From Investigational Product to Active Reference: Evolution of Oral Sumatriptan Efficacy Versus Placebo for the Treatment of Acute Migraine Episodes and Potential Impact in Comparative Analyses

Abstract

To prevent hemolytic disease of the fetus and newborn, routine antenatal care in many countries involves RhD immunoglobulin (anti-D) being offered to all RhD negative pregnant women. Recent advances in non-invasive cell-free fetal DNA testing of the RHD gene has made targeted administration of anti-D possible to women with a baby predicted to be RhD positive. Our objective was to undertake a cost-effectiveness analysis and budget impact analysis of non-invasive fetal RHD genotyping to target pregnant women for antenatal anti-D prophylaxis therapy. METHODS: A decision-analytic model was constructed to compare RHD testing and targeted anti-D prophylaxis, with current universal anti-D prophylaxis among pregnant women with RhD negative blood type. Model estimates were derived from national perinatal statistics, published literature, donor program records and national cost sources. One-way sensitivity analyses addressed the uncertainty of variables on the main findings. RESULTS: The unit cost for RHD genotyping was