2 The technology
2.1 Omalizumab (Xolair, Novartis) is a monoclonal antibody that targets IgE. It has a UK marketing authorisation 'as an add‑on therapy for the treatment of chronic spontaneous urticaria in adult and adolescent (12 years and above) patients with an inadequate response to H1‑antihistamines'.
2.2 Omalizumab is available as a 150 mg solution for subcutaneous injection in a pre‑filled syringe, and the recommended dose is 300 mg (as 2 injections) once every 4 weeks. In the summary of product characteristics, prescribers are advised to periodically reassess patients for the need for continued treatment. It also notes that clinical trial experience of long‑term treatment beyond 6 months in this indication is limited.
2.3 The summary of product characteristics lists sinusitis, headache, arthralgia, upper respiratory tract infections and injection site reactions as common adverse reactions with omalizumab treatment for chronic spontaneous urticaria. For full details of adverse reactions and contraindications, see the summary of product characteristics.
2.4 Omalizumab costs £256.15 for a 150 mg prefilled syringe (excluding VAT; 'British national formulary' [BNF] online October 2014). A single dose of 300 mg costs £512.30 and the cost for a 24‑week course of treatment is £3073.80 (excluding VAT).
2.5 The company has agreed a patient access scheme with the Department of Health. This scheme would provide a simple discount to the list price of omalizumab across all indications, with the discount applied at the point of purchase or invoice. The level 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.