WASHINGTON, D.C. – The Centers for Medicare and Medicaid Services (CMS) today announced a final national coverage decision under which the Medicare program will cover the drug aducanumab only for beneficiaries with Alzheimer’s disease who enroll in a properly designed randomized, controlled clinical trial of the drug. Dr. Michael Carome, director of Public Citizen’s Health Research Group, released the following statement:
“Public Citizen applauds CMS for standing its ground in the face of intense pressure orchestrated by Big Pharma and industry-funded ‘patient’ advocacy groups. The final decision restricts Medicare coverage for aducanumab to beneficiaries with Alzheimer’s disease who enroll in randomized, controlled clinical trials of the drug.
“CMS’ science-based action will significantly mitigate the damage done by the U.S. Food and Drug Administration’s reckless decision last year to approve aducanumab despite the lack of evidence that the drug provides any clinically meaningful benefit to Alzheimer’s patients with respect to cognitive function outcomes and clear evidence of that it can cause serious brain injury.
“Today’s action is a win for patients, Medicare beneficiaries, the American taxpayer, and evidence-based medicine.”