BackgroundCurrent asthma management guidelines are based on the level of asthma control. The impact of asthma control on health care resources and quality of life (QoL) is insufficiently studied. EUCOAST study was designed to describe costs and QoL in adult patients according to level of asthma control in France and Spain.MethodsAn observational cost of illness study was conducted simultaneously in both countries among patients age greater or equal to 18 with a diagnosis of asthma for at least 12 months. Patients were recruited prospectively by GPs in 2010 in four waves to avoid a seasonal bias. Health care resources utilization of the three months before the inclusion was collected through physician questionnaires. Asthma control was evaluated using 2009 GINA criteria over a 3-month period. QoL was assessed using EQ-5D-3L®.Results2,671 patients (France: 1,154; Spain: 1,517) were enrolled. Asthma was controlled in 40.6% [95% CI: 37.7% - 43.4%] and 29.9% [95% CI: 27.6% - 32.3%] of French and Spanish patients respectively.For all types of costs, the percentage of patients using health care resources varied significantly according to the level of asthma control. The average cost (euros/3-months/patient) of controlled asthma was €85.4 (SD: 153.5) in France compared with €314.0 (SD: 2,160.4) for partially controlled asthma and €537.9 (SD: 2,355.7) for uncontrolled asthma (p<0.0001). In Spain, the corresponding figures were €152.6 (SD: 162.1), €241.2 (SD: 266.8), and €556.8 (SD: 762.4). EQ-5D-3L® score was higher (p<0.0001) in patients with controlled asthma compared to partially controlled and uncontrolled asthma in both countries (respectively 0.88; 0.78; 0.63 in France and 0.89; 0.82; 0.69 in Spain).ConclusionsIn both countries, patients presenting with uncontrolled asthma had a significantly higher asthma costs and lower scores of Qol compared to the others.

PurposeUmeclidinium/vilanterol (UMEC/VI) is a novel fixed dose combination of a long-acting muscarinic receptor antagonist (LAMA) and a long-acting beta 2 receptor antagonist (LABA) agent. This analysis evaluated the incremental cost-effectiveness ratio (ICER) of UMEC/VI compared with tiotropium (TIO), from the Spanish National Health System (NHS) perspective.MethodsA previously published linked equations cohort model based on the epidemiological longitudinal study ECLIPSE (Evaluation of COPD Longitudinally to Identify Predictive Surrogate End-points) was used. Patients included were COPD patients with a post-bronchodilator forced expiratory volume in 1 second (FEV1) ≤70% and the presence of respiratory symptoms measured with the modified Medical Research Council dyspnea scale (modified Medical Research Council ≥2). Treatment effect, expressed as change in FEV1 from baseline, was estimated from a 24-week head-to-head phase III clinical trial comparing once-daily UMEC/VI with once-daily TIO and was assumed to last 52 weeks following treatment initiation (maximum duration of UMEC/VI clinical trials). Spanish utility values were derived from a published local observational study. Unitary health care costs (€2015) were obtained from local sources. A 3-year time horizon was selected, and 3% discount was applied to effects and costs. Results were expressed as cost/quality-adjusted life years (QALYs). Univariate and probabilistic sensitivity analysis (PSA) was performed.ResultsUMEC/VI produced additional 0.03 QALY and €590 vs TIO, leading to an ICER of €21,475/QALY. According to PSA, the probability of UMEC/VI being cost-effective was 80.3% at a willingness-to-pay of €30,000/QALY.ConclusionUMEC/VI could be considered as a cost-effective treatment alternative compared with TIO in symptomatic COPD patients from the Spanish NHS perspective.

Purpose: To evaluate the cost-effectiveness of once-daily fluticasone furoate/umeclidinium/ vilanterol (FF/UMEC/VI) vs twice-daily budesonide/formoterol (BUD/FOR) in patients with symptomatic chronic obstructive pulmonary disease (COPD) at risk of exacerbations, from the Spanish National Healthcare System perspective. Patients and Methods: The validated GALAXY-COPD model was used to simulate disease progression and predict healthcare costs, quality-adjusted life years (QALYs), and incremental cost-effectiveness ratios (ICERs) over a 3-year time horizon for a Spanish population. Patient characteristics from published literature were supplemented by data from FULFIL (NCT02345161), which compared FF/UMEC/VI vs BUD/FOR in patients with symptomatic COPD at risk of exacerbations. Treatment effects, extrapolated to 3 years, were based on Week 24 results in the FULFIL intent-to-treat population, including change in forced expiratory volume in 1 second, St. George's Respiratory Questionnaire score, and exacerbation rates. Treatment, exacerbations, and COPD management costs (2019€) were informed by Spanish public sources and published literature. A 3% discount rate for costs and benefits was applied. One-way sensitivity and scenario analyses, and probabilistic sensitivity analysis (PSA), were performed. Results: FF/UMEC/VI treatment led to fewer moderate and severe exacerbations (2.126 and 0.306, respectively) vs BUD/FOR (2.608 and 0.515, respectively), with a mean incremental cost of €69 and gain of 0.107 QALYs, which resulted in an ICER of €642 per QALY gained. In sensitivity analyses, the ICER was most sensitive to treatment effect variations in exacerbations and healthcare resource utilization/event costs. Overall, 95% of 1000 PSA simulations resulted in an ICER less than €11,000 per QALY gained for FF/UMEC/VI vs BUD/FOR, confirming robustness of the results. The probability of FF/UMEC/VI being cost-effective vs BUD/FOR was 100% at a willingness-to-pay threshold of €30,000 per QALY gained. Conclusion: At the accepted Spanish ICER threshold of €30,000, FF/UMEC/VI represents a cost-effective treatment option vs BUD/FOR in patients with symptomatic COPD at risk of exacerbations.

PurposeHealth utilities are widely used in health economics as a measurement of an individual’s preference and show the value placed on different health states over a specific period. Thus, health utilities are used as a measure of the benefits of health interventions in terms of quality-adjusted life years. This study aimed to determine the demographic and clinical variables significantly associated with health utilities for chronic obstructive pulmonary disease (COPD) patients.Patients and methodsThis was a multicenter, observational, cross-sectional study conducted between October 2012 and April 2013. Patients were aged ≥40 years, with spirometrically confirmed COPD. Utility values were derived from the preference-based generic questionnaire EQ-5D-3L applying weighted Spanish societal preferences. Demographic and clinical variables associated with utilities were assessed by univariate and multivariate linear regression models.ResultsThree hundred and forty-six patients were included, of whom 85.5% were male. The mean age was 67.9 (standard deviation [SD] =9.7) years and the mean forced expiratory volume in 1 second (%) was 46.2% (SD =15.5%); 80.3% were former smokers, and the mean smoking history was 54.2 (SD =33.2) pack-years. Median utilities (interquartile range) were 0.81 (0.26) with a mean value of 0.73 (SD =0.29); 22% of patients had a utility value of 1 (ceiling effect) and 3.2% had a utility value lower than 0. The factors associated with utilities in the multivariate analysis were sex (beta =-0.084, 95% confidence interval [CI]: −0.154; -0.013 for females), number of exacerbations the previous year (−0.027, 95% CI: −0.044; -0.010), and modified Medical Research Council Dyspnea Scale (mMRC) score (−0.123 [95% CI: −0.185; −0.061], −0.231 [95% CI: −0.301; −0.161], and −0.559 [95% CI: −0.660; −0.458] for mMRC scores 2, 3, and 4 versus 1), all P<0.05.ConclusionMultivariate analysis showed that female sex, frequent exacerbations, and an increased level of dyspnea were the main factors associated with reduced utility values in patients with COPD.

Taking the social perspective, the economic impact of severe asthma in Spain was estimated to be €8554/patient/year.