Hematology - Casgevy™

Policy approves one lifetime IV infusion of Casgevy for patients ≥12 years with either sickle cell disease (specified genotypes such as S/S, S/β0, S/β+) with ≥4 severe VOCs in 2 years despite standard therapy, or transfusion‑dependent beta‑thalassemia per policy genotype/transfusion criteria; it excludes prior HSCT or prior gene therapy, active infections, advanced liver disease, severe cerebral vasculopathy, significant iron overload (for TDT), certain malignancies/immunodeficiencies, and concurrent use of specified agents. Authorization requires extensive documentation (genetic confirmation, viral/infectious and liver testing, VOC or transfusion history, reproductive precautions/confirmatory testing, physician attestation of mobilization/apheresis/myeloablative conditioning plan), verification of weight and a minimum CD34+ cell dose ≥3×10^6 CD34+ cells/kg, and is limited to a single dose with a one‑year approval window.

"Casgevy is given one-time (per lifetime) as a single dose."