By Deena Beasley
(Reuters) -The U.S. government health plan for people over the age of 65 on Wednesday said it would 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) reaffirmed its policy allowing 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 would also continue to require a registry to collect evidence of patient outcomes to reflect "real-world" care.
The Alzheimer's Association said in a statement it "is appalled that the Biden Administration is extending its unjust decision to deny access to FDA-approved treatments for people living with Alzheimer's - a fatal disease."
The patient advocacy group estimated that for each day CMS leaves its policy in place, more than 2,000 individuals aged 65 or older may progress from mild dementia due to Alzheimer's to a more advanced stage of the disease at which they are no longer eligible for the new treatments.
Two Alzheimer's drugs developed by partners Eisai Co (OTC:ESAIY) Ltd and Biogen Inc (NASDAQ:BIIB), Leqembi and Aduhelm, have so far been approved only under the FDA's accelerated review program, based on evidence of their ability remove sticky deposits of a protein called amyloid.
Leqembi is currently also undergoing the FDA's standard review process, which will weigh the drug's impact on cognitive function. Trial results published last year showed that, in patients with early Alzheimer's, Leqembi reduced the rate of cognitive decline by 27% compared with a placebo.
Eisai and Biogen have said they expect full U.S. approval for Leqembi by summer or late this year.
Because Alzheimer's is an age-related disease, around 85% of people who might use the medicines are covered by Medicare.
CMS said it "will expeditiously review any new evidence that becomes available that could lead to a reconsideration and change" in its current national coverage decision, including approval by the FDA based on evidence of clinical benefit.