Abstract
Omalizumab offers an alternative to maintenance oral corticosteroids (OCS) in the treatment of severe persistent asthma. Despite widespread recognition of the adverse effects from OCS, there is little quantitative evidence on their health burden or costs. Failing to account for the adverse effects of OCS may underestimate the cost-effectiveness of innovative steroid-sparing medicines such as omalizumab. This study aims to explore the possibilities for integrating evidence on the burden of OCS in cost-effectiveness analysis using omalizumab as a case study. A model was developed to evaluate the long-term cost-effectiveness of omalizumab in patients requiring maintenance OCS. Costs were from a health service perspective and outcomes were measured as quality-adjusted life years (QALYs). The burden from maintenance use of OCS was quantified with population-based approach, with a decision model and with threshold analysis. The incremental cost-effectiveness ratio (ICER) was £37,987 per QALY gained, which is above conventional thresholds used in the UK. Threshold analysis showed that the annual health losses from maintenance use of oral corticosteroids would need to be 0.12 QALYs per year. This is double the quantifiable health losses with the population-based approach and with the decision model and 10% of the health gains achieved with omalizumab. The burden from maintenance OCS can be integrated in cost-effectiveness analysis but the extent to which these estimates account for their full impact on health depends on the approach used and underlying assumptions. The challenges arise from sparse randomised evidence, time lag in the adverse effects and unclear relationship between risk and long-term steroid load. These are empirical questions which can be answered with further research. Such research would be valuable not only for decision making in severe asthma but also for other conditions treated with maintenance OCS.
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