Voretigene Neparvovec-rzyl (Luxturna™)

Luxturna (voretigene neparvovec‑rzyl) is covered only as a one-time course (two subretinal injections, one per eye) for patients ≥1 year with confirmed biallelic RPE65 mutation–associated retinal dystrophy who have viable retinal cells and have not previously received Luxturna; it is excluded for patients <1 year, without biallelic RPE65 mutations or viable retinal cells, prior Luxturna recipients, non–retinal specialist administration, or non‑subretinal routes. Coverage requires administration by a retinal specialist at the recommended dose (1.5 × 10^11 vg in 0.3 mL per eye) with the two eyes treated on separate days at least 6 days apart and documentation of genetic test results, retinal viability assessment, age, prior therapy history, and a treatment plan/orders.

"Treatment of patients with confirmed biallelic RPE65 mutation-associated retinal dystrophy (FDA-approved indication)."