Pharmacy Prior Authorization Criteria

Hyrnuo (sevabertinib)

Indications for Prior Authorization

Hyrnuo (sevabertinib)

• For diagnosis of Non-squamous non-small cell lung cancer (NSCLC)
  Indicated for the treatment of adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain (TKD) activating mutations, as detected by an FDA-approved test, and who have received prior systemic therapy. This indication is approved under accelerated approval based on objective 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.

Criteria

Hyrnuo

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)

• Diagnosis of non-squamous non-small cell lung cancer (NSCLC)
AND
• Disease is one of the following:
• Locally advanced
• Metastatic
AND
• Presence of HER2 (ERBB2) tyrosine kinase domain activating mutations as detected by an FDA-approved test or a test performed at a facility approved by Clinical Laboratory Improvement Amendments (CLIA)
AND
• Patient has received prior systemic therapy (e.g., chemotherapy)

Hyrnuo

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)

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

P & T Revisions

2025-12-30

References

1. Hyrnuo Prescribing Information. Bayer HealthCare Pharmaceuticals Inc. Whippany, NJ. November 2025.

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Revision History

• 2025-12-30: New criteria.

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