OBJECTIVES : To estimate the economic impact of FDC of IND/MF in asthma patients – 12 years of age and older – not adequately controlled with inhaled corticosteroids and short acting beta2-agonists, in the Italian market.

METHODS : A budget impact model was developed to compare 3-year costs, in a scenario that considers IND/MF as a treatment option reimbursed by the Italian National Health Service and a scenario in which IND/MF is not available and its potential shares are redistributed among available alternatives. According to GINA guidelines, only partially- and not- controlled treated patients were eligible to start a therapy with IND/MF. Direct medical costs per patient account for drugs and exacerbation management. Epidemiological data, exacerbation rates and unit costs are collected from clinical trials and Italian published sources. Deterministic sensitivity analysis was performed to assess if, and how much, model results are sensitive to uncertain parameter values.

RESULTS : The patient flow model adopted has resulted in a population of about 316,000 people per year. The introduction of IND/MF led to a gradual reduction in total costs over the period of analysis, with savings of € 482,294, € 928,821 and € 1,150,203 in the first, second and third year of analysis respectively, for a cumulative saving of € 2,561,318. Sensitivity analysis showed that the parameter whose variation determines the greatest impact in terms of deviation from the results is the IND/MF cost, though considerable savings remain.

CONCLUSIONS : The reimbursement of IND/MF should result in savings on the direct health care costs borne by the National Health Service. The increase in savings over the 3 year period is mainly due to the increased use of IND/MF. The sensitivity analysis shows that none of the considered parameters modify the main conclusion of the analysis.