OBJECTIVES: A new biological therapy, dupilumab, has been recently approved for the treatment of severe asthma with type 2 inflammation, characterized by raised blood eosinophils and/or raised fractional exhaled nitric oxide (FeNO). The objective of this analysis was to estimate the incremental cost-effectiveness ratio (ICER) of dupilumab, as an add-on treatment to background therapy (BT), versus the main therapeutic alternatives approved in Italy for severe asthma.

METHODS: Simulation of outcomes and costs was conducted using a lifetime horizon Markov model. In the base-case analysis dupilumab + BT, was compared to BT alone for the treatment of type 2 asthma patients, with raised blood eosinophils (EOS- ≥150 cells/μL) and/or raised fractional exhaled nitric oxide (FeNO≥25 ppb) in the previous 12 months, with experiencing at least 2 acute asthma exacerbations despite maximum inhalation therapy (treated with systemic steroid for at least 3 days and/or who have requested access to the emergency room and/or hospitalization and/or intubation. Data source were retrieved from QUEST trial. An alternative analysis was conducted to compare dupilumab + BT to BT in the treatment of severe asthma (any EOS and FeNO levels; all patients treated with oral corticosteroids); data input were obtained from VENTURE trial. The Italian National Healthcare Service (NHS) perspective was adopted.

RESULTS: In the base-case analysis, treatment with Dupilumab + BT reduced the burden of severe exacerbations, and prolonged both survival and quality-adjusted survival compared to BT alone. The resulting incremental cost-effectiveness ratio (ICER) was € 36,829 per QALY gained, below the directional willingness-to-pay threshold considered in Italy (€ 50,000 per QALY gained). The results of the alternative analysis confirmed the base case results with an ICER of € 40,047 per QALY gained.

CONCLUSIONS: Cost-effectiveness analysis shows that dupilumab + background therapy is a cost-effective and economically sustainable treatment option for the Italian NHS.