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