Voretigene Neparvovec-rzyl (Luxturna)

Covered: Luxturna is authorized only as a one-time treatment course (two subretinal injections, one per eye) for patients ≥1 year with confirmed biallelic RPE65 mutation-associated retinal dystrophy; off‑label uses, repeat courses, prior Luxturna recipients, patients <1 year, or those without viable retinal cells are excluded. Key requirements: coverage requires genetic documentation of pathogenic mutations in both RPE65 alleles, physician documentation of viable retinal cells, administration by a retinal specialist at the specified dose (1.5×10^11 vg/eye in 0.3 mL) via subretinal injection with each eye treated on separate days at least 6 days apart, plus records confirming no prior Luxturna and full dosing/administration documentation.

"Documentation of patient age to confirm patient is at least 1 year of age."

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