Evaluation of the Cost Effectiveness of Vesico-Amniotic Shunting in the Management of Congenital Lower Urinary Tract Obstruction (Based on Data from the PLUTO Trial)

OBJECTIVE To determine the cost-effectiveness of in-utero percutaneous Vesico Amniotic Shunt (VAS) in the management of fetal lower urinary tract obstruction (LUTO). DESIGN Model based economic analysis using data from the randomised controlled arm of the PLUTO (percutaneous vesico-amniotic shunting for lower urinary tract obstruction) trial. SETTING Fetal medicine departments in United Kingdom, Ireland and Netherlands. POPULATION OR SAMPLE Pregnant women with a male, singleton fetus with LUTO. METHODS Costs and outcomes were prospectively collected in the trial; three separate base case analyses were performed using the intention to treat (ITT), per protocol and uniform prior methods. Deterministic and probabilistic sensitivity analyses were performed to explore data uncertainty. MAIN OUTCOME MEASURES Survival at 28 days, 1 year and disease free survival at 1 year. RESULTS VAS was more expensive but appeared to result in higher rates of survival compared with conservative management in patients with LUTO. Using ITT analysis the incremental cost effectiveness ratios based on outcomes of survival at 28 days, 1 year, or 1 morbidity-free year on the VAS arm were £ 15,506, £ 15,545, and £ 43,932, respectively. CONCLUSIONS VAS is a more expensive option compared to the conservative approach in the management of individuals with LUTO. Data from the RCT suggest that VAS improves neonatal survival but does not result in significant improvements in morbidity. Our analysis concludes that VAS is not likely to be cost effective in the management of these patients given the NICE (National Institute of Health and Clinical Excellence) cost threshold of £ 20,000 per QALY.