Valoctocogene Roxaparvovec-rvox (Roctavian) (CPB 1037, reviewed 2026-04-20)

By 2026-04-20: (1) Billing team must configure system to require mandatory precertification for HCPCS code J1412 (Roctavian injection) by calling (866) 752-7021 or faxing (888) 267-3277 before claims submission. (2) Update billing software to flag J1412 claims and automatically route for prior authorization review; failure to obtain precertification will result in claim denial. (3) Providers must verify patient meets ALL Aetna coverage criteria before ordering: age 18+, severe hemophilia A (factor VIII <1 IU/dL), negative AAV5 antibodies, no factor VIII inhibitor history, negative inhibitor test within 30 days, current factor VIII prophylaxis with 150+ exposure days, and required baseline labs (platelets ≥100K, creatinine <1.5, liver enzymes and bilirubin ≤1.25x ULN, INR <1.4, no stage 3-4 liver fibrosis). (4) Ensure patients have hepatic ultrasound/elastography completed and documented in medical record prior to treatment. (5) Confirm treatment will only be administered at Aetna Institutes GCIT Network facilities; verify facility credentialing before proceeding. (6) Add precertification workflow to encounter forms and EMR templates for hematology providers. (7) Document that Factor VIII prophylaxis will not be continued post-Roctavian once adequate levels achieved. (8) Implement requirement for provider attestation that liver enzymes and Factor VIII activity will be monitored per prescribing information post-infusion.