News Briefs: CMS Denies Request to Reconsider Alzheimer’s Drug Coverage Decision

CMS said on Feb. 22 that it will not reconsider its national coverage determination (NCD) for a class of Alzheimer’s disease drugs that includes Biogen, Inc.’s Aduhelm and the more recently approved Leqembi. Both drugs are monoclonal antibodies that target amyloid plaque on the brain in patients with mild dementia, and under an NCD issued in April, CMS said Medicare will cover the treatments only for patients enrolled in randomized, controlled clinical trials conducted either through the FDA or the National Institutes of Health. The Alzheimer’s Association requested that CMS revisit its determination, but the agency said in a letter to the patient advocacy group that “there is not yet evidence meeting the criteria for reconsideration.” Still, CMS noted that it “will expeditiously review any new evidence that becomes available that could lead to a reconsideration and change in the NCD, such as evidence that answers the Coverage with Evidence Development (CED) questions or approval by the FDA based upon evidence of clinical benefit.”

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