Medicare unveils plan for coverage of new Alzheimer’s drugs 

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Medicare on Thursday announced plans for coverage of new Alzheimer’s drugs whose accessibility has become a point of controversy. 

For drugs that are granted traditional Food and Drug Administration approval, Medicare will provide coverage for beneficiaries with an appropriate diagnosis and a qualified doctor participating in collection of real-world evidence on how the drugs are working — a system known as a registry, the Centers for Medicare and Medicaid Services said. 

“CMS has always been committed to helping people obtain timely access to innovative treatments that meaningfully improve care and outcomes for this disease,” CMS administrator Chiquita Brooks-LaSure said in a statement. For drugs with traditional FDA approval, she said, “CMS is prepared to ensure anyone with Medicare Part B who meets the criteria is covered.” 

Next week, an FDA advisory committee will review the Alzheimer’s treatment lecanemab, which goes by the brand name Leqembi and was developed by Eisai Co.
ESALF,
+2.32%

and Biogen Inc.
BIIB,
+2.72%
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Advisory-committee recommendations are not binding. The FDA could make a decision on traditional approval of the treatment within weeks, CMS said, and “broader Medicare coverage would begin on the same day the FDA grants traditional approval.” The U.S. Veterans’ Health Administration has also said that it would cover the treatment. 

About 6.7 million Americans have Alzheimer’s disease, which was the fifth leading cause of death among people 65 and older in 2019, according to the Alzheimer’s Association. 

While new treatments represent long-awaited hope for people affected by the disease, they have also generated debate about Medicare spending. If 5% of the older adults with Alzheimer’s take Leqembi at an annual list price of $26,500, Medicare Part B annual spending would increase by $8.9 billion, according to a recent analysis by KFF, a health-policy nonprofit. 

Medicare last year put strict coverage limitations on the Biogen Alzheimer’s treatment Aduhelm amid concerns about its safety and effectiveness. 

Eli Lilly & Co.
LLY,
+1.64%
,
which is developing another new Alzheimer’s treatment, donanemab, criticized Medicare’s inclusion of patient registries as part of the coverage requirements announced Thursday. “We strongly believe that mandating patient enrollment in registries will continue to pose unnecessary barriers and contradicts CMS’ promise of broad coverage to all Medicare beneficiaries,” the company said in a statement. “Establishing a precedent where the agency can restrict coverage for new medicines, singling out groups of patients and exacerbating health disparities, is not in the best interest of patients.” 

The Alzheimer’s Association also opposes the registry requirement. While registries are important tools for gathering real-world evidence, the group said in a statement Thursday, “we continue to believe that registry as a condition of coverage is an unnecessary barrier.” Additional details are also needed on the data-submission and enrollment process for doctors and patients, the Alzheimer’s Association said. 

CMS said in a statement that “registries are common tools in clinical settings that have successfully gathered information on patient outcomes for decades. There is strong precedent for using registries to gather more information on a newly approved treatment.” 

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