Scoop: VA decides against adding Biogen's Aduhelm to its formulary as PBM shuns controversial Alzheimer's drug
The Department of Veterans Affairs has decided to not include Biogen’s pricey new Alzheimer’s drug Aduhelm on its formulary, and its PBM even went so far as to recommend against offering it, noting “the lack of evidence of a robust and meaningful clinical benefit and the known safety signal.”
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 centers that have the necessary diagnostic and management expertise — and only by those with the needed resources for close monitoring to assure safety,” Endpoints News has learned.
“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,” confirmed a spokesperson for the VA on Wednesday, after we reported the move.
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 the drug, 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 HHS 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 (VA Drug Class CN900), including some like galantamine, which are included on the VA’s formulary.
“We are pleased the Department of Veterans Affairs (VA) recommendation will allow access to ADUHELM for veterans who meet the criteria as published in the ‘Place in Therapy’ section of the clinical monograph,” a Biogen spokesperson told Endpoints News in a statement. “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.”
Endpoints reviewed a copy of the monograph, which includes the “Place in Therapy” section, making clear that the VA PBM recommends against Aduhelm given the unclear evidence and safety concerns.
The monograph also lays out extensive safety standards that should be adhered to if the drug is used, including ensuring that ApoE genotype has been obtained and documented, and the patient has a recent brain MRI, meets clinical criteria for mild cognitive impairment with Alzheimer’s pathology or mild AD, and has an amyloid PET imaging that is consistent with Alzheimer’s pathology, and/or CSF analysis. It also includes a half dozen conditions under which Aduhelm should not be administered.
Biogen previously said it was working to finalize a multi-year agreement in order to support access for veterans throughout the VHA system, which includes 9 million enrolled veterans, approximately 48% of which are over the age of 65. The VA said it estimates the number of US veterans with Alzheimer’s dementia in FY 2021 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 have 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 the age of 65 are enrolled in Medicare, the decision may be a cost-saving one, especially if Medicare decides to not cover the drug. That 9-month process is ongoing.
The VA also explains this process for obtaining a drug not on its formulary, noting that such products may be approved under certain circumstances, such as if there are no alternative therapies on the formulary or if a patient has previously responded to a nonformulary agent and risk is associated with a change to a formulary agent.
Separately, Aduhelm also appears to be included in the VA’s Non-Promotable List, which is a list of drugs that are not to be promoted or detailed by pharma sales representatives.
