Roctavian™ (valoctocogene roxaparvovec-rvox)

Roctavian (valoctocogene roxaparvovec) is covered as a one-time, single-dose IV gene therapy per lifetime for adult males (≥18 years) with severe congenital hemophilia A (baseline FVIII <1 IU/dL) and is excluded for those with detectable AAV5 antibodies, prior Roctavian receipt, active/chronic hepatitis B, active hepatitis C, significant hepatic fibrosis/cirrhosis, HIV positivity, known mannitol hypersensitivity, or current/history of FVIII inhibitors. Authorization requires documentation of age/sex, baseline FVIII <1 IU/dL, negative FDA‑approved AAV5 antibody test, ≥150 FVIII exposure days, FVIII inhibitor testing within 30 days showing no inhibitor, recent labs within 30 days meeting specified liver (ALT/AST/total bilirubin/ALP/GGT ≤1.25×ULN; INR <1.4), platelet (≥100×10^9/L) and creatinine (<1.4 mg/dL) thresholds (or hepatologist clearance), current weight, negative HIV/hepatitis status, and prescription by a hemophilia specialist.

"Does not have a known hypersensitivity to mannitol."