Lapatinib for breast cancer (for use in women with previously treated advanced or metastatic breast cancer)
Status Suspended
Decision Selected
Process STA pre-2018
Referral date 01 December 2006
Topic area
  • Cancer

6th appraisal committee meeting: 17 November 2009

7th appraisal committee meeting: 16 February 2010 

Provisional Schedule

Closing date for invited submissions / evidence submission: 17 April 2007
Final scope published: February 2007
1st appraisal committee meeting: 22 January 2008
2nd appraisal committee meeting 18 September 2008
3rd appraisal committee meeting: 19 November 2008
4th appraisal committee meeting: 22 January 2009
5th appraisal committee meeting: 23 September 2009

Project Team

Assessment Group / Evidence Review Group: Southampton Health Technology Assessment Centre
Communications manager: Laura Gibson
Executive Lead: Gillian Leng
Project manager: Bijal Joshi
Technical Lead: Joao Vieira


Manufacturers / Sponsors GlaxoSmithKline
Others Department of Health
  North Hertfordshire and Stevenage PCT
  Rugby PCT
  Welsh Assembly Government
Patient / Carer Groups Breakthrough Breast Cancer
  Breast Cancer Campaign
  Breast Cancer Care
  Macmillan Cancer Support
Professional Groups British Association of Surgical Oncology
  Cancer Research UK
  Royal College of Nursing
  Royal College of Pathologists
  Royal College of Physicians (Medical Oncology Joint Special Committee)
Associated Public Health Groups None
Comparator Manufacturers Bristol Myers Squibb (Paclitaxal)
  Eli Lilly & Co Ltd (Gemcitabine)
  Mayne Pharma Plc (Paclitaxel, Vinorelbine) - Not participating
  Pierre Fabre Ltd (Vinorelbine)
  Roche Products Ltd (Capecitabine)
  Teva UK Ltd (Paclitaxel) - Not participating
  Wockhardt UK (Vinorelbine) - Not participating
Evidence Review Groups National Institute for Health Research Health Technology Assessment Programme
  Southampton Health Technology Assessment Centre
  Associated Guideline Groups
  National Collaborating Centre for Cancer
General British National Formulary
  Department of Health, Social Services and Public Safety for Northern Ireland
  NHS Quality Improvement Scotland


Key events during the development of the guidance:

Date Update
5 July 2007 Following clarification of European regulatory timings for lapatinib, its consideration at the Appraisal Committee meeting of the 25 July 2007 has been cancelled. The Institute is currently discussing the timings for this appraisal and will inform you of new dates shortly.
22 February 2008 As a result of uncertainty in the exact date at which the marketing authorisation for lapatinib in previously treated women with advanced or metastatic breast cancer will be issued, and the Institute's commitment to full public consultation on the preliminary recommendations of the Appraisal Committee, the next meeting of the Committee has been postponed to 23 April 2008.

In accordance with the Guide to the Technology Appraisals Process, the Appraisal Consultation Documentation (ACD) will be distributed to consultees and commentators once the full marketing authorisation has been received. The ACD will be sent to you via email. These documents will be placed on the NICE website 5 working days after consultees and commentators have received them.
23 September 2008 The NICE Appraisal Committee met on 18 September 2008 to discuss the consultation comments received on the Appraisal consultation document (ACD) for the above appraisal. The committee received further evidence and proposals from the manufacturer. Consequently, the Institute have requested that a second consultation takes place on the ACD.

The next Committee Meeting is expected to be held on 19 November 2008.
12 January 2009 The FAD was sent to Guidance Executive (GE) for sign-off including consideration of the draft criteria listed in the ‘End of Life Medicines' consultation paper. Guidance Executive concluded that the Appraisal Committee should consider their recommendations in light of the final criteria for considering 'End of Life' treatments.

Consequently the anticipated Final Appraisal Determination (FAD) has not been agreed by the Committee. There will be an extension in the timelines for this appraisal and discussion of the topic at the next Committee Meeting on 22nd January 2009.
17 July 2009 The Appeal Panel met on 8 June 2009 to consider the appeal lodged against the Final Appraisal Determination (FAD) for this appraisal. The decision of the appeal panel has been received and is below.

With reference to the decision of the Appeal Panel, NICE is seeking further evidence to inform future deliberations of the Appraisal Committee.

Specifically, the Appeal Panel instructs NICE to do the following: ‘GlaxoSmithKline must now be asked to provide a submission on the question of whether and how lapatinib falls within the Supplementary Advice’.

The Appeal Panel recommends that the same opportunity should be given to the other consultees and commentators in this appraisal.

The Appeal Panel also allowed the appeal ‘in so far as the Committee should consider whether, exceptionally, a life extension of less than three months might be acceptable in this case’. NICE’s Guidance Executive considers it appropriate for the Board to address this particular instruction of the Appeal Panel before consultees and commentators are asked to make submissions in the context of this appraisal, and, where relevant, for NICE to provide specific advice to consultees and commentators following the Board discussion.

This Board discussion is planned for 22 July 2009. NICE will therefore formally invite consultees and commentators on 27 July 2009 to prepare a submission for the Appraisal Committee which will need to be submitted by Monday 24 August 2009 at 5pm.

Following review of the submissions, the Appraisal Committee will be discussing this topic on Wednesday 23 September 2009.
20 January 2010 The document below [Breast cancer (advanced) - lapatinib (2nd line) paper - post GE January 2010] describes NICE’s Guidance Executive’s conclusions after having received the final appraisal determination for the single technology appraisal of lapatinib for the treatment of advanced or metastatic breast cancer.

NICE have planned for this reconsideration to be held at the Committee meeting on 16 February 2010. Consultees and Commentators have not be asked to make further submissions.
15 October 2010 On receipt of the appeal decision, and in particular when reflecting on paragraph 66 of the advice, NICE’s guidance executive decided that whilst the Department of Health is considering NICE’s request to extend the review of technology appraisal guidance 34 (Trastuzumab, as monotherapy and in combination with a taxane, for the treatment of metastatic breast cancer) to include the appraisal of continued use of trastuzumab post progression in the metastatic setting and to possibly also include the review of the lapatinib appraisal, publication of the guidance on the use of lapatinib is not in the interests of patients or the efficiency of the NHS and should therefore be postponed.

For further information on our processes and methods, please see our CHTE processes and methods manual