The Department of Veterans Affairs (VA) will not include Biogen’s (NSDQ:BIIB) and Eisai’s (TYO:4523) controversial Alzheimer’s drug Aduhelm (aducanumab) in its drug formulary, citing what it deemed to be unclear efficacy paired with a significant risk of adverse events.
The department’s pharmacy benefit manager advised against providing the drug given “the lack of evidence of a robust and meaningful clinical benefit and the known safety signal,” according to Endpoints News.
The VA also added Aduhelm to its non-promotable list, which forbids pharmaceutical sales reps from promoting the drug to the VA.
The list price for Aduhelm is approximately $56,000 annually.
The VA, however, included aducanumab in the ‘Place in Therapy’ section of its national drug monograph, which provides an assessment of the drug’s clinical evidence. The document concluded that the VA “recommend[s] against offering this agent to patients with Alzheimer’s dementia (mild or otherwise) or mild cognitive impairment.”
In June, Biogen said in a press release that it was working with the Veterans Health Administration to “finalize a multi-year agreement in order to support access for veterans throughout the VHA system.”
The Cleveland Clinic and Mount Sinai have also decided not to use aducanumab for the time being, while some Blue Cross Blue Shield affiliates reached similar conclusions.
Earlier this year, the Centers for Medicare and Medicaid Services (CMS) announced that it had begun a National Coverage Determination (NCD) analysis for monoclonal antibodies targeting amyloid, such as aducanumab (Aduhelm).
At the beginning of August, the HHS Office of Inspector General announced it would review FDA’s accelerated approval pathway used to approve the drug.
FDA approved the drug conditionally in June.
Filed Under: Neurological Disease