Health care delivery and quality
Cost-effectiveness analysis of early intervention with budesonide in mild persistent asthma

https://doi.org/10.1016/j.jaci.2003.09.025Get rights and content

Abstract

Background

The Inhaled Steroid as Regular Therapy in Early Asthma (START) study reported that early intervention with budesonide in mild persistent asthma reduces severe asthmatic events and improves symptom outcomes and lung function in adults and children.

Objective

We sought to estimate the incremental cost-effectiveness of early intervention with budesonide, as observed within the START study.

Methods

START was a randomized, 3-year controlled trial of budesonide in early onset mild asthma among 7165 subjects ages 5 to 66 years. Three age groups (5-10, 11-17, and ≥18 years) were studied separately and overall. Differences in the probability of emergency treatments, symptom-free days (SFDs), and costs of health care were determined. Incremental cost-effectiveness ratios were estimated from the health care payer and societal perspectives.

Results

Compared with usual therapy, patients receiving budesonide experienced an average of 14.1 (SE, 1.3) more SFDs per year (P < .001), fewer hospital days (69%, P < .001), and fewer emergency department visits (67%, P < .05). From the health care payer perspective, the net cost of early use of budesonide was an additional US$0.42 (SE, $0.04) per day, and the resultant cost-effectiveness ratio was $11.30 (95% CI, $8.60-$14.90) per SFD gained. From the societal perspective, the cost offsets of lower absence from school or work reduced the net cost of early budesonide to $0.14 (SE, $0.07) per day and decreased the cost-effectiveness ratio to $3.70 (95% CI, $0.10-$8.00). Early intervention was more effective and cost saving in the youngest age group.

Conclusion

Long-term treatment with budesonide appears to be cost-effective in patients with mild persistent asthma of recent onset.

Section snippets

Methods

START was a pragmatic study conducted in 32 countries in which 7241 patients were randomized to budesonide once daily (200 μg for children <11 years at baseline and 400 μg for other patients) or usual asthma therapy. If judged appropriate by the investigators, all patients were allowed to receive other asthma treatments, including other inhaled or oral corticosteroids, according to local practice.

We have previously reported the design and analysis plan of the cost-effectiveness evaluation for

Background data

Seven thousand two hundred forty-one patients entered the study. Data from 4 centers (56 patients) were discarded for administrative reasons. Twenty patients did not receive the study drug, leaving 7165 patients (budesonide, 3597; usual asthma therapy, 3568) for analysis. Drop-out rates and reasons for discontinuation were equally distributed between the 2 groups.11 A total of 5155 patients completed the 3-year follow-up.

Cost data were available for all 7165 patients of the analysis set, but

Discussion

The START study investigators have reported that once-daily treatment with low-dose budesonide reduced the risk of a severe asthma-related event by nearly 50%, improved symptom-free time, reduced the need for additional courses of systemic glucocorticoids, and improved FEV1.11 These data support earlier studies that have shown that regular treatment with ICSs initiated in the year after recognition and diagnosis of asthma can reduce the risk of asthma exacerbations and hospitalizations for

Acknowledgements

Yu Zhi Chen and Romain A. Pauwels contributed on behalf of the START Steering Committee, which included the following: B. Andersson, W. W. Busse, L. G. Carlsson, Y. Z. Chen, C. J. Lamm, P. M. O'Byrne, S. Pedersen, S. V. Ohlsson, R. A. Pauwels, W. C. Tan, and A. Ullman. We thank Ann-Sofi Hörstedt for statistical programming, Eva Runnerström and Ulf Farmängen for monitoring the clinical trial, and Catrena Sullivan for assistance with data collection.

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    On behalf of the Inhaled Steroid as Regular Therapy in Early Asthma Steering Committee.

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