Last Review Date: 03/05/2024

Date of Origin: 03/05/2024

Dates Reviewed: 03/2024

1. Length of Authorization

Coverage will be provided for one treatment course (1 dose) and may not be renewed.

2. Dosing Limits

1. Quantity Limit (max daily dose) [NDC Unit]:

• A single dose of Amtagvi containing a minimum of 7.5 x 10⁹ of viable cells suspended in one or more patient-specific infusion bags

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

• A single dose of Amtagvi containing a minimum of 7.5 x 10⁹ of viable cells suspended in one or more patient-specific infusion bags

3. Initial Approval Criteria ¹

Coverage 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 (refer to manufacturer’s prescribing label for more information); 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

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

4. Renewal Criteria

Coverage cannot be renewed.

5. Dosage/Administration

6. Billing Code/Availability Information

HCPCS Code:

• J9999 – Not otherwise classified, antineoplastic drug

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 February 2024.
2. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) lifileucel. National Comprehensive Cancer Network, 2024. 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 February 2024.

3. Referenced with permission from the NCCN Clinical Practice Guidelines (NCCN Guidelines®) Melanoma: Cutaneous. Version 1.2024. National Comprehensive Cancer Network, 2024. 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 February 2024.
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 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