Abstract

Contents

• NIHR Health Technology Assessment programme
• List of abbreviations
• Executive summary
• 1. Background
  • Description of underlying health problem
  • Current service provision
  • Description of technology under assessment
• 2. Definition of the decision problem
  • Decision problem
  • Overall aims and objectives of assessment
• 3. Methods
  • Search strategy
  • Inclusion and exclusion criteria
  • Inclusion and data extraction process
  • Critical appraisal strategy
  • Methods of data synthesis
• 4. Clinical effectiveness
  • Results of the systematic review of clinical effectiveness
  • SHTAC review of clinical effectiveness in manufacturers' submissions
  • Ongoing studies
  • Summary of clinical effectiveness
• 5. Economic analysis
  • Introduction
  • Systematic review of existing cost-effectiveness evidence
  • Systematic review of health-related quality-of-life studies
  • Review of the Janssen–Cilag submission to NICE (bortezomib)
  • Review of the Celgene submission to NICE (thalidomide)
  • SHTAC independent economic assessment
• 6. Assessment of factors relevant to the NHS and other parties
• 7. Discussion
  • Statement of principal findings
  • Strengths and limitations of the assessment
  • Uncertainties
• 8. Conclusions
  • Implications for service provision
  • Suggested research priorities
• Acknowledgements
• References
• Appendix 1 Report methods for synthesis of evidence of clinical effectiveness and cost-effectiveness as described in the research protocol
• Appendix 2 Example MEDLINE search strategies for clinical effectiveness and cost-effectiveness
• Appendix 3 Response criteria
• Appendix 4 Table of excluded studies
• Appendix 5 Clinical effectiveness included studies – data extraction forms
• Appendix 6 Karnofsky performance status and WHO performance status scores
• Appendix 7 SHTAC data summary of manufacturers' submissions of clinical effectiveness
• Appendix 8 Table of excluded studies for systematic review of cost-effectiveness
• Appendix 9 Table of excluded studies for systematic review of health-related quality of life
• Appendix 10 Health-related quality-of-life studies – data extraction forms
• Appendix 11 Cost-effectiveness data extraction forms for manufacturers' submissions
• Appendix 12 Critical appraisal checklist of economic evaluation
• Appendix 13 Methodology used for disease projection
• Appendix 14 Parameters included in the sensitivity analyses
• Appendix 15 Additional scenario analyses
• Health Technology Assessment programme

Note: This monograph is based on the Technology Assessment Report produced for NICE. The full report contained a considerable number of data that was deemed commercial-in-confidence and academic-in-confidence. The full report was used by the Appraisal Committee at NICE in their deliberations. The full report with each piece of commercial-in-confidence and academic-in-confidence data removed and replaced by the statement ‘commercial-in-confidence and academic-in-confidence information (or data) removed’ is available on the NICE website: www.nice.org.uk.

The present monograph presents as full a version of the report as is possible while retaining readability, but some sections, sentences, tables and figures have been removed. Readers should bear in mind that the discussion, conclusions and implications for practice and research are based on all the data considered in the original full NICE report.

Suggested citation:

Picot J, Cooper K, Bryant J, Clegg AJ. The clinical effectiveness and cost-effectiveness of bortezomib and thalidomide in combination regimens with an alkylating agent and a corticosteroid for the first-line treatment of multiple myeloma: a systematic review and economic evaluation. Health Technol Assess 2011;15(41).

Declared competing interests of the authors: none

The research reported in this issue of the journal was commissioned and funded by the HTA programme on behalf of NICE as project number 08/96/01. The protocol was agreed in July 2009. The assessment report began editorial review in February 2010 and was accepted for publication in July 2010. The authors have been wholly responsible for all data collection, analysis and interpretation, and for writing up their work. The HTA editors and publisher have tried to ensure the accuracy of the authors' report and would like to thank the referees for their constructive comments on the draft document. However, they do not accept liability for damages or losses arising from material published in this report.

The views expressed in this publication are those of the authors and not necessarily those of the HTA programme or the Department of Health.