Omalizumab for Previously Treated Chronic Spontaneous Urticaria (TA339)

Technology Appraisal Guidance No. 339

Source: National Institute for Health and Care Excellence

1. Guidance

1.1 Omalizumab is recommended as an option as add-on therapy for treating severe chronic spontaneous urticaria in adults and young people aged 12 years and over only if:

  • the severity of the condition is assessed objectively, for example, using a weekly urticaria activity score of 28 or more
  • the person's condition has not responded to standard treatment with H1-antihistamines and leukotriene receptor antagonists
  • omalizumab is stopped at or before the fourth dose if the condition has not responded
  • omalizumab is stopped at the end of a course of treatment (6 doses) if the condition has responded, to establish whether the condition has gone into spontaneous remission, and is restarted only if the condition relapses
  • omalizumab is administered under the management of a secondary care specialist in dermatology, immunology or allergy
  • the company provides omalizumab with the discount agreed in the patient access scheme.
1.2 People whose treatment with omalizumab is not recommended in this NICE guidance, but was started within the NHS before this guidance was published, should be able to continue treatment until they and their NHS clinician consider it appropriate to stop.

The guidance shown above constitutes Section 1 of the full document. A copy of the full document and a summary of the evidence is available on the Internet at

This guidance represents the view of the Institute which was arrived at after careful consideration of the available evidence. Health professionals are expected to fully take it into account when exercising their clinical judgement. This guidance does not, however, override the individual responsibility of health professionals to make appropriate decisions in the circumstances of the individual patient, in consultation with the patient and/or guardian or carer.

© Copyright National Institute for Health and Care Excellence. All rights reserved. This material may be freely reproduced for educational and not for profit purposes within the NHS. No reproduction by or for commercial organisations is permitted without the express written permission of the Institute.

Enquiries concerning the guidance should be addressed to: National Institute for Health and Care Excellence, MidCity Place, 71 High Holborn, London WC1V 6NA. email:

Omalizumab for previously treated chronic spontaneous urticaria

Issue Date: June 2015

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