Lifileucel (Amtagvi™)

Restricted Product(s):

• Lifileucel (Amtagvi™) intravenous infusion for administration by a healthcare professional 

FDA Approved Use:

• For treatment of adults with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor.

Criteria for Medical Necessity:

The restricted product(s) may be considered medically necessary when the following criteria are met:

1. The patient is 18 years of age or older; AND 
2. The patient has a diagnosis of unresectable or metastatic melanoma [medical record documentation required]; AND 
3. The patient has not previously received genetically modified T cell therapy or lifileucel (Amtagvi) [medical record documentation required]; AND 
4. Patient does not have uncontrolled brain metastases; [medical record documentation required]; AND 
5. The patient has experienced disease progression following a trial of one or more lines of systemic therapy including a programmed cell death protein-1 (PD-1) blocking antibody; and if proto-oncogene B-Raf (BRAF) V600 mutation-positive, a BRAF inhibitor or BRAF inhibitor in combination with mitogen-activated extracellular signal-regulated kinase MEK) inhibitor [medical record documentation required]; AND 
6. The patient has received or will receive a lymphodepleting chemotherapy regimen of cyclophosphamide 60mg/kg intravenously daily with mesna for 2 days followed by fludarabine 25 mg/m2 /day intravenously daily for 5 days before infusion of lifileucel (Amtagvi) [medical record documentation required]; AND 
7. The patient is deemed eligible for IL-2 (aldesleukin) therapy [medical record documentation required]; AND 
8. The patient will NOT be treated with more than 72 x 109 viable T cells [documentation of planned dosage required]; AND 
9. The patient does not have melanoma of uveal/ocular origin [medical record documentation required]; AND 
10. The patient does not have signs and symptoms of acute renal failure prior to treatment [medical record documentation required]; AND 
11. The patient does not have hemorrhage (grade 2 or higher) within 14 days prior to therapy [medical record documentation required]; AND 
12. The patient does not have a left ventricular ejection fraction (LVEF) less than 45% or New York Heart Association (NYHA) functional classification greater than Class 1 [medical record documentation required]; AND 
13. The patient does not have forced expiratory volume in one second (FEV1) of less than or equal to 60% [medical record documentation required]; AND
14. . The patient does not have a clinically significant active systemic infection [medical record documentation required]; AND 
15. The patient will not receive concomitant prophylactic systemic corticosteroid therapy [medical record documentation required]; AND
16. The requested quantity does NOT exceed the maximum units allowed for the duration of approval (see table below) 

Duration of Approval: 180 days (one treatment course per lifetime)

References

all information referenced is from FDA package insert unless otherwise noted below.

Policy Implementation/Update Information

Criteria and treatment protocols are reviewed annually by the Blue Cross NC P&T Committee, regardless of change. This policy is reviewed in Q3 annually.

May 2024: Original medical policy criteria issued.