CommercialPrior AuthMedium impact
Elivaldogene Autotemcel (Skysona) (CPB 1017, reviewed 2026-04-08)
Aetna·Genetics, Hematology, Oncology +2 more·Medical Policy
Effective date
Apr 8, 2026
We identified it
Aug 13, 2026
Summary
Aetna has issued a new Clinical Policy Bulletin (CPB 1017, effective 2026-04-08) establishing coverage criteria for Skysona (elivaldogene autotemcel), a gene therapy for early active cerebral adrenoleukodystrophy (CALD) in boys ages 4-17. This is a specialized therapy requiring precertification, administration at designated Aetna Institutes GCIT Network facilities, and compliance with strict clinical and laboratory eligibility criteria. Billing teams must implement precertification requirements and ensure only qualifying patients are billed for this high-cost therapy.
Action Required
By 2026-04-08, the billing team must: (1) Implement precertification workflow requiring all Skysona claims (J3387) to be submitted to National Medical Excellence (NME) at 877-212-8811 before treatment authorization; (2) Update billing system to flag J3387 claims and verify patient meets ALL clinical criteria (age 4-17 male, confirmed ABCD1 pathogenic variant, elevated VLCFA, Loes score 0.5-9, NFS ≤1, HLA-matched donor unavailable, no prior gene therapy/allo-HSCT, normal hematologic/hepatic/renal/cardiac function, negative serology for HIV/HBV/HCV/HTLV); (3) Ensure claims are billed ONLY when treatment occurs at Aetna Institutes GCIT Designated Network facilities; (4) Add ICD-10 codes E71.520, E71.521, E71.528, E71.529 to encounter forms for CALD diagnosis verification; (5) Update provider billing guidelines to require physician specialization in adrenoleukodystrophy treatment; (6) Configure system to deny claims for patients with exclusions (CALD secondary to head trauma, full ABCD1 deletions, or adrenal insufficiency treatment). Failure to obtain precertification will result in claim denials and recoupment.