Medicare Aduhelm Coverage Policy Overrules FDA: Can Two Wrongs Make A Right?

Plenty of people believe the US FDA should never have approved Biogen/Eisai’s Alzheimer’s therapy. But does that really mean it is okay for the Medicare agency to decide as a matter of policy that the drug has not been proven safe and effective?

Alzheimer's disease on MRI
The draft NCD from CMS had a very different reading of the data than FDA. • Source: Shutterstock

The Washington Post’s January 12 front-pageheadline on the US Centers for Medicare & Medicaid Services’ proposed policy on the beta amyloid antibody Audhelm was, to put it mildly, misleading: “Medicare plans to cover pricey Alzheimer’s drug.”

In fact (as the article itself makes very clear), Medicare is doing nothing of the kind: the Biogen, Inc./Eisai Co., Ltd. Alzheimer’s treatment will be “covered” only in...

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