CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Tevimbra (tislelizumab-jsgr) — Coverage Criteria for Specified Oncology Indications

Defines accepted indications, exclusions, and coding for Tevimbra (tislelizumab-jsgr) use in adults for specific cancer indications and describes evidence sources required for authorization. Affects providers and prior authorization processors for Neighborhood Health Plan of Rhode Island lines of business listed.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyTevimbra (tislelizumab-jsgr) — Coverage Criteria for Specified Oncology Indications

Policy CodePolicy N/A

Change TypeAdded clinical indicationstemplate migration

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization demonstrating the patient meets indication-specific clinical criteria (e.g., CLL/SLL Richter transformation with qualifying features or ESCC after chemotherapy without prior ICI).

SourceLink

POLICY UPDATE CHANGES

Added new indication(s) for use in CLL/SLL with Richter transformation in combination with zanubrutinib and for unresectable or metastatic esophageal squamous cell carcinoma after prior chemotherapy without prior checkpoint inhibitor.

Converted to new Evolent guideline template and this guideline replaces UM ONC_1499 Tevimbra (tislelizumab-jsgr).

2Specific covered indications listed

200 mgSingle dose maximum (exclusion if exceeded)

J9329HCPCS code for tislelizumab-jsgr

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Coverage Criteria for Tevimbra (tislelizumab-jsgr)

CLL/SLL (Richter transformation) — Initial therapy

Covered when ALL of the following are met for CLL/SLL Richter transformation

CLL/SLL Richter transformation criteria: Member is an adult with histologic transformation of CLL/SLL to diffuse large B-cell lymphoma (Richter transformation; clonally related or unknown clonal status).

Regimen: Tislelizumab (Tevimbra) is being used in combination with zanubrutinib (Brukinsa).

Qualifying clinical feature (ONE of): Presence of del(17p)/TP53 mutation OR chemotherapy-refractory disease OR inability to receive chemoimmunotherapy.

This OR group fulfills the final required clinical feature for eligibility.

Esophageal Squamous Cell Carcinoma — Second-line after chemo without prior ICI

Covered when ALL of the following are met for ESCC

Esophageal squamous cell carcinoma criteria: Member is an adult with unresectable or metastatic esophageal squamous cell carcinoma.

Prior therapy requirement: Tislelizumab (Tevimbra) is requested after prior systemic chemotherapy that did not include an immune checkpoint inhibitor (e.g., nivolumab, pembrolizumab, durvalumab).

Prior exposure to an immune checkpoint inhibitor excludes coverage for this indication.

Coverage is not authorized when there is disease progression while taking Tevimbra (tislelizumab-jsgr). Requests for continuation or renewal should demonstrate the member has not progressed on therapy as described in the authorization criteria.

Prior exposure to another immune checkpoint inhibitor (for example, nivolumab, pembrolizumab, durvalumab) is an exclusion and will generally preclude coverage for the listed indications.

Dosing that would result in a single administered dose exceeding 200 mg is excluded from coverage; authorization requests must reflect dosing at or below this single-dose maximum.

Uses that are investigational or off‑label and lack sufficient supportive evidence as defined in this policy are excluded. The policy defines sufficiency by explicit considerations of population and regimen representativeness, clinically meaningful outcomes (for example, ASCO-recommended thresholds such as hazard ratio < 0.80 or survival benefits of at least 3 months for OS/PFS), study design appropriateness, and the strength of the evidence hierarchy (with case reports and meeting abstracts without full peer‑reviewed articles generally insufficient).

Requests for uses considered investigational or off‑label must be supported by sufficient evidence. Sufficient evidence is defined in this policy by whether the patient and regimen are adequately represented in published studies, whether reported outcomes are clinically meaningful (using ASCO-recommended benchmarks where applicable), and whether the study design appropriately addresses the clinical question.

Evidence sources that are considered insufficient include uncontrolled case reports and abstracts without a full peer‑reviewed publication; such sources alone will not meet the policy standard. The policy also notes that non‑randomized trials with a substantial number of subjects may provide supportive evidence when other design elements are appropriate.

Indication	Regimen	Coverage status
CLL/SLL with histologic (Richter) transformation to diffuse large B-cell lymphoma (clonally related or unknown clonal status)
Tislelizumab (Tevimbra) in combination with zanubrutinib (Brukinsa)
Covered when criteria met (see coverage criteria)

Indication	Regimen	Coverage status	Notes
Unresectable or metastatic esophageal squamous cell carcinoma (adult) after prior systemic chemotherapy that did NOT include an immune checkpoint inhibitor
Tislelizumab (Tevimbra) monotherapy per approved dosing
Covered when criteria met (see coverage criteria)
Single-dose maximum 200 mg — dosing requests exceeding single-dose limit excluded

Coding and Dose Limits

Covered HCPCS CodesHCPCSCovered

J9329

Injection, tislelizumab-jsgr, 1mg

Single dose maximum

Single dose maximum200 mg

Consequence if exceededRequest excluded — dosing that exceeds single dose limit of 200 mg is a denial trigger

Relevant sectionEXCLUSION CRITERIA — Dosing exceeds single dose limit of 200 mg

Provider Actions and Authorization Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for all requests for Tevimbra (tislelizumab-jsgr) for the listed indications. Providers must submit a prior authorization request that demonstrates the indication-specific criteria are met (see medical necessity criteria). Requests that do not provide sufficient evidence of an FDA‑approved indication, CMS‑recognized compendia support, or acceptable clinical guideline / peer‑reviewed literature may be denied.

Applies to initial and new‑to‑therapy requests
Include prior treatment history (e.g., prior systemic chemotherapy, prior immune checkpoint inhibitor exposure) where relevant
Requests for continuation should reference the existing authorization ID and documentation of no disease progression (see continuation criteria)

Documentation Required

Evidence and Documentation Required

Evidence supporting medical necessity must be included with the request. Acceptable sources include FDA‑approved product labeling, CMS‑recognized compendia (e.g., NCCN Drugs & Biologics compendium, AHFS, Micromedex, Clinical Pharmacology), professional society guidelines (e.g., NCCN, ASCO), and peer‑reviewed literature. Cite relevant references and include clinical documentation that demonstrates the patient meets the indication‑specific criteria (diagnosis, molecular markers, prior therapies, mutation status, and line of therapy).

Line of Therapy Requirements

second-line

Second-line therapy requirement: Requested use is for second-line therapy following prior systemic chemotherapy (see indication-specific criteria).

Represents a top-level second-line requirement per policy.

mixed

Mixed line/qualifying feature: Use is contingent on presence of qualifying clinical features (e.g., del(17p)/TP53 mutation OR chemotherapy-refractory disease OR inability to receive chemoimmunotherapy) when used in combination regimens as specified in the policy.

Single top-level node reflecting the policy's mixed line/qualification requirement.

Biomarker and Diagnostic Requirements

del(17p)/TP53

Required biomarkerdel(17p)/TP53 mutation

Indication contextRequired (or alternative qualifying feature) for CLL/SLL with Richter transformation when using tislelizumab plus zanubrutinib

Clonality noteApplies to histologic (Richter) transformation to diffuse large B-cell lymphoma (clonally related or unknown clonal status)

Regimens and Dosing

Agent	Dose / Schedule	Route	Coverage status
Tislelizumab (Tevimbra)
Per regimen studied in RT1 trial (use in combination with zanubrutinib) — refer to supporting documentation for exact trial dosing
Intravenous infusion
Covered when criteria met
Zanubrutinib (Brukinsa)
Per product labeling for zanubrutinib (oral dosing) — follow prescribing information
Oral
Covered when criteria met

Agent	Dose / Schedule	Route	Coverage status	Notes
Tislelizumab (Tevimbra)
Administered per approved product dosing for unresectable/metastatic ESCC (refer to prescribing information); single-dose maximum 200 mg applies
Intravenous infusion
Covered when criteria met

Definitions

Richter transformation

DefinitionHistologic transformation of CLL/SLL to diffuse large B-cell lymphoma (clonally related or unknown clonal status).

Clinical relevanceSpecifies the Richter transformation population for which tislelizumab plus zanubrutinib may be used

Associated optionsMembers must have del(17p)/TP53 mutation OR be chemotherapy refractory OR be unable to receive chemoimmunotherapy

Prior immune checkpoint inhibitor exposure

DefinitionPrior immune checkpoint inhibitor exposure = previous systemic therapy with agents such as nivolumab, pembrolizumab, or durvalumab.

Coverage impactPrior exposure to an immune checkpoint inhibitor excludes eligibility for the ESCC indication of tislelizumab (coverage requires no prior ICI).

Background

Tislelizumab (Tevimbra) is an anti–PD‑1 immune checkpoint inhibitor used in oncology; its clinical utility in this policy is framed by indication‑specific trial evidence and FDA/compendia references. When considering requests, reviewers should recognize the agent’s mechanism as PD‑1 pathway blockade and that coverage decisions hinge on indication‑specific trial representation and the predefined evidence sufficiency criteria described in this policy.

Revision History and Policy Changes

2025-03operationalLatest

Converted to new Evolent guideline template and replaced prior policy UM ONC_1499; updated references.

2024-05added_indication

New drug policy created and initial coverage criteria established (new policy introduction).