Roctavian™ (valoctocogene roxaparvovec-rvox)

Covered: Roctavian is authorized as a one‑time IV dose (6 × 10^13 vg/kg) for adult males (≥18) with severe congenital hemophilia A (baseline FVIII <1 IU/dL) who are AAV5 antibody–negative and have ≥150 FVIII exposure days, prescribed by a hemophilia specialist. Key requirements/exclusions: approval requires extensive documentation and testing within 30 days (negative FDA‑approved AAV5 test, inhibitor titer, liver panel within specified limits or hepatology clearance, platelets ≥100×10^9/L, creatinine <1.4 mg/dL), no current/history of FVIII inhibitors, no active infection/hepatitis/HIV/immunosuppression, no prior Roctavian or mannitol hypersensitivity, no live vaccine within 30 days, prohibition on prophylactic FVIII after adequate levels, and contraception/semen‑donation counseling.

"Not covered if evidence of significant hepatic fibrosis or cirrhosis."

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