CMS Announces It Will Cover Alzheimer’s Drugs, With a Caveat

Last Thursday, the Centers for Medicare and Medicaid Services (CMS) announced that it would reverse course on anti-amyloid treatments for Alzheimer’s patients and cover Leqembi should it receive full approval from the U.S. Food and Drug Administration (FDA). June is Alzheimer’s Awareness month.

Leqembi, produced by Biogen and Eisai, has been awarded conditional approval since January with a July 6 deadline for the agency to grant it full approval. The Wall Street Journal reports that Eli Lilly said it would also seek full FDA approval for its similar treatment, donanemab.

From CMS Administrator Chiquita Brooks-LaSure, in a CMS press release:

If the FDA grants traditional approval CMS is prepared to ensure anyone with Medicare Part B who meets the criteria is covered. I’m pleased to make this announcement today as part of CMS’ mission to help improve the lives of Americans we serve. I hope we see more private sector partners in this work making their own announcements soon.

The release said that Medicare would cover the drugs so long as a clinician would participate in the collection of evidence on how these drugs work through the submission of information to a CMS database called a “registry.”

As Inside Health Policy explains, the registry is seen by the Alzheimer’s Association and the Global Alzheimer’s Platform Foundation (GAP) as an unnecessary barrier to care. From a GAP statement:

GAP is concerned about the undue burden this plan imposes on Alzheimer’s patients. It is not full coverage of an FDA-approved treatment for all beneficiaries, free of any additional bureaucratic hurdles.

Representatives Anna Eshoo (D-Calif.) and Nanette Diaz Barragan (D-Calif.) are requesting more information from CMS on how Medicare plans to cover the new class of drug, as the agency did not say when the registry will be live and accessible, or how patients could find participating providers, the Hill reports.

There needs to be clarity and transparency about the standards of coverage for FDA-approved treatments for deadly diseases with unmet medical needs. Please do not allow CMS’s demand for additional evidence generation be a barrier to patient care.

Researchers like Scott McGinnis, assistant professor of neurology at Harvard Medical School have expressed great optimism at the successes of the drug. The Harvard Gazette spoke to Dr. McGinnis on the drug’s trials and how it works:

… [O]ur patients and their family members understand that this is not a cure. They understand that we’re talking about slowing down a rate of decline. In a perfect world, we’d have treatments that completely stop decline and even restore function. We’re not there yet, but this represents an important step toward that goal. So there’s hope. There’s optimism.

Researchers at Phoenix’s Barrow Neurological Institute have found that a common gout medication, allopurinol, was associated with 13 to 34% lower risk for neurodegenerative diseases including Alzheimer’s and Parkinson’s, Dignity Health announced last month. From Brad Racette, MD, FAAN, and Senior Vice President at Barrow:

In this large, population-based study, we took a unique approach to investigate the association between various medication categories in relation to the three most common neurodegenerative diseases: Alzheimer’s disease, Parkinson’s disease and amyotrophic lateral sclerosis. These findings suggest a possible new direction for repurposing or developing medications for neuroprotection.

The National Institutes of Health (NIH) have selected VillageMD for a new, two-year study in cooperation with Together Senior Health and University of California San Francisco to identify people with undiagnosed Alzheimer’s and dementia using electronic health records and other health information, Yahoo! reports.