July 7, 2022

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Medicare Officially Limits Coverage of Aduhelm to Patients in Clinical Trials

2 min read

Ever since Medicare proposed to sharply limit coverage of the controversial Alzheimer’s drug Aduhelm, the agency has been deluged with impassioned pleas. Groups representing patients insisted the federal insurance program pay for the drug. Many Alzheimer’s experts and doctors cautioned against broadly covering a treatment that has uncertain benefit and serious safety risks. Individual patients and families weighed in with emotional statements on both sides.

On Thursday, Medicare officials announced their final decision. Though the Food and Drug Administration has approved Aduhelm for some 1.5 million people, Medicare will cover it only for people who receive it as participants in a clinical trial.

Chiquita Brooks-LaSure, the administrator of the Centers for Medicare and Medicaid Services said the decision was intended to protect patients while gathering data to indicate whether Aduhelm, an expensive monoclonal antibody given as a monthly infusion, could actually help them by slowing the pace of their cognitive decline.

“It’s our obligation at C.M.S. to really make sure it’s reasonable and necessary,” Ms. Brooks-LaSure said in an interview Thursday. “The vast majority” of the approximately 10,000 comments the agency received on its website, she said, were in favor of “really limiting coverage of Aduhelm to a really controlled space where we could continue to evaluate its appropriateness for the Medicare population.”

A major issue for Medicare had been how to deal with other similar drugs for Alzheimer’s, several of which are likely to be considered for F.D.A. approval soon. In a proposal in January, C.M.S. had said it would cover them in the same way as Aduhelm because it typically made coverage decisions for an entire class of drugs.

But after both experts and advocacy groups raised concerns, Medicare officials said Thursday that they would not automatically apply the same restrictions to each new drug. If, unlike with Aduhelm, the F.D.A….

Pam Belluck

2022-04-07 17:27:46

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