Tislelizumab-jsgr (Tevimbra) coverage
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Defines medical necessity and prior authorization criteria for tislelizumab-jsgr (Tevimbra) for adults with specified malignancies and describes coding implications and approval durations for Health Net lines of business.
Added HCPCS code J9329 and removed HCPCS codes J3590 and C93991.
Updated criteria to include new indication for gastric/gastroesophageal junction adenocarcinoma (G/GEJ) in combination with platinum and fluoropyrimidine-based chemotherapy for PD-L1 positive tumors.
Updated criteria to include first-line ESCC treatment in combination with platinum-containing chemotherapy for PD-L1 positive tumors and added an option for planned esophagectomy as bypass for unresectable disease criterion.
Added HCPCS code J9329 and removed HCPCS codes J3590 and C93991.
Updated criteria to include new indication for G/GEJ and first-line ESCC treatment in combination with platinum-containing chemotherapy for tumors expressing PD-L1; added multiple off-label indications supported by NCCN.
For HCC, clarified criterion as first-line systemic therapy and added option to be prescribed as subsequent-line systemic therapy.
Coverage Criteria
Initial Therapy
Covered when ALL of the following are met for initial therapy:
Combine with disease-specific nodes below.
Off-label/NCCN Recommended Uses
NCCN‑Recommended Off‑label Uses (covered when ALL criteria met):
Prescriber must supply supporting evidence for off‑label uses not FDA‑approved.
Continuation Therapy
Continuation therapy criteria (must meet ALL):
Updated covered indications and line-of-therapy clarifications
Criteria were updated to add labeled and off‑label oncology indications and to clarify line‑of‑therapy designations for specific cancers.
Supported by updated prescribing information and P&T review.
NCCN support required and prescriber must submit supporting evidence for off‑label uses not FDA‑approved.
3Q 2025 annual review update.
Coverage is NOT authorized for non‑FDA approved indications that are not specifically addressed in this policy unless the provider supplies sufficient documentation of efficacy and safety per the applicable off‑label use policies or evidence of coverage documents. See off‑label use policies: CP.CPA.09 (Commercial), HIM.PA.154 (Health Insurance Marketplace), and CP PMN.53 (Medicaid) for required supporting evidence and documentation pathways.
This clinical policy is guidance to assist in medical necessity determinations but is not a contract or guarantee of payment. Coverage decisions and benefit administration remain subject to the terms, conditions, exclusions, and limitations of the member's coverage documents (for example, Evidence of Coverage, Certificate of Coverage, policy or contract). Where state Medicaid provisions conflict with this policy, the state Medicaid manual and requirements take precedence.
Use of tislelizumab‑jsgr (Tevimbra) for indications not listed in this policy and lacking adequate supporting evidence per the referenced off‑label use policies is considered not authorized. Requests for such off‑label uses must follow the applicable off‑label policy requirements and include the evidence and justification specified by those policies.
This policy provides clinical guidance on medical necessity criteria but does not guarantee payment. Providers must follow applicable coverage documents and administrative policies when submitting authorization requests; specific conditions that would render a request not medically necessary or not payable are detailed elsewhere in the member’s formulary, benefit, and administrative documents.
Initial Therapy Criteria
Initial Therapy
Initial coverage rules:
Document prior therapies and absence of prior PD‑(L)1 inhibitor exposure when required.
Initial therapy indications
Initial therapy indications updated to include new labeled uses and NCCN‑supported off‑label uses.
Providers must request authorization using updated HCPCS code J9329 per coding implications.
Continuation Therapy Criteria
Continuation Therapy
Criteria for continued coverage:
Request must include documentation of clinical response and dosing.
HCC continuation therapy
For HCC, continuation/subsequent‑line use was explicitly added as an option.
3Q 2025 annual review; providers should reference updated Appendix B for details.
Coding and Dosing
Provider Actions and Requirements
Prior Authorization Required
Prior authorization is required. Provider must submit documentation that the member meets the policy's initial or continuation criteria (diagnosis, prescriber specialty, prior therapies, PD-L1/HER2 status where applicable) to support medical necessity determinations.
Authorization Criteria Updated — Coding and Indications
Authorization criteria were updated to add labeled and multiple off‑label oncology indications and to reflect updated coding. Providers should use HCPCS J9329 when billing and include supporting clinical documentation for any off‑label requests (dose, regimen, and citation to guideline or peer‑reviewed literature where required).
- Add supporting evidence for off‑label indications per off‑label use policies (CP.CPA.09, HIM.PA.154, CP.PMN.53) and member's evidence of coverage.
- When requesting coverage for newly added indications (e.g., G/GEJ, first‑line ESCC in combination with platinum agents for PD‑L1 positive tumors), include documentation of PD‑L1 status and prior/planned chemotherapy sequencing.
Therapy Sequencing and Required Prior Therapy Documentation
For esophageal squamous cell carcinoma (ESCC) when Tevimbra is prescribed as a single agent after prior chemotherapy, include documentation of prior fluoropyrimidine‑ and platinum‑based chemotherapy and sequencing rationale. If prescribed in combination with platinum‑containing chemotherapy as first‑line therapy, document PD‑L1 tumor status when required by the criteria.
- Document prior systemic chemotherapy agents and dates (e.g., 5‑fluorouracil, capecitabine; cisplatin, oxaliplatin).
- If member is planned for esophagectomy, include surgical plan to meet the bypass option for disease extent criteria.
Required Clinical Documentation
Provider must submit office chart notes, relevant lab results, pathology reports, PD‑L1 and HER2 testing results where applicable, and documentation of prior therapies to demonstrate the member meets all approval criteria.
- Include treatment history (agents, dates, responses), imaging or surgical plans (e.g., planned esophagectomy), and tumor biomarker results (PD‑L1, HER2).
- For continuation requests, document clinical benefit or stability and that member has been on therapy for at least 30 days when applicable.
Insufficient Documentation / Non‑Covered Indications
Failure to provide sufficient documentation that the member meets all approval criteria or requests for non‑FDA approved indications without adequate supporting evidence may result in denial. Follow applicable off‑label use policies and submit guideline or literature support when seeking coverage for off‑label indications.
- Denial risk if documentation of prior therapies, biomarker status, or prescriber specialty is missing.
- Off‑label requests must reference NCCN or peer‑reviewed literature and comply with CP.CPA.09, HIM.PA.154, or CP.PMN.53 as applicable.
Documentation and Coverage Governance
Providers must follow the Health Plan's coverage documents, administrative policies, and the clinical policy as guidance for medical necessity determinations. Coverage decisions remain subject to the member's contract terms, exclusions, and limitations.
- Adhere to applicable plan‑level administrative policies and evidence of coverage when submitting requests.
- This policy is effective as of the listed date and may be subject to legal/regulatory provider notification requirements.
(Provider action placeholder) Include any additional provider‑action text or updates from source documents here as needed.
Step Therapy / Sequencing
| Step | Requirement |
|---|---|
| 1 | Provider documents prior systemic chemotherapy did NOT include a PD-(L)1 inhibitor and member previously received fluoropyrimidine- and platinum-based chemotherapy (e.g., 5‑fluorouracil or capecitabine plus cisplatin or oxaliplatin). |
| 2 | For ESCC when prescribed as a single agent after prior chemotherapy: submit clinical documentation confirming absence of prior PD-(L)1 inhibitor exposure and prior fluoropyrimidine- and platinum-based chemotherapy. |
| 3 | When requested in combination regimens (ESCC or G/GEJ): request must be for first-line treatment or member is planned for esophagectomy (ESCC). Tumor must be PD‑L1 positive for combination use. |
| Step | Updated sequencing / notes |
|---|---|
| 1 | Updated criteria add first-line combination use for ESCC and G/GEJ: Tevimbra in combination with platinum-containing chemotherapy (ESCC) or with both platinum- and fluoropyrimidine-containing chemotherapy (G/GEJ) for PD‑L1 positive tumors. |
| 2 | For ESCC the policy allows a bypass of the 'unresectable' disease requirement when member is planned for esophagectomy; sequencing requirement remains that combination use is first-line. |
| 3 | For hepatocellular carcinoma (HCC) the criterion was clarified to allow first-line systemic therapy and added an option for subsequent-line systemic therapy (see 3Q 2025 update). |
| 4 | Off-label NCCN-supported indications (anal carcinoma, CLL/SLL with Richter transformation, head and neck cancers, small bowel adenocarcinoma, colorectal cancer) were added; off-label requests must meet NCCN-based sequencing and prescriber justification requirements. |
Quantity Limits and Product Info
Definitions
Background
Tislelizumab‑jsgr (brand name Tevimbra) is a PD‑1 blocking monoclonal antibody used in adults for select advanced malignancies. The product is indicated for certain unresectable or metastatic cancers including esophageal squamous cell carcinoma (ESCC) and specific gastric/gastroesophageal junction (G/GEJ) adenocarcinomas when used per the approved regimens and biomarker requirements.
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