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 a Fellowship-trained Retina Specialist;
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