U.S. Medicare says no change to Alzheimer's drug restrictions
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[February 23, 2023]
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 Ltd and Biogen Inc,
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.
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![](../images/022323PIX/health71.jpg)
The Alzheimer's drug Leqembi is seen in
this undated handout image obtained by Reuters on January 20, 2023.
Eisai/Handout via REUTERS
![](http://archives.lincolndailynews.com/2023/Feb/23/images/ads/current/graue_lda_22COLORADOpreowned_022023.jpg) 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.
(Reporting By Deena Beasley; Editing by Sonali Paul and Bradley
Perrett)
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