Budget impact analysis of sFlt-1/PlGF ratio as prediction test in Italian women with suspected preeclampsia

Abstract

Introduction: Preeclampsia (PE) is a pregnancy disease which represents a leading cause of maternal and perinatal mortality and morbidity. Accurate prediction of PE risk could provide an increase in health benefits and better patient management.

Objective: To estimate the economic impact of introducing Elecsys sFlt-1/PlGF ratio test, in addition to standard practice, for the prediction of PE in women with suspected PE in the Italian National Health Service (INHS).

Methods: A decision tree model has been developed to simulate the progression of a cohort of pregnant women from the first presentation of clinical suspicion of PE in the second and third trimesters until delivery. The model provides an estimation of the financial impact of introducing sFlt-1/PlGF versus standard practice. Clinical inputs have been derived from PROGNOSIS study and from literature review, and validated by National Clinical Experts. Resources and unit costs have been obtained from Italian-specific sources.

Results: Healthcare costs associated with the management of a pregnant woman with clinical suspicion of PE equal €2384 when following standard practice versus €1714 using sFlt-1/PlGF ratio test.

Conclusions: Introduction of sFlt-1/PlGF into hospital practice is cost-saving. Savings are generated primarily through improvement in diagnostic accuracy and reduction in unnecessary hospitalization for women before PE’s onset.

Keywords:

• Preeclampsia
• sFlt-1
• PlGF
• budget impact
• sFlt

Declaration of interest

Davide Paolini and Matteo Dionisi reported being employees of Roche Diagnostics S.p.A. The research has been supported by an unconditional grant from Roche Diagnostics S.p.A.

Notes

¹ Suspicion of clinical diagnosis of PE implicates new onset of elevated blood pressure; aggravation of preexisting hypertension; new onset of protein in urine; one or more of the following reasons, such as epigastric pain; severe edema; headache; visual disturbances; weight gain; low platelets; elevated liver transaminases; suspected intrauterine growth restriction; abnormal uterine perfusion detected by Doppler sonography with mean Pulsatility Index (PI) < 95th percentile in the second trimester and/or bilateral uterine artery notching.

² Population growth was calculated as the average compound annual growth rate of female population (2012–2105).

³ PE signs are identified as epigastric pain; severe edema; headache; oliguria; visual disturbances; confirmed hypertension; confirmed proteinuria; proteinuria dipstick result of +1; one or more criteria met for HELLP syndrome: increased AST (<70 IU/L); reduced thrombocyte counts (<100,000/μL); increased LDH levels (>600 IU/L); intrauterine growth restriction; abnormal uterine perfusion detected by Doppler Sonography with mean PI > 95th percentile.

⁴ Exchange rate Pound to Euro was applied (Bank of Italy 26 August 2015).