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AbstractObjective:Pre-eclampsia (PE), a leading cause of maternal and perinatal morbidity and mortality, is only detected after symptomatic onset. Early diagnosis may be possible with a new serum test, with resulting clinical and economic benefits versus standard practice. The authors evaluated the financial impact to the UK National Health Service (NHS).Methods:A decision-analytic model was developed in which a cohort of 1,000 pregnant women receiving UK obstetric care was simulated. The economic impact of improved sensitivity and specificity of the novel PE test [Roche Diagnostics, Rotkreuz, Switzerland] over current diagnostic practice was modeled. While there is no specific approved diagnostic test to detect PE, physicians are using a combination of tests including blood pressure, proteinuria, Doppler, serum uric acid, etc. The novel PE test constitutes two novel biomarkers Placenta Growth Factor (PlGF) and soluble fms-like tyrosine kinase-1 (sFlt-1) which can be quantitatively analyzed using an automated system widely available in hospitals or laboratories (Elecsys/Cobas, Roche Diagnostics) and measures the levels of PlGF and sFlt-1 growth factors in pregnant women. The analysis assumed administration of the £31.13 test (the equivalent of 52 Swiss Francs [CHF]) after 20 weeks of gestation as an addition to current practice. True-positive and false-negative patients were assumed to develop mild or severe PE, eclampsia, or death. A hybrid research approach was adopted; when available, data for model inputs were obtained from published literature and public databases. Interviews with obstetricians, laboratory managers, and healthcare payers were used to validate model inputs and fill utilization-related data gaps.Results:The model estimates that the costs associated with managing a typical pregnancy are £1,781 per patient when the new test is used versus £2,726 with standard practice. This represents savings of £945 per pregnant woman, if the test is used as a supplementary diagnostic tool. The savings are attributed to the new test's improved performance and its ability to better classify the pregnant patients.Conclusions:The novel test has the potential to provide substantial cost savings for NHS. Even when the novel test's cost is added to the current cost of care, the benefits exceed the additional cost, driven by the test's ability to reduce the rates of false-positive and false-negative diagnoses compared to current standard of care. Potential study limitations include the use of a pooled average of the individual sensitivities and specificities of currently used tests since no data were available on combination testing, the reliance on clinical trial data versus actual practice, and the use of clinical expert opinion when published data were unavailable. |
