CurrentCareSourcePolicy N/A

Tevimbra (tislelizumab) — Utilization Management Medical Policy (Oncology)

Defines prior authorization, coverage criteria, dosing, and authorized indications for Tevimbra (tislelizumab) for adult oncology indications for CareSource members and requires prescribing by or in consultation with an oncologist.

Policy Summary

PayerCareSource

PolicyTevimbra (tislelizumab) — Utilization Management Medical Policy (Oncology) — coverage with criteria for multiple adult oncology indications

Policy CodePolicy N/A

Change TypeMaterial additions and revisions to indications and prior-exposure logic

Effective DateN/A

Next Review DateMay 21, 2025

Key ActionSubmit prior authorization with documentation of age, tumor type/stage, required biomarkers (e.g., PD-L1 CPS, HER2, dMMR/TMB) and prior therapy including checkpoint inhibitor exposure and progression status.

SourceLink

POLICY UPDATE CHANGES

Esophageal adenocarcinoma (HER2-negative, PD-L1 CPS ≥1) in combination with chemotherapy was added as an option for approval.

The prior restriction 'patient has NOT previously received checkpoint inhibitor' was revised to include 'OR patient has NO tumor progression while on checkpoint inhibitor.'

Multiple additional tumor types were added as conditions of approval (e.g., gastric/gastroesophageal junction adenocarcinoma, anal carcinoma, CLL/SLL transformation, hepatocellular carcinoma, nasopharyngeal carcinoma, small bowel, colon/rectal/appendiceal cancers).

200 mg q3wCommon dosing

3 mg/kg q2wAnal carcinoma dosing

1 year

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CPS ≥1PD-L1 threshold

Recommended Authorization Criteria

FDA-Approved Indications — Covered when ALL of the following are met for each indication as specified below

Covered when ALL of the following are met for each indication as specified below

Esophageal and Esophagogastric Junction Cancers (including esophageal squamous cell carcinoma and esophageal adenocarcinoma)

A: Patient is ≥18 years of age
B: Patient has unresectable locally advanced, recurrent, or metastatic disease
C: Patient meets ONE of the following tumor/biomarker conditions: (i) Tumor PD-L1 combined positive score (CPS) ≥1 by an approved test; OR (ii) other specified biomarker/clinical pathways per indication
D: Treatment context — meet ONE of the following specific to histology: (i) For esophageal squamous cell carcinoma: medication used as first-line/induction therapy in combination with chemotherapy; OR medication used as subsequent therapy as a single agent; (ii) For esophageal adenocarcinoma (HER2-negative): medication used as a single agent for subsequent therapy; OR patient has NOT previously received a checkpoint inhibitor OR patient has NO tumor progression while on a checkpoint inhibitor
E: Medication prescribed by or in consultation with an oncologist

Gastric or Gastroesophageal Junction Adenocarcinoma (HER2-negative)

A: Patient is ≥18 years of age
B: Patient has unresectable locally advanced, recurrent, or metastatic HER2-negative disease
C: Medication is used first-line
D: Medication is used in combination with platinum- and fluoropyrimidine-based chemotherapy (examples include cisplatin + fluorouracil or capecitabine; oxaliplatin + fluorouracil or capecitabine)
F: Medication prescribed by or in consultation with an oncologist

Coverage of Tevimbra is not recommended when the request is for circumstances that are not listed in the Recommended Authorization Criteria. The Recommended Authorization Criteria will be updated as new published evidence becomes available; coverage decisions should follow the most current criteria.

Use of Tevimbra for indications that are not listed in the Recommended Authorization Criteria is not recommended for approval. Requests for off‑label or non‑listed indications should be denied unless and until they meet documented criteria supported by published evidence and incorporated into the policy.

Authorized Dosing and Regimens

Regimen	Indication / Context	Dosing	Coverage Status
Tevimbra (tislelizumab) 200 mg IV every 3 weeks in combination with platinum-containing chemotherapy (examples: cisplatin + fluorouracil or capecitabine; oxaliplatin + fluorouracil or capecitabine; paclitaxel + oxaliplatin or cisplatin)
Esophageal cancers (including esophageal squamous cell carcinoma as first-line/induction with chemotherapy) — used when PD-L1 CPS ≥1 where specified; or gastric/gastroesophageal junction (HER2‑negative) adenocarcinoma first‑line in combination with platinum + fluoropyrimidine-based chemotherapy
Approve 200 mg administered by IV infusion no more frequently than once every 3 weeks
Covered when indication‑specific criteria are met (see FDA‑Approved Indications / authorization criteria)

Regimen	Indication / Context	Dosing	Coverage Status
Tevimbra (tislelizumab) 3 mg/kg IV every 2 weeks as a single agent
Anal carcinoma — for adults (≥18 years) in specified contexts (locally recurrent/progressive disease, pre‑abdominoperineal resection use, or metastatic disease as subsequent therapy) when patient has NOT received prior immunotherapy
Approve 3 mg/kg administered by IV infusion no more frequently than once every 2 weeks
Covered when indication‑specific criteria are met (see Other Uses with Supportive Evidence / authorization criteria)

Regimen	Indication / Context	Dosing	Coverage Status
Tevimbra (tislelizumab) 200 mg IV every 3 weeks in combination with cisplatin and gemcitabine
Nasopharyngeal carcinoma — first‑line treatment in adults (≥18 years) when used in combination with cisplatin and gemcitabine; also permitted as subsequent single‑agent therapy per specified subcriteria
Approve 200 mg administered by IV infusion no more frequently than once every 3 weeks
Covered when indication‑specific criteria are met (see Other Uses with Supportive Evidence / authorization criteria)

Billing and Code Information

Covered/Administration Codes (not specified)mixed

NDC/HCPCS

Specific codes not listed in policy document; dosing guidance provided.

inv-05: Tumor mutation burden — ≥ 50 mutations/megabase

Tumor mutation burden (TMB) threshold≥ 50 mutations/megabase

Context of useUsed to define ultra-hypermutated phenotype for approval of single-agent Tevimbra

Approval durationAuthorization period: 1 year when criteria met

inv-06: PD-L1 combined positive score (CPS) — ≥ 1

PD-L1 combined positive score (CPS) threshold≥ 1 (CPS ≥1)

Indications referencing CPSRequired for certain esophageal and esophagogastric junction approvals (as determined by an approved test)

Prior Authorization & Provider Requirements

Prior Authorization

Prior Authorization Recommended

Prior Authorization is recommended for medical benefit coverage. Approval is recommended when the patient meets the Listed Criteria and Dosing for the indicated tumor type(s). Extended approvals are allowed if the patient continues to meet the Criteria and Dosing. Requests for doses outside the established dosing documented in this policy will be considered case-by-case by a clinician (e.g., Medical Director or Pharmacist). Tevimbra must be prescribed by, or in consultation with, a physician who specializes in the condition being treated.

Approval duration: 1 year when criteria met
Dosing: 200 mg IV every 3 weeks (no more frequently than once every 3 weeks)

Documentation Required

Required Documentation

Documentation must demonstrate the following: patient is ≥18 years of age; tumor type and stage (e.g., unresectable locally advanced, recurrent, or metastatic); prior treatments and response (including whether patient has NOT previously received a checkpoint inhibitor OR has NO tumor progression while on a checkpoint inhibitor); biomarker status (e.g., PD-L1 CPS and HER2 status where applicable); prescribing clinician specialty (oncologist or specialist consult); and relevant clinical notes supporting indication and regimen.

Line of Therapy Specifications

Line-of-Therapy Distinctions (First-line vs Subsequent-line)

Policy distinguishes first-line combination use versus subsequent-line single-agent use; authorization depends on the indication-specific requirements below.

First-line

Example: Esophageal squamous cell carcinoma: Medication used as first-line or induction therapy in combination with chemotherapy for tumors with PD-L1 CPS ≥1 (per approved test)
Example: Gastric/Gastroesophageal junction adenocarcinoma: Medication used first-line in combination with platinum- and fluoropyrimidine-based chemotherapy for HER2-negative disease
Example: Nasopharyngeal carcinoma (first-line): Medication used in combination with cisplatin and gemcitabine for first-line treatment

Subsequent-line

Biomarker and Molecular Criteria

inv-15: PD-L1 (CPS) — ≥ 1

PD-L1 (CPS) threshold≥ 1 (CPS ≥1)

Required for specific esophageal/gastric approvalsReferenced for esophageal squamous cell carcinoma and gastric/GJ adenocarcinoma where specified

Measurement methodPD-L1 expression determined by an approved test per policy

inv-16: Tumor mutation burden (TMB) — ≥ 50 mutations/megabase

Tumor mutation burden (TMB) threshold≥ 50 mutations/megabase

Role in policyDefines ultra-hypermutated phenotype for single-agent approvals

Authorization period

Context and Drug Overview

Tevimbra (tislelizumab) is a programmed death receptor‑1 (PD‑1) blocking monoclonal antibody approved for multiple adult oncology indications, including esophageal cancers and other tumor types. Coverage criteria in this policy reference tumor histology and stage (for example, unresectable, locally advanced, recurrent, or metastatic disease), relevant biomarkers (such as PD‑L1 CPS ≥1 where specified), prior therapies, and whether treatment is given as first‑line combination therapy or subsequent‑line single‑agent therapy.

Key Definitions and Thresholds

inv-12: PD-L1 combined positive score (CPS) threshold used for some approvals — PD-L1 CPS ≥1

PD-L1 CPS threshold used for some approvalsPD-L1 CPS ≥1

Specific useRequired by FDA‑approved indication criteria for esophageal/esophagogastric cancers and gastric/GJ adenocarcinoma where specified

Testing noteExpression determined by an approved PD-L1 test as stated in policy

inv-13: Ultra-hypermutated phenotype / TMB — Ultra-hypermutated phenotype defined as tumor mutation burden ≥50 mutations/megabase.

Definition of ultra-hypermutated phenotypeTumor mutation burden ≥50 mutations/megabase

Role in approvalsQualifies tumors for single-agent Tevimbra under ultra-hypermutated/high‑TMB criteria

Policy Summary

PayerCareSource

PolicyTevimbra (tislelizumab) — Utilization Management Medical Policy (Oncology) — coverage with criteria for multiple adult oncology indications

Policy CodePolicy N/A

Change TypeMaterial additions and revisions to indications and prior-exposure logic

Effective DateN/A

Next Review DateMay 21, 2025

SourceLink

On This Page

PD-L1 as determined by an approved test per policy language

PD-L1 testing result (CPS ≥1) when required by indication
HER2-negative status documentation for gastric/GEJ adenocarcinoma indications
Prior chemotherapy and regimen details when used in combination

Note

Prior Therapy Conditions

Policy includes prior therapy considerations. Approvals depend on prior therapy status per indication: examples include use as first-line/induction therapy in combination with chemotherapy for esophageal squamous cell carcinoma with PD-L1 CPS ≥1; use as subsequent therapy or single-agent therapy in certain esophageal adenocarcinoma scenarios; and use in combination with platinum and fluoropyrimidine-based chemotherapy for gastric/GEJ HER2-negative disease. Requests should specify prior checkpoint inhibitor exposure and whether progression occurred while on therapy.

Examples of chemotherapy: cisplatin + fluorouracil or capecitabine; oxaliplatin + fluorouracil or capecitabine; paclitaxel + oxaliplatin or cisplatin
Examples of checkpoint inhibitors: pembrolizumab (Keytruda), nivolumab (Opdivo)

Denial Risk

Non‑listed Indications

Coverage is not recommended for requests that do not meet the Recommended Authorization Criteria. Criteria will be updated as new published data become available.

Requests for indications or dosing outside those listed are not recommended for approval
Non-listed clinical scenarios should be escalated for peer-to-peer review or medical director consideration

Example: Esophageal adenocarcinoma (HER2-negative): Medication used as a single agent for subsequent therapy; prior checkpoint inhibitor exposure is acceptable if no tumor progression while on that therapy or if patient has not previously received a checkpoint inhibitor
Example: Hepatocellular carcinoma: Medication may be used for subsequent-line therapy in liver-confined unresectable disease when criteria met
Example: Nasopharyngeal carcinoma (subsequent): Medication used as a single agent for subsequent treatment per indication subcriteria
Example: Anal carcinoma (supportive evidence): Medication used as a single agent for specified recurrent/progressive/metastatic contexts and patient has not received prior immunotherapy

Approval duration: 1 year when criteria met

inv-17: HER2 — Negative (HER2-negative disease)

HER2 status requirementNegative (HER2-negative disease)

Applicable indicationsRequired for gastric/gastroesophageal junction and esophageal adenocarcinoma approvals specifying HER2 status

Clinical contextHER2-negative disease is part of first-line gastric/GJ and certain esophageal adenocarcinoma criteria

inv-18: dMMR / MSI-H — dMMR / MSI-H positive

dMMR / MSI-H statusdMMR / MSI-H positive

Applicable tumor typesUsed to qualify colon/rectal/appendiceal and other approvals for single-agent therapy

Relation to TMB/POLEdMMR/MSI-H listed alongside POLE mutation and ultra-hypermutated phenotype in biomarker criteria

Associated biomarkersListed alongside dMMR/MSI-H and POLE mutation in biomarker criteria