The US Department of Veterans Affairs has decided to not include Biogen’s pricey new Alzheimer’s drug Aduhelm (aducanumab) on its formulary, and its Personal Benefits Management services (PBM) even recommended against offering it, noting “the lack of evidence of a robust and meaningful clinical benefit and the known safety signal”.
According to Endpoint News, the decision, which is one of the first nationwide determinations on whether to cover the controversial new drug, also recommends that if Aduhelm is to be used by exception, then it should be used “only in highly selected patients by experts and centres that have the necessary diagnostic and management expertise — and only by those with the needed resources for close monitoring to assure safety”.
“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,” said a VA spokesperson.
Aduhelm has been under constant fire since its approval, as two major health systems — the Cleveland Clinic and Mount Sinai — are now refusing to administer it, and as affiliates of Blue Cross Blue Shield are declining to cover it while other insurers remain in a wait-and-see-what-Medicare-does mode. The national Health & Human Services inspector general has also opened an investigation into the close ties between FDA and Biogen, and other congressional investigations are ongoing.
In a listing posted on the VA website, in which the department says that aducanumab is not on the formulary, the drug is grouped with other Alzheimer’s drugs, including some like galantamine, which are included on the VA’s formulary.
“We are pleased the VA recommendation will allow access to Aduhelm for veterans who meet the criteria,” a Biogen spokesperson told Endpoints News. “Biogen remains committed to ensuring veterans have access to the latest therapies for Alzheimer’s and we will continue to engage closely with the VA as they evaluate potential updates to their guidance.”
Biogen previously said it was working to finalise a multi-year agreement to support access for veterans throughout the VHA system, which includes nine million enrolled veterans, 48% of whom are over 65. The VA said it estimates the number of veterans with Alzheimer’s dementia is about 457,000.
The VA’s decision to not include Aduhelm on its formulary does not mean that access to the drug will necessarily be restricted. As VA doctors explained to Endpoints, every VA facility has the ability to request access, electronically, to a drug not on the formulary. And since all veterans over 65 are enrolled in Medicare, the decision may be a cost-saving one, especially if Medicare decides to not cover the drug. That nine-month process is ongoing.
Endpoint News article – VA decides against adding Biogen's Aduhelm to its formulary as PBM shuns controversial Alzheimer's drug (Open access)
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