Medicare officials announced that a new Alzheimer’s drug will be covered only for patients participating in approved clinical trials. In a preliminary decision, the Centers for Medicare and Medicaid Services (“CMS”) said on Tuesday that the federal health insurance program should cover the Alzheimer’s drug ‘Aduhelm’ only for use in “CMS-approved randomized controlled trials” and trials supported by the National Institutes of Health.  According to the CMS, “All trials must be conducted in a hospital-based outpatient setting.”  Aduhelm is currently the only Food and Drug Administration-approved monoclonal antibody directed against amyloid beta for the treatment of Alzheimer’s but the CMS said similar drugs provided outside of approved trials are also “nationally non-covered.”

CMS Administrator Chiquita Brooks-LaSure said in a statement: “CMS has proposed an evidence-based coverage policy after experts reviewed all relevant publicly available evidence and feedback received from stakeholders.” Dr. Lee Fleisher, CMS chief medical officer and director of the Center for Clinical Standards and Quality, said that the decision was also made due to the presence of “potential for harm to patients” who use the drug, adding that “this harm may range from headaches, dizziness and falls, to other potentially serious complications such as brain bleeds. We believe that any appropriate assessment of patient health outcomes must weigh both harm and benefit before arriving at a final decision.”

The CMS will hold a public comment period for the next 30 days and is expected to announce a final decision on whether to cover the drug by mid-April.

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