Hemgenix (etranacogene dezaparvovec-drlb)

Hemgenix is covered as a one‑time, single IV infusion (recommended dose 2×10^13 genome copies/kg) for adult males (≥18 years) with hemophilia B who meet FDA indications (current prophylaxis, life‑threatening hemorrhage, or repeated serious spontaneous bleeds) and have moderately severe/severe disease. Key requirements include documentation of baseline (off replacement) Factor IX level ≤2% and one qualifying clinical history (≥2 months continuous prophylaxis with ≥150 exposure days OR life‑threatening hemorrhage OR repeated serious spontaneous bleeds), recent (within 30 days) lab/infection screening showing no active HBV/HCV, no current or prior Factor IX inhibitors, acceptable liver/platelet/renal function, treatment by a hemophilia specialist, and one‑time (lifetime) authorization.

"Does not currently have an inhibitor to Factor IX."

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