Bevacizumab in combination with capecitabine for the first-line treatment of metastatic breast cancer
| Status: |
In progress |
| Expected date of issue: |
August 2012 |
| Referral date: |
November 2008 |
| Wave: |
19 |
| Process: |
STA |
| Topic area:
|
NICE project team
| Executive Lead: |
Gillian Leng
|
| Technical Lead: |
Christian Griffiths
|
| Communications manager: |
Alice Law
|
| Project manager: |
Kate Moore
|
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 |
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) (CA&U not returned, not participating)
- Hospira UK (vinorelbine) (CA&U not returned, not participating)
- Medac UK (vinorelbine) (CA&U not returned, not participating)
- Pierre Fabre (vinorelbine) (CA&U not returned, not participating)
- Roche Products (capecitabine)
- Wockhardt UK (vinorelbine) (CA&U not returned, not participating)
Relevant research groups
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
|
|
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 |
|
Key documents
This page was last updated: 16 January 2012
