(Reuters) – The U.S. Veterans Health Administration (VHA) will not include Aduhelm, the $56,000-a-year Alzheimer’s drug made by Biogen Inc and Eisai Co Ltd, on its list of approved drugs due to a lack of evidence that it is effective as well as safety concerns, the agency said on Wednesday.
“It is not being 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,” the agency said in an emailed statement.
The Department of Veterans Affairs is the largest health system so far to decline use of the drug, which was approved in June by the Food and Drug Administration even though one of Biogen’s two large-scale clinical trials failed to show a benefit for patients diagnosed with the mind-wasting disease.
The FDA itself called last month for an independent federal probe into its representatives’ interactions with Biogen ahead of the drug’s approval.
Biogen had said in a June press release that it was working “to finalize a multi-year agreement in order to support access for veterans throughout the VHA system … with nine million enrolled veterans, approximately 48 percent of which are over the age of 65.”
Still, VA facilities do have the ability to request access to drugs that are not on the list of approved medications.
“Veterans in the VA system have a pathway to access Aduhelm … We will continue to engage closely with the VA as they evaluate potential updates to their guidance,” Biogen said in an emailed statement on Wednesday.
Several other healthcare providers, including the Cleveland Clinic and Mount Sinai Health System, have also said they would not prescribe Aduhelm for patients.
Some hospitals have begun to use the drug, but patient numbers have been low as providers await clarity on whether Medicare, the federal Medicare health plan for people over the age of 65, will cover the drug’s cost.
(Reporting By Deena Beasley; editing by Richard Pullin)
