Hemgenix (etranacogene dezaparvovec-drlb)

Hemgenix is covered as a one‑time, per‑lifetime treatment for male adults (≥18) with moderate‑severe/severe hemophilia B (baseline FIX ≤2%) who meet specified bleeding or prophylaxis history and do not have current or historical FIX inhibitors, active HBV/HCV, uncontrolled HIV, advanced liver disease/fibrosis, other coagulopathies, platelet <50×10^9/L, or creatinine clearance <30 mL/min (patients with FIX >2% or prior Hemgenix are excluded). Coverage requires a hemophilia specialist prescriber, documentation of baseline FIX and qualifying history, FIX inhibitor testing within 30 days, liver/renal/platelet labs within 30 days meeting policy thresholds, agreement to discontinue prophylactic FIX after adequate FIX levels are achieved, and specified post‑infusion monitoring (weekly LFTs and FIX activity for 3 months, steroid plan for ALT elevations, and HCC surveillance if at risk).

"Baseline Factor IX level must be ≤ 2% of normal (policy requirement); patients with baseline Factor IX > 2% excluded."