WHA
 

Tarceva (erlotinib)

Indications for Prior Authorization

Tarceva (erlotinib)
  • For diagnosis of Non-Small Cell Lung Cancer (NSCLC)
    Indicated for 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 receiving first-line, maintenance, or second or greater line treatment after progression following at least one prior chemotherapy regimen.

    Limitations of use: Safety and efficacy of Tarceva have not been established in patients with NSCLC whose tumors have other EGFR mutations. Tarceva is not recommended for use in combination with platinum-based chemotherapy.

  • For diagnosis of Pancreatic Cancer
    Indicated for the first-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer in combination with gemcitabine.

Criteria

Brand Tarceva, Generic erlotinib

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Non-Small Cell Lung Cancer (NSCLC)

  • Diagnosis of locally advanced or metastatic non-small cell lung cancer (NSCLC) [2]
    • AND
  • Presence of epidermal growth factor receptor (EGFR) exon 19 deletions, exon 21 (L858R) substitution, G719X, L861Q, or S7681 mutation 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) [2]
Brand Tarceva, Generic erlotinib

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Pancreatic Cancer

  • One of the following diagnoses:
    • Locally advanced pancreatic cancer
    • Unresectable pancreatic cancer
    • Metastatic pancreatic cancer
    AND
  • Used in combination with Gemzar (gemcitabine)
Brand Tarceva, Generic erlotinib

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of All indications listed above

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

  • Guideline ID
    GL-556264

  • Formulary
    premium

  • Effective date
    Jun 1, 2026

  • P&T approval date
    Jul 14, 2003

P & T Revisions

2026-04-01, 2025-04-03, 2024-04-03, 2023-07-05, 2023-04-10, 2022-04-07, 2021-09-27, 2021-05-25, 2021-04-13, 2021-03-04, 2020-03-20, 2019-06-28

  1. Tarceva Prescribing Information. Genentech USA, Inc. South San Francisco, CA. October 2016.
  2. National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology. Non-small cell lung cancer. v.5.2026. Available by subscription at: https://www.nccn.org/professionals/physician_gls/pdf/nscl.pdf. Accessed March 30, 2026.
  3. Erlotinib Prescribing Information. Mylan Pharmaceuticals. Morgantown, WV. January 2019.
  • 2026-04-01: 2026 Annual Review - updated NSCLC criteria and references
  • 2025-04-03: 2025 Annual Review - Updated verbiage for mutation criteria, removed obsolete Brand Tarceva 25mg and 100mg, and updated references.
  • 2024-04-03: 2024 annual review - no criteria changes
  • 2023-07-05: update guideline
  • 2023-04-10: 2023 Annual Review - references updated
  • 2022-04-07: 2022 Annual Review - no criteria changes
  • 2021-09-27: Addition of EHB formulary to guideline, no changes to criteria
  • 2021-05-25: Addition of EHB formulary to guideline, no changes to criteria
  • 2021-04-13: Updated GPIs
  • 2021-03-04: 2021 Annual review: updated criterion to "test performed a facility approved by CLIA" . Also removed drug name from reauthorization criteria.
  • 2020-03-20: Annual review: no changes
  • 2019-06-28: Approved at June P&T for generic add to policy, eff 8/1/2019.