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Brief Summary

GUIDELINE TITLE

Omalizumab for severe persistent allergic asthma.

BIBLIOGRAPHIC SOURCE(S)

  • National Institute for Health and Clinical Excellence (NICE). Omalizumab for severe persistent allergic asthma. London (UK): National Institute for Health and Clinical Excellence (NICE); 2007 Nov. 28 p. (Technology appraisal guidance; no. 133).

GUIDELINE STATUS

This is the current release of the guideline.

** REGULATORY ALERT **

FDA WARNING/REGULATORY ALERT

BRIEF SUMMARY CONTENT

 ** REGULATORY ALERT **
 RECOMMENDATIONS
 EVIDENCE SUPPORTING THE RECOMMENDATIONS
 IDENTIFYING INFORMATION AND AVAILABILITY
 DISCLAIMER

 Go to the Complete Summary

RECOMMENDATIONS

MAJOR RECOMMENDATIONS

Omalizumab is recommended, within its licensed indication, as an option for the treatment of severe persistent allergic (immunoglobulin E [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.

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.

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.

Omalizumab add-on therapy should be initiated and monitored by a physician experienced in both allergy and respiratory medicine in a specialist centre.

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.

CLINICAL ALGORITHM(S)

None provided

EVIDENCE SUPPORTING THE RECOMMENDATIONS

TYPE OF EVIDENCE SUPPORTING THE RECOMMENDATIONS

The type of evidence supporting the recommendations is not specifically stated.

IDENTIFYING INFORMATION AND AVAILABILITY

BIBLIOGRAPHIC SOURCE(S)

  • National Institute for Health and Clinical Excellence (NICE). Omalizumab for severe persistent allergic asthma. London (UK): National Institute for Health and Clinical Excellence (NICE); 2007 Nov. 28 p. (Technology appraisal guidance; no. 133).

ADAPTATION

Not applicable: The guideline was not adapted from another source.

DATE RELEASED

2007 Nov

GUIDELINE DEVELOPER(S)

National Institute for Health and Clinical Excellence (NICE) - National Government Agency [Non-U.S.]

SOURCE(S) OF FUNDING

National Institute for Health and Clinical Excellence (NICE)

GUIDELINE COMMITTEE

Appraisal Committee

COMPOSITION OF GROUP THAT AUTHORED THE GUIDELINE

Committee Members: Professor David Barnett, Professor of Clinical Pharmacology, University of Leicester; Dr David W Black, Director of Public Health, Chesterfield PCT; Professor Mike Campbell, Professor of Medical Statistics, University of Sheffield; Dr Carol Campbell, Senior Lecturer, University of Teesside; Mr Peter Clarke, Consultant Medical Oncologist, Clatterbridge Centre for Oncology, Merseyside; Ms Jude Cohen, Chief Executive, Womens Nationwide Cancer Control Campaign; Dr Christine Davey, Senior Researcher, North Yorkshire Alliance R&D Unit; Dr Mike Davies, Consultant Physician, Manchester Royal Infirmary; Mr Richard Devereaux-Phillips, Public Affairs Manager, Medtronic Ltd; Dr Rachel A Elliott, Clinical Senior Lecturer, The University of Manchester; Mrs Eleanor Grey, Lay member; Dr Dyfrig Hughes, Senior Research Fellow in Pharmacoeconomics, Centre for the Economics of Health and Policy in Health, University of Wales; Dr Catherine Jackson, Clinical Lecturer in Primary Care Medicine, Alyth Health Centre; Dr Peter Jackson, Clinical Pharmacologist, the University of Sheffield; Professor Peter Jones, Professor of Statistics & Dean Faculty of Natural Sciences, Keele University; Ms Rachel Lewis, Nurse Adviser to the Department of Health; Dr Damien Longson, Consultant in Liaison Psychiatry, Manchester Mental Health and Social Care Trust; Professor Jonathan Michaels, Professor of Vascular Surgery, University of Sheffield; Dr Eugene Milne, Deputy Medical Director, North East Strategic Health Authority; Dr Simon Mitchell, Consultant Neonatal Paediatrician, St Mary's Hospital, Manchester; Dr Richard Alexander Nakielny, Consultant Radiologist, Royal Hallamshire Hospital, Sheffield; Dr Katherine Payne, Health Economics Research Fellow, The University of Manchester; Dr Martin J Price, Head of Outcomes Research, Janssen-Cilag Ltd; Mr Miles Scott, Chief Executive, Bradford Teaching Hospitals NHS Foundation Trust; Professor Mark Sculpher, Professor of Health Economics, University of York; Professor Andrew Stevens (Chair) Professor of Public Health, University of Birmingham

FINANCIAL DISCLOSURES/CONFLICTS OF INTEREST

Committee members are asked to declare any interests in the technology to be appraised. If it is considered there is a conflict of interest, the member is excluded from participating further in that appraisal.

GUIDELINE STATUS

This is the current release of the guideline.

GUIDELINE AVAILABILITY

AVAILABILITY OF COMPANION DOCUMENTS

The following are available:

Print copies: Available from the National Health Service (NHS) Response Line 0870 1555 455. ref: N1404. 11 Strand, London, WC2N 5HR.

PATIENT RESOURCES

The following is available:

  • Omalizumab for severe persistent allergic asthma. Understanding NICE guidance - Information for people who use NHS services. London (UK): National Institute for Health and Clinical Excellence (NICE); 2007 Nov. 4 p. (Technology appraisal 133).

Electronic copies: Available in Portable Document Format (PDF) from the National Institute for Health and Clinical Excellence (NICE) Web site.

Print copies: Available from the NHS Response Line 0870 1555 455. ref: N1405. 11 Strand, London, WC2N 5HR.

Please note: This patient information is intended to provide health professionals with information to share with their patients to help them better understand their health and their diagnosed disorders. By providing access to this patient information, it is not the intention of NGC to provide specific medical advice for particular patients. Rather we urge patients and their representatives to review this material and then to consult with a licensed health professional for evaluation of treatment options suitable for them as well as for diagnosis and answers to their personal medical questions. This patient information has been derived and prepared from a guideline for health care professionals included on NGC by the authors or publishers of that original guideline. The patient information is not reviewed by NGC to establish whether or not it accurately reflects the original guideline's content.

NGC STATUS

COPYRIGHT STATEMENT

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DISCLAIMER

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