Last Review Date: 10/03/2024

Date of Origin: 12/01/2022

Dates Reviewed: 12/2022, 03/2023, 06/2023, 12/2023, 03/2024, 07/2024, 10/2024

1. Length of Authorization ^{∆ 1,7,8}

• Gastric, Esophageal, and Esophagogastric Junction Cancers: Coverage will be provided for one (1) dose only and may NOT be renewed.

• Hepatocellular Carcinoma (HCC): Coverage will be provided for one (1) dose only and may NOT be renewed.
• Non-Small Cell Lung Cancer (NSCLC): Coverage will be provided for up to a maximum of 16 weeks of therapy (5 doses) and may NOT be renewed.

2. Dosing Limits

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

• Imjudo 25 mg/1.25 mL (20 mg/mL) solution for injection: 3 vials every 21 days x 4 doses, then 3 vials on day 112
• Imjudo 300 mg/15 mL (20 mg/mL) solution for injection: 1 vial once

2. Max Units (per dose and over time) [HCPCS Unit]:
   • HCC, Gastric Cancer, and Esophageal and Esophagogastric Junction Cancers: 300 billable units (300 mg) one time only
   • NSCLC: 75 billable units (75 mg) every 21 days x 4 doses, followed by 75 billable units (75 mg) x 1 dose on day 112

3. Initial Approval Criteria ¹

Coverage is provided under the following conditions:

• Patient is at least 18 years of age; AND

Hepatocellular Carcinoma (HCC) † ‡ Ф ^1-5

• Used as first-line therapy in combination with durvalumab; AND
  • Patient has unresectable disease †; OR
  • Patient has extrahepatic/metastatic disease and is deemed ineligible for resection, transplant, or locoregional therapy

Non-Small Cell Lung Cancer (NSCLC) † ‡ ^1,2,6,9

• Patient has recurrent, advanced, or metastatic disease (excluding locoregional recurrence or symptomatic local disease without evidence of disseminated disease) or mediastinal lymph node recurrence with prior radiation therapy; AND
  • Used as first-line therapy; AND
    • • Used for one of the following:
        • • Patients with tumors that are negative for actionable molecular biomarkers*¥ and PD-L1 ≥ 1% to 49%
          • Patients with a performance status (PS) of 0-1 who have tumors that are negative for actionable molecular biomarkers*¥ and PD-L1 < 1%
          • Patients with PS of 0-1 who are positive for one of the following molecular biomarkers: EGFR exon 20, BRAF V600E, NTRK1/2/3 gene fusion, MET exon 14 skipping, RET rearrangement, or ERBB2 (HER2); AND
        • Used in combination with durvalumab, albumin-bound paclitaxel, and carboplatin; OR
        • Used in combination with durvalumab, pemetrexed, and either carboplatin or cisplatin for nonsquamous cell histology; OR
        • Used in combination with durvalumab, gemcitabine, and either carboplatin or cisplatin for squamous cell histology; OR
  • Used as subsequent therapy; AND
    • • Used for one of the following:
        • • Patients with PS of 0-1 who are positive for one of the following molecular biomarkers: BRAF V600E, NTRK1/2/3 gene fusion, MET exon 14 skipping, or RET rearrangement
          • Patients with PS of 0-1 who are positive for one of the following molecular biomarkers AND received prior targeted therapy§: EGFR exon 19 deletion or exon 21 L858R tumors, EGFR S768I, L861Q, and/or G719X mutation, ALK rearrangement, or ROS1 rearrangement; AND
        • Used in combination with durvalumab, albumin-bound paclitaxel, and carboplatin; OR
        • Used in combination with durvalumab, pemetrexed, and either carboplatin or cisplatin for nonsquamous cell histology; OR
        • Used in combination with durvalumab, gemcitabine, and either carboplatin or cisplatin for squamous cell histology

Esophageal and Esophagogastric Junction Cancers ‡ ^2,7

• Used as neoadjuvant therapy in combination with durvalumab; AND
• Patient has microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) disease as determined by an FDA-approved or CLIA-compliant testv; AND
• Patient has adenocarcinoma; AND
• Used as primary treatment for patients who are medically fit for surgery with cT2, N0 (high-risk lesions: lymphovascular invasion, ≥ 3 cm, poorly differentiated), cT1b-cT2, N+ or cT3-cT4a, Any N disease

Gastric Cancer ‡ ^2,8

• Used as neoadjuvant therapy in combination with durvalumab; AND
• Patient has microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) disease as determined by an FDA-approved or CLIA-compliant testv; AND
• Patient has adenocarcinoma; AND
• Used as primary treatment for potentially resectable locoregional disease (cT2 or higher, any N) in patients who are medically fit for surgery

v If confirmed using an FDA approved assay – http://www.fda.gov/CompanionDiagnostic

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

4. Renewal Criteria ^{∆ 1,7,8}

• Coverage may NOT be renewed.

5. Dosage/Administration ^{∆ 1,7,8}

6. Billing Code/Availability Information

HCPCS Code:

• J9347 – Injection, tremelimumab-actl, 1 mg; 1 billable unit = 1 mg

NDC(s):

• Imjudo 25 mg/1.25 mL solution for injection (single-dose vial): 00310-4505-xx
• Imjudo 300 mg/15 mL solution for injection (single-dose vial): 00310-4535-xx

7. References

1. Imjudo [package insert]. Wilmington, DE; AstraZeneca Pharm.; July 2024. Accessed August 2024.
2. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) tremelimumab. 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 August 2024.
3. Abou-Alfa GK, Lam Chan S, Furuse J, et al. A randomized, multicenter phase 3 study of durvalumab (D) and tremelimumab (T) as first-line treatment in patients with unresectable hepatocellular carcinoma (HCC): HIMALAYA study. Journal of Clinical Oncology 36, no. 15_suppl. DOI: 10.1200/JCO.2018.36.15_suppl.TPS4144
4. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium^®) Hepatocellular Carcinoma. Version 2.2024. 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 Compendium, go online to NCCN.org. Accessed August 2024.
5. Llovet JM, Bru C, Bruix J. Prognosis of hepatocellular carcinoma: the BCLC staging classification. Semin Liver Dis. 1999;19:329–38.
6. Johnson ML, Cho BC, Luft A, et al; POSEIDON investigators. Durvalumab With or Without Tremelimumab in Combination With Chemotherapy as First-Line Therapy for Metastatic Non-Small-Cell Lung Cancer: The Phase III POSEIDON Study. J Clin Oncol. 2022 Nov 3:JCO2200975. doi: 10.1200/JCO.22.00975.
7. Referenced with permission from the NCCN Clinical Practice Guidelines (NCCN Guidelines®) Esophageal and Esophagogastric Junction Cancers. Version 4.2024. 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 August 2024.
8. Referenced with permission from the NCCN Clinical Practice Guidelines (NCCN Guidelines®) Gastric Cancer. Version 4.2024. 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 September 2024.
9. Referenced with permission from the NCCN Clinical Practice Guidelines (NCCN Guidelines®) Non-Small Cell Lung Cancer. Version 9.2024. 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 September 2024.

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