The VA recommends against offering this agent to patients with Alzheimer’s dementia, mild or otherwise.
Following the lead of some commercial insurers, the US Veterans Administration is declining coverage of Aduhelm (aducanumab-avwa), Biogen’s controversial new Alzheimer’s medication, on its National Formulary.
The VA is declining coverage of Aduhelm, approved by the FDA in June, "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 FormularyWatch®.
Some Blue Cross Blue Shield plans also said they won't cover Aduhelm, noting that Aduhelm is considered investigational due to insufficient evidence of clinical benefit and not applicable for consideration of medical necessity.
While VA’s PBM acknowledges the recent FDA decision on Aduhelm, “given the lack of evidence of a robust and meaningful clinical benefit and the known safety signal, we recommend against offering this agent to patients with Alzheimer’s dementia (mild or otherwise) or mild cognitive impairment,” the VA said in a notice.
However, since there is an accelerated Aducanumab Monograph Updated version, “we also recommend that, if it is to be used by exception, then it should be utilized 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 notice said. “As such, any use should be governed by stringent regulation, and safety and appropriateness of use monitored real time by VAMedSAFE.”
Aduhelm has been controversial since its approval due to safety and efficacy concerns. Three members of the FDA advisory committee that recommended its approval resigned after the approval. One of those who resigned, Aaron Kesselheim, M.D., JD, MPH, a Harvard Medical School professor and director of program on drug law and regulations at Harvard-affiliated Brigham and Women’s Hospital in Boston said in his resignation letter that Aduhelm’s "was probably the worst approval decision in recent U.S. history."
However, the FDA recently approved updated prescribing information for Aduhelm to specify its use in patients with mild Alzheimer’s disease.
The Indications and Usage section of the label now reads: “Treatment with Aduhelm should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials. There are no safety or effectiveness data on initiating treatment at earlier or later stages of the disease than were studied. This indication is approved under accelerated approval based on reduction in amyloid beta plaques observed in patients treated with Aduhelm. Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trial(s).”