WASHINGTON, D.C. — The Centers for Medicare and Medicaid Services (CMS) today announced a proposed national coverage decision under which the Medicare program would 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 proposing to limit Medicare coverage for aducanumab to beneficiaries with Alzheimer’s disease who enroll in a randomized, controlled clinical trial of the drug.
“Implementation of this proposed decision would significantly mitigate the damage done by the Food and Drug Administration’s (FDA’s) reckless decision last year to approve aducanumab despite the lack of scientific 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.
“Unlike the FDA, CMS wisely chose to follow the scientific evidence.”