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Single technology appraisal and highly specialised technologies evaluation: User guide for company evidence submission template

NICE process and methods [PMG24] Published: 08 January 2015 Last updated: 03 December 2024

  • Process
  • Tools and resources
  • Overview
  • Instructions for companies
  • 1 Decision problem, description of the technology and clinical care pathway
  • 2 Clinical effectiveness
  • 3 Cost effectiveness
  • 4 References
  • 5 Appendices
  • Appendix A: Summary of product characteristics (SmPC) and UK public assessment report
  • Appendix B: Identification, selection and synthesis of clinical evidence
  • Appendix C: Subgroup analysis
  • Appendix D: Adverse reactions
  • Appendix E: Published cost-effectiveness studies
  • Appendix F: Health-related quality-of-life studies
  • Appendix G: Cost and healthcare resource identification, measurement and valuation
  • Appendix H: Clinical outcomes and disaggregated results from the model
  • Appendix I: Price details of treatments included in the submission
  • Update information
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Appendix A: Summary of product characteristics (SmPC) and UK public assessment report

  • 1.1 SmPC
  • 1.2 UK public assessment report

Appendix A: Summary of product characteristics (SmPC) and UK public assessment report

1.1 SmPC

Include the (draft) SmPC for pharmaceuticals or information for use (IFU) for devices in appendix A.

1.2 UK public assessment report

Provide the (draft) UK public assessment report for pharmaceuticals, or a (draft) technical manual for devices in appendix A.


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