Public Summary Document Application 1351 Point of care tests to exclude pre-term labour: Quantitative Fetal – Fibronectin (fFN) testing for predicting pre-term labour Applicant: Hologic Australia Pty Ltd Date of MSAC consideration: MSAC 62nd Meeting, 26-28 November 2014 Context for decision: MSAC makes its advice in accordance with its Terms of Reference, see at Purpose of application and links to other applications An application requesting the Medicare Benefits Schedule (MBS) listing of fetal fibronectin (fFn) tests for excluding false preterm labour was received from Hologic Australia Pty Ltd by the Department of Health in July 2013. The applicant proposed one MBS item descriptor and fee that could be used for either the quantitative version of the fFN test or the qualitative version of the fFN test. A related application proposing MBS listing of the Phosphorylated Insulin-like Growth Factor Binding Protein (phIGFBP-1) test for excluding false preterm labour was received from Alere Pty Ltd (Inverness Medical Innovations Australia) (Application Number 1335) and considered by MSAC at the same meeting. advice to the Minister MSAC’s After considering the available evidence in relation to safety, clinical effectiveness and of quantitative fFN testing for predicting pre-term labour, MSAC did not support public funding because of inadequate test performance and thus unacceptable overall clinical effectiveness and cost-effectiveness. MSAC noted that the evidence demonstrated poor and variable accuracy of the test, no verification of additive value over existing methods of assessing the risk of pre-term labour, but also evidence that use of the test would not change current clinical practice. Summary of consideration and rationale for advice MSAC’s MSAC noted the application requested MBS listing of point of care testing of fFN in cervicovaginal secretions of women presenting with symptoms of early labour for the purposes of excluding pre-term labour. Two presentations of the test were proposed: a dipstick qualitative test and an optical reader quantitative test. The fFN test can be used to distinguish between false labour and true labour in women threatening pre-term labour. fFN is typically absent from cervicovaginal secretions between 24 and 36 weeks gestation, becoming detectable as full term approaches. Elevated levels of
Public Summary Document Application 1351 – Point of care tests to exclude pre-term labour: Quantitative Fetal Fibronectin (fFN) testing for predicting pre-term labour Applicant: Hologic Australia Pty Ltd Date of MSAC consideration: MSAC 62nd Meeting, 26-28 November 2014 Context for decision: MSAC makes its advice in accordance with its Terms of Reference, see at Purpose of application and links to other applications An application requesting the Medicare Benefits Schedule (MBS) listing of fetal fibronectin (fFn) tests for excluding false preterm labour was received from Hologic Australia Pty Ltd by the Department of Health in July 2013. The applicant proposed one MBS item descriptor and fee that could be used for either the quantitative version of the fFN test or the qualitative version of the fFN test. A related application proposing MBS listing of the Phosphorylated Insulin-like Growth Factor Binding Protein (phIGFBP-1) test for excluding false preterm labour was received from Alere Pty Ltd (Inverness Medical Innovations Australia) (Application Number 1335) and considered by MSAC at the same meeting. MSAC’s advice to the Minister After considering the available evidence in relation to safety, clinical effectiveness and of quantitative fFN testing for predicting pre-term labour, MSAC did not support public funding because of inadequate test performance and thus unacceptable overall clinical effectiveness and cost-effectiveness. MSAC noted that the evidence demonstrated poor and variable accuracy of the test, no verification of additive value over existing methods of assessing the risk of pre-term labour, but also evidence that use of the test would not change current clinical practice. Summary of consideration and rationale for MSAC’s advice MSAC noted the application requested MBS listing of point of care testing of fFN in cervicovaginal secretions of women presenting with symptoms of early labour for the purposes of excluding pre-term labour. Two presentations of the test were proposed: a dipstick qualitative test and an optical reader quantitative test. The fFN test can be used to distinguish between false labour and true labour in women threatening pre-term labour. fFN is typically absent from cervicovaginal secretions between 24 and 36 weeks gestation, becoming detectable as full term approaches. Elevated levels of
1351-Final-PSD-accessible.docx