Hematology – Zynteglo™

Covers one lifetime intravenous dose of Zynteglo for transfusion‑dependent beta‑thalassemia (typically ages 4–50) and excludes patients with prior HSCT or gene therapy, active malignancy or familial cancer syndrome, significant organ dysfunction (eGFR <70, DLCO <50%, advanced liver disease), active infection, an available/willing HLA‑matched family donor, or concurrent Reblozyl use. Coverage requires extensive documentation and prescriber attestations including transfusion‑dependence (≥100 mL/kg/yr OR ≥8 transfusions/yr for the prior 2 years), genotype confirmation, hematologist/stem‑cell transplant specialist prescribing, planned mobilization/apheresis with G‑CSF + plerixafor and busulfan myeloablative conditioning, hemoglobin ≥11.0 g/dL before mobilization and conditioning, HIV/HTLV negative screening, VOD prophylaxis, stopping/avoiding iron chelation as specified, contraception/pregnancy testing, performance/lab minima, and is approved for one dose with a 6‑month authorization window.