Cost-effectiveness of umeclidinium compared with tiotropium and glycopyrronium as monotherapy for chronic obstructive pulmonary disease: a UK perspective

Dhvani Shah, Maurice Driessen, Nancy Risebrough, Timothy Baker, Ian Naya, Andrew Briggs, Afisi S Ismaila, Dhvani Shah, Maurice Driessen, Nancy Risebrough, Timothy Baker, Ian Naya, Andrew Briggs, Afisi S Ismaila

Abstract

Background: Cost-effectiveness of once-daily umeclidinium bromide (UMEC) was compared with once-daily tiotropium (TIO) and once-daily glycopyrronium (GLY) in patients with chronic obstructive pulmonary disease (COPD) from a UK National Health Service (NHS) perspective.

Methods: A linked-equation model was implemented to estimate COPD progression, associated healthcare costs, exacerbations rates, life years (LY) and quality-adjusted LY (QALYs). Statistical risk equations for endpoints and resource use were derived from the ECLIPSE and TORCH studies, respectively. Treatment effects [mean (standard error)] at 12 weeks on forced expiratory volume in 1 s and St George's Respiratory Questionnaire score were obtained from the intention-to-treat populations of two head-to-head studies [GSK study identifiers 201316 (NCT02207829) and 201315 (NCT02236611)] which compared UMEC 62.5 mcg with TIO 18 mcg and UMEC 62.5 mcg with GLY 50 mcg, respectively. Treatment costs reflect UK list prices (2016) and NHS unit costs; UMEC and GLY prices being equal and less than TIO. A lifetime horizon, discounted costs and effects at 3.5% were used. Sensitivity analyses were performed to evaluate the robustness of variations in input parameters and assumptions in the model.

Results: Over a lifetime horizon, UMEC was predicted to increase LYs (+ 0.195; 95% confidence interval [CI]: 0.069, 0.356) and QALYs (+ 0.118; 95% CI: 0.055, 0.191) and reduce the number of annual exacerbations (- 0.053; 95% CI: - 0.171, 0.028) compared with TIO, with incremental cost savings of £460/patient (95% CI: - £645, - £240). Compared with GLY, UMEC increased LYs (+ 0.124; 95% CI: 0.015, 0.281) and QALYs (+ 0.101; 95% CI: 0.043, 0.179) and reduced annual exacerbation (- 0.033; 95% CI: - 0.135, 0.017) at an additional cost of £132/patient (95% CI: £12, £330), resulting in an incremental cost-effectiveness ratio of £1310/QALY (95% CI: £284, £2060). Similar results were observed in alternative time horizons and additional sensitivity analyses.

Conclusions: For treatment of patients with COPD in the UK over a lifetime horizon, treatment with UMEC dominates treatment with TIO, providing both improved health outcomes and cost savings. In comparison with GLY, treatment with UMEC achieved improved health outcomes but was associated with a higher cost.Trial registration 201316, NCT02207829; 201315, NCT02236611.

Keywords: Chronic obstructive pulmonary disorder; Cost-effectiveness; Economic evaluation; Long-acting muscarinic antagonist.

Figures

Fig. 1
Fig. 1
Cost-effectiveness scatter plots for a UMEC versus TIO and b UMEC versus GLY, lifetime horizon. GL, glycopyrronium, QALY quality-adjusted life year, TIO tiotropium, UMEC umeclidinium

References

    1. Celli BR, Decramer M, Wedzicha JA, Wilson KC, Agusti AA, Criner GJ, MacNee W, Make BJ, Rennard SI, Stockley RA, et al. An official American Thoracic Society/European Respiratory Society statement: research questions in COPD. Eur Respir Rev. 2015;24:159–172. doi: 10.1183/16000617.00000315.
    1. Global strategy for the diagnosis, management and prevention of chronic obstructive pulmonary disease. Updated 2017. . Accessed 11 Apr 2017.
    1. Ehteshami-Afshar S, FitzGerald JM, Doyle-Waters MM, Sadatsafavi M. The global economic burden of asthma and chronic obstructive pulmonary disease. Int J Tuberc Lung Dis. 2016;20:11–23. doi: 10.5588/ijtld.15.0472.
    1. Lopez-Campos JL, Tan W, Soriano JB. Global burden of COPD. Respirology. 2016;21:14–23. doi: 10.1111/resp.12660.
    1. GBD 2015 Chronic Respiratory Disease Collaborators Global, regional, and national deaths, prevalence, disability-adjusted life years, and years lived with disability for chronic obstructive pulmonary disease and asthma, 1990–2015: a systematic analysis for the Global Burden of Disease Study 2015. Lancet Respir Med. 2015;2017(5):691–706.
    1. Guarascio AJ, Ray SM, Finch CK, Self TH. The clinical and economic burden of chronic obstructive pulmonary disease in the USA. ClinicoEcon Outcomes Res CEOR. 2013;5:235–245.
    1. Lazic Z, Gajovic O, Tanaskovic I, Milovanovic D, Atanasijevic D, Jakovljevic M. Gold stage impact on COPD direct medical costs in elderly. Health Behav Public Health. 2012;2:1–7.
    1. Jakovljevic M, Lazic Z, Verhaeghe N, Jankovic S, Gajovic O, Annemans L. Direct medical costs of COPD diagnosis and treatment, Eastern vs Western European country—examples of Serbia and Belgium. Farmeconomia Health Econ Ther Pathw. 2013;14:161–168. doi: 10.7175/fe.v14i4.676.
    1. Estimating the economic burden of respiratory illness in the UK. 2017. . Accessed 12 Apr 2017.
    1. Cazzola M, Page CP, Calzetta L, Matera MG. Pharmacology and therapeutics of bronchodilators. Pharmacol Rev. 2012;64:450–504. doi: 10.1124/pr.111.004580.
    1. Tashkin DP, Cooper CB. The role of long-acting bronchodilators in the management of stable COPD. Chest. 2004;125:249–259. doi: 10.1378/chest.125.1.249.
    1. Vogelmeier C, Hederer B, Glaab T, Schmidt H, Rutten-van Mölken MP, Beeh KM, Rabe KF, Fabbri LM. Tiotropium versus salmeterol for the prevention of exacerbations of COPD. N Engl J Med. 2011;364:1093–1103. doi: 10.1056/NEJMoa1008378.
    1. Decramer ML, Chapman KR, Dahl R, Frith P, Devouassoux G, Fritscher C, et al. Once-daily indacaterol versus tiotropium for patients with severe chronic obstructive pulmonary disease (INVIGORATE): a randomised, blinded, parallel-group study. Lancet Respir Med. 2013;1:524–533. doi: 10.1016/S2213-2600(13)70158-9.
    1. Incruse 55 micrograms inhalation powder, pre-dispensed: summary of product characteristics. Updated 2017. . Accessed 12 Apr 2017.
    1. Incruse Ellipta (umeclidinium bromide) inhalation powder. 2014. . Accessed 25 July 2017.
    1. EPAR summary for the public: Incruse, umeclidinium bromide. 2015. . Accessed 25 July 2017.
    1. New drugs approved in FY 2014. . Accessed May 2018.
    1. Decramer M, Maltais F, Feldman G, Brooks J, Harris S, Mehta R, et al. Bronchodilation of umeclidinium, a new long-acting muscarinic antagonist, in COPD patients. Respir Physiol Neurobiol. 2013;185:393–399. doi: 10.1016/j.resp.2012.08.022.
    1. Segreti A, Calzetta L, Rogliani P, Cazzola M. Umeclidinium for the treatment of chronic obstructive pulmonary disease. Expert Rev Respir Med. 2014;8:665–671. doi: 10.1586/17476348.2014.962519.
    1. Trivedi R, Richard N, Mehta R, Church A. Umeclidinium in patients with COPD: a randomised, placebo-controlled study. Eur Respir J. 2014;43:72–81. doi: 10.1183/09031936.00033213.
    1. Feldman G, Maltais F, Khindri S, Vahdati-Bolouri M, Church A, Fahy WA, et al. A randomized, blinded study to evaluate the efficacy and safety of umeclidinium 62.5 mug compared with tiotropium 18 mug in patients with COPD. Int J Chronic Obstr Pulm Dis. 2016;11:719–730. doi: 10.2147/COPD.S102494.
    1. Rheault T, Khindri S, Vahdati-Bolouri M, Church A, Fahy WA. A randomised, open-label study of umeclidinium versus glycopyrronium in patients with COPD. ERJ Open Res. 2016;2(2). pii:00101-2015.
    1. Briggs AH, Baker T, Risebrough NA, Chambers M, Gonzalez-McQuire S, Ismaila AS, et al. Development of the Galaxy chronic obstructive pulmonary disease (COPD) model using data from ECLIPSE: internal validation of a linked-equations cohort model. Med Decis Making. 2017;37:469–480. doi: 10.1177/0272989X16653118.
    1. Agusti A, Calverley PM, Celli B, Coxson HO, Edwards LD, Lomas DA, et al. Characterisation of COPD heterogeneity in the ECLIPSE cohort. Respir Res. 2010;11:122. doi: 10.1186/1465-9921-11-122.
    1. Calverley PM, Anderson JA, Celli B, Ferguson GT, Jenkins C, Jones PW, et al. Salmeterol and fluticasone propionate and survival in chronic obstructive pulmonary disease. N Engl J Med. 2007;356:775–789. doi: 10.1056/NEJMoa063070.
    1. Exuzides A, Colby C, Briggs AH, Lomas DA, Rutten-van Molken M, Tabberer M, et al. Statistical modeling of disease progression for chronic obstructive pulmonary disease using data from the ECLIPSE study. Med Decis Making. 2017;37:453–468. doi: 10.1177/0272989X15610781.
    1. Tabberer M, Gonzalez-McQuire S, Muellerova H, Briggs AH, Rutten-van Molken M, Chambers M, Lomas DA. Development of a conceptual model of disease progression for use in economic modeling of chronic obstructive pulmonary disease. Med Decis Making. 2017;37:440–452. doi: 10.1177/0272989X16662009.
    1. Risebrough NA, Briggs A, Baker TM, Exuzides A, Colby C, Rutten van-Molken M, Gonzalez MS, Lomas D, Muellerova H, Tal-Singer R, Ismaila A. Validating a model to predict disease progression outcomes in patients with COPD. Value Health. 2014;17:A560–A561. doi: 10.1016/j.jval.2014.08.1852.
    1. Hoogendoorn M, Feenstra TL, Asukai Y, Briggs AH, Hansen RN, Leidl R, Risebrough N, Samyshkin Y, Wacker M, Rutten-van Molken MP. External validation of health economic decision models for chronic obstructive pulmonary disease (COPD): report of the third COPD modeling meeting. Value Health. 2017;20:397–403. doi: 10.1016/j.jval.2016.10.016.
    1. Guide to the methods of technology appraisal 2013. 2013. . Accessed 12 Apr 2017.
    1. Haymarket Media Group: monthly index of medical specialities (MIMS). . Accessed Sept 2016.
    1. Unit costs of health & social care. 2015. . Accessed Sept 2015.
    1. NHS Reference costs 2014 to 2015. . Accessed Sept 2016.
    1. . Accessed 1 Sept 2016.
    1. Starkie HJ, Briggs AH, Chambers MG, Jones P. Predicting EQ-5D values using the SGRQ. Value Health. 2011;14:354–360. doi: 10.1016/j.jval.2010.09.011.
    1. National Institute for Health and Care Excellence 2012. . Accessed 6 June 2017.
    1. Costa-Scharplatz M, Ställberg B, Goyal P, Asukai Y, Gruenberger J-B, Price D. Cost-effectiveness of glycopyrronium bromide compared with tiotropium in patients with chronic obstructive pulmonary disease in Sweden. Appl Health Econ Health Policy. 2015;13:637. doi: 10.1007/s40258-015-0193-2.
    1. Eklund O, Afzal F, Borgstrom F, Flavin J, Ternouth A, Ojanguren ME, et al. Cost-effectiveness of tiotropium versus glycopyrronium in moderate to very severe chronic obstructive pulmonary disease in Canada, Spain, Sweden, and the UK. ClinicoEcon Outcomes Res. 2016;8:243–252. doi: 10.2147/CEOR.S105579.
    1. Eklund O, Afzal F, Borgstrom F. Cost-effectiveness of tiotropium versus usual care and glycopyrronium in the treatment of chronic obstructive pulmonary disease in Sweden. Cost Eff Resour Alloc. 2015;13:13. doi: 10.1186/s12962-015-0040-1.
    1. Tashkin DP, Celli B, Senn S, Burkhart D, Kesten S, Menjoge S, et al. A 4-year trial of tiotropium in chronic obstructive pulmonary disease. N Engl J Med. 2008;359:1543–1554. doi: 10.1056/NEJMoa0805800.
    1. Wedzicha JA, Decramer M, Ficker JH, Niewoehner DE, Sandström T, Taylor AF, et al. Analysis of chronic obstructive pulmonary disease exacerbations with the dual bronchodilator QVA149 compared with glycopyrronium and tiotropium (SPARK): a randomised, double-blind, parallel-group study. Lancet Respir Med. 2013;1:199–209. doi: 10.1016/S2213-2600(13)70052-3.
    1. Hoogendoorn M, Feenstra TL, Asukai Y, Borg S, Hansen RN, Jansson SA, et al. Cost-effectiveness models for chronic obstructive pulmonary disease: cross-model comparison of hypothetical treatment scenarios. Value Health. 2014;17:525–536. doi: 10.1016/j.jval.2014.03.1721.
    1. Zider AD, Wang X, Buhr RG, Sirichana W, Barjaktarevic IZ, Cooper CB. Reduced COPD exacerbation risk correlates with improved FEV1: a meta-regression analysis. Chest. 2017;152:494–501. doi: 10.1016/j.chest.2017.04.174.
    1. Rodrigo GJ, Price D, Anzueto A, Singh D, Altman P, Bader G, et al. LABA/LAMA combinations versus LAMA monotherapy or LABA/ICS in COPD: a systematic review and meta-analysis. Int J Chronic Obstr Pulm Dis. 2017;12:907–922. doi: 10.2147/COPD.S130482.
    1. Maleki-Yazdi MR, Kaelin T, Richard N, Zvarich M, Church A. Efficacy and safety of umeclidinium/vilanterol 62.5/25 mcg and tiotropium 18 mcg in chronic obstructive pulmonary disease: results of a 24-week, randomized, controlled trial. Respir Med. 2014;108:1752–1760. doi: 10.1016/j.rmed.2014.10.002.
    1. Miravitlles M, Galdiz JB, Huerta A, Villacampa A, Carcedo D, Garcia-Rio F. Cost-effectiveness of combination therapy umeclidinium/vilanterol versus tiotropium in symptomatic COPD Spanish patients. Int J Chronic Obstr Pulm Dis. 2016;11:123–132. doi: 10.2147/COPD.S94006.
    1. Siler TM, Kerwin E, Sousa AR, Donald A, Ali R, Church A. Efficacy and safety of umeclidinium added to fluticasone furoate/vilanterol in chronic obstructive pulmonary disease: results of two randomized studies. Respir Med. 2015;109:1155–1163. doi: 10.1016/j.rmed.2015.06.006.
    1. Feldman GJ, Sousa AR, Lipson DA, Tombs L, Barnes N, Riley JH, Patel S, Naya I, Compton C, Alcazar Navarrete B. Comparative efficacy of once-daily umeclidinium/vilanterol and tiotropium/olodaterol therapy in symptomatic chronic obstructive pulmonary disease: a randomized study. Adv Ther. 2017;34:2518–2533. doi: 10.1007/s12325-017-0626-4.

Source: PubMed

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