Eisai Co. Ltd and Eli Lilly & Co. on Friday said they are
seeking accelerated US approval for experimental Alzheimer’s drugs despite the
Medicare health plan’s decision to severely restrict coverage of medicines
approved in that manner, reported Reuters.

On Thursday, after months of review and a pressure
campaign from patient advocacy groups, the Centers for Medicare and Medicaid
Services (CMS) said it would only cover Biogen’s Inc’s Aduhelm, and other
similar drugs, for patients enrolled in valid clinical studies, unless the
treatments demonstrate clear benefits for patients.

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According to a Reuters report, Medicare pays for around
64 million Americans of age 65 and older, so the coverage decision could affect
85% of people who might otherwise use the medications for the age-related

Like Aduhelm, Eisai’s lecanemab and Lilly’s donanemab are
monoclonal antibodies designed to remove beta-amyloid, a type of protein
fragment that builds up in Alzheimer’s patient’s brains. According to the two
drugmakers, upcoming Phase III trial results could validate earlier-stage data
under review by the US Food and Drug Administration.

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In June 2021, the FDA approved Biogen’s Aduhelm – the
first drug in this category and the first US-approved Alzheimer’s treatment in
20 years – under the agency’s pathway based on the drug’s plaque-clearing
ability, rather than proof it slows cognitive decline in Alzheimer’s patients.

However, Medicare has decided to only allow reimbursement
for Alzheimer’s drugs approved through the traditional FDA process based on
“a direct measure of clinical benefit”.

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Eisai in partnership with Biogen said it aims to finish a
rolling FDA application for lecanemab, under the accelerated pathway, by
mid-year. The Japan-based drugmaker said it also expects results from its
1,800-patient, Phase III trial this fall.

According to Eisai, if the results are positive the large
study could meet the “high level of evidence” criteria Medicare uses
in its coverage decision.

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The study is designed to demonstrate that lecanemab can
slow the rate of cognitive and functional decline by at least 25%.

Ivn Cheung, Eisai’s US Chairman told Reuters that lecanemab
is a life-saving drug. “You expect to see a separation between the treated and
untreated groups that improve over time,” he added.

In a statement, Lilly said it aims to complete its
current, rolling application for accelerated FDA approval of donanemab this
year. It does not expect to have results from a Phase III trial of the drug

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Lilly, in a statement, said it intends to complete its
current, rolling application for accelerated FDA approval of donanemab this
year. Results of a Phase III trial of the drug are not expected until mid-2023.

The company called the Medicare coverage restrictions for
FDA-approved drugs “unnecessary, restrictive and inappropriate”.