Hematology - Zynteglo™

Zynteglo is covered as a one‑time (per‑lifetime) IV infusion for transfusion‑dependent beta‑thalassemia in patients ≥4 years who meet all policy criteria, and is excluded for patients <4 years, prior hematopoietic stem cell transplant or prior gene‑therapy recipients, concurrent luspatercept use, or any failure to meet the listed eligibility. Approval requires documented genotype, transfusion‑dependence over the prior 2 years (≥100 mL/kg/year or ≥8 transfusions/year), no severe iron overload, negative infectious and malignancy/advanced‑liver disease screens, Hb ≥11.0 g/dL before mobilization and conditioning, planned mobilization/apheresis with G‑CSF and a stem‑cell mobilizer, busulfan myeloablative conditioning, reproductive precautions (pregnancy testing and contraception), hematologist/transplant prescriber, recent weight and documentation/claims verification (including no prior gene therapy) and a minimum dose of 5.0×10^6 CD34+ cells/kg.

"Transfusion-Dependent Beta-Thalassemia: Approve a one-time (per lifetime) single dose if the patient meets ALL of the following (A through P): A) Patient is ≥ 4 years of age; AND B) Patient has not..."