Voretigene Neparvovec-rzyl (Luxturna™)

Covered: Luxturna is covered as a one-time treatment course (two subretinal injections, one per eye) for confirmed biallelic RPE65 mutation-associated retinal dystrophy; prior Luxturna recipients and patients without viable retinal cells are excluded. Key requirements: documented genetic confirmation of mutations in BOTH RPE65 alleles, treating-physician documentation of viable retinal cells, age ≥1 and <65 years, administration by a retinal specialist at 1.5×10^11 vg/eye in 0.3 mL via subretinal injection, the two eye procedures on separate days ≥6 days apart, and documentation of all of the above.

"Treatment of patients with confirmed biallelic RPE65 mutation-associated retinal dystrophy."

Sign up to see full coverage criteria, indications, and limitations.