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Background <p>Severe uncontrolled asthma (SUA) represents a complex and heterogeneous form of asthma that persists despite treatment. Allergic immunoglobulin E (IgE)-mediated SUA can be treated with tezepelumab or omalizumab.</p> Objective <p>The aim was to estimate the cost-effectiveness of tezepelumab compared to omalizumab in the treatment of patients with allergic SUA, from the perspective of the Spanish National Health System (NHS).</p> Methods <p>A Markov model was developed with a time horizon of 60 years, 28-day cycles, and five health states: controlled asthma; uncontrolled asthma; controlled asthma with exacerbation; uncontrolled asthma with exacerbation; and death. The efficacy parameters of the model were based on the NAVIGATOR and SOURCE clinical trials for tezepelumab and standard therapy, and on a network meta-analysis for omalizumab. Utilities and disutilities were extracted from NAVIGATOR and SOURCE and from the literature. The model considered direct costs (€, 2025): pharmacological, administration, exacerbations, disease management, and adverse events arising from oral corticosteroid use, obtained from Spanish data sources. Incremental costs per quality-adjusted life-year (QALY) gained were estimated for tezepelumab compared to the 106 omalizumab dosing profiles defined by weight and IgE. The results were contextualized to the Spanish setting using weight and IgE data obtained from the Primary Care Clinical Database and the literature. Deterministic sensitivity analysis (DSA) and probabilistic sensitivity analysis (PSA) were performed.</p> Results <p>Tezepelumab was cost-effective compared with omalizumab (450 mg/4 weeks;&#xa0;incremental cost-effectiveness ratio €17,213.44/QALY), considering a willingness-to-pay threshold of €30,000/QALY, and was dominant (more effective and less costly) at higher doses. This represents 69.81% of the dosing profiles and 53.47% of the population with allergic SUA in Spain. The DSA confirmed that tezepelumab was cost-effective compared to omalizumab (450 mg) despite the variations in the parameters used. Tezepelumab was cost-effective or dominant in 80.00% of the PSA simulations.</p> Conclusion <p>In this analysis, tezepelumab was a cost-effective option compared with omalizumab (≥&#xa0;450&#xa0;mg/4&#xa0;weeks) for the treatment of patients with allergic SUA aged 12&#xa0;years and older from the perspective of the Spanish NHS.</p>

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Cost-Effectiveness of Tezepelumab Versus Omalizumab in Patients with Severe Uncontrolled Allergic Asthma in Spain

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  • 发表日期：

    2026年7月1日

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  • Elena Villamañan,
  • Santiago Quirce,
  • Covadonga Torres,
  • Néstor Martínez,
  • Carla Garí,
  • Neus Vidal-Vilar,
  • Carlos Almonacid

摘要

Background

Severe uncontrolled asthma (SUA) represents a complex and heterogeneous form of asthma that persists despite treatment. Allergic immunoglobulin E (IgE)-mediated SUA can be treated with tezepelumab or omalizumab.

Objective

The aim was to estimate the cost-effectiveness of tezepelumab compared to omalizumab in the treatment of patients with allergic SUA, from the perspective of the Spanish National Health System (NHS).

Methods

A Markov model was developed with a time horizon of 60 years, 28-day cycles, and five health states: controlled asthma; uncontrolled asthma; controlled asthma with exacerbation; uncontrolled asthma with exacerbation; and death. The efficacy parameters of the model were based on the NAVIGATOR and SOURCE clinical trials for tezepelumab and standard therapy, and on a network meta-analysis for omalizumab. Utilities and disutilities were extracted from NAVIGATOR and SOURCE and from the literature. The model considered direct costs (€, 2025): pharmacological, administration, exacerbations, disease management, and adverse events arising from oral corticosteroid use, obtained from Spanish data sources. Incremental costs per quality-adjusted life-year (QALY) gained were estimated for tezepelumab compared to the 106 omalizumab dosing profiles defined by weight and IgE. The results were contextualized to the Spanish setting using weight and IgE data obtained from the Primary Care Clinical Database and the literature. Deterministic sensitivity analysis (DSA) and probabilistic sensitivity analysis (PSA) were performed.

Results

Tezepelumab was cost-effective compared with omalizumab (450 mg/4 weeks; incremental cost-effectiveness ratio €17,213.44/QALY), considering a willingness-to-pay threshold of €30,000/QALY, and was dominant (more effective and less costly) at higher doses. This represents 69.81% of the dosing profiles and 53.47% of the population with allergic SUA in Spain. The DSA confirmed that tezepelumab was cost-effective compared to omalizumab (450 mg) despite the variations in the parameters used. Tezepelumab was cost-effective or dominant in 80.00% of the PSA simulations.

Conclusion

In this analysis, tezepelumab was a cost-effective option compared with omalizumab (≥ 450 mg/4 weeks) for the treatment of patients with allergic SUA aged 12 years and older from the perspective of the Spanish NHS.