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. 2018 Aug 6;18(1):603.
doi: 10.1186/s12913-018-3406-1.

Economic assessment of the use of the sFlt-1/PlGF ratio test to predict preeclampsia in Germany

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Economic assessment of the use of the sFlt-1/PlGF ratio test to predict preeclampsia in Germany

Dietmar Schlembach et al. BMC Health Serv Res. .

Abstract

Background: The PRediction of short-term Outcome in preGNant wOmen with Suspected preeclampsIa Study (PROGNOSIS) demonstrated that a soluble fms-like tyrosine kinase 1/placental growth factor (sFlt-1/PlGF) ratio ≤ 38 ruled out the occurrence of preeclampsia in the next week with a negative predictive value of 99.3%; a ratio > 38 indicates an increased risk of developing preeclampsia in the next 4 weeks. We performed an assessment of the economic impact of the sFlt-1/PlGF ratio test for short-term prediction of preeclampsia in Germany.

Methods: We adapted a cost-effectiveness model, which had been developed to estimate the incremental value of adding the sFlt-1/PlGF ratio test with a cut-off ratio of 38 to standard diagnostic procedures for guiding the management of women with suspected preeclampsia in the UK. We used the adapted model to estimate the incremental value of the sFlt-1/PlGF ratio test (cut-off 38) for guiding the management of women with suspected preeclampsia from a German Diagnosis-Related Group (DRG) payer perspective. The economic model estimated costs associated with diagnosis and management of preeclampsia in women managed in either a 'no-test' scenario in which clinical decisions are based on standard diagnostic procedures alone, or a 'test' scenario in which the sFlt-1/PlGF test is used in addition to standard diagnostic procedures. Test characteristics and rates of hospitalization were derived from patient-level data from PROGNOSIS. The main outcome measure from the economic model was the total cost per patient.

Results: In the model adapted to the German DRG payer system, introduction of the sFlt-1/PlGF ratio test with a cut-off value of 38 could reduce the proportion of women hospitalized in Germany from 44.6 to 24.0%, resulting in an expected cost saving of €361 per patient.

Conclusions: The sFlt-1/PlGF ratio test is likely to reduce unnecessary hospitalization of women with a low risk of developing preeclampsia, and identify those at high risk to ensure appropriate management. Even within the restrictions of the DRG system in Germany, this results in substantial cost savings for women with suspected preeclampsia.

Keywords: Angiogenic factors; Cost-effectiveness; Cost-saving; Diagnosis; Diagnosis-related group; Economic; Germany; Hospitalization; Hypertension; Preeclampsia; Pregnancy; sFlt-1/PlGF.

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Conflict of interest statement

Ethics approval and consent to participate

Each participating site in the original PROGNOSIS study provided Ethics Committee/Institutional Review Board approval of the study protocol and associated documents (participant informed consent, participant information) before the start of the clinical part of the study. All women provided written informed consent before enrollment (26, 27; Additional file 2). Ethics approval and participant consent for this health economic analysis for Germany was not necessary as this study involved the use of a previously published de-identified database of PROGNOSIS according to German legislation.

Consent for publication

Not applicable (no data from an individual person).

Competing interests

Martin Hund, Cyrill Wolf and Annabel Schroer are employees of Roche Diagnostics.

Dietmar Schlembach has provided counselling services to Roche and has received fees from Roche for lectures.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Decision trees in a) the no-test scenario, and b) the test scenario
Fig. 2
Fig. 2
Preeclampsia management in Germany – four categories of treatment intensity (all costs are based on the EBM 2017 and DRG 2017). *MRT (2017): €3.376,11.**Ø = 15.2 days in PROGNOSIS. EBM, Einheitlicher Bewertungsmassstab; DRG, Diagnosis-Related Group; MRT, mean residence time
Fig. 3
Fig. 3
Results of sensitivity analyses. *Re-test scenario A: Re-test applied to 6.5% of women with initial ratio ≤ 38 who did not develop preeclampsia at week two and who were treated in an outpatient setting. **Re-test scenario B: Re-test applied to all women irrespective of the initial test result, preeclampsia status at week two and treatment location

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