7 June 2021 - Today, the FDA will announce a decision on whether to approve the biologic aducanumab, intended to alleviate symptoms in patients with Alzheimer’s disease.

Aducanumab, the much anticipated biologic made by Biogen and Eisai, was supposed to be a game changer for Alzheimer’s treatment. Instead, it has become an ethical watershed moment for both the FDA and the Centers for Medicare and Medicaid Services (CMS). 

If the FDA approves aducanumab in light of significant efficacy and safety concerns and in the face of a resounding negative vote by an FDA Advisory Committee last November, all eyes will turn to CMS to launch a Medicare National Coverage Determination process for aducanumab, including an independent assessment and evidentiary review.

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