Economic Impact and Clinical Outcomes of Omalizumab Add-On Therapy for Patients with Severe Persistent Asthma: A Real-World Study.

BACKGROUND: Omalizumab is a fully humanized monoclonal antibody indicated as add-on therapy to improve asthma control in patients with severe persistent allergic asthma. AIMS: The aim of this study was to evaluate social, healthcare expenditure and clinical outcomes changes after incorporating omalizumab into standard treatment in the control of severe asthma. METHODS: In this multicentre retrospective study, a total of 220 patients were included from 15 respiratory medicine departments in the regions of Andalusia and Extremadura (Spain). Effectiveness was calculated as a 3-point increase in the Asthma Control Test (ACT) and a reduction in the annual number of exacerbations. The economic evaluation included both direct and indirect costs. Incremental cost-effectiveness ratio (ICER) was calculated. Results from the year before and the year after incorporation of omalizumab were compared. RESULTS: After adding omalizumab, improvement of lung function, asthma and rhinitis according to patient perception, as well as the number of exacerbations and asthma control measured by the ACT score were observed. Globally, both healthcare resources and pharmacological costs decreased after omalizumab treatment, excluding omalizumab cost. When only direct costs were considered, the ICER was €1712 (95% CI 1487-1995) per avoided exacerbation and €3859 (95% CI 3327-4418) for every 3-point increase in the ACT score. When both direct and indirect costs were considered, the ICER was €1607 (95% CI 1385-1885) for every avoided exacerbation and €3555 (95% CI 3012-4125) for every 3-point increase. CONCLUSIONS: Omalizumab was shown to be an effective add-on therapy for patients with persistent severe asthma and allowed reducing key drivers of asthma-related costs.

Clinical outcomes and cost analysis of exacerbations in chronic obstructive pulmonary disease.

BACKGROUND: Exacerbations are a major cause of disability, hospital admissions, and increased healthcare costs in patients with chronic obstructive pulmonary disease (COPD). This study investigated the clinical outcomes of outpatients with moderate to severe exacerbated COPD and their related costs. METHODS: An observational study on the outcomes of ambulatory exacerbations of COPD was conducted. The course of the exacerbation was evaluated at a follow-up visit at 4 weeks. A cost analysis that encompassed the use of healthcare resources for treatment of the exacerbation was performed. RESULTS: A total of 260 patients were included, with a mean age of 68.3 years and a mean FEV1 (% predicted) of 58.9 %. Twenty-two percent of patients had significant cardiovascular comorbidity. The most frequently prescribed antibiotics were moxifloxacin in 137 cases and amoxicillin-clavulanate in 50 cases. The rate of failure at 4 weeks was 12.5 %, with no differences between the two most prescribed antibiotics; however, patients treated with moxifloxacin had symptoms for 1.9 fewer days (P = 0.01). The mean cost of the exacerbation was 344.96 (95 % CI: 48.55-641.78), with 9.6 % of the costs for drugs and 72.9 % for hospital care of patients for whom treatment had failed. CONCLUSIONS: Antibiotic treatment of our population was in compliance with local guidelines. The rate of failure observed in our study was lower than that reported in previous studies; however, the small percentage of patients that required hospital attention generated almost two-thirds of the total costs of the exacerbations.

Factors associated with high healthcare resource utilisation among COPD patients.

BACKGROUND: Chronic obstructive pulmonary disease (COPD) places a huge economic burden on healthcare systems, especially patients with frequent exacerbations and co-morbidities. OBJECTIVES: To identify factors associated with high utilisation of healthcare resources in a population of patients with COPD. METHOD: We conducted an observational, cross-sectional, multicentre study with the aim of identifying the factors associated with high resource utilisation among patients with COPD. Sociodemographic and anthropometric characteristics of the study population, as well as data on health-related quality of life, respiratory symptoms, presence of anxiety and depression, physical activity and lung function were collected. We examined the relationship between these variables and high utilisation of healthcare resources, by performing a multivariate analysis based on a logistic regression model. RESULTS: 115 patients (64 were high users of healthcare resources, and 51 control patients) from 13 hospitals were selected. Patients presenting high resource utilisation had worse FEV1, worse basal SpO2, less distance walked in the 6-minute walk test, and increased dyspnoea. They also had a worse BODE index, worse scores in all dimensions of the EURO-QOL 5D and the LCADL scale, and displayed a higher prevalence of depression. Multivariate analysis yielded a statistically significant association between SpO2, LCADL scores, serum fibrinogen values and total leukocyte count, and high healthcare resource utilisation. CONCLUSIONS: COPD patients who incur higher healthcare resource utilisation show reduced physical activity, increased respiratory failure and increased systemic inflammation.