Burden of Disease Among Exacerbating Patients with COPD Treated with Triple Therapy in Spain.

Background: The cost of chronic obstructive pulmonary disease (COPD) in Spain has been studied from different perspectives, but parameters such as the patient's phenotype have seldom been considered. Our aim was to describe the disease burden of COPD patients with frequent exacerbator phenotype, treated with triple therapy. Methods: An observational, multicenter study was carried out from December 2017 to November 2018 in pulmonology services among patients ≥40 years with COPD confirmed diagnosis receiving triple therapy (ICS/LAMA/LABA) and history of ≥2 moderate or ≥1 severe exacerbation in the 12 months prior to the inclusion visit. COPD-related healthcare resources were collected over a 12-months period prior to the inclusion visit: pharmacological and non-pharmacological treatments, medical and ER visits, hospitalizations, tests and productivity loss. Costs were updated to €2019. Patients were classified according to blood eosinophil levels: <150 cells/µL and ≥150 cells/µL. Results: A total of 306 patients were included (77.1% men), with mean age of 69.9 years. Mean COPD exacerbation rate was 2.5/patient/year and 51.3% of patients had ≥150 cells/µL eosinophil level. On average, for the total population, COPD-related visits/patients/year were 6.2. Resource use in moderate exacerbation was higher in patients with eosinophils ≥150 cells/µL, whereas in severe exacerbation was higher in patients with eosinophils <150cells/µL. According to eosinophil levels, total annual mean (SD) costs/patient accounted for €8382 (9863) and €5144 (5444) for patients with eosinophils <150 cells/µL and ≥150 cells/µL, respectively. Conclusion: The impact of exacerbating COPD patients treated with triple therapy in Spain is large, especially among those with eosinophils <150 cells/µL.

Economic impact of severe asthma exacerbations in Spain: multicentre observational study.

Objective: To describe resource use and costs of severe exacerbations in patients with severe asthma.Method: Secondary analysis of an observational, longitudinal, retrospective study that estimated the economic impact of severe asthma. The study was carried out in severe asthma units of the pulmonology and allergy services of 20 public hospitals (inclusion period: June to November 2016). The study included adult patients diagnosed with severe asthma according to the European Respiratory Society/American Thoracic Society consensus in the stable phase (no exacerbation during the last 2 months), and with at least one severe exacerbation during the study period (12 months). Healthcare resource use due to severe exacerbations (emergency visits, hospitalizations and pharmacological treatment) was recorded. The direct health costs associated with severe exacerbations were calculated by multiplying the resources used by the corresponding unit cost (in 2018 euros).Results: 134 patients with ≥1 severe exacerbation were included: 63% were female and the mean age was 54 years. 249 severe exacerbations were registered. There were 1.5 physician visits at primary care, hospital care and/or emergency room per episode, 13% of episodes required hospitalization, with a mean hospital stay of 7.2 days. Systemic corticosteroids were prescribed in 92% of exacerbations. The mean direct cost was €758.7/exacerbation (95% confidence interval: 556.8-1,011.1), of which 82% was due to hospitalizations (€623.3/episode). Considering only episodes requiring hospital admission, the mean cost increased by €4,997/exacerbation.Conclusions: It was estimated that the economic impact of a severe exacerbation in Spanish patients with severe asthma was €758.7/exacerbation.

Incidence and costs of cardiovascular events in Spanish patients with type 2 diabetes mellitus: a comparison with general population, 2015.

INTRODUCTION: Cardiovascular (CV) disease affects a high percentage of patients with type 2 diabetes mellitus (T2DM), especially in the hospital setting, impacting on mortality, complications, quality of life and use of health resources. The aim of this study was to estimate the incidence, mean length of hospital stay (LOHS) and costs attributable to hospital admissions due to CV events in patients with T2DM versus patients without diabetes mellitus (non-DM) in Spain. RESEARCH DESIGN AND METHODS: Retrospective observational study based on the Spanish National Hospital Discharge Database for 2015. Hospital admissions for patients aged ≥35 years with a diagnosis of CV death, non-fatal acute myocardial infarction (AMI), non-fatal stroke, unstable angina, heart failure and revascularization were evaluated. The International Classification of Diseases, Ninth Revision (250.x0 or 250.x2) coding was used to classify records of patients with T2DM. For each CV complication, the hospital discharges of the two groups, T2DM and non-DM, were precisely matched and the number of hospital discharges, patients, LOHS and mean cost were quantified. Additional analyses assessed the robustness of the results. RESULTS: Of the 276 925 hospital discharges analyzed, 34.71% corresponded to patients with T2DM. A higher incidence was observed in all the CV complications studied in the T2DM population, with a relative risk exceeding 2 in all cases. The mean LOHS (days) was longer in the T2DM versus the non-DM group for: non-fatal AMI (7.63 vs 7.02, p<0.001), unstable angina (5.11 vs 4.78, p=0.009) and revascularization (7.96 vs 7.57, p<0.001). The mean cost per hospital discharge was higher in the T2DM versus the non-DM group for non-fatal AMI (€6891 vs €6876, p=0.029) and unstable angina (€3386 vs €3304, p<0.001). CONCLUSIONS: Patients with T2DM had a higher incidence and number of hospital admissions per patient due to CV events versus the non-DM population. This generates a significant clinical and economic burden given the longer admission stay and higher costs associated with some of these complications.

Economic impact of severe asthma in Spain: multicentre observational longitudinal study.

Objective: Estimate the economic impact of severe asthma from the Spanish social perspective through the estimation of the associated annual direct and indirect costs. Methods: Observational, longitudinal, retrospective study carried out in 20 Spanish secondary settings (Pulmonology and Allergy Services) among patients aged ≥18, diagnosed with severe asthma according to European Respiratory Society/American Thoracic Society consensus and who have not experienced an exacerbation in the previous 2 months. Asthma-related healthcare resource utilization as well as asthma-related days off work were collected over a retrospective 12-month period from medical records review (inclusion period: June to November 2016). Total costs were calculated by multiplying the natural resource units used within 1 year by the corresponding unit cost. Costs were expressed in Euros for 2018. Results: A total of 303 patients were included, mean age was 54 years old and 67% were women. There were 5.7 physician visits per patient (3.3 in secondary care). The most common pharmacologic treatment was fixed dose combination of inhaled corticosteroids/long-acting ß2-adrenergic agonists (96.7%), followed by leukotriene receptor antagonists (57.1%). 134 patients (44.2%) had at least one severe asthma exacerbation (mean: 1.9 exacerbation/patient), of whom 22 patients required hospitalization, with a mean hospital stay of 10.9 days/patient. Mean sick leave due to severe asthma was 9.1 days per patient per year. Mean annual direct cost (confidence interval 95%) was €7472/patient (€6578-8612). The cost per exacerbation was €1410/patient. When indirect costs were added (€1082/patient [€564-1987]), the total annual mean cost rose to €8554/patient (€7411-10199). Conclusions: Taking the social perspective, the economic impact of severe asthma in Spain was estimated to be €8554/patient/year.

Cost-Effectiveness Analysis of Omalizumab for the Treatment of Severe Persistent Asthma in Real Clinical Practice in Spain.

BACKGROUND AND OBJECTIVE: Omalizumab is a humanized monoclonal antibody that targets circulating immunoglobulin E molecules to treat severe uncontrolled asthma. The aim of this study was to determine the cost effectiveness of omalizumab compared with standard treatment for the control of severe persistent asthma according to data from patients treated in a specialized asthma unit. METHODS: This was an observational, retrospective, single-center study in the setting of the Pulmonology and Respiratory Allergy Service, Thorax Institute, Hospital Clínic de Barcelona, Barcelona, Spain. Data were collected by review of medical records of 86 uncontrolled severe persistent asthma patients treated with omalizumab from January 2005 to April 2014. Effectiveness was assessed by the reduction in asthma exacerbations and 3-point increases in the Asthma Control Test (ACT) score. The economic evaluation was performed from the societal perspective, including direct health costs (resource use and drug treatments) and indirect costs (disease impact on labor productivity) in 2016 Euros. The time horizon was 12 months before and after the initiation of treatment with omalizumab. Results were expressed using the incremental cost-effectiveness ratio (ICER). RESULTS: Taking into account only direct costs, the ICERs were €1487.46 (95 % confidence interval [CI] 1241.21-1778.34) per exacerbation avoided and €5425.13 (95 % CI 4539.30-6551.03) per 3-point increase in the ACT. When indirect costs were included, the ICERs were €1130.93 (95 % CI 909.08-1392.86) per exacerbation avoided, and €4124.79 (95 % CI 3281.69-5186.73) per 3-point increase in the ACT. CONCLUSIONS: The results of this study confirm the effectiveness of the addition of omalizumab to standard therapy in patients with uncontrolled severe persistent asthma.