Source: New York Times
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.
“It’s our obligation at C.M.S. to really make sure it’s reasonable and necessary,” said Chiquita Brooks-LaSure, the administrator of the Centers for Medicare and Medicaid Services. 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.”
Dr. Lee Fleisher, the chief medical officer at C.M.S., said the two-track way of dealing with the fast-developing field of Alzheimer’s therapies, a program called Coverage with Evidence Development, “is meant to be nimble and really respond to any new drugs in this class that are in the pipeline, and do demonstrate clinical benefit.”
While the Food and Drug Administration has approved Aduhelm, Medicare will cover it only for people who receive it as participants in a clinical trial. The decision is extremely unusual for Medicare, which almost always automatically pays for drugs that the F.D.A. has approved.
But Aduhelm’s path has been very unusual, too. The F.D.A. itself 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.
The clinical trial evidence reviewed by the F.D.A. showed that patients in one trial appeared to experience slight slowing of cognitive decline, while patients in a nearly identical trial didn’t appear to benefit at all. About 40 percent of patients on the dosage later approved experienced brain swelling or brain bleeding, often mild, but sometimes serious. Both a council of senior F.D.A. officials and the agency’s independent advisory committee had said there wasn’t enough evidence for approval.
Questions about the approval, and whether the F.D.A. worked too closely with Biogen, Aduhelm’s manufacturer, have prompted investigations by congressional committees.
As a result of concerns raised by Alzheimer’s experts and some groups, Medicare officials have announced that Instead of requiring randomized controlled trials approved by C.M.S., Medicare will cover participants in any trial approved by the F.D.A. or the National Institutes of Health. It will allow those trials to be conducted in a broader array of locations, not just hospital settings, and to include people with other neurological conditions like Down syndrome, many of whom develop Alzheimer’s but had been excluded from the earlier proposed plan.