Cost-effectiveness analysis of anti-IL-5 therapies of severe eosinophilic asthma in Spain.

AIM: To analyse the cost-effectiveness of MEP with standard of care (SoC) versus other anti-IL-5 therapies approved for the treatment of severe eosinophilic asthma (SEA) patients, within the Spanish National Health System (NHS) perspective. METHODS: A Markov model with a 4-week cycle length was used to compare MEP with BEN and RES as therapies added to SoC in the management of SEA, in terms of cost per QALY gained and incremental cost-effectiveness ratio (ICER). Costs (€2019) were obtained from public sources, while utilities and transition probabilities were retrieved from literature, e.g. network meta-analysis. Continuation criteria for biological treatment and reduction of oral corticosteroids (OCS) was set at 50% minimum reduction of exacerbation rate. Adverse events related to chronic OCS use included diabetes, osteoporosis, cataracts, acute myocardial infarct, and peptic ulcer. The analysis was performed over a 5-year time horizon from the National Healthcare System (NHCS) perspective, with a yearly discount rate of 3% applied to both costs and QALYs. Probabilistic sensitivity analysis and univariate deterministic sensitivity analysis were performed to address uncertainty around the cost-effectiveness results. RESULTS: On top of SoC, the model indicates that MEP is dominant (lower cost, higher benefit) compared to BEN and RES: For BEN and RES, respectively, treatment with MEP had a point estimate of 0.076 and 0.075 additional QALYs, and savings of €3,173.47 and €7,772.95 per patient. The findings were robust to variation as estimated using sensitivity analysis. CONCLUSIONS: MEP is a cost-effective treatment in comparison with BEN and RES added to SoC for patients with SEA in the Spanish setting.

Clinical and Economic Consequences of Inhaled Corticosteroid Doses and Particle Size in Triple Inhalation Therapy for COPD: Real-Life Study.

Objective: To determine the clinical and economic consequences of inhaled corticosteroid doses and particle size in patients on triple-inhalation therapy for COPD. Methods: Patients aged ≥40 years who initiated treatment with multi-inhaler triple-inhaled therapy between 1 January 2015 and 31 March were included and followed for 1 year. Patients were grouped according to inhaled corticosteroid (ICS) dose (low/medium/high) and particle size device (extrafine/non-extrafine particles). Outcome variables were moderate and severe exacerbations, pneumonia and healthcare resource use (HCRU) costs. A multivariate analysis was performed for model correction (p<0.05). Results: A total of 2185 patients (mean age 72.3 years, 82.9% male) were analysed. Of these, 849 (38.9%) patients received low-dose ICS, 612 medium-dose ICS (28.0%) and 724 (33.1%) high-dose ICS. Exacerbations occurred more frequently with increasing IC dose (low: 26.4%, medium: 28.7% and high: 30.4%; p=0.047), as did the proportion of pneumonia (3.4%, 4.2% and 6.9%, respectively (p=0.041)). The annual mean cost/unit was € 2383 for low dose, € 2401 for medium dose and € 2625 for high dose (p=0.024). Four hundred and sixty-two (31.6%) patients used an extrafine particle device and 999 (68.4%) a non-extrafine particle device: the proportion of exacerbations was 24.0% vs 30.4% (p=0.012), and the annual mean cost/unit was € 2090 vs € 2513, respectively (p<0.001). The number of exacerbations was directly correlated with FEV1 (ß= -0.157), age (ß=0.071), Charlson index (ß=0.050) and device type (extrafine: ß=0.049) (p<0.02). Conclusion: In patients with COPD receiving multi-inhaler triple therapy, higher ICS doses were not associated with a further reduction in exacerbations, whereas we found an increased risk of pneumonia. The use of inhaler devices delivering extrafine ICS particle was associated with a lower rate of exacerbations, resulting in lower overall HCRU costs.

Cost-Effectiveness Analysis of a Once-Daily Single-Inhaler Triple Therapy for Patients with Chronic Obstructive Pulmonary Disease (COPD) Using the FULFIL Trial: A Spanish 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.

Clinical utility and economic impact of conventional transbronchial needle aspiration of mediastinal lymphadenopathies in bronchogenic carcinoma.

OBJECTIVES: To analyze the clinical utility and economic impact of conventional transbronchial needle aspiration (TBNA) in patients with diagnosis of bronchogenic carcinoma (BC) and mediastinal lymphadenopathies in thoracic computed tomography (CT). To assess the predictive factors of valid aspirations. PATIENTS AND METHODS: Retrospective observational study between 2006 and 2011 of all TBNA performed in patients with final diagnosis of BC and accessible hilar or mediastinal lymphadenopathies on thoracic CT. RESULTS: We performed TBNA on 267 lymphadenopathies of 192 patients. In 34.9% of patients, two or more lymph nodes were biopsied. Valid aspirations were obtained in 153 patients (79.7%) that were diagnostic in 124 (64.6%). Multivariate analysis showed that factors associated with valid or diagnostic results are the diameter of the lymph node and the number of lymph nodes explored. TBNA was the only endoscopic technique that provided the diagnosis of BC in 54 patients (28.1%). Staging mediastinoscopy was avoided in 67.6% of patients. The prevalence of mediastinal lymph node involvement was 74.4%, sensitivity of TBNA was 86.2% and negative predictive value was 63.6%. Including mediastinoscopy and other avoided diagnostic techniques, TBNA saved 451.57 € per patient. CONCLUSIONS: TBNA is a clinically useful, cost-effective technique in patients with BC and mediastinal or hilar lymphadenopathies. It should therefore be performed on a regular basis during diagnostic bronchoscopy of these patients.

The use of the lower limit of normal as a criterion for COPD excludes patients with increased morbidity and high consumption of health-care resources.

The objective of this study is to analyze the clinical characteristics of two COPD patient populations: one diagnosed using the lower limit of normal (LLN) and another diagnosed by the GOLD criteria. We also compared the population excluded by the LLN criterion with a non-COPD control population. The COPD patients determined with the LLN criterion presented significantly lower levels of FEV1/FVC at 0.55 (0.8) vs. 0.66 (0.2), P=.000; FEV1 44.9% (14) vs. 53.8% (13), P=.000, and FVC 64.7% (17) vs. 70.4% p 0.04. The two COPD groups presented more frequent ER visits in the last year (57% and 52% of the patients, respectively, compared with 11.9% of the control group), without any statistically significant differences between the two. This same pattern was observed in the number of ER visits in the last year: 1.98 (1.6), 1.84 (1.5) and 1.18 (0.7), respectively. When we analyzed the prevalence of the comorbidities that are most frequently associated COPD, there was a clear increase in the percentage of patients who presented associated disorders compared with the control group. Nevertheless, these differences were not very relevant between the two COPD groups. The differences also were not relevant between both COPD groups in the pharmacological prescription profile. In conclusion, the use of the LLN as a criterion for establishing the diagnosis of COPD, compared with the GOLD criteria, excludes a population with important clinical manifestations and with a high consumption of health-care resources. Before its implementation, the relevance of applying this criterion in clinical practice should be analyzed.

Economic impact of pulmonary drugs on direct costs of stable chronic obstructive pulmonary disease.

QUESTION OF THE STUDY: To assess the impact of prescribing pulmonary drugs according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines on direct costs in stable chronic obstructive pulmonary disease (COPD). PATIENTS AND METHODS: A total of 560 ambulatory COPD patients completed a specific questionnaire that included data regarding drug therapy. Severity was graded according to the British Thoracic Society (BTS) criteria and appropriateness of pharmacological treatment according to GOLD guidelines. RESULTS: Annual direct costs were 1,657 EUR in stage I, 2,425 EUR in stage II, and 3,303 EUR in stage III. The mean direct costs was 2,061 EUR (38% corresponded to drug therapy). Medication accounted for 43%, 37.6%, and 28.4% of total direct costs for stage I, II, and III, respectively. Inhaled steroids and long-acting beta2-agonists accounted for 78%, 76%, and 75% of total drugs costs in stages I, II, and III, respectively. Drug therapy which was not in accordance with guidelines accounted for 78.7% and 54% of total drug costs in stages I and II, respectively. Most patients with severe disease were treated adequately. ANSWER TO THE QUESTION: Pharmacologic treatment has a great impact on direct medical costs in stable COPD. According to GOLD guidelines, patients with mild or moderate COPD are frequently treated with nonrecommended drugs.