Hematology - Lyfgenia®

Lyfgenia is covered as a one-time (per lifetime) single IV infusion (minimum 3 × 10^6 CD34+ cells/kg) for patients ≥12 years with sickle cell disease and a documented history of ≥4 severe vaso‑occlusive events in the prior 2 years, and is excluded for prior HSCT or prior gene therapy, >2 α‑globin deletions, active significant infection, advanced liver disease, Moyamoya-related severe cerebral vasculopathy, prior/current malignancy or immunodeficiency. Key requirements include documented sickle cell genotype, trial of ≥1 disease‑modifying therapy, negative viral screening, planned mobilization/apheresis with a stem cell mobilizer (e.g., plerixafor) and busulfan myeloablative conditioning, HbS <30% and total Hb ≤11 g/dL at specified timepoints, contraception/pregnancy testing for reproductive‑age patients, prescribing by a hematologist or transplant physician, recent weight for dosing verification, and confirmation the manufactured dose meets the CD34+ cell/kg minimum.