1669 – KRAS G12C variant testing to determine eligibility for PBS-subsidised sotorasib second-line therapy in patients with locally advanced or metastatic non small cell lung cancer

Amendment to existing MBS item.

The proposed medical service is tumour testing in patients with non-squamous or not otherwise specified histology non-small cell lung cancer (NSCLC) to detect Kirsten rat sarcoma (KRAS) G12C pathogenic variants. The testing would determine eligibility for Pharmaceutical Benefits Schedule (PBS) subsidised sotorasib second-line therapy.Most testing in Australia is now done using next-generation sequencing with gene panels that include KRAS.

Type: Co-dependent technology

Non-squamous or not otherwise specified (NOS) non-small cell lung cancer (NSCLC). Lung cancer can be divided into two main subtypes, non-small cell lung cancer (NSCLC), which represents 85% of all lung cancer cases, and small cell carcinoma. Non-small cell lung cancer (NSCLC) comprises a heterogeneous group of tumours, including adenocarcinoma, the most common histologic subtype, squamous cell carcinoma and large cell carcinoma. Adenocarcinoma and large cell carcinoma (or NSCLC, NOS) constitute the non-squamous histologic subtypes. NSCLC is also a heterogeneous disease from a genomic standpoint, with a wide variety of genomic subtypes known to drive tumour growth. Pathogenic variants in the KRAS gene are the most prevalent oncogenic driver abnormality in NSCLC, reported in 20-25% of NSCLC in recent Australian studies, with about 13% of tumours having the KRAS G12C subtype.

• PASC consultation: Not applicable
• MSAC consultation: Closed 11 February 2022

• PASC meeting: 12 to 13 August 2021
• ESC meeting: 10 to 11 February 2022
• MSAC meeting: 31 March to 1 April 2022