Hematology - Zynteglo™

Covered as a one‑time (per‑lifetime) gene therapy for transfusion‑dependent beta‑thalassemia in patients ≥4 years who meet authorization criteria; excluded for patients with prior hematopoietic stem cell transplant or prior gene therapy, for concurrent use with Reblozyl, or any circumstance not meeting the listed criteria. Key requirements include documented genotype confirmation, transfusion‑dependence (≥100 mL RBC/kg/yr or ≥8 transfusions/yr), no severe iron overload or active infection, negative HIV/HBV/HCV/HTLV screens, no prior/current malignancy or advanced liver disease, Hb ≥11 g/dL before mobilization and conditioning, discontinuation of iron chelation ≥7 days pre‑conditioning, prescription by a hematologist/stem cell transplant specialist with planned mobilization/apheresis and busulfan myeloablative conditioning using G‑CSF and a mobilizer, reproductive precautions, and documentation/verification including a minimum delivered dose of 5.0×10^6 CD34+ cells/kg and confirmation of no prior gene therapy/HSCT.