Budesonide/formoterol maintenance and reliever therapy in childhood asthma: Real‐world effectiveness and economic assessment

Abstract Introduction The study aims to compare the real‐world effectiveness and economy of the budesonide/formoterol reliever and maintenance therapy (SMART) with fixed‐dose inhaled corticosteroids (ICS)/long‐acting b‐agonist (LABA) or ICS alone plus as‐needed, short‐acting β2 agonists (SABA) in pediatric patients. Methods The outpatient data warehouse of a hospital in China was used. A total of 103 patients under 18 years old in the SMART group and 63 patients in the control group were included from January 1, 2020 to December 31, 2021. The effectiveness was assessed using asthma attacks and lung function at baseline, 6 months and 12 months follow‐up. Cost‐effectiveness analysis was performed with a three‐state Markov model from the healthcare system perspective. One‐way sensitivity analyses and probabilistic sensitivity analyses were performed to check the robustness of the results. Results The SMART regimen was more effective than other strategies in reducing the risk of mild and severe attacks in the real‐life management of childhood asthma. Patients in both groups showed significant improvement in lung function at 6 and 12 months in contrast to baseline. Compared with other strategies, the forced expiratory volume in 1 s (FEV 1 ) level in the SMART group was markedly improved at 6 months. The total cost of outpatient service using the SMART regimen was lower than that of other strategies, while the drug costs were similar in different groups. Incremental cost‐effectiveness analysis results showed that using the SMART regimen reduced the total cost by approximately CNY 10,516.11 per year with a 0.12 quality‐adjusted life year (QALYs) increase. Sensitive analyses supported that the SMART regimen was the dominant choice at the willingness‐to‐pay threshold of CNY 85,698, per capita GDP in China. Conclusions Collectively, our findings indicate that the real‐world effectiveness and economy of the SMART regimen are superior to the traditional strategies in pediatric asthma patients.