Pharmacy Prior Authorization Criteria

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.

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 (stage III or IV) non-small cell lung cancer (NSCLC) [2]

AND

Patient has known active epidermal growth factor receptor (EGFR) exon 19 deletions, exon 21 (L858R) substitution, exon 18 (G719X, G719) or exon 20 (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]

Prior Authorization (Initial Authorization)

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

AND

Prior Authorization (Reauthorization)

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

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

Tarceva Prescribing Information. Genentech USA, Inc. South San Francisco, CA. October 2016.
National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology. Non-small cell lung cancer. v.3.2022. Available by subscription at: https://www.nccn.org/professionals/physician_gls/pdf/nscl.pdf. Accessed March 27, 2023.
Erlotinib Prescribing Information. Mylan Pharmaceuticals. Morgantown, WV. January 2019.

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.