ModifiedEmpire BluecrossPolicy CC-0262

Tevimbra (tislelizumab-jsgr) Coverage Criteria

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This policy governs medical-necessity and prior-authorization review for intravenous Tevimbra in adults and specified oncology indications. Coverage is subject to diagnosis, disease characteristics, prior therapy, biomarker results, treatment line, performance status, and combination regimen requirements.

Policy Summary

PayerEmpire Bluecross

PolicyTevimbra (tislelizumab-jsgr) Coverage Criteria

Policy CodePolicy CC-0262

Change TypeModified

Effective DateJune 23, 2026

Last ReviewMay 15, 2026

Next Review DateN/A

Key ActionSubmit Tevimbra requests for prior authorization and demonstrate that the applicable medical-necessity criteria are met.

SourceLink

POLICY UPDATE CHANGES

The policy added NCCN category 2A criteria for Tevimbra with paclitaxel and carboplatin in anal carcinoma, classic Hodgkin lymphoma, and endometrial carcinoma.

The policy clarified that colorectal cancer use requires that the individual has not received prior checkpoint inhibitor therapy.

The policy removed HER2 criteria from the esophageal squamous cell carcinoma criteria and removed ECOG requirements from the gastric and gastroesophageal junction cancer criteria.

The policy added NCCN criteria for appendiceal cancer and separated small bowel adenocarcinoma criteria from colorectal cancer criteria.

The policy clarified first-line combination and subsequent single-agent use for esophageal squamous cell carcinoma and clarified metastatic use for nasopharyngeal cancer.

The policy added or clarified NCCN-supported uses across esophageal squamous cell carcinoma, gastric and gastroesophageal junction cancers, chronic lymphocytic leukemia/small lymphocytic lymphoma, anal carcinoma, colorectal cancer, nasopharyngeal cancer, and hepatocellular carcinoma.

The policy added a gastric cancer indication and an NCCN recommendation for Tevimbra with Brukinsa (zanubrutinib) in chronic lymphocytic leukemia/small lymphocytic lymphoma.

The policy replaced HCPCS J3590 and J9999 with HCPCS J9329 and added or revised esophageal cancer diagnosis coding.

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ModifiedEmpire BluecrossPolicy CC-0262

Tevimbra (tislelizumab-jsgr) Coverage Criteria

Customize your policy alerts

Sign up for Empire Bluecross Policy CC-0262 alerts

Get alerted when Policy CC-0262 changes without checking for updates manually.

Monitor payer policy activity

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Policy Summary

PayerEmpire Bluecross

PolicyTevimbra (tislelizumab-jsgr) Coverage Criteria

Policy CodePolicy CC-0262

Change TypeModified

Effective DateJune 23, 2026

Last ReviewMay 15, 2026

Next Review DateN/A

Key ActionSubmit Tevimbra requests for prior authorization and demonstrate that the applicable medical-necessity criteria are met.

SourceLink

POLICY UPDATE CHANGES

The policy added NCCN category 2A criteria for Tevimbra with paclitaxel and carboplatin in anal carcinoma, classic Hodgkin lymphoma, and endometrial carcinoma.

The policy clarified that colorectal cancer use requires that the individual has not received prior checkpoint inhibitor therapy.

The policy removed HER2 criteria from the esophageal squamous cell carcinoma criteria and removed ECOG requirements from the gastric and gastroesophageal junction cancer criteria.

The policy added NCCN criteria for appendiceal cancer and separated small bowel adenocarcinoma criteria from colorectal cancer criteria.

The policy clarified first-line combination and subsequent single-agent use for esophageal squamous cell carcinoma and clarified metastatic use for nasopharyngeal cancer.

The policy added a gastric cancer indication and an NCCN recommendation for Tevimbra with Brukinsa (zanubrutinib) in chronic lymphocytic leukemia/small lymphocytic lymphoma.

The policy replaced HCPCS J3590 and J9999 with HCPCS J9329 and added or revised esophageal cancer diagnosis coding.

Coverage Criteria

Initial Coverage Criteria

Requests for Tevimbra (tislelizumab-jsgr) may be approved when <strong>any one</strong> of the following criteria groups is met:

ANY one of the following criteria groups

I
- Individual is under 19 years of age.
II
- Individual has a diagnosis of unresectable locally advanced, recurrent, or metastatic esophageal squamous cell carcinoma (ESCC) (Label, NCCN 1).
- Individual is using in one of the following ways
  - Disease has progressed after prior systemic chemotherapy that did not include a PD-L1 inhibitor as a single agent.
  - As first-line therapy in combination with platinum-containing chemotherapy for tumors with PD-L1 ≥1.
III
- Individual has a diagnosis of unresectable locally advanced, recurrent, or metastatic esophageal or esophagogastric junction cancer, or gastric cancer (Label, NCCN 1, 2A).
- Individual has either unresectable or metastatic HER2-negative disease.
- Individual has a tumor that expresses PD-L1 ≥1.
- Individual is using Tevimbra as first-line therapy.
- Individual has not received another anti-PD-1 or anti-PD-L1 agent, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways.
- Individual is using Tevimbra in combination with platinum and fluoropyrimidine-based chemotherapy.
IV
- Individual has a diagnosis of esophageal and esophagogastric junction cancer (NCCN 1, 2A).
- Individual is using Tevimbra for induction systemic therapy to relieve dysphagia.
- Individual has PD-L1 CPS ≥1.
- Individual is using Tevimbra in combination with platinum and fluoropyrimidine-based chemotherapy.
V
- Individual has a diagnosis of chronic lymphocytic leukemia/small lymphocytic leukemia (CLL/SLL) (NCCN 2A).
- Individual is using Tevimbra in combination with Brukinsa (zanubrutinib) for histologic (Richter) transformation to diffuse large B-cell lymphoma.
- One of the following
  - Individual has a del(17p)/TP53 mutation.
  - Individual is chemotherapy refractory or unable to receive chemoimmunotherapy.
VI
- Individual has a diagnosis of metastatic anal carcinoma (NCCN 2A).
- Individual is using in one of the following ways
  - Individual is using Tevimbra as second-line or subsequent therapy.
  - ALL of the following
    Individual is using Tevimbra as a single agent.
    Individual has not received a prior anti-PD-1 or anti-PD-L1 agent.
  - Individual is using Tevimbra as a single agent.
VII
- Individual has a diagnosis of appendiceal carcinoma (NCCN 2A).
- Individual has advanced or metastatic disease.
- Individual has one of the following mutations
  - dMMR/MSI-H (deficient mismatch repair/microsatellite instability-high).
  - POLE/POLD1 (polymerase epsilon/delta) with an ultra-hypermutated phenotype, such as TMB >50 mut/Mb.
VIII
- Individual has a diagnosis of colorectal cancer (NCCN 2A).
- Individual has one of the following mutations
  - dMMR/MSI-H (deficient mismatch repair/microsatellite instability-high).
  - POLE/POLD1 (polymerase epsilon/delta) with an ultra-hypermutated phenotype, such as TMB >50 mut/Mb.
IX
- Individual has a diagnosis of small bowel adenocarcinoma (NCCN 2A).
- Individual has one of the following mutations
  - dMMR/MSI-H (deficient mismatch repair/microsatellite instability-high).
  - POLE/POLD1 (polymerase epsilon/delta) with an ultra-hypermutated phenotype, such as TMB >50 mut/Mb.
X
- Individual has a diagnosis of metastatic nasopharyngeal cancer (NCCN 2A).
- Individual has squamous cell carcinoma and is using Tevimbra as systemic therapy.
- Individual is using Tevimbra in combination with cisplatin and gemcitabine for subsequent-line therapy.
- Individual has a current ECOG performance status of 0–2.
XI
- Individual has a diagnosis of classic Hodgkin lymphoma (NCCN 2A).
- Individual is using Tevimbra in combination with gemcitabine and oxaliplatin.
XII
- Individual has a diagnosis of hepatocellular carcinoma (NCCN 1, 2A).
- Individual is using Tevimbra as a single agent.
XIII
- Individual has a diagnosis of endometrial (or uterine) carcinoma (NCCN 2A).
- Individual is using Tevimbra as second-line or subsequent therapy.
- Individual is using Tevimbra as a single agent.
- Individual is using Tevimbra for recurrent MSI-H or dMMR tumors.

Tevimbra is not approved for indications outside the listed criteria.

Requests that do not meet the applicable listed criteria may not be approved.

Initial Therapy

Initial Therapy Criteria

Requests for Tevimbra may be approved when the applicable indication-specific clinical conditions are met. At least one of the following pathways must apply:

Indication-specific initial therapy criteria

ESCC: Unresectable locally advanced, recurrent, or metastatic esophageal squamous cell carcinoma; either progression after prior systemic chemotherapy that did not include a PD-L1 inhibitor with Tevimbra as a single agent, or first-line Tevimbra with platinum-containing chemotherapy for a tumor with PD-L1 ≥1.PD-L1 ≥1 for first-line combination therapy
HER2-negative esophageal, esophagogastric junction, or gastric cancer: Unresectable or metastatic HER2-negative disease with PD-L1 expression of at least 1; first-line treatment; no prior anti-PD-1, anti-PD-L1, or other drug specifically targeting T-cell co-stimulation or checkpoint pathways; and Tevimbra combined with platinum and fluoropyrimidine-based chemotherapy.HER2-negative; PD-L1 ≥1

Coding Requirements

HCPCSHCPCS

J9329

Injection, tislelizumab-jsgr, 1mg [Tevimbra]

ICD-10 DiagnosisICD-10

C11.0-C11.9	Malignant neoplasm of nasopharynx
C14.0	Malignant neoplasm of pharynx, unspecified
C14.2	Malignant neoplasm of Waldeyer's ring
C15.3-C15.9	Malignant neoplasm of esophagus
C16.0-C16.9	Malignant neoplasm of stomach
C17.0-C17.9	Malignant neoplasm of small intestine
C18.0-C18.9	Malignant neoplasm of colon
C19	Malignant neoplasm of rectosigmoid junction
C20	Malignant neoplasm of rectum
C21.0-C21.8	Malignant neoplasm of anus and anal canal

1–10 of 22

1/3

ICD-10-CM codes added in annual reviewICD-10

C14.0	ICD-10-CM code added in the policy history
C14.2	ICD-10-CM code added in the policy history
C54.0-C54.9	ICD-10-CM code range added in the policy history
C55	ICD-10-CM code added in the policy history
C81.10-C81.99	ICD-10-CM code range added in the policy history

ICD-10-CM codes added in annual reviewICD-10

C11.0-C11.9	ICD-10-CM code range added in the policy history
C17.0-C21.8	ICD-10-CM code range added in the policy history
C22.0	ICD-10-CM code added in the policy history
C22.8	ICD-10-CM code added in the policy history
C22.9	ICD-10-CM code added in the policy history
C30.0	ICD-10-CM code added in the policy history

ICD-10-CM codes added or revised in select reviewsICD-10

C15.3-C15.9	Consolidated ICD-10-CM code range in the policy history
C16.0-C16.9	ICD-10-CM code range added in the policy history
C83.00-C83.09	ICD-10-CM code range added in the policy history
C83.30-C83.38	ICD-10-CM code range added in the policy history
C83.398	ICD-10-CM code added in the policy history
C91.10-C91.12	ICD-10-CM code range added in the policy history
C15.3	ICD-10-CM code added in the policy history
C15.4	ICD-10-CM code added in the policy history
C15.5	ICD-10-CM code added in the policy history
C15.8	ICD-10-CM code added in the policy history

1–10 of 12

1/2

HCPCS codesHCPCS

J9329	HCPCS code added to replace prior codes
J3590	HCPCS code removed and replaced in the policy history
J9999	HCPCS code removed and replaced in the policy history

PD-L1 Tumor Expression

Required thresholdPD-L1 tumor expression ≥1

Esophageal squamous cell carcinomaRequired for first-line Tevimbra combined with platinum-containing chemotherapy in unresectable or metastatic ESCC

Gastric or gastroesophageal junction cancerRequired for first-line Tevimbra combined with platinum and fluoropyrimidine-based chemotherapy in unresectable or metastatic HER2-negative disease

PD-L1 Combined Positive Score

Required thresholdPD-L1 combined positive score (CPS) ≥1

Provider Actions

Prior Authorization

Prior Authorization Required

Prior authorization is required for Tevimbra (tislelizumab-jsgr) requests subject to clinical review under the member’s medical benefit. Submit documentation supporting the applicable coverage criteria, including the individual’s age, diagnosis, treatment regimen and combination agents, line of therapy, ECOG performance status, and MSI-H or dMMR status when applicable.

Clinical review applies to the intended or prescribed use, including requests under prior authorization.
Document the applicable NCCN-supported diagnosis and all required treatment details before submitting the request.

Denial Risk

Criteria Not Met or Unlisted Indication

Requests may not be approved when the applicable Tevimbra criteria are not met. Requests for all other indications may also be denied.

Denial risk applies when required age, diagnosis, regimen, line-of-therapy, performance-status, or biomarker criteria are not documented or satisfied.

Background

Tevimbra (tislelizumab-jsgr) is an intravenous programmed death receptor-1 (PD-1) blocking antibody. This policy addresses its use in selected oncology indications, including esophageal, gastric, gastroesophageal junction, hematologic, hepatocellular, gynecologic, colorectal, small bowel, anal, and nasopharyngeal cancers, subject to the applicable diagnosis, disease characteristics, biomarker, treatment-line, regimen, and performance-status requirements.

Definitions

ECOG or Eastern Cooperative Oncology Group Performance Status

PurposeA scale used to assess disease progression, effects on daily living, appropriate treatment, and prognosis

Score rangeScores range from 0 (fully active) through 4 (completely disabled); 5 indicates death

Alternative namesAlso referred to as the WHO (World Health Organization) or Zubrod score

Metastasis

DefinitionThe spread of cancer from one part of the body to another

Tumor relationshipA metastatic tumor contains cells that are like those in the original primary tumor

Clinical meaning