Pharmacy Prior Authorization Criteria

Hernexeos (zongertinib)

Indications for Prior Authorization

Hernexeos (zongertinib)

• For diagnosis of Non-squamous non-small cell lung cancer (NSCLC)
  Indicated for the treatment of adult patients with unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain activating mutations, as detected by an FDA-approved test. 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

Hernexeos

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:
• Unresectable
• 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)

Hernexeos

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)

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

P & T Revisions

2026-03-23, 2025-10-01

References

1. Hernexeos Prescribing Infomation. Boehringer Ingelheim Pharmaceuticals, Inc. Ridgefield, CT 06877 USA. February 2026.

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Revision History

• 2026-03-23: Removed criteria requiring that the patient has received prior systemic therapy. Hernexeos was previously approved via accelerated approval for this indication in patients who received prior systemic therapy. This new approval expands the indication to include patients who have not received prior therapy.
• 2025-10-01: New program.

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