Hemophilia - Roctavian®

Coverage: one lifetime single IV dose of Roctavian (6 x 10^13 vg/kg) is covered for adults with severe congenital hemophilia A (Factor VIII <1 IU/dL) and is excluded for patients with pre-existing AAV5 antibodies, active hepatitis B/C or significant hepatic fibrosis/cirrhosis, current or historical Factor VIII inhibitors, HIV, active malignancy, thrombophilia or thrombosis, prior receipt of Roctavian, known mannitol hypersensitivity, or other listed contraindications. Key requirements: prior authorization and prescribing by a hemophilia specialist plus documentation (male ≥18 years, ≥150 Factor VIII exposure days, negative AAV5 antibody test, baseline Factor VIII <1 IU/dL, inhibitor titer and liver/renal/platelet labs within 30 days or hepatology clearance, no systemic immunosuppression or live vaccine within 30 days, current weight for dosing verification, and claims/physician confirmation of no prior Roctavian).

"Roctavian is indicated for the treatment of adults with severe hemophilia A (congenital Factor VIII deficiency with Factor VIII activity < 1 IU/dL) without pre-existing antibodies to adeno-associat..."