Criteria
Coverage is subject to the specific terms of the member's benefit plan.
Federal Employee Program members (FEP) should check with their Retail Pharmacy Program to determine if prior approval is required by calling the Retail Pharmacy Program at 1-800-624-5060 (TTY: 1-800-624-5077). FEP members can also obtain the list through the
www.fepblue.org
website.
Lifileucel (Amtagvi) may be considered medically necessary when
ALL
the following criteria are met:
-
The individual is at least 18 years of age;
and
-
The individual does not have uncontrolled brain metastases;
and
-
The individual does not have signs and symptoms of acute renal failure prior to treatment;
and
-
The individual does not have hemorrhage (grade 2 or higher) within 14 days prior to therapy;
and
-
The individual does not have a left ventricular ejection fraction (LVEF) less than 45% or New York Heart Association (NYHA) functional classification greater than Class 1;
and
-
The individual does not have forced expiratory volume in one second (FEV1) of less than or equal to 60%;
and
-
The individual does not have a clinically significant active systemic infection;
and
-
The individual is deemed eligible for IL-2 (aldesleukin) therapy (refer to manufacturer's prescribing label for more information);
and
-
The individual will not receive concomitant prophylactic systemic corticosteroid therapy;
and
-
The individual has a diagnosis of unresectable or metastatic melanoma;
and
-
The individual does not have uveal melanoma;
and
-
Lifileucel (Amtagvi) will be used as subsequent therapy after the following:
-
Programmed cell death protein-1 (PD-1) blocking antibody;
and
- If BRAF V600 mutation-positive, a BRAF inhibitor with or without a MEK inhibitor.
Length of approval: One (1) treatment course (one (1) dose) and may not be renewed.
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
