Initial Approval Criteria A. Uveal Melanoma
(must meet all):
1.
Diagnosis of unresectable or metastatic uveal melanoma;
2.
Prescribed by or in consultation with an oncologist;
3. Age
≥ 18 years;
4.
Disease is HLA-A*02:01-positive;
5.
Request meets one of the following (a or b):*
a. Dose does not exceed
20 mcg (1 vial) on Day 1, 30 mcg (1 vial) on Day 8, 68 mcg (1 vial) on Day 15,
and 68 mcg (1 vial) weekly thereafter;
b. Dose is supported by
practice guidelines or peer-reviewed literature for the relevant off-label use
(prescriber
must submit supporting evidence).
*Prescribed regimen must be FDA-approved or recommended by NCCN
Approval duration: 6 months
Continued Therapy
A.
Uveal Melanoma
(must meet all
1.
Currently receiving medication via Centene benefit, or documentation supports
that member is currently receiving Kimmtrak for a covered indication and has
received this medication for at least 30 days;
2.
Member is responding positively to therapy;
3. If
request is for a dose increase, request meets one of the following (a or b):*
a. New dose does not
exceed 68 mcg (1 vial) weekly;
b. New dose is supported
by practice guidelines or peer-reviewed literature for the relevant off-label
use
(prescriber
must submit supporting evidence).
*Prescribed regimen must be FDA-approved or recommended by NCCN
Approval duration: 12 months
Codes
Used In This BI:
C9095 – Inj, tebentafusp-tebn, 1mcg (Code deleted & replaced by J9274 eff
10-1-22)
J9274 - Inj, tebentafusp-tebn, 1 mcg