Multiple myeloma - bortezomib: review decision - November 2012 information
History
Documents created during the development process.
Background information
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Appendix A: GE decision paper
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Multiple myeloma - bortezomib: review proposal - March 2012 information
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Appendix A: provisional matrix of stakeholders
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Appendix B: proposal paper presented to the Institute's Guidance Executive
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Appendix B: proposal paper presented to the Institute's Guidance Executive (PDF 148 KB)
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TA129 Multiple myeloma - bortezomib: review update - November 2011 information
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TA129 Multiple myeloma - bortezomib: review update - January 2011 information
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Bortezomib monotherapy for relapsed multiple myeloma (final appraisal determination)
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Bortezomib monotherapy for relapsed multiple myeloma (final appraisal determination)
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Bortezomib monotherapy for relapsed multiple myeloma (final appraisal determination) information
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Bortezomib monotherapy for relapsed multiple myeloma (final appraisal determination) (PDF 1.23 MB)
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Response to comments received from consultees, commentators and the public on the post appeal Appraisal Consultation Document (May 2007 ACD)
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Consultee and commentator comments on the ACD
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Manufacturer/sponsor submission from Janssen-Cilag
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Manufacturer/sponsor submission from Janssen-Cilag (PDF 345 KB)
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Cancer Network Pharmacists Forum and British Oncology Pharmacy (joint comments)
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Cancer Network Pharmacists Forum and British Oncology Pharmacy (joint comments) (PDF 191 KB)
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Myeloma UK
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RCN
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RCP
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UK Myeloma Forum, the British Society for Haematology and the RC of Pathologists
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UK Myeloma Forum, the British Society for Haematology and the RC of Pathologists (PDF 77 KB)
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Commentator - DHSSPSNI
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Commentator - Department of Health
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Professor Gareth Morgan
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Supporting letter confirming the Velcade response scheme - Department of Health
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Supporting letter confirming the Velcade response scheme - Department of Health (PDF 21 KB)
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Supporting letter confirming the Velcade response scheme - Janssen Cilag
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Supporting letter confirming the Velcade response scheme - Janssen Cilag (PDF 34 KB)
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Supporting letter confirming the Velcade response scheme - WAG
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Supporting letter confirming the Velcade response scheme - WAG (PDF 26 KB)
Multiple myeloma - bortezomib: appraisal consultation
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Multiple myeloma - bortezomib: appraisal consultation
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Multiple myeloma - bortezomib: appraisal consultation document information
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Multiple myeloma - bortezomib: evaluation report
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Additional analysis (post-appeal) from Ortho Biotech
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Additional analysis (post-appeal) from Ortho Biotech (PDF 184 KB)
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Department of Health response to responder scheme
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Department of Health response to responder scheme (PDF 16 KB)
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Department of Health summary of responder scheme
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Department of Health summary of responder scheme (PDF 17 KB)
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Welsh Assembly Government response to responder scheme
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Welsh Assembly Government response to responder scheme (PDF 35 KB)
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Janssen-Cilag - Issues for clarification
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Further clarification
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Table from Janssen-Cilag
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Comparative results from Jansen-Cilag
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Incremental and Pairwise analysis (prepared by Technical Lead and Technical Adviser)
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Incremental and Pairwise analysis (prepared by Technical Lead and Technical Adviser) (PDF 93 KB)
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Additional expert statements detailing response to the request made by the Appeal Panel in terms of the three scenarios outlined in the Appeal Panel Decision
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Cavenagh
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Jackson
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Jago
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Morgan
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Low
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Letter sent to consultees and commentators updating them on the status of the appraisal
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Letter sent to consultees and commentators updating them on the status of the appraisal
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Letter sent to consultees and commentators updating them on the status of the appraisal (PDF 25 KB)
Letter to Department of Health following Appeal Panel decision
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Letter to Department of Health following Appeal Panel decision
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Letter to Department of Health following Appeal Panel decision (PDF 37 KB)
Letter to consultees and commentators requesting views on unlicensed use
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Letter to consultees and commentators requesting views on unlicensed use
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Letter to consultees and commentators requesting views on unlicensed use (PDF 26 KB)
Letter to Janssen-Cilag (Ortho Biotech) following Appeal Panel decision requesting additional cost effectiveness evidence
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Letter to Janssen-Cilag (Ortho Biotech) following Appeal Panel decision requesting additional cost effectiveness evidence
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Letter to Welsh Assembly Government following Appeal Panel decision
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Letter to Welsh Assembly Government following Appeal Panel decision
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Letter to Welsh Assembly Government following Appeal Panel decision (PDF 38 KB)
Multiple myeloma - bortezomib: Appeal panel decision
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Multiple myeloma - bortezomib: Appeal panel decision
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Multiple myeloma - bortezomib: Appeal panel decision (PDF 59 KB)
Appeal by Janssen-Cilag Ltd
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Appeal by Janssen-Cilag Ltd
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Joint appeal by the Royal College of Pathologists and the British Society for Haematology
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Joint appeal by the Royal College of Pathologists and the British Society for Haematology
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Covering letter for joint appeal by Myeloma UK, Cancerbackup and Leukaemia CARE
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Covering letter for joint appeal by Myeloma UK, Cancerbackup and Leukaemia CARE
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Covering letter for joint appeal by Myeloma UK, Cancerbackup and Leukaemia CARE (PDF 61 KB)
Joint appeal by Myeloma UK, Cancerbackup and Leukaemia CARE
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Joint appeal by Myeloma UK, Cancerbackup and Leukaemia CARE
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Joint appeal by Myeloma UK, Cancerbackup and Leukaemia CARE (PDF 490 KB)
Letter to John Redwood referenced in Myeloma UK joint submission
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Letter to John Redwood referenced in Myeloma UK joint submission
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Letter to John Redwood referenced in Myeloma UK joint submission (PDF 82 KB)
Appeal by UK Myeloma Forum
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Appeal by UK Myeloma Forum
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Appeal against bortezomib monotherapy for relapsed multiple myeloma
Final appraisal determination
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Final appraisal determination: Bortezomib monotherapy for relapsed multiple myeloma information
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Final appraisal determination
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Response to consultee and commentator comments on the ACD
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Response to consultee and commentator comments on the ACD (PDF 347 KB)
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Response to patient carer organisations public and web comments on the ACD
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Response to patient carer organisations public and web comments on the ACD (PDF 26 KB)
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Response to professional organisation's public and web comments on the ACD
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Response to professional organisation's public and web comments on the ACD (PDF 55 KB)
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Consultee and commentator comments on the ACD
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Department of Health
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Department of Health, Social Services and Public Safety - Northern Ireland
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Department of Health, Social Services and Public Safety - Northern Ireland (PDF 45 KB)
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Leukaemia care
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Leukemia Research, International Myeloma Foundation (UK) and Leukaemia Care
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Leukemia Research, International Myeloma Foundation (UK) and Leukaemia Care (PDF 18 KB)
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Leukemia Research, International Myeloma Foundation (UK), Leukaemia Care and Cancerbackup
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Royal College of Pathologists
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Royal College of Radiologists
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UK Myeloma Forum
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Welsh Assembly Government
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Ortho Biotech
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Expert statements
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Jackson
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Jago
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Morgan
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Appeal announcement
Multiple myeloma - bortezomib: Appraisal consultation document
Evidence considered
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Evidence considered
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Pre Meeting Briefing
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Multiple myeloma - bortezomib: evidence review group report
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Multiple myeloma - bortezomib: evidence review group report (PDF 1.86 MB)
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Manufacturer/sponsor submission (Ortho Biotech)
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Manufacturer/sponsor submission (Ortho Biotech) (PDF 964 KB)
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Expert comments on the ACD
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Jackson
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Jago
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Low
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Morgan
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