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

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 company evidence submission template. Companies making evidence submissions to NICE should also refer to NICE's health technology evaluation guidance development 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 stand-alone 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:

See section 5.3 and 5.4 of NICE's health technology evaluation guidance development 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 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 regulatory authorities directly providing NICE with 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. This includes all data that have been submitted to the regulatory authorities by the company or any of its associated companies and that were relevant to the granting of a marketing authorisation, and for NICE to use those data in carrying out the technology evaluation. NICE will only ask regulatory authorities directly after having first approached the company for the information and the company is unable or unwilling to provide the information in a timely manner.