Hematology - Casgevy™

The policy approves a one‑time, per‑lifetime IV dose of Casgevy for patients ≥12 years with either sickle cell disease with recurrent VOCs or transfusion‑dependent beta‑thalassemia, and excludes prior HSCT or prior gene therapy recipients, active clinically significant infection, advanced liver disease, certain malignancies/immunodeficiencies, and concurrent use with Reblozyl. Approval requires extensive documentation including genotype confirmation, prior treatment/transfusion or event‑level VOC records, negative pre‑manufacturing infectious disease testing, planned mobilization/apheresis with specified stem cell mobilizers and busulfan myeloablative conditioning, reproductive precautions, weight/dose verification (minimum 3×10^6 CD34+ cells/kg), and disease‑specific lab thresholds (SCD: HbS <30% and total Hb ≤11 g/dL; TDT: total Hb ≥11 g/dL and no severe iron overload).

"Casgevy is indicated for Sickle cell disease in patients ≥ 12 years of age with recurrent vaso-occlusive crises (VOCs)."