MED.00120 Gene Therapy for Ocular Conditions

This policy addresses gene therapy for ocular conditions, specifically voretigene neparvovec-rzyl (Luxturna). It is covered as medically necessary only when all criteria are met: confirmed biallelic RPE65 mutation causing retinal dystrophy, age ≥1 year, and for each eye adequate viable retinal cells by OCT/ophthalmoscopy (e.g., posterior pole retinal thickness >100 μm, ≥3 disc areas without atrophy/pigmentary change, or visual field within 30° of fixation). It is not covered when criteria are not met, for repeat injections in the same eye, or for any other ocular gene replacement therapies, which are considered investigational.

"The use of voretigene neparvovec-rzyl is consideredmedically necessaryin individuals who meetallof the following criteria:"

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