domingo, 18 de enero de 2009

DEGENERACIÓN MACULAR: terapias específicas

Brief Summary
GUIDELINE TITLE
Ranibizumab and pegaptanib for the treatment of age-related macular degeneration.


BIBLIOGRAPHIC SOURCE(S)
National Institute for Health and Clinical Excellence (NICE). Ranibizumab and pegaptanib for the treatment of age-related macular degeneration. London (UK): National Institute for Health and Clinical Excellence (NICE); 2008 Aug. 43 p. (Technology appraisal guidance; no. 155).
GUIDELINE STATUS
This is the current release of the guideline.

BRIEF SUMMARY CONTENT
RECOMMENDATIONS
EVIDENCE SUPPORTING THE RECOMMENDATIONS
IDENTIFYING INFORMATION AND AVAILABILITY
DISCLAIMER

RECOMMENDATIONS
MAJOR RECOMMENDATIONS
Ranibizumab, within its marketing authorisation, is recommended as an option for the treatment of wet age-related macular degeneration if:

All of the following circumstances apply in the eye to be treated:
* The best-corrected visual acuity is between 6/12 and 6/96
* There is no permanent structural damage to the central fovea
* The lesion size is less than or equal to 12 disc areas in greatest linear dimension
* There is evidence of recent presumed disease progression (blood vessel growth, as indicated by fluorescein angiography, or recent visual acuity changes)
and

The cost of ranibizumab beyond 14 injections in the treated eye is met by the manufacturer.
It is recommended that treatment with ranibizumab should be continued only in people who maintain adequate response to therapy. Criteria for discontinuation should include persistent deterioration in visual acuity and identification of anatomical changes in the retina that indicate inadequate response to therapy. It is recommended that a national protocol specifying criteria for discontinuation is developed.

Pegaptanib is not recommended for the treatment of wet age-related macular degeneration.
People who are currently receiving pegaptanib for any lesion type should have the option to continue therapy until they and their clinicians consider it appropriate to stop.

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). Ranibizumab and pegaptanib for the treatment of age-related macular degeneration. London (UK): National Institute for Health and Clinical Excellence (NICE); 2008 Aug. 43 p. (Technology appraisal guidance; no. 155).
ADAPTATION
Not applicable: The guideline was not adapted from another source.

DATE RELEASED
2008 Aug

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 (Vice-Chair) Professor of Clinical Pharmacology, University of Leicester; Dr David W Black, Director of Public Health, Chesterfield PCT; Mr Brian Buckley, Chair, Incontact; Dr Carol Campbell, Senior Lecturer, University of Teesside; Professor Mike Campbell, Professor of Medical Statistics, University of Sheffield; Ms Jude Cohen, Special Projects Consultant, UK Council for Psychotherapy; 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, Lord Trent Professor of Medicines and Health, Nottingham University; Mrs Eleanor Grey, Lay representative; Dr Catherine Jackson, Clinical Lecturer in Primary Care Medicine, Alyth Health Centre; Dr Peter Jackson, Clinical Pharmacologist, Sheffield Teaching Hospitals NHS Foundation Trust; Ms Rachel Lewis, Nurse Adviser to the Department of Health; Dr Damien Longson, Consultant in Liaison Psychiatry, Manchester Mental Health & 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 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; Professor Andrew Stevens (Chair) Professor of Public Health, University of Birmingham; Dr Cathryn Thomas, Senior Lecturer, Department of Primary Care and General Practice, 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
Electronic copies: Available in Portable Document Format (PDF) format from the National Institute for Health and Clinical Excellence (NICE) Web site.

AVAILABILITY OF COMPANION DOCUMENTS
The following are available:

Ranibizumab and pegaptanib for the treatment of age-related macular degeneration. Quick reference guide. London (UK): National Institute for Health and Clinical Excellence (NICE); 2008 Aug. 2 p. (Technology appraisal 155). Available in Portable Document Format (PDF) from the National Institute for Health and Clinical Excellence (NICE) Web site.
Ranibizumab and pegaptanib for age-related macular degeneration. Costing template. London (UK): National Institute for Health and Clinical Excellence (NICE); 2008 Aug. Various p. (Technology appraisal 155). Available in Portable Document Format (PDF) from the NICE Web site.
Ranibizumab and pegaptanib for age-related macular degeneration. Audit support. London (UK): National Institute for Health and Clinical Excellence (NICE); 2008. 5 p. (Technology appraisal 155). Available in Portable Document Format (PDF) from the NICE Web site.
Ranibizumab and pegaptanib for the treatment of age-related macular degeneration: a systematic review and economic evaluation. Technology Assessment Report. Southampton Health Technology Assessments Centre (SHTAC); 2006 Nov. 278 p. (Technology appraisal 155). Available in Portable Document Format (PDF) from the NICE Web site.
Print copies: Available from the National Health Service (NHS) Response Line 0870 1555 455. ref: N1664. 11 Strand, London, WC2N 5HR.

PATIENT RESOURCES
The following is available:

Ranibizumab and pegaptanib for wet age-related macular degeneration. Understanding NICE guidance. Information for people who use NHS services. London (UK): National Institute for Health and Clinical Excellence (NICE); 2008 Aug. 4 p. (Technology appraisal 155). 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: N1665. 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
This NGC summary was completed by ECRI Institute on December 19, 2008.

The National Institute for Health and Clinical Excellence (NICE) has granted the National Guideline Clearinghouse (NGC) permission to include summaries of their Technology Appraisal guidance with the intention of disseminating and facilitating the implementation of that guidance. NICE has not verified this content to confirm that it accurately reflects the original NICE guidance and therefore no guarantees are given by NICE in this regard. All NICE technology appraisal guidance is prepared in relation to the National Health Service in England and Wales. NICE has not been involved in the development or adaptation of NICE guidance for use in any other country. The full versions of all NICE guidance can be found at www.nice.org.uk.

COPYRIGHT STATEMENT
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Date Modified: 1/12/2009

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