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Cost Effectiveness of Budesonide/Formoterol for Maintenance and Reliever Therapy versus Salmeterol/ Fluticasone plus Salbutamol in the Treatment of Asthma

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Abstract

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.

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  1. The use of trade names is for product identification purposes only and does not imply endorsement.

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Acknowledgements

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.

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Authors and Affiliations

  1. Department of Public Health and Caring Sciences, Uppsala University, Uppsala, Sweden

    Gunnar Johansson

  2. Nycomed, Roskilde, Denmark

    Emma B. Andreasson

  3. AstraZeneca R&D, Lund, Sweden

    Per E. Larsson

  4. Marburg University, Marburg, Germany

    Claus F. Vogelmeier

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  1. Gunnar Johansson
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Correspondence to Gunnar Johansson.

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Johansson, G., Andreasson, E.B., Larsson, P.E. et al. Cost Effectiveness of Budesonide/Formoterol for Maintenance and Reliever Therapy versus Salmeterol/ Fluticasone plus Salbutamol in the Treatment of Asthma. Pharmacoeconomics 24, 695–708 (2006). https://doi.org/10.2165/00019053-200624070-00008

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