Roctavian® (Valoctocogene Roxaparvovec-Rvox) – Commercial Medical Benefit Drug Policyopen_in_new

UnitedHealthcare covers Roctavian only for adults (≥18) with severe hemophilia A (endogenous FVIII <1%) and excludes use for hemophilia B, mild/moderate A, repeat or prior gene‑therapy recipients, patients with pre‑existing AAV5 antibodies, prior ITI, certain active infections, unresolved liver abnormalities, or those on antiviral therapy for HBV/HCV. Key requirements: treatment must be prescribed/managed by a bleeding‑disorder specialist at a federally designated Hemophilia Treatment Center, have negative AAV5 DetectCDx®, inhibitor <0.6 BU, meet exposure criteria (≥150 FVIII exposure days or current chronic Hemlibra/Hympavzi or HTC‑approved candidacy), pass liver and infectious disease screening (HIV suppressed if positive, HBsAg negative, HCV RNA negative if Ab positive), agree to weekly ALT and FVIII monitoring for ≥26 weeks and alcohol abstinence counseling, follow FDA dosing, and is limited to one lifetime administration with authorization no longer than 45 days.