Hematology - Lyfgenia®

Policy covers one-time, prior‑authorized Lyfgenia infusion (single IV dose ≥3×10^6 CD34+ cells/kg) for patients ≥12 with sickle cell disease and recurrent severe VOEs, and excludes those with prior HSCT or prior gene therapy, >2 α‑globin deletions, active significant infection, advanced liver disease, severe cerebral vasculopathy (e.g., high‑risk Moyamoya), prior/current malignancy or significant immunodeficiency. Key requirements include extensive documentation and physician attestation of specific SCD genotypes, ≥4 severe VOEs in 2 years, trial of ≥1 disease‑modifying therapy, no suitable/willing HLA‑matched donor, negative infectious disease screening, specified medication washouts, reproductive safeguards, hematologist/transplant prescriber, weight and dose verification, sickle hemoglobin <30% and total hemoglobin ≤11 g/dL prior to mobilization and until conditioning, and post‑treatment malignancy monitoring.

"N) Current patient body weight has been obtained within 30 days [documentation required]."