Coverage is subject to the specific terms of the member’s benefit plan.
Federal Employee Program members (FEP) should check with their Retail Pharmacy Program to determine if prior approval is required by calling the Retail Pharmacy Program at 1-800-624-5060 (TTY: 1-800-624-5077). FEP members can also obtain the list through the www.fepblue.org website.
Voretigene neparvovec-rzyl (Luxturna) may be considered medically necessary when ALL of the following criteria are met:
- Individual age 12 months to 65 years of age; and
- Individual has vision loss due to biallelic RPE65 mutation-associated retinal dystrophy; and
- Confirmed diagnosis of inherited retinal disease caused by RPE65 gene mutations demonstrated by documented mutation in both copies of the RPE65 gene; and
- Voretigene neparvovec-rzyl (Luxturna) is prescribed by a retinal specialist; and
- Individual has sufficient viable retinal cells as determined by the treating physician and assessed via optical coherence tomography (OCT) imaging and/or ophthalmoscopy, demonstrating EITHER of the following:
- Retinal thickness on spectral domain optical coherence tomography is greater than 100 microns within the posterior pole; or
- Clinical exam, noting greater than or equal to three (3) disc areas of retina without atrophy or pigmentary degeneration within the posterior pole; and
- No intraocular surgery in the past six (6) months; and
- Individual is not currently pregnant or breastfeeding; and
- Individual has not previously received RPE65 gene therapy in intended eye.
Note: Coverage for voretigene neparvovec-rzyl (Luxturna) is limited to one (1) subretinal injection per eye, administered on separate days within a close interval, but no fewer than six (6) days apart (6-18 days per available body of evidence).
The use of Voretigene neparvovec-rzyl (Luxturna) not meeting the criteria as indicated in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature.