Biogen's controversial Alzheimer's med Aduhelm turned away by VA on efficacy and safety worries

In the quest to score national coverage for its controversial Alzheimer’s disease drug Aduhelm, Biogen has been dealt a blow by one of the U.S.' key payers.

The Department of Veterans Affairs (VA) has decided not to include Biogen’s drug aducanumab on its national formulary over “the risk of significant adverse drug events,” plus a “lack of evidence of a positive impact on cognition,” a Veterans Affairs spokesperson said over email. The VA’s pharmacy benefit manager (PBM) specifically credited its decision to a “lack of evidence of a robust and meaningful clinical benefit,” alongside safety concerns, a document posted by Stat News shows.

Meanwhile, sales reps won’t be allowed to promote the drug to VA doctors, either, another agency document shows. Endpoints News broke the news of the VA’s coverage decision earlier Wednesday.

Given the drug’s accelerated approval, there could be instances where VA makes an exception, the notice says. In those cases, Aduhelm should only be used 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.”

Biogen said in an emailed statement that it was “pleased” with the VA’s decision to provide Aduhelm to patients who meet the department’s criteria.

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As part of its formulary update, the VA unveiled a laundry list of safety standards that patients would have to meet to receive Aduhelm. Prescribers need to be VA neurologists, psychiatrists or geriatricians who specialize in dementia treatment and patients must sign an informed consent form. Patients would also need to have undergone a recent brain MRI and meet the clinical criteria for mild cognitive impairment with Alzheimer’s disease or mild Alzheimer’s, among other requirements.

Biogen's Alzheimer's drug scored approval in early June. On the same day, Biogen telegraphed its access plans for the drug, which included finalizing a multi-year agreement with the Veterans Health Administration (VHA). The VHA is the U.S.’ largest integrated healthcare system, with 9 million veterans enrolled, Biogen noted at the time.

RELATED: How well will Biogen's Alzheimer's drug Aduhelm perform in the real world? This study is set to find out

Elsewhere, Biogen is currently awaiting a coverage decision from the Centers for Medicare & Medicaid Services (CMS). It could be April 2022 before the CMS reaches a verdict, Cowen analysts wrote to clients in July. During an earnings call last month, Biogen credited Aduhelm’s slower-than-expected launch on that pending National Coverage Decision.

Analysts expect blockbuster sales for the drug, which costs $56,000 per year on average.

Editor's note: This story has been updated with comments from the Department of Veterans Affairs.