Alzheimer's research news

Officials cited data showing the new Alzheimer’s drug has serious safety risks and may not help patients.

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.

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, or C.M.S., 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.”

Aduhelm’s manufacturer, Biogen, said the decision “effectively denies all Medicare beneficiaries access to Aduhelm,” adding that “Biogen is carefully considering its options and will provide updates as the company further evaluates the business impact of this decision.”

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, Medicare had said it would cover them in the same way as Aduhelm because it typically made coverage decisions for an entire class of drugs.