Medicare will cover breakthrough Alzheimer’s drug Aduhelm only for participants in clinical trials, says the final national coverage determination—an “enormous setback for Alzheimer’s patients and an unprecedented and dangerous infringement on the FDA’s scientific autonomy and decision making,” according to Biotechnology Innovation Organization (BIO).
“Medicare will cover monoclonal antibodies that target amyloid (or plaque) for the treatment of Alzheimer’s disease that receive traditional approval from FDA under coverage with evidence development,” the Centers for Medicare and Medicaid Services (CMS) announced. “[F]or drugs that FDA has not determined to have shown a clinical benefit (or that receive an accelerated FDA approval), Medicare will cover in the case of FDA or National Institutes of Health (NIH) approved trials.”
For drugs with accelerated approval, “we are staying with the original decision, and saying that trials will be covered,” CMS Chief Medical Officer Dr. Lee Fleisher explained on a call yesterday. “If any of the drugs have shown a clinical benefit through the traditional approval pathway, there will be quick coverage.”
‘A chilling effect’
“These coverage restrictions, including the distinction between accelerated approval and traditional approval, have never been applied to FDA-approved medicines for other disease areas,” said Biogen, the BIO member who developed Aduhlem.
“This overreach means an entire class of cures may never make it to market. Worse, it will have a chilling effect on innovation and future cures,” said U.S. Reps. Cathy McMorris Rodgers (R-WA) and Kevin Brady (R-TX).
“CMS does not have the scientific expertise to do this critical work. While FDA has thousands of experienced scientists and clinicians, CMS has less than 30,” said BIO President and CEO Dr. Michelle McMurry-Heath. “In the end, CMS has actually made its initial proposal far worse and expanded the damage it will cause to many more patient populations and their loved ones.”
Biogen’s Aduhelm is the first FDA-approved drug for Alzheimer’s in 20 years, and the first-ever disease-modifying treatment. Bipartisan Members of Congress, as well as industry and patient groups, are widely united against this decision.