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Breast cancer (metastatic) - bevacizumab (1st line, with capecitabine) [ID54]

Bevacizumab in combination with capecitabine for the first-line treatment of metastatic breast cancer

Status: History
Expected date of issue: August 2012
Referral date: November 2008
Process: STA
Topic area:
  • Cancer
 

NICE project team

Executive Lead: Gillian Leng
Technical Lead: Nwamaka Umeweni
Communications manager: Laura Gibson
Project manager: Rebecca Pye
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Provisional schedule

Closing date for invited submissions / evidence submission: 8 December 2011
1st appraisal committee meeting: 22 March 2012
2nd appraisal committee meeting 23 May 2012
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Consultees and commentators

Consultees Commentators (no right to submit or appeal)

Manufacturers/sponsors

  • Roche Products (bevacizumab)

Patient/carer groups

  • Breakthrough Breast Cancer
  • Breast Cancer Campaign
  • Macmillan Cancer Support

Professional groups

  • Cancer Research UK
  • Royal College of Nursing
  • Royal College of Physicians

Others

  • Department of Health
  • Welsh Government

General

  • Commissioning Support Appraisals Service
  • Department of Health, Social Services and Public Safety for Northern Ireland
  • Healthcare Improvement Scotland

Comparator manufacturers

  • Actavis UK (vinorelbine) (Confidentiality agreement not signed, not participating)
  • Hospira UK (vinorelbine) (Confidentiality agreement not signed, not participating)
  • Medac UK (vinorelbine) (Confidentiality agreement not signed, not participating)
  • Pierre Fabre (vinorelbine) (Confidentiality agreement not signed, not participating)
  • Roche Products (capecitabine)
  • Wockhardt UK (vinorelbine) (Confidentiality agreement not signed, not participating)

Relevant research groups

  • None

Evidence Review Group

  • Liverpool Reviews and Implementation Group (LRiG)
  • National Institute for Health Research Health Technology Assessment Programme

Associated Guideline Groups

  • National Collaborating Centre for Cancer

Associated Public Health Groups

  • None

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Project history

Date Update
5 August 2011 CHMP Re-examination procedure on Bevacizumab concluded – Suspended NICE Technology Appraisal to be reinstated.

In November 2008, the Department of Health asked NICE to ‘appraise the clinical and cost effectiveness of bevacizumab in combination with non-taxane chemotherapy within its licensed indications for the first line treatment of metastatic breast cancer.’

During January 2011 this appraisal was suspended due to an update on regulatory status that the Committee for Medicinal Products for Human Use (CHMP) had adopted a negative opinion for this indication.

Following a re-examination of its previous negative opinion, the Committee for Medicinal Products for Human Use (CHMP) have now adopted a final positive opinion, recommending that the therapeutic indications of bevacizumab, should be extended to include first-line treatment in combination with capecitabine of patients with metastatic breast cancer in whom treatment with other chemotherapy options, including taxanes or anthracyclines, is not considered appropriate.
Therefore, Ministers have agreed to revise the final remit of the appraisal to the following:

‘To appraise the clinical and cost effectiveness of bevacizumab in combination with capecitabine within its licensed indications for the first line treatment of metastatic breast cancer.’

This appraisal has now be rescheduled into the NICE technology appraisal work programme.  The anticipated timelines are as follows:

The appraisal is expected to start in approximately mid October 2011 when we will write to you about how you can get involved. The deadline for submissions is expected in approximately mid December 2011.   For information, a decision will be taken shortly on whether an additional draft scope consultation is required for this appraisal. If required, it is anticipated it will be issued for consultation during August 2011.
5 January 2011 Please note that this appraisal has been suspended and the appraisal committee discussion that was due to take place on 25 January 2011 has been cancelled.  This is due to an update on regulatory status that the Committee for Medicinal Products for Human Use (CHMP) recently adopted a negative opinion for this indication. We will continue to monitor any development and will update this webpage if the situation changes.
6 May 2010 Please note that this appraisal is now expected to start in approximately mid-August 2010.  The deadline for submissions is expected in approximately mid-October 2010.
11 November 2009 This appraisal has been rescheduled to align with latest regulatory expectations.  Therefore, we now anticipate that the appraisal will begin during late April 2010. The deadline for submissions is expected in approximately early July 2010.
2 July 2009 This appraisal has been rescheduled to align with latest regulatory expectations.  Therefore, we now anticipate that the appraisal will begin during early October 2009. The deadline for submissions is expected in approximately mid-December 2009
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Key documents

This page was last updated: 21 August 2012

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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.