ModifiedAmbetter NevadaPolicy CP.PHAR.687

Clinical Policy: Tislelizumab-jsgr (Tevimbra)

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Prior authorization and medical-necessity coverage for Tevimbra in adults with specified esophageal, gastric, gastroesophageal-junction, and other NCCN-supported cancers across Ambetter commercial, HIM/ICHRA, and Medicaid lines of business.

Policy Summary

PayerAmbetter Nevada

PolicyTislelizumab-jsgr (Tevimbra) coverage

Policy CodePolicy CP.PHAR.687

Change TypeModified

Effective DateSep 1, 2024

Last ReviewAug 1, 2026

Next Review DateN/A

Key ActionSubmit documentation demonstrating that all applicable initial approval criteria are met, including diagnosis, age, oncology prescriber involvement, disease characteristics, treatment line, biomarker status, combination therapy, and dose.

SourceLink

POLICY UPDATE CHANGES

Added coverage criteria for first-line HER2-positive gastric or gastroesophageal-junction cancer or esophageal adenocarcinoma treated with zanidatamab-hrii, chemotherapy, and tislelizumab-jsgr.

Added uterine neoplasms, appendiceal neoplasms, and Hodgkin lymphoma among the NCCN-supported off-label indications.

Revised the anal carcinoma off-label indication to allow treatment in combination with paclitaxel and carboplatin.

Removed the prior criterion requirements for chronic lymphocytic leukemia or small lymphocytic lymphoma.

Revised approval-duration rules to allow 12-month initial approval for Medicaid, HIM, and ICHRA and establish a commercial approval duration of six months or the member's renewal date, whichever is longer.

Added the 150 mg/15 mL dosage form and corresponding tislelizumab-jsgr dosing regimens.

Added HCPCS code J9329 and removed HCPCS codes J3590 and C9399 from the policy coding references.

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ModifiedAmbetter NevadaPolicy CP.PHAR.687

Clinical Policy: Tislelizumab-jsgr (Tevimbra)

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Sign up for Ambetter Nevada Policy CP.PHAR.687 alerts

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Policy Summary

PayerAmbetter Nevada

PolicyTislelizumab-jsgr (Tevimbra) coverage

Policy CodePolicy CP.PHAR.687

Change TypeModified

Effective DateSep 1, 2024

Last ReviewAug 1, 2026

Next Review DateN/A

SourceLink

POLICY UPDATE CHANGES

Added coverage criteria for first-line HER2-positive gastric or gastroesophageal-junction cancer or esophageal adenocarcinoma treated with zanidatamab-hrii, chemotherapy, and tislelizumab-jsgr.

Added uterine neoplasms, appendiceal neoplasms, and Hodgkin lymphoma among the NCCN-supported off-label indications.

Revised the anal carcinoma off-label indication to allow treatment in combination with paclitaxel and carboplatin.

Removed the prior criterion requirements for chronic lymphocytic leukemia or small lymphocytic lymphoma.

Added the 150 mg/15 mL dosage form and corresponding tislelizumab-jsgr dosing regimens.

Added HCPCS code J9329 and removed HCPCS codes J3590 and C9399 from the policy coding references.

18+Minimum member age

30 daysMinimum prior therapy

150–400 mgDosing schedule range

6 or 12 monthsApproval duration

J9329Current HCPCS code

150 mgAvailable vial strength added

Coverage Criteria

FDA-Approved Gastric, Esophageal, or Gastroesophageal-Junction Cancer

Covered when ALL of the following criteria are met:

ALL of the following

Diagnosis of esophageal squamous cell carcinoma (ESCC), gastric or gastroesophageal-junction (G/GEJ) cancer, or esophageal adenocarcinoma.
Prescribed by or in consultation with an oncologist.
Member is age ≥ 18 years.
For ESCC, ONE of the following
- Disease is unresectable, locally advanced, recurrent, or metastatic.
- Member is planned for esophagectomy.
For ESCC, ONE of the following treatment regimens applies
- ALL of the following
  - Tevimbra is prescribed as a single agent.
  - Member has had previous treatment with a fluoropyrimidine-based (e.g., 5-fluorouracil or capecitabine) and platinum-based (e.g., cisplatin or oxaliplatin) chemotherapy.
  - Prior systemic chemotherapy did not include a PD-1 or PD-(L)1 inhibitor (e.g., nivolumab, ipilimumab, or pembrolizumab).
- ALL of the following
  - Tevimbra is prescribed in combination with platinum (e.g., cisplatin or oxaliplatin)-containing chemotherapy.
  - Request is for ONE of the following
For G/GEJ or esophageal adenocarcinoma, ALL of the following
- Disease is unresectable, locally advanced, recurrent, or metastatic.
- Request is for first-line treatment.
- Disease is ONE of the following
  - HER2-negative disease
    Tumor is PD-L1 positive.
    Tevimbra is prescribed in combination with fluoropyrimidine (e.g., capecitabine or fluorouracil)- and platinum (e.g., cisplatin or oxaliplatin)-containing chemotherapy.
  - HER2-positive disease (IHC 3+ or IHC 2+/ISH+)
Dose meets ONE of the following
- Dose does not exceed 150 mg IV every 2 weeks.
- Dose does not exceed 200 mg IV every 3 weeks.
- Dose does not exceed 300 mg IV every 4 weeks.
- Dose does not exceed 400 mg IV every 6 weeks.
- Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use; prescriber must submit supporting evidence.

NCCN-Recommended Off-Label Uses

Covered when ALL of the following criteria are met:

ALL of the following

Tevimbra is prescribed in ONE of the following ways
- As a single agent for ONE of the following diagnoses
  - dMMR/MSI-H or POLE/POLD1 mutation-positive disease
    Small bowel adenocarcinoma, with disease that is locally unresectable, medically inoperable, advanced, or metastatic.
    Colorectal cancer.
    Uterine neoplasms.

Continuation Therapy

Continued coverage requires ALL of the following:

ALL of the following

Member is currently receiving Tevimbra through a Centene benefit, or documentation supports that the member is currently receiving Tevimbra for a covered indication and has received the medication for at least 30 days.
Member is responding positively to therapy.
If the request is for a dose increase, ONE of the following applies
- New dose does not exceed 150 mg IV every 2 weeks.
- New dose does not exceed 200 mg IV every 3 weeks.
- New dose does not exceed 300 mg IV every 4 weeks.

Coverage is not authorized for non-FDA-approved indications that are not addressed in this policy, unless sufficient documentation of efficacy and safety is provided according to the applicable off-label use policy: CP.CPA.09 for Commercial, HIM.PA.154 for Health Insurance Marketplace/ICHRA, or CP.PMN.53 for Medicaid, or according to the applicable evidence of coverage documents.

Coding and Clinical Parameters

HCPCS CodeHCPCS

J9329

Injection, tislelizumab-jsgr, 1 mg

Removed HCPCS CodesHCPCS

J3590	Removed from policy coding references
C9399	Removed from policy coding references

PD-L1 Expression

BiomarkerPD-L1 expression

Policy thresholdAt least 1 (≥ 1)

Applies toSpecified esophageal, gastric, gastroesophageal-junction, and esophageal adenocarcinoma indications

HER2-Positive Disease

HER2-positiveHuman epidermal growth factor receptor 2-positive disease

IHC criterionIHC 3+

ISH criterion

Provider Actions and Authorization Requirements

Prior Authorization

Initial Prior Authorization Required

Submit a complete initial prior authorization request with documentation showing that the member meets all applicable coverage criteria for the requested Tevimbra regimen. The regimen must be FDA-approved or recommended by NCCN, and the requested dose must be within a listed limit or supported for the relevant off-label use.

Include the applicable diagnosis and clinical details listed below.
Submit office chart notes, laboratory results, and other clinical information supporting every approval criterion.
For NCCN-recommended off-label uses, submit the applicable regimen and supporting clinical information.
Approval duration: Medicaid/HIM/ICHRA—12 months; Commercial—6 months or to the member’s renewal date, whichever is longer.

Prior Authorization

Continuation Prior Authorization

For continuation prior authorization, document that the member is actively receiving Tevimbra for a covered indication and is responding positively to treatment. A dose-increase request must also satisfy the applicable dose-limit or evidence-support requirements.

Clinical Background

Tislelizumab-jsgr (Tevimbra) is a programmed death receptor-1 (PD-1) blocking antibody. This policy addresses its use in adults with advanced or unresectable esophageal squamous cell carcinoma, gastric or gastroesophageal-junction adenocarcinoma, esophageal adenocarcinoma, and selected NCCN-recommended off-label cancer indications.

Definitions and Abbreviations

Abbreviation Definition

AbbreviationCLL

DefinitionChronic lymphocytic leukemia

Policy contextMay occur with Richter transformation to diffuse B-cell lymphoma when treated in combination with zanubrutinib

Abbreviation Definition

AbbreviationdMMR

DefinitionDeficient mismatch repair

Policy contextUsed to identify selected NCCN-recommended off-label tumor indications

Initial Therapy Criteria

FDA-Approved Indications

Initial approval requires the applicable diagnosis, oncology involvement, age, disease setting, regimen, biomarker, prior-treatment, and dose criteria.

General eligibility

Diagnosis is ESCC, gastric or gastroesophageal-junction cancer, or esophageal adenocarcinoma.
Prescribed by or in consultation with an oncologist.
Member is age 18 years or older.Age ≥ 18 years

Eligible disease and regimen pathway

ESCC pathway

Continuation Therapy Criteria

Continuation Approval

Continued therapy requires current treatment or at least 30 days of documented treatment for a covered indication, positive response, and compliant dosing.

Continuation criteria

Current treatment status
- Member is currently receiving Tevimbra through the Centene benefit.
- Documentation supports that the member is currently receiving Tevimbra for a covered indication and has received it for at least 30 days.At least 30 days
Member is responding positively to therapy.

Dose increase

Quantity and Dosing Limits

Quantity Limits

DrugTislelizumab-jsgr (Tevimbra)

Dosing schedules150 mg IV every 2 weeks; 200 mg IV every 3 weeks; 300 mg IV every 4 weeks; or 400 mg IV every 6 weeks

Quantity-limit referenceIV dose and interval per course

Dose-increase requirementA new dose must remain within the listed schedules or be supported by FDA limits, practice guidelines, or peer-reviewed literature for the relevant off-label use

Policy Summary

PayerAmbetter Nevada

PolicyTislelizumab-jsgr (Tevimbra) coverage

Policy CodePolicy CP.PHAR.687

Change TypeModified

Effective DateSep 1, 2024

Last ReviewAug 1, 2026

Next Review DateN/A

SourceLink

On This Page

First-line treatment.

Member is planned for esophagectomy.

Tumor is PD-L1 positive.

Tevimbra is prescribed in combination with Ziihera®.

Tevimbra is prescribed in combination with fluoropyrimidine (e.g., capecitabine or fluorouracil)- and platinum (e.g., cisplatin or oxaliplatin)-containing chemotherapy.

Hepatocellular carcinoma (HCC).

Head and neck cancers, as subsequent-line therapy.

Appendiceal neoplasms and cancers.

As a single agent or in combination with paclitaxel and carboplatin for locally recurrent, progressive, or metastatic anal carcinoma.

In combination with cisplatin and gemcitabine as first-line or subsequent therapy for head and neck cancers.

In combination with zanubrutinib for chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) with histologic (Richter) transformation to diffuse B-cell lymphoma. Prior authorization may be required for zanubrutinib.

In combination with gemcitabine and oxaliplatin as second-line or subsequent therapy for Hodgkin lymphoma.

Prescribed by or in consultation with an oncologist.

Member is age ≥ 18 years.

For HCC, ONE of the following

First-line systemic therapy for ONE of the following
- Member has liver-confined, unresectable disease and is deemed ineligible for transplant.
- Member has extrahepatic, metastatic disease and is deemed ineligible for resection, transplant, or locoregional therapy.
Prescribed as subsequent-line systemic therapy.

Dose is within the FDA maximum limit 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.

New dose does not exceed 400 mg IV every 6 weeks.

New dose is within the FDA maximum limit 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.

Tevimbra Dosing Schedules

Schedule 1150 mg IV every 2 weeks

Schedule 2200 mg IV every 3 weeks

Schedule 3300 mg IV every 4 weeks

Schedule 4400 mg IV every 6 weeks

Document that Tevimbra is being received through the Centene benefit, or that the member has received Tevimbra for a covered indication for at least 30 days.
Document positive response to therapy.
For a dose increase, the new dose must not exceed 150 mg IV every 2 weeks, 200 mg IV every 3 weeks, 300 mg IV every 4 weeks, or 400 mg IV every 6 weeks; alternatively, it must be within the FDA maximum for an FDA-approved indication or supported by practice guidelines or peer-reviewed literature for the relevant off-label use.
The prescribed regimen must be FDA-approved or recommended by NCCN.
Approval duration: Medicaid/HIM/ICHRA—12 months; Commercial—6 months or to the member’s renewal date, whichever is longer.

Documentation Required

Clinical Documentation Required

Provider documentation must support that the member meets all applicable approval criteria before coverage can be authorized. Submit office chart notes, laboratory results, and other relevant clinical information with the request.

Include the diagnosis, treatment history, disease status and extent, biomarker results, treatment regimen, and response information applicable to the requested indication.
Ensure the submitted records support the prescribing oncologist’s involvement and the requested dose and treatment line.

Documentation Required

Support for Off-Label or Non-Listed Dosing

When the requested dose exceeds the listed Tevimbra schedules or is used for a relevant off-label indication, the prescriber must submit supporting evidence. Evidence may include applicable practice guidelines or peer-reviewed literature, and the prescribed regimen must be FDA-approved or recommended by NCCN.

Listed dose schedules are 150 mg IV every 2 weeks, 200 mg IV every 3 weeks, 300 mg IV every 4 weeks, or 400 mg IV every 6 weeks.
For an off-label request, identify the relevant guideline or peer-reviewed evidence supporting the dose, regimen, efficacy, and safety.
The same evidence requirement applies to a continuation request involving a dose increase.

Documentation Required

Required Clinical Details

The initial request must include the clinical details applicable to the disease-specific criteria. Tevimbra must be prescribed by, or in consultation with, an oncologist for an adult member and the requested disease and treatment setting must satisfy the applicable criteria.

Document diagnosis of ESCC, gastric/gastroesophageal junction cancer, or esophageal adenocarcinoma, as applicable; NCCN-recommended uses also include HCC, subsequent-line head and neck cancers, appendiceal neoplasms/cancers, anal carcinoma, head and neck cancers treated with cisplatin/gemcitabine, CLL/SLL with Richter transformation to diffuse B-cell lymphoma, and Hodgkin lymphoma.
Document age ≥18 years and prescribing by or consultation with an oncologist.
For ESCC, document unresectable, locally advanced, recurrent, or metastatic disease, or a planned esophagectomy.
For ESCC monotherapy, document prior fluoropyrimidine- and platinum-based chemotherapy and that prior systemic chemotherapy did not include a PD-1 or PD-(L)1 inhibitor. For combination therapy, document first-line treatment or planned esophagectomy and PD-L1-positive disease.
For G/GEJ or esophageal adenocarcinoma, document unresectable, locally advanced, recurrent, or metastatic disease and first-line treatment. For HER2-negative disease, document PD-L1 positivity and combination fluoropyrimidine/platinum chemotherapy; for HER2-positive disease (IHC 3+ or IHC 2+/ISH+), document combination with Ziihera and fluoropyrimidine/platinum chemotherapy.
For HCC, document first-line or subsequent-line systemic treatment as applicable; for first-line treatment, document liver-confined unresectable disease with transplant ineligibility or extrahepatic metastatic disease with ineligibility for resection, transplant, or locoregional therapy.
For other NCCN-recommended uses, document the specific disease extent, treatment line, combination regimen, and other indication-specific requirements.

Denial Risk

Initial Approval Denial Conditions

Initial coverage may be denied when the request does not satisfy all applicable initial approval criteria or lacks adequate supporting documentation. The requested regimen must also meet the policy’s FDA-approval, NCCN, dosing, and evidence requirements.

Denial risk includes an unsupported diagnosis, age under 18 years, or no oncologist prescribing or consultation.
Denial risk includes failure to document the required disease extent, treatment line, prior therapy, PD-L1 or HER2 status, planned esophagectomy, or required combination regimen.
Denial risk includes a regimen or dose that exceeds the listed schedules without supporting guideline or peer-reviewed evidence, or a regimen that is neither FDA-approved nor recommended by NCCN.
For ESCC, G/GEJ cancer, or esophageal adenocarcinoma, failure to meet any required criterion results in failure of the initial approval request.

Denial Risk

Continuation Approval Denial Conditions

Continuation coverage may be denied when the member is not documented as actively receiving Tevimbra for a covered indication for at least 30 days, is not responding positively to therapy, or a requested dose increase does not meet the policy’s dose and evidence requirements.

Submit current treatment and response documentation with the continuation request.
A dose increase must remain within the listed schedules or be within the FDA maximum for an approved indication or supported by guidelines or peer-reviewed literature for the relevant off-label use.
The prescribed regimen must be FDA-approved or recommended by NCCN.

Denial Risk

Unaddressed Non-FDA-Approved Indication

Coverage is not authorized for non-FDA-approved indications that are not addressed in this policy unless the request includes sufficient documentation of efficacy and safety under the applicable off-label-use policy or evidence-of-coverage provisions.

For Commercial requests, refer to CP.CPA.09; for Health Insurance Marketplace/ICHRA requests, refer to HIM.PA.154; for Medicaid requests, refer to CP.PMN.53.
An unaddressed non-FDA-approved indication without the required efficacy and safety documentation is at risk for denial.

Abbreviation Definition

AbbreviationESCC

DefinitionEsophageal squamous cell carcinoma

Policy contextCovered indications include unresectable or metastatic ESCC

Abbreviation Definition

AbbreviationG/GEJ

DefinitionGastric or gastroesophageal junction

Policy contextUsed for gastric or gastroesophageal-junction cancer and adenocarcinoma indications

Abbreviation Definition

AbbreviationSLL

DefinitionSmall lymphocytic lymphoma

Policy contextMay occur with Richter transformation to diffuse B-cell lymphoma when treated in combination with zanubrutinib

PD-L1 Positive

TermPD-L1 positive

DefinitionProgrammed death-ligand 1 expression

Policy thresholdAt least 1 (≥ 1) for specified indications

Abbreviation Definition

AbbreviationCLL

DefinitionChronic lymphocytic leukemia

Policy contextMay occur with Richter transformation to diffuse B-cell lymphoma when treated in combination with zanubrutinib

Abbreviation Definition

AbbreviationdMMR

DefinitionDeficient mismatch repair

Policy contextUsed to identify selected NCCN-recommended off-label tumor indications

Abbreviation Definition

AbbreviationESCC

DefinitionEsophageal squamous cell carcinoma

Policy contextCovered indications include unresectable or metastatic ESCC

Abbreviation Definition

AbbreviationG/GEJ

DefinitionGastric or gastroesophageal junction

Policy contextUsed for gastric or gastroesophageal-junction cancer and adenocarcinoma indications

Abbreviation Definition

AbbreviationHER2

DefinitionHuman epidermal growth factor receptor 2

Policy contextHER2-positive disease is defined as IHC 3+ or IHC 2+/ISH+

Abbreviation Definition

AbbreviationMSI-H

DefinitionMicrosatellite instability-high

Policy contextIncluded among selected NCCN-recommended off-label tumor indications

Abbreviation Definition

AbbreviationPD-1

DefinitionProgrammed death receptor-1

Policy contextTevimbra is a programmed death receptor-1 blocking antibody

Abbreviation Definition

AbbreviationPD-L1

DefinitionProgrammed death-ligand 1

Policy thresholdExpression of at least 1 (≥ 1) is required for specified indications

Abbreviation Definition

AbbreviationSLL

DefinitionSmall lymphocytic lymphoma

Policy contextMay occur with Richter transformation to diffuse B-cell lymphoma when treated in combination with zanubrutinib

Disease is unresectable, locally advanced, recurrent, or metastatic.
Member is planned for esophagectomy.

Treatment pathway

Tevimbra is prescribed as a single agent after prior fluoropyrimidine-based and platinum-based chemotherapy, and prior systemic chemotherapy did not include a PD-1 or PD-(L)1 inhibitor.
Tevimbra is combined with platinum-containing chemotherapy, the request is for first-line treatment or planned esophagectomy, and the tumor is PD-L1 positive.PD-L1 ≥ 1

Gastric, gastroesophageal-junction, or esophageal adenocarcinoma pathway

Disease is unresectable, locally advanced, recurrent, or metastatic.
Request is for first-line treatment.
Biomarker and regimen branch
- For HER2-negative disease, tumor is PD-L1 positive and Tevimbra is combined with fluoropyrimidine- and platinum-containing chemotherapy.PD-L1 ≥ 1
- For HER2-positive disease, tumor is IHC 3+ or IHC 2+/ISH+ and Tevimbra is combined with Ziihera and fluoropyrimidine- and platinum-containing chemotherapy.

Dose requirement

Dose does not exceed 150 mg IV every 2 weeks, 200 mg IV every 3 weeks, 300 mg IV every 4 weeks, or 400 mg IV every 6 weeks.150 mg q2w; 200 mg q3w; 300 mg q4w; 400 mg q6w
Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use.
Prescriber must submit supporting evidence. The prescribed regimen must be FDA-approved or recommended by NCCN.

NCCN-Recommended Off-Label Indications

NCCN-recommended off-label initial therapy requires a listed use, oncology involvement, adult age, and supported dosing.

NCCN-supported use

Single-agent use for dMMR/MSI-H or POLE/POLD1 mutation-positive small-bowel adenocarcinoma, colorectal cancer, or uterine neoplasms.
Single-agent use for hepatocellular carcinoma, subsequent-line head and neck cancers, or appendiceal neoplasms and cancers.
Use alone or with paclitaxel and carboplatin for locally recurrent, progressive, or metastatic anal carcinoma.
Use with cisplatin and gemcitabine as first-line or subsequent therapy for head and neck cancers.
Use with zanubrutinib for CLL or SLL with Richter transformation to diffuse B-cell lymphoma.
Zanubrutinib may require separate prior authorization.
Use with gemcitabine and oxaliplatin as second-line or subsequent therapy for Hodgkin lymphoma.

Provider and age

Prescribed by or in consultation with an oncologist.
Member is age 18 years or older.Age ≥ 18 years

HCC disease setting

First-line systemic therapy for liver-confined unresectable disease when the member is ineligible for transplant, or for extrahepatic metastatic disease when the member is ineligible for resection, transplant, or locoregional therapy.
Subsequent-line systemic therapy.

Dose support

Dose is within the FDA maximum limit for an FDA-approved indication.
Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use.
Prescriber must submit supporting evidence. The prescribed regimen must be FDA-approved or recommended by NCCN.

New dose is within 150 mg IV every 2 weeks, 200 mg IV every 3 weeks, 300 mg IV every 4 weeks, or 400 mg IV every 6 weeks.150 mg q2w; 200 mg q3w; 300 mg q4w; 400 mg q6w

New dose is within the FDA maximum limit for an FDA-approved indication or is supported by practice guidelines or peer-reviewed literature for the relevant off-label use.

Prescriber must submit supporting evidence. The prescribed regimen must be FDA-approved or recommended by NCCN.