In a highly unusual decision for a therapy approved by FDA, the Centers for Medicare and Medicaid Services (CMS) took action to limit prescribing and use of Biogen’s new and controversial Alzheimer’s treatment Aduhelm (aducanumab). The CMS National Coverage Determination (NCD) did this by applying its Coverage with Evidence Development (CED) requirement to the drug, utilizing a process that has been directed primarily in recent years to a limited number of approved medical products, mainly medical devices and diagnostics. If the proposal is finalized, only patients able to enroll in postapproval trials would have access to the drug.
