Cost‐effectiveness of budesonide/formoterol for maintenance and reliever asthma therapy

Background: Budesonide/formoterol (Symbicort ® ) Maintenance and Reliever Therapy (SMART) is an effective asthma‐management approach that treats symptoms with rapid increases in budesonide/formoterol. The cost‐effectiveness of SMART vs higher fixed‐dose budesonide/formoterol or salmeterol/fluticasone is unknown. Methods: This 6‐month, double‐blind study randomized patients with asthma uncontrolled by inhaled corticosteroids alone ( n = 3335; age ≥12 years) to budesonide/formoterol 160/4.5 μg b.i.d. plus additional doses as needed (SMART), budesonide/formoterol 320/9 μg b.i.d. plus as‐needed terbutaline, or salmeterol/fluticasone 50/250 μg b.i.d. plus as‐needed terbutaline. Economic analysis, assuming health care and societal perspectives, applied 2004 UK and Australian unit costs to pooled resource‐use data. The effectiveness variable was the rate of severe exacerbations/patient/6 months. Results: Patients treated using the SMART approach experienced fewer severe exacerbations than fixed‐dose budesonide/formoterol and salmeterol/fluticasone patients (0.12 vs 0.16 and 0.19 events/patient/6 months, respectively; P ≤ 0.0048). Budesonide/formoterol (Symbicort ® ) Maintenance and Reliever Therapy provided similar improvements in other markers of asthma control at a lower overall daily inhaled corticosteroid dose compared with fixed‐dose treatment. Study drug costs accounted for a majority of both direct costs (DC; 78–87%) and total costs (TC; 50–63%) for all treatments, and were significantly lower in the SMART group compared with the fixed‐dose groups ( P ≤ 0.0014). Direct and TC per patient/6 months were lower for SMART vs salmeterol/fluticasone (DC:–AUS$154, P < 0.0001; TC:–AUS$163, P = 0.0036;–£87, P = 0.0026) and vs budesonide/formoterol using UK costs (DC:–£73, P < 0.0001; TC:–£91, P = 0.0014). Costs tended to be lower for SMART vs budesonide/formoterol using Australian costs (DC:–AUS$35, P = 0.16; TC:–AUS$70, P = 0.20). Results were stable under sensitivity testing. Indirect resource use and cost were not significantly different between groups. Conclusion: Compared with higher fixed‐dose budesonide/formoterol and salmeterol/fluticasone, SMART reduces the incidence of severe exacerbations at a lower or similar overall cost and can be considered a cost‐effective treatment regimen.