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.”

0 Comments
© 2023 MMIT
AIS Health Staff

AIS Health Staff

Related Posts

stars
September 22

Only Two Plans Get ‘5 out of 5’ in 2023 NCQA Ratings

READ MORE
businessman-viewing-news-update-journalism-headline-on-a-laptop
September 22

News Briefs: CMS Says 30 States Pause Medicaid Disenrollments

READ MORE
happy-fit-seniors
September 22

CMS Administrator, AHIP Agree: Medicare Marketing Fixes Were Overdue 

READ MORE

GAIN THERAPEUTIC AREA-SPECIFIC INTEL TO DRIVE ACCESS FOR YOUR BRAND

Sign up for publications to get unmatched business intelligence delivered to your inbox.

subscribe today