An application for an MBS item for the gene expression profiling test, EndoPredict, for prediction of risk of distant recurrence of breast cancer under endocrine treatment has received support from the Medical Services Advisory Committee (MSAC).

At its July meeting, MSAC recommended an MBS item be established for the test as a prognostic aid in patients with estrogen receptor positive (ER+) and human epidermal growth factor receptor 2 negative (HER2–) early breast cancer. However it did not accept that the test could predict the benefit of chemotherapy (in addition to endocrine therapy) in this population, and therefore rejectd its use for making treatment decisions.

The MSAC approval followed two previous unsuccessful pitches by the test’s sponsor, Myriad Genetics Australia, which had been rejected due to issues with the evidence presented and the proposed item descriptor.

With these issues both clarified, MSAC said it now considered the test “comparatively safe, effective and good value for money when used as a prognostic test”.

It noted that some patients had already used the test at their own cost, saying one Australian pathology website “

The committee noted that some patients used the test at their own cost, although it said “one Australian pathology claims that EndoPredict can supply information about whether the patient can safely avoid chemotherapy, how beneficial chemotherapy would be and whether the patient can avoid extended endocrine therapy.”

It added: “MSAC reiterated that there was insufficient evidence to conclude that using EndoPredict would change health outcomes (predictive value), so to reduce the potential for inappropriate use on the MBS, advised that the supported item descriptor should state that the test is not to be used for predictive purposes.”

Rare cancer risk MRI screening

At its July meeting, MSAC also supported an application for an MBS item to support annual MRI screening for patients with a germline pathogenic or likely pathogenic germline variant of the Tumour Protein 53 (TP53).

It’s estimated about 330 Australian patients are affected by heritable TP53-related cancer (hTP53rc) syndrome, a number growing by 10-15 each year.

With its impact on a tumour suppressor gene, men and women with hTP53rc syndrome have a 90% and 100% chance, respectively, of developing cancer in their lifetime.

This is the highest risk of all cancer predisposition syndromes, MSAC heard.

The Australian Genomic Cancer Medicine Centre (Omico), which made the bid, stressed surveillance would be limited to once per year and would augment other current surveillance (which includes some use of dedicated MRI breast and MRI brain).

MSAC noted the scan must also be requested by a specialist or consultant physician in consultation with a clinical geneticist, although it said there should be few other restrictions on the item given the small size and high clinical needs of the population.

This was despite the major limitations to the evidence base supporting whole-body MRI in the patient group, it said. The only prospective RCT, LIFSCREEN, had “flawed data, which have only been presented at a conference and have not undergone peer review for publication”, it said.

Nevertheless, due to the rarity of the condition there likely always would be a limited evidence base to support the screening, MSAC said.

Beyond that the committee found general concerns regarding the potential for overtesting and overtreatment in this population were “not relevant, as the population is highly predisposed to developing cancer over the lifetime.”

“MSAC considered that surveillance that finds no tumours or a benign tumour is still important clinical information, as well as for monitoring the potential future development of malignant cancer for this population.”