Hemophilia – Hemgenix®

Hemgenix is covered as a one‑time (per‑lifetime) intravenous gene therapy for biological males ≥18 with moderately severe or severe hemophilia B (baseline Factor IX ≤2%) and is excluded for pediatric patients, those with Factor IX >2%, prior hemophilia B gene therapy, positive Factor IX inhibitors, active HBV/HCV or uncontrolled HIV, advanced liver disease/fibrosis, platelet <50 x10^9/L, or failure to meet renal criteria. Coverage requires documented negative Factor IX inhibitor testing within 30 days, qualifying bleeding/Factor IX exposure history (≥150 exposure days or life‑threatening hemorrhage or recurrent serious spontaneous bleeds), liver tests ≤2x ULN, platelet ≥50 x10^9/L, CrCl ≥30 mL/min or creatinine ≤2x ULN, prescribing by a hemophilia specialist, recent weight for dose verification, and physician attestation that prophylactic Factor IX will not be continued once adequate levels are achieved.

"Hemophilia B (congenital Factor IX deficiency) in adults."