Criteria
Coverage is subject to the specific terms of the member's benefit plan.
Lifileucel (Amtagvi) may be considered medically necessary when
ALL
the following criteria are met:
-
Individual is 18 years of age or older with unresectable or metastatic melanoma;
and
-
Previously treated with PD-1 blocking antibody and, for individuals with BRAF V600 positive mutation, previous treatment also includes BRAF inhibitor or BRAF inhibitor with MEK inhibitor;
and
-
Individual has at least one (1) resectable lesion for TIL generation (greater than or equal to 1.5 cm in diameter);
and
-
Individual has received or will receive a lymphodepleting chemotherapy regimen;
and
-
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
and
-
Individual does
NOT
have any of the following:
-
Uncontrolled brain metastases;
or
-
Organ allograft or prior cell transfer;
or
-
Melanoma of uveal or ocular origin;
or
-
Systemic steroid therapy for any reason;
or
-
Grade 2 or higher hemorrhage within 14 days prior to trial enrollment (tumor resection);
or
-
Left ventricular ejection fraction (LVEF) less than 45%;
or
-
New York Heart Association (NYHA) functional classification greater than Class 1;
or
- Forced expiratory volume in one second (FEV1) of less than or equal to 60%.
Note:
The safety and effectiveness of repeat administration of lifileucel (Amtagvi) has not been evaluated. Therefore, coverage will be limited to once per lifetime.
The use of lifileucel (Amtagvi)
for all other indications not listed in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness cannot be established by the available published peer-reviewed literature.
Procedure Code
