Raloxifene for the primary prevention of osteoporotic fragility fractures in postmenopausal women

TA160 Osteoporosis - primary prevention: Review Decision - March 2014 information

TA161 Osteoporosis - secondary prevention including strontium ranelate: Appendix B - GE decision paper - March 2014

TA161 Osteoporosis - secondary prevention including strontium ranelate: Appendix B - GE decision paper - March 2014 (PDF 309 KB)

TA160 Osteoporosis - primary prevention: review proposal - August 2013  information

TA160 Technologies for the primary and secondary prevention of osteoporotic fractures: Appendix A - provisional matrix of stakeholders

TA160 Technologies for the primary and secondary prevention of osteoporotic fractures: Appendix A - provisional matrix of stakeholders (PDF 102 KB)

TA160 Technologies for the primary and secondary prevention of osteoporotic fractures: Appendix B - proposal paper presented to the Institute's Guidance Executive

TA160 Technologies for the primary and secondary prevention of osteoporotic fractures: Appendix B - proposal paper presented to the Institute's Guidance Executive (PDF 1.02 MB)

TA160 Technologies for the primary and secondary prevention of osteoporotic fractures: Appendix C - Decision Support Unit Report

TA160 Technologies for the primary and secondary prevention of osteoporotic fractures: Appendix C - Decision Support Unit Report (PDF 560 KB)

TA160 Osteoporosis - primary prevention: review update - August 2012 information

Osteoporosis - primary prevention: final appraisal determination 3 information

Osteoporosis - primary prevention: final appraisal determination guidance

Osteoporosis - primary prevention: final appraisal determination guidance (PDF 363 KB)

Osteoporosis - primary prevention: Court Order, Memorandum of Understanding, background information and matrix of stakeholders for this reconsideration

Osteoporosis - primary prevention: Court Order and Memorandum of Understanding

Osteoporosis - primary prevention: Court Order and Memorandum of Understanding (PDF 367 KB)

Osteoporosis - primary prevention: background to the reconsideration of strontium ranelate

Osteoporosis - primary prevention: background to the reconsideration of strontium ranelate (PDF 27 KB)

Osteoporosis - primary prevention: history of the appraisal development

Osteoporosis - primary prevention: history of the appraisal development (PDF 31 KB)

Osteoporosis - primary prevention: guidance for the committee on the reconsideration of strontium ranelate

Osteoporosis - primary prevention: guidance for the committee on the reconsideration of strontium ranelate (PDF 32 KB)

Osteoporosis - primary prevention: final matrix of Consultees and Commentators for the reconsideration of strontium ranelate

Osteoporosis - primary prevention: final matrix of Consultees and Commentators for the reconsideration of strontium ranelate (PDF 35 KB)

Osteoporosis - primary prevention: NICE Statement of Reasons

Osteoporosis - primary prevention: NICE Statement of Reasons (PDF 37 KB)

Osteoporosis - primary prevention: Servier response to the NICE Statement of Reasons and clarification on Servier response

Osteoporosis - primary prevention: Servier response to the NICE Statement of Reasons

Osteoporosis - primary prevention: Servier response to the NICE Statement of Reasons (PDF 104 KB)

Osteoporosis - primary prevention: Appendices A and B to Servier response

Osteoporosis - primary prevention: Appendices A and B to Servier response (PDF 418 KB)

Osteoporosis - primary prevention: NICE request to Servier for clarification of their response

Osteoporosis - primary prevention: NICE request to Servier for clarification of their response (PDF 60 KB)

Osteoporosis - primary prevention: Servier response to NICE's request for clarification

Osteoporosis - primary prevention: Servier response to NICE's request for clarification (PDF 92 KB)

Osteoporosis - primary prevention: Appendix 1 of Servier response to clarification request

Osteoporosis - primary prevention: Appendix 1 of Servier response to clarification request (PDF 2.35 MB)

Osteoporosis - primary prevention: Decision Support Unit (DSU) report

Osteoporosis - primary prevention: DSU specification

Osteoporosis - primary prevention: DSU specification (PDF 56 KB)

Osteoporosis - primary prevention: DSU report

Osteoporosis - primary prevention: DSU report (PDF 71 KB)

Osteoporosis - primary prevention: Servier response to Decision Support Unit report

Osteoporosis - primary prevention: final appraisal determination 2 information

Osteoporosis - primary prevention: final appraisal determination 2

Osteoporosis - primary prevention: final appraisal determination 2 (PDF 303 KB)

Overview

Osteoporosis - secondary prevention including strontium ranelate: overview (PDF 161 KB)

Court judgment

Osteoporosis - secondary prevention including strontium ranelate: court judgment

Osteoporosis - secondary prevention including strontium ranelate: court judgment (PDF 313 KB)

Osteoporosis - secondary prevention including strontium ranelate: court order

Osteoporosis - secondary prevention including strontium ranelate: court order (PDF 237 KB)

Comments on the economic model

Bone Research Society

Bone Research Society (PDF 228 KB)

National Osteoporosis Society

National Osteoporosis Society (PDF 45 KB)

Servier

Servier (PDF 92 KB)

Society for Endocrinology

Society for Endocrinology (PDF 10 KB)

Decision Support Unit report

DSU specification

DSU specification (PDF 29 KB)

DSU report

DSU report (PDF 692 KB)

Comments on the Decision Support Unit report

Bone Research Society

Bone Research Society (PDF 22 KB)

British Society for Rheumatology

British Society for Rheumatology (PDF 34 KB)

Department of Health

Department of Health (PDF 11 KB)

National Osteoporosis Society

National Osteoporosis Society (PDF 73 KB)

Servier

Osteoporosis - primary prevention: final appeal panel decision

Osteoporosis - primary and secondary prevention: appeal announcement information

Servier Laboratories Ltd

Appeals received

Appeals received (PDF 155 KB)

Initial scrutiny letter

Initial scrutiny letter (PDF 103 KB)

Response to initial scrutiny letter

Response to initial scrutiny letter (PDF 59 KB)

Scrutiny letter

Scrutiny letter (PDF 49 KB)

Response to scrutiny letter

Response to scrutiny letter (PDF 98 KB)

Final scrutiny letter

Osteoporosis - primary prevention: final appraisal determination

Osteoporosis - primary prevention: final appraisal determination information

Osteoporosis - primary prevention: final appraisal determination (PDF 281 KB)

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

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

Response to consultee, commentator and public comments on the ACD and comments from website consultation (PDF 507 KB)

Addendum to the Assessment Report information

Addendum to the Assessment Report (PDF 56 KB)

Consultee and commentator comments on the ACD

The Alliance for Better Bone Health (Proctor and Gamble in association with Aventis)

The Alliance for Better Bone Health (Proctor and Gamble in association with Aventis) (PDF 247 KB)

Bone Research Society

Bone Research Society (PDF 96 KB)

British Society for Rheumatology

British Society for Rheumatology (PDF 120 KB)

Department of Health

Department of Health (PDF 12 KB)

Eli Lilly and Company

Eli Lilly and Company (PDF 21 KB)

National Osteoporosis Society

National Osteoporosis Society (PDF 50 KB)

NHS Quality Improvement Scotland

NHS Quality Improvement Scotland (PDF 111 KB)

Novartis

Novartis (PDF 28 KB)

Roche

Roche (PDF 27 KB)

Royal College of Nursing

Royal College of Nursing (PDF 23 KB)

Royal College of Pathologists

Royal College of Pathologists (PDF 20 KB)

Royal College of Physicians

Royal College of Physicians (PDF 20 KB)

Servier

Servier (PDF 667 KB)

Society for Endocrinology

Society for Endocrinology (PDF 146 KB)

Southwark PCT

Southwark PCT (PDF 13 KB)

Comments from the NICE Guideline Development Group

Comments from the NICE Guideline Development Group (PDF 143 KB)

Expert comments on the ACD

Compston

Compston (PDF 18 KB)

Francis

Francis (PDF 28 KB)

Selby

Osteoporosis - primary prevention: appraisal consultation (March 2008)

Osteoporosis - primary prevention: appraisal consultation document (March 2008) information

Evaluation report (March 2008)

Comments or observations from consultees and commentators

Society for Endocrinology

Society for Endocrinology (PDF 74 KB)

Servier

Servier (PDF 173 KB)

National Osteoporosis Society

National Osteoporosis Society (PDF 93 KB)

Guideline Development Group

Guideline Development Group (PDF 55 KB)

Letter from NICE regarding additional comments

Letter from NICE regarding additional comments (PDF 24 KB)

Critique of evidence put forward by Servier suggesting an association between acid-suppressive medication and fracture risk

Critique of evidence put forward by Servier suggesting an association between acid-suppressive medication and fracture risk (PDF 93 KB)

Analyses of cost-effective BMD scanning and treatment strategies for generic alendronate, and the cost-effectiveness of risedronate and strontium ranelate in those people who would be treated with generic alendronate

Analyses of cost-effective BMD scanning and treatment strategies for generic alendronate, and the cost-effectiveness of risedronate and strontium ranelate in those people who would be treated with generic alendronate (PDF 204 KB)

Specifications issued to the Decision Support Unit

Osteoporosis - primary prevention: decision support unit specification

Osteoporosis - primary prevention: appraisal update to consultees and commentators

Osteoporosis - primary prevention: appeal panel decision letter

Osteoporosis - primary prevention: appeal documents

Alliance for Better Bone Health and sanofi-aventis

ABBH response to scrutiny letter

sanofi-aventis - July 2007

sanofi-aventis - July 2007 (PDF 1.22 MB)

sanofi-aventis - September 2007

sanofi-aventis - September 2007 (PDF 130 KB)

Appeals received

Alliance for Better Bone Health - secondary prevention

Alliance for Better Bone Health - secondary prevention (PDF 1.31 MB)

Alliance for Better Bone Health - primary prevention

Alliance for Better Bone Health - primary prevention (PDF 1.22 MB)

Final scrutiny letter

Final scrutiny letter (PDF 19 KB)

Initial scrutiny letter

Initial scrutiny letter (PDF 57 KB)

Servier

Final scrutiny letter

Final scrutiny letter (PDF 21 KB)

Servier response to scrutiny letter

Servier response to scrutiny letter (PDF 218 KB)

Initial scrutiny letter

Initial scrutiny letter (PDF 24 KB)

Appeals received

Appeals received (PDF 201 KB)

NOS/SfE/BRS/BSR

Final scrutiny letter

Final scrutiny letter (PDF 101 KB)

NOS response to scrutiny letter

NOS response to scrutiny letter (PDF 375 KB)

Initial scrutiny letter

Initial scrutiny letter (PDF 115 KB)

Appeals received

Osteoporosis - primary prevention: details of appeal announced to consultees and commentators information

Osteoporosis - primary and secondary prevention: final appraisal determination information

Osteoporosis - primary prevention (final appraisal determination)

Osteoporosis - primary prevention (final appraisal determination) (PDF 161 KB)

Response to consultee, commentator and public comments on the 2007 Appraisal Consultation Document (ACD) (Primary Prevention)

Response to consultee, commentator and public comments on the 2007 Appraisal Consultation Document (ACD) (Primary Prevention) (PDF 620 KB)

Osteoporosis - secondary prevention (final appraisal determination)

Osteoporosis - secondary prevention (final appraisal determination) (PDF 172 KB)

Response to consultee, commentator and public comments on the 2007 Appraisal Consultation Document (ACD) (Secondary Prevention)

Response to consultee, commentator and public comments on the 2007 Appraisal Consultation Document (ACD) (Secondary Prevention) (PDF 286 KB)

Responses to summarised comments from consultees, commentators and the public on the 2005 Appraisal Consultation Document (ACD)

Osteoporosis - primary prevention: appraisal consultation document and evaluation report (February 2007)

Osteoporosis - primary prevention: Appraisal consultation document information

Evaluation report (February 2007)

Response from Committee to GDG comments on ACDs (September 2006) for Osteoporosis - Primary and Secondary

Response from Committee to GDG comments on ACDs (September 2006) for Osteoporosis - Primary and Secondary (PDF 260 KB)

Additional Analyses - Analyses of cost-effective BMD scanning and treatment strategies for generic alendronate, risedronate, strontium ranelate, raloxifene and teriparatide following corrections to the methodology associated with lower efficacy in some risk factors

Additional Analyses - Analyses of cost-effective BMD scanning and treatment strategies for generic alendronate, risedronate, strontium ranelate, raloxifene and teriparatide following corrections to the methodology associated with lower efficacy in some risk factors (PDF 250 KB)

Outcome from November 2006 Committee Meeting discussion on alendronate, etidronate, risedronate, raloxifene and strontium ranelate for the primary prevention of osteoporotic fragility fractures in postmenopausal women

Outcome from November 2006 Committee Meeting discussion on alendronate, etidronate, risedronate, raloxifene and strontium ranelate for the primary prevention of osteoporotic fragility fractures in postmenopausal women (PDF 996 KB)

Table of Consultee and Commentator Comments on ACDs (September 2006) for Osteoporosis - Primary and the Institute's response

Table of Consultee and Commentator Comments on ACDs (September 2006) for Osteoporosis - Primary and the Institute's response (PDF 909 KB)

Table of Non-Consultee and Commentator Comments on ACD (2006) for Osteoporosis - Primary

Table of Non-Consultee and Commentator Comments on ACD (2006) for Osteoporosis - Primary (PDF 309 KB)

Table of Consultee and Commentator Comments on ACDs (September 2006) for Osteoporosis - Secondary and the Institute's response

Table of Consultee and Commentator Comments on ACDs (September 2006) for Osteoporosis - Secondary and the Institute's response (PDF 206 KB)

Table of Non-Consultee and Commentator Comments on ACD (2006) for Osteoporosis - Secondary

Table of Non-Consultee and Commentator Comments on ACD (2006) for Osteoporosis - Secondary (PDF 81 KB)

Comments received from non- consultees and commentators and the Institute's response on the ACD (2006) - Primary

Comments received from non- consultees and commentators and the Institute's response on the ACD (2006) - Primary (PDF 391 KB)

Comments received from non-consultees and commentators and the Institute's response on the ACD (2006) - Secondary

Comments received from non-consultees and commentators and the Institute's response on the ACD (2006) - Secondary (PDF 101 KB)

Osteoporosis - primary prevention: Appraisal consultation document (September 2006 - for reference only) information

Osteoporosis - primary prevention: letter sent to consultees and commentators regarding the delay to the release of the FAD

Osteoporosis - primary prevention: appraisal consultation document and evaluation report (September 2006)

Appraisal Consultation Document: Osteoporosis - primary prevention (Sept 2005 - for reference only)

Appraisal Consultation Document: Osteoporosis - primary prevention (Sept 2005 - for reference only) (PDF 207 KB)

Evaluation report (September 2006)

Summary of web comments on the ACDs (September 2005 - for reference only: Not for consultation)

Summary of web comments on the first secondary ACD (Sep 05 - for reference only)

Summary of web comments on the first secondary ACD (Sep 05 - for reference only) (PDF 57 KB)

Summary of web comments on the first primary ACD (Sep 05 - for reference only)

Summary of web comments on the first primary ACD (Sep 05 - for reference only) (PDF 88 KB)

Consultee and Commentator comments on ACDs (September 2005 - for reference only: Not for consultation)

Royal College of Pathologists (comment on primary: reference only)

Royal College of Pathologists (comment on primary: reference only) (PDF 24 KB)

Society of Radiographers

Society of Radiographers (PDF 24 KB)

Society for Endocrinology

Society for Endocrinology (PDF 27 KB)

ScHARR

ScHARR (PDF 54 KB)

Selby - Clinical Expert

Selby - Clinical Expert (PDF 49 KB)

Royal College of Pathologists (comment on secondary)

Royal College of Pathologists (comment on secondary) (PDF 25 KB)

Royal College of Pathologists (comment on primary)

Royal College of Pathologists (comment on primary) (PDF 24 KB)

Royal College of Physicians (comment on secondary)

Royal College of Physicians (comment on secondary) (PDF 37 KB)

Royal College of Physicians (letter 2)

Royal College of Physicians (letter 2) (PDF 46 KB)

Royal College of Physicians (letter 1)

Royal College of Physicians (letter 1) (PDF 46 KB)

Royal National Orthapaedic Hospital (Bone Research Society)

Royal National Orthapaedic Hospital (Bone Research Society) (PDF 32 KB)

Royal College of Nursing

Royal College of Nursing (PDF 34 KB)

Royal College of General Practitioners (comment 2)

Royal College of General Practitioners (comment 2) (PDF 17 KB)

Royal College of General Practitioners (comment 1)

Royal College of General Practitioners (comment 1) (PDF 22 KB)

Novartis

Novartis (PDF 49 KB)

National Osteoporosis Society

National Osteoporosis Society (PDF 58 KB)

Moniz - Clinical Expert

Moniz - Clinical Expert (PDF 46 KB)

Merck Sharp & Dohme

Merck Sharp & Dohme (PDF 50 KB)

Juliet Compston

Juliet Compston (PDF 19 KB)

Franks - Patient Expert

Franks - Patient Expert (PDF 19 KB)

Francis - Clinical Expert

Francis - Clinical Expert (PDF 27 KB)

Eli Lilly

Eli Lilly (PDF 26 KB)

Guideline Development Group

Guideline Development Group (PDF 83 KB)

British Society for Rheumatology

British Society for Rheumatology (PDF 34 KB)

Additional information tabled

Summarised results for self-identifying women (using the 30K threshold)

Summarised results for self-identifying women (using the 30K threshold) (PDF 40 KB)

Additional analyses requested by the committee

Additional analyses requested by the committee (PDF 63 KB)

Updated analyses of change in price of generic alendronate

Updated analyses of change in price of generic alendronate (PDF 283 KB)

Decision Support Unit economic evaluation and systematic review

DSU systematic review of adverse effects and persistence

DSU systematic review of adverse effects and persistence (PDF 657 KB)

DSU economic evaluation of pooled alendronate and risedronate compared with strontium ranelate, raloxifene, etidronate and teriparatide

DSU economic evaluation of pooled alendronate and risedronate compared with strontium ranelate, raloxifene, etidronate and teriparatide (PDF 581 KB)

Consultee and Commentator comments on the Decision Support Unit economic evaluation and systematic review

Society for Endocrinology

Society for Endocrinology (PDF 28 KB)

Servier

Servier (PDF 137 KB)

Selby - Clinical Expert

Selby - Clinical Expert (PDF 28 KB)

Royal College of Nursing

Royal College of Nursing (PDF 18 KB)

Royal College of General Practitioners

Royal College of General Practitioners (PDF 35 KB)

Novartis Pharmaceuticals UK

Novartis Pharmaceuticals UK (PDF 37 KB)

NHS Quality Improvement Scotland

NHS Quality Improvement Scotland (PDF 35 KB)

National Osteoporosis Society

National Osteoporosis Society (PDF 217 KB)

Merck Sharp & Dohme

Merck Sharp & Dohme (PDF 106 KB)

Guideline Development Group - Response 2

Guideline Development Group - Response 2 (PDF 20 KB)

Guideline Development Group - Response 1

Guideline Development Group - Response 1 (PDF 209 KB)

Roger Francis

Roger Francis (PDF 18 KB)

Eli Lilly

Eli Lilly (PDF 24 KB)

Compston - Clinical Expert

Compston - Clinical Expert (PDF 20 KB)

Alliance for Better Bone Health

Alliance for Better Bone Health (PDF 164 KB)

Osteoporosis - primary prevention: decision support unit project specification

Osteoporosis - primary prevention: decision support unit project specification letter

Osteoporosis - primary prevention: letter to consultees and commentators regarding additional work

Osteoporosis - primary prevention: appraisal consultation document and evaluation report (September 2005)

Appraisal Consultation Document: Alendronate, etidronate, risedronate, raloxifene and strontium ranelate for the primary prevention of osteoporotic fragility fractures in postmenopausal women information

Osteoporosis - primary and secondary prevention: Evaluation report (September 2005)

Overview

Overview (PDF 239 KB)

Clinical effectiveness from DSU report

Clinical effectiveness from DSU report (PDF 147 KB)

Literature Review economic models

Literature Review economic models (PDF 39 KB)

Response to consultee and commentator comments on the Assessment Report

Osteoporosis - primary prevention: letter to consultees and commentators regarding ongoing development

Osteoporosis - primary prevention: appraisal consultation document and reports (December 2003)

Appraisal Consultation Document: Technologies for the prevention and treatment of osteoporosis and prevention of osteoporotic fractures in postmenopausal women information