Medicare/Medicaid Won’t Lift Restrictions on Alzheimer Drug Coverage

The Centers for Medicare and Medicaid Services (CMS) has reaffirmed its policy that restricts coverage for drugs used to treat Alzheimer disease (AD) only if they are approved under the Food and Drug Administration’s (FDA) standard review and approval process. The federal agency which provides health coverage to 100 million Americans will not reconsider the coverage limits it put in place in 2022 for new AD treatments.

Two AD drugs, lecanemab (Leqembi; Eisai Co. Ltd., Tokyo, Japan) and aducanumab (Aduhelm; Biogen, Cambridge, MA), have been approved by the FDA under their accelerated review process, based on evidence of their ability to remove amyloid from the brains of those with early stages of AD. In January 2023, Eisai submitted a supplemental biologics license application for lecanemab requesting that the FDA convert accelerated approval to standard approval.

The decision from CMS denies a request from the Alzheimer’s Association for approval of drugs that have proven benefits but have not gone through the FDA standard review process. According to the Alzheimer’s Association, “The Centers for Medicare and Medicaid Services has denied the Alzheimer’s Association’s request to change its policy, despite significant new evidence published since the release of its decision.”

CMS has stated that it “will expeditiously review any new evidence that becomes available that could lead to a reconsideration and change in its current coverage decision, including approval by the FDA based on evidence of clinical benefit.” The agency said it would also continue to require a registry to collect evidence of patient outcomes to reflect “real-world” care.