In a clash of two American health care giants, the Centers for Medicare and Medicaid Services (CMS) and the Food and Drug Administration (FDA) had locked horns over Aduhelm, a controversial Alzheimer’s drug. Medicare gained the upper hand on Thursday when it released its final decision to limit coverage of the FDA-approved drug.
To recap: The FDA gave the green light to Aduhelm (aducanumab) in June 2021. It was the first drug approved to treat Alzheimer’s disease in 18 years. The announcement came amid a swirl of controversy, marked by several FDA advisers resigning and Congress investigating the FDA’s approval process, which heavily involved Biogen, the drug’s manufacturer. In January 2022, Medicare announced its intention to cover the cost of the drug only for individuals enrolled in randomized trials testing Aduhelm’s effectiveness. On Thursday, three days before its decision was due to be made public, Medicare announced its final decision to restrict coverage to those participating in clinical trials.
As federally funded physician-scientists with expertise in measuring health care value and who treat patients with Alzheimer’s dementia, we believe Medicare made the right decision based on Aduhelm’s highly uncertain benefits and known harms. This decision came in the face of intense opposition from special interest groups and lobbyists, who ultimately failed to convince Medicare to reverse course. Meanwhile, Biogen threatened to sue Medicare, and the Wall Street Journal’s editorial board accused Medicare of becoming an “Alzheimer’s death panel” for government “rationing” of care.
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