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

Aug 31, 2026

User guide for submitting evidence to the National Institute for Health and Care Excellence (NICE) for the single technology appraisal and highly specialised technologies evaluations process. Specifies required information and submission format, including limits on length, electronic Word submission, and standalone document requirements with clearly marked appendices for external assessment group critique. Details confidentiality handling, required economic model inclusion with full programming code, checklist completion, transparency expectations, and obligations around disclosure of all relevant clinical trial data and regulatory consent.

LanguageEnglish

CategoryPresentations

FormatDOCX

Pages71

Reading Time25 min

AccessFree to download

Instructions for companies

Evidence submission requirements and format

Confidentiality and economic model inclusion

Decision problem and technology description

Health condition and clinical care pathway

Single technology appraisal and highly specialised technologies evaluation: User guide for company evidence submission template 8 January 2015 31 March 2026 Instructions for companies This is the user guide for submission of evidence to the National Institute for Health and Care Excellence (NICE) as part of the single technology appraisal and highly specialised technologies evaluations process. It explains what information NICE requires and the format in which it should be presented. Information should be submitted in the HYPERLINK "https://www.nice.org.uk/what-nice-does/our-guidance/about-technology-appraisal-guidance/technology-appraisal-submission-templates-and-supporting-documents" single technology appraisal company evidence submission template. Companies making evidence submissions to NICE should also refer to the HYPERLINK "https://www.nice.org.uk/process/pmg36/chapter/introduction-to-health-technology-evaluation" NICE health technology evaluations manual, which gives further details of procedures and methods relating to single technology appraisal and highly specialised technologies evaluation submissions. The submission should be as brief and informative as possible. The main body of the submission must not be longer than 150 pages, excluding the appendices and the pages covered by the template. The submission should be sent to NICE electronically in Word or a compatible format, and not as a PDF file. The submission must be a standalone document. Some of the information we request should be submitted as appendices to the main submission (when this is the case, it is clearly marked). The information in these appendices is required by the external assessment group (EAG) to fully critique the submission. The appendices are not normally presented to the evaluation committee, but will be available to them on request. When making an evidence submission, companies must ensure that: All confidential information is highlighted and underlined in the electronic version sent to NICE. An executable electronic copy of the economic model is included in the version sent to NICE, with full access to the programming code. The content of the evidence submission and the content of the economic model should match. The checklist of confidential information (provided by NICE with the invitation to submit) is completed and submitted. See section 5.3 and 5.4 of HYPERLINK "https://www.nice.org.uk/process/pmg36/chapter/introduction-to-health-technology-evaluation" NICE’s health technology evaluations manual for information about all aspects of information handling. To ensure that the evaluation process is as transparent as possible, NICE considers that evidence on which the evaluation committee’s decisions are based should be publicly available. NICE requires the medical director of the company to sign a statement confirming that all clinical trial data necessary to address the remit and scope of the technology evaluation as issued by the Department of Health and Social Care and NICE, within the company's or any of its associated companies’ possession, custody, or control in the UK, or elsewhere in the world, have been disclosed. NICE considers that the definition of ‘all clinical trial data’ is not limited to conventional randomised controlled trials (RCTs), but is meant to include other types of interventional or observational clinical research methodologies, such as large simple trials, cohort studies, case control studies, or registry data. This definition is consistent with that used by the HYPERLINK "https://www.ema.europa.eu/en/human-regulatory-overview/marketing-authorisation/clinical-data-publication/background-clinical-data-publication-policy" \l ":~:text=The%20European%20Medicines%20Agency%20developed,and%20mechanisms%20to%20ensure%20transparency." European Medicines Agency in its policy on publication of clinical data on medicinal products for human use. NICE requires companies to consent to European Economic Area re

FAQs

What format and length limits apply to the evidence submission to NICE?

Submissions must be sent electronically in Word or a compatible format, not as a PDF. The main body must not exceed 150 pages, excluding appendices and pages covered by the template.

Which information must be included regarding confidential content and the economic model?

Confidential information must be highlighted and underlined in the electronic version. An executable electronic copy of the economic model must be included with full access to the programming code, and its content must match the evidence submission.

What disclosure and regulatory consent obligations do companies have?

The medical director must sign a statement that all required clinical trial data have been disclosed. Companies must consent to European Economic Area regulatory authorities directly providing NICE with all necessary clinical trial data so NICE can use it for the technology evaluation.

Aug 31, 2026

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