CommercialPrior AuthMedium impact
Etuvetidigene Autotemcel (Waskyra) (CPB 1097, reviewed 2026-10-05)
Aetna·Allergy & Immunology, Hematology, Pediatrics +2 more·Medical Policy
We identified it
Oct 8, 2026
Summary
Aetna has established a medical policy (CPB 1097, reviewed 2026-10-05) covering etuvetidigene autotemcel (Waskyra), an autologous gene therapy for Wiskott-Aldrich syndrome (WAS) in pediatric and adult patients. The policy requires precertification for all participating providers and members, mandates administration at Aetna Institutes GCIT Network facilities, and establishes specific clinical criteria for initial approval based on patient age, genetic confirmation, donor availability, and absence of contraindications.
Action Required
Billing team and providers must implement the following requirements for Waskyra (etuvetidigene autotemcel) claims: (1) Obtain precertification from National Medical Excellence (NME) at 877-212-8811 before treatment for all applicable plan designs—claims will be denied without prior authorization; (2) Verify that treatment is administered at an Aetna Institutes GCIT Designated Network facility (unless the member's plan has elected not to require network restriction); (3) Confirm that the prescribing provider is an immunologist, hematologist, or WAS specialist; (4) Validate all clinical approval criteria are met before submission, including patient age (6 months or older), WAS gene mutation confirmation, WASP expression/phenotype assessment, HSCT candidacy, HLA donor status, absence of prior gene therapy, and exclusion of patients with HIV, hepatitis B/C, active TB, malignancy, or other contraindications listed in the policy; (5) Update billing systems and claim submission workflows to reference HCPCS code J3386 (covered if criteria met) and relevant CPT codes for harvesting, preparation, and infusion procedures; (6) Flag claims for manual review if any approval criteria are not met, as these will be considered experimental/investigational and denied. Contact Aetna for clarification on current plan applicability and network facility lists.