Cost effectiveness of budesonide/formoterol in a single inhaler for COPD compared with each monocomponent used alone

Objective: To compare the healthcare costs and effects of budesonide/formoterol in,a single inhaler with those of budesonide and formoterol monotherapies, and placebo, in a multinational study in patients with chronic obstructive pulmonary disease (COPD), National Heart, Lung and Blood Institute (NHLBI)/WHO Global Initiative for Chronic Obstructive Lung Disease (GOLD) stages III or IV. Previous analysis of the clinical data from the study had shown that budesonide/formoterol was associated with better lung function and improved health-related QOL compared with the monocomponents or placebo and lower frequency of exacerbations compared with formoterol and placebo. Method: Patients (n = 1022) were randomised to twice-daily treatment with two inhalations of budesonide/formoterol (160 mu g/4.5 mu g) in a single inhaler, budesonide 200 mu g, formoterol 4.5 mu g or placebo for 12 months. Data on medication and healthcare use were combined with Swedish unit cost data to estimate the total annual healthcare cost per patient from the Swedish healthcare payer perspective. Costs were valued in Swedish kronor (SEK) [2001 values] and converted to euros (SEK1 = E0.11, 25th April 2003). Results: This evaluation estimated the total annual healthcare costs per patient to be numerically lower for budesonide/formoterol (E2518) than for budesonide (E3194), formoterol (E3653) or placebo (E3213). Cost-effectiveness acceptability curves suggest that budesonide/formoterol may be cost effective compared with formoterol, even if the decision maker is not willing to pay anything for the additional clinical effects, and that budesonide/formoterol is cost effective compared with placebo if a decision maker is willing to pay about E2 per day, per avoided exacerbation. Conclusion: This economic analysis suggests that the clinical benefits of using budesonide/formoterol in a single inhaler are achieved at a numerically lower total healthcare cost than either monocomponent or placebo. Budesonide/formoterol in patients with severe COPD (GOLD stages III or IV) may be cost effective, from the healthcare provider perspective, compared with either monocomponent.