Hemgenix® (etranacogene dezaparvovec-drlb)

Hemgenix is covered as a one‑time, single IV infusion (2 × 10^13 gc/kg) for adult males (≥18) with hemophilia B who meet the FDA indication—baseline Factor IX ≤2% and qualifying bleeding history (≥150 exposure days or life‑threatening/recurrent spontaneous bleeds); prior hemophilia B gene therapy is excluded. Approval requires documentation and a hemophilia specialist prescription plus recent negative Factor IX inhibitor testing, no active HBV/HCV or uncontrolled HIV, liver/platelet/renal labs within specified limits, and a current body weight.

"Does not have uncontrolled human immunodeficiency virus infection (uncontrolled HIV is exclusionary)."

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