Pharmacy Prior Authorization Criteria

Tevimbra (tislelizumab)

Indications for Prior Authorization

Tevimbra (tislelizumab)

• For diagnosis of Esophageal Squamous Cell Carcinoma
  (1) Indicated 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-(L)1 inhibitor (2) Indicated in combination with platinum-containing chemotherapy for the first-line treatment of adults with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) whose tumors express PD-L1 (≥1).

• For diagnosis of Gastric or Gastroesophageal Junction Adenocarcinoma
  Indicated in combination with platinum and fluoropyrimidine-based chemotherapy 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
AND
• One of the following:
• All of the following:
• Patient has received prior systemic chemotherapy
AND
• Used as a single agent
AND
• Patient has not previously been treated with a PD-(L)1 inhibitor (e.g., Keytruda, Opdivo)
OR
• Both of the following:
• Used in combination with platinum-containing chemotherapy (e.g., carboplatin, cisplatin, oxaliplatin)
AND
• Tumor(s) express PD-L1 (greater than or equal to 1) as detected by an FDA-approved test or a test performed at a facility approved by Clinical Laboratory Improvement Amendments (CLIA)

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
AND
• Disease is human epidermal growth factor receptor 2 (HER2)-negative
AND
• Tumor(s) express PD-L1 (great than or equal to 1) 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

2025-10-13, 2025-03-31, 2025-02-05, 2024-09-27, 2024-09-26

References

1. Tevimbra Prescribing Information. BeiGene USA, Inc. San Mateo, CA. June 2025.

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Revision History

• 2025-10-13: Criteria verbiage update to align with label.
• 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

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