Pharmacy Prior Authorization Criteria

Augtyro (repotrectinib)

Indications for Prior Authorization

Augtyro (repotrectinib)

• For diagnosis of 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).

• For diagnosis of Solid Tumors
  Indicated for the treatment of adult and pediatric patients 12 years of age and older with solid tumors that: 1) have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion, 2) are locally advanced or metastatic or where surgical resection is likely to result in severe morbidity, and 3) have progressed following treatment or have no satisfactory alternative therapy. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

Criteria

Augtyro

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
• Patient has ROS1 rearrangement positive tumor(s) [A]

Augtyro

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Solid Tumors

• Diagnosis of solid tumors
AND
• Disease has neurotrophic tyrosine receptor kinase (NTRK) gene fusion (e.g., ETV6-NTRK3, TPM3-NTRK1, LMNA-NTRK1) [B]
AND
• Patient is 12 years of age or older
AND
• Disease is one of the following:
• Locally advanced
• Metastatic
• Unresectable (including cases where surgical resection is likely to result in severe morbidity)
AND
• One of the following:
• Disease has progressed following previous treatment (e.g., radiation therapy, systemic therapy, tyrosine kinase inhibitor [TKI])
• Disease has no satisfactory alternative treatments

Augtyro

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

2024-12-04, 2024-07-31, 2024-01-30

References

1. Augtyro Prescribing Information. Bristol-Myers Squibb Company. Princeton, NJ. June 2024.

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End Notes

1. An FDA-approved test to detect ROS1 rearrangements for selecting patients for treatment with AUGTYRO is not currently available. [1]
2. An FDA approved test to detect NTRK1/2/3 rearrangements for selecting patients for treatment with Augtyro is not currently available. [1]

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Revision History

• 2024-12-04: Addition of new 160mg capsule
• 2024-07-31: Addition of new indication of Solid Tumors
• 2024-01-30: New Program

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