Project documents | Lapatinib for breast cancer (for use in women with previously treated advanced or metastatic breast cancer) [ID20] | Guidance | NICE

Documents

A list of downloadable documents created during development.

Breast cancer (advanced or metastatic) - lapatinib: second appeal

Breast cancer (advanced or metastatic) - lapatinib: second appeal information
Breast cancer (advanced or metastatic) - lapatinib: second notice of appeal information
Breast cancer (advanced or metastatic) - lapatinib: appeal decision ^{PDF 56 KB} 14 October 2010
Breast cancer (advanced or metastatic) - lapatinib: appeal announcement information
Appeal received ^{PDF 49 KB} 17 August 2010
Initial scrutiny letter ^{PDF 34 KB} 17 August 2010
Response to scrutiny letter ^{PDF 34 KB} 17 August 2010
Final scrutiny letter ^{PDF 20 KB} 17 August 2010

Breast cancer (advanced or metastatic) - lapatinib: final appraisal determination

Breast cancer (advanced or metastatic) - lapatinib: final appraisal determination information
Breast cancer (advanced or metastatic) - lapatinib: final appraisal determination ^{PDF 234 KB} 10 June 2010
Response to consultee, commentator and public comments on the appraisal consultation document (ACD 3) ^{PDF 96 KB} 09 June 2010
Consultee and commentator comments on the ACD
GlaxoSmithKline ^{PDF 43 KB} 10 June 2010
Breakthrough Breast Cancer, Breast Cancer Campaign, Breast Cancer Care and Macmillan Cancer Support ^{PDF 12 KB} 10 June 2010
Royal College of Nursing ^{PDF 11 KB} 09 June 2010
The Royal College of Pathologists ^{PDF 11 KB} 10 June 2010
NCRI Breast Clinical Studies Group/RCP/RCR/ACP/JCCO ^{PDF 54 KB} 10 June 2010
Department of Health ^{PDF 23 KB} 10 June 2010
Welsh Assembly Government ^{PDF 18 KB} 10 June 2010
Roche ^{PDF 11 KB} 10 June 2010
Letter to consultees and commentators ^{PDF 15 KB} 10 June 2010
Letter to Guidance Executive - prepared by Professor Philip Home (Vice-Chair of Committee) ^{PDF 21 KB} 10 June 2010

Breast cancer (advanced or metastatic) - lapatinib: (2nd line) paper - post GE January 2010

Breast cancer (advanced or metastatic) - lapatinib: (2nd line) paper - post GE January 2010 ^{PDF 14 KB} 20 January 2010

Breast cancer (advanced or metastatic) - lapatinib: appraisal consultation document

Evaluation report
Appraising life - extending, end of life treatments paper ^{PDF 23 KB} 21 October 2009
Report by the Decision Support Unit ^{PDF 101 KB} 21 October 2009
Breast cancer (advanced or metastatic) - lapatinib: appeal decision ^{PDF 178 KB} 21 October 2009
Non-manufacturer submissions
Breakthrough Breast Cancer, Breast Cancer Campaign, Breast Cancer Care and Macmillan Cancer Support ^{PDF 17 KB} 21 October 2009
Royal College of Nursing ^{PDF 20 KB} 21 October 2009
Royal College of Physicians ^{PDF 35 KB} 21 October 2009
Roche ^{PDF 24 KB} 21 October 2009
GlaxoSmithKline (including clarification required from NICE)
Final submission ^{PDF 404 KB} 21 October 2009
Responses to DSU questions ^{PDF 161 KB} 21 October 2009

Breast cancer (advanced or metastatic) - lapatinib: appeal

Breast cancer (advanced or metastatic) - lapatinib: appeal information
Breast cancer (advanced or metastatic) - lapatinib: appeal announcement information
Appeals received ^{PDF 115 KB} 08 June 2009
Initial scrutiny letter ^{PDF 40 KB} 08 June 2009
Response to scrutiny letter ^{PDF 73 KB} 08 June 2009
Final scrutiny letter ^{PDF 23 KB} 08 June 2009
Clarification letter from appellant ^{PDF 23 KB} 08 June 2009
Response to clarification letter ^{PDF 16 KB} 08 June 2009
Breast cancer (advanced or metastatic) - lapatinib: appeal decision ^{PDF 178 KB} 09 July 2009

Breast cancer (advanced or metastatic) - lapatinib: final appraisal determination

Breast cancer (advanced or metastatic) - lapatinib: final appraisal determination information
Breast cancer (advanced or metastatic) - lapatinib: final appraisal determination ^{PDF 167 KB} 05 March 2009
Response to consultee, commentator and public comments on the ACD and comments from website consultation
Response and comments to the website consultation on the Appraisal Consultation Document - prepared by the technical lead ^{PDF 170 KB} 05 March 2009
Response to consultee and commentator comments on the Appraisal Consultation Document - prepared by the technical lead ^{PDF 168 KB} 05 March 2009
Consultee and commentator comments on the ACD
Breakthrough Breast Cancer ^{PDF 13 KB} 05 March 2009
Department of Health ^{PDF 12 KB} 05 March 2009
GlaxoSmithKline - 1 ^{PDF 70 KB} 05 March 2009
GlaxoSmithKline - 2 ^{PDF 205 KB} 05 March 2009
National Collaborating Centre for Cancer ^{PDF 22 KB} 05 March 2009
Royal College of Nursing ^{PDF 19 KB} 05 March 2009
Royal College of Physicians ^{PDF 43 KB} 05 March 2009
Roche ^{PDF 110 KB} 05 March 2009
Expert comments on the ACD
Carolyn Rogers ^{PDF 11 KB} 05 March 2009
Justin Stebbing ^{PDF 12 KB} 05 March 2009

Breast cancer (advanced or metastatic) - lapatinib (appraisal consultation 2)

Breast cancer (advanced or metastatic) - lapatinib: evaluation report
Non-manufacturer submissions
Breakthrough Breast Cancer, Breast Cancer Campaign, Breast Cancer Care, and Macmillian Cancer Support (joint submission) ^{PDF 29 KB} 09 October 2008
Breast Cancer Care supporting letter ^{PDF 25 KB} 09 October 2008
Department of Health (2) ^{PDF 21 KB} 09 October 2008
National Collaborating Centre for Cancer ^{PDF 13 KB} 10 October 2008
Roche ^{PDF 37 KB} 10 October 2008
Royal College of Nursing ^{PDF 20 KB} 10 October 2008
Royal College of Physicians ^{PDF 46 KB} 10 October 2008
Royal College of Pathologists ^{PDF 12 KB} 10 October 2008
Sanofi Aventis ^{PDF 26 KB} 10 October 2008
Southampton Health Technology Assessment Centre ^{PDF 13 KB} 10 October 2008
Manufacturer submission
GlaxoSmithKline comments on ERG report ^{PDF 245 KB} 10 October 2008
GlaxoSmithKline response to ACD1 ^{PDF 107 KB} 10 October 2008
GlaxoSmithKline appendices to ACD1 ^{PDF 779 KB} 10 October 2008
GlaxoSmithKline addendum ^{PDF 562 KB} 10 October 2008
GlaxosmithKline response to clarification letter ^{PDF 217 KB} 10 October 2008
NICE Clarification letter ^{PDF 22 KB} 10 October 2008
Decision Support Unit report
DSU Report ^{PDF 227 KB} 10 October 2008
DSU specification form ^{PDF 67 KB} 10 October 2008
DSU addendum to report ^{PDF 43 KB} 10 October 2008
Rogers ^{PDF 27 KB} 10 October 2008

Breast cancer (advanced or metastatic) - lapatinib (appraisal consultation)

Breast cancer (advanced or metastatic) - lapatinib: evaluation report
Breast cancer (advanced or metastatic) - lapatinib: Evidence Review Group report ^{PDF 576 KB} 03 July 2008
Breast cancer (advanced or metastatic) - lapatinib: Non-manufacturer submissions
Breakthrough Breast Cancer, Breast Cancer Campaign, Breast Cancer Care, and Cancerbackup (joint submission)
Breast Cancer Campaign supporting letter ^{PDF 60 KB} 03 July 2008
Breast Cancer Care supporting letter ^{PDF 23 KB} 03 July 2008
Cancerbackup supporting letter ^{PDF 19 KB} 03 July 2008
Breast cancer (advanced or metastatic) - lapatinib: Pre-meeting briefing ^{PDF 162 KB} 03 July 2008
British Association of Surgical Oncology ^{PDF 479 KB} 03 July 2008
NCRI Breast Group, Joint Collegiate Council for Oncology, Royal College of Radiologists, Association of Clinical Pathologists and Royal College of Physicians (joint submission) ^{PDF 38 KB} 03 July 2008
Royal College of General Practitioners ^{PDF 12 KB} 03 July 2008
Royal College of Pathologists ^{PDF 11 KB} 03 July 2008
GlaxoSmithKline ^{PDF 1018 KB} 01 July 2100
Expert written personal statements
Rogers ^{PDF 22 KB} 01 July 2100
Sinnett ^{PDF 22 KB} 01 July 2100
Wilby ^{PDF 191 KB} 01 July 2100

Update on status of lapatinib for the treatment of previously treated women with advanced, metastatic or recurrent breast cancer

Update on status of lapatinib for the treatment of previously treated women with advanced, metastatic or recurrent breast cancer ^{PDF 13 KB} 26 March 2008

Breast cancer (advanced or metastatic) - lapatinib: final scope

Breast cancer (advanced or metastatic) - lapatinib: final scope ^{PDF 40 KB} 14 February 2007

Breast cancer (advanced or metastatic) - lapatinib: response to consultee and commentators comments on the scope

Breast cancer (advanced or metastatic) - lapatinib: final scope ^{PDF 40 KB} 14 February 2007

Breast cancer (advanced or metastatic) - lapatinib: response to consultee and commentators comments on the matrix

Breast cancer (advanced or metastatic) - lapatinib: response to consultee and commentators comments on the matrix ^{PDF 21 KB} 14 February 2007

Breast cancer (advanced or metastatic) - lapatinib: pre-referral scope

Breast cancer (advanced or metastatic) - lapatinib: final scope ^{PDF 40 KB} 14 February 2007

Breast cancer (advanced or metastatic) - lapatinib: pre-referral matrix

Breast cancer (advanced or metastatic) - lapatinib: pre-referral matrix ^{PDF 42 KB} 14 February 2007