CMS not ready to reconsider its block on covering new Alzheimer's drugs
The Centers for Medicare and Medicaid Services won’t yet reconsider a decision that FDA-approved, amyloid-targeting monoclonal antibodies for Alzheimer’s disease shouldn’t be covered outside of clinical trials.
The agency’s January 2022 ruling, known as a national coverage determination, or NCD, set the precedent for coverage of Biogen’s first Alzheimer’s drug Aduhelm, which won an accelerated approval in June 2021. In Aduhelm’s case, the CMS decision to require further trials ultimately led to the drug’s commercial flop.
Unlock this article instantly by becoming a free subscriber.
You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.