Coverage is subject to the specific terms of the member’s benefit plan.
The use of voretigene neparvovec-rzyl (Luxturna) may be considered medically necessary when ALL of the following criteria are met:
- The individual must meet criteria as outlined in prescribing information (PI) including recommendations for diagnosis and age; and
- The prescriber is a, or in consult with, an ophthalmologist or retinal surgeon with experience providing subretinal injections; and
- The individual must have a diagnosis of inherited retinal dystrophy (i.e., Leber’s congenital amaurosis [LCA], retinitis pigmentosa [RP]); confirmed by biallelic pathogenic variants in the RPE65 gene by molecular genetic testing (as evidenced with submitted documentation); and
- The individual has sufficient viable retinal cells as measured by OCT (optical coherence tomography) defined as one of the following:
- retinal thickness greater than 100 microns within the posterior pole; or
- ≥ 3-disc areas of the retina without atrophy or pigmentary degeneration within the posterior pole; or
- remaining visual field within 30 degrees of fixation as measured by a III4e isopter or equivalent; and
- The individual has remaining light perception in the eye(s) that will receive treatment; and
- Patient has not previously received RPE65 gene therapy in intended eye.
Authorization: 1 month (once per lifetime per eye)
Voretigene neparvovec-rzyl (Luxturna) is considered experimental/investigational for any other indications. Scientific evidence does not support its efficacy or safety for any other indications than those listed on this policy.