OBJECTIVES : To evaluate the cost-utility of FDC of IND/GLY/MF relative to a combination of salmeterol/fluticasone (SF) and tiotropium (Tio) or SF or IND/MF in adult asthma patients, from the Italian Health Service (NHS) perspective.

METHODS : A two-state and four-week cycle Markov model was used to estimate lifetime clinical outcomes and costs. Patients entered the model in stable disease and could experience a non-fatal exacerbation event. The exacerbation rate is dependent upon the therapy a patient is receiving, as per the IND/GLY/MF clinical trials. The impact of each type of exacerbation is accounted by applying a utility decrement, obtained from literature, and a treatment cost. Utility values were obtained from the EQ-5D questionnaires in the IND/GLY/MF clinical trials. Lifetime costs considered in the analysis were drugs and exacerbation management. Probabilistic sensitivity analyses were carried out, with the aim of evaluating impact of uncertainty in input parameters.

RESULTS : IND/GLY/MF is associated with higher quality of life (+0.254 QALY) than SF+Tio, with an incremental cost of -€3,213.90. The incremental cost-utility ratio (ICUR) indicates dominance. At a threshold of €5,000 per QALY, IND/GLY/MF has nearly 100% probability of being cost-effective. IND/GLY/MF is associated with higher quality of life (+0.214 QALY) than SF, with an incremental cost of €2,547.76. ICUR results in €11,897 per QALY. At a threshold of €20,000 per QALY, IND/GLY/MF has nearly 100% probability of being cost-effective. IND/GLY/MF is associated with higher quality of life (+0.337 QALY) than IND/MF, with an incremental cost of €4,745.91. ICUR results of €14,088. At a threshold of €20,000 per QALY, IND/GLY/MF has nearly 100% probability of being cost-effective.

CONCLUSIONS : The results indicate that IND/GLY/MF is cost-effective among the considered comparisons in a representative cohort of adult asthma patients in Italy.