omalizumab (Xolair)

following a full submission

omalizumab (Xolair®) is accepted for restricted use within NHS Scotland.

Indication under review: as add-on therapy for the treatment of chronic spontaneous urticaria in adult and adolescent (12 years and above) patients with inadequate response to H1 antihistamine treatment.

SMC restriction: use in adults and adolescents with chronic spontaneous urticaria who have an inadequate response to combination therapy with H1 antihistamines, leukotriene receptor antagonists (LTRA) and H2 antihistamines, used according to current treatment guidelines.

The addition of omalizumab to combination therapy with H1-antihistamines, and/or leukotriene receptor antagonists and/or H2-antihistamines was more effective than placebo in reducing the weekly itch severity score (ISS) at 12 weeks.

This advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of omalizumab.  This advice is contingent upon the continuing availability of the Patient Access Scheme in NHS Scotland or a list price that is equivalent or lower.