WASHINGTON, D.C. — The Centers for Medicare and Medicaid Services (CMS) must reject coverage for aducanumab for Alzheimer’s disease due to the lack of evidence that the drug provides clinically meaningful benefits to patients with the disease, Dr. Michael Carome, director of Public Citizen’s Health Research Group told the agency today.
On June 7, the U.S. Food and Drug Administration (FDA) approved aducanumab for the treatment of Alzheimer’s disease despite insufficient evidence of the drug’s efficacy and the FDA’s unprecedented, inappropriately close collaboration with drug manufacturer Biogen, which compromised the agency’s review of the company’s marketing application for the drug.
“CMS must not compound the FDA’s egregious error in approving aducanumab, which showed a stunning disregard for science and eviscerated the FDA’s standards for approving new drugs,” said Carome. “Without evidence that aducanumab significantly slows the decline in cognitive function in patients with Alzheimer’s disease, the drug cannot possibly be deemed reasonable and necessary for the treatment of such patients, which is the standard that must be met for Medicare coverage of a treatment.”
The approval of aducanumab was based on seriously flawed post hoc analyses of two identical trials that were stopped early because a preliminary review of the data found that the trials, if continued to completion, were unlikely to show the drug benefitted Alzheimer’s patients, Carome told the agency. Thus, the drug should not be covered under the Medicare program. Further, aducanumab’s annual cost of $56,000 per patient could cost Medicare more than $50 billion per year and would place an enormous financial strain on the program.
Since December, Public Citizen has called for an independent investigation by the U.S. Department of Health and Human Services’ Office of Inspection General (OIG) of the inappropriately close collaboration between the FDA and Biogen regarding the company’s marketing application for aducanumab. On Jan. 28, Public Citizen sent a letter to acting FDA Commissioner Janet Woodcock urging her to endorse the organization’s call for an OIG investigation. On July 9, Dr. Woodcock belatedly requested an OIG investigation into the “interactions between Biogen and the FDA” during the review and approval process for aducanumab. Public Citizen has also called for an investigation into her personal role in the process.
Carome’s comments to the agency are available here.