Luxturna™ (voretigene neparvovec-rzyl)

Covered only as a one‑time Luxturna (voretigene neparvovec‑rzyl) treatment for the FDA‑approved indication of confirmed biallelic RPE65 mutation‑associated retinal dystrophy; all other uses are excluded. Approval requires documented biallelic RPE65 mutations, physician confirmation of viable retinal cells, age 1 to <65 years, administration by a retinal specialist, no prior Luxturna, and adherence to dosing/administration (1.5×10^11 vg/eye in 0.3 mL subretinally, one injection per eye on separate days ≥6 days apart) with supporting documentation.

"Documentation of patient age to confirm the patient is at least 1 year of age and less than 65 years of age."

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