Fluticasone furoate/Vilanterol 92/22 μg once-a-day vs Beclomethasone dipropionate/ Formoterol 100/6 μg b.i.d.: a 12-week cost analysis in mild-to-moderate asthma

BACKGROUND: Asthma is a disease with high cost for the National Health Service. Two of the most recent LABA/ICS combinations for persistent bronchial asthma are Beclomethasone dipropionate/Formoterol (B/F) delivered via the Nexthaler device and Fluticasone furoate/Vilanterol (F/V) delivered via the Ellipta device. No comparison has been carried out yet in terms of cost analysis in asthma, to our knowledge. Aim of the present monocentric, observational, retrospective study was to calculate and compare the costs of mild-to-moderate asthma patients assuming B/F 100/6 μg b.i.d. to those of patients assuming F/V 92/22 μg once-a-day over a 12-week treatment period from the Italian National Health Service perspective. METHODS: Data were obtained automatically and anonymously from the institutional database of the Lung Unit of the Specialist Medical Centre (CEMS), Verona, Italy, UNI EN ISO 9001-2008 validated. FEV(1) values, number of relapses, healthcare resources as hospitalizations due to asthma relapses, days of hospitalization, general practitioner (GP), specialist visits, and days of inactivity, were recorded over the study period together with the use of extra medications (systemic steroids and antibiotics). In order to compare the outcomes achieved in both groups, the propensity score matching method was used in STATA, and statistical significance was accepted for p < 0.05. RESULTS: Clinical data of 77 patients treated with B/F b.i.d (Group A) and of 40 patients treated with F/V 92/22 μg once-a-day (Group B) were selected. The PS-matching process, designed as matching on the baseline covariates, gender, age, FEV(1) and comorbidities, returned a cohort of 40 group A patients of the entire cohort matched with 40 patients of group B, fully comparable for demographics and clinical characteristics. In the PS-matched cohort, the mean (±SE) number of relapses per patient during the follow-up was 0.53 (±0.12) in group A and 0.28 (±0.07) in group B. In group A, n = 25 (62.50 %), n = 9 (22.50 %), and n = 6 (15 %) patients had 0, 1, 2 relapses, respectively. In group B, n = 29 (72.50 %), and n = 11 (27.50 %) had 0 and 1 relapse, respectively. Over the study period, the average number of hospitalizations per patient was 0.15 (±0.06), with 0.28 (±0.12) days of hospitalization in group A, and 0.08 (±0.04) with 0.08 (±0.04) days of hospitalization in group B, respectively. The difference between the two groups in terms of FEV(1)(L) improvement vs baseline was 0.11 in favour of group B (p = 0.007). When results were compared, the improvement in lung function obtained in group B proved significantly higher both in terms of absolute FEV(1) and of FEV(1) % predicted. The mean (±SE) cost of hospitalizations per patient was € 345.30 (±133.23) in group A and € 172.65 (±98.18) in group B, respectively, with a mean not significant difference of - € 172.65 in favour of group B (p = 0.9). In particular, the mean (±SE) cost for visits per patient was € 26.82 (±3.73) in group A and € 11.36 (±2.30) in group B (p = 0.002), and the mean cost for rescue medications per patient was € 35.24 (±6.93) in group A, and € 18.73 (±3.38) in group B, respectively (p = 0.05). CONCLUSIONS: Even if both ICS/LABA combinations were checked over a limited period of time, they seem characterized by a different profile in terms of effect on lung function and economic impact on mild-to-moderate asthma. The once-daily inhalation of combined Fluticasone furoate/Vilanterol 92/22 μg showed the potential for enhanced clinical outcomes and reduced costs when compared to Beclomethasone dipropionate/Formoterol 100/6 μg b.i.d.