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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 H 1 -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., (© 2018 The Authors. British Journal of Dermatology published by John Wiley & Sons Ltd on behalf of British Association of Dermatologists.)

Background: Chronic spontaneous urticaria (CSU) negatively impacts patient quality of life and productivity and is associated with considerable indirect costs to society., Objective: The aim of this study was to assess the cost utility of add-on omalizumab treatment compared with standard of care (SOC) in moderate or severe CSU patients with inadequate response to SOC, from the UK societal perspective., Methods: A Markov model was developed, consisting of health states based on Urticaria Activity Score over 7 days (UAS7) and additional states for relapse, spontaneous remission and death. Model cycle length was 4 weeks, and total model time horizon was 20 years in the base case. The model considered early discontinuation of non-responders (response: UAS7 ≤6) and retreatment upon relapse (relapse: UAS7 ≥16) for responders. Clinical and cost inputs were derived from omalizumab trials and published sources, and cost utility was expressed as incremental cost-effectiveness ratios (ICERs). Scenario analyses included no early discontinuation of non-responders and an altered definition of response (UAS7 <16)., Results: With a deterministic ICER of £3183 in the base case, omalizumab was associated with increased costs and benefits relative to SOC. Probabilistic sensitivity analysis supported this result. Productivity inputs were key model drivers, and individual scenarios without early discontinuation of non-responders and adjusted response definitions had little impact on results. ICERs were generally robust to changes in key model parameters and inputs., Conclusions: In this, the first economic evaluation of omalizumab in CSU from a UK societal perspective, omalizumab consistently represented a treatment option with societal benefit for CSU in the UK across a range of scenarios.

Chronic spontaneous urticaria (CSU) is a skin disease characterised by wheal appearance, swelling, itching, and painful skin. Omalizumab has been used for CSU treatment demonstrating good efficacy. To investigate the efficacy and safety of omalizumab treatment in CSU patients in real-life practice. A retrospective analysis was performed on 38 patients suffering from CSU who received 300 mg of omalizumab every four weeks. After omalizumab treatment, 68.4% of patients showed a complete response (UAS7 = 0). All the patients were able to stop treatment with corticosteroids, cyclosporine, and anti-leukotrienes, and only 39.5% of patients remained on anti-histamines. Omalizumab treatment led to a 96% and 65% decrease in emergency room and primary health care visits, respectively, as well as a reduction in the direct costs associated with the disease. No omalizumab-related adverse events were reported. Omalizumab exhibits good efficacy in alleviating the symptoms of CSU, leads to a decrease in concomitant medication use, restores patients' quality of life, and has economic benefits by reducing disease-related health care costs.