Medicare will not fund liquid biopsy testing for lung cancer patients, after the Medical Services Advisory Committee (MSAC) rejected an industry application to list ctDNA testing for NSCLC on the MBS.

The decision puts MSAC at odds with 2025 consensus recommendations from the Royal College of Pathologists of Australasia and the Thoracic Oncology Group of Australasia, which back ctDNA testing when tissue specimens are inadequate or unavailable [link here].

What MSAC decided

MSAC said the available evidence did not support public funding of plasma-based ctDNA testing to detect clinically actionable genetic alterations in NSCLC patients.

The committee reviewed three patient groups:

• Suspected NSCLC, tissue biopsy unavailable: MSAC found limited clinical utility, noting that identifying variants would not change treatment because current PBS restrictions for targeted therapies require histological confirmation of NSCLC.
• Confirmed NSCLC, initial tissue biopsy insufficient or failed: MSAC suggested any future re-application restrict this population to those with unresectable or metastatic disease, given greater clinical need.
• Recurrence or progression on first-line targeted therapy (e.g. EGFR-TKIs): MSAC found ctDNA produced smaller yields of clinically actionable variants than tumour tissue testing.

Across all three groups, MSAC flagged the risk of discordant results between ctDNA and tissue biopsy, and the potential for ctDNA to detect variants unrelated to the tumour, such as clonal haematopoiesis of indeterminate potential (CHIP).

MSAC also raised a structural concern: ctDNA testing is interdependent with PBS-subsidised targeted therapies, and advised that any future application be submitted as a joint PBAC/MSAC codependent application addressing clinical effectiveness, cost-effectiveness and budgetary impact.

Clinical response

It comes after a survey of Thoracic Oncology Group of Australasia (TOGA) members found 83% of oncologists would adopt ctDNA testing in advanced NSCLC if cost barriers were removed.

Professor Ben Solomon

Professor Ben Solomon, from the Peter MacCallum Cancer Centre and scientific chair of TOGA, said speed and non-invasiveness were the key advantages of ctDNA testing.

“We want to get results to make treatment decisions as quickly as possible — that’s one of the great advantages of ctDNA, apart from it being non-invasive,” he said.

Professor Solomon rejected MSAC’s concern that ctDNA listing would expand the pool of patients eligible for PBS-funded targeted therapies.

“This is what personalised medicine is all about — getting the right drug to the right patient. If you identify a genetic alteration and there’s a drug that’s going to work, it really is only a good thing if that patient gets that drug,” he said.

In the meantime, TOGA is preparing to launch the MRFF-funded ASPiRATION-2 Liquid study, which will offer ctDNA testing to 500 patients with advanced NSCLC who have disease progression on targeted therapies. The study uses a telehealth model, allowing remote consent and national reach, but Professor Solomon acknowledged the cap limits its scope.

“We do need avenues for testing beyond this,” he said.

The application was submitted by a cross-industry consortium: AstraZeneca, Boehringer Ingelheim, Daiichi Sankyo Australia, Illumina, SOPHiA Genetics and Thermo Fisher Scientific.

MSAC defers decision on HPV testing

Meanwhile, the MSAC has deferred its advice on the public funding of anal human papillomavirus (HPV) and cytology testing in high-risk populations such as men who have sex with men, transgender women, people living with HIV, people who have had vulval cancer or vulval pre-cancerous lesions, and solid organ transplant recipients commencing from 10 years post-transplant.

MSAC also deferred the codependent application for MBS listing of high-resolution anoscopy and ablative treatment of high-grade squamous intraepithelial lesions to prevent anal cancer in high-risk populations.

It said further assessment was required for MSAC to provide advice on the safety, comparative effectiveness, cost-effectiveness and financial estimates noting that proposed anal cancer testing approach results in relatively fewer deaths prevented than other screening programs.

“MSAC advised that in addition to re-assessing the clinical evidence available for each of the proposed populations, a new economic model should be commissioned for this application, with the aim of identifying the population(s) who are most likely to benefit from the screening approach and for whom such an approach is cost-effective.”