Pharmacy Prior Authorization Criteria

Lazcluze (lazertinib)

Indications for Prior Authorization

Lazcluze (lazertinib)

• For diagnosis of Non-small cell lung cancer (NSCLC)
  Indicated in combination with amivantamab, for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test.

Criteria

Lazcluze

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)

• Diagnosis of non-small cell lung cancer (NSCLC)
AND
• Disease is one of the following:
• Locally advanced
• Metastatic
AND
• Used as first line treatment of NSCLC
AND
• Used in combination with Rybrevant (amivantamab)
AND
• Presence of epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations as detected by a U.S. Food and Drug Administration (FDA) approved test or a test performed at a facility approved by Clinical Laboratory Improvement Amendments (CLIA)

Lazcluze

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)

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

P & T Revisions

2024-10-01

References

1. Lazcluze Prescribing Information. Janssen Biotech, Inc. Horsham, PA. August 2024.

---

Revision History

• 2024-10-01: New Program.

---