Gene Therapies for Hemophilia B – Commercial Medical Benefit Drug Policyopen_in_new

UnitedHealthcare covers a one‑time (single‑lifetime) administration of Beqvez or Hemgenix for adults (≥18) with severe or moderately severe Hemophilia B and excludes pediatric patients, hemophilia A, repeat dosing or prior gene‑therapy recipients, patients with FIX inhibitors (≥0.6 BU), high anti‑AAV neutralizing antibodies, prior ITI, unsuppressed HIV, active hepatitis B or C or current antiviral therapy, non‑HTC management, or non‑FDA dosing. Coverage requires documented FIX activity and bleeding history, ≥50 exposure days to FIX or current Hympavzi/HTC determination of candidacy, pre‑treatment testing for vector neutralizing antibodies (AAVRh74var for Beqvez; validated AAV5 NAb test for Hemgenix), liver imaging/enzymes, HIV viral suppression (<200 copies/mL) if positive, HBV surface antigen negative and HCV RNA negative if antibody positive, management at a CDC‑designated Hemophilia Treatment Center with prescriber attestation to weekly ALT/AST and FIX monitoring for at least 4 months (Beqvez) or 3 months (Hemgenix), alcohol counseling, FDA‑label dosing, and authorization limited to ≤45 days from approval.