CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Tevimbra (tislelizumab-jsgr) — coverage criteria

Defines accepted indications, exclusions, and coding for Tevimbra (tislelizumab-jsgr) for oncology medication requests processed by Evolent on behalf of the payer; applies to network ordering providers and affected membership lines of business.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyTevimbra (tislelizumab-jsgr) — coverage criteria

Policy CodePolicy N/A

Change TypeConverted to new templateadded indication

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization from Evolent and provide supporting evidence per FDA labeling, CMS compendia, NCCN/ASCO guidelines, or peer‑reviewed literature.

SourceLink

POLICY UPDATE CHANGES

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

2FDA/compendium-backed cancer indications listed

J9329HCPCS code for tislelizumab-jsgr

200 mgsingle dose maximum (exclusion if exceeded)

Commercial, Medicaidapplicable lines of business

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

CLL/SLL (Richter transformation) — combination with zanubrutinib

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

CLL/SLL Richter transformation with zanubrutinib

High-risk or chemo-ineligible: Member has del(17p)/TP53 mutation OR is chemotherapy refractory OR is unable to receive chemoimmunotherapy

Esophageal Squamous Cell Carcinoma — post-chemotherapy

Covered when ALL of the following are met for esophageal squamous cell carcinoma (ESCC)

ESCC after prior chemotherapy without prior ICI: Tislelizumab (Tevimbra) may be used in adult members with unresectable or metastatic ESCC after prior systemic chemotherapy that did not include an immune checkpoint inhibitor

Prior systemic chemotherapy must not have included nivolumab, pembrolizumab, durvalumab, or other ICIs

Requests for Tevimbra (tislelizumab-jsgr) will be excluded (denied) when any of the following apply: disease progression while taking Tevimbra, prior use with an immune checkpoint inhibitor, or dosing that exceeds a single dose of 200 mg. Prior authorization and continuation approvals are contingent on absence of disease progression and adherence to dosing limits; continuation requests may be allowed per authorization rules only when these exclusion criteria are not met. Denials also apply when the requested use is investigational or off-label without sufficient supporting evidence as defined by this policy.

Use of Tevimbra for off-label or investigational indications that lack adequate supporting evidence is considered not approvable. The policy defines insufficient evidence to include situations where the patient or cancer characteristics are not adequately represented in published studies, the administered regimen is not adequately represented, study outcomes are not clinically meaningful (for example, not meeting ASCO-recommended thresholds such as a hazard ratio < 0.80 or survival benefit of at least 3 months for OS/PFS), or the experimental design is inappropriate to answer the clinical question. Case reports, meeting abstracts without a full peer-reviewed publication, and other uncontrolled anecdotal reports are explicitly noted as generally inadequate to establish accepted use.

Covered Regimens and Administration

Regimen	Indication	Coverage
Tislelizumab (Tevimbra) in combination with zanubrutinib (Brukinsa)
Histologic (Richter) transformation of CLL/SLL to diffuse large B‑cell lymphoma (clonally related or unknown clonal status); member has del(17p)/TP53 mutation OR is chemotherapy refractory OR is unable to receive chemoimmunotherapy
Covered with criteria

Regimen	Indication	Coverage
Tislelizumab (Tevimbra) monotherapy
Unresectable or metastatic esophageal squamous cell carcinoma (ESCC) after prior systemic chemotherapy that did not include an immune checkpoint inhibitor (e.g., nivolumab, pembrolizumab, durvalumab)
Covered with criteria

Provider Actions and Requirements

Prior Authorization

Prior Authorization and Continuation Requirements

Prior authorization is required for Tevimbra (tislelizumab-jsgr). Continuation requests may be approved only when the member has not experienced disease progression on Tevimbra, the prior authorization remains active without a lapse of more than 30 days within the past year, and no additional medications are being added to the continuation request.

Prior authorization required for initial and continuation therapy.
Continuation allowed if: no disease progression on Tevimbra; prior authorization active within past year with ≤30-day lapse; no additional drugs added.

Step Therapy

Implied Prior Therapy Requirement for ESCC

Use of Tevimbra for esophageal squamous cell carcinoma (ESCC) is limited to adult members with unresectable or metastatic ESCC after prior systemic chemotherapy. The prior chemotherapy must not have included an immune checkpoint inhibitor (for example nivolumab, pembrolizumab, durvalumab).

Applicable population: adult members with unresectable or metastatic ESCC.
Required prior therapy: prior systemic chemotherapy without prior immune checkpoint inhibitor exposure.

Documentation Required

Required Supporting Evidence

Coverage and continued use must be supported by one or more accepted evidence sources. Acceptable sources include FDA prescribing information, CMS-recognized compendia, NCCN or ASCO clinical guidelines, or peer-reviewed literature meeting CMS standards.

FDA labeling (prescribing information).
CMS-approved compendia (e.g., NCCN Drugs & Biologics Compendium).
Professional society guidelines (NCCN, ASCO).
Peer-reviewed literature that meets CMS Medicare Benefit Policy Manual Chapter 15 criteria.

Denial Risk

Exclusion Criteria Triggering Denial

Requests must be denied when any exclusion criteria are met. Carefully review the following denial triggers before submitting an authorization request.

Disease progression while taking Tevimbra (tislelizumab-jsgr).
Prior use of an immune checkpoint inhibitor (e.g., nivolumab, pembrolizumab, durvalumab).
Requested dosing exceeds the single-dose limit of 200 mg.
Investigational or off-label use lacking sufficient evidence or not generally accepted by the medical community (including unsupported case reports or abstracts without full peer-reviewed publication).
Off-label indications not supported by CMS-recognized compendia, NCCN/ASCO guidance, or acceptable peer-reviewed literature.

Biomarker and Diagnostic Requirements

del(17p)/TP53

Biomarkerdel(17p)/TP53 mutation

Role in eligibilityPresence of del(17p)/TP53 is one qualifying criterion for coverage of tislelizumab plus zanubrutinib for Richter transformation

Alternative qualifying criteriaIf del(17p)/TP53 is not present, members may still qualify if chemotherapy refractory or unable to receive chemoimmunotherapy

Richter transformation (CLL/SLL → DLBCL)

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

Coverage contextIndication for use of tislelizumab (Tevimbra) in combination with zanubrutinib (Brukinsa)

Qualification noteMember must have transformation to DLBCL; coverage requires clonal relatedness may be related or unknown (policy accepts either)

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyTevimbra (tislelizumab-jsgr) — coverage criteria

Policy CodePolicy N/A

Change TypeConverted to new templateadded indication

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization from Evolent and provide supporting evidence per FDA labeling, CMS compendia, NCCN/ASCO guidelines, or peer‑reviewed literature.

SourceLink

On This Page

OpenPayer

Tevimbra (tislelizumab-jsgr) — coverage criteria

Coverage Criteria

Covered Regimens and Administration

Coding and Dose Limits

Provider Actions and Requirements

Line of Therapy Specifications

Biomarker and Diagnostic Requirements

Background

Revision History