Pharmacy Prior Authorization Criteria

Rybrevant (amivantamab)

Indications for Prior Authorization

Rybrevant (amivantamab)

• For diagnosis of First-Line Treatment of NSCLC with EGFR Exon 20 Insertion Mutations
  Indicated in combination with carboplatin and pemetrexed 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 20 insertion mutations, as detected by an FDA-approved test. 2) Indicated in combination with carboplatin and pemetrexed 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 20 insertion mutations, as detected by an FDA-approved test.

• For diagnosis of First-Line Treatment of NSCLC with EGFR Exon 19 Deletions or Exon 21 L858R Substitution Mutations
  Indicated in combination with lazertinib 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.

• For diagnosis of Previously Treated NSCLC with EGFRExon 19 Deletions or Exon 21 L858R Substitution Mutations
  Indicated in combination with carboplatin and pemetrexed, is indicated for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations, whose disease has progressed on or after treatment with an EGFR tyrosine kinase inhibitor

• For diagnosis of Previously Treated non-small Cell Lung Cancer (NSCLC) with EGFR Exon 20 Insertion Mutations
  Indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy.

Criteria

Rybrevant

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
• One of the following:
• Both of the following:
• Presence of epidermal growth factor receptor (EGFR) exon 20 insertion 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)
AND
• One of the following:
• Disease has progressed on or after platinum-based chemotherapy (e.g., carboplatin, cisplatin)
OR
• Both of the following:
• Used as first-line treatment of NSCLC
• Used in combination with carboplatin and pemetrexed
OR
• Both of the following:
• 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
AND
• One of the following:
• Both of the following:
• Used as first line treatment of NSCLC
• Used in combination with Lazcluze (lazertinib)
OR
• Both of the following:
• Disease has progressed on or after treatment with an EGFR tyrosine kinase inhibitor (e.g., osimertinib)
• Used in combination with carboplatin and pemetrexed
AND
• Used in combination with Lazcluze (lazertinib)

Rybrevant

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)

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

P & T Revisions

2024-10-25, 2024-10-01, 2024-05-30, 2024-04-03, 2023-06-15, 2022-07-21, 2021-06-28

References

1. Rybrevant Prescribing Information. Janssen Biotech, Inc. Horsham, PA. September 2024.

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Revision History

• 2024-10-25: Added PA criteria for new indication: Previously Treated NSCLC with EGFR exon 19 Deletions or Exon 21 L858R Substitution Mutations
• 2024-10-01: Added PA criteria for new indication: First-Line Treatment of NSCLC with EGFRExon 19 Deletions or Exon 21 L858R Substitution Mutations.
• 2024-05-30: 2024 annual review. No criteria changes.
• 2024-04-03: Added PA criteria for new indication: First-Line Treatment of non-small Cell Lung Cancer (NSCLC). Updated accelerated approval to full approval.
• 2023-06-15: Annual review - removed prescriber requirement. Updated references.
• 2022-07-21: Annual review - no changes.
• 2021-06-28: New program.

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