Hemophilia – Roctavian®

Roctavian is covered as a one‑time, weight‑based IV gene therapy (6×10^13 vg/kg) for biological males ≥18 with severe hemophilia A (baseline FVIII <1 IU/dL) and is excluded for prior Roctavian/gene‑therapy recipients or patients with active/chronic hepatitis B or C, HIV, FVIII inhibitors, significant hepatic fibrosis/cirrhosis, or known mannitol hypersensitivity. Approval requires extensive documentation and specialist prescribing, including negative AAV5 antibody by an FDA‑approved test, ≥150 FVIII exposure days, recent (≤30 days) baseline FVIII and inhibitor titer, specified liver tests (or hepatologist clearance), platelets ≥100×10^9/L, creatinine <1.4 mg/dL, current weight and claims verification that Roctavian was not previously received.

"Baseline (without Factor VIII replacement therapy) Factor VIII level of < 1 IU/dL [documentation required]."

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