WHA

Iressa (gefitinib)

Indications for Prior Authorization

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.

Criteria

Brand Iressa, Generic gefitinib

For state-mandated plans in Illinois or other states where applicable: Step therapy requirements do NOT apply. Beginning January 1, 2026, step therapy requirements or use of the authorization of alternative covered medications in a manner that effectively creates a step therapy requirement will not be imposed.

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)

  • Diagnosis of metastatic non-small cell lung cancer (NSCLC)
    • 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)
Brand Iressa, Generic gefitinib

For state-mandated plans in Illinois or other states where applicable: Step therapy requirements do NOT apply. Beginning January 1, 2026, step therapy requirements or use of the authorization of alternative covered medications in a manner that effectively creates a step therapy requirement will not be imposed.

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)

  • Patient does not show evidence of progressive disease while on therapy
    • AND
  • Trial and failure, or intolerance to generic gefitinib (Applies to Brand Iressa only)

  • Guideline ID
    GL-486428

  • Formulary
    Premium

  • Effective date
    Jan 1, 2026

  • P&T approval date
    Jul 14, 2003

P & T Revisions

1970-01-01, 2025-12-18, 2025-04-03, 2024-04-03, 2023-06-30, 2023-04-10, 2022-04-06, 2021-04-13, 2020-03-16

  1. Iressa Prescribing Information. AstraZeneca Pharmaceuticals LP. Wilmington, DE. February 2023.
  2. 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.
  • 2025-12-18: no criteria changes, added IL statute operational note
  • 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