LCDActive
Voretigene Neparvovec-rzyl (Luxturna®)
L37863
Effective: April 20, 2023
Updated: December 31, 2025
Policy Summary
Voretigene neparvovec-rzyl (Luxturna) is covered only for patients with inherited retinal degeneration due to confirmed biallelic RPE65 pathogenic variants presenting as retinitis pigmentosa or Leber congenital amaurosis. Coverage is limited to a single 1.5 x 10^11 vector genome dose per eligible eye per lifetime and must be performed at manufacturer-designated Centers of Excellence by vitreoretinal surgeons who have completed the manufacturer's surgical and pharmacy training, with genetic test results and relevant medical records submitted.
Coverage Criteria Preview
Key requirements from the full policy
"Retinitis pigmentosa with confirmed biallelic pathogenic RPE65 mutations."
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