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Crohn's disease - infliximab (review) and adalimumab

Use of tumour necrosis factor alpha (TNF a) inhibitors (adalimumab, and infliximab [review]) for Crohn's disease

Status: History
Expected date of issue: May 2010
Referral date: December 2006
Process: MTA
Topic area:
 

NICE project team

Executive Lead: Peter Littlejohns
Technical Lead: Fiona Rinaldi
Communications manager: Shalu Kanal
Project manager: Bijal Joshi
Assessment Group / Evidence Review Group: West Midlands Health Technology Assessment Collaboration
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Provisional schedule

Consultation on draft scope by stakeholders: March 2007
Information meeting with consultees: 04 June 2007
Closing date for invited submissions / evidence submission: 30 July 2007
Final scope published: April 2007
1st appraisal committee meeting: 20 August 2008
2nd appraisal committee meeting: 22 October 2008
3rd appraisal committee meeting: 20 August 2009
4th appraisal committee meeting: 22 October 2009
5th appraisal committee meeting: 19 January 2010
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Consultees and commentators

Consultees Commentators (no right of appeal)

Manufacturers / Sponsors

  • Abbott Laboratories Ltd (adalimumab))
  • Schering Plough (infliximab)

 

Patient / Carer Groups

  • National Association for Colitis and Crohn's Disease (NACC)

 

Professional Groups

  • Association of Coloproctology of Great Britain and Ireland
  • British Society of Gastroenterology
  • Royal College of Nursing
  • Royal College of Physicians

 

Others

  • Bedfordshire PCT
  • Central and East Cheshire PCT
  • Department of Health
  • Welsh Assembly Government

General

  • British National Formulary
  • Department of Health, Social Services and Public Safety for Northern Ireland
  • NHS Quality Improvement Scotland
  • Scottish Medicines Consortium

 

Comparator Manufacturers

  • Novartis Pharmaceuticals Ltd (ciclosporin)

 

Assessment Team

  • National Institute for Health Research Health Technology Assessment Programme
  • West Midlands Health Technology Assessment Collaboration

 

Associated Guideline Groups

  • National Collaborating Centre for Nursing & Supportive Care

 

Associated Public Health Groups

  • None

 

Research Groups

  • None

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Project history

Date Update
25 August 2006 This topic was referred by the Department of Health and the Welsh Assembly Government as part of the Institute's 12th wave work programme.
31 August 2006 Topic amended to include the review of infliximab as part of this appraisal.
5 March 2007 Date scheduled for consultation on draft scope, publication of final scope on website and 1st appraisal committee meeting
8 March 2007 Please note that we have received an updated referral from the Department of Health for Crohn's disease. The revised remit is as follows: To appraise the clinical and cost effectiveness of the tumour necrosis factor alpha (TNF a) inhibitors and natalizumab within their licensed indications for Crohn's disease.
18 April 2007 Schedule updated.
26 September 2007 The manufacturer of natalizumab has advised us that there has been a delay in the timelines of their regulatory application for use in Crohn's Disease. The Institute has therefore decided to remove this technology from this multiple technology appraisal. The Institute will be liaising with the Department of Health about how we progress with natalizumab. The appraisal of adalimimab, certolizumab and infliximab for the treatment of Crohn's Disease will continue as per our timelines.
10 November 2008 After careful consideration, and in response to the points raised at the committee meeting, we have commissioned the Decision Support Unit (DSU) to carry out extra work and perform re-analysis of the evidence considered. The DSU specification is attached below for your information.
15 January 2008 We have now received the DSU report that suggests that a full reconciliation of the economic evaluations included in the current evidence base may be required in order to develop estimates of cost effectiveness which are reliable and appropriately reflect areas of uncertainty. The DSU further states that this reconciliation requires that structural issues as well as individual parameter values are fully considered and amended where appropriate.

The Institute accepts the conclusions of the DSU report and will commission the reconciliation work shortly.

Consequently, this topic will not be discussed at the next Appraisal Committee meeting on 22 January 2009.
21 April 2009 In January 2009 the Decision Support Unit (DSU) report suggested that a full reconciliation of the economic evaluations included in the current evidence base may be required in order to develop estimates of cost-effectiveness which are reliable and appropriately reflect areas of uncertainty. Structural issues and individual parameter values were also areas to be considered.

NICE have commissioned the DSU to carry out this extra work and consider the above points within a timeframe of their current capacity and resources. Please see DSU specification below.

Consequently this topic will be discussed at the 20 August 2009 Committee Meeting, with consultation on the DSU report during June / July 2009.
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Key documents

This page was last updated: 19 May 2010

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Selected, reliable information for health and social care in one place

Accessibility | Cymraeg | Freedom of information | Vision Impaired | Contact Us | Glossary | Data protection | Copyright | Disclaimer | Terms and conditions

Copyright 2014 National Institute for Health and Care Excellence. All rights reserved.

Accessibility | Cymraeg | Freedom of information | Vision Impaired | Contact Us | Glossary | Data protection | Copyright | Disclaimer | Terms and conditions

Copyright 2014 National Institute for Health and Care Excellence. All rights reserved.