What’s the Latest on Controversial New Alzheimer’s Drug Aduhelm?

McNair Dallas Law

Alzheimer's Drug

Medicare officials have decided that the federal health insurance program should only cover the controversial new Alzheimer’s drug Aduhelm for patients who are participating in approved clinical trials. The preliminary decision, reached after lengthy deliberations, was released on Tuesday by the Center for Medicare and Medicaid Services, or C.M.S. If it is finalized later this year, it would significantly limit the number of patients who could use the expensive drug.

The latest decision by the Center for Medicare and Medicaid Services (CMS) on the new Alzheimer’s drug Aduhelm said that coverage should be provided for patients in “C.M.S. approved randomized controlled trials” and trials supported by the National Institutes of Health. The decision said, “all trials must be conducted in a hospital-based outpatient setting.”

The agency added that Aduhelm or other similar drugs for Alzheimer’s that are provided outside of these trials “are nationally non-covered”. “C.M.S. has proposed an evidence-based coverage policy after experts reviewed all relevant publicly available evidence and feedback received from stakeholders,” said the C.M.S. administrator, Chiquita Brooks-LaSure, in a statement.

New York Times’ recent article entitled “Medicare Proposes to Cover Aduhelm Only for Patients in Clinical Trials” says that Medicare’s coverage decision is considered critical to the future of Aduhelm, which is made by Biogen and priced at $28,200 a year per patient. About 80% of the 1.5 million Americans who have the type of condition the FDA-approved the drug to treat — mild Alzheimer’s-related cognitive decline — are old enough to receive coverage under Medicare.

The fact that Medicare is conducting a comprehensive review of Aduhelm is unusual, since the program almost always pays for FDA-approved drugs, at least for the medical conditions designated on their label.

Aduhelm was approved by the Food and Drug Administration in June in a decision that was roundly criticized by doctors and Alzheimer’s experts because clinical trial results showed it had significant safety risks and unclear benefit to patients. Thus far, only a small number of patients — a fraction of the number Biogen and industry analysts had initially expected — have used Aduhelm, a monoclonal antibody administered as a monthly infusion. However, many large American health care systems have declined to offer the drug, citing questions about its benefits and risks.

The FDA said it based accelerated approval on Aduhelm’s reduction of a protein, called amyloid, that clumps into plaques in the brains of people with Alzheimer’s. However, many Alzheimer’s specialists say that extensive research has shown little evidence that reducing amyloid slows cognitive decline.

The FDA is also mandating that Biogen conduct another clinical trial to determine if the drug provided any evidence of benefit. In the years it will take for that trial to be completed, Aduhelm will be available to patients.

Reference: New York Times (Jan. 11, 2022) “Medicare Proposes to Cover Aduhelm Only for Patients in Clinical Trials”

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