ModifiedEmblemHealthPolicy MG.MM.PH.416

Tevimbra (tislelizumab) intravenous infusion

Defines clinical and administrative coverage criteria, renewal rules, billing codes, maximum units, and diagnosis codes for Tevimbra (tislelizumab) intravenous infusion for specified cancer indications under EmblemHealth/ConnectiCare.

Policy Summary

PayerEmblemHealth

PolicyTevimbra (tislelizumab) intravenous infusion

Policy CodePolicy MG.MM.PH.416

Change TypeAdded gastric/GEJ indication; revised ESCC criteria; ICD-10 updates

Effective DateNov 5, 2024

Next Review Date

Key ActionThe treating physician or PCP must submit clinical evidence that the member meets criteria for treatment; without documentation EmblemHealth will not review the request for preauthorization or post-payment review.

SourceLink

POLICY UPDATE CHANGES

Added gastric or gastroesophageal junction adenocarcinoma indication with specific criteria including HER2-negative disease and PD-L1 > 1% for first-line use in combination with platinum and fluoropyrimidine chemotherapy.

Revised ESCC initial criteria to allow first-line use in combination with platinum-containing chemotherapy and single-agent use for previously treated ESCC after prior systemic chemotherapy that did not include a PD-(L)1 inhibitor.

Updated ICD-10 codes.

2Covered Indications

200 mgMax billable units per dose (mg)

Coverage Summary

Coverage stance: Covered with criteria. Indications covered include esophageal squamous cell carcinoma (unresectable or metastatic ESCC) (single-agent for previously treated disease after prior systemic chemotherapy that did not include a PD-(L)1 inhibitor, and in combination with platinum-containing chemotherapy as first-line) and gastric or gastroesophageal junction (GEJ) adenocarcinoma (first-line for unresectable or metastatic HER2-negative disease with tumor PD-L1 > 1% in combination with platinum and fluoropyrimidine chemotherapy). See scope_summary for full scope of clinical and administrative coverage criteria.

Thresholds & Quick Facts

PD-L1 expression threshold> 1%

Max units (per dose / frequency)200 billable units every 3 weeks

Length of authorization (initial)6 months

RenewalMay be renewed with documentation of disease response and acceptable toxicity

Max units (stats)200 mg per dose (max billable units shown as 200)

Initial Therapy Criteria

Continuation / Renewal Criteria

Documentation Required

Renewal documentation

For renewal, provide evidence that the member has experienced disease response (stabilization of disease or decrease in tumor size or tumor spread) and that they have not experienced unacceptable toxicity from the drug.

Imaging reports showing stable disease or tumor shrinkage (CT, MRI, PET)
Clinician progress notes documenting tumor response or clinical improvement
Relevant laboratory results supporting absence of severe immune-mediated toxicity (e.g., liver enzymes, renal function, thyroid tests)

Exclusions / Prior Therapy Restrictions

Denial Risk

Previous PD-1/PD-L1 therapy exclusion

Patients who have received prior programmed death (PD-1/PD-L1)-directed therapy (for example, nivolumab, pembrolizumab, atezolizumab, avelumab, cemiplimab, dostarlimab, retifanlimab, toripalimab, durvalumab, etc.) do not meet the criterion for the previously treated ESCC single-agent indication and may be denied coverage.

Applicable Codes

HCPCS J-code for drugHCPCSCovered

J9329

Injection, tislelizumab-jsgr, 1 mg; 1 billable unit = 1 mg

NDCNDCCovered

72579-0121-01

Tevimbra 100 mg/10 mL single-dose vial

Applicable ICD-10 DiagnosesICD-10Covered

C15.3	Malignant neoplasm of upper third of esophagus
C15.4	Malignant neoplasm of middle third of esophagus
C15.5	Malignant neoplasm of lower third of esophagus
C15.8	Malignant neoplasm of overlapping sites of esophagus
C15.9	Malignant neoplasm of esophagus, unspecified
C16.0	Malignant neoplasm of cardia
C16.1	Malignant neoplasm of fundus of stomach
C16.2	Malignant neoplasm of body of stomach
C16.3	Malignant neoplasm of pyloric antrum
C16.4	Malignant neoplasm of pylorus

1–10 of 14

1/2

Billing Rule

HCPCS unit billing

Report J9329 with 1 billable unit = 1 mg; maximum 200 billable units every 3 weeks.

Billable unit definition: 1 billable unit = 1 mg of tislelizumab

Provider Actions & Requirements

Prior Authorization

Submit clinical documentation for preauthorization

The treating physician or primary care provider must submit clinical evidence that the member meets the criteria for treatment; without this documentation EmblemHealth will not review the request for preauthorization or post-payment review.

Documentation Required

Oncologist involvement

Medication must be prescribed by or in consultation with an oncologist for covered indications.

Clinical Evidence & Sources

Evidence sources: Source prescribing information: Tevimbra intravenous infusion [prescribing information], BeiGene; March 2024. Policy was developed from the prescribing information and review of the clinical literature as described in the guideline development background.

Background

Background: Tevimbra (tislelizumab-jsgr) is indicated for adult patients with unresectable or metastatic esophageal squamous cell carcinoma after prior systemic chemotherapy that did not include a PD-(L)1 inhibitor. The policy was developed from the Tevimbra prescribing information and the clinical literature. EmblemHealth requires submission of clinical documentation to determine medical necessity and coverage; without this documentation EmblemHealth will not review requests for preauthorization or post-payment review.

Definitions & Policy Info

Billable unit definition1 billable unit = 1 mg of tislelizumab (per J9329)

Policy numberMG.MM.PH.416

StatusMODIFIED

Effective date2024-11-05

Last review date2025-06-05

Revision History

05/06/2025icd_updateLatest

Updated ICD-10 codes (ICD-10 list expanded/edited as of 05/06/2025).

05/06/2025added_indicationLatest

Added gastric or gastroesophageal junction (GEJ) adenocarcinoma indication with specific criteria: patients > 18 years, unresectable or metastatic HER2-negative disease, tumor PD-L1 > 1%, medication used first-line in combination with platinum and fluoropyrimidine-based chemotherapy, and must be prescribed by or in consultation with an oncologist.

05/06/2025