The Medical Services Advisory Committee has rejected a bid to publicly fund FibroScan for detecting advanced liver fibrosis in patients with MAFLD because it is not convinced an MBS item will change clinical management or improve outcomes.

However, the Gastroenterological Society of Australia, which supported the application, says the evidence in the MAFLD treatment space is rapidly changing with therapeutic options on the horizon and would strongly support reconsideration of the decision, particularly in specialist settings.

The application, put forward by Health Technology Analysts, requested a MBS item for vibration-controlled transient elastography, delivered by FibroScan devices, to be used in both specialist and primary care settings to help GPs triage referrals.

It proposed patients with a FIB-4 score of ≥1.3 should be recommended for the non-invasive test, with a liver stiffness measurement of ≥8 kPa the threshold for identifying higher risk patients requiring specialist referral for further assessment.

In a recently published public summary document [link here], MSAC argued the liver stiffness measurement of ≥8 kPa was too low, potentially leading to too many false positive results and unnecessary specialist referrals.

The committee also said it could not advise the government on how much funding the technology would cost due to “highly uncertain” economic modelling in the application. The financial implications were likely to be considerable based on the high prevalence of MAFLD in the community, it added.

Among other concerns, the committee said much of the application’s evidence for clinical effectiveness, such as test accuracy, was “indirect, non-comparative and of low generalisability and applicability to the proposed testing scenario”.

It also considered there was a risk the MBS item would be inappropriately used for monitoring patients with MAFLD or for assessing patients with other liver conditions, that the proposed item fee was too high, and that GPs were unlikely to purchase or have the devices already available in their clinics limiting access.

Professor Alex Thompson.

GESA keen to continue push for funding

GESA president Professor Alex Thompson said the outcome was disappointing.

“We think that FibroScan is an accurate and clinically useful triage tool to identify patients either with cirrhosis or at risk of advanced liver fibrosis when used properly,” said the hepatologist, who also leads the gastroenterology department at St Vincent’s Hospital Melbourne.

“We would strongly support it being reimbursed and available.

“One of the outcomes of this disappointing rejection is that in the cities through the hospitals, the local population has pretty good access to FibroScan already, but in regional and non-metropolitan areas, access is very limited. This will be a barrier to increasing access to FibroScan in those regional and non-metropolitan areas.”

As for MSAC’s concerns about the lack of medical treatment for MAFLD to justify funding the test, Professor Thompson stressed the space was rapidly changing, with phase 3 data now showing semaglutide could lead to a histological benefit.

He also pointed to the US Food and Drug Administration’s breakthrough approval of resmetirom in 2024 for metabolic dysfunction-associated steatohepatitis, although it was still unclear if this drug would be approved in Australia.

“We know that fatty liver disease is driven by metabolic dysfunction, and that the GLP-1 analogues can reverse metabolic dysfunction. So it is very likely that in Australia GLP-1s will have a label for fatty liver disease in the future,” he said.

“Once that is available, there will need to be a triage tool to identify patients with more advanced disease who are candidates for reimbursed treatment. FibroScan would seem like the most suitable tool for identifying those patients.”

Professor Thompson said GESA would be interested in partnering or even strategically leading a reapplication for FibroScan, although, as the rejection was “hot off the press”, there were no formal plans as of yet for that to happen.

He defended the application’s 8 kPa threshold, which had been recommended by international societies including Europe’s liver disease society, but said GESA would be open to a conversation with MSAC about adjusting the threshold.

He also said GESA would work with MSAC on the other evidence and value metrics required to ensure the next funding application gets across the line.

Health Technology Analysts also responded to the rejection, stating that while the test was already being used in Australian clinical practice, it believed that the absence of public funding would result in inequitable and fragmented access.