Cost Effectiveness of Budesonide/Formoterol for Maintenance and Reliever Therapy versus Salmeterol/ Fluticasone plus Salbutamol in the Treatment of Asthma
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Introduction: Budesonide/formoterol (Symbicort®) Maintenance And Reliever Therapy (SMART) is an effective and well tolerated treatment option for patients with asthma. We compared the cost effectiveness from a societal perspective of this one-inhaler regimen with that of maintenance salmeterol/fluticasone propionate (Seretide®) plus salbutamol (albuterol) as needed (Seretide® Fixed Combination [SFC]).
Study design: A cost-effectiveness analysis was performed based on effectiveness and resource-utilisation data collected prospectively in a randomised, 12-month study performed in 2143 patients in 16 countries. Resource utilisation data were pooled and unit costs (€, year 2003 values) from Italy, France, the UK and Germany were used to generate estimates of direct and total costs per patient per year and cost per severe exacerbation avoided.
Methods: Adolescents and adults with asthma (n = 2143; mean forced expiratory volume in 1 second [FEV1] 73% predicted; mean inhaled corticosteroid [ICS] dose 884 µg/day) were randomised to SMART or SFC. The effectiveness measure used was the number of severe exacerbations per patient per year. Direct costs included medication use (budesonide/formoterol 160µg/4.5µg or salmeterol/fluticasone 50µg/100µg, 50µg/250µg or 50µg/500µg plus salbutamol) and nonmedication-related resource use, including days in hospital, emergency room visits, specialist or primary care physician visits and other healthcare provider contacts. Indirect costs, including the number of days when the patient or their carer was unable to attend to their normal daily activities, were also assessed. The study assumed a European societal perspective (i.e. including direct and indirect costs).
Results: Treatment with SMART resulted in significantly fewer severe exacerbations per patient per year compared with SFC (0.24 vs 0.31 events per patient per year; p = 0.0025). Resource use was low in both groups. Medication costs accounted for the majority of the total costs. The increased effectiveness of SMART was achieved at a reduced or similar cost compared with SFC. SMART dominated when German unit costs were applied (i.e. there was a statistically significant reduction in both costs and number of exacerbations). In all other countries, the incremental cost-effectiveness ratios showed that there was a reduction in mean total cost per exacerbation avoided; however, this difference was not statistically significant.
Conclusion: This analysis demonstrates that, compared with SFC, SMART may be cost effective from a societal perspective for the treatment of patients with asthma in Italy, Germany, France and the UK. SMART provided a reduction in the number of severe exacerbations per patient per year, at no statistically significant increase in cost — or even at a lower cost — compared with SFC plus as-needed reliever salbutamol.
KeywordsSalbutamol Budesonide Formoterol Severe Exacerbation Reliever Therapy
Gunnar Johansson and Claus Vogelmeier were involved in the clinical study and in the interpretation of the data and the writing of the manuscript. Emma Andreasson was involved in the design and implementation of the study, interpretation of data and development of the manuscript. Per Larsson contributed to the study design, statistical analysis and interpretation of results. All authors had free and unlimited access to the clinical study report and statistical reports. All authors were involved in the decision to submit the manuscript. All authors made final decisions on all aspects of the manuscript and hence are in agreement with, and approve, the final version of the submitted manuscript.
AstraZeneca provided financial support for this study as recommended by national guidelines and approved by local ethics committees. AstraZeneca provided study medication, clinical trial materials and study monitors, and paid other study-related costs.
Emma Andreasson was employed by AstraZeneca, Lund, Sweden, at the time this article was written.
Gunnar Johansson does not hold any stocks or shares in any organisation that could gain or lose financially from the results of this study. He has conducted clinical trials for AstraZeneca, Boehringer-Ingelheim, GlaxoSmithKline and Merck, Sharpe & Dohme and has also been an invited speaker for these companies during the last 5 years. Emma Andreasson was an AstraZeneca employee at the time of the study. Per Larsson is an AstraZeneca employee. During the last 5 years, Claus Vogelmeier has presented at symposia sponsored by Altana, AstraZeneca, Aventis, Bayer, Boehringer Ingelheim, GlaxoSmithKline and Merck Darmstadt. He has also been a paid consultant for Altana, AstraZeneca, Bayer, Boehringer Ingelheim and GlaxoSmithKline.
We acknowledge the contribution of Deirdre Carman from Adelphi Communications, who provided medical writing services on behalf of AstraZeneca.
- 1.Global Initiative for Asthma. Global strategy for asthma management and prevention. National Institutes of Health publication No. 02-3659 (updated 2004). Bethesda (MD): National Institutes of Health, 2004 [online]. Available from URL: http://www.ginasthma.org [Accessed 2005 Jul 6]Google Scholar
- 24.Medical Products Agency, Uppsala, Sweden. Seretide Diskus mite, Seretide Diskus, Seretide Diskus forte (salmeterol/flutikason) [online]. Available from URL: http://www.lakemedelsverket.se/Tpl/MonographyPage_597.aspx [Accessed 2006 May 25]Google Scholar
- 25.Medical Products Agency, Uppsala, Sweden. Symbicort Turbubaler/Symbicort mite Turbuhaler [online]. Available from URL: http://www.lakernedelsverket.set/Tpl/MonographyPage_604.aspx [Accessed 2006 May 25]Google Scholar
- 26.National formulary 2004, Official Gazette No.4, 2003 Jan 7th ed. Rome: Italian Ministry of Health, 2004Google Scholar
- 27.Groupement pour l’Elaboration et la Realisation de Statistiques. Paris: 2004 [online]. Available from URL: http://www.giegers.fr/ [Accessed 2005 Mar]Google Scholar
- 28.Monthly Index of Medical Specialties (MIMS) 2004 Jun ed. London: Haymarket Publications, 2004Google Scholar
- 29.Lauer-Taxe: WINAPO® Lauer-Taxe, Lauer-Fischer, Germany [online]. Available from URL: http://www.arz.de/LAUERFISCHER/default.htm [Accessed 2004 Jul]Google Scholar
- 31.IMS Health, IMS MIDAS Quantum MAT/Q2/04 [database]. London: IMS Health, 2005Google Scholar
- 32.Italian Ministry of Health. Official gazette No. 209, 1997 Sept 8. Ordinary Supplement, 1997 March 12Google Scholar
- 33.MEDTAP. Database of international unit costs for economic evaluations in health care. London: MEDTAP International Inc, 2002 Dec 18 [online]. Available from URL: http://www.medtap.com/products/unitcost.cfm [Accessed 2006 May 30]Google Scholar
- 34.NHS reference costs 2003 and national tariff 2004, Appendix 4. National schedule of reference costs: NHS Trusts and Primary Care Trusts combined; TCCS, Service Code CCI [online]. Available from URL: http://www.dh.gov.uk/assetRoot/04/07/01/16/04070116.xls [Accessed 2005 Jul 6]Google Scholar
- 35.PKV, Zahlenbericht 2002/2003, PKV Verband der privaten Krankenversicherung e.V., Köln, Germany [online]. http://www.pkv.de/downloads/Zb031.pdf [Accessed 2006 May 24]Google Scholar
- 36.Potena A, Ballerin L, Putinati S, et al. The intensive respiratory care units in Italy: analysis of clinical activity and coding system. Rev Pathol Respir System 2002; 17: 96–105Google Scholar
- 37.NHS reference costs 2003, HRG code D22 [online]. Available from URL: http://www.nhselect.org.uk/downloads/nhselect_price_list_2005-06a.htm [Accessed 2005 Jul 6]Google Scholar
- 38.Arrêté du 2 Août 2004 fixant les tarifs de référence nationaux par activité. Annexe 1 titre II et III. Journal Officiel de la République Française (JORF) du 22 août 2004 [online]. Available from URL: http://www.legifrance.gouv.fr/ [Accessed 2006 May 25]Google Scholar
- 39.Curtis L, Netten A. Unit costs of health and social care 2004. Canterbury (UK): PSSRU, University of Kent at Canterbury, 2004Google Scholar
- 40.Deutsche Krankenhausgesellschaft, DKG-NTIBG Tariff, 2002/2003. Germany: Kohlhammer Verlag, 2003Google Scholar
- 41.Nomenclature Générale des Actes Professionnels, Union des Caisses Nationales de Sécurité Sociale (UCANSS), 2004 [online]. Available from URL: http://www.ucanss.fr/ucanss.nsf/ [Accessed 2005 Jul 6]Google Scholar
- 42.Kölner Kommentar zum EBM. Kommentierung zum einheitlichen Bewertungsmaßstab Manfred Moewes, Erhard Effer, Rainer Hess. Köln: Deutscher Ärzteverlag, 1994 (updated October 2002)Google Scholar
- 43.Lucioni C, Mangrella M, Mazzi S, et al. Treatment of patients with asthma with a fixed combination of budesonide and formoterol: a pharmacoeconomic evaluation vs some therapeutic alternatives. Pharmacoeconomics Italian Res Articles 2002; 4 (1): 15–23Google Scholar
- 44.Bondonio P, Eandi M. The times and costs of work associated to the pharmacological treatment: analysis of some cost-saving opportunities. Farmeconomia 1995; 2: 36–45Google Scholar
- 45.Démarches des soins infirmiers. Paris: CNAMTS (Caisse nationale d’ Assurance Maladie des Travailleurs Salariés), 2002 [online]. Available from URL: http://www.ameli.fr/ [Accessed 2006 May 30]Google Scholar
- 46.INSEE Première No 1007. France: INSEE (National Institute for Statistics and Economic Studies), 2005 Mar [online]. Available from URL: http://www.insee.fr/ [Accessed 2006 May 30]Google Scholar
- 47.United Kingdom National Statistics. New earning survey 2003 [online]. Available from URL: http://www.statistics.gov.uk/pdfdir/nesl003.pdf [Accessed 2005 Jul 6]Google Scholar
- 48.Statistisches Jahrbuch für die Bundesrepublik Deutschland 2003. Wiesbaden: Statistisches Bundessamt (Federal Statistics Office), 2003Google Scholar
- 49.Tatiersfield AE, Postma DS, Barnes PI, et al. Exacerbations of asthma: a descriptive study of 425 severe exacerbations. The FACET International Study Group. Am J Respir Crit Care Med 1999 Aug; 160 (2): 594–599Google Scholar