OBJECTIVES: Dupilumab, a first-in-class, monoclonal antibody that targets type-2 inflammatory asthma, has been investigated in clinical trials, demonstrating significantly lower rates of severe asthma exacerbation, better lung function and asthma control vs. background therapy (BT). We aimed to assess cost-effectiveness of dupilumab (DUP)+BT as compared to other biologics+BT in adults and adolescents (>=12 years) with uncontrolled persistent severe asthma in Portugal.

METHODS: We built a Markov model with two treatment-related health states (each with five health substates – controlled/uncontrolled asthma, moderate/severe exacerbation, asthma-related death) and other-cause death state, to estimate and compare effectiveness (life years/QALY) and costs of DUP+BT versus mepolizumab, reslizumab (adults), benralizumab (adults), and omalizumab (increased IgE), all plus BT. Clinical data obtained from pivotal double-blind randomized clinical trials and pairwise indirect treatment comparisons. Health state utilities based on EQ-5D-5L clinical trial considering Portuguese tariffs. Direct medical costs (drug acquisition and administration, disease management, exacerbations,) based on literature, expert opinion and official public sources. We used confidential price of dupilumab. Base-case analysis conducted from NHS perspective, over lifetime horizon, 4% discount rate, costs expressed in 2021 euros.

RESULTS: Over a lifetime horizon, DUP+BT results in a lower number of severe exacerbations and consequently in less asthma-related deaths and longer life expectancy versus other biologics. A patient treated with DUP+BT is expected to gain on average 0.09-0.63 QALY (omalizumab-benralizumab) versus other biologics+BT. Moreover, Portuguese NHS may save up around €14,000-30,000 (mepolizumab-omalizumab) per patient treated with DUP+BT versus other biologics+BT, over lifetime. Savings with dupilumab are still expected considering -10% over list price of other biologics (€5,800-€21,400).

CONCLUSIONS: In our analysis, dupilumab is dominant as compared with other biologics used in the treatment of severe asthma in adults and adolescents in Portugal. Practice of confidential drug price of biologics and lack of head-to-head trials are limitations of this analysis.