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DrugLuxturna™ (voretigene neparvovec-rzyl) [Spark Therapeutics, Inc.]

July 2018

Therapeutic area - Retinal dystrophy

Approval criteria

  • Patient must be at least 12 months old AND
  • The provider requesting prior authorization for Luxturna must be an enrolled provider in Minnesota Health Care Programs (MHCP) AND
  • Provider must attest that the patient did not previously participate or is not currently participating in any clinical trials for Luxturna AND
  • At time of request, provider must provide a comprehensive treatment plan and follow-up care plan which include but are not limited to all needed ancillary services (e.g., transportation and lodging, etc) AND
  • Patient has a definitive diagnosis confirming biallelic RPE65 mutation-associated retinal dystrophy AND
  • Patient must have viable retinal cells as determined by non-invasive means, such as optical coherence tomography (OCT) and/or ophthalmoscopy indicating one or more of the following:
    • An area of retina within the posterior pole of >100 μm thickness shown on OCT
    • ≥ 3 disc areas of retina without atrophy or pigmentary degeneration within the posterior pole
    • Remaining visual field within 30 degrees of fixation as measured by a III4e isopter or equivalent AND
  • Patient must have one or more of the following in each eye:
    • Best corrected visual acuity of 20/60 or worse OR
    • Visual field less than 20 degrees in any meridian as measured by a III4e isopter or equivalent OR
    • Significant visual loss if patient is unable to complete one or both assessments above AND
  • Patient has not had intraocular surgery within six months AND
  • Patient must have an adequate washout period from retinoid therapies prior to receipt of Luxturna

Quantity limits

  • 1 treatment per eye per lifetime; may not be renewed

Billing of Luxturna

Luxturna is not covered through the MHCP fee-for-service pharmacy benefit and must be submitted as a medical claim. A retail or specialty pharmacy dispensing a drug for administration in an outpatient setting is not eligible for direct reimbursement.


MHCP Provider Call Center 651-431-2700 or 800-366-5411

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