Hemophilia – Beqvez™
EVICORE-EMBARC-9F628ADA
Beqvez is covered as a one-time, per‑lifetime IV dose (5×10^11 vg/kg, weight‑adjusted for BMI >30) for biologic males ≥18 with moderately severe–severe hemophilia B (baseline FIX ≤2%) who meet specified bleeding‑history criteria; exclusions include prior gene therapy receipt, Factor IX inhibitors/history of inhibitors, uncontrolled HIV, active hepatitis B/C, advanced liver fibrosis, and prescriptions not from a hemophilia specialist. Approval requires extensive documentation: negative AAVRh74var neutralizing antibody by an FDA‑approved test, negative FIX inhibitor titer within 30 days, liver chemistries within specified thresholds, platelets ≥100×10^9/L, creatinine ≤2.0 mg/dL, current weight for dosing, and verification/attestation of no prior gene therapy.
"One-time (per lifetime) single dose of Beqvez (fidanacogene elaparvovec-dzkt) intravenous infusion for treatment of hemophilia B (congenital Factor IX deficiency) in adult males (defined biological..."