Medicare Proposes to Cover Aduhelm Only for Patients in Clinical Trials
Source: New York Times
Aduhelm was approved by the F.D.A. in June in a decision that has been criticized by many doctors and Alzheimer’s experts who say the treatment showed significant safety risks and unclear benefit to patients during its clinical trials.Credit...Pool photo by Jessica Rinaldi
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 decision 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 of other similar drugs for Alzheimer’s that are provided outside of these trials “are nationally non-covered.” “Alzheimer’s disease is a devastating illness that has touched the lives of millions of American families. Throughout this National Coverage Determination process, CMS has been and remains committed to providing the American public with a clear, trusted, evidence-based decision that is made only after a thorough analysis of public feedback on the benefits and risks of coverage for Medicare patients,” said the C.M.S. administrator, Chiquita Brooks-LaSure.
“C.M.S. has proposed an evidence-based coverage policy after experts reviewed all relevant publicly available evidence and feedback received from stakeholders.”Whether Medicare ends up covering Aduhelm is considered pivotal to the future of the drug, which is made by Biogen and priced at $28,200 a year per patient. Roughly 80 percent of the 1.5 million Americans who have the type of condition the F.D.A. approved the drug to treat — mild Alzheimer’s-related cognitive decline — are old enough to receive coverage under Medicare.
For the next 30 days, C.M.S. will have a public comment period on the preliminary decision, and the agency is expected to announce its final decision about covering the drug by mid-April. The fact that Medicare is conducting an extensive review of Aduhelm is itself unusual. The program almost always pays for F.D.A.-approved drugs, at least for the medical conditions designated on their label, health policy experts said.
Read more: https://www.nytimes.com/2022/01/11/health/aduhelm-medicare-alzheimers.html
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