After a barrage of criticism and intense lobbying by patients, their families and advocacy groups like the Alzheimer's Association, Medicare issued a statement Thursday saying it will cover drugs for people in the early stages of Alzheimer's disease.
Earlier, when those drugs designed to treat Alzheimer's disease received accelerated U.S. Food and Drug Administration approval, the Centers for Medicare and Medicaid Services declined coverage outside of clinical trials and said the drugs did not meet its "necessary and reasonable" standard.
That drug is already available, since it does have accelerated approval, but outside of clinical trials patients have to be able to bear the full cost. Eli Lilly's drug, donanemab, didn't get accelerated approval but is expected to apply for traditional approval in the fall or soon after. Thursday, the Alzheimer's Association in a news release called the registry requirement an "unnecessary barrier." The national patient advocacy group said that while registries can provide "much-needed real-world evidence to transform and improve patient care," they shouldn't be a condition of coverage when the FDA has approved a treatment.
Time is of the essence when it comes to accessing the amyloid-targeting monoclonal antibodies because their use is only approved for people in the early stages of Alzheimer's. About 2,000 people pass out of that stage into the moderate dementia category every day, advocates told the Deseret News. Aducanemab, marketed as Aduhelm, was the first Alzheimer's drug in the class. It received accelerated approval in 2021 but has been controversial. Besides questions of effectiveness, an investigation said the FDA worked too closely with Eisai and Biogen, which also manufactures it, during the approval process. Those and other issues made doctors reluctant to prescribe it.
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