BUDESONIDE / FORMOTE ROL AS MAINTENANCE AND RELIEVER TREATMENT COMPARED TO FIXED DOSE COMBINATION STRATEGIES – A CANADIAN ECONOMIC EVALUATION

Main Article Content

Elizabeth Miller
J Mark FitzGerald

Keywords

Asthma, budesonide/formoterol, economic evaluation, comparison, salmeterol/fluticasone

Abstract

Objective


To compare the cost-effectiveness of budesonide/formoterol  in a single inhaler used as Maintenance and Reliever Therapy (SMART) versus fixed higher-dose budesonide/formoterol  plus as-needed terbutaline reliever  (FHDBF)  or fixed  dose  fluticasone/salmeterol  plus  as-needed  terbutaline  reliever  (FDFS)  in controlling asthma in adults and adolescents.


 Methods


An economic evaluation was conducted by applying Canadian costs to the results of a large (N=3,335) international   randomized,   double-blind,   controlled   trial  in  which  health  resource   utilization   was prospectively collected. Although no Canadian subjects were enrolled in this clinical trial, it was assumed that the results would apply to Canadian patients. Primary outcome measurements included time to first exacerbation and the number of severe exacerbations. Costs included direct medical costs (physician/emergency  room visits, hospitalizations,  asthma drug costs) and productivity (absenteeism). The time horizon was six months, which corresponded to the duration of the trial. Prices were obtained from 2006 Canadian sources. Both healthcare and societal perspectives were considered. Deterministic univariate sensitivity analyses were conducted.


 Results


In the clinical trial, SMART was superior to FHDBF and FDFS with respect to total number of severe exacerbations  (RR  0.72;  95%  CI  0.57,  0.90;  p=0.0048;  RR  0.61;  95%  CI  0.49,  0.76;  p<0.001, respectively).  Exacerbation rates (reported as events per patient per 6 months) were 0.12 for SMART, 0.16 for FHDBF, and 0.19 for FDFS. All treatments provided similar improvements  in lung function, asthma control days and asthma-related quality of life. The mean cost per patient per 6 months was $545 in the SMART  arm versus $690 in the FHDBF arm and $842 in the FDFS arm from the healthcare perspective; and $676 for SMART, $838 for FHDBF, and $954 for FDFS from the societal perspective. SMART was dominant (more effective, less expensive) in the base case analysis from both the healthcare and societal perspectives. The results were robust under sensitivity testing.


 Conclusions


The SMART strategy, which allows budesonide/formoterol  to be used as both maintenance and reliever medication, is dominant over the alternate strategies of fixed higher dose budesonide and formoterol plus as-needed terbutaline or fixed dose salmeterol and fluticasone plus as-needed terbutaline.

Abstract 252 | PDF Downloads 223

References

1. Global Initiative for Asthma (GINA). Global Strategy for Asthma Management and Prevention. National Institutes of Health: national Heart, Lung, and Blood Institute. Bethesda, MD: National Institutes of health, 2002. (Publication no. NIH-NHLI 02-3569.)
2. Scicchitano R, Aalbers R, Ukena D, et al. Efficacy and safety of budesonide/formoterol single inhaler therapy versus a higher dose of budesonide in moderate to severe asthma. Curr Med Res Opin 2004;20:1403-18.
3. O’Byrne PM, Bisgaard H, Godard PP, et al. Budesonide/formoterol combination therapy as both maintenance and reliever medication in asthma. Am J Respir Crit Care Med 2005;171:129-36.
4. Horn CR, Clark TJH, Cochrane GM. Compliance with inhaled therapy and morbidity from asthma. Respir Med 1990;84:67-70.
5. Rabe KF, Pizzichini E, Ställberg B, et al. Budesonide/formoterol in a single inhaler for maintenance and relief in mild to moderate asthma: a randomized, double-blind trial. Chest 2006;129:246-56.
6. Vogelmeier C, D’Urzo A, Pauwels R, et al. Budesonide/formoterol maintenance and reliever therapy: an effective asthma treatment option? Eur Respir J 2005;26:819-28.
7. Kuna P, Peters MJ, Manjra AI, et al. Effect of budesonide/formoterol maintenance and reliever therapy on asthma exacerbations. Int J Clin Prac (online early articles) doi:10.1111/j.17421241.2007.01338.x
8. Price D, Wiren A, Kuna P. Cost-effectiveness of budesonide/formoterol for maintenance and reliever asthma therapy. Allergy 2007;62(10):1189-98.
9. Juniper EF, Svensson K, Mork AC, Stahl E. Measurement properties and interpretation of three shortened versions of the asthma control questionnaire. Respir Med 2005;99: 553-58.
10. Juniper EF, Buist AS, Cox FM, et al. Validation of a standardized version of the Asthma Quality of Life Questionnaire. Chest 1999;115:1265-70.
11. Becker A, Lemiere C, Berube D, et al. Asthma Guidelines Working Group of the Canadian Network For Asthma Care. Summary of recommendations from the Canadian Asthma Consensus guidelines, 2003. Can Med Assoc J 2005 Sep 13;173(6 Suppl):S3-11.
12. Accordini S, Bugiani M, Arossa W, et al. Poor control increases the economic cost of asthma. A multicentre population-based study. Int Arch Allergy Immun 2006;141(2):189-98.
13. Johansson G, Andreasson EM, Larsson PE, Vogelmeier CF. Cost-effectiveness of budesonide/formoterol for maintenance and reliever therapy versus Salmeterol/fluticasone plus salbutamol in the treatment of asthma. Pharmacoeconomics 2006;24(7):695-708.
14. Price D, Haughney J, Lloyd A, et al. An economic evaluation of adjustable and fixed dosing with budesonide/formoterol via a single inhaler in asthma patients: the ASSURE study. Curr Med Res Opin 2004;20(10):1671-9.
15. Statistics Canada. Table 326-0001 - Consumer price index (CPI), monthly (Index, 1992=100 unless otherwise noted).Canada. http://www.statcan.ca. Accessed January 16, 2007.
16. Ontario Ministry of Health and Long-Term Care. Ontario Drug Benefit Formulary/Comparative Index: Electronic version. http://www.health.gov.on.ca/english/providers/p rogram/drugs/odbf_eformulary.html Accessed on January 16, 2007.
17. Ontario Ministry of Health and Long-Term Care. Ontario Health Insurance Schedule of Benefits and Fees for physician services. http://222.health.gov.on.ca/english/providers/pro gram/ohip/sob/physserv/physserv_mn.html. Accessed on November 22, 2006.
18. WSIB Fee schedule for registered nurses. http://www.wsib.on.ca/wsib/wsibsite/nsf/public/ HealthProfessionalFees Effective January 1, 2004. Accessed on November 22, 2006.
19. Doran D, Pickard J, et al. Competitive Bidding for Community-Based Nursing Services, Report of Phase I, Community Nursing Services Study, Faculty of Nursing, University of Toronto, Aug 2002.
20. Ontario Ministry of Health and Long-Term Care. Ontario Health Insurance Program (OHIP): Ambulance Services Billing. http://www.health.gov.on.ca/english/public/pub/ ohip/amb.html Accessed on November 22, 2006.
21. Health Costing in Alberta 2005 Annual Report. Health Funding and Costing Branch. Alberta Health and Wellness. http://www.health.gov.ab.ca Accessed on November 20, 2006.
22. Statistics Canada. Average hourly wages of employees by selected characteristics and profession, unadjusted data. http://www40.statcan.ca/101/cst01/labr69a.htm Accessed on November 20, 2006.
23. Miller E, Sears M, McIvor A, Liovas A. Canadian economic evaluations of budesonide/formoterol as maintenance and reliever treatment in patients with moderate to severe asthma. Can Resp J 2007;14(5):269-275.
24. Stempel DA, Stoloff SW, Carranza-Rosenzweig JR, et al. Adherence to asthma controller medication regimens. Respir Med 2005;99:1263-7.
25. Stoloff SW, Stempel DA, Meyer J, et al. Improved refill persistence with fluticasone proprionate and salmeterol in a single inhaler compared with other controller therapies. J Allergy Clin Immunol 2004;113:245-51.