Cost-effectiveness of two models of pessary care for pelvic organ prolapse: Findings from the TOPSY randomised controlled trial.

Objectives Pelvic organ prolapse is the descent of one or more reproductive organs from their normal position, causing associated negative symptoms. One conservative treatment option is pessary management. The aim of this study was to investigate the cost-effectiveness of pessary self-management (SM) when compared to clinic-based care (CBC). A decision-analytic model was developed to extend the economic evaluation. Methods A randomised controlled trial with health economic evaluation. The SM group received: 30-minute self-management teaching session; information leaflet; 2-week follow-up call; and a local helpline number. The CBC group received routine outpatient pessary appointments, determined by usual practice. The primary outcome for the cost-effectiveness analysis was incremental cost per QALY, 18 months post-randomisation. Uncertainty was handled using nonparametric bootstrap analysis. In addition, a simple decision analytic model was developed using the trial data to extend the analysis over a 5-year period. Results There was no significant difference in the mean number of QALYs gained between SM and CBC (1.241 vs 1.221) but mean cost was lower for SM (£578 vs £728). The incremental net benefit estimated at a willingness to pay of £20,000 per QALY gained was £564, with an 80.8% probability of cost-effectiveness. The modelling results were consistent with the trial analysis: the incremental net benefit was estimated as £4,221 and the probability of SM being cost-effective at 5 years was 69.7%. Conclusions Results suggest that pessary self-management is likely to be cost-effective. The decision analytic model suggests this result is likely to persist over longer durations.