Hemophilia – Hemgenix®

Hemgenix is covered as a one-time (per lifetime) IV dose (2×10^13 gc/kg) only for biological males ≥18 with moderately severe/severe hemophilia B (baseline FIX ≤2%) who meet FDA criteria (current FIX prophylaxis with ≥150 exposure days, or history of life‑threatening hemorrhage, or repeated serious spontaneous bleeds) and is excluded for prior gene‑therapy or prior Hemgenix recipients, females, patients <18, those with FIX inhibitors, active hepatitis B/C or uncontrolled HIV, advanced liver disease, platelet <50×10^9/L, CrCl <30 mL/min, other coagulation disorders, or lack of specialist prescribing. Coverage requires extensive documentation and pre‑treatment testing (recent negative FIX inhibitor titer, liver/renal/platelet labs within 30 days, weight and medical‑director verified weight‑based dosing, claims/physician confirmation of no prior Hemgenix, and attestations regarding prophylaxis discontinuation once adequate FIX levels are achieved).

"FDA-Approved Indication: Treatment of adults with hemophilia B (congenital Factor IX deficiency) who: 1) currently use Factor IX prophylaxis therapy; or 2) have current or historical life‑threateni..."