoing controversy over the decision to approve Aduhelm for Alzheimer’s, with some scientists questioning the strength of the data, and allegations of improper interference in the review process.

Priced at $56,000 per year, US senators have called for a probe in a bid to ensure value for taxpayers. The US Food and Drug Administration has also called for an independent investigation into the decision.