Last Review Date: 02/04/2025

Date of Origin: 04/04/2024

Dates Reviewed: 04/2024, 07/2024, 10/2024, 01/2025, 02/2025

1. Length of Authorization ^Δ

Coverage will be provided for 6 months and may be renewed.

2. Dosing Limits

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

• 200 billable units every 3 weeks

3. Initial Approval Criteria ¹

Coverage is provided in the following conditions:

• Patient is at least 18 years of age; AND

Universal Criteria

• Patient has not received previous therapy with a programmed death (PD-1/PD-L1)-directed therapy, unless otherwise specified ^Δ; AND

Esophageal Squamous Cell Carcinoma (ESCC) † Ф ^1-3

• Used as single-agent therapy; AND
• Patient is not a surgical candidate or has unresectable locally advanced, recurrent, or metastatic disease; AND
• Used as second-line therapy after disease progression on initial chemotherapy

Gastric and Gastroesophageal Junction Cancers † ¹

• Used in combination with a fluoropyrimidine- and platinum-containing chemotherapy-based regimen; AND
• Patient has unresectable or metastatic adenocarcinoma; AND
• Used as first-line therapy; AND

• Patient has human epidermal growth factor receptor 2 (HER2)-negative disease; AND
• Tumor expresses PD-L1 (CPS ≥1) as determined by an FDA-approved or CLIA-compliant testv

Hepatocellular Carcinoma ‡ ³

• Used as single-agent therapy; AND

• Used as first-line systemic therapy; AND
  • Patient has liver-confined, unresectable disease and are deemed ineligible for transplant; OR
  • Patient has extrahepatic/metastatic disease and are deemed ineligible for resection, transplant, or locoregional therapy

Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma ‡ ^3,5

• Used in combination with zanubrutinib for histologic (Richter) transformation to diffuse large B-cell lymphoma; AND
  • Patient has del(17p)/TP53 mutation; OR
  • Patient is chemotherapy refractory or unable to receive chemoimmunotherapy

Head and Neck Cancers ‡ ^3,6

• Patient has Cancer of the Nasopharynx; AND
  • Used as subsequent therapy; AND
  • Used in combination with cisplatin and gemcitabine for oligometastatic or metastatic disease; OR

• Patient has Very Advanced Head and Neck Cancer*; AND
  • • Patient has nasopharyngeal cancer; AND
  • Patient has a performance status 0-1; AND
  • Used as subsequent therapy in combination with cisplatin and gemcitabine; AND  
    • Used for one of the following:

• Unresectable locoregional recurrence with prior radiation therapy (RT)
• Unresectable second primary with prior RT
• Unresectable persistent disease with prior RT
• Recurrent/persistent disease with distant metastases

* Very Advanced Head and Neck Cancer includes: Newly diagnosed locally advanced T4b (M0) disease; newly diagnosed unresectable regional nodal disease (typically N3); metastatic disease at initial presentation (M1); or recurrent or persistent disease.

Small Bowel Adenocarcinoma ‡ ^3,7

• Used as single agent treatment; AND
• Patient has microsatellite instability-high (MSI-H)/deficient mismatch repair (dMMR) disease OR polymerase epsilon/delta [POLE/POLD1] mutation with ultra-hypermutated phenotype [e.g., tumor mutational burden (TMB) > 50 mut/Mb] as determined by an FDA-approved or CLIA-compliant testv; AND
  • Patient has advanced or metastatic disease; OR
  • Patient has locally unresectable or medically inoperable disease; AND
    • Used as primary treatment

Anal Carcinoma ‡ ^3,8

• Patient has metastatic squamous cell carcinoma; AND
• Used as a single agent as subsequent therapy

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

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

4. Renewal Criteria ^{Δ 1,3}

Coverage may be renewed based upon the following criteria:

• Patient continues to meet the universal and other indication-specific relevant criteria identified in section III; AND
• Disease response with treatment as defined by stabilization of disease or decrease in size of tumor or tumor spread; AND
• Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include: severe or life-threatening infusion-related reactions, severe immune-mediated adverse reactions (e.g., pneumonitis, hepatitis, colitis, endocrinopathies, nephritis with renal dysfunction, dermatologic adverse reactions/rash, etc.), complications of allogeneic hematopoietic stem cell transplantation (HCST), etc.

5. Dosage/Administration ^{Δ 1,4,7-10}

6. Billing Code/Availability Information

HCPCS Code:

• J9329 – Injection, tislelizumab-jsgr, 1 mg; 1 billable unit = 1 mg

NDC:

• Tevimbra 100 mg/10 mL single-dose vial: 72579-0121-xx

7. References

1. Tevimbra [package insert]. San Mateo, CA; BeiGene USA, Inc.; December 2024. Accessed January 2025.
2. Shen L, Kato K, Kim SB, et al; RATIONALE-302 Investigators. Tislelizumab Versus Chemotherapy as Second-Line Treatment for Advanced or Metastatic Esophageal Squamous Cell Carcinoma (RATIONALE-302): A Randomized Phase III Study. J Clin Oncol. 2022 Sep 10;40(26):3065-3076. Doi: 10.1200/JCO.21.01926. Epub 2022 Apr 20. Erratum In: J Clin Oncol. 2024 Feb 1;42(4):486.
3. Referenced with permission from the NCCN Drugs and Biologics Compendium (NCCN Compendium^®) tislelizumab. 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 November 2024.
4. Qin S, Kudo M, Meyer T, et al. Tislelizumab vs Sorafenib as First-Line Treatment for Unresectable Hepatocellular Carcinoma: A Phase 3 Randomized Clinical Trial. JAMA Oncol. 2023 Dec 1;9(12):1651-1659. doi: 10.1001/jamaoncol.2023.4003.
5. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines^®) Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma, Version 1.2025. National Comprehensive Cancer Network, 2024. 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 December 2024.
6. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines^®) Head and Neck Cancers, Version 1.2025. National Comprehensive Cancer Network, 2024. 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 December 2024.
7. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines^®) Small Bowel Adenocarcinoma, Version 1.2025. National Comprehensive Cancer Network, 2024. 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 December 2024.
8. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines^®) Anal Carcinoma, Version 1.2025. National Comprehensive Cancer Network, 2024. 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 December 2024.
9. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for CISplatin/Gemcitabine + Tislelizumab-jsgr: Cancer of the Nasopharynx Order Template, HDN147. National Comprehensive Cancer Network, 2024. 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 December 2024.
10. Al-Sawaf O, Ligtvoet R, Robrecht S, et al. Tislelizumab plus zanubrutinib for Richter transformation: the phase 2 RT1 trial. Nat Med 2024;30:240-248.
11. Qiu MZ, Oh DY, Kato K, et al.; Tislelizumab plus chemotherapy versus placebo plus chemotherapy as first line treatment for advanced gastric or gastro-oesophageal junction adenocarcinoma: RATIONALE-305 randomised, double blind, phase 3 trial. BMJ. 2024 May 28;385:e078876.

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