Gene Therapies for Sickle Cell Disease

This policy covers FDA‑approved gene therapies for sickle cell disease—specifically exagamglogene autotemcel (Casgevy®) and lovotibeglogene autotemcel (Lyfgenia™)—when use is consistent with FDA labeling or supported by nationally recognized compendia and peer‑reviewed literature. Coverage is limited to patients ≥12 years with documented sickle cell disease who have had qualifying clinical events within the prior 12 months despite appropriate supportive care and who meet institutional stem‑cell transplant, organ‑function, infection, and performance‑status requirements; exclusions include age <12, prior allogeneic HSCT, non‑FDA or insufficiently supported off‑label uses, and plan/state benefit limitations (HCSC Ohio).

"Drug therapy is covered when proven effective for the relevant diagnosis and the proposed dose, frequency, and duration are consistent with recommendations in at least one authoritative source."