Pharmacy Prior Authorization Criteria

Amtagvi (lifileucel)

Indications for Prior Authorization

Amtagvi (lifileucel)

• For diagnosis of Melanoma
  Indicated for the treatment of adult patients 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

Amtagvi

*Per prescribing information, Amtagvi is for one-time, single dose intravenous use only.

Prior Authorization

Length of Approval: 1 Time Authorization in Lifetime*

• Diagnosis of melanoma
AND
• Patient has an Eastern Cooperative Oncology Group (ECOG) Score of 0 or 1
AND
• Disease is one of the following:
• Unresectable
• Metastatic
AND
• Previous treatment with a programmed cell death protein-1 (PD-1) blocking antibody (e.g., Opdivo, Keytruda)
AND
• If cancer is BRAF V600 mutation positive, one of the following:
• Previous treatment with a BRAF inhibitor alone (e.g., Zelboraf, Tafinlar)
• Previous treatment with combination of a BRAF inhibitor and MEK inhibitor (e.g., Zelboraf/Cotellic, Tafinlar/Mekinist, Braftovi/Mektovi)
AND
• Prescribed by an oncologist at an authorized treatment center [A, 7-8]
AND
• Patient has never received Amtagvi treatment in their lifetime

P & T Revisions

2024-05-20, 2024-04-11

References

1. Amtagvi Prescribing Information. Iovance Biotherapeutics Manufacturing LLC. Philadelphia, PA . February 2024.
2. ClinicalTrials.gov. Study of Lifileucel (LN-144), Autologous Tumor Infiltrating Lymphocytes, in the Treatment of Patients With Metastatic Melanoma (LN-144). Available at: https://www.clinicaltrials.gov/study/NCT02360579?cond=NCT02360579&rank=1. Accessed March 6, 2024.
3. Oli, A., Rowaiye, A., Adejumo, S., et al. Classic and Current Opinions in Human Organ and Tissue Transplantation. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9624478/. Accessed March 7, 2024.
4. Proietti, I., Skroza, N., Michelini, S., et al. BRAF Inhibitors: Molecular Targeting and Imunomodulatory Actions. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7408709/#:~:text=The%20BRAF%20inhibitors%20vemurafenib%2C%20dabrafenib,and%20survival%20of%20melanoma%20cells. Accessed March 7, 2024.
5. Subbiah, V., Baik, C., Kirkwood, J. Clinical Development of BRAF plus MEK Inhibitor Combinations. Available at: https://www.cell.com/trends/cancer/fulltext/S2405-8033%2820%2930164-3. Accessed March 7, 2024.
6. Chesney, J., Lewis, K., Kluger, H., et al. Efficacy and safety of lifileucel, a one-time autologous tumor-infiltrating lymphocyte (TIL) cell therapy, in patients with advanced melanoma after progression on immune checkpoint inhibitors and targeted therapies: pooled analysis of consecutive cohorts of the C-144-01 study. Available at: https://jitc.bmj.com/content/jitc/10/12/e005755.full.pdf. Accessed March 7, 2024.
7. IPD Analytics - Amtagvi (lifileucel). Available at: file:///C:/Users/kdekhtaw/Downloads/IPD%20Analytics_RxInsights_New%20Drug%20Review_Amtagvi_02%202024%20(1).pdf. Accessed March 7, 2024.
8. Amtagvi.com. Available at https://amtagvi.com. Accessed March 7, 2024.
9. UptoDate. Eastern Cooperative Oncology Group (ECOG) performance status. Available at: https://www.uptodate.com/contents/image?imageKey=HEME%2F72901. Accessed March 11, 2024.
10. Eastern Cooperative Oncology Group (ECOG) performance status. Available at: https://www.mdcalc.com/calc/3170/eastern-cooperative-oncology-group-ecog-performance-status. Accessed March 11, 2024.
11. Azam, F., Latif, M., Farooq, A., et al. Performance Status Assessment by Using ECOG (Eastern Cooperative Oncology Group) Score for Cancer Patients by Oncology Healthcare Professionals. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6792426/. Accessed March 11, 2024.
12. Clinical Consult April 11, 2024 with an oncologist.

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End Notes

1. Amtagvi (lifileucel) is a tumor - derived autologous T cell immunotherapy comprised of a suspension of tumor-derived T-cells for intravenous infusion. It is indicated for the treatment of advanced melanoma in patients who have failed prior initial therapies. The manufacturing process for Amtagvi involves the removal of the tumor to obtain a sample for the amplification of TILs (tumor-infiltrating lymphocytes) cells in a culture . It typically takes about 34 days from the moment the manufacturing center receives tumor tissue until Amtagvi is prepared for shipment back to the healthcare provider. Before administration of Amtagvi, the patient undergoes non-myeloablative lymphodepletion (chemotherapy) regimen consisting of cyclophosphamide, mesna, and fludarabine. Following lymphodepletion, Amtagvi is administered as a one-time infusion, followed by up to six doses of intravenous IL-2 (aldesleukin), to support cell expansion in vivo.. It is estimated that patients receiving Amtagvi will be hospitalized for at least 3 days to complete the Amtagvi and IL-2 administration. Amtagvi will be administered at authorized treatment centers (ATCs), primarily in dense urban areas throughout the United States. These are centers selected based on patient volume, NCCN status, relationships with key opinion leaders, experience with existing cell therapy/bone marrow transplant, inpatient capacity, and whether they were involved in the Amtagvi clinical trials. Iovance foresees the initiation of Amtagvi administration in at least 30 ATCs at launch, aiming to increase this figure to 50 centers by the end of May. The ATCs already have a backlog of patients waiting for the commencement of Amtagvi manufacturing. Since receiving approval, Iovance has indicated that there are at least 20 Amtagvi patients currently undergoing the process, with 10 of them already enrolled in IovanceCares and having manufacturing slots either scheduled or pending [1, 7]
2. Eastern Cooperative Oncology Group (ECOG) performance status is the assessment of the patient’s level of function and capability of self-care. It determines ability of patient to tolerate therapies in serious illness (e.g., chemotherapy): 0 = Fully active; no performance restrictions; 1 = Strenuous physical activity restricted; fully ambulatory and able to carry out light work; 2 = Capable of all self-care but unable to carry out any work activities. Up and about >50% of waking hours; 3 = Capable of only limited self-care; confined to bed or chair >50% of waking hours; 4 = Completely disabled; cannot carry out any self-care; totally confined to bed or chair. [9 - 11]

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Revision History

• 2024-05-20: update guideline
• 2024-04-11: New UM PA criteria

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