Application Detail
Description of Medical Service
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.Description of Medical Condition
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.Reason for Application
Amendment to existing MBS itemMedical Service Type
Co-dependent technologyPrevious Application Number/s
Not ApplicableAssociated Documentation
Application Form
Application Form (PDF 1182 KB)Application Form (Word 162 KB)
Consultation Survey
Consultation Survey (PDF 587 KB)Consultation Survey (Word 68 KB)
PASC Consultation
Not applicable
MSAC Consultation
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 Confirmation
PICO Confirmation (PDF 1644 KB)PICO Confirmation (Word 351 KB)
Assessment Report
-Public Summary Document
Public Summary Document (PDF 534 KB)Public Summary Document (Word 144 KB)