ModifiedmhnPolicy CP.PHAR.687

Clinical Policy: Tislelizumab-jsgr (Tevimbra)

Policy governs medical necessity and prior authorization criteria for tislelizumab-jsgr (Tevimbra) for adults with specified esophageal, gastric/GEJ, and NCCN-recommended oncology indications across Commercial, HIM, and Medicaid lines of business.

Policy Summary

Payermhn

PolicyClinical Policy: Tislelizumab-jsgr (Tevimbra)

Policy CodePolicy CP.PHAR.687

Change TypeMaterial clinical and coding updates — new HCPCS codeadded indications and clarified line-of-therapy placement

Effective Date09.01.24

Next Review Date

Key ActionSubmit prior authorization with clinical documentation and use HCPCS J9329 for billing; include supporting records such as PD-L1 status and line-of-therapy information.

SourceLink

POLICY UPDATE CHANGES

Added HCPCS code J9329 and removed HCPCS codes J3590 and C9399.

Updated criteria to include new indication for gastric/GEJ and first-line ESCC in combination with platinum chemotherapy for PD-L1 ≥1, and added various NCCN off-label indications (anal carcinoma, CLL/SLL with Richter transformation, head and neck cancers, HCC, small bowel adenocarcinoma, colorectal cancer).

Added HCPCS code J9329 and removed HCPCS codes J3590 and C9399.

Updated criteria to include new indication for gastroesophageal (G/GEJ) cancers and first-line ESCC treatment in combination with platinum-containing chemotherapy for tumors expressing PD-L1 ≥1.

Added off-label indications supported by NCCN including anal carcinoma, CLL/SLL with Richter transformation to diffuse large B-cell lymphoma, head and neck cancers, HCC, small bowel adenocarcinoma, and colorectal cancer.

For HCC clarified criterion as first-line systemic therapy and added option for subsequent-line systemic therapy.

200 mg Q3W

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Coverage Criteria

Initial Therapy — Gastric, Esophageal, or Gastroesophageal Junction Cancer (Initial Approval)

Covered when ALL of the following are met for Gastric, Esophageal, or Gastroesophageal Junction Cancer (Initial Approval):

Gastric/Esophageal/GEJ initial: 1. Diagnosis of ESCC or G/GEJ; 2. Prescribed by or in consultation with an oncologist; 3. Age ≥ 18 years; 4. For ESCC, one of the following: (a) disease is unresectable, locally advanced, recurrent, or metastatic; OR (b) member is planned for esophagectomy; 5. For ESCC, one of the following: (a) Prescribed as a single agent AND both: (i) prior treatment with a fluoropyrimidine- and platinum-based chemotherapy, AND (ii) prior systemic chemotherapy did NOT include a PD-1 or PD-(L)1 inhibitor; OR (b) Prescribed in combination with platinum-containing chemotherapy AND both: (i) request is for first-line treatment or member is planned for esophagectomy, AND (ii) tumor is PD-L1 positive; 6. For G/GEJ, all of the following: (a) disease is unresectable, locally advanced, recurrent, or metastatic; (b) disease is HER2-negative; (c) tumor is PD-L1 positive; (d) request is for first-line treatment; (e) Tevimbra is prescribed in combination with both fluoropyrimidine-containing and platinum-containing chemotherapy; 7. Request meets one of the following: (a) dose does not exceed 200 mg IV every 3 weeks; OR (b) dose is supported by practice guidelines or peer-reviewed literature for the indication (prescriber must submit supporting evidence).

Approval duration: 6 months.

NCCN Recommended Uses (Off-label)

Covered when ALL of the following are met for NCCN recommended off-label uses:

NCCN off-label uses: 1. Tevimbra is prescribed as one of the following: (a) as a single agent for one of: locally recurrent/progressive/metastatic anal carcinoma; dMMR/MSI-H or POLE/POLD1 mutation-positive small bowel adenocarcinoma or colorectal cancer; hepatocellular carcinoma (HCC); or head and neck cancers prescribed as subsequent-line therapy; (b) in combination with cisplatin and gemcitabine as first-line or subsequent therapy for head and neck cancers; (c) in combination with zanubrutinib for CLL/SLL with histologic (Richter) transformation to diffuse B-cell lymphoma (prior authorization for zanubrutinib may be required); 2. Prescribed by or in consultation with an oncologist; 3. Age ≥ 18 years; 4. For HCC, one of: (a) prescribed as first-line systemic therapy for either (i) liver-confined unresectable disease deemed ineligible for transplant, OR (ii) extrahepatic/metastatic disease deemed ineligible for resection/transplant/locoregional therapy; OR (b) prescribed as subsequent-line systemic therapy; 5. For CLL/SLL with Richter transformation, one of: (a) presence of del(17p)/TP53 mutation; (b) chemotherapy refractory; (c) unable to receive chemoimmunotherapy; 6. Dose is within the FDA maximum for any FDA-approved indication or is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).

Prescribed regimen must be FDA-approved or recommended by NCCN. Approval duration: 6 months.

Continuation Therapy

Covered when ALL of the following are met for Continuation/Repeat Authorization:

Continuation therapy: 1. Member is currently receiving medication via the benefit, or documentation supports member has received Tevimbra for at least 30 days; 2. Member is responding positively to therapy; 3. If request is for a dose increase, one of: (a) new dose does not exceed 200 mg IV every 3 weeks; OR (b) new dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).

Approval duration: 12 months.

Updated Indications and Placement

Policy updated to add indications and clarify line-of-therapy placement; coverage subject to meeting the detailed criteria in the main policy.

New and revised indications: Includes new indication for G/GEJ cancers; first-line ESCC in combination with platinum-containing chemotherapy for tumors with PD-L1 ≥ 1; added NCCN-supported off-label indications including anal carcinoma, CLL/SLL with Richter transformation to DLBCL, head and neck cancers, HCC, small bowel adenocarcinoma, and colorectal cancer.

See Appendix B and policy criteria for full requirements.

HCC Line of Therapy

Hepatocellular carcinoma (HCC) placement

HCC therapy line: HCC clarified as an indication that can be prescribed as first-line systemic therapy for liver-confined unresectable disease (ineligible for transplant) or extrahepatic/metastatic disease (ineligible for resection/transplant/locoregional therapy), with an added option for subsequent-line systemic therapy per 3Q 2025 annual review.

Appendix B and references updated; prescriber should provide documentation supporting line of therapy.

Requests for use of tislelizumab-jsgr (Tevimbra) for non–FDA approved indications that are not explicitly addressed in this policy will not be authorized unless the provider supplies sufficient documentation of efficacy and safety consistent with the plan's off‑label use policies. Refer to off‑label use policies: CP.CPA.09 (Commercial), HIM.PA.154 (Health Insurance Marketplace), and CP.PMN.53 (Medicaid) for the standards required to support off‑label authorization.

This policy was updated to reflect new indications and coding changes; providers should ensure requests meet the current clinical criteria and use the updated HCPCS code for billing. Documentation supporting the specific indication and line of therapy should be submitted with prior authorization requests.

For requests that fall outside the indications listed in this policy, the provider must submit clinical documentation (e.g., office chart notes, pertinent lab/pathology results, imaging, and any guideline or peer‑reviewed literature) demonstrating that the proposed off‑label use meets the efficacy and safety standards described in the referenced off‑label policies. Without such documentation, coverage will not be authorized.

The criteria set for tislelizumab-jsgr has been revised to add gastroesophageal junction and gastric cancer indications and to clarify placement of first‑line and subsequent‑line therapy for select disease states. Providers should follow the updated criteria and Appendix B for indication‑specific requirements when submitting authorization requests.

Coding

Covered HCPCSHCPCSCovered

J9329

Injection, tislelizumab-jsgr, 1 mg

Removed HCPCSHCPCS

J3590	Unclassified biologics (removed)
C9399	Unclassified drugs or biologics (removed)

HCPCS code changesHCPCS

J9329	Added HCPCS code for tislelizumab-jsgr
J3590	Removed HCPCS code (previous miscellaneous J-code)
C9399	Removed HCPCS code

inv-13: Maximum dose — FDA maximum dosing (200 mg Q3W)

Maximum doseDoes not exceed 200 mg IV every 3 weeks (200 mg on Day 1 of every 3-week cycle).

Alternative dosing supportDose above 200 mg only if supported by practice guidelines or peer-reviewed literature (prescriber must submit supporting evidence).

Dose check at renewalContinuation requests that increase dose must still not exceed 200 mg Q3W unless supported by literature/guidelines (documentation required).

inv-14: PD-L1 expression — PD-L1 threshold referenced for ESCC

PD-L1 threshold for ESCC first-line combinationTumor PD-L1 expression ≥ 1 (PD-L1 ≥1) required for first-line Tevimbra in combination with platinum-containing chemotherapy for ESCC.

Provider Actions & Billing

Prior Authorization

Prior Authorization & Coding

Prior authorization is required. Providers must obtain PA before dispensing or administering tislelizumab (Tevimbra). Use HCPCS code J9329 for billing (Injection, tislelizumab-jsgr, 1 mg). Claims submitted with previously used or removed codes J3590 or C9399 may be denied; update billing to J9329 to avoid coding-based denials.

Prior authorization required prior to service
Bill using HCPCS J9329; do not bill J3590 or C9399

Documentation Required

Supportive Documentation Required

Providers must submit supportive clinical documentation demonstrating the member meets the approval criteria. Acceptable documentation includes office/chart notes, relevant laboratory results, pathology reports, PD-L1 status when required by the indication, prior treatment history (line-of-therapy), and imaging or surgical plans (e.g., planned esophagectomy when applicable).

Include PD-L1 status when indication-specific criteria require PD-L1 ≥ 1%

Background

Tislelizumab-jsgr is a programmed cell death protein‑1 (PD‑1) blocking monoclonal antibody. It is indicated in specified adult patients with unresectable, locally advanced, recurrent, or metastatic esophageal squamous cell carcinoma (ESCC) and for certain gastric/gastroesophageal junction (G/GEJ) adenocarcinomas when the tumor meets biomarker and other criteria in this policy. The agent is also included for several NCCN‑recommended off‑label oncology uses described in the policy. Clinical requirements include tumor biomarker status (for example, PD‑L1 tumor expression ≥ 1 where specified), HER2 status for G/GEJ, prior chemotherapy exposure rules, and age ≥ 18 years; dosing follows the FDA‑referenced regimen (commonly 200 mg IV every 3 weeks) unless an alternative is supported by guidelines or literature.

Definitions

inv-24: ESCC — definition entry for esophageal squamous cell carcinoma

TermESCC = esophageal squamous cell carcinoma.

Context in policyIndication includes unresectable, locally advanced, recurrent, or metastatic ESCC and first-line combination therapy when PD-L1 ≥1; single-agent use after prior chemo is also an FDA indication.

Abbreviation sourceDefined in Appendix A (abbreviation/acronym key).

inv-25: G/GEJ — definition entry for gastric or gastroesophageal junction adenocarcinoma

TermG/GEJ = gastric or gastroesophageal junction adenocarcinoma.

Context in policyFDA indication: first-line combination with platinum and fluoropyrimidine chemotherapy for unresectable/metastatic HER2-negative G/GEJ whose tumors express PD-L1 ≥1.

Line of Therapy

first-line | second-line | salvage

First-line ESCC: Tevimbra in combination with platinum-containing chemotherapy for first-line treatment of unresectable or metastatic ESCC whose tumors express PD-L1 ≥ 1; allowed also when member is planned for esophagectomy (bypass option).

First-line G/GEJ: Tevimbra in combination with fluoropyrimidine- and platinum-containing chemotherapy for first-line treatment of unresectable or metastatic HER2-negative G/GEJ whose tumors express PD-L1 ≥ 1.

Subsequent-line ESCC (salvage): Tevimbra as a single agent for adults with unresectable or metastatic ESCC after prior systemic chemotherapy that did not include a PD-(L)1 inhibitor.

first-line | subsequent-line

Biomarker Requirements

inv-30: PD-L1 — tumor PD-L1 expression threshold (>=1) required for certain indications

Required thresholdTumor PD-L1 expression ≥ 1 is required for select indications (first-line combination therapy for ESCC and G/GEJ).

Indications referencing PD-L1ESCC first-line in combination with platinum-containing chemotherapy; G/GEJ first-line in combination with platinum and fluoropyrimidine chemotherapy.

Evidence submissionPD-L1 status must be documented in the prior authorization submission per Appendix B and updated criteria.

inv-31: HER2 — tumor must be HER2-negative for specific indications

RequirementTumor must be HER2-negative for G/GEJ first-line combination therapy with Tevimbra.

Context

Covered Regimens

Regimen	Dosing / administration	Indication / notes
Tislelizumab-jsgr (single agent or in combination)	200 mg IV on Day 1 of every 3-week cycle; dose does not exceed 200 mg IV every 3 weeks (or dose supported by practice guidelines or peer-reviewed literature with submitted evidence)	For FDA-labeled indications for ESCC and G/GEJ: use as single agent or in combination with platinum and/or fluoropyrimidine-containing chemotherapy as specified per indication; approval duration: 6 months

Regimen	Examples (per NCCN)	Coverage conditions / notes
Tislelizumab-jsgr as single agent or in specified combinations	Single agent for locally recurrent/progressive/metastatic anal carcinoma; single agent for dMMR/MSI-H or POLE/POLD1 mutation–positive small bowel adenocarcinoma or colorectal cancer; single agent for hepatocellular carcinoma (HCC); single agent as subsequent-line therapy for head and neck cancers; combination with cisplatin + gemcitabine for head and neck cancers; combination with zanubrutinib for CLL/SLL with Richter transformation	Must be prescribed by or in consultation with an oncologist; age ≥ 18 years; indication-specific criteria apply (e.g., HCC: first-line or subsequent-line systemic therapy as specified); prior authorization may be required for partners such as zanubrutinib; approval duration: 6 months

Regimen	Dosing / administration	Indication / biomarker requirement
Tislelizumab-jsgr plus platinum-containing chemotherapy	Tislelizumab-jsgr 200 mg IV on Day 1 of every 3-week cycle (does not exceed 200 mg IV every 3 weeks); administered in combination with a platinum-containing agent (e.g., cisplatin, oxaliplatin)	First-line treatment for unresectable, locally advanced, recurrent, or metastatic ESCC whose tumors express PD-L1 ≥ 1; also allowed when request is for first-line treatment or member is planned for esophagectomy; approval duration: 6 months

Policy Summary

Payermhn

PolicyClinical Policy: Tislelizumab-jsgr (Tevimbra)

Policy CodePolicy CP.PHAR.687

Change TypeMaterial clinical and coding updates — new HCPCS codeadded indications and clarified line-of-therapy placement

Effective Date09.01.24

Next Review Date

Key ActionSubmit prior authorization with clinical documentation and use HCPCS J9329 for billing; include supporting records such as PD-L1 status and line-of-therapy information.

SourceLink

On This Page

Denial Risk

Non‑Covered / Off‑Label Indication Risk

Non‑FDA approved (off‑label) indications are not authorized unless there is sufficient documentation of efficacy and safety per applicable off‑label use policies. Providers should reference and provide evidence consistent with CP.CPA.09 (commercial), HIM.PA.154 (Marketplace), or CP.PMN.53 (Medicaid) or other evidence of coverage documents when requesting coverage for off‑label uses.

Off‑label use requests must include supporting literature or guideline (e.g., NCCN) evidence and clinical rationale
Specify which off‑label indication is being requested and include detailed documentation of prior therapies and tumor histology