Hemophilia – Hemgenix®

Coverage is limited to a single one‑time (per lifetime) IV infusion of Hemgenix (2×10^13 genome copies/kg) for male patients ≥18 with moderately severe or severe hemophilia B (baseline FIX ≤2%) only if they meet all specified Authorization Criteria A–Q; coverage is not recommended for any circumstances outside those criteria. Key requirements include a qualifying bleeding history (prophylaxis ≥2 months with ≥150 exposure days, or life‑threatening hemorrhage, or repeated serious spontaneous bleeds), negative FIX inhibitor testing within 30 days, no active hepatitis B/C or uncontrolled HIV (if HIV+, CD4 ≥200 or VL ≤200), recent acceptable liver/renal/platelet labs and no advanced fibrosis, specialist prescriber and no prior Hemgenix, documented weight within 30 days for dosing, and intensive post‑infusion monitoring (weekly ALT and FIX activity for ≥3 months, corticosteroid plan for ALT elevations, and HCC surveillance when indicated).

"Treatment of adults with hemophilia B (congenital Factor IX deficiency) who currently use Factor IX prophylaxis therapy."