Cost-effectiveness of as-needed budesonide-formoterol in adults with mild asthma: the Novel START trial

Background: The Global Initiative for Asthma recommends as-needed combination inhaled corticosteroid-formoterol reliever for mild asthma. Its cost-effectiveness is uncertain outside double-blind regulatory trials. The study objectives were to assess the cost-effectiveness of as-needed budesonide-formoterol versus maintenance budesonide plus as-needed salbutamol, and versus as-needed salbutamol, in averting exacerbations in adults with mild asthma during 12-month follow-up of the New Zealand participants (n=551) of the open-label Novel START multicountry clinical trial. Methods: New Zealand health-system and societal perspectives were adopted using 2025 resource costs. Healthcare utilisation comprised electronically monitored inhaler use (with multiple imputation for missing data), asthma-related pharmaceuticals, primary-care visits, emergency-department visits and hospitalisations. Regression methods were used for cost-effectiveness analysis. Scenarios included generic substitution and prescription-charge exemption. Results: As-needed budesonide-formoterol, compared with maintenance budesonide plus as-needed salbutamol, is more effective at reducing severe exacerbations and provides an annual health-system cost saving of NZD 12 (95% CI 0-28) per patient, increasing to NZD 22 (95% CI -15-58) if a societal perspective is adopted. Compared with as-needed salbutamol alone, as-needed budesonide-formoterol costs the health system NZD 38 and NZD 111, respectively, to prevent an exacerbation and a severe exacerbation. From a societal perspective it is cost-saving NZD 70 (95% CI 2-134). Findings were robust to scenario analyses. Conclusion: For patients with mild asthma, as-needed budesonide-formoterol 200/6 μg is cost-saving from health-system, patient and societal perspectives, while improving outcomes, dominating maintenance budesonide plus as-needed salbutamol. Compared with as-needed salbutamol, as-needed budesonide-formoterol is cost-effective from a health-system perspective and dominates from a societal perspective.