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    NICE health technology evaluations: the manual

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    Introduction to health technology evaluation

    This guide describes the methods and processes, including expected timescales, that NICE follows when carrying out health technology evaluations. 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 Centre for Health Technology Evaluation topic selection manual. All documents are available on the NICE website.

    Health technology evaluations are developed by NICE's Centre for Health Technology Evaluation. This manual describes the methods and processes used for developing guidance in the:

    • Diagnostics Assessment Programme

    • Medical Technologies Evaluation Programme

    • Highly Specialised Technologies Evaluation Programme

    • Technology Appraisal Programme.

    The health technology evaluation methods and processes are designed to provide recommendations, in the form of NICE guidance, on the use of new and existing medicines, products and treatments in the NHS. Health technologies include:

    • medicinal products

    • medical devices

    • diagnostic techniques

    • digital products

    • surgical procedures or other therapeutic techniques

    • therapeutic technologies other than medicinal products

    • systems of care

    • screening tools.

    Some of these technologies will also be considered by other programmes within NICE, such as NICE guidelines or the Interventional Procedures Programme, or will have medicines and prescribing support from the Medicines and Technologies Programme. This manual relates only to technologies evaluated through the health technology evaluation programmes.

    To support the robustness of NICE's processes, all health technology evaluation programmes and processes comply with the principles underpinning the UK government's review of quality assurance of government models (the Macpherson recommendations). The director of the Centre for Health Technology Evaluation has 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.

    Diagnostics Assessment Programme

    The Diagnostics Assessment Programme evaluates diagnostic technologies. It is responsible for evaluating diagnostic tests and technologies when such evaluation is complex, for example, if recommendations can only be made on the basis of clinical utility and cost-effectiveness analysis or if meaningful assessment requires the consideration of multiple technologies or indications. The Diagnostics Assessment Programme evaluates diagnostic technologies that have the potential to improve health outcomes but whose introduction is likely to be associated with an overall increase in cost to the NHS. The Diagnostics Assessment Programme also evaluates diagnostic technologies that may offer similar health outcomes at less cost, or improved health outcomes at the same cost as current NHS practice.

    The programme evaluates diagnostics that are intended for use in the NHS in England and are paid for by the NHS with public funds, either in part or in whole.

    The aims of the programme are to:

    • promote the rapid and consistent adoption of innovative clinically and cost-effective diagnostic technologies in the NHS

    • improve treatment choice or length and quality of life by evaluating diagnostic technologies that have the potential to improve key clinical decisions

    • improve the efficient use of NHS resources by evaluating diagnostic technologies that have the potential to improve systems and processes for the delivery of health and social care.

    Medical Devices Evaluation Programme

    The Medical Technologies Evaluation Programme evaluates new or innovative medical technologies (including devices and simple diagnostics). It aims to help the NHS adopt efficient and cost-saving medical devices and simple diagnostics more rapidly and consistently. This supports innovation and transformation and improves healthcare delivery.

    The programme looks at medical technologies that:

    • deliver treatment – like those implanted during surgical procedures

    • give greater independence to patients

    • detect or monitor medical conditions.

    The Medical Technologies Evaluation Programme uses a cost-minimisation approach to assess products. This approach considers the costs and resource consequences resulting from, or associated with, the technology under evaluation and comparator technologies. It considers clinical benefits (for example, effectiveness outcomes) alongside the cost analysis.

    Technology Appraisal and Highly Specialised Technologies Programmes

    The Technology Appraisal and Highly Specialised Technologies Programmes appraise technologies using clinical utility and cost-effectiveness analysis. The process normally covers new technologies (typically, new pharmaceutical products or new licensed indications) and enables NICE to produce guidance soon after the technology is introduced in the UK.

    These programmes have a range of processes available:

    • the single technology appraisal process (this is the most commonly used process across the programmes and is used for the first assessment of a technology and updates to existing guidance)

    • the multiple technology appraisal process

    • cost comparison

    • rapid review

    • update after loss of market exclusivity of a technology.

    For the Technology Appraisal and Highly Specialised Technologies programmes, 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:

    • in relation to a health technology identified in a direction by the secretary of state

    • 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:

    • the broad balance between the benefits and costs of the provision of health services or of social care in England

    • the degree of need of persons for health services or social care in England, and

    • 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, 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 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 the programme 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 health technology evaluations.

    Other resources are available on the NICE website, including: