Background:The objective of this study was to compare the cost-effectiveness of the
fixed-dose combination (FDC) of tiotropium + olodaterol Respimat®
FDC with tiotropium alone for patients with chronic obstructive pulmonary
disease (COPD) in the Italian health care setting using a newly developed
patient-level Markov model that reflects the current understanding of the
disease.Methods:While previously published models have largely been based around a cohort
approach using a Markov structure and GOLD stage stratification, an
individual-level Markov approach was selected for the new model. Using
patient-level data from the twin TOnado trials assessing Tiotropium +
olodaterol Respimat® FDC versus tiotropium,
outcomes were modelled based on the trough forced expiratory volume
(tFEV1) of over 1000 patients in each treatment arm, tracked
individually at trial visits through the 52-week trial period, and after the
trial period it was assumed to decline at a constant rate based on disease
stage. Exacerbation risk was estimated based on a random-effects logistic
regression analysis of exacerbations in UPLIFT. Mortality by age and disease
stage was estimated from an analysis of TIOSPIR trial data. Cost of
bronchodilators and other medications, routine management, and costs of
treatment for moderate and severe exacerbations for the Italian setting were
included. A cost-effectiveness analysis was conducted over a 15-year time
horizon from the perspective of the Italian National Health Service.Results:Aggregating total costs and quality-adjusted life years (QALYs) for each
treatment cohort over 15 years and comparing tiotropium + olodaterol
Respimat® FDC with tiotropium alone, resulted in mean
incremental costs per patient of €1167 and an incremental cost-effectiveness
ratio (ICER) of €7518 per additional QALY with tiotropium + olodaterol
Respimat® FDC. The lung function outcomes observed for
tiotropium + olodaterol Respimat® FDC in TOnado drove the results
in terms of slightly higher mean life-years (12.24 versus
12.07) exacerbation-free months (11.36 versus 11.32) per
patient and slightly fewer moderate and severe exacerbations per
patient-year (0.411 versus 0.415; 0.21
versus 0.24) versus tiotropium.
Probabilistic sensitivity analyses showed tiotropium + olodaterol
Respimat® FDC to be the more cost-effective treatment in
95.2% and 98.4% of 500 simulations at thresholds of €20,000 and €30,000 per
QALY respectively.Conclusion:Tiotropium + olodaterol Respimat® FDC is a cost-effective
bronchodilator in the maintenance treatment of COPD for the Italian health
care system.