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

New MBS item.

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 TEPMETKO® (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.

Type: Therapeutic

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. 

• PASC meeting: 15 to 16 April 2021
• ESC meeting: 7 to 8 October 2021
• MSAC meeting: 25 to 26 November 2021