(Reuters) – The U.S. government health plan for people over the age of 65 on Wednesday said it will not reconsider strict coverage limits put in place last year for new Alzheimer’s treatments, rejecting a request from the Alzheimer’s Association.
The Centers for Medicare and Medicaid Services (CMS) said it would allow coverage for drugs designed to clear amyloid plaques from the brains of Alzheimer’s patients only if a medication is approved under the Food and Drug Administration’s standard review process, not under its accelerated review program.
The agency said it will also continue to require a registry to collect evidence of patient outcomes to reflect “real-world” care.
Two Alzheimer’s drugs developed by partners Eisai Co Ltd and Biogen Inc, Leqembi and Aduhelm, have so far only been approved under the FDA’s accelerated review program based on evidence of their ability to reduce levels of amyloid brain plaques.
Leqembi is currently also undergoing the FDA’s standard review process, which will weigh the drug’s impact on cognitive function.
Because Alzheimer’s is an age-related disease, around 85% of people who might use the medicines are covered by Medicare.
(Reporting By Deena Beasley; Editing by Sonali Paul)
