Initial Approval Criteria
A.
Ophthalmic Disease
(must meet all):
1.
Diagnosis of one of the following (a or b):
a. nAMD;
b. DME;
2.
Prescribed by or in consultation with an ophthalmologist;
3. Age
≥ 18 years;
4.
Failure of bevacizumab intravitreal solution, unless contraindicated or
clinically significant adverse effects are experienced;
*Prior
authorization may be required for bevacizumab intravitreal solution. Requests
for IV formulations of Avastin, Mvasi, and Zirabev will not be approved
5.
Dose does not exceed (a or b):
a. nAMD: 6 mg (1 vial)
every 4 weeks for the first 4 doses;
b. DME: one of the
following (i or ii):
i. Fixed dosing regimen:
6 mg (1 vial) every 4 weeks for the first 6 doses, then 6 mg every 8 weeks
thereafter;
ii. Variable dosing
regimen: 6 mg (1 vial) every 4 weeks for at least 4 doses and until a central
subfield thickness (CST) of < 325 μM is achieved, then one of the following (a
or b):
a) 6 mg (1 vial) every 8
to 16 weeks;
b) 6 mg (1 vial) every 4
weeks, and one of the following (a or b):
6.
Member has had an inadequate response to every 8-week dosing, defined as one of
the following (a or b):
a) CST has increased
between > 10% and ≤ 20% with an associated ≥ 5- to < 10-letter best-corrected
visual acuity (BCVA) decrease from the reference values;
b) CST has increased by >
20% without an associated ≥ 10-letter BCVA decrease from the reference values;
7.
Member has had an inadequate response to every 12-week dosing, defined as > 10%
increase in CST and ≥ 10-letter BCVA decrease from the reference value.
Approval duration:
nAMD – 4
months (first 4 doses)
DME
– 6 months (up
to 6 doses)
Continued Therapy
A.
Ophthalmic Disease
(must meet all):
1.
Currently receiving medication via QualChoice benefit or member has previously
met initial approval criteria;
2.
Member is responding positively to therapy as evidenced by one of the following
(a, b, c, or d):
a. Regressed
neovascularization;
b. Improvement in visual
acuity;
c. Maintenance of
corrected visual acuity from prior treatment;
d. Supportive findings
from optical coherence tomography or fluorescein angiography;
3. If
request is for a dose increase, new dose does not exceed (a or b):
a. nAMD: one of the
following (i, ii, or iii):
i. 6 mg (1 vial) every 16
weeks;
ii. 6 mg (1 vial) every
12 weeks if member has documented active disease at week 24;
iii. 6 mg (1 vial) every
8 weeks if member has documented active disease at week 20;
b. DME: one of the
following (i or ii):
i. Fixed dosing regimen: 6 mg (1 vial)
every 8 weeks;
ii. Variable dosing
regimen: 6 mg (1 vial) every 4 weeks until a CST of < 325 μM is achieved, then
one of the following (1 or 2):
1) 6 mg (1 vial) every 8
to 16 weeks;
2) 6 mg (1 vial) every 4
weeks, and one of the following (a or b):
a) Member has had an
inadequate response to every 8-week dosing, defined as one of the following (i
or ii):
i) CST has increased
between > 10% and ≤ 20% with an associated ≥ 5- to < 10-letter BCVA decrease
from the reference values);
ii) CST has increased by
> 20% without an associated ≥ 10-letter BCVA decrease from the reference values;
b) Member has had an
inadequate response to every 12-week dosing, defined as > 10% increase in CST
and ≥ 10-letter BCVA decrease from the reference value.
Approval duration: 6 months
Codes
Used In This BI:
1)
C9097
Inj, faricimab-svoa, 0.1mg (Code deleted and replaced by J2777 eff
10-1-22)
2)
J2777
Injection, faricimab-svoa, 0.1 mg