Luxturna™

Drug - Luxturna™ (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.

Questions?

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