WHA
 

Tepmetko (tepotinib)

Indications for Prior Authorization

Tepmetko (tepotinib)
  • For diagnosis of Non-small cell lung cancer (NSCLC)
    Indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition (MET) exon 14 skipping alterations.

Criteria

Tepmetko

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)

  • Diagnosis of non-small cell lung cancer (NSCLC)
    • AND
  • Disease is metastatic
    • AND
  • Presence of mesenchymal-epithelial transition (MET) exon 14 skipping alterations as detected by an FDA-approved test or a test performed at a facility approved by Clinical Laboratory Improvement Amendments (CLIA) [A]
Tepmetko

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)

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

  • Guideline ID
    GL-482192

  • Formulary
    Premium

  • Effective date
    Mar 1, 2026

  • P&T approval date
    Apr 21, 2021

P & T Revisions

2026-02-20, 2025-04-18, 2024-04-18, 2023-07-06, 2023-04-22, 2022-04-21, 2021-11-24, 2021-09-28, 2021-07-07, 2021-04-07

  1. Tepmetko Prescribing Information. EMD Serono, Inc. Boston, MA. February 2024.
  1. An FDA-approved test for detection of MET exon 14 skipping alterations in NSCLC for selecting patients for treatment with Tepmetko is not available. Testing for the presence of MET exon 14 skipping alterations in plasma specimens is recommended only in patients for whom a tumor biopsy cannot be obtained. [1]
  • 2026-02-20: 2026 annual review: Removed step through Tabrecta, removed NF criteria, updated genetic testing language to require FDA-approved test or a test performed at a facility approved by CLIA, updated guideline name to remove guideline types. Removed EHB formulary from guideline.
  • 2025-04-18: 2025 annual review: no criteria changes, background updates.
  • 2024-04-18: 2024 annual review: Added trial and failure requirement of Tabrecta or COT to reauth. Background updates.
  • 2023-07-06: Removed specialist requirement
  • 2023-04-22: Annual review: no criteria changes.
  • 2022-04-21: Annual review: no criteria changes.
  • 2021-11-24: Update Non-Formulary Criteria
  • 2021-09-28: GPI replication update.
  • 2021-07-07: Updated guideline name, guideline type (added Non Formulary), and added formulary strategy.
  • 2021-04-07: New Program