Beqvez® (fidanacogene elaparvovec-dzkt)

Covered: a one‑time, lifetime intravenous infusion of Beqvez (5×10^11 genome copies/kg) for adult (≥18) male patients with moderate‑to‑severe hemophilia B (baseline Factor IX ≤2%) who meet specified bleeding/exposure criteria; excluded are females, patients <18, baseline FIX >2%, prior hemophilia B gene therapy, neutralizing antibodies to AAVRh74var, Factor IX inhibitors, active hepatitis B/C, uncontrolled HIV, advanced liver disease, or other disqualifying lab abnormalities. Key requirements: extensive documentation including recent (≤30 days) labs (ALT/AST ≤2×ULN, total bilirubin ≤1.5×ULN, ALP ≤2×ULN, platelets ≥100×10^9/L, creatinine ≤2.0 mg/dL), negative AAVRh74var antibody by an FDA‑approved test and negative FIX inhibitor within 30 days, documented bleeding/exposure history (e.g., ≥150 exposure days or life‑threatening/recurrent serious bleeds), current weight for dosing, hemophilia specialist prescribing, confirmation of no prior gene therapy, and discontinuation of prophylactic FIX once adequate FIX levels are achieved.