Commercial

Medical Policy

Title:

Tislelizumab-jsgr (Tevimbra®)

Policy #:

08.02.23b

Policy

The Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member's medical needs and condition.

INDEX OF MEDICALLY NECESSARY INDICATIONS

This policy addresses numerous medically necessary indications for the use of tislelizumab-jsgr (Tevimbra^®) (listed in order of appearance within the Policy section). Please see below for the specific medical necessity criteria. (NOTE: Experimental/Investigational section below must also be reviewed).

Type of Cancer	Subtype of Cancer
Anal carcinoma
Appendiceal neoplasms and cancers
Chronic lymphocytic leukemia/ Small lymphocytic lymphoma
Colon cancer
Endometrial carcinoma
Esophageal and esophagogastric junction cancers
Gastric cancer
Head and neck cancers	Cancer of the nasopharynx Very advanced head and neck cancer
Hepatocellular carcinoma
Hodgkin lymphoma
Rectal cancer
Small bowel adenocarcinoma

MEDICALLY NECESSARY

ANAL CARCINOMA
Tislelizumab-jsgr (Tevimbra), as a single agent, is considered medically necessary and, therefore, covered as second-line (National Comprehensive Cancer Network [NCCN] preferred) and subsequent therapy for metastatic anal carcinoma if no prior immunotherapy received.

Tislelizumab-jsgr (Tevimbra), used in combination with paclitaxel and carboplatin, is considered medically necessary and, therefore, covered for anal carcinoma in ANY of the following scenarios:

Treatment of inguinal node recurrence
Primary treatment of metastatic disease
First-line treatment of metastatic disease if persistent or progressive locoregional disease

APPENDICEAL NEOPLASMS AND CANCERS

Tislelizumab-jsgr (Tevimbra), as a single agent, is considered medically necessary and, therefore, covered for appendiceal cancer as neoadjuvant systemic therapy when ALL of the following are met:

Has ONE of the following mutations with ultra-hypermutated phenotype (e.g., total mutational burden [TMB] >50 mutations/million bases [mut/Mb]):

Deficient mismatch repair/microsatellite instability-high (dMMR/MSI-H)
Polymerase epsilon/delta (POLE/POLD1) mutation

No previous treatment with a checkpoint inhibitor
ONE of the following scenarios:

Biopsy-proven recurrence of high-risk disease and no previous cytoreductive surgery
Metastatic disease in peritoneal-only

Tislelizumab-jsgr (Tevimbra), as a single agent, is considered medically necessary and, therefore, covered for appendiceal cancer as systemic therapy when ALL of the following are met:

Has ONE of the following mutations with ultra-hypermutated phenotype (e.g., TMB >50 mut/Mb):

dMMR/MSI-H
POLE/POLD1 mutation

No previous treatment with a checkpoint inhibitor
ONE of the following scenarios:

Recurrence with serial tumor marker elevation or radiographic progression and progressive or positive findings
Biopsy-proven recurrence of high-risk disease if cytoreductive surgery was previously received or not possible
Progressive disease or inadequate response after neoadjuvant systemic therapy for metastatic peritoneal-only disease
Extraperitoneal disease

CHRONIC LYMPHOCYTIC LEUKEMIA/SMALL LYMPHOCYTIC LYMPHOMA
Tislelizumab-jsgr (Tevimbra), in combination with zanubrutinib*, is considered medically necessary and, therefore, covered for individuals with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) with histologic (Richter) transformation in ONE of the following scenarios:

Untreated CLL or clonally unrelated disease at initial diagnosis as additional therapy for partial response, refractory disease, or progression while on treatment with chemoimmunotherapy (CIT) regimens
Previously treated CLL** and clonally related or clonal relation unknown*** as first-line treatment
Previously treated CLL** and clonally related or clonal relation unknown*** as continuation therapy for complete response until progression or as additional therapy not previously used for partial response, refractory disease, or progression while on treatment with CIT or non-CIT regimens

*Immune checkpoint inhibitor (ICI)-based combination regimens with covalent Bruton Tyrosine Kinase inhibitor (cBTKi) used for prior therapy are not appropriate for individuals who are intolerant to or have disease progression on the same cBTKi.
**In individuals with previously treated CLL, options depend on treatment received for CLL prior to transformation.
***It is recommended that clonal relatedness be determined; however, if it is not feasible and CLL has not been previously treated, consider treating as clonally unrelated.

COLON CANCER
Tislelizumab-jsgr (Tevimbra), as a single agent, is considered medically necessary and, therefore, covered, for individuals with dMMR/MSI-H or POLE/POLD1 mutation with ultrahypermutated phenotype (e.g., TMB >50 mut/Mb) colon cancer, who have not received prior immunotherapy, in ONE of the following scenarios:

As neoadjuvant therapy for resectable, non-obstructing disease (for T4 or bulky primary)
As neoadjuvant therapy in clinical T4b or bulky nodal disease
As neoadjuvant therapy for resectable synchronous liver only and/or lung metastases
For locally unresectable or medically inoperable disease
As primary treatment for synchronous abdominal/peritoneal metastases that are nonobstructing, or following local therapy for individuals with existing or imminent obstruction
As primary treatment for synchronous unresectable metastases
As initial treatment for resectable metachronous metastases
As treatment for unresectable metachronous metastases

ENDOMETRIAL CARCINOMA
Tislelizumab-jsgr (Tevimbra), as a single agent, is considered medically necessary and, therefore, covered as second-line or subsequent therapy, for recurrent MSI-H or dMMR endometrial tumors (if not previously used) in ONE of the following scenarios:

May be considered for isolated metastases
For disseminated metastases with or without sequential palliative external beam radiation therapy (EBRT)
After surgical exploration, with sequential EBRT for locoregional recurrence (not confined to vagina or paravaginal soft tissue) in individuals with pelvic or para-aortic lymph node disease
After surgical exploration, with or without sequential EBRT for locoregional recurrence (not confined to vagina or paravaginal soft tissue) in individuals with microscopic residual upper abdominal/peritoneal disease
With or without sequential palliative EBRT or brachytherapy for locoregional recurrence in individuals who have received prior EBRT to site of recurrence

ESOPHAGEAL AND ESOPHAGOGASTIC JUNCTION CANCERS
Tislelizumab-jsgr (Tevimbra) is considered medically necessary and, therefore, covered as induction systemic therapy for relieving dysphagia in individuals with esophageal and esophagogastric junction (EGJ) cancers who meet ALL of the following:

Programmed death ligand1 (PD-L1) combined positive score (CPS) of 1 or greater disease
Documented medically fit (i.e., medically able to tolerate general anesthesia and major surgery)
Planned for esophagectomy
Meet ONE of the following stages:

cT2, N0 (high-risk lesions: lymphovascular invasion, 3 cm or greater, poorly differentiated)
cT1b-cT2, N+
cT3-cT4a, any N

In ONE of the following regimens:

Oxaliplatin and a fluoropyrimidine (i.e., fluorouracil or capecitabine) (NCCN preferred)
Cisplatin and a fluoropyrimidine (i.e., fluorouracil or capecitabine) (NCCN preferred)
Paclitaxel and either oxaliplatin or cisplatin (NCCN preferred)

Tislelizumab-jsgr (Tevimbra) is considered medically necessary and, therefore, covered as first-line palliative therapy for individuals with esophageal and EGJ cancers who meet ALL of the following:

With human epidermal growth factor receptor2 (HER2) overexpression–negative disease
PD-L1 CPS of 1 or greater
Not surgical candidate or have unresectable locally advanced, recurrent, or metastatic adenocarcinoma
Karnofsky performance score of 60 percent or greater OR European Cooperative Oncology Group (ECOG) performance status (PS) 2 or less
In ONE of the following regimens if no prior checkpoint inhibitor or no tumor progression while on therapy with a checkpoint inhibitor:

Oxaliplatin and a fluoropyrimidine (i.e., fluorouracil or capecitabine) (NCCN preferred)
Cisplatin and a fluoropyrimidine (i.e., fluorouracil or capecitabine) (NCCN preferred)
Paclitaxel and either oxaliplatin or cisplatin* (NCCN preferred)

*For HER2 positive disease only

Tislelizumab-jsgr (Tevimbra), as a single agent, is considered medically necessary and, therefore, covered as NCCN preferred second-line or subsequent palliative therapy for individuals with esophageal and EGJ cancers who meet ALL of the following:

Have esophageal squamous cell carcinoma
No prior checkpoint inhibitor or no tumor progression while on therapy with a checkpoint inhibitor
Not surgical candidates or have unresectable locally advanced, recurrent, or metastatic disease
Karnofsky performance score of 60 percent or greater OR ECOG PS 2 or less

GASTRIC CANCER
Tislelizumab-jsgr (Tevimbra) is considered medically necessary and, therefore, covered as primary treatment for individuals with gastric cancer who meet ALL of the following:

Documented medically fit for surgery (i.e., medically able to tolerate general anesthesia and major surgery) but have surgically unresectable locoregional HER2 overexpression–negative disease
PD-L1 CPS of 1 or greater
Used in ONE of the following regimens:

Oxaliplatin and a fluoropyrimidine (i.e., fluorouracil or capecitabine) (NCCN preferred)
Cisplatin and a fluoropyrimidine (i.e., fluorouracil or capecitabine) (NCCN preferred)

Tislelizumab-jsgr (Tevimbra) is considered medically necessary and, therefore, covered as first-line palliative therapy for individuals with gastric cancer who meet ALL of the following:

Not surgical candidates or have unresectable locally advanced, recurrent, or metastatic disease (including peritoneal only metastatic disease, including positive cytology)
HER2 overexpression negative disease
PD-L1 CPS of 1 or greater
Karnofsky performance score of 60 percent or greater OR ECOG PS 2 or less
Used in ONE of the following regimens (if no prior checkpoint inhibitor therapy or no tumor progression while on therapy with a checkpoint inhibitor)

Oxaliplatin and a fluoropyrimidine (i.e., fluorouracil or capecitabine) (NCCN preferred)
Cisplatin and a fluoropyrimidine (i.e., fluorouracil or capecitabine) (NCCN preferred)

HEAD AND NECK CANCERS
Cancer of the nasopharynx

Tislelizumab-jsgr (Tevimbra) is considered medically necessary and, therefore, covered for subsequent-line systemic therapy, in combination with cisplatin and gemcitabine for T1-4, N0-3, M1 disease, if not previously used, for individuals with nasopharyngeal cancer who meet ONE of the following:

Oligometastatic disease and PS 0-2
Widely metastatic disease and good PS (0-2)

Very advanced nasopharyngeal cancer

Tislelizumab-jsgr (Tevimbra) is considered medically necessary and, therefore, covered for subsequent-line systemic therapy, in combination with cisplatin and gemcitabine, if not previously used, for individuals with very advanced nasopharyngeal cancer and PS 0-1 who meet ONE of the following:

Unresectable locoregional recurrence with prior radiation therapy (RT)
Unresectable second primary with prior RT
Unresectable persistent disease with prior RT
Recurrent/persistent disease with distant metastases

HEPATOCELLULAR CARCINOMA
Tislelizumab-jsgr (Tevimbra) as a single agent is considered medically necessary and, therefore, covered, for individuals with hepatocellular carcinoma in ONE of the following:

As first-line systemic therapy for ONE of the following:

Have liver-confined, unresectable disease and are deemed ineligible for transplant (as initial treatment or following progression on or after locoregional therapy)
Have extrahepatic/metastatic disease and are deemed ineligible for resection, transplant, or locoregional therapy

As subsequent-line systemic therapy (if not previously used for those who have not been previously treated with a checkpoint inhibitor) if progression on or after systemic therapy

HODGKIN LYMPHOMA
Tislelizumab-jsgr (Tevimbra), in combination with gemcitabine and oxaliplatin (GEMOX) (NCCN preferred if no prior checkpoint inhibitor [CPI] exposure), is considered medically necessary and, therefore, covered, as second-line systemic therapy for individuals with Hodgkin lymphoma, in ANY of the following scenarios:

For primary refractory disease or relapse (within any time frame) and candidate for high-dose therapy and autologous stem cell rescue (HDT/ASCR)
For primary refractory disease or relapse if not a candidate for HDT/ASCR if no prior CPI or progression after 3 or more months of a CPI-containing regimen
For primary refractory disease or relapse if not a candidate for HDT/ASCR if no prior CPI or brentuximab vedotin (BV) exposure and progression after <3 months of a CPI or BV-containing regimen
For primary refractory disease or relapse and not a candidate for HDT/ASCR, with radiation therapy (RT), in individuals who received abbreviated chemotherapy (3-4 cycles) without RT

Tislelizumab-jsgr (Tevimbra), in combination with gemcitabine and oxaliplatin (GEMOX), as subsequent systemic therapy (if not previously used), for individuals with Hodgkin lymphoma, for primary refractory disease or biopsy proven relapse in ONE of the following scenarios:

Within 3 months and candidate for HDT/ASCR if Deauville 4 or 5 following restaging with fluorodeoxyglucose positron emission tomography and computed tomography (FDG-PET/CT)
After 3 or more months and candidate for HDT/ASCR if Deauville 4 or 5 following restaging with FDG-PET/CT
Not a candidate for HDT/ASCR if Deauville 4 or 5 following restaging with FDG-PET/CT for those individuals that received second-line systemic therapy plus RT for previously abbreviated chemotherapy without RT

RECTAL CANCER
Tislelizumab-jsgr (Tevimbra) as a single agent is considered medically necessary and, therefore, covered, for individuals with dMMR/MSI-H or POLE/POLD1 mutation with ultrahypermutated phenotype (e.g., TMB >50 mut/Mb) rectal cancer, who have not received prior immunotherapy, in ONE of the following scenarios:

As neoadjuvant/definitive immunotherapy for T3, N Any; T1-2, N1-2; T4, N Any; or locally unresectable or medically inoperable disease
As neoadjuvant treatment for resectable synchronous liver only and/or lung-only metastases
As initial treatment for resectable metachronous metastases
As primary treatment for synchronous abdominal/peritoneal metastases that are nonobstructing, or following local therapy for individuals with existing or imminent obstruction
As primary treatment for synchronous unresectable metastases
As primary treatment for unresectable metachronous metastases
As primary treatment for potentially resectable or unresectable isolated pelvic/anastomotic recurrence

SMALL BOWEL ADENOCARCINOMA
Tislelizumab-jsgr (Tevimbra) as a single agent is considered medically necessary and, therefore, covered, for individuals with dMMR/MSI-H or POLE/POLD1 mutation with ultrahypermutated phenotype (e.g., TMB >50 mut/Mb) small bowel adenocarcinoma who meet ONE of the following:

As neoadjuvant therapy for resectable disease that is T4 or has a bulky primary
As primary treatment for locally unresectable or medically inoperable disease
For any line of therapy for advanced or metastatic disease if no previous treatment with a checkpoint inhibitor

EXPERIMENTAL/INVESTIGATIONAL

All other uses for tislelizumab-jsgr (Tevimbra) are considered experimental/investigational and, therefore, not covered unless the indication is supported as an accepted off-label use, as defined in the Company medical policy on off-label coverage for prescription drugs and biologics.

MANDATES

PENNSYLVANIA MEMBERS
In accordance with the Commonwealth of Pennsylvania's Act 6 of 2020 or Fair Access to Cancer Treatment Act, for members who are enrolled in Pennsylvania commercial products who have Stage 4, advanced metastatic cancer, refer to the Medical Policy titled "Coverage of Anticancer Prescription Oral and Injectable Drugs and Biologics and Supportive Agents" (08.01.08) for additional information regarding the applicable coverage of drugs and biologics.

REQUIRED DOCUMENTATION

The individual's medical record must reflect the medical necessity for the care provided. These medical records may include, but are not limited to: records from the professional provider's office, hospital, nursing home, home health agencies, therapies, and test reports.

The Company may conduct reviews and audits of services to our members, regardless of the participation status of the provider. All documentation is to be available to the Company upon request. Failure to produce the requested information may result in a denial for the drug.

Guidelines

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable benefit contract, tislelizumab-jsgr (Tevimbra) is covered under the medical benefits of the Company's products when the medical necessity criteria listed in this medical policy are met.

COMBINED POSITIVE SCORE

In order to assess the efficacy of treatments, a scoring system was developed to calculate programmed death ligand-1 (PD-L1) expression in certain types of cancers. Combined positive score (CPS) is a scoring system that can be used for individuals with gastroesophageal cancer, urothelial carcinoma, and head and neck squamous cell carcinoma. The following equation is used for calculation:

Number of PD-L1 positive cells × 100 = CPS

Total number of viable tumor cells

KARNOFSKY PERFORMANCE SCORE

The Karnofsky Performance Status (KPS) is a standard way of measuring the ability of individuals with cancer to perform ordinary tasks. Performance scores range from 0 to 100; a higher score indicates that the individual is better able to perform activities. KPS may be used to determine an individual's prognosis, to measure changes in an individual's ability to function, or to decide if an individual can participate in a clinical trial.

The Karnofsky Performance Status Scale
100 percent	Normal, no complaints; no signs of disease
90 percent	Capable of normal activity; few symptoms or signs of disease
80 percent	Normal activity with some difficulty; some symptoms or signs of disease
70 percent	Caring for self; not capable of normal activity or work
60 percent	Requiring some help; can take care of most personal requirements
50 percent	Requires help often; requires frequent medical care
40 percent	Disabled; requires special care and help
30 percent	Severely disabled, but no risk of death
20 percent	Very ill; requires supportive measures or treatment
10 percent	Moribund; rapidly progressive fatal disease processes
0 percent	Death

MDCALC. Karnofsky performance status scale. [MDCALC Web site]. 2026. Available at: https://www.mdcalc.com/calc/3168/karnofsky-performance-status-scale. Accessed April 3, 2026.

THE EASTERN COOPERATIVE ONCOLOGY GROUP PERFORMANCE STATUS

The Eastern Cooperative Oncology Group (ECOG), established in 1955, was one of the first groups to coordinate multicenter cancer clinical trials. The National Cancer Institute (NCI) is the primary funding source, and ECOG has evolved from a small consortium of institutions in the eastern United States to one of the largest clinical cancer research organizations in the country. As part of their work in the treatment of cancer, ECOG has developed the ECOG Performance Status (PS), originally published in 1982 in the American Journal of Clinical Oncology. The use of the scales and the criteria in the ECOG PS allows clinicians and researchers to determine an individual’s disease progression in terms of how the activities of daily living (ADL) are affected.

ECOG Performance Status
Grade	ECOG
0	Fully active, able to carry on all pre-disease performance without restriction
1	Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature (eg, light housework, office work)
2	Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50 percent of waking hours
3	Capable of only limited self-care, confined to bed or chair more than 50 percent of waking hours
4	Completely disabled. Cannot carry on any self-care: totally confined to bed or chair
5	Dead

Oken MM, Creech RH, Tormey DC, et al. Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol. 1982;5(6):649-655.

US FOOD AND DRUG ADMINISTRATION STATUS

The US Food and Drug Administration (FDA) approved

tislelizumab-jsgr (Tevimbra) on March 13, 2024, for the treatment of adults with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) after prior systemic chemotherapy that did not include a programmed death-1/programmed death ligand-1 (PD-[L]1) inhibitor. Supplemental approvals for tislelizumab-jsgr (Tevimbra) have since been issued by the FDA.

PEDIATRIC USE
The safety and effectiveness of tislelizumab-jsgr (Tevimbra) in pediatric individuals have not been established.

Description

TISLELIZUMAB-JSGR (TEVIMBRA)

Tislelizumab-jsgr (Tevimbra) is an immunoglobulin G4 (IgG4) monoclonal antibody against programmed death-1 (PD-1). PD-1 is a checkpoint protein expressed on the membrane of activated T cells. The programmed death ligand-1 (PD-L1) and the programmed death ligand-2 (PD-L2) are checkpoint proteins expressed on tumor cells and tumor-infiltrating immune cells. When PD-L1 and PD-L2 attach to PD-1 receptors on the T cells, the T cells become inhibited and will not attack the tumor; thus, the tumor can continue to proliferate. By binding PD-1, the interaction with PD-L1 is inhibited, allowing the anti-tumor immune response.

ESOPHAGEAL CANCER

CLINICAL INFORMATION
Most esophageal cancers are made up of two types: adenocarcinoma and squamous cell carcinoma (SCC). Adenocarcinoma makes up more than 60 percent of the esophageal cancers in the United States, but SCC makes up the majority of esophageal cancers worldwide. Risk factors for adenocarcinoma include gastroesophageal reflux disease (GERD), smoking, and obesity. Risk factors for SCC include smoking and alcohol use. Each type of cancer not only acts differently clinically, but are also treated differently. Treatment is not only differentiated by the cancer type, but also by the stage of the cancer at diagnosis. Treatment usually consists of surgery and/or pharmacologic therapy.

CLINICAL TRIAL INFORMATION
Second line

On March 13, 2024, the US Food and Drug Administration (FDA) approved tislelizumab-jsgr (Tevimbra), as a single agent, for the treatment of adults with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) after prior systemic chemotherapy that did not include a PD-1 or PD-L1 inhibitor. This approval was based on a phase III randomized, active-controlled, open-label, multicenter clinical trial (NCT03430843; RATIONALE-302). Individuals with ESCC, who experienced tumor progression during or after first-line treatment for advanced unresectable or metastatic disease, were eligible to enroll. A total of 512 individuals were randomly assigned 1:1 into a cohort where they received tislelizumab-jsgr (Tevimbra) (n=256) or a cohort where they received investigator-chosen chemotherapy (ICC: paclitaxel, docetaxel, or irinotecan) (n=256). The primary endpoint was overall survival (OS). Key secondary endpoints included progression-free survival (PFS), objective response rate (ORR), and duration of response (DOR).

At the time of data cutoff, the median OS for the tislelizumab-jsgr (Tevimbra) cohort was 8.6 months versus 6.3 months for the ICC cohort (hazard ratio [HR], 0.7 [95 percent confidence interval (CI), 0.57–0.85; P=0.0001]). The median PFS in the intention-to-treat analysis set for the tislelizumab-jsgr (Tevimbra) cohort was 1.6 months versus 2.1 months for the ICC cohort (HR, 0.83 [95 percent CI, 0.67–1.01]). The median PFS in the PD-L1–positive analysis set for the tislelizumab-jsgr (Tevimbra) cohort was 2.7 months versus 2.3 months in the ICC cohort. The ORR was 15.2 percent (2 percent complete response [CR], 13.3 partial response [PR]) for the tislelizumab-jsgr (Tevimbra) cohort versus 6.6 percent (0.4 percent CR, 6.3 percent PR) for the ICC cohort. The median DOR for the tislelizumab-jsgr (Tevimbra) cohort was 7.1 months versus 4.0 months for the ICC cohort. Fewer individuals in the tislelizumab-jsgr (Tevimbra) cohort experienced treatment-related adverse events (TRAEs) or grade 3 or greater TRAEs than in the ICC cohort. For both cohorts, the primary cause of death was progression of disease, but the frequency was lower in the tislelizumab-jsgr (Tevimbra) cohort versus the ICC cohort.

First line

On April 22, 2025, the FDA approved tislelizumab-jsgr (Tevimbra), in combination with platinum-containing chemotherapy, for the first-line treatment of adults with unresectable or metastatic ESCC whose tumors express PD-L1 of 1 or greater. This approval was based on a phase III randomized, placebo-controlled, double-blind, multicenter clinical trial (NCT03783442; RATIONALE-306). Individuals with stage IV unresectable ESCC at diagnosis, or unresectable, locally advanced recurrent or metastatic ESCC that had received prior neoadjuvant/adjuvant platinum-based chemotherapy were eligible to enroll. A total of 649 individuals were randomly assigned 1:1 into a cohort where they received tislelizumab-jsgr (Tevimbra) plus chemotherapy (n=326) or a cohort where they received placebo plus chemotherapy (n=323). The primary endpoint was OS. Key secondary endpoints included PFS and ORR.

At the time of data cutoff, median OS for the tislelizumab-jsgr (Tevimbra) cohort was 17.2 months versus 10.6 months in the placebo cohort (HR 0.66 [95 percent CI, 0.54–0.80; P<0.0001]). The PFS, as assessed by blinded independent review committee (BIRC), for the tislelizumab-jsgr (Tevimbra) cohort was 8.4 months versus 5.7 months for the placebo cohort (HR 0.60, 95 percent CI, 0.49–0.74). The ORR in the tislelizumab-jsgr (Tevimbra) cohort was 63 percent versus 42 percent in the placebo cohort (odd ratio, 2.38 [95 percent CI, 1.73–3.27; P<0.0001). Adverse events were mostly evenly balanced between the two cohorts, but a higher proportion of individuals in the tislelizumab-jsgr (Tevimbra) cohort (29 percent) versus the placebo cohort (19 percent) experienced serious treatment-related treatment-emergent adverse events. The most common ones in the tislelizumab-jsgr (Tevimbra) cohort were pneumonia and neutropenia. An equal percentage of individuals in both cohorts experienced treatment-emergent adverse events that led to death.

GASTRIC CANCER

CLINICAL INFORMATION
Gastric cancer is cancer that arises in the stomach. The two most common risk factors include Helicobacter pylori infection and a family history of gastric cancer. Treatment is determined by the stage of the cancer at identification, and usually consists of surgery and/or pharmacologic therapy. Gastric cancer is often identified in later stages because the initial symptoms are similar to the symptoms of GERD. This may result in the cancer not being appropriate for surgical management due to invasion and/or spread.

CLINICAL TRIAL INFORMATION
On April 22, 2025, the FDA approved tislelizumab-jsgr (Tevimbra), in combination with platinum and fluoropyrimidine-based chemotherapy in adults for the first-line treatment of unresectable or metastatic human epidermal growth factor receptor-2 (HER2)-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 of 1 or greater. This approval was based on a phase III randomized, double-blind, placebo-controlled, multicenter clinical trial (NCT03777657; RATIONALE-305). Individuals with locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma, who had not received previous systemic therapy for the locally advanced or metastatic disease, were eligible to enroll. A total of 997 individuals were randomly assigned to receive tislelizumab-jsgr (Tevimbra) plus chemotherapy (n=501) versus placebo plus chemotherapy (n=496). The primary endpoint was OS. Key secondary endpoints included PFS, ORR, and DOR.

At the time of data cutoff, the median OS for the tislelizumab-jsgr (Tevimbra) cohort was 15.0 months versus 12.9 months for the placebo cohort (HR 0.80 [95 percent CI, 0.73–0.92; P=0.001]). The median PFS for the tislelizumab-jsgr (Tevimbra) cohort was 6.9 months versus 6.2 months for the placebo cohort (HR 0.78 [95 percent CI, 0.67–0.90]). The ORR for the tislelizumab-jsgr (Tevimbra) cohort was 47 percent (4 percent CR, 44 percent PR) versus 41 percent (4 percent CR, 37 percent PR) for the placebo cohort. The DOR was 8.6 percent in the tislelizumab-jsgr (Tevimbra) cohort versus 7.2 percent in the placebo cohort. TRAEs, and grade 3 or greater TRAEs, were evenly balanced between the two cohorts. TRAEs that let to death occurred in six (1 percent) individuals in the tislelizumab-jsgr (Tevimbra) cohort versus two (<1 percent) individuals in the placebo cohort.

OFF-LABEL INDICATIONS

There may be additional indications contained in the Policy section of this document due to evaluation of criteria highlighted in the Company's off-label policy, and/or review of clinical guidelines issued by leading professional organizations and government entities.

References

American Hospital Formulary Service (AHFS). Tislelizumab-jsgr (Tevimbra^®). AHFS Drug Information. [UpToDate Lexidrug Web site]. 03/24/2026. Available at: https://online.lexi.com/lco/action/home [via subscription only]. Accessed April 3, 2026.

Chan AOO, Wong BCY. Risk factors for gastric cancer. [UpToDate Web site]. 11/12/2025. Available at: https://www.uptodate.com/contents/risk-factors-for-gastric-cancer?search=Risk factors for gastric cancer&source=search_result&selectedTitle=1~150&usage_type=default&display_rank=1. [via subscription only]. Accessed April 3, 2026.

ClinicalTrials.gov. A study of tislelizumab (BGB-A317) in combination with chemotherapy as first line treatment in participants with advanced esophageal squamous cell carcinoma. ClinicalTrials.gov Identifier: NCT03783442. First Posted: December 21, 2018. Last Update Posted: July 29, 2025. Available at: https://clinicaltrials.gov/. Accessed April 3, 2026.

ClinicalTrials.gov. A study of tislelizumab (BGB-A317) versus chemotherapy as second line treatment in participants with advanced esophageal squamous cell carcinoma. ClinicalTrials.gov Identifier: NCT03430843. First Posted: February 13, 2018. Last Update Posted: October 26, 2024. Available at: https://clinicaltrials.gov/. Accessed April 3, 2026.

ClinicalTrials.gov. Tislelizumab in combination with chemotherapy as first-line treatment in adults with inoperable, locally advanced or metastatic gastric, or gastroesophageal junction carcinoma. ClinicalTrials.gov Identifier: NCT03777657. First Posted: December 17, 2018. Last Update Posted: February 14, 2025. Available at: https://clinicaltrials.gov/. Accessed April 3, 2026.

Elsevier's Clinical Pharmacology Compendium. Tislelizumab-jsgr (Tevimbra^®). [Clinical Key Web site]. 12/15/2025. Available at: https://www.clinicalkey.com/#!/ [via subscription only]. Accessed April 3, 2026.

Marletta S, Fusco N, Munari E, et al. Atlas of PD-L1 for pathologists: indications, scores, diagnostic platforms and reporting systems. J Pers Med. 2022;12(7):1073.

MDCALC. Karnofsky performance status scale. [MDCALC Web site]. 2026. Available at: https://www.mdcalc.com/calc/3168/karnofsky-performance-status-scale. Accessed April 3, 2026.

Merative Micromedex^® DRUGDEX^® (electronic version). Tislelizumab-jsgr (Tevimbra^®). [Micromedex Web site]. 03/05/2026. Available at: https://www.micromedexsolutions.com/micromedex2/librarian [via subscription only]. Accessed April 3, 2026.

National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology^®. Anal carcinoma, V1.2026. [NCCN Web site]. 01/26/2026. Available from: https://www.nccn.org/professionals/physician_gls/pdf/anal.pdf. [via subscription only]. Accessed April 3, 2026.

National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology^®. Appendiceal neoplasms and cancers, V1.2026. [NCCN Web site]. 10/30/2025. Available from: https://www.nccn.org/professionals/physician_gls/pdf/appendiceal.pdf. [via subscription only]. Accessed April 3, 2026.

National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology^®. Chronic lymphocytic leukemia/small lymphocytic lymphoma, V2.2026. [NCCN Web site]. 12/22/2025. Available from: https://www.nccn.org/professionals/physician_gls/pdf/cll.pdf. [via subscription only]. Accessed April 3, 2026.

National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology^®. Colon cancer, V1.2026. [NCCN Web site]. 03/05/2026. Available from: https://www.nccn.org/professionals/physician_gls/pdf/colon.pdf. [via subscription only]. Accessed April 3, 2026.

National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology^®. Esophageal and esophagogastric junction cancers, V2.2026. [NCCN Web site]. 01/21/2026. Available from: https://www.nccn.org/professionals/physician_gls/pdf/esophageal.pdf. [via subscription only]. Accessed April 3, 2026.

National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology^®. Gastric cancer, V2.2026. [NCCN Web site]. 01/21/2026. Available from: https://www.nccn.org/professionals/physician_gls/pdf/gastric.pdf. [via subscription only]. Accessed April 3, 2026.

National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology^®. Head and neck cancers, V1.2026. [NCCN Web site]. 12/08/2025. Available from: https://www.nccn.org/professionals/physician_gls/pdf/head-and-neck.pdf. [via subscription only]. Accessed April 3, 2026.

National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology^®. Hepatocellular carcinoma, V1.2026. [NCCN Web site]. 03/10/2026. Available from: https://www.nccn.org/professionals/physician_gls/pdf/hcc.pdf. [via subscription only]. Accessed April 3, 2026.

National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology^®. Hodgkin lymphoma, V1.2026. [NCCN Web site]. 10/22/2025. Available from: https://www.nccn.org/professionals/physician_gls/pdf/hodgkins.pdf. [via subscription only]. Accessed April 3, 2026.

National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology^®. Rectal cancer, V1.2026. [NCCN Web site]. 03/05/2026. Available from: https://www.nccn.org/professionals/physician_gls/pdf/rectal.pdf. [via subscription only]. Accessed April 3, 2026.

National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology^®. Small bowel adenocarcinoma, V1.2026. [NCCN Web site]. 01/22/2026. Available from: https://www.nccn.org/professionals/physician_gls/pdf/small_bowel.pdf. [via subscription only]. Accessed April 3, 2026.

National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology^®. Uterine neoplasms, V2.2026. [NCCN Web site]. 11/14/2025. Available from: https://www.nccn.org/professionals/physician_gls/pdf/uterine.pdf. [via subscription only]. Accessed April 3, 2026.

National Comprehensive Cancer Network (NCCN). NCCN Drugs & Biologics Compendium^®. [NCCN Web site]. Tislelizumab-jsgr (Tevimbra®). Available at: https://www.nccn.org/professionals/drug_compendium/content/ [via subscription only]. Accessed April 3, 2026.

Oken MM, Creech RH, Tormey DC, et al. Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol. 1982;5(6):649-655.

Qiu MZ, Oh DY, Kato K, et al. Tislelizumab plus chemotherapy versus placebo plus chemotherapy as first line treatment for advanced gastric or gastro-oesophageal junction adenocarcinoma: RATIONALE-305 randomised, double blind, phase 3 trial. BMJ. 2024; May 28;385:e078876.

Saltzman JR, Gibson MK, Sachdeva UM. Clinical presentation, diagnosis, and staging of esophageal cancer. [UpToDate Web site]. 09/02/2025. Available at: https://www.uptodate.com/contents/clinical-presentation-diagnosis-and-staging-of-esophageal-cancer?search=Clinical manifestations, diagnosis, and staging of esophageal cancer&source=search_result&selectedTitle=1~150&usage_type=default&display_rank=1. [via subscription only]. Accessed April 3, 2026.

Shen L, Kato K, Kim SB, et al. Tislelizumab versus chemotherapy as second-line treatment for advanced or metastatic esophageal squamous cell carcinoma (RATIONALE-302): a randomized phase III study. J Clin Oncol. 2022;40(26):3065-3076.

UpToDate^® Lexidrug^TM. Tislelizumab-jsgr (Tevimbra^®). [UpToDate Lexidrug Web site]. 02/02/2026. Available at: https://online.lexi.com/lco/action/home [via subscription only]. Accessed April 3, 2026.

US Food and Drug Administration (FDA). Center for Drug Evaluation and Research. Tislelizumab-jsgr (Tevimbra^®). Prescribing information. [FDA Web site]. 12/09/2025. Available at: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm. Accessed April 3, 2026.

Xu J, Kato K, Raymond E, et al. Tislelizumab plus chemotherapy versus placebo plus chemotherapy as first-line treatment for advanced or metastatic oesophageal squamous cell carcinoma (RATIONALE-306): a global, randomised, placebo-controlled, phase 3 study. Lancet Oncol. 2023;24(5):483-495.

Coding

CPT Procedure Code Number(s)

N/A

ICD - 10 Procedure Code Number(s)

N/A

ICD - 10 Diagnosis Code Number(s)

C11.0 Malignant neoplasm of superior wall of nasopharynx

C11.1 Malignant neoplasm of posterior wall of nasopharynx

C11.2 Malignant neoplasm of lateral wall of nasopharynx

C11.3 Malignant neoplasm of anterior wall of nasopharynx

C11.8 Malignant neoplasm of overlapping sites of nasopharynx

C11.9 Malignant neoplasm of nasopharynx, unspecified

C14.0 Malignant neoplasm of pharynx, unspecified

C14.2 Malignant neoplasm of Waldeyer's ring

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

C16.5 Malignant neoplasm of lesser curvature of stomach, unspecified

C16.6 Malignant neoplasm of greater curvature of stomach, unspecified

C16.8 Malignant neoplasm of overlapping sites of stomach

C16.9 Malignant neoplasm of stomach, unspecified

C17.0 Malignant neoplasm of duodenum

C17.1 Malignant neoplasm of jejunum

C17.2 Malignant neoplasm of ileum

C17.3 Meckel's diverticulum, malignant

C17.8 Malignant neoplasm of overlapping sites of small intestine

C17.9 Malignant neoplasm of small intestine, unspecified

C18.0 Malignant neoplasm of cecum

C18.1 Malignant neoplasm of appendix

C18.2 Malignant neoplasm of ascending colon

C18.3 Malignant neoplasm of hepatic flexure

C18.4 Malignant neoplasm of transverse colon

C18.5 Malignant neoplasm of splenic flexure

C18.6 Malignant neoplasm of descending colon

C18.7 Malignant neoplasm of sigmoid colon

C18.8 Malignant neoplasm of overlapping sites of colon

C18.9 Malignant neoplasm of colon, unspecified

C19 Malignant neoplasm of rectosigmoid junction

C20 Malignant neoplasm of rectum

C21.0 Malignant neoplasm of anus, unspecified

C21.1 Malignant neoplasm of anal canal

C21.2 Malignant neoplasm of cloacogenic zone

C21.8 Malignant neoplasm of overlapping sites of rectum, anus and anal canal

C22.0 Liver cell carcinoma

C22.8 Malignant neoplasm of liver, primary, unspecified as to type

C22.9 Malignant neoplasm of liver, not specified as primary or secondary

C30.0 Malignant neoplasm of nasal cavity

C54.0 Malignant neoplasm of isthmus uteri

C54.1 Malignant neoplasm of endometrium

C54.2 Malignant neoplasm of myometrium

C54.3 Malignant neoplasm of fundus uteri

C54.8 Malignant neoplasm of overlapping sites of corpus uteri

C54.9 Malignant neoplasm of corpus uteri, unspecified

C55 Malignant neoplasm of uterus, part unspecified

C78.01 Secondary malignant neoplasm of right lung

C78.02 Secondary malignant neoplasm of left lung

C78.32 Secondary malignant neoplasm of pharynx

C78.6 Secondary malignant neoplasm of retroperitoneum and peritoneum

C78.7 Secondary malignant neoplasm of liver and intrahepatic bile duct

C79.89 Secondary malignant neoplasm of other specified sites

C81.10 Nodular sclerosis Hodgkin lymphoma, unspecified site

C81.11 Nodular sclerosis Hodgkin lymphoma, lymph nodes of head, face, and neck

C81.12 Nodular sclerosis Hodgkin lymphoma, intrathoracic lymph nodes

C81.13 Nodular sclerosis Hodgkin lymphoma, intra-abdominal lymph nodes

C81.14 Nodular sclerosis Hodgkin lymphoma, lymph nodes of axilla and upper limb

C81.15 Nodular sclerosis Hodgkin lymphoma, lymph nodes of inguinal region and lower limb

C81.16 Nodular sclerosis Hodgkin lymphoma, intrapelvic lymph nodes

C81.17 Nodular sclerosis Hodgkin lymphoma, spleen

C81.18 Nodular sclerosis Hodgkin lymphoma, lymph nodes of multiple sites

C81.19 Nodular sclerosis Hodgkin lymphoma, extranodal and solid organ sites

C81.20 Mixed cellularity Hodgkin lymphoma, unspecified site

C81.21 Mixed cellularity Hodgkin lymphoma, lymph nodes of head, face, and neck

C81.22 Mixed cellularity Hodgkin lymphoma, intrathoracic lymph nodes

C81.23 Mixed cellularity Hodgkin lymphoma, intra-abdominal lymph nodes

C81.24 Mixed cellularity Hodgkin lymphoma, lymph nodes of axilla and upper limb

C81.25 Mixed cellularity Hodgkin lymphoma, lymph nodes of inguinal region and lower limb

C81.26 Mixed cellularity Hodgkin lymphoma, intrapelvic lymph nodes

C81.27 Mixed cellularity Hodgkin lymphoma, spleen

C81.28 Mixed cellularity Hodgkin lymphoma, lymph nodes of multiple sites

C81.29 Mixed cellularity Hodgkin lymphoma, extranodal and solid organ sites

C81.30 Lymphocyte depleted Hodgkin lymphoma, unspecified site

C81.31 Lymphocyte depleted Hodgkin lymphoma, lymph nodes of head, face, and neck

C81.32 Lymphocyte depleted Hodgkin lymphoma, intrathoracic lymph nodes

C81.33 Lymphocyte depleted Hodgkin lymphoma, intra-abdominal lymph nodes

C81.34 Lymphocyte depleted Hodgkin lymphoma, lymph nodes of axilla and upper limb

C81.35 Lymphocyte depleted Hodgkin lymphoma, lymph nodes of inguinal region and lower limb

C81.36 Lymphocyte depleted Hodgkin lymphoma, intrapelvic lymph nodes

C81.37 Lymphocyte depleted Hodgkin lymphoma, spleen

C81.38 Lymphocyte depleted Hodgkin lymphoma, lymph nodes of multiple sites

C81.39 Lymphocyte depleted Hodgkin lymphoma, extranodal and solid organ sites

C81.40 Lymphocyte-rich Hodgkin lymphoma, unspecified site

C81.41 Lymphocyte-rich Hodgkin lymphoma, lymph nodes of head, face, and neck

C81.42 Lymphocyte-rich Hodgkin lymphoma, intrathoracic lymph nodes

C81.43 Lymphocyte-rich Hodgkin lymphoma, intra-abdominal lymph nodes

C81.44 Lymphocyte-rich Hodgkin lymphoma, lymph nodes of axilla and upper limb

C81.45 Lymphocyte-rich Hodgkin lymphoma, lymph nodes of inguinal region and lower limb

C81.46 Lymphocyte-rich Hodgkin lymphoma, intrapelvic lymph nodes

C81.47 Lymphocyte-rich Hodgkin lymphoma, spleen

C81.48 Lymphocyte-rich Hodgkin lymphoma, lymph nodes of multiple sites

C81.49 Lymphocyte-rich Hodgkin lymphoma, extranodal and soild organ sites

C81.70 Other Hodgkin lymphoma, unspecified site

C81.71 Other Hodgkin lymphoma, lymph nodes of head, face, and neck

C81.72 Other Hodgkin lymphoma, intrathoracic lymph nodes

C81.73 Other Hodgkin lymphoma, intra-abdominal lymph nodes

C81.74 Other Hodgkin lymphoma, lymph nodes of axilla and upper limb

C81.75 Other Hodgkin lymphoma, lymph nodes of inguinal region and lower limb

C81.76 Other Hodgkin lymphoma, intrapelvic lymph nodes

C81.77 Other Hodgkin lymphoma, spleen

C81.78 Other Hodgkin lymphoma, lymph nodes of multiple sites

C81.79 Other Hodgkin lymphoma, extranodal and solid organ sites

C81.90 Hodgkin lymphoma, unspecified, unspecified site

C81.91 Hodgkin lymphoma, unspecified, lymph nodes of head, face, and neck

C81.92 Hodgkin lymphoma, unspecified, intrathoracic lymph nodes

C81.93 Hodgkin lymphoma, unspecified, intra-abdominal lymph nodes

C81.94 Hodgkin lymphoma, unspecified, lymph nodes of axilla and upper limb

C81.95 Hodgkin lymphoma, unspecified, lymph nodes of inguinal region and lower limb

C81.96 Hodgkin lymphoma, unspecified, intrapelvic lymph nodes

C81.97 Hodgkin lymphoma, unspecified, spleen

C81.98 Hodgkin lymphoma, unspecified, lymph nodes of multiple sites

C81.99 Hodgkin lymphoma, unspecified, extranodal and solid organ sites

C83.00 Small cell B-cell lymphoma, unspecified site

C83.01 Small cell B-cell lymphoma, lymph nodes of head, face, and neck

C83.02 Small cell B-cell lymphoma, intrathoracic lymph nodes

C83.03 Small cell B-cell lymphoma, intra-abdominal lymph nodes

C83.04 Small cell B-cell lymphoma, lymph nodes of axilla and upper limb

C83.05 Small cell B-cell lymphoma, lymph nodes of inguinal region and lower limb

C83.06 Small cell B-cell lymphoma, intrapelvic lymph nodes

C83.07 Small cell B-cell lymphoma, spleen

C83.08 Small cell B-cell lymphoma, lymph nodes of multiple sites

C83.09 Small cell B-cell lymphoma, extranodal and solid organ sites

C83.30 Diffuse large B-cell lymphoma, unspecified site

C83.31 Diffuse large B-cell lymphoma, lymph nodes of head, face, and neck

C83.32 Diffuse large B-cell lymphoma, intrathoracic lymph nodes

C83.33 Diffuse large B-cell lymphoma, intra-abdominal lymph nodes

C83.34 Diffuse large B-cell lymphoma, lymph nodes of axilla and upper limb

C83.35 Diffuse large B-cell lymphoma, lymph nodes of inguinal region and lower limb

C83.36 Diffuse large B-cell lymphoma, intrapelvic lymph nodes

C83.37 Diffuse large B-cell lymphoma, spleen

C83.38 Diffuse large B-cell lymphoma, lymph nodes of multiple sites

C83.398 Diffuse large B-cell lymphoma of other extranodal and solid organ sites

C91.10 Chronic lymphocytic leukemia of B-cell type not having achieved remission

C91.12 Chronic lymphocytic leukemia of B-cell type in relapse

D37.05 Neoplasm of uncertain behavior of pharynx

D37.1 Neoplasm of uncertain behavior of stomach

D37.3 Neoplasm of uncertain behavior of appendix

D37.8 Neoplasm of uncertain behavior of other specified digestive organs

D37.9 Neoplasm of uncertain behavior of digestive organ, unspecified

D38.5 Neoplasm of uncertain behavior of other respiratory organs

D38.6 Neoplasm of uncertain behavior of respiratory organ, unspecified

HCPCS Level II Code Number(s)

J9329 Injection, tislelizumab-jsgr, 1 mg

Revenue Code Number(s)

N/A

MPMiscCodesNarrativesPub

Coding and Billing Requirements

Cross Reference

Policy History

Revisions From 08.02.23b

10/01/2026	This version of the policy will become effective 10/01/2026. Inclusion of a policy in a Code Update memo does not imply that a full review of the policy was completed at this time. The following ICD-10 code has been added to this policy: C78.32 Secondary malignant neoplasm of pharynx

Revisions From 08.02.23a:

06/01/2026

This policy will become effective 06/01/2026.

The following policy criteria have been added to this policy as medically necessary in accordance with the National Comprehensive Cancer Network (NCCN):

Appendiceal neoplasms and cancers
Endometrial carcinoma
Hodgkin lymphoma

The following policy criteria have been revised in accordance with NCCN:

Anal carcinoma

Chronic lymphocytic leukemia/small lymphocytic lymphoma
Colon cancer
Esophageal and esophagogastric junction cancers
Hepatocellular carcinoma
Rectal cancer
Small bowel adenocarcinoma

The following ICD-10 codes have been added to this policy:

C11.0, C11.1, C11.2, C11.3, C11.8, C11.9, C14.0, C14.2, C15.3, C15.4, C15.5, C15.8, C15.9, C16.0, C16.1, C16.2, C16.3, C16.4, C16.5, C16.6, C16.8, C16.9, C17.0, C17.1, C17.2, C17.3, C17.8, C17.9, C18.0, C18.1, C18.2, C18.3, C18.4, C18.5, C18.6, C18.7, C18.8, C18.9, C19, C20, C21.0, C21.1, C21.2, C21.8, C22.0, C22.8, C22.9, C30.0, C54.0, C54.1, C54.2, C54.3, C54.8, C54.9, C55, C78.01, C78.02, C78.6, C78.7, C79.89, C81.10, C81.11, C81.12, C81.13, C81.14, C81.15, C81.16, C81.17, C81.18, C81.19, C81.20, C81.21, C81.22, C81.23, C81.24, C81.25, C81.26, C81.27, C81.28, C81.29, C81.30, C81.31, C81.32, C81.33, C81.34, C81.35, C81.36, C81.37, C81.38, C81.39, C81.40, C81.41, C81.42, C81.43, C81.44, C81.45, C81.46, C81.47, C81.48, C81.49, C81.70, C81.71, C81.72, C81.73, C81.74, C81.75, C81.76, C81.77, C81.78, C81.79, C81.90, C81.91, C81.92, C81.93, C81.94, C81.95, C81.96, C81.97, C81.98, C81.99, C83.00, C83.01, C83.02, C83.03, C83.04, C83.05, C83.06, C83.07, C83.08, C83.09, C83.30, C83.31, C83.32, C83.33, C83.34, C83.35, C83.36, C83.37, C83.38, C83.398, C91.10, C91.12, D37.05, D37.1, D37.3, D37.8, D37.9, D38.5, D38.6

Revisions From 08.02.23:

08/25/2025

The policy will become effective 08/25/2025.

The following new policy has been developed to communicate the Company's coverage criteria for tislelizumab-jsgr (Tevimbra^®).

Version Effective Date:

10/1/2026

Version Issued Date: