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.

  • National Institute for Health and Care Excellence (NICE)