Recommendation for improved genetic testing for Non-Small Cell Lung Cancer Patients
Recommendation by the Medical Services Advisory Committee (MSAC)
Why is gene testing important for lung cancer patients?
Non-small cell lung cancer (NSCLC) accounts for about 80% to 85% of lung cancers. The main subtypes of NSCLC are adenocarcinoma, squamous cell carcinoma, or large undifferentiated carcinoma depending on the cell type where the cancer is identified. These subtypes are often grouped together as NSCLC because their treatment and prognoses (outlook) are often similar.
A minority of NSCLC subtypes have certain genetic changes that drive tumour growth and can be used as targets for treatments. Targeted treatments only work in NSCLC patients with a target gene variant, so genetic testing (also sometimes referred to as biomarker testing) is needed to determine if someone should receive a certain treatment or not. Currently, people with lung cancer are tested for EGFR, ALK fusion and ROS1 genes sequentially – that is, one after another. Reimbursed treatment options exist if one of these genetic variants is found, and patients on these targeted treatment can live for many years and enjoy good quality of life. There has been a large and continually growing number of genetic variants identified that drive NSCLC tumour growth, and accompanying development of new targeted treatments starting to become available outside of clinical trials. Sequential testing can delay the commencement of treatment or there may not be sufficient tissue to conduct a test for each genetic variant, and some genetic variants may not be included in testing at all.
Recent proposal for an additional MBS item
The Medical Services Advisory Committee (MSAC) is an independent non-statutory committee established by the Australian Government Minister for Health in 1998. MSAC appraises new medical services proposed for public funding, and provides advice to Government on whether a new medical service should be publicly funded (and if so, its circumstances) on an assessment of its comparative safety, clinical effectiveness, cost-effectiveness and total cost, using the best available evidence.
At the MSAC meeting held on the 24-25 November 2022, one of the applications that was considered for MSAC recommendation was the “Small gene panel testing for non-small cell lung carcinoma” application which can be found here. This application is for a gene panel, which means the laboratory can test for many gene variants at once from the same tumour sample. Different tests are available but EGFR, BRAF, KRAS, MetExon14, ALK fusion, ROS1, RET and NTRK1, 2 and 3 are included.
This approach significantly improves the diagnostic process as it maximises the use of tumour tissue available and is faster than sequential testing. The tissue to be used in gene panel testing has to meet certain qualitative and quantitative criteria so it is important for patients to discuss with their treating clinicians whether this is a viable option for them. Furthermore, the gene panel approach will only be offered to non-squamous NSCLC patients as it is rare for people with squamous NSCLC to have gene variants.
Following the review of the application, MSAC officially recommended that the gene panel test be funded for non-squamous NSCLC patients, marking a significant milestone in improved diagnosis and treatment for lung cancer patients. The Federal Government announced in the May budget that funding for this test will commence from 1 November 2023, meaning that all metastatic NSCLC patients will be able to access testing for EGFR, BRAF, KRAS, MetExon14, ALK fusion, ROS1, RET and NTRK 1,2, and 3.
Until November, options to gain expanded gene panel testing include clinical trials such as the ASPiRATION study, its replacement CaSP or self-funding. Some State-based services may also pay for further testing. Outside of these options, newly-diagnosed advanced NSCLC patients access testing for EGFR, ROS1 and ALK, which all have options for reimbursed targeted treatments. Please talk to your oncologist about your options.
TOGA’s role in the gene panel application
TOGA has long recognised the importance of improved genetic testing in patient care, and established a national multicentre study in 2020 – The ASPiRATION study, an observational cohort study to assess the clinical impact of upfront comprehensive genomic profiling (CGP) on the management of patients with metastatic NSCLC. Amongst providing other information, ASPiRATION enabled access to testing for the expanded number of genetic variants in a single test for newly diagnosed metastatic NSCLC patients. If a genetic variant was identified, the patient was then offered options to access targeted treatments, such as a clinical trial. As part of TOGA’s commitment for advocacy on improved patient care TOGA wrote a letter in support for the small gene panel testing application to MSAC and provided feedback on the small gene panel application consultation survey. TOGA commends the funding for this panel as the wide availability of this testing provides the best possible care for people living with metastatic NSCLC throughout Australia.