Luxturna™ (voretigene neparvovec-rzyl)

Covered: one-time Luxturna treatment (two subretinal injections total; 1.5×10^11 vg per eye in 0.3 mL, eyes treated on separate days ≥6 days apart) for patients ≥1 and <65 years with genetically confirmed biallelic RPE65 mutation-associated retinal dystrophy who have viable retinal cells, have not previously received Luxturna, and will be treated by a retinal specialist. Key requirements: documentation of biallelic RPE65 mutations, physician documentation of viable retinal cells, proof of age and retinal specialist credentials, and treatment records verifying dose and separate administration dates.

"Approval limited to a one-time treatment course (2 injections total, 1 injection in each eye)."

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