Patients with systemic sclerosis could soon have access to a Medicare-funded blood test to detect pulmonary arterial hypertension (PAH), after an item was officially recommended to the Federal Government.
The subsidy would streamline the screening process for finding PAH, which roughly 4800 SSc patients undergo every year and currently involves a lung function test and then a transthoracic echocardiogram.
This latter, performed by a trained sonographer or cardiologist with specialised ultrasound equipment, usually takes about an hour and has been described as difficult to access, particularly outside major cities.
The Medical Services Advisory Committee (MSAC) considered an application for an MBS item for N-terminal pro B-type natriuretic peptide (NT-proBNP) biomarker assay, performed via blood test as an alternative.
It noted NT-proBNP tests were already TGA approved and subject to Royal College of Pathologists Australia (RCPA) Quality Assurance Programs. Some five companies were currently offering seven lab-based assays, it said in its findings handed down last month.
Based on evidence submitted by the applicant, Janssen, the committee also found the blood test was at least as effective as transthoracic echocardiogram at detecting PAH and was also more specific, correctly identifying patients without PAH.
“If patients with systemic scleroderma could have a lung function test and a blood test which showed a normal NTproBNP level, they might not need to have a transthoracic echocardiogram that year,” it wrote.
“This would reduce the number of other tests people would need to have, saving money and time.”
Additionally, the committee heard evidence from the Australian Scleroderma Interest Group (ASIG) that, while annual testing was now considered standard of care for patients with scleroderma, it was “often performed ad-hoc, or not at all”.
As a result, it found GPs should be allowed to refer the tests, if done in consultation with the patient’s specialist.
But it rejected an application to fund NT-proBNP testing in patients already diagnosed with PAH for monitoring purposes.
It said the trial data presented suggested in these patients, NT-proBNP testing was not expected to perform better than echocardiograms, which would also potentially be required anyway for other clinical reasons.
“MSAC considered this could make NT-proBNP testing an unnecessary additional test that might not change how the patient was managed,” it said.
On the other hand, it said it was possible doctors would use NT-proBNP testing for patients with other types of heart conditions that had not been assessed by MSAC for clinical or cost-effectiveness, potentially increasing the overall cost to government.
“MSAC considered that having an MBS item that is only for people with systemic sclerosis would reduce use in patients with other types of heart conditions,” it added.
Proposed item descriptor:
Category 6 – PATHOLOGY SERVICES
Group P2 – Chemical
|Quantification of laboratory-based NT-proBNP testing in a patient with systemic sclerosis (scleroderma) to assess risk of pulmonary arterial hypertension, requested by:
Maximum of two tests in a 12 month period.
Fee: $58.50 Benefit: 75% = 43.90 85% = $49.75
|Proposed explanatory note
NT-proBNP testing should be performed along with a pulmonary function test (PFT) measuring diffusing capacity for carbon monoxide in accordance with the 2012 Australian Scleroderma Interest Group (ASIG) pulmonary arterial hypertension (PAH) screening algorithm.
Repeat testing within a 12 month period should only be performed for a patient presenting with new symptoms suggestive of PAH since last assessment or a patient that has a borderline NT-proBNP level between 168-209 pg/mL.