Ophthalmology - Luxturna®

Covered: one-time Luxturna for genetically‑confirmed biallelic RPE65 mutation–associated retinal dystrophy—one 1.5×10^11 vg subretinal injection per eye (two eyes allowed, injections ≥6 days apart); excluded: re‑treatment of previously treated eyes or use outside the listed criteria. Key requirements: prior authorization and documentation of genetic test confirming biallelic RPE65, age ≥12 months and <65 years, administration by a retinal specialist, clinical evidence of viable retinal cells, confirmation no prior Luxturna to the treated eye(s), and planned dosing/scheduling.

"Biallelic Human Retinal Pigment Epithelial 65 kDa Protein (RPE65) Mutation-Associated Retinal Dystrophy (FDA-approved indication). Approve for one-time treatment course (i."

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