CommercialPrior AuthHigh impact
Aducanumab-avwa (Aduhelm) (CPB 0996, reviewed 2025-12-09)
Aetna·Geriatrics, Neurology, Psychiatry +1 more·Medical Policy
Effective date
Dec 9, 2025
We identified it
Aug 17, 2026
Summary
Aetna has issued a new clinical policy bulletin (CPB 0996) establishing coverage criteria for aducanumab-avwa (Aduhelm), an amyloid-directed monoclonal antibody for Alzheimer's disease. This policy requires precertification for all commercial medical plans, mandates enrollment in clinical trials, and establishes strict eligibility requirements including biomarker confirmation, cognitive assessment scores, and MRI evaluation. The policy also implements a tiered reauthorization schedule (6 months, then 12 months) with mandatory ARIA monitoring.
Action Required
Effective immediately (December 9, 2025): (1) Billing and prior authorization teams must establish a precertification workflow requiring all Aduhelm requests to be submitted to Aetna at (866) 752-7021 or fax (866) 267-3277 before treatment initiation. (2) Providers must document and verify at submission: member age (50+) or genetic mutation (APP, PSEN1, PSEN2), mild cognitive impairment or mild AD dementia diagnosis, baseline cognitive assessment (CDR-GS, MMSE, or MoCA scores), amyloid pathology confirmation (PET scan or CSF biomarkers), MRI within 1 year, ApoE ε4 genotyping status, and active enrollment in NIH-supported or IND clinical trial. (3) Clinical staff must flag and exclude members with: non-AD neurodegenerative conditions, therapeutic anticoagulation (except aspirin ≤325mg), TIA/stroke/seizures in past 12 months, uncontrolled bleeding disorders, or concurrent amyloid-directed antibody therapy. (4) Establish reauthorization protocols: first reauth at 6 months (requires ARIA-E/ARIA-H assessment pre-dose 5 and 7), second reauth at 12 months (requires ARIA assessment pre-dose 9 and 12), and subsequent reauths at 12-month intervals (requires evidence of stabilization on cognitive measures or ongoing trial enrollment). (5) Update billing system to route all Aduhelm claims through specialty pharmacy precertification process and Site of Care utilization management. (6) Ensure prescriber specialty verification: only geriatricians, neurologists, psychiatrists, or neuropsychiatrists may prescribe. Failure to obtain precertification or meet eligibility criteria will result in claim denials.