Pharmacy Prior Authorization Criteria

Ibtrozi (taletrectinib) - PA, NF

Indications for Prior Authorization

Ibtrozi (taletrectinib)

• For diagnosis of Locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC)
  Indicated for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC).

Criteria

Ibtrozi

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Non-Small Cell Lung Cancer

• Diagnosis of non-small cell lung cancer (NSCLC)
AND
• Disease is one of the following:
• Locally advanced
• Metastatic
AND
• Presence of ROS1 rearrangement-positive tumor as detected by an FDA-approved test or a test performed at a facility approved by Clinical Laboratory Improvement Amendments (CLIA)
AND
• One of the following:
• Trial and failure, contraindication, or intolerance to one of the following:
• Rozlytrek (entrectinib)
• Augtyro (repotrectinib)
OR
• For continuation of prior therapy

Ibtrozi

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Non-Small Cell Lung Cancer

• Patient does not show evidence of progressive disease while on therapy

Ibtrozi

Non Formulary

Length of Approval: 12 Month(s)
For diagnosis of Non-Small Cell Lung Cancer

• Submission of medical records (e.g., chart notes) confirming a diagnosis of non-small cell lung cancer (NSCLC)
AND
• Disease is one of the following:
• Locally advanced
• Metastatic
AND
• Presence of ROS1 rearrangement-positive tumor as detected by an FDA-approved test or a test performed at a facility approved by Clinical Laboratory Improvement Amendments (CLIA)
AND
• One of the following:
• Paid claims or submission of medical records (e.g., chart notes) confirming trial and failure, contraindication, or intolerance to one of the following:
• Rozlytrek (entrectinib)
• Augtyro (repotrectinib)
OR
• For continuation of prior therapy

P & T Revisions

2025-11-04, 2025-08-04

References

1. Ibtrozi Prescribing Information. Nuvation Bio Inc. Burlington, MA. June 2025.

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Revision History

• 2025-11-04: Commercial Formulary Strategy: To add a step through ONE of the following: Augtyro (repotrectinib) or Rozlytrek (entrectinib). With allowance for CoT. Add Ibtrozi NF criteria to mirror PA requiring paid claims and/or chart notes where appropriate. Update guideline name to Ibtrozi (taletrectinib) - PA, NF
• 2025-08-04: New program.

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