Introduction to health technology evaluation
This guide describes the methods and processes, including expected timescales, that NICE follows when producing technology appraisal and highly specialised technologies guidance. The methods and processes are designed to produce robust guidance for the NHS in an open, transparent and timely way, with appropriate contribution from stakeholders. Organisations invited to contribute to health technology evaluation development should read this manual in conjunction with the NICE-wide topic prioritisation process. All documents are available on the NICE website.
The methods and processes are designed to provide recommendations, in the form of NICE guidance, on the use of new and existing medicinal products and HealthTech including medical devices, diagnostics and digital technologies. When necessary, this manual distinguishes health technologies as being medicines or HealthTech. If not indicated otherwise, 'health technologies' refers to both medicines and HealthTech.
Some of these technologies will also be considered in other NICE guidance (without mandated funding associated with recommendations for use), such as NICE guidelines or HealthTech guidance. This manual relates only to technologies evaluated for technology appraisal and highly specialised technologies guidance.
While it is expected that most evaluations of HealthTech will evaluate multiple technologies, when only 1 technology is available, guidance will be produced for a single technology. The process for evaluation of HealthTech will be the same regardless of how many technologies are being evaluated.
To support the robustness of NICE's processes, our programmes and processes comply with the principles underpinning the UK government's review of quality assurance of government models (the Macpherson recommendations). NICE directors have overall responsibility for assuring the quality of models developed in the director's areas of responsibility. Model quality is assured through the requirements for evidence submission development and the process used to involve stakeholders in testing the reliability of models.
NICE is committed to advancing equality of opportunity, eliminating unlawful discrimination and fostering good relations between people with protected characteristics and society as a whole, and to complying with its legal obligations on equality and human rights. NICE's equality scheme describes how NICE meets these commitments and obligations.
In formulating its recommendations, NICE's independent committees will have regard to the provisions and regulations of the Health and Social Care Act 2012 relating to NICE. The committees will also take into account NICE's social value judgements: principles for the development of NICE guidance. This document, developed by NICE's Board, describes the principles NICE should follow when designing the processes used to develop its guidance. In particular, it outlines the social value judgements that NICE and its advisory bodies, including evaluation committees, should apply when making decisions about the effectiveness and value for money of interventions.
Service-level agreements are in place to help disseminate NICE technology evaluation guidance in the devolved administrations in Wales and Northern Ireland.
Technology Appraisal and Highly Specialised Technologies guidance
Evaluations for technology appraisal and highly specialised technologies guidance appraise technologies using clinical utility and cost-effectiveness analysis. The process normally covers new technologies and enables NICE to produce guidance soon after the technology is introduced in the UK.
A range of processes are available:
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the single technology appraisal process (this is the most commonly used process and is used for the first evaluation of a medicine and updates to existing medicines guidance)
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the multiple technology appraisal process
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cost comparison
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rapid review
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update after loss of market exclusivity of a technology.
For technology appraisal and highly specialised technologies guidance, the National Institute for Health and Care Excellence (Constitution and Functions) and the Health and Social Care Information Centre (Functions) Regulations 2013 indicate that NICE may make a recommendation:
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in relation to a health technology identified in a direction by the secretary of state
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that relevant health bodies provide funding within a specified period to ensure that the health technology be made available for the purposes of treatment of patients.
The Health and Social Care Act 2012 describes NICE's general duties as follows: 'In exercising its functions NICE must have regard to:
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the broad balance between the benefits and costs of the provision of health services or of social care in England
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the degree of need of persons for health services or social care in England, and
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the desirability of promoting innovation in the provision of health services or of social care in England.'
The regulations require clinical commissioning groups, NHS England and NHS Improvement, and, with respect to their public health functions, local authorities, to comply with NICE technology appraisal guidance that recommends the relevant health service body provides funding within the period specified. When NICE recommends that a treatment be funded by the NHS, the regulations require that the period within which the health service must comply will be stated in the recommendations as 3 months, except when particular barriers to implementation within that period are identified (see section 5.10 on varying the funding requirement). NICE provides advice and tools to support the local implementation of its guidance. This includes resource impact tools or statements for most technology appraisals and additional tools for some technology appraisals.
Further information and advice
Committees and stakeholders should refer to this manual throughout evaluations.
NICE also has additional resources and advice to help stakeholders and committees apply the methods and use this manual. Committees and stakeholders are encouraged to refer to these resources when helpful, but they are not bound by them and may depart from the information and advice if they consider it appropriate.
Similarly, the Decision Support Unit produces a series of technical support documents, which provide further information on technical aspects of evaluations.
Other resources are available on the NICE website, including:
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the following webpages, which provide more information about each programme, including submission templates:
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the principles that guide the development of NICE guidance and standards