Hematology - Zynteglo™

Zynteglo is covered as a one‑time (per‑lifetime) IV gene therapy for transfusion‑dependent beta‑thalassemia in patients ≥4 years who meet the policy's detailed eligibility, and is excluded for prior allogeneic/autologous HSCT, prior gene therapy for beta‑thalassemia, concurrent use with Reblozyl, or any situations not listed in the criteria. Approval requires documentation of genotype and transfusion dependence (≥100 mL RBC/kg/year or ≥8 transfusions/year over the prior 2 years), absence of severe iron overload/active infection/malignancy/significant immunodeficiency/advanced liver disease, negative pre‑collection viral tests (HIV, HBV, HCV, HTLV), planned mobilization with G‑CSF plus a stem cell mobilizer and busulfan myeloablative conditioning, hemoglobin ≥11.0 g/dL before mobilization and conditioning, reproductive safety measures, prescribing by a hematologist or stem‑cell transplant specialist, recent weight and verification of a one‑time dose (minimum 5.0×10^6 CD34+ cells/kg), and claims/physician attestation that no prior gene therapy was received.