Hematology - Casgevy™

Covered: Casgevy is covered as a one‑time, per‑lifetime IV gene therapy for patients ≥12 years with either sickle cell disease with recurrent VOCs or transfusion‑dependent beta‑thalassemia, and is excluded in patients with prior HSCT or prior gene therapy, active infections, advanced liver disease, significant malignancy/immunodeficiency, or concurrent Reblozyl use. Key requirements: approval requires extensive documentation (genotype confirmation, no available/willing HLA‑matched donor, infection and reproductive screening, prescriber is a hematologist/stem‑cell transplant physician), minimum product dose ≥3×10^6 CD34+ cells/kg, disease‑specific criteria (SCD: ≥4 severe VOCs in 2 years and prior trial of disease‑modifying therapy, sickle Hb <30% and total Hb ≤11 g/dL at specified timepoints; TDT: transfusion ≥100 mL/kg/yr or ≥10 units/yr and no severe iron overload), planned mobilization/apheresis and busulfan myeloablative conditioning, and one‑time administration with a 1‑year authorization to prepare and deliver.