3.1 Omalizumab (Xolair, Novartis) is a monoclonal antibody that binds to IgE. It has a UK marketing authorisation as add‑on therapy to improve control of asthma in adults and adolescents 12 years and over (hereafter referred to as adults and adolescents) and children aged 6 to 11 years (hereafter referred to as children) with severe persistent allergic asthma who have:
a positive skin test or in vitro reactivity to a perennial aeroallergen
reduced lung function (forced expiratory volume at 1 second [FEV1] less than 80% in adults and adolescents)
frequent daytime symptoms or night‑time awakenings
multiple documented severe exacerbations despite daily high‑dose inhaled corticosteroids plus a long‑acting inhaled beta2 agonist.
3.2 The marketing authorisation states that omalizumab treatment 'should only be considered for patients with convincing IgE (immunoglobulin E) mediated asthma'. It also specifies that, 16 weeks after the start of omalizumab, physicians should assess how effective the treatment is, and should continue omalizumab only in patients whose asthma has markedly improved. It also specifies that omalizumab should be initiated and monitored in a specialist centre by a physician experienced in the diagnosis and treatment of severe persistent asthma.
3.3 Omalizumab is given subcutaneously every 2 or 4 weeks. The dosage is determined by the concentration of serum IgE before the start of treatment and body weight. (See the summary of product characteristics.)
3.4 The summary of product characteristics lists injection site pain, swelling, erythema and pruritus, and headaches as the most commonly reported adverse reactions for omalizumab treatment in adults and adolescents. The most commonly reported adverse reactions for omalizumab treatment in children are headaches, pyrexia and upper abdominal pain. For full details of adverse reactions and contraindications, see the summary of product characteristics.
3.5 The price of omalizumab is £256.15 for a 150‑mg vial and £128.07 for a 75‑mg vial (excluding VAT; 'British national formulary' [BNF] edition 63). The dosage administered is 75–600 mg every 2 or 4 weeks, up to a maximum dosage of 600 mg every 2 weeks. The cost of omalizumab ranges from approximately £1665 per patient per year (excluding VAT) for a 75 mg dose administered every 4 weeks to approximately £26,640 per patient per year (excluding VAT) for a 600 mg dose (the maximum recommended dose in the summary of product characteristics) administered every 2 weeks. Costs may vary in different settings because of negotiated procurement discounts. The manufacturer of omalizumab has agreed a patient access scheme with the Department of Health, which makes omalizumab available with a discount applied to all invoices. The size of the discount is commercial in confidence. The Department of Health considered that this patient access scheme does not constitute an excessive administrative burden on the NHS.