Hematology - Zynteglo™

Approve one-time (per‑lifetime) IV Zynteglo for transfusion‑dependent β‑thalassemia in patients ≥4 to <51 years who meet strict inclusion/exclusion criteria; coverage is not recommended for prior gene therapy or prior HSCT, active infection, malignancy/myeloproliferative disease or significant immunodeficiency, advanced liver disease, severe iron overload, or concurrent use with Reblozyl. Key requirements: documented eligible genotype and transfusion dependence, negative HIV/HBV/HCV/HTLV screening, evaluation and absence of severe iron overload, hemoglobin ≥11 g/dL before mobilization and conditioning, discontinuation of iron chelation ≥7 days pre‑conditioning, planned mobilization/apheresis/myeloablative conditioning with G‑CSF + mobilizer and busulfan, specialist prescriber, recent weight, contraception/pregnancy testing, and verification the product provides ≥5.0×10^6 CD34+ cells/kg (claims verification if available).

"Documentation that patient has been evaluated for severe iron overload and documentation confirming absence of severe iron overload [documentation required]."