Cost-utility analysis of omalizumab for the treatment of chronic spontaneous urticaria in China.

Background: Chronic spontaneous urticaria (CSU) is a common inflammatory immune skin disease. It has a serious impact on the patients' quality of life and imposes a serious financial burden on patients. The standard therapy for CSU (using antihistamines), while less costly, has limited efficacy and no longer adequately meets the clinical needs of CSU patients. Omalizumab is the world's first and currently the only biologic approved for the treatment of CSU. Several studies have confirmed the efficacy and safety of omalizumab for CSU. However, the economics of omalizumab treatment relative to standard therapies remains unknown in China.

Objective: The purpose of this study was to analyze the cost-effectiveness of omalizumab versus standard treatments for CSU after omalizumab's inclusion in the National Drug Insurance List from the patient's perspective.

Methods: We developed a Markov model based on the Urticaria Activity Score over 7 days (UAS7). The modeling period was 4 weeks. The time horizon was 10 years. The willingness-to-pay threshold (WTP) of 1-3 times gross domestic product (GDP) per capita was selected. Incremental cost-effectiveness ratio (ICER) was calculated from the base-case analysis, and one-way sensitivity analysis and probabilistic sensitivity analysis were performed.

Results: The ICER of omalizumab treatment relative to standard treatment was ¥160,411/QALY, which was between 1 and 3 times GDP per capita. Sensitivity analyses illustrated that the direct cost of omalizumab had a significant effect on the ICER and demonstrated the stability of the results.

Conclusions: Omalizumab treatment is a cost-effective regimen compared with standard therapy under certain circumstances. This demonstrates the important role that health insurance policies play in reducing the burden on CSU patients. However, the limitations of applying foreign clinical data in this paper and the uncertainty of cost-effectiveness at a low WTP threshold are two aspects that cannot be ignored, and subsequent related studies are needed. This study will help patients to make decisions about treatment options, and will be a reference to relevant healthcare organizations.