Cost-effectiveness analysis of umeclidinium bromide/vilanterol 62.5/25 mcg versus tiotropium/olodaterol 5/5 mcg in symptomatic patients with chronic obstructive pulmonary disease: a Spanish National Healthcare System perspective

Abstract

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.

<p>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</p>

“…The GALAXY model has been validated and is a well-established, published tool for the assessment of the cost-effectiveness of COPD treatments. 18,19,[21][22][23][24][25][26] Model Inputs…”

A randomized controlled trial of long-acting muscarinic antagonist and long-acting β2 agonist fixed-dose combinations in patients with chronic obstructive pulmonary disease

“…These three LAMA/LABA FDCs were previously found to have similar incremental cost-effectiveness ratios [ 16 ], efficacy, and safety [ 17 ]. In a comparison of two medications, Ume/Vil was reported to be superior to Tio/Olo in rescue medication use and medication adherence [ 18 ], and was also reported to show better cost-effectiveness (compared to Tio/Olo) [ 19 ]. In a direct comparison test, Ume/Vil was superior to Tio/Olo regarding the change of trough FEV1 [ 14 , 15 ].…”

Economic evaluations of chronic obstructive pulmonary disease pharmacotherapy: how well are the real-world issues of medication adherence, comorbidities and adverse drug-reactions addressed?

“…Twenty-five out of the 28 studies (89%) were economic evaluations or BIAs conducted in a single country/region: Canada [18], France [19], USA [20,27], Czech Republic [23], Spain [22,34,[37][38][39], UK [21,24,28,35,43], Taiwan [25], Sweden [26], the Netherlands [15,29], Scotland [30], Italy [32,40,41], Singapore [36] and Russia [44]. Three studies included multiple countries [31,33,42].…”

“…Twenty-two studies [18][19][20][21][22][23][24][25][26][27][28][29][30][31][32][33][34][35][36][37]43,44] explored COPD treatment cost-effectiveness (79%), of which two [29,44] performed a BIA as well. Six studies [15,[38][39][40][41][42] conducted BIA only.…”