Pharmacy Prior Authorization Criteria

Gilotrif (afatinib)

Indications for Prior Authorization

Gilotrif (afatinib)

• For diagnosis of EGFR Mutation-Positive, Metastatic Non-Small Cell Lung Cancer (NSCLC)
  Indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have non-resistant epidermal growth factor receptor (EGFR) mutations as detected by an FDA-approved test. Limitation of Use: Safety and efficacy of Gilotrif have not been established in patients whose tumors have resistant EGFR mutations.

• For diagnosis of Previously Treated, Metastatic Squamous Non-Small Cell Lung Cancer (NSCLC)
  Indicated for the treatment of patients with metastatic, squamous non-small cell lung cancer (NSCLC) progressing after platinum-based chemotherapy.

Criteria

Gilotrif

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)

• Diagnosis of advanced or metastatic (stage IIIB or IV) non-small cell lung cancer (NSCLC)
AND
• One of the following:
• Both of the following:
• Presence of non-resistant epidermal growth factor (EGFR) mutations as detected by an U.S. Food and Drug Administration (FDA) -approved test or a test performed at a facility approved by Clinical Laboratory Improvement Amendments (CLIA).
AND
• Gilotrif will be used as first-line treatment
OR
• Both of the following:
• Diagnosis of squamous NSCLC
AND
• Disease progressed after platinum-based chemotherapy (e.g., cisplatin, carboplatin)

Gilotrif

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)

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

P & T Revisions

2024-11-15, 2023-06-29, 2023-04-10, 2022-04-04, 2021-09-27, 2021-05-19, 2021-04-13, 2020-03-12

References

1. Gilotrif Prescribing Information. Boehringer Ingelheim Pharmaceuticals, Inc. Ridgefield, CT. April 2022.

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Revision History

• 2024-11-15: 2024 Annual Review - minor update
• 2023-06-29: Removed specialist requirement
• 2023-04-10: 2023 Annual Review - references updated
• 2022-04-04: 2022 Annual Review- added examples of platinum-based chemotherapy
• 2021-09-27: Addition of EHB formulary to guideline, no changes to criteria
• 2021-05-19: Addition of EHB formulary to guideline, no changes to criteria
• 2021-04-13: 2021 Annual review: updated criterion to "test performed a facility approved by CLIA." Updated GPIs.
• 2020-03-12: Annual Review; updated references and background

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