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

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 the context of randomized, controlled trials intended to establish safety and efficacy. In other words, the Medicare program is essentially returning aducanumab to investigational status – the June 2021 approval by the Food & Drug Administration notwithstanding