Cost effectiveness of fluticasone propionate in the treatment of chronic obstructive pulmonary disease: a double-blind randomized, placebo-controlled trial

Background: Chronic obstructive pulmonary disease (COPD) is a debilitating disease and places a large financial burden on health-care systems and society. We prospectively evaluated the cost-effectiveness of fluticasone propionate (FP) treatment in patients with moderate-to-severe COPD, who were symptomatic on regular bronchodilator therapy. Methods: An economic analysis was performed in a 6-month, randomized, double-blind clinical trial comparing FP 1000 mug/day with placebo in 281 patients aged 45-79 years with symptomatic moderate-to-severe COPD. Data on clinical efficacy health-care resource use and productivity loss associated with the management of COPD were prospectively collected. The main outcome measures were the incremental cost-effectiveness of achieving a greater than or equal to10% improvement in FFV1 and of remaining exacerbation-free throughout the study. The economic evaluation was costed from the perspective of the NHS (direct costs) and of society (direct and indirect costs). Results: FP was significantly more effective than placebo in terms of the proportions of patients demonstrating a : 10% improvement in FEV1 (32 vs. 19%; P=0.02) and remaining free of moderate/severe exacerbations (75 vs. 63%; P=0.02).The difference between the groups in total costs was not significantly different. Incremental cost-effectiveness analyses showed that the additional clinical benefits of FP relative to placebo, in terms of a greater than or equal to10% improvement in FEV1 or an increased number of patients free of moderate/severe exacerbations, were achieved at minimal additional costs from an NHS perspective (additional E0.25 per day for both) or at a net saving from a societal perspective. Sensitivity analysis showed that these results were robust to changes in the underlying assumptions. Conclusions: Treatment with FP was associated with statistically significant clinical benefits in patients with moderate-to-severe COPD currently symptomatic on regular bronchodilator therapy As the differences in direct and total costs compared with placebo were small and non-significant, this treatment can be considered cost effective in this patient population. (C) 2002 Published by Elsevier Science Ltd.