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      Indacaterol/glycopyrronium is cost-effective compared to salmeterol/fluticasone in COPD: FLAME-based modelling in a Swedish population

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          Abstract

          Background

          This study assessed the cost-effectiveness of indacaterol/glycopyrronium (IND/GLY) versus salmeterol/fluticasone (SFC) in chronic obstructive pulmonary disease (COPD) patients with moderate to very severe airflow limitation and ≥1 exacerbation in the preceding year.

          Methods

          A previously published and validated patient-level simulation model was adapted using clinical data from the FLAME trial and real-world cost data from the ARCTIC study. Costs (total monetary costs comprising drug, maintenance, exacerbation, and pneumonia costs) and health outcomes (life-years (LYs), quality-adjusted life-years (QALYs)) were projected over various time horizons (1, 5, 10 years, and lifetime) from the Swedish payer’s perspective and were discounted at 3% annually. Uncertainty in model input values was studied through one-way and probabilistic sensitivity analyses. Subgroup analyses were also performed.

          Results

          IND/GLY was associated with lower costs and better outcomes compared with SFC over all the analysed time horizons. Use of IND/GLY resulted in additional 0.192 LYs and 0.134 QALYs with cost savings of €1211 compared with SFC over lifetime. The net monetary benefit (NMB) was estimated to be €8560 based on a willingness-to-pay threshold of €55,000/QALY. The NMB was higher in the following subgroups: severe (GOLD 3), high risk and more symptoms (GOLD D), females, and current smokers.

          Conclusion

          IND/GLY is a cost-effective treatment compared with SFC in COPD patients with mMRC dyspnea grade ≥ 2, moderate to very severe airflow limitation, and ≥1 exacerbation in the preceding year.

          Electronic supplementary material

          The online version of this article (10.1186/s12931-017-0688-5) contains supplementary material, which is available to authorized users.

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          Efficacy and safety of once-daily QVA149 compared with twice-daily salmeterol-fluticasone in patients with chronic obstructive pulmonary disease (ILLUMINATE): a randomised, double-blind, parallel group study.

          Peter D’Andrea, Hungta Chen, C Vogelmeier … (2013)
          QVA149 is an inhaled fixed-dose combination therapy under development for the treatment of chronic obstructive pulmonary disease (COPD). It combines indacaterol (a longacting β2-agonist) with glycopyrronium (a longacting muscarinic antagonist) as a dual bronchodilator. We aimed to compare the efficacy, safety, and tolerability of QVA149 versus salmeterol-fluticasone (SFC) over 26 weeks in patients with moderate-to-severe COPD. In this multicentre double-blind, double-dummy, parallel-group study, 523 patients (age 40 years or older, Global Initiative for Chronic Obstructive Lung Disease [GOLD] stages II-III, without exacerbations in the previous year) were randomly assigned (1:1; via automated, interactive response technology and stratified for smoking status) to once-daily QVA149 110/50 μg or twice-daily SFC 50/500 μg for 26 weeks. Efficacy was assessed in the full analysis set (randomised patients who received at least one dose of study drug); safety was assessed in all patients who received at least one dose of study drug. The primary endpoint was to demonstrate the superiority of QVA149 compared with SFC for the standardised area under the curve from 0 to 12 h post dose for forced expiratory volume in 1 second (FEV1 AUC0-12h) after 26 weeks of treatment. This trial was registered at ClinicalTrial.gov, NCT01315249. Between March 25, 2011, and March 12, 2012, 259 patients were randomly assigned to receive QVA149 and 264 to receive SFC. At week 26, FEV1 AUC0-12h was significantly higher with QVA149 than with SFC (treatment difference 0·138 L; 95% CI 0·100-0·176; p<0·0001). Overall incidence of adverse events (including COPD exacerbations) was 55·4% (143 of 258) for the QVA149 group and 60·2% (159 of 264) for the SFC group. Incidence of serious adverse events was similar between treatment groups (QVA149, 13 of 258 [5·0%]; SFC 14 of 264 [5·3%]); COPD worsening was the most frequent serious adverse event (one of 13 [0·4%] and three of 14 [1·1%], respectively). Once-daily QVA149 provides significant, sustained, and clinically meaningful improvements in lung function versus twice-daily SFC, with significant symptomatic benefit. These results indicate the potential of dual bronchodilation as a treatment option for non-exacerbating symptomatic COPD patients. Novartis Pharma AG. Copyright © 2013 Elsevier Ltd. All rights reserved.
          Article 0 comments Cited 108 times – based on 0 reviews     Review now
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            Does quality of life of COPD patients as measured by the generic EuroQol five-dimension questionnaire differentiate between COPD severity stages?

            Brigitta Monz, Deborah Burkhart, Jan Oostenbrink … (2006)
            To assess the discriminative properties of the EuroQol five-dimension questionnaire (EQ-5D) with respect to COPD severity according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria in a large multinational study. Baseline EQ-5D visual analog scale (VAS) scores, EQ-5D utility scores, and St. George Respiratory Questionnaire scores were obtained from a subset of patients in the Understanding the Potential Long-term Impact on Function with Tiotropium trial, which was a 4-year placebo-controlled trial designed to assess the effect of tiotropium on the rate of decline in FEV(1) in COPD patients aged > or = 40 years, an FEV(1) of /= 10 pack-years. A total of 1,235 patients (mean post bronchodilator FEV(1), 48.8% predicted) from 13 countries completed the EQ-5D. The EQ-5D VAS and utility scores differed significantly among patients in GOLD stages 2, 3, and 4, also after correction for age, sex, smoking, body mass index (BMI), and comorbidity (p < 0.001). The mean EQ-5D VAS scores for patients in GOLD stages 2, 3, and 4 were 68 (SD, 16), 62 (SD, 17), and 58 (SD, 16), respectively. The mean utility scores were 0.79 (SD, 0.20) for patients in GOLD stage 2, 0.75 (SD, 0.21) for patients in GOLD stage 3, and 0.65 (SD, 0.23) for patients in GOLD stage 4. Effect sizes for the difference in utility scores between patients in GOLD stages 3 and 4 were more than twice as high as those for the difference between patients in GOLD stages 2 and 3. Gender, postbronchodilator FEV(1) percent predicted, the number of hospital admissions and emergency department visits in the year prior to baseline measurements, measures of comorbidity, and BMI were independently associated with EQ-5D utility. EQ-5D utility scores also differed between patients from different countries. French patients especially had lower utility scores than US patients. Utility scores calculated with the US value set were on average 5% higher than those calculated with the UK value set. Increasing severity of COPD was associated with a significant decline in EQ-5D VAS scores and utility scores. These results demonstrate that a generic instrument can assess COPD impact on quality of life and that the scores discriminate between patient groups of known severity. These utility scores will be useful in cost-effectiveness assessments.
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              Risk-to-benefit ratio of inhaled corticosteroids in patients with COPD.

              David Price, Barbara Yawn, Guy Brusselle … (2013)
              While the pharmacological management of chronic obstructive pulmonary disease (COPD) has evolved from the drugs used to treat asthma, the treatment models are different and the two diseases require clear differential diagnosis in order to determine the correct therapeutic strategy. In contrast to the almost universal requirement for anti-inflammatory treatment of persistent asthma, the efficacy of inhaled corticosteroids (ICS) is less well established in COPD and their role in treatment is limited. There is some evidence of a preventive effect of ICS on exacerbations in patients with COPD, but there is little evidence for an effect on mortality or lung function decline. As a result, treatment guidelines recommend the use of ICS in patients with severe or very severe disease (forced expiratory volume in 1 second <50% predicted) and repeated exacerbations. Patients with frequent exacerbations - a phenotype that is stable over time - are likely to be less common among those with moderate COPD (many of whom are managed in primary care) than in those with more severe disease. The indiscriminate use of ICS in COPD may expose patients to an unnecessary increase in the risk of side-effects such as pneumonia, osteoporosis, diabetes and cataracts, while wasting healthcare spending and potentially diverting attention from other more appropriate forms of management such as pulmonary rehabilitation and maximal bronchodilator use. Physicians should carefully weigh the likely benefits of ICS use against the potential risk of side-effects and costs in individual patients with COPD.
              Article 0 comments Cited 66 times – based on 0 reviews     Review now
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                Author and article information

                Contributors
                Leif Bjermer: leif.bjermer@med.lu.se
                Job F. M. van Boven: j.f.m.van.boven@rug.nl
                Madlaina Costa-Scharplatz: madlaina.costa-scharplatz@novartis.com
                Dorothy L. Keininger: dorothy.keininger@novartis.com
                Florian S. Gutzwiller: florian.gutzwiller@novartis.com
                Karin Lisspers: karin.lisspers@ltdalarna.se
                Ronan Mahon: ronan.mahon@novartis.com
                Petter Olsson: petter.olsson@novartis.com
                Nicolas Roche: +33-1-58-41-21-53 , nicolas.roche@aphp.fr
                Journal
                Journal ID (nlm-ta): Respir Res
                Journal ID (iso-abbrev): Respir. Res
                Title: Respiratory Research
                Publisher: BioMed Central (London )
                ISSN (Print): 1465-9921
                ISSN (Electronic): 1465-993X
                Publication date (Electronic): 11 December 2017
                Publication date PMC-release: 11 December 2017
                Publication date (Print): 2017
                Volume: 18
                Electronic Location Identifier: 206
                Affiliations
                [1 ]Department of Respiratory medicine & Allergology, Skane University Hospital, Lund University, Lund, Sweden
                [2 ]Department of General Practice, Groningen Research Institute for Asthma and COPD (GRIAC), University Medical Center Groningen, University of Groningen, Groningen, The Netherlands
                [3 ]ISNI 0000 0004 0407 1981, GRID grid.4830.f, Unit of Pharmacoepidemiology & Pharmacoeconomics, Department of Pharmacy, , University of Groningen, ; Groningen, The Netherlands
                [4 ]Novartis Sverige AB, Täby, Sweden
                [5 ]ISNI 0000 0001 1515 9979, GRID grid.419481.1, Novartis Pharma AG, ; Basel, Switzerland
                [6 ]ISNI 0000 0004 1936 9457, GRID grid.8993.b, Department of Public Health and Caring Sciences, Family Medicine and Preventive Medicine, , Uppsala University, ; Uppsala, Sweden
                [7 ]Novartis Ireland Limited, Dublin, Ireland
                [8 ]ISNI 0000 0001 0274 3893, GRID grid.411784.f, Respiratory and Intensive Care Medicine, , Cochin Hospital (AP-HP) and University Paris Descartes, ; Paris, France
                Article
                Publisher ID: 688
                DOI: 10.1186/s12931-017-0688-5
                PMC ID: 5725803
                SO-VID: 86dbb144-893c-404c-8e01-cc16ee0353f2
                Copyright © © The Author(s). 2017
                License:

                Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

                History
                Date received : 6 July 2017
                Date accepted : 23 November 2017
                Funding
                Funded by: Novartis Pharma AG (Switzerland)
                Categories
                Subject: Research
                Custom metadata
                issue-copyright-statement © The Author(s) 2017

                ScienceOpen disciplines: Respiratory medicine
                Keywords: chronic obstructive pulmonary disease,indacaterol/glycopyrronium,cost-effective,exacerbation
                Data availability:
                ScienceOpen disciplines: Respiratory medicine
                Keywords: chronic obstructive pulmonary disease, indacaterol/glycopyrronium, cost-effective, exacerbation

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