04/08/2022
THis hits home for me as my mom and her father (my grandfather) both have/had Alzheimer's.
Medicare limits payments for new Alzheimer’s drug to clinical trials
The federal government on Thursday affirmed its plan to limit coverage for a costly new medication for Alzheimer’s disease, restricting it to Medicare patients enrolled in clinical trials.
Despite the Food and Drug Administration’s accelerated approval of the drug, Aduhelm, last June, the Centers for Medicare and Medicaid Services said it would limit payments for the drug to people in carefully controlled tests of the medication’s effectiveness for the progressive neurological disease.
Those trials could be approved by the FDA itself or by the National Institutes of Health, and would not have to be sanctioned by CMS, as originally proposed.
In a small victory for Alzheimer’s patients, CMS said if the FDA approves future drugs through a more traditional process, it would allow wider access to coverage for those medications. Those drugs also would target the amyloid plaques suspected of causing the devastating effects of Alzheimer’s.
The decision means Aduhelm will remain unavailable for now to some of the nation’s 6.2 million people with Alzheimer’s who had hoped to try it for mild cognitive impairment or dementia that results from the disease. The population with milder Alzheimer’s disease, the target group for the drug, is estimated at 1 million to 2 million people.
Aduhelm is the first Alzheimer’s treatment intended to slow cognitive decline.
Lee A. Fleisher, chief medical officer and director of CMS’s Center for Clinical Standards and Quality, said in a briefing for news media Thursday that “there is not currently enough evidence of clinical benefit to say [Aduhelm] is reasonable and necessary for people with Medicare.”
The decision reflects a wide spectrum of opinion on whether Aduhelm is effective enough to warrant greater distribution. A monoclonal antibody taken as a monthly infusion, the drug is the first new treatment for Alzheimer’s approved by the FDA since 2003. Its cost — $28,200 per patient, per year — also has raised concerns.
Medicare coverage for a costly, but controversial, new Alzheimer's drug will go only to people enrolled in approved clinical trials despite FDA endorsement of the medication.