NICE process and methods
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.
Appendices should start at C, because document A is the submission summary and document B is the main submission.
All information that should be provided in an appendix is outlined in the user guide for company evidence submission appendices
Appendix C: Summary of product characteristics or information for use, UK public assessment report, scientific discussion or drafts
Appendix D: Identification, selection and synthesis of clinical evidence (see sections 2.1, 2.4, 2.5 and 2.9)
Appendix E: Subgroup analysis (see section 2.7)
Appendix F: Adverse reactions (see section 2.10)
Appendix G: Published cost-effectiveness studies (see section 3.1)
Appendix H: Health-related quality-of-life studies (see section 3.4.3)
Appendix I: Cost and healthcare resource identification, measurement and valuation (see section 3.5)
Appendix J: Clinical outcomes and disaggregated results from the model (see sections 3.7.1–3.7.2)
Appendix K: Price details of treatments included in the submission
Appendix L: Checklist of confidential information
Any additional appendices should start at appendix M.
ISBN: 978-1-4731-0933-9