OBJECTIVES: To compare budesonide/formoterol in single inhaler with budesonide + formoterol from separate inhalers and adjustable dosing of single inhaler budesonide/formoterol with fixed dosing in patients with moderate and severe persistent asthma. To assess national payers budget impact. METHODS: The clinical effectiveness analysis was performed according to Cochrane Collaboration Guidelines. Budget impact model consist of 3 refund settings scenarios for single inhaler, adjustable dosing budesonide/formoterol. RESULTS: Budesonide/formoterol in single inhaler vs budesonide + formoterol from separate inhalers Three RTC were included. No significant difference in quality of life and others parameters of disease symptoms control. Only dysphonia presence was statistically lower in single inhaler group (I 3 months follow-up), OR=0.12 (0.02; 0.88). Fixed dosing versus adjustable dosing 7 RTC were included. No significant difference in quality of life and number of patients with at least one disease exacerbation (three months follow-up). Metaanalysis of trials with 5-6 months follow-up showed lower disease exacerbation risk with adjustable dosing, RR=0.56 (0.40; 0.77). No significant difference in frequency of severe disease exacerbation, multiple exacerbation of disease, necessity of oral administration of corticosteroids and additional therapy. Lower risk of hospitalization/emergency treatment with adjustable dosing, RR=0.65 (0.43; 0.98) was observed. Both treatments were well tolerated but the adverse event profile was statistically lower in adjustable dosing - less sever, asthma related adverse events, OR=0.12 (0.02; 0.72) in three months follow-up was noticed. Budget impact model Single inhaler budesonide/formoterol refund consequences per year: 0.4 million sold drug units; 3248 avoided medical visits; 518 avoided hospital/emergency asthma exacerbations treatments; 27.7% reduction in drugs intake volumen; 11-32 millions PLN national insurer budget savings. CONCLUSIONS: Single inhaler budesonide/formoterol therapy, especially adjustable dosing, is a clinically effective and well-tolerated treatment for patients with asthma. Refund of this therapy may generate savings for national insurer budget.