1.1 Omalizumab is recommended, within its licensed indication, as an option for the treatment of severe persistent allergic (IgE mediated) asthma as add-on therapy to optimised standard therapy, only in adults and adolescents (12 years and older) who have been identified as having severe unstable disease.
1.2 For the purposes of this guidance, optimised standard therapy is defined as a full trial of, and documented compliance with, inhaled high-dose corticosteroids and long-acting beta-2 agonists in addition to leukotriene receptor antagonists, theophyllines, oral corticosteroids and beta-2 agonist tablets and smoking cessation where clinically appropriate.
1.3 Omalizumab add-on therapy should only be initiated if the patient fulfils the following criteria of severe unstable allergic asthma.
Confirmation of IgE mediated allergy to a perennial allergen by clinical history and allergy skin testing.
Either two or more severe exacerbations of asthma requiring hospital admission within the previous year, or three or more severe exacerbations of asthma within the previous year, at least one of which required admission to hospital, and a further two which required treatment or monitoring in excess of the patient's usual regimen, in an accident and emergency unit.
1.4 Omalizumab add-on therapy should be initiated and monitored by a physician experienced in both allergy and respiratory medicine in a specialist centre.
1.5 Omalizumab add-on therapy should be discontinued at 16 weeks in patients who have not shown an adequate response to therapy. Response to treatment should be defined on the basis of a full clinical assessment comprising: degree of asthma control, quality of life, control of exacerbations, avoidance of unscheduled healthcare utilisation; spirometry and peak expiratory flow measures and a global evaluation of treatment effectiveness, as assessed by the physician.