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: 10 May 2021

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)

PICO Confirmation

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Assessment Report

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Public Summary Document

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Meetings for this Application

PASC

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ESC

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MSAC