Process and methods
1.1.1 This document provides an overview of the principles and methods of health technology assessment and appraisal within the NICE technology appraisal process. It introduces the general methodological concepts underlying each stage of the appraisal process and describes what is required of participants submitting evidence to NICE. Earlier versions of this guide were published in 2004 and 2008.
1.1.2 The Institute has 2 appraisal processes: the multiple technology appraisal (MTA) process and the single technology appraisal (STA) process. Although there are differences between the 2 processes, the principles relating to decision-making, the methods of assessment and the decision outcomes are consistent.
1.1.3 Two other documents describe the Institute's appraisal processes.
1.1.4 The Institute's appraisal processes rely on information from a number of sources, including independent academic groups, manufacturers and sponsors (see sections 4.1 and 4.2), healthcare professionals, commissioners of health services and patient or carer representatives. These groups are also consulted on the draft scope of the technology appraisal and, when appropriate and in line with the technology appraisal process, on the decisions made by the Appraisal Committee.
1.1.5 Documents describing the Institute's current methods and processes are available on the NICE website.
1.1.6 The Institute supports the development of methods through its Research and Development programme, its links with the National Institute for Health Research, the Medical Research Council, and its liaison with academic groups.
1.1.7 This document includes a glossary of terms (see section 7).
1.2.1 The Institute undertakes appraisals of new and established technologies, as formally requested by the Department of Health. Health technologies referred to the NICE technology appraisals programme include:
therapeutic technologies other than medicinal products
systems of care
Some of these technologies will be considered by other programmes within NICE such as the clinical guidelines programme, the medical technologies evaluation programme, the diagnostics assessment programme or the interventional procedures programme, or will have medicines and prescribing support from the Medicines and Prescribing Centre at NICE. This methods guide relates only to technologies appraised through the technology appraisals programme.
1.2.2 The purpose of an appraisal carried out by the Institute is as described in the Directions from the Secretary of State for Health; that is, to appraise the health benefits and the costs of those technologies notified by the Secretary of State for Health and to make recommendations to the NHS in England and Wales.
1.2.3 Potential topics for technology appraisals come predominantly from the National Institute for Health Research (NIHR) Horizon Scanning Centre. Other sources include individual healthcare professionals, NHS commissioners, and the Department of Health's policy teams. The NICE website provides details on how NICE selects topics for appraisal. Ministers at the Department of Health make the final decision about which topics are referred to NICE for appraisal.
1.2.4 The Department of Health refers technologies for appraisal based on 1 or more of the following criteria:
Is the technology likely to have a significant health benefit, taken across the NHS as a whole, if given to all patients for whom it is indicated?
Is the technology likely to have a significant impact on other health-related government policies (for example, reduction in health inequalities)?
Is the technology likely to have a significant impact on NHS resources (financial or other) if given to all patients for whom it is indicated?
Is there significant inappropriate variation in the use of the technology across the country?
Is the Institute likely to be able to add value by issuing national guidance? For example, in the absence of such guidance is there likely to be significant controversy over the interpretation or significance of the available evidence on clinical and cost effectiveness?
The appraisal of a health technology is divided into 3 distinct phases:
1.3.1 During the scoping process, the Institute determines the appropriateness of the proposed remit and defines the specific questions that each technology appraisal will address. The scope defines the issues of interest (for example, population, potential comparators and potential subgroups) as clearly as possible and the questions that the Appraisal Committee should address when considering the clinical and cost effectiveness of the technology. These questions are fundamental to the assessment process and require an understanding of the context within which to investigate a technology, including currently available care and any alternative technologies for the specific indication. Consultees and commentators are consulted during the scoping process. The Institute revises the scope in response to comments received and develops a final scope that describes the boundaries of the appraisal and the main issues. The methods and principles that underpin the scoping process are described in detail in section 2.
1.3.2 The assessment process is a systematic evaluation of the relevant evidence (see section 3) available on a technology. The aim is to assess a technology's clinical and cost effectiveness for a specific indication, taking account of uncertainty, compared with the appropriate comparator(s) listed in the scope. Assessment has 2 components: a systematic review of the evidence and an economic evaluation. Assessment, therefore, consists of an analysis of the quality, findings and implications of the available evidence (mainly from research). Strengths, weaknesses and gaps in the evidence are identified and evaluated.
1.3.3 An independent academic group reviews the evidence. For MTAs, the academic group is known as the 'Assessment Group', and it conducts an independent systematic review and economic analysis. For STAs, the academic group is the 'Evidence Review Group', and it reviews and critiques the submission provided by the manufacturer or sponsor of a technology. The Evidence Review Group may recommend that the Institute requests additional analyses from the manufacturer or sponsor, and may explore alternative scenarios or conduct further exploratory analyses to address uncertainty in the cost-effectiveness results.
1.3.4 Within the appraisal process (see section 6), an Appraisal Committee considers evidence contained in the reports and analyses produced in the assessment phase and additional information supplied by consultees, commentators, clinical specialists, patient experts and commissioning experts. The Appraisal Committee considers the evidence and makes a decision, applying judgements on a range of factors.
1.4.1 The Institute takes into account the clinical and cost effectiveness of a technology, along with other considerations (see section 6.2), when issuing guidance to the NHS.
1.4.2 In general, a technology can be considered clinically effective if, in normal clinical practice, it confers a health benefit, taking account of any harmful effects and opportunity costs. A technology can be considered to be cost effective if its health benefits are greater than the opportunity costs of programmes displaced to fund the new technology, in the context of a fixed NHS budget. In other words, the general consequences for the wider group of patients in the NHS are considered alongside the effects for those patients who may directly benefit from the technology.
1.4.3 NICE is committed to advancing equality of opportunity, eliminating unlawful discrimination and fostering good relations between people who share a protected characteristic and society as a whole, and to complying fully with its legal obligations on equality and human rights. NICE's equality scheme (see section 7) describes how the Institute meets these commitments and obligations.
1.4.4 In formulating its recommendations, the Appraisal Committee will have regard to the provisions and regulations of the Health and Social Care Act 2012 relating to NICE. The Appraisal Committee will also take into account the Institute's guidance on social value judgements described in the Institute's document, 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 Appraisal Committees, should apply when making decisions about the effectiveness and cost effectiveness of interventions.
1.5.1 The National Institute for Health and Care Excellence (Constitution and Functions) and the Health and Social Care Information Centre (Functions) Regulations 2013 require clinical commissioning groups, NHS England and, with respect to their public health functions, local authorities to comply with NICE technology appraisal recommendations that recommend the relevant health service body provide funding within the period specified. Where 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 three months, except where particular barriers to implementation within that period are identified. The Institute provides advice and tools to support the local implementation of its guidance. This includes costing tools or statements and audit support for most technology appraisals and additional tools for selected technology appraisals.