Hemophilia – Beqvez™
EVICORE-EMBARC-63E5B6F9
Covers a one‑time (per lifetime) IV dose of Beqvez (5 × 10^11 vg/kg, with adjusted body‑weight calculation for BMI >30) for adult biological males ≥18 with moderately severe–severe hemophilia B (baseline FIX ≤2%) who meet FDA indication and bleeding‑history criteria (≥150 FIX exposure days, life‑threatening bleed requiring on‑demand FIX, or repeated serious spontaneous bleeds). Approval requires absence of neutralizing AAVRh74var antibodies and Factor IX inhibitors (testing within 30 days), no prior hemophilia B gene therapy, no active hepatitis B/C or uncontrolled HIV, liver/renal/platelet lab thresholds (ALT/AST ≤2×ULN, total bilirubin ≤1.5×ULN, ALP ≤2×ULN, platelets ≥100×10^9/L, creatinine ≤2.0 mg/dL), hemophilia specialist prescriber, weight documentation and Medical Director dosing verification; exclusions include prior gene therapy, history of FIX inhibitors, positive NAb/FIX inhibitor, active hepatitis/antiviral therapy, advanced liver disease, pediatric patients, and repeat dosing.