OBJECTIVES : To evaluate the cost-utility of IND/MF FDC low-high dose relative to low–high dose of MF or salmeterol/fluticasone (SF) in not adequately controlled asthma patients 12 years or older, from the Italian National 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/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/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 around model assumptions.

RESULTS : IND/MF-low dose is associated with higher quality of life (+0.533 QALY) than MF-low dose, with an incremental cost of €1,900.09. The incremental cost-utility ratio (ICUR) results of €3,565 per QALY. IND/MF-medium dose is associated with higher quality of life (+0.609 QALY) than MF-medium dose, with an incremental cost of €436.57. ICUR results of €717 per QALY. IND/MF-high dose is associated with higher quality of life (+0.350 QALY) than MF-high dose, with an incremental cost of -€1,297.80, which is a dominant treatment strategy. IND/MF-high dose is associated with higher quality of life (+0.102 QALY) than SF, with an incremental cost of -€1,719.01, which is also dominant. At a threshold of €5,000 per QALY, IND/MF has nearly 100% of probability of being cost-effective compared to all 3 doses of MF.

CONCLUSIONS : The results indicate that IND/MF is cost-effective among the considered comparisons in a representative cohort of asthma patients 12 years or older in Italy.