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SHTAC is critically appraising the manufacturer’s submission to NICE on omalizumab as a second-line treatment for chronic spontaneous urticaria

Published: 14 August 2014

SHTAC is assessing the clinical-effectiveness and cost-effectiveness of omalizumab as an add-on treatment for chronic spontaneous urticaria in patients with inadequate response to currently available treatments, as part of the National Institute for Health and Care Excellence (NICE) Single Technology Appraisal process.

Urticaria, commonly referred to as nettle rash or hives, is a severe and distressing skin condition presenting as a raised, itchy rash on the skin, which may cause a burning or stinging sensation. Around 15% of people in the UK experience urticaria at some time in their lives. While symptoms may be short-lived and often resolve completely after a few months, in around 20% of cases symptoms can persist for more than 10 years. Chronic spontaneous urticaria (CSU) often has a non-specific/ unknown (idiopathic) cause, with daily or almost daily symptoms occurring for more than 6 weeks. The symptoms of CSU can have a severe impact on the quality of life of sufferers, negatively affecting sleep, daily activities, work (or school in the case of children), and social interactions.

There are currently no NICE clinical guidelines or technology appraisals for CSU and antihistamines are the only licensed treatment for CSU in the UK other than omalizumab. Guidelines issued by the British Association of Dermatologists and the British Society for Allergy and Clinical Immunology recommend the use of non-sedating, second generation H1-antihistamines as first-line treatment for CSU. However, a large number of patients are resistant to the licensed dose of H1 antihistamines. For these cases, current guidelines recommend an off-label increase of up to four times the standard licensed dose.

Omalizumab is a humanised antibody already used to control moderate to severe allergic asthma unresponsive to high doses of corticosteroids. Omalizumab is the first product to hold a marketing authorisation as an add-on therapy for CSU in adults and adolescents (12 years and above) with inadequate response to H1 antihistamines.

NICE is expected to issue guidance to the health service in England on omalizumab in April 2015.

For more information on SHTAC's research on skin diseases please visit our Research page.

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