Tevimbra (tislelizumab)
Indications for Prior Authorization
Tevimbra (tislelizumab)
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For diagnosis of Esophageal Squamous Cell Carcinoma
(1) Indicated for the treatment of adult patients with unresectable or metastatic esophageal squamous cell carcinoma after prior systemic chemotherapy that did not include a PD-(L)1 inhibitor (2) In combination with platinum-containing chemotherapy, indicated for first-line treatment of adults with unresectable or metastatic esophageal squamous cell carcinoma whose tumors express PD-L1 (≥1) -
For diagnosis of Gastric or Gastroesophageal Junction Adenocarcinoma
Indicated for the first-line treatment of adults with unresectable or metastatic HER2- negative gastric or gastroesophageal junction adenocarcinoma (G/GEJ) whose tumors express PD-L1 (≥1)
Criteria
Tevimbra
Prior Authorization (Initial Authorization)
Length of Approval: 12 Month(s)
For diagnosis of Esophageal Squamous Cell Carcinoma
- Diagnosis of esophageal squamous cell carcinoma AND
- Disease is one of the following:
- Unresectable
- Metastatic
- One of the following:
- Both of the following:
- Patient has received prior systemic chemotherapy AND
- Patient has not previously been treated with a PD-(L)1 inhibitor (e.g., Keytruda, Opdivo
- Used in combination with platinum-containing chemotherapy (e.g., carboplatin, cisplatin, oxaliplatin)
Tevimbra
Prior Authorization (Initial Authorization)
Length of Approval: 12 Month(s)
For diagnosis of Gastric or gastroesophageal junction adenocarcinoma
- Diagnosis of gastric or gastroesophageal junction adenocarcinoma AND
- Disease is one of the following:
- Unresectable
- Metastatic
- Disease is human epidermal growth factor receptor 2 (HER2)-negative AND
- Tumor(s) express PD-L1 as detected by an FDA-approved test or a test performed at a facility approved by Clinical Laboratory Improvement Amendments (CLIA) AND
- Used in combination with platinum (e.g., carboplatin, cisplatin, oxaliplatin) and fluoropyrimidine (e.g., fluorouracil) -based chemotherapy
Tevimbra
Prior Authorization (Reauthorization)
Length of Approval: 12 Month(s)
For diagnosis of All indications listed above
- Patient does not show evidence of progressive disease while on therapy
P & T Revisions
2025-03-31, 2025-02-05, 2024-09-27, 2024-09-26
References
- Tevimbra Prescribing Information. BeiGene USA, Inc. San Mateo, CA. March 2025.
Revision History
- 2025-03-31: Updated criteria for new indication for Esophageal Squamous Cell Carcinoma
- 2025-02-05: Added criteria for new indication of gastric or gastroesophageal junction adenocarcinoma
- 2024-09-27: New Program for Tevimbra
- 2024-09-26: New Program for Tevimbra