VA Health System Won’t Cover Biogen’s Alzheimer’s Drug (The Wall Street Journal):
The Department of Veterans Affairs won’t cover Biogen Inc.’s new Alzheimer’s drug, the latest rebuke of the controversial treatment since it was approved earlier this summer.
The VA decided not add the drug, called Aduhelm, to its formulary list of available medicines because of the drug’s risk of causing serious side effects and a lack of evidence that it improves cognitive function, an agency spokeswoman said.
The VA provides medical benefits to more than nine million veterans, and is the largest integrated healthcare system in the U.S. The agency is known for being a shrewd customer of prescription drugs, using its large purchasing power to haggle steep discounts from manufacturers. By law, the VA has greater leeway than other government health programs such as Medicare and Medicaid to deny coverage of medicines it deems to be of poor value … On Thursday, the VA posted on its website a document detailing its review of Aduhelm and its decision. The document provides guidance to doctors not to offer the drug to VA patients, but allows for doctors to seek exceptions for certain patients.
VA’s Review of Aduhelm’s Clinical Evidence and Safety (opens PDF). VA’s Projected Place in Therapy:
- AD is a progressive neurologic disorder affecting approximately 6 million Americans. More women than men are affected, and African Americans and Hispanics are at higher risk of developing AD. Safe and effective agents that halt or delay the progression of AD are clearly needed. Aducanumab-avwa is a human monoclonal antibody that promotes clearance of betaamyloid plaques from the brain and is indicated for the treatment of AD, specifically, in patients with mild cognitive impairment or mild dementia stage of disease.
- While VA PBM acknowledges the recent FDA decision on aducanumab-avwa, 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. However, recognizing that there is an accelerated FDA approval, 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. As such, any use should be governed by stringent regulation, and safety and appropriateness of use monitored real time by VAMedSAFE.
News in Context:
- Alzheimer’s & Dementia researchers challenge FDA’s approval of Aduhelm given lack of evidence for beta-amyloid as a marker
- Can the controversial FDA approval of Aduhelm backfire and delay the discovery of actual Alzheimer’s treatments? (Yes, it can)
- Study challenges the “seductive” amyloid hypothesis of Alzheimer’s disease (AD)
- Cognitive training, diet, exercise, and vascular management seen to improve cognition even in people with genetic predisposition for dementia (APOE e4)