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

Page last updated: 27 October 2022

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 item

Medical Service Type

Co-dependent technology

Previous Application Number/s

Not Applicable

Associated 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)

Meetings for this Application


12-13 August 2021


10-11 February 2022


31 March-1 April 2022