Pharmacy Prior Authorization Criteria

Iressa (gefitinib)

For diagnosis of 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 epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test.
Limitation of Use: Safety and efficacy of Iressa have not been established in patients with metastatic NSCLC whose tumors have EGFR mutations other than exon 19 deletions or exon 21 (L858R) substitution mutations.

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)

AND

Presence of epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution 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

Trial and failure, or intolerance to generic gefitinib (Applies to Brand Iressa only)

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)

AND

Trial and failure, or intolerance to generic gefitinib (Applies to Brand Iressa only)

2025-04-03, 2024-04-03, 2023-06-30, 2023-04-10, 2022-04-06, 2021-04-13, 2020-03-16

Iressa Prescribing Information. AstraZeneca Pharmaceuticals LP. Wilmington, DE. February 2023.
National Comprehensive Cancer Network (NCCN) Drugs and Biologics Compendium [internet database]. National Comprehensive Cancer Network, Inc.; 2014. Updated periodically. Available by subscription at: www.nccn.org. Accessed March 27, 2023.

2025-04-03: 2025 Annual Review - updated verbiage for mutation criteria
2024-04-03: 2024 Annual Review - t/f requirement added to reauth criteria and updated references
2023-06-30: update guideline
2023-04-10: 2023 Annual Review - references updated
2022-04-06: 2022 Annual Review.
2021-04-13: Updated GPIs
2020-03-16: Annual Review: updated background & references