Hemophilia – Roctavian®

Covered: a one-time, lifetime IV dose of Roctavian (6×10^13 vg/kg) is approved for adult males (≥18) with severe congenital hemophilia A (FVIII <1 IU/dL) who have no detectable AAV5 antibodies; prior gene therapy recipients and patients with preexisting AAV5 antibodies, active/chronic hepatitis B or C, HIV, significant hepatic fibrosis/cirrhosis, or mannitol hypersensitivity are excluded. Key requirements: FDA‑approved AAV5 antibody negative test, baseline FVIII <1 IU/dL, ≥150 FVIII exposure days, no current/history of FVIII inhibitors with inhibitor testing within 30 days, liver labs within 30 days meeting specified thresholds (ALT/AST/total bilirubin/ALP/GGT ≤1.25×ULN, INR <1.4) or hepatologist clearance, platelets ≥100×10^9/L, creatinine <1.4 mg/dL, prescribing hemophilia specialist, recent weight documentation, and claims/physician verification of no prior Roctavian.

"Platelet count must be ≥ 100 x 10^9 / L within past 30 days."