If the US Food and Drug Administration grants approval to Biogen, Inc.’s aducanumab, the Centers for Medicare and Medicaid Service’s Innovation Center should launch a randomized trial of the Alzheimer’s treatment and only cover the drug in that context until more solid data is obtained, Peter Bach, director of the Center for Health Policy and Outcomes at Memorial Sloan Kettering Cancer Center said.
Biogen’s Aducanumab And The Case For A Medicare-Driven Clinical Trial
Peter Bach warns against Medicare ceding its scientific authority to FDA and automatically covering all drugs and devices the agency clears, suggesting the Alzheimer’s drug be subject to a CMS Innovation Center trial if FDA-approved. Others say the drug could highlight flaws in Medicare Part B’s payment system.
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