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BackgroundA head-to-head study demonstrated the superiority of once-daily umeclidinium bromide/vilanterol (UMEC/VI) 62.5/25 mcg on trough forced expiratory volume in 1 s (FEV1) versus once-daily tiotropium/olodaterol (TIO/OLO) 5/5 mcg in symptomatic patients with chronic obstructive pulmonary disease (COPD). This analysis evaluated the cost effectiveness of UMEC/VI versus TIO/OLO from a Spanish National Healthcare System perspective, using data from this study and Spanish literature.MethodsThis analysis was conducted from the perspective of the Spanish National Healthcare System with a 3-year horizon as base case. A disease progression model using a linked risk equation approach was used to estimate disease progression and associated healthcare costs, and quality-adjusted life years (QALYs). The Evaluation of COPD Longitudinally to Identify Predictive Surrogate Endpoints (ECLIPSE) study was used to develop the statistical risk equations for clinical endpoints, and costs were calculated using a health state approach (by dyspnea severity). Utilities for QALY calculation were estimated using patient baseline characteristics within a regression fit to Spanish observational data. Treatment effect, expressed as change from baseline in FEV1 was obtained from the head-to-head study and used in the model (UMEC/VI minus TIO/OLO difference: + 52 mL [95% confidence interval: 28, 77]). Baseline patient characteristics were sourced from Spanish literature or the head-to-head study if unavailable. A scenario analysis using only the intent-to-treat (ITT) population from the head-to-head study, and sensitivity analyses (including probabilistic sensitivity analyses), were conducted. Direct healthcare costs (2017 Euro) were obtained from Spanish sources and costs and benefits were discounted at 3% per annum.ResultsUMEC/VI was associated with small improvements in QALYs (+ 0.029) over a 3-year time horizon, compared with TIO/OLO, alongside cost savings of €393/patient. The ITT scenario analysis and sensitivity analyses had similar results. All probabilistic simulations resulted in UMEC/VI being less costly and more effective than TIO/OLO.ConclusionUMEC/VI dominated TIO/OLO (more effective and less expensive). These results may aid payers and decision-makers in Spain when making judgements on which long-acting muscarinic antagonist/long-acting β2-agonist (LAMA/LABA) treatments can be considered cost effective in Spain.Electronic supplementary materialThe online version of this article (10.1186/s12931-018-0916-7) contains supplementary material, which is available to authorized users.

ObjectivesThe Salford Lung Study in Chronic Obstructive Pulmonary Disease (SLS COPD) is a 12-month, open-label randomized clinical trial comparing clinical effectiveness and safety of initiating once-daily fluticasone furoate/vilanterol (FF/VI) 92/22 mcg with continuing usual care (UC) in patients with COPD followed in primary care in the UK. The objective of this analysis is to estimate the economic impact of these results when applied to Spain.Materials and methodsAn Excel-based cost–consequence model with a one-year time horizon was populated with SLS COPD results, adopting the Spanish National Health System (NHS) perspective. Patients analyzed were diagnosed COPD patients ≥40 years old, currently managed with maintenance treatment and with a history of exacerbations (total number estimated from Spanish data). Mean least squares annual rates of moderate/severe exacerbations after 1 year for the intention-to-treat population from SLS COPD were included in the model (1.50 [FF/VI] and 1.64 [UC]); serious adverse events were excluded from the analysis as no differences between treatment arms were found. Medication and exacerbation management costs in euros were estimated from Spanish public sources for 2016. Model base-case analysis assumed an increased usage of FF/VI from 4% to 10% within 1 year, and a 100% proportion of days covered with study medications. Deterministic sensitivity analyses were performed for mitigating uncertainty.ResultsAt base case, within 50,522 COPD patients analyzed, substitution of UC with FF/VI 92/22 mcg was associated with reduced medication and exacerbation management costs, leading to potential total annual savings of €353,623. Deterministic sensitivity results ranged from €218,333 up to €1,532,366 potential cost savings associated with FF/VI, showing the robustness of base-case results.ConclusionThe decreased rate of exacerbations with FF/VI 92/22 mcg compared with UC observed in SLS COPD could be translated into potential health care savings for the Spanish NHS. These results may be useful to inform decision-making processes.

analysis was based on a head-to-head trial comparing changes from baseline in lung function (FEV1) between umeclidinium 62.5mcg and tiotropium 18mcg, on a 12-week-period (Feldman G. et al. Int J Chron Obstruct Pulmon Dis 2016). A previously published linked equations cohort model, based on ECLIPSE and TORCH studies, which estimates COPD progression, exacerbation rates, associated healthcare-costs, quality-adjusted-life-years (QALYs) and survival, was used (Miravitlles M. et al. Int J Chron Obstruct Pulmon Dis 2016). A 3-year time horizon was selected. COPD diagnosed patients with post-bronchodilator FEV1 of 30%-70% predicted and respiratory symptoms (mMRC dyspnoea scale ≥ 2) were included. Differential treatment effect was maintained until first year of analysis, based on a 52-weeks umeclidinium trial; subsequently no differences were assumed. Effectiveness was measured in QALYs, deriving utilities from a Spanish observational study. Directcosts were obtained from local sources and treatments-costs from Spain retail prices for 2017 (€ 45.27 and € 49.06 for umeclidinium and tiotropium respectively). Results were expressed as incremental costs per QALY gained (ICER), applying a 3% discount to costs and QALYs. Deterministic (DSA) and probabilistic sensitivity analyses (PSA) were performed. On DSA different discounts for tiotropium retail price were tested. Results: At base-case umeclidinium was dominant over tiotropium, gaining 0.0135 QALYs with cost-savings of € 192.20. DSA for tiotropium price showed that umeclidinium was cost-effective up to 36.3% tiotropium discount, as ICERs were below the accepted € 30,000/QALY willingness-to-pay threshold in Spain. Varying main parameters in PSA did not have a significant impact on results. ConClusions: From the Spanish NHS perspective, umeclidinium is a dominant alternative to tiotropium, the standard of care for COPD. PRS40 CoSt-EffECtivEnESS AnAlySiS of Adding nEw dRug thiozonidE to iv-th dRug REgimEnS foR multidRug-RESiStAnt tubERCuloSiS

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