LUXTURNA (voretigene neparvovec-rzyl)

LUXTURNA (voretigene neparvovec-rzyl)

OFFICE ADMINISTRATION

Indications for Prior Authorization:

• Treatment of patients with confirmed biallelic human retinal pigment epithelial 65 kDa protein (RPE65) mutation-associated retinal dystrophy. Patients must have viable retinal cells as determined by the treating physician

Patients must meet the following criteria for the indication(s) above:

• Prescribed by an ophthalmologist, AND
• Member is at least 4 years or older, AND
• Diagnosis of retinal dystrophy, or Leber congenital amaurosis, confirmed by genetic diagnosis of biallelic RPE65 gene mutations, AND
• Member has sufficient viable retinal cells as evidenced by both of the following:
  • Retinal thickness on spectral domain optical coherence tomography (i.e. areas of retina with thickness measurements > 100 microns within the posterior pole), AND
  • Fundus photography (i.e. presence of neural retina), AND
• Member has significant vision loss determined by one of the following:
  • Visual acuity of 2-/6- or worse in both eyes, OR
  • Visual field less than 20 degrees in any meridian, AND
• Member has not had intraocular surgery in the past 6 months, AND
• Member has a baseline passing score on the Multi-Luminance Mobility Testing (MLMT) lower than level of 1 lux (lowest luminance level), AND
• Will not exceed 1.5 x 10¹¹ vector genomes (vg) per eye
• Luxturna will be administered to each eye on separate days within a close interval, but no fewer than 6 days apart

Dosing:

• 1.5 x 10¹¹ vector genomes (vg) for each eye administered by subretinal injection in a total volume of 0.3mL
• Perform subretinal administration of Luxturna to each eye on separate days within a close interval, but no fewer than 6 days apart
• Systemic oral corticosteroids recommended equivalent to prednisone at 1mg/kg/day (maximum of 40 mg/day) for a total of 7 days (starting 3 days before administration of Luxturna to the first eye) and followed by tapering the dose during the following 10 days. Same corticosteroid dosing regimen applies for the administration of Luxturna to the second eye

Approval:

• 1 lifetime dose per eye