1 Introduction

NICE process and methods

1.1 This guide describes the processes, including expected timescales, that NICE follows when carrying out a technology appraisal. The processes are designed to produce robust guidance for the NHS with appropriate contribution from stakeholders. This guide should be read with NICE's guide to the methods of technology appraisal.

1.2 Technology appraisals are developed by the Centre for Health Technology Evaluation in NICE.

1.3 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 technology 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.

1.4 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 providing health services or of social care in England
the degree of need of people for health services or social care in England and
the desirability of promoting innovation in providing health services or of social care in England.

1.5 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.

1.6 The technology appraisal 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 referred to NICE's Technology Appraisal Programme include:

medicinal products
medical devices
diagnostic techniques
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, 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 Technologies Programme at NICE. This process guide relates only to technologies appraised through the Technology Appraisal Programme.

1.7 The technology appraisal process is specifically designed to appraise a product, device or other technology, for a single indication. 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. NICE seeks relevant evidence from several sources. The company submits the principal evidence. The evidence review group (ERG), an external academic organisation independent of NICE, produces a review of the evidence submission (see sections 3.3.8 and 3.3.9). Consultees provide information (see table 1) and selected clinical experts, NHS commissioning experts and patient experts also give evidence (see section 3.4).

1.8 Companies can ask to fast track an appraisal using the fast track process. The aim of this option is to provide an equally robust but less resource-intensive appraisal process than the standard appraisal process. NHS England and commissioners have committed to provide funding for the highly cost-effective technologies recommended in fast track guidance within 30 calendar days of publication.

1.9 NICE makes the decision on whether the standard or fast track process will be used to appraise a technology. Once published, NICE technology appraisal guidance has the same status, regardless of whether it was produced by the standard or the fast track process. Any health technologies that are referred to NICE for technology appraisal, such as pharmaceuticals or medical devices, can be fast tracked as long as they fulfil the criteria (see sections 2.4.31 and 2.4.32).

1.10 An appraisal is based on a review of clinical and economic evidence, mainly provided by the company, supported by testimonies from patients, healthcare professionals and commissioners. Clinical evidence shows how well the technology works – the health benefits. The evidence includes the impact on quality of life (for example, pain and disability), and the likely effects on mortality. Economic evidence shows how well the technology works in relation to how much it costs the NHS and whether it represents value for money.

1.11 The appraisal committee (see table 1) considers the evidence and decides whether or not the technology should be recommended as a clinically effective and cost-effective use of NHS resources, or whether it should only be recommended for specific groups of people.

1.12 The appraisal committee provides its recommendations to NICE in either an appraisal consultation document (ACD) or a final appraisal document (FAD). Normally, the committee produces an ACD only if its preliminary recommendations are substantially more restrictive than the terms of the marketing authorisation (or equivalent, for example, CE marking for devices) for the technology being appraised or do not recommend use of the technology. If the committee produces an ACD, then NICE invites consultees, commentators and the public to comment on it. After considering these comments, the committee finalises its recommendations and provides them to NICE in the form of a FAD. The FAD forms the basis of the guidance that NICE issues to the NHS in England.

1.13 The NICE technology appraisal process complies 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 is the senior responsible owner with overall responsibility for assuring the quality of models developed in their areas of responsibility. The quality of models is assured through the requirements for the development of evidence submissions (see NICE's guide to the methods of technology appraisal) and the process used to involve stakeholders in testing the reliability of models (see section 3.2.11).

1.14 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 describes how NICE meets these commitments and obligations.

1.15 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 committee 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 appraisal committees, should apply when making decisions about the effectiveness and cost effectiveness of interventions.

1.16 Service level agreements are in place to help disseminate NICE technology appraisal guidance within the devolved administrations in Wales and Northern Ireland.

Table 1 Participants in the technology appraisal processes

Appraisal committee	The appraisal committee considers and discusses the evidence for a technology. The appraisal committee is an independent standing committee that produces recommendations. NICE recruits committee members through open, competitive advertising and appoints members initially for a 3‑year term. Committee members are from: the NHS lay backgrounds (with an understanding of patient and public perspectives on healthcare issues) academia pharmaceutical and medical devices industries. Full details of how NICE recruits members can be found in the recruitment and selection procedure for advisory bodies. NICE allocates members to 1 of 4 standing committees. Members will normally remain in the same committee for the duration of their membership. Sometimes members may be needed to join another committee to ensure that the meeting is quorate and that business can be done in line with the committee standing orders and terms of reference. Although the committee seeks the views of organisations representing healthcare professionals, patients, carers, companies and government, its advice is independent. Names of committee members are posted on NICE's website. See the appraisal committee's standing orders and terms of reference.
Lead team	A lead team, selected from the committee members at the start of each appraisal, helps the NICE team prepare a technical report to brief the committee. The lead team normally consists of 3 committee members; 1 focuses on clinical effectiveness; 1 on cost effectiveness and 1 on patient and carer evidence (called the lay lead).
The technical team	The technical team consists of the chair or vice chair of the committee along with the NICE team, which normally comprises of the following: the associate director, the technical adviser and the technical lead. The technical team will be responsible for considering the company evidence submission, evidence review group (ERG) critique and submissions from other consultees and commentators. It aims to identify and explore issues, come to preliminary scientific judgements, and advise the appraisal committee in its discussion of the evidence. The technical team will seek input from the lead team, the ERG and experts where appropriate.
Consultees	NICE invites consultees to take part in the appraisal. They include: national groups representing patients and carers organisations representing healthcare professionals the company that holds, or is expected to hold, the marketing authorisation for medicinal products, or the equivalent for other technologies the Department of Health and Social Care the Welsh government NHS England as the commissioner for specialised services clinical commissioning groups (2 are randomly selected). As part of the scoping process, NICE invites consultees to comment on draft remits and draft scopes. Consultees can submit evidence and take part in the consultation on the appraisal consultation document (ACD; if produced). All non‑company consultees can nominate clinical experts and patient experts to take part in the appraisal. Company consultees can only nominate clinical experts. Representatives from NHS England and clinical commissioning groups invited to take part in the appraisal may also nominate NHS commissioning experts to attend appraisal committee meetings. All consultees have the opportunity to appeal against the final recommendations, or report any factual errors, in the final appraisal document (FAD). Consultees can also comment on the proposal for reviewing the guidance (see section 6).
Commentators	NICE invites commentator organisations with an interest in the technology to take part in the appraisal. They include, but are not restricted to: relevant comparator technology companies any relevant National Collaborating Centres (groups commissioned by NICE to develop clinical and social care guidelines) and/or the relevant group for public health guidance other related research groups (for example, the Medical Research Council and the National Cancer Research Institute) other groups (such as the NHS Confederation, the NHS Commercial Medicines Unit, the Scottish Medicines Consortium, the Medicines and Healthcare products Regulatory Agency, the Department of Health and Social Care, Social Services and Public Safety for Northern Ireland and the Academic Health Science Networks). As part of the scoping process, NICE invites commentators to comment on draft remits and draft scopes. Commentators can take part in the consultation on the ACD (if produced), but NICE does not ask them to submit evidence for the appraisal. Non-company commentator organisations can nominate clinical experts and patient experts to take part in the appraisal. Commentator organisations can only nominate clinical experts. These organisations receive the FAD and have the opportunity to report any factual errors. Commentators can also comment on the proposal for reviewing the guidance (see section 6).
Clinical experts and patient experts	The chair of the appraisal committee selects clinical experts and patient experts from those nominated by consultees and commentators; taking into account the NICE policy on declaring and managing interests for NICE advisory committees. Experts are invited to help clarify issues about the submitted evidence and attend committee meetings. They may be asked to provide advice before, during and after committee meetings.
NHS commissioning experts	NICE invites 2 NHS commissioning experts from those nominated by NHS England and the clinical commissioning groups to help clarify issues about the submitted evidence. They may be asked to provide advice before, during and after committee meetings about their views and experiences of the technology and the condition from an NHS perspective.
Cancer Drugs Fund clinical lead	For appraisals of pharmaceutical products for cancer indications, the clinical lead for the Cancer Drugs Fund, or a nominated deputy, is invited to submit a statement and attend both the public and private parts of appraisal committee meetings.
Evidence review group (ERG)	The ERG is an independent (academic) group that reviews the company's evidence submission and may also prepare some additional analyses. The ERG is normally commissioned by the National Institute for Health Research's Health Technology Assessment Programme.
Decision Support Unit (DSU)	The DSU is commissioned by NICE to provide a research and training resource to support NICE's Technology Appraisal Programme.
NICE staff
Centre director	The centre director is responsible for delivering all outputs of the Centre for Health Technology Evaluation. The centre director must also ensure that appraisals are carried out in line with the published appraisal process and methods.
Programme director	The programme director is responsible for all aspects of managing and delivering the appraisal work programme. The programme director interacts with the NICE sponsor branch at the Department of Health and Social Care and other national bodies, and with healthcare industry bodies. The programme director is responsible for signing off guidance at specific stages of an individual appraisal. The programme director is also responsible for ensuring that appraisals are carried out in line with the published appraisal process and methods.
Associate director	The associate director is responsible for developing individual appraisals within the appraisal programme and has delegated responsibility, from the programme director, for approving documentation for consultation at specific stages of an individual appraisal.
Project manager	The project manager is responsible for planning individual appraisal timelines, ensuring the timelines and process are followed, and liaising with consultees, commentators and other individuals and organisations contributing to the appraisal.
Administrator	The administrator is responsible for supporting the project manager in the planning and management of individual appraisals, including ensuring the timelines and process are followed, and liaising with consultees, commentators and other individuals and organisations.
Technical lead	The technical lead is the analyst responsible for the technical aspects of the appraisal, including liaising with the ERG, scoping the appraisal, preparing drafts of guidance and advising the appraisal committee. There may be more than 1 technical lead for an appraisal.
Technical adviser	The technical adviser is responsible for the technical quality of the appraisal. This involves providing advice on technical issues, and if appropriate, reviewing and quality assuring the work of the technical lead. The technical adviser also ensures a consistent approach is taken across the appraisal programme.
Communications lead	The communications lead is responsible for circulating and communicating the guidance to appropriate groups within the NHS in England, and to patients and the public.
Guidance Information services lead	The guidance information services lead is responsible for supporting the technical lead in scoping the appraisal. The information services lead gathers information to support the production of a draft scope and continues to track key information throughout the life cycle of the appraisal to support the work of the technical lead.
Editorial lead	The editorial lead is responsible for ensuring that all guidance documents are accurate, clear and consistent. The editorial lead prepares the final versions of the guidance and information for the public.
Public Involvement Programme (PIP) public involvement adviser	The PIP is the team at NICE that supports and develops public involvement across NICE's work programme. A PIP public involvement adviser is assigned to each appraisal and supports patient and carer consultee organisations, their representatives, and individual patients or carers throughout the appraisal. This may include making it easier to attend workshops or meetings, giving advice on completing submissions and statements, consultation responses or other documentation, and nominating experts. The PIP public involvement adviser also supports the lay members of the appraisal committees and supplies the patient and carer organisations for the 'information for the public' tab of the guidance page of the NICE website.
Commercial and Managed Access Programme (CMAP)	The CMAP will be responsible for managed access activities, including the Cancer Drugs Fund and Patient Access Schemes Liaison Unit. This team will support commercial engagement between companies and NHS England when a commercial access agreement or patient access scheme is needed to address specific uncertainties within a topic.
Resource impact lead	The resource impact lead works with the technical lead and clinical experts to produce guidance-related costing tools. The tools consist of a resource impact report and template to help organisations assess the financial impact of implementing NICE guidance. They are published at the same time as the guidance and are subject to a limited consultation. The resource impact lead also provides input at the topic selection stage, assessing the potential financial impact of each topic scoped.
Implementation adviser	The implementation adviser provides support from the scoping stage through to post-publication activities, liaising with the internal NICE teams, development teams and external organisations to support the implementation of NICE guidance, including the development of implementation support tools.
Pathways lead	The pathways lead is responsible for ensuring there is a process in place for making guidance accessible through NICE Pathways. This includes ensuring that new guidance is included in new or existing NICE Pathways with agreement from the Centre for Health Technology Evaluation management team.
Adoption lead	The medicines and technologies programme adoption team lead will work with the NHS to provide a systematic approach to the adoption of new technologies such as pharmaceuticals, diagnostic and monitoring devices, surgical implants and other technologies that improve the care given to patients.