USA – Eisai Co Ltd and Eli Lilly and Co have said that they will continue to seek accelerated U.S. approval for experimental Alzheimer’s drugs, despite Medicare’s decision to severely limit coverage of medicines approved in this manner, Reuters reports.

After a months-long review and a patient advocacy campaign, the Centers for Medicare and Medicaid Services (CMS) announced that it would only pay for Biogen Inc’s Aduhelm and other drugs that work in a similar manner for patients enrolled in valid clinical studies, unless the treatments demonstrate clear evidence of patient benefit.

Because Medicare covers nearly 64 million Americans aged 65 and up, the coverage decision could affect 85 percent of those who would otherwise use the medications for the age-related condition.

Like Aduhelm, Eisai’s lecanemab and Lilly’s donanemab are monoclonal antibodies designed to remove beta-amyloid, a type of protein fragment that accumulates in Alzheimer’s patients’ brains.

The two pharmaceutical companies said they expect upcoming Phase III trial results to validate earlier-stage data currently being reviewed by the US Food and Drug Administration.

Gantenerumab, a fourth plaque-targeting antibody, is in late-stage development at Roche Holding, which is not requesting an accelerated FDA review.

The FDA approved Biogen’s Aduhelm, the first drug in this class and the first Alzheimer’s treatment approved in the United States in 20 years, under the agency’s accelerated pathway in June, based on the drug’s plaque-clearing ability rather than proof that it slows cognitive decline in Alzheimer’s patients.

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

Eisai, in collaboration with Biogen, stated that it expects to complete a rolling FDA application for lecanemab under the accelerated pathway by mid-year.

The Japanese pharmaceutical company also stated that it expects results from its 1,800-patient Phase III trial this fall.

If the results are positive, Eisai believes the large study will meet Medicare’s “high level of evidence” criteria in its coverage decision.

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

Roche also plans to release gantenerumab Phase III trial results later this year.

In a statement, Lilly stated that it plans to finish its current, rolling application for accelerated FDA approval of donanemab this year. It does not expect to see results from the drug’s Phase III trial until mid-2023.

The Indianapolis-based company believes Medicare coverage restrictions for FDA-approved drugs are “unnecessary, restrictive, and inappropriate.”

The “amyloid hypothesis” is the idea that removing amyloid plaques is reasonably likely to slow cognitive and functional decline in people with early Alzheimer’s, a theory that has led to a long history of drugs that tried and failed to clear the plaques or help patients.

In a recent interview, Greg Rippon, neuroscience and Alzheimer’s Disease medical lead at Roche’s Genentech unit, explained that the theory is supported by analysis of inherited forms of Alzheimer’s disease, which are all caused by mutations in amyloid processing.

According to him, more recent studies have shown that amyloid buildup is a precursor to other brain dysfunction that accelerates neurodegeneration in Alzheimer’s patients.

Obviously, it comes down to clinical data and demonstrating that clinical benefit and that’s where a lot of skepticism is centered,” Rippon said.

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