UnitedHealthcare adopts limited coverage policy for Aduhelm

UnitedHealthcare is adopting a limited coverage policy for Biogen's controversial Alzheimer's drug Aduhelm, according to a bulletin sent to providers.

The health insurance giant's coverage policy aligns with Medicare's recent coverage determination, with the insurer saying it will cover the drug for people in clinical trials and will require prior authorization. While Medicare's national coverage decision drew ire from pharmaceutical manufacturers, patient advocates and lawmakers, it has been roundly praised by health plans.

"Aduhelm is unproven and not medically necessary for the treatment of Alzheimer’s disease due to insufficient evidence of efficacy," UnitedHealthcare said in the bulletin.

UnitedHealthcare is the first publicly traded insurer to issue a coverage determination for Aduhelm as the industry awaited final word from the Centers for Medicare & Medicaid Services. The coverage policy takes effect on June 1, according to the bulletin.

In its policy bulletin, UnitedHealthcare cited multiple studies to back up its determination, including a Institute for Clinical and Economic Review study that did not find patient benefit from the drug compared to existing supportive care strategies alone.

Medicare finalized a plan last month that would limit coverage for drugs targeting amyloid beta plaques in people with Alzheimer's disease or dementia to those in eligible clinical trials. It did, however, create a new coverage pathway option that would expand coverage should a drug in this class receive traditional approval from the Food and Drug Administration.

Biogen's Aduhlem is the only drug in its class approved so far, earning accelerated and broad approval from the FDA in the face of criticism from the healthcare industry and its own advisory committee.

Several Blues insurers previously decided not to include Aduhelm on formularies. Multiple health systems, including big names like Cleveland Clinic, have said they would not prescribe the drug.