Hematology - Lyfgenia®

Lyfgenia is covered with prior authorization as a single (one-time, lifetime) IV dose for sickle cell disease patients ≥12 years with a history of vaso‑occlusive events, while excluded for those with prior HSCT or prior gene therapy, >2 α‑globin deletions, active infection, advanced liver disease, Moyamoya at bleeding risk, malignancy, or significant immunodeficiency. Approval requires extensive documentation and compliance with criteria including specific SCD genotype (or MD review), ≥4 severe VOEs in the past 2 years despite therapy, lack of (or unwilling) HLA‑matched donor, cessation of specified meds pre‑mobilization, planned mobilization/apheresis and busulfan myeloablative conditioning, negative HIV/HBV/HCV/HTLV screening, sickle Hb <30% and total Hgb ≤11 g/dL at required timepoints, contraception/pregnancy testing, hematologist/stem‑cell transplant prescriber, weight and verification of ≥3×10^6 CD34+ cells/kg, plus other lab/monitoring documentation.