Medicare limits drug coverage

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. Although 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, administrator of the Centers for Medicare & 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.

The decision is unusual for Medicare, which almost always pays for drugs that the FDA has approved, at least for the medical conditions designated on labels.

But Aduhelm’s path has been unusual, too. The FDA acknowledged that it was unclear if the drug was beneficial when it approved Aduhelm last June. It greenlighted the drug under a program called “accelerated approval,” which allows authorization of drugs that have uncertain benefit if they are for serious diseases with few treatments and if the drug affects a biological mechanism in a way considered reasonably likely to help patients.

Questions about the approval, and whether the FDA worked too closely with Biogen, Aduhelm’s manufacturer, have prompted investigations by several agencies.