Bevacizumab (first-line), sorafenib (first- and second-line), sunitinib (second-line) and temsirolimus (first-line) for the treatment of advanced and/or metastatic renal cell carcinoma

Renal cell carcinoma: review decision - December 2014 information

Appendix A: decision paper presented to the Institute's Guidance Executive

Appendix A: decision paper presented to the Institute's Guidance Executive (PDF 62 KB)

Appendix A: decision paper presented to the Institute's Guidance Executive

Appendix A: decision paper presented to the Institute's Guidance Executive (PDF 62 KB)

TA178 Renal cell carcinoma: review decision - May 2012 information

TA178 Renal cell carcinoma: review proposal - March 2012 information

Appendix A: provisional matrix of stakeholders

Appendix A: provisional matrix of stakeholders (MSWord 62 KB)

Appendix B: proposal paper presented to the Institute's guidance executive

Appendix B: proposal paper presented to the Institute's guidance executive (PDF 179 KB)

Renal cell carcinoma - bevacizumab, sorafenib, sunitinib and temsirolimus: appeal information

Renal cell carcinoma - bevacizumab, sorafenib, sunitinib and temsirolimus: notice of appeal hearing information

Renal cell carcinoma - bevacizumab, sorafenib, sunitinib and temsirolimus: appeal announcement information

Roche

Roche: appeals received

Roche: appeals received (PDF 74 KB)

Roche: initial scrutiny letter

Roche: initial scrutiny letter (PDF 24 KB)

Roche: response to scrutiny letter

Roche: response to scrutiny letter (PDF 47 KB)

Roche: final scrutiny letter

Roche: final scrutiny letter (PDF 15 KB)

Wyeth

Wyeth: appeals received

Wyeth: appeals received (PDF 89 KB)

Wyeth: initial scrutiny letter

Wyeth: initial scrutiny letter (PDF 25 KB)

Wyeth: response to scrutiny letter

Wyeth: response to scrutiny letter (PDF 79 KB)

Wyeth: final scrutiny letter

Wyeth: final scrutiny letter (PDF 18 KB)

Wyeth: clarification letter

Wyeth: clarification letter (PDF 60 KB)

Wyeth: response to clarification letter

Wyeth: response to clarification letter (PDF 14 KB)

James Whale Fund for Kidney Cancer

James Whale Fund for Kidney Cancer: appeals received

James Whale Fund for Kidney Cancer: appeals received (PDF 66 KB)

James Whale Fund for Kidney Cancer: initial scrutiny letter

James Whale Fund for Kidney Cancer: initial scrutiny letter (PDF 26 KB)

James Whale Fund for Kidney Cancer: response to scrutiny letter

James Whale Fund for Kidney Cancer: response to scrutiny letter (PDF 105 KB)

James Whale Fund for Kidney Cancer: final scrutiny letter

James Whale Fund for Kidney Cancer: final scrutiny letter (PDF 16 KB)

Rarer Cancers Forum and Macmillan Cancer Support

Rarer Cancers Forum and Macmillan Cancer Support: appeals received

Rarer Cancers Forum and Macmillan Cancer Support: appeals received (PDF 46 KB)

Rarer Cancers Forum and Macmillan Cancer Support: initial scrutiny letter

Rarer Cancers Forum and Macmillan Cancer Support: initial scrutiny letter (PDF 27 KB)

Rarer Cancers Forum and Macmillan Cancer Support: response to scrutiny letter

Rarer Cancers Forum and Macmillan Cancer Support: response to scrutiny letter (PDF 17 KB)

Rarer Cancers Forum and Macmillan Cancer Support: final scrutiny letter

Rarer Cancers Forum and Macmillan Cancer Support: final scrutiny letter (PDF 18 KB)

Renal cell carcinoma: appeal decision

Renal cell carcinoma - bevacizumab, sorafenib, sunitinib and temsirolimus: final appraisal determination information

Renal cell carcinoma - bevacizumab, sorafenib, sunitinib and temsirolimus: final appraisal determination

Renal cell carcinoma - bevacizumab, sorafenib, sunitinib and temsirolimus: final appraisal determination (PDF 254 KB)

Response to consultee, commentator and public comments on the first ACD and comments from website consultation

Response to consultee, commentator and public comments on the first ACD and comments from website consultation (PDF 286 KB)

Response to consultee, commentator and public comments on the second ACD and comments from website consultation

Response to consultee, commentator and public comments on the second ACD and comments from website consultation (PDF 441 KB)

Consultee and commentator comments on the ACD

Bayer

Bayer (PDF 45 KB)

Department of Health

Department of Health (PDF 7.8 KB)

Macmillan and Rarer Cancers forum

Macmillan and Rarer Cancers forum (PDF 54 KB)

NHS Quality Improvement Scotland

NHS Quality Improvement Scotland (PDF 9.9 KB)

Roche

Roche (PDF 119 KB)

Royal College of Nursing

Royal College of Nursing (PDF 19 KB)

Wyeth

Wyeth (PDF 122 KB)

Expert comments on the ACD

David Chao

David Chao (PDF 11 KB)

Bill Savage

Sunitinib for the first-line treatment of advanced and/or metastatic renal cell carcinoma: final appraisal determination information

Sunitinib for the first-line treatment of advanced and/or metastatic renal cell carcinoma: final appraisal determination information

Sunitinib for the first-line treatment of advanced and/or metastatic renal cell carcinoma: final appraisal determination (PDF 155 KB)

Update on renal cell carcinoma drugs

Response to consultee, commentator and public comments on the Appraisal Consultation Document (ACD)

Renal cell carcinoma - bevacizumab, sorafenib, sunitinib and temsirolimus: appraisal consultation 2

Renal cell carcinoma - bevacizumab, sorafenib, sunitinib and temsirolimus: appraisal consultation document 2 information

Renal cell carcinoma - bevacizumab, sorafenib, sunitinib and temsirolimus: evaluation report

Consultee and commentator comments on the first ACD

Bayer

Bayer (PDF 29 KB)

British Uro-oncology Group (BUG)

British Uro-oncology Group (BUG) (PDF 70 KB)

Cancer Research UK

Cancer Research UK (PDF 39 KB)

Kidney cancer UK/James Whale fund for kidney cancer

Kidney cancer UK/James Whale fund for kidney cancer (PDF 70 KB)

Macmillan and Rarer Cancers Forum

Macmillan and Rarer Cancers Forum (PDF 42 KB)

National Kidney Federation

National Kidney Federation (PDF 26 KB)

NHS Cambridgeshire

NHS Cambridgeshire (PDF 29 KB)

NHS Quality Improvement Scotland

NHS Quality Improvement Scotland (PDF 17 KB)

Novartis

Novartis (PDF 20 KB)

Pfizer

Pfizer (PDF 331 KB)

Royal College of Physicians

Royal College of Physicians (PDF 46 KB)

Roche

Roche (PDF 48 KB)

Welsh Assembly Government

Welsh Assembly Government (PDF 54 KB)

Wyeth

Wyeth (PDF 85 KB)

Wyeth 2

Wyeth 2 (PDF 22 KB)

External expert comments on the appraisal consultation document

Dr David Chao

Dr David Chao (PDF 24 KB)

Patient expert

Patient expert (PDF 17 KB)

Bill Savage

Bill Savage (PDF 20 KB)

Report to the Appraisal Committee summarising comments (received by letter and email) on the appraisal consultation document - prepared by the Patient and Public Involvement Programme (PPIP) and Enquiry Handling team, September 2008

Report to the Appraisal Committee summarising comments (received by letter and email) on the appraisal consultation document - prepared by the Patient and Public Involvement Programme (PPIP) and Enquiry Handling team, September 2008 (PDF 1014 KB)

Bevacizumab, sorafenib tosylate, sunitinib and temsirolimus for renal cell carcinoma: a systematic and economic evaluation - addendum to the report submitted on 2 May 2008 - prepared by Peninsula Technology Assessment Group (PenTAG), University of Exeter

Bevacizumab, sorafenib tosylate, sunitinib and temsirolimus for renal cell carcinoma: a systematic and economic evaluation - addendum to the report submitted on 2 May 2008 - prepared by Peninsula Technology Assessment Group (PenTAG), University of Exeter (PDF 156 KB)

Extra work on bevacizumab, sorafenib tosylate, sunitinib and temsirolimus for renal cell carcinoma - prepared by Decision Support Unit

Extra work on bevacizumab, sorafenib tosylate, sunitinib and temsirolimus for renal cell carcinoma - prepared by Decision Support Unit (PDF 133 KB)

First appraisal consultation document

First appraisal consultation document (PDF 233 KB)

Response from the Assessment Group to comments on the Assessment report

Response from the Assessment Group to comments on the Assessment report (PDF 210 KB)

Consultee and commentator comments on the extra work consultation

Bayer

Bayer (PDF 50 KB)

British Uro-oncology Group

British Uro-oncology Group (PDF 93 KB)

Novartis

Novartis (PDF 7.7 KB)

Pfizer

Pfizer (PDF 35 KB)

Roche

Roche (PDF 185 KB)

Royal College of Nursing

Royal College of Nursing (PDF 20 KB)

Royal College of Physicians

Royal College of Physicians (PDF 39 KB)

Wyeth

Wyeth (PDF 59 KB)

Extra work done by the Assessment Group (PenTAG) and the Decision Support Unit (DSU) on new data received

Extra work done by the Assessment Group (PenTAG) and the Decision Support Unit (DSU) on new data received (PDF 711 KB)

External expert comments received on the extra work consultation

Pat Hanlon

Pat Hanlon (PDF 15 KB)

Dr David Chao

Dr David Chao (PDF 17 KB)

Bill Savage

Bill Savage (PDF 22 KB)

Response from the DSU to comments on the extra work consultation

Response from the DSU to comments on the extra work consultation (PDF 16 KB)

Revised analyses submitted by Bayer incorporating the sorafenib patient access scheme and new price of sorafenib

Revised analyses submitted by Bayer incorporating the sorafenib patient access scheme and new price of sorafenib (PDF 362 KB)

Extra work done by the DSU on the revised analyses submitted by Bayer

Extra work done by the DSU on the revised analyses submitted by Bayer (PDF 54 KB)

Department of Health approval for the Technology Appraisal Committee to consider patient access schemes submitted for sorafenib and sunitinib

Department of Health approval of sunitinib patient access scheme

Department of Health approval of sunitinib patient access scheme (PDF 25 KB)

Department of Health approval of patient access scheme for sorafenib

Department of Health approval of patient access scheme for sorafenib (PDF 24 KB)

Consultee and commentator comments on the executable economic model

Pfizer

Pfizer (PDF 9.2 KB)

Bayer

Bayer (PDF 17 KB)

DSU addendum to the review of Roche's request for parameter changes

DSU addendum to the review of Roche's request for parameter changes (PDF 17 KB)

Addendum to the pre-meeting briefing: end of life - a quantitative exploration

Renal cell carcinoma - bevacizumab, sorafenib, sunitinib and temsirolimus: letter to consultees and commentators

Renal cell carcinoma - bevacizumab, sorafenib, sunitinib and temsirolimus: appraisal consultation

Renal cell carcinoma - bevacizumab, sorafenib, sunitinib and temsirolimus: appraisal consultation document information

Renal cell carcinoma - bevacizumab, sorafenib, sunitinib and temsirolimus: evaluation report

Renal cell carcinoma - sunitinib: assessment report

Renal cell carcinoma - sunitinib: assessment report (PDF 1.82 MB)

Overview

Overview (PDF 353 KB)

Renal cell carcinoma - bevacizumab, sorafenib, sunitinib and temsirolimus: consultee and commentator comments on the assessment report

Bayer

Bayer (PDF 13 KB)

Kidney Research UK

Kidney Research UK (PDF 27 KB)

NHS Quality Improvement Scotland

NHS Quality Improvement Scotland (PDF 17 KB)

Pfizer

Pfizer (PDF 46 KB)

Pfizer 1

Pfizer 1 (PDF 128 KB)

Pfizer 2

Pfizer 2 (PDF 418 KB)

Roche

Roche (PDF 110 KB)

Royal College of Nursing

Royal College of Nursing (PDF 21 KB)

Royal College of Physicians

Royal College of Physicians (PDF 48 KB)

Wyeth

Wyeth (PDF 183 KB)

Renal cell carcinoma - bevacizumab, sorafenib, sunitinib and temsirolimus: non-manufacturer submission

Cancer Backup

Cancer Backup (PDF 50 KB)

National Kidney Federation

National Kidney Federation (PDF 99 KB)

Joint submission from Kidney Cancer UK and James Whale Fund for Kidney Cancer

Joint submission from Kidney Cancer UK and James Whale Fund for Kidney Cancer (PDF 48 KB)

Joint submission from NCRI Renal Clinical Studies Group/Royal College of Radiologists/Royal College of Physicians/Joint Collegiate Council for Oncology/Association of Cancer Physicians

Joint submission from NCRI Renal Clinical Studies Group/Royal College of Radiologists/Royal College of Physicians/Joint Collegiate Council for Oncology/Association of Cancer Physicians (PDF 69 KB)

Kidney Research UK

Kidney Research UK (PDF 27 KB)

Renal cell carcinoma - bevacizumab, sorafenib, sunitinib and temsirolimus: manufacturer submissions (executive summary only)

Bayer

Bayer (PDF 38 KB)

Pfizer

Pfizer (PDF 83 KB)

Pfizer - addendum to submission

Pfizer - addendum to submission (PDF 52 KB)

Roche

Roche (PDF 32 KB)

Wyeth

Wyeth (PDF 74 KB)

Renal cell carcinoma - bevacizumab, sorafenib, sunitinib and temsirolimus: expert written personal statements

Chao

Chao (PDF 22 KB)

Hanlon

Hanlon (PDF 21 KB)

Savage

Savage (PDF 38 KB)

Patient Expert Statement

Response to comments on pre referral remit and scope for STA sorafenib tosylate for advanced renal cell carcinoma

Response to comments on pre referral remit and scope for STA bevacizumab for metastatic renal cell carcinoma

Renal cell carcinoma - bevacizumab, sorafenib, sunitinib and temsirolimus: final matrix

Renal cell carcinoma - bevacizumab, sorafenib, sunitinib and temsirolimus: final scope

Renal cell carcinoma - bevacizumab, sorafenib, sunitinib and temsirolimus: response to consultee and commentators comments on the scope

Renal cell carcinoma - bevacizumab, sarofenib and sunitinib: draft matrix

Renal cell carcinoma - bevacizumab, sarofenib and sunitinib: draft scope

Renal cell carcinoma - bevacizumab, sorafenib, sunitinib and temsirolimus: final protocol