Voretigene Neparvovec-rzyl (Luxturna)

Covered: Luxturna is covered only for FDA‑approved biallelic RPE65 mutation‑associated retinal dystrophy and is excluded for patients with prior Luxturna, age <1 year, or absence of viable retinal cells. Key requirements: documented genetic confirmation of biallelic RPE65 mutations, clinician documentation of viable retinal cells, administration by a retinal specialist at 1.5×10^11 vg in 0.3 mL subretinally (one dose per eye, max two lifetime doses) with the two eyes treated on separate days at least 6 days apart and complete supporting documentation.

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

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