omalizumab (Xolair)

Following an abbreviated submission

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

Licensed indication under review: add-on therapy to improve asthma control in children (6 to <12 years of age) with severe persistent allergic asthma who have a positive skin test or in vitro reactivity to a perennial aeroallergen and frequent daytime symptoms or night-time awakenings and who have had multiple documented severe asthma exacerbations despite daily high-dose inhaled corticosteroids, plus a long-acting inhaled beta2-agonist.  Omalizumab treatment should only be considered for patients with convincing IgE (immunoglobulin E) mediated asthma.
SMC restriction: Use is restricted to patients who are prescribed chronic systemic steroids and in whom all other treatments have failed.  The response to omalizumab treatment should be assessed in all patients at 16 weeks and treatment should be discontinued in patients who have not shown a marked improvement in overall asthma control.
The Scottish Medicines Consortium has previously accepted this product for restricted use in adults and adolescents (12 years of age and above).  Omalizumab is listed in the British National Formulary for Children for the prophylaxis of allergic asthma.