Coverage Policies

Effective Date:

a)    This policy will apply to all services performed on or after the above revision date which will become the new effective date.

b)    For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply.

1)    Luxturna (voretigene neparvovec-ryzl) requires prior authorization.

2)    Luxturna is used to treat patients with confirmed biallelic RPE65 mutation-associated retinal dystrophy.

3)    Luxturna is covered under the medical benefit.

Luxturna (voretigene neparvovec-rzyl) is considered medically necessary for members meeting ALL of the following criteria:

1)    Diagnosis of retinal dystrophy, or Leber congenital amaurosis, confirmed by genetic diagnosis of biallelic RPE65gene mutations;

2)    Prescribed by or in consultation with an ophthalmologist;

3)    Age >3 years;

4)    Member has not previously been treated with Luxturna in the requested treatment eye(s);

5)    Sufficient viable retinal cells as evidenced by both of the following (a and b):

a.    Retinal thickness on spectral domain optical coherence tomography (i.e., areas of retina with thickness measurements > 100 microns within the posterior pole);

b.    Fundus photography (i.e., presence of neural retina);

6)    Significant vision loss as evidenced by at least one of the following (a or b):

a.    Visual acuity of 20/60 or worse in both eyes

b.    Visual field less than 20 degrees in any meridian

7)    Member has not received intraocular surgery within prior 6 months;

8)    Member meets one of the following (a or b):

a.    A baseline Multi-Luminance Mobility Testing (MLMT) score lower than 6 points (i.e., unable to pass at the lowest luminance level of 1 lux);

b.    Full-field stimulus testing (FST) for blue and red light baseline score of > -2.00 log10(cd/m2) (e.g., + 1.00 log10(d/m2);

9)    Dose does not exceed 1.5 x 1011vector genomes (vg) per eye.

Approval Duration is 4 weeks (1 lifetime dose per eye)

Codes Used In This BI:

1)    J3398 – Injection, voretigene neparvovec-rzyl, 1 bilion vector genomes

1)    One (1) lifetime dose per eye.

1)    Luxturna Prescribing Information. Philadelphia, PA: Spark Therapeutics, Inc.; December 2017.

2)    Russell S, Bennett J, Wellman JA, et al. Efficacy and safety of voretigene neparvovec in patients with RPE65-mediated inherited retinal dystrophy: a randomized, controlled, open-label, phase 3 trial. Lancet 2017; 390:849-60.

3)    Dias MF, Joo K, Kemp JA, et al. Molecular genetics and emerging therapies for tetinitis pigmentosa: Basic research and clinical perspectives. Prog Retin Eye Res 2017; pii: S1350-9462:30052-6. Doi: 10.1016/j.preteyeres.2017.10.004. [Epub ahead of print]

4)    U.S. National Library of Medicine. Leber congentialamaurosis. Genetics Home Reference.

5)    Evans JM. Standardsfor visual acuity. Intelligent SystemsDivision: National Institute for Standards and Technology. June 2006.

6)    Klen M, the Retina Foundation of the Southwest. Psychophysical assessment of low visual function in patients with retinal degenerative disease (RDDs) with the Diagnosys full-field stimulus threshold (D-FST). Doc Ophthalmol. 2009; 119(3):217-224. Doi:10.1007/s10633-009-9204-7.