Description of Medical ServiceThe 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.
Description of Medical ConditionNon-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.
Reason for ApplicationAmendment to existing MBS item
Medical Service TypeCo-dependent technology
Previous Application Number/sNot Applicable
Application FormApplication Form (PDF 1182 KB)
Application Form (Word 162 KB)
Consultation SurveyConsultation Survey (PDF 587 KB)
Consultation Survey (Word 68 KB)
MSAC consultation closed 11 February 2022.
For further information please refer to PASC, ESC, MSAC Key Dates
For further information on the consultation process please refer to MSAC Consultation Process
PICO ConfirmationPICO Confirmation (PDF 1644 KB)
PICO Confirmation (Word 351 KB)
Public Summary DocumentPublic Summary Document (PDF 534 KB)
Public Summary Document (Word 144 KB)
Meetings for this Application
PASC12-13 August 2021
ESC10-11 February 2022
MSAC31 March-1 April 2022
24-25 November 2022