Last Review Date: 10/02/2025

Date of Origin: 03/05/2024

Dates Reviewed: 03/2024, 10/2025

1. Length of Authorization

• Initial: Prior authorization validity will be provided initially for one treatment course (1 dose).
• Renewal: Prior authorization validity may NOT be renewed.

2. Dosing Limits

Max Units (per dose and over time) [HCPCS Unit]:

• A single dose of Amtagvi containing a maximum of 72 x 10⁹ of viable cells suspended in one or more patient-specific infusion bags

3. Initial Approval Criteria ¹

Prior authorization validity is provided for the following conditions:

• Patient is at least 18 years of age; AND
• Patient does not have uncontrolled brain metastases; AND
• Patient does not have signs and symptoms of acute renal failure prior to treatment; AND
• Patient does not have hemorrhage (grade 2 or higher) within 14 days prior to therapy; AND
• 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; AND
• Patient does not have forced expiratory volume in one second (FEV1) of less than or equal to 60%; AND
• Patient does not have a clinically significant active systemic infection; AND
• Patient is deemed eligible for IL-2 (aldesleukin) therapy; AND
• Patient will not receive concomitant prophylactic systemic corticosteroid therapy; AND

Cutaneous Melanoma † ‡ Ф ^1-5

• Patient has a diagnosis of unresectable or metastatic* melanoma; AND
• Patient does not have uveal melanoma; AND
• 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

*Metastatic disease includes stage III unresectable/borderline resectable disease with clinically positive node(s) or clinical satellite/in-transit metastases, or as well as unresectable/borderline resectable local satellite/in-transit recurrence, unresectable nodal recurrence, and widely disseminated distant metastatic disease.

† FDA Approved Indication(s); ‡ Compendia Recommended Indication(s); Ф Orphan Drug

4. Renewal Criteria

 Duration of authorization has not been exceeded (refer to Section I).

5. Dosage/Administration

6. Billing Code/Availability Information

HCPCS Code(s):

• J9999 – Not otherwise classified, antineoplastic drug
• C9399 – Unclassified drugs or biologics

NDC(s):

• Amtagvi contains 7.5 x 10⁹ to 72 x 10⁹ viable cells suspended in 1 to 4 patient-specific infusion bag(s): 73776-0001-xx

7. References

1. Amtagvi [package insert]. Philadelphia, PA; Iovance Biotherapeutics Manufacturing, LLC; February 2024. Accessed September 2025.
2. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) lifileucel. National Comprehensive Cancer Network, 2025. The NCCN Compendium® is a derivative work of the NCCN Guidelines®. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the Compendium, go online to NCCN.org. Accessed August 2025.

3. Referenced with permission from the NCCN Clinical Practice Guidelines (NCCN Guidelines®) Melanoma: Cutaneous. Version 2.2025. National Comprehensive Cancer Network, 2025. The NCCN Compendium® is a derivative work of the NCCN Guidelines®. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the Guidelines, go online to NCCN.org. Accessed August 2025.
4. ClinicalTrials.gov. A Phase 2, Multicenter Study to Assess the Efficacy and Safety of Autologous Tumor Infiltrating Lymphocytes (LN-144) for Treatment of Patients With Metastatic Melanoma. https://clinicaltrials.gov/study/NCT02360579?intr=NCT02360579&rank=1.
5. Sarnaik A, Khushalani NI, Chesney JA, et al. Safety and efficacy of cryopreserved autologous tumor infiltrating lymphocyte therapy (LN-144, lifileucel) in advanced metastatic melanoma patients who progressed on multiple prior therapies including anti-PD-1. Journal of Clinical Oncology 2019 37:15_suppl, 2518-2518

Appendix A – Non-Quantitative Treatment Limitations (NQTL) Factor Checklist

Non-quantitative treatment limitations (NQTLs) refer to the methods, guidelines, standards of evidence, or other conditions that can restrict how long or to what extent benefits are provided under a health plan. These may include things like utilization review or prior authorization. The utilization management NQTL applies comparably, and not more stringently, to mental health/substance use disorder (MH/SUD) Medical Benefit Prescription Drugs and medical/surgical (M/S) Medical Benefit Prescription Drugs. The table below lists the factors that were considered in designing and applying prior authorization to this drug/drug group, and a summary of the conclusions that Prime’s assessment led to for each.

Appendix 1 – Covered Diagnosis Codes

Appendix 2 – Centers for Medicare and Medicaid Services (CMS)

The preceding information is intended for non-Medicare coverage determinations. Medicare coverage for outpatient (Part B) drugs is outlined in the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, §50 Drugs and Biologicals. In addition, National Coverage Determinations (NCDs) and/or Local Coverage Determinations (LCDs) may exist and compliance with these policies is required where applicable. Local Coverage Articles (LCAs) may also exist for claims payment purposes or to clarify benefit eligibility under Part B for drugs which may be self-administered. The following link may be used to search for NCD, LCD, or LCA documents: https://www.cms.gov/medicare-coverage-database/search.aspx. Additional indications, including any preceding information, may be applied at the discretion of the health plan.

Medicare Part B Covered Diagnosis Codes (applicable to existing NCD/LCD/LCA): N/A