The Department of Veterans Affairs will not include Aduhelm on its formulary, Endpoints News reported Aug. 11.
Biogen's drug, intended to slow cognitive decline from Alzheimer's disease, won't be added to the VA National Formulary "due to the risk of significant adverse drug events and to the lack of evidence of a positive impact on cognition," a VA spokesperson told Endpoints News.
The VA said it will make exceptions "only in highly selected patients by experts and centers that have the necessary diagnostic and management expertise — and only by those with the needed resources for close monitoring to assure safety."
The decision comes after several health systems, including the Cleveland Clinic, Providence in Renton, Wash., and Mount Sinai in New York City, have said they won't administer Aduhelm, at least until more data on the drug's efficacy is released.
The FDA's June 7 approval of the drug has been met with a wave of criticism and allegations of an "inappropriately close relationship" between the FDA and the pharmaceutical industry, the HHS Office of Inspector General said. On Aug. 4, the inspector general said HHS will review the approval process for Aduhelm.