Last Review Date: 10/03/2024

Date of Origin: 04/04/2024

Dates Reviewed: 04/2024, 07/2024, 10/2024

1. Length of Authorization ^{Δ 1}

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

2. Dosing Limits

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

• Tevimbra 100 mg/10 mL single-dose vial: 2 vials per 3 weeks

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

• 200 mg 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 (e.g., nivolumab, pembrolizumab, atezolizumab, avelumab, cemiplimab, dostarlimab, nivolumab/relatlimab, retifanlimab, toripalimab, durvalumab, etc.), unless otherwise specified ^Δ; AND
• Used as single-agent therapy; AND

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

• 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

Hepatocellular Carcinoma ‡ ³

• 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

† 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}

6. Billing Code/Availability Information

HCPCS Code(s):

• J9999 – Not otherwise classified, antineoplastic drugs
• C9399 – Unclassified drugs or biologicals (Hospital Outpatient Use Only)

NDC:

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

7. References

1. Tevimbra [package insert]. San Mateo, CA; BeiGene USA, Inc.; March 2024. Accessed August 2024.
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 August 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.

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