Technology Appraisal Guidance No. 133
Source: National Institute for Health and Clinical Excellence
1. Guidance
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.
The guidance shown above constitutes Section 1 of the full document. A copy of the full document and a summary of the evidence is available on the Internet at http://guidance.nice.org.uk/TA133
An abridged version of this guidance (a 'quick reference guide') is also available. Printed copies of the quick reference guide can be obtained by contacting 0845 003 7783 or emailing publications@nice.org.uk and quoting reference number N1404. It is also available on the Internet at http://www.nice.org.uk/guidance/index.jsp?action=download&o=38394
This guidance represents the view of the Institute which was arrived at after careful consideration of the available evidence. Health professionals are expected to fully take it into account when exercising their clinical judgement. This guidance does not, however, override the individual responsibility of health professionals to make appropriate decisions in the circumstances of the individual patient, in consultation with the patient and/or guardian or carer.
© Copyright National Institute for Health and Clinical Excellence. All rights reserved. This material may be freely reproduced for educational and not for profit purposes within the NHS. No reproduction by or for commercial organisations is permitted without the express written permission of the Institute.
Enquiries concerning the guidance should be addressed to: National Institute for Health and Clinical Excellence, MidCity Place, 71 High Holborn, London WC1V 6NA. email: nice@nice.nhs.uk
Omalizumab for Severe Persistent Allergic Asthma
Issue Date: November 2007
Review Date: August 2010
