Cost-Effectiveness of Omalizumab for the Treatment of Chronic Spontaneous Urticaria

T.A. Kanters; H.B. Thio; L. Hakkaart


The British Journal of Dermatology. 2018;179(3):702-708. 

In This Article

Abstract and Introduction


Background: Chronic spontaneous urticaria (CSU) is a skin disease with itchy hives and/or angio-oedema that last for at least 6 weeks without an obvious external trigger.

Objectives: To determine the cost-effectiveness of omalizumab relative to standard of care (SoC; up to four times the daily dose of H1-antihistamines) in the Netherlands from a societal perspective.

Methods: The Markov model used consisted of five health states based on Urticaria Activity Score over 7 days. Model settings and characteristics of the Dutch patient population were based on an online survey among clinical experts and were validated during an expert committee meeting. Transition probabilities were derived from the GLACIAL trial. Healthcare consumption, quality of life (using EuroQol-5D) and productivity losses were derived from a burden-of-illness study (ASSURE-CSU) among 93 Dutch patients. Healthcare consumption and productivity losses were evaluated using the Dutch costing manual. The comparator treatment was SoC, consisting of (updosed) antihistamines. A 10-year time horizon was used.

Results: The incremental cost-effectiveness ratio (ICER) of omalizumab vs. SoC was €17 502 per quality-adjusted life-year (QALY) gained. Productivity costs played an important role in the value of the ICER; discarding productivity costs resulted in an ICER of €85 310 per QALY.

Conclusions: Omalizumab is cost-effective compared with SoC. The outcomes of this study were used to establish omalizumab as third-line therapy in the Dutch treatment guidelines for CSU.


Chronic spontaneous urticaria (CSU) is a debilitating inflammatory skin disease. Patients with CSU experience itchy hives, angio-oedema or both, over a period of at least 6 weeks, occurring without a specific external trigger.[1] The prevalence of CSU at any point in time is between 0·5% and 1·0% of the population.[2] Evidence suggests that 33–67% of patients experience weals and angio-oedema. Many patients have psychiatric comorbidities. Patients with CSU experience impaired quality of life, and in addition patients' performance at school and work is affected.[2,3] Finally, CSU has a large socioeconomic impact, due to direct and indirect healthcare costs, and costs related to productivity losses.[2]

International guidelines[3] recommend modern H1-antihistamines at the licensed dose as the first-line therapy for CSU. If patients remain symptomatic, second-line treatment consists of updosed antihistamines (up to four times). Some patients also receive leukotriene antagonists (LTRAs). Third-line treatment consists of ciclosporin and omalizumab. Ciclosporin has been shown to be an effective third-line treatment, but it is associated with potential side-effects.[4] Compared with standard of care (SoC) and placebo, omalizumab on top of SoC reduces the clinical symptoms and signs of CSU.[5–7] Omalizumab is an add-on treatment; patients also receive updosed antihistamines and LTRAs.

To oppose rising healthcare costs, healthcare authorities increasingly use cost-effectiveness as a factor in reimbursement decisions. A cost-effectiveness model was built to assess the cost-effectiveness of omalizumab for use in the U.K.[8] The objective of this study was to determine the cost-effectiveness of omalizumab compared with SoC, namely updosed antihistamines, in the Netherlands from a societal perspective.