Roctavian (valoctocogene roxaparvovec-rvox)

Covered: one-time, single IV dose of Roctavian (6×10^13 vg/kg) for adult males with severe hemophilia A who are AAV5 seronegative; excluded are prior Roctavian recipients, detectable AAV5 antibodies, current or historical FVIII inhibitors, known mannitol hypersensitivity, active/uncontrolled infections, chronic/active hepatitis B or active hepatitis C, significant hepatic fibrosis/cirrhosis, HIV, additional bleeding disorders, history of thrombosis/thrombophilia, current active malignancy, recent live vaccine, or recent systemic immunosuppression. Key requirements/documentation: male ≥18 with baseline FVIII <1 IU/dL, ≥150 FVIII exposure days, negative FDA‑approved AAV5 test, inhibitor titer within 30 days showing no inhibitor, liver labs within 30 days (ALT/AST/total bilirubin/ALP/GGT ≤1.25×ULN, INR <1.4) or hepatology approval, platelets ≥100×10^9/L, creatinine <1.4 mg/dL, no systemic immunosuppressive agents within 30 days, hemophilia specialist prescription, recent weight for dosing, and counseling on contraception/semen restrictions for up to 6 months.