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Budesonide

An Appraisal of the Basis of its Pharmacoeconomic and Quality-of-Life Benefits in Asthma

  • Pharmacoeconomic Drug Evaluation
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Summary

Synopsis

Budesonide is an inhaled corticosteroid that is used prophylactically to reduce the underlying inflammation and consequent airways narrowing associated with asthma. Widespread clinical experience has shown that inhaled budesonide is effective and well tolerated, and its use is well established in the management of adult and childhood asthma.

In developed countries, asthma is a major health problem and consumes a large proportion of healthcare resources. Both the prevalence and severity of asthma appear to be increasing. Additionally, asthma-related mortality has been reported to have gradually increased since the mid-to late-1970s in many countries, possibly due to undertreatment and/or suboptimal management of the disease. Current guidelines recommend a shift away from initial treatment with oral bronchodilators, such as theophylline, or regular use of β2-agonist inhalers, toward the earlier use of more expensive inhalers containing corticosteroids. Inhaled bronchodilators are still used as indicated for treatment acacute attacks.

Data suggest that the acquisition cost of budesonide is more than offset by decreased morbidity and reductions in costs associated with acme asthma exacerbations. Both once-daily administration and its administration in dry powder form via Turbuhaler® appear to be well accepted by patients; these factors may potentially improve patient compliance with therapy. Budesonide appears to have positive effects on some quality-of-life indices, although studies using validated quality-of-life instruments are needed to confirm these conclusions. Modelling studies would be helpful in order to assess the possible economic benefits to society through reduction of the considerable direct and indirect costs of asthma and cost-effectiveness comparisons with other inhaled corticosteroids are needed to clarify its relative positioning in this regard. Until then, the available data provide an encouraging pharmacoeconomic rationale for budesonide as firstline asthma therapy, and a good basis for future pharmacoeconomic analysis of asthma management.

Phormocoeconomic Benefits and Costs

Recent studies have estimated the costs of asthma in the US, Australia (New South Wales) and Sweden at $US6.2 billion (1990 dollars), $A209 million (1989 dollars) and SEK2.6 billion (1991 Swedish kronor), respectively. In these studies, total direct medical costs associated with hospitalisation, emergency care and asthma drug therapy generally represented the largest proponion of the total costs related to asthma. Substantial indirect costs were associated with loss of school days in children, loss of outside employment or housekeeping (either due of asthma or the need to care for children with asthma), and premature death. It is difficult to assign a monetary value to intangible costs: however, the negative impact of asthma on quality of life is likely to be one of the major perceived costs from the perspective of the patient or caregiver of a child with asthma.Accordingly, in 1 study, children rated respiratory symptoms, emotional function.physical activity limitations, and drug-related problems as ‘bothersome’ features of their disease; parents rated emotional items (worry and concern about various aspects of the disease) higher than items related to interference with daily activities.

Pharmocoeconomic Considerations

Although cost estimates were not included, budesonide markedly reduced oral prednisolone requirements, hospital admissions, and days spent in clinic in patients with asthma who were dependent on oral conicosteroids. In a large Swedish retrospective pooled regression analysis, a significant negative correlation between consumption of inhaled eonieosteroids and duration of hospitalisation was reponed. The cost of inhaled conicosteroids was covered by a reduction in hospitalisation costs in the sub-models evaluated in this study.

In 2 placebo-controlled double-blind studies which used symptom-free days as one of the composite measures of clinical efficacy, cost-effectiveness ratios were in favour of inhaled budesonide recipients. The use of the symptom-free day as an end-point in phannacocconomic evaluations has been criticised, and therefore more well-designed trials are required to validate th is outcome measurement. Studies arc also needed to assess the marginal cost effectiveness of budesonide relative to clinically relevant asthma treatments, particularly other inhaled conicosteroids.

In 2 large noncomparative studies, inhaled budesonide demonstrated some improvements in sleep and lifestyle indices relative to baseline in patients with mild to moderate asthma. The majority of patients in I study reponed improvements in feeling rested upon waking, limitation of physical activity by asthma, ability to perfonn hard physical work, and overall satisfaction with lifestyle.Inhaled budesonide administered once daily at night in dry powder fonn via Turbuhaler® was associated with significant improvements in patient scores at 4 and 8 weeks relative to baseline scores for some measures of lifestyle indices. 100% of physicians and patients judged the Turbuhaler® easy to usc and 97% of patients preferred once-daily administration to previous multiple-dose regimens: both of these factors may improve patient compliance with treatment. While non-validated quality-of-life surveys were used to assess the effects of budesonide on patients’ lifestyles, suggesting that the results of these studies must be interpreted with caution. the findings have been consistent. In addition. comparative studies are needed to demonstrate any quality-of-life benefits of budesonide relative to other asthma treatments.

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Various sections of the manuscript reviewed by: U.C. Gerdtham, Center for Health Economics, Stockholm, Sweden; M.E. Hyland, Department of Psychology, University of Plymouth, Plymouth, England; M. Krahn, Department of Medicine, Toronto Hospital, Toronto, Ontario, Canada; C.M. Mellis, Department of Respiratory Medicine, Royal Alexandra Hospital for Children, Camperdown, New South Wales, Australia; M. Rutten, Department of Health Economics, University of Limburg, Maastricht, The Netherlands; M.J. Schulpher, Health Economics Research Group, Brunei University. Uxbridge. England; S.D. Sullivan, Departments of Pharmacy and Health Services, University of Washington, Seattle, Washington, USA; C. Trautner, Department of Biometrics and Epidemiology, Diabetes Research Institute at Düsseldorf, Düsseldorf, Germany; K.B. Weiss, Center for Health Services Research, Rush Primary Care Institute, Chicago, Illinois, USA; A.S. Zbrozek, Office of Clinical Economics, University of Texas Medical Branch, Galveston, Texas, USA.

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Davis, R., McTavish, D. Budesonide. Pharmacoeconomics 7, 457–470 (1995). https://doi.org/10.2165/00019053-199507050-00009

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