1660 - Diagnostic testing for mesenchymal-epithelial transition Exon 14 skipping alterations in non-small cell lung cancer, to determine Pharmaceutical Benefits Scheme eligibility for tepotinib treatment

Page last updated: 23 February 2022

Application Detail

Description of Medical Service

Testing of tumour material in patients with non-small cell lung cancer (NSCLC) to detect mesenchymal-epithelial transition Exon 14 (METex14) skipping alterations, to determine eligibility for treatment with TEPMETKOŽ (tepotinib) through the Pharmaceutical Benefits Scheme (PBS). PBS subsidy is also being sought for tepotinib for the treatment of patients with advanced NSCLC and confirmed METex14 skipping alterations.

Description of Medical Condition

NSCLC comprises approximately 85%-90% of all lung cancer. Surgical resection is unfeasible for patients that present with advanced disease. For the selection of therapies for advanced NSCLC, current clinical guidelines recommend performing molecular testing prior to the initiation of an anticancer drug. If a predictive oncogenic marker is identified, treatment with respective approved targeted agents is to be applied when possible. The MET receptor plays an important role in embryogenesis, tumour growth and metastasis. Genetic mutations that affect the splice sites of METex14 were identified predominantly in NSCLC. The consequence of METex14 mutations is the expression of a truncated MET receptor with increased and sustained activation and impaired ubiquitin-mediated degradation, resulting in oncogenic activation of MET. METex14 skipping alterations are reported to occur approximately in 3-5% of NSCLC cases

Reason for Application

New MBS item

Medical Service Type


Previous Application Number/s

Not Applicable

Associated Documentation

Application Form

Application Form (PDF 1145 KB)
Application Form (Word 242 KB)

Consultation Survey

Consultation Survey (PDF 560 KB)
Consultation Survey (Word 71 KB)

PICO Confirmation

PICO Confirmation (PDF 1313 KB)
PICO Confirmation (Word 271 KB)

Assessment Report


Public Summary Document

Public Summary Document (PDF 650 KB)
Public Summary Document (Word 266 KB)

Meetings for this Application


15-16 April 2021


7-8 October 2021


25-26 November 2021