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

  • NICE process and methods
  • Reference number: PMG24
  • Published:  08 January 2015
  • Last updated:  03 December 2024
  • Process
  • Tools and resources
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  • 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

5 Appendices

Clinical trial reports and protocols must be made available for relevant clinical studies; the remainder must be available on request. The information that NICE requests in appendices is needed by the EAG to fully critique the submission.

The appendices are not normally provided to the evaluation committee or published on the NICE website; please send these as separate documents to the main submission.

All information that should be provided in appendices A to I is outlined in the following sections. Any additional appendices should start at appendix J.


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