C B Okeke Ogwulu1, E V Williams1, J J Chu2, A J Devall2, L E Beeson3, P Hardy3, V Cheed3, S Yongzhong3, L L Jones3, J H La Fontaine Papadopoulos3, R Bender-Atik4, J Brewin5, K Hinshaw6, M Choudhary7, A Ahmed6, J Naftalin8, N Nunes9, A Oliver10, F Izzat11, K Bhatia12, I Hassan13, Y Jeve13, J Hamilton14, S Debs15, C Bottomley8, J Ross16, L Watkins17, M Underwood18, Y Cheong19, C S Kumar20, P Gupta21, R Small22, S Pringle20, F S Hodge23, A Shahid24, A W Horne25, S Quenby26, I D Gallos2, A Coomarasamy2, T E Roberts1. 1. Health Economics Unit, Institute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK. 2. Institute of Metabolism and Systems Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK. 3. Institute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK. 4. The Miscarriage Association, Wakefield, UK. 5. Tommy's Charity, London, UK. 6. Sunderland Royal Hospital, South Tyneside & Sunderland NHS Foundation Trust, Sunderland, UK. 7. Royal Victoria Infirmary, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK. 8. University College Hospital, University College London Hospitals NHS Foundation Trust, London, UK. 9. West Middlesex University Hospital, Chelsea and Westminster Hospital NHS Foundation Trust, Isleworth, UK. 10. St Michael's Hospital, University Hospitals Bristol NHS Foundation Trust, Bristol, UK. 11. University Hospital Coventry, University Hospitals Coventry and Warwickshire NHS Trust, Coventry, UK. 12. Burnley General Hospital, East Lancashire Hospitals NHS Trust, Burnley, UK. 13. Birmingham Women's Hospital, Birmingham Women's and Children's NHS Foundation Trust, Birmingham, UK. 14. Guy's and St Thomas' Hospital, Guy's and St. Thomas' NHS Foundation Trust, London, UK. 15. Queen's Medical Centre, Nottingham University Hospitals NHS Trust, Nottingham, UK. 16. Kings College Hospital, King's College Hospital NHS Foundation Trust, London, UK. 17. Liverpool Women's Hospital, Liverpool Women's NHS Foundation Trust, Liverpool, UK. 18. Princess Royal Hospital, Shrewsbury and Telford Hospital NHS Trust, Telford, UK. 19. Department of Reproductive Medicine, University of Southampton, Southampton, UK. 20. NHS Greater Glasgow and Clyde, Glasgow, UK. 21. Birmingham Heartlands Hospital, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK. 22. University Hospital Birmingham NHS Foundation Trust, Birmingham, UK. 23. Singleton Hospital, Swansea Bay University Health Board, Swansea, UK. 24. Barts Health NHS Trust, The Royal London Hospital, London, UK. 25. Royal Infirmary of Edinburgh, NHS Lothian, Edinburgh, UK. 26. The Biomedical Research Unit in Reproductive Health, University of Warwick, Warwick, UK.
Abstract
OBJECTIVE: To assess the cost-effectiveness of mifepristone and misoprostol (MifeMiso) compared with misoprostol only for the medical management of a missed miscarriage. DESIGN: Within-trial economic evaluation and model-based analysis to set the findings in the context of the wider economic evidence for a range of comparators. Incremental costs and outcomes were calculated using nonparametric bootstrapping and reported using cost-effectiveness acceptability curves. Analyses were performed from the perspective of the UK's National Health Service (NHS). SETTING:Twenty-eight UK NHS early pregnancy units. SAMPLE: A cohort of 711 women aged 16-39 years with ultrasound evidence of a missed miscarriage. METHODS: Treatment with mifepristone and misoprostol or with matched placebo and misoprostol tablets. MAIN OUTCOME MEASURES: Cost per additional successfully managed miscarriage and quality-adjusted life years (QALYs). RESULTS: For the within-trial analysis, MifeMiso intervention resulted in an absolute effect difference of 6.6% (95% CI 0.7-12.5%) per successfully managed miscarriage and a QALYs difference of 0.04% (95% CI -0.01 to 0.1%). The average cost per successfully managed miscarriage was lower in the MifeMiso arm than in the placebo and misoprostol arm, with a cost saving of £182 (95% CI £26-£338). Hence, the MifeMiso intervention dominated the use of misoprostol alone. The model-based analysis showed that the MifeMiso intervention is preferable, compared with expectant management, and this is the current medical management strategy. However, the model-based evidence suggests that the intervention is a less effective but less costly strategy than surgical management. CONCLUSIONS: The within-trial analysis found that based on cost-effectiveness grounds, the MifeMiso intervention is likely to be recommended by decision makers for the medical management of women presenting with a missed miscarriage. TWEETABLE ABSTRACT: The combination of mifepristone and misoprostol is more effective and less costly than misoprostol alone for the management of missed miscarriages.
RCT Entities:
OBJECTIVE: To assess the cost-effectiveness of mifepristone and misoprostol (MifeMiso) compared with misoprostol only for the medical management of a missed miscarriage. DESIGN: Within-trial economic evaluation and model-based analysis to set the findings in the context of the wider economic evidence for a range of comparators. Incremental costs and outcomes were calculated using nonparametric bootstrapping and reported using cost-effectiveness acceptability curves. Analyses were performed from the perspective of the UK's National Health Service (NHS). SETTING: Twenty-eight UK NHS early pregnancy units. SAMPLE: A cohort of 711 women aged 16-39 years with ultrasound evidence of a missed miscarriage. METHODS: Treatment with mifepristone and misoprostol or with matched placebo and misoprostol tablets. MAIN OUTCOME MEASURES: Cost per additional successfully managed miscarriage and quality-adjusted life years (QALYs). RESULTS: For the within-trial analysis, MifeMiso intervention resulted in an absolute effect difference of 6.6% (95% CI 0.7-12.5%) per successfully managed miscarriage and a QALYs difference of 0.04% (95% CI -0.01 to 0.1%). The average cost per successfully managed miscarriage was lower in the MifeMiso arm than in the placebo and misoprostol arm, with a cost saving of £182 (95% CI £26-£338). Hence, the MifeMiso intervention dominated the use of misoprostol alone. The model-based analysis showed that the MifeMiso intervention is preferable, compared with expectant management, and this is the current medical management strategy. However, the model-based evidence suggests that the intervention is a less effective but less costly strategy than surgical management. CONCLUSIONS: The within-trial analysis found that based on cost-effectiveness grounds, the MifeMiso intervention is likely to be recommended by decision makers for the medical management of women presenting with a missed miscarriage. TWEETABLE ABSTRACT: The combination of mifepristone and misoprostol is more effective and less costly than misoprostol alone for the management of missed miscarriages.