Doctor, clinician wearing surgical gloves, readying an intravenous infusion

The Department of Veterans Affairs will not include the Alzheimer’s disease drug aducanumab (Aduhelm) in its national list of covered drugs.

The decision was “due to the risk of significant adverse drug events and to the lack of evidence of a positive impact on cognition,” sources told Endpoints News, which broke the story Wednesday.

What’s more, the VA’s pharmacy benefits manager recommends against offering Aduhelm, which was approved by the Food and Drug Administration in early July. The drug lacks “a robust and meaningful clinical benefit and the known safety signal,” it noted. Physicians are not barred from prescribing it at their own discretion, however.

A leading long-term care physicians’ group also recommends that geriatricians do not prescribe the drug. AMDA – The Society for Post-Acute and Long-Term Care Medicine, in July pressed LTC clinicians to “resist the urge to prescribe a potentially dangerous and ineffective medication that is untested in our population, even if it has FDA approval.”

Aduhelm was not studied in populations that fit the health profiles of people who reside in post-acute and long-term care facilities, AMDA said, in explaining its decision to steer physicians from prescribing the drug. The drug lacks evidence of benefit, has significant potential for dangerous side effects, requires sophisticated neuroimaging scans on follow-up, and costs too much, it said. 

The FDA has restricted the use of Aduhlem to Alzheimer’s patients with mild cognitive impairment or mild dementia.