Process and methods

Glossary

Abstract

A summary of a study, which may be published alone or as an introduction to a full scientific paper.

Academic in confidence

See 'in-confidence material'.

Appraisal

See technology appraisal.

Appraisal committee

A standing advisory committee of NICE. Includes people who work in the NHS, lay members, people from relevant academic disciplines and the pharmaceutical and medical device industries.

Appraisal consultation document (ACD)

Sets out the appraisal committee's preliminary recommendations to NICE.

Carer

In this guide the term 'carer' refers to a person who provides unpaid care by looking after a relative, friend or partner who needs support because of ill health, frailty or disability.

Cancer Drugs Fund

New technology appraisal processes and methods were implemented in line with the new operating model of the Cancer Drugs Fund. A modified appraisal process for cancer drugs was introduced on 1 April 2016. Information on the new Cancer Drugs Fund operating model is available on NHS England's website.

CE mark(ing)

The CE mark is a mandatory conformity mark on medical device products placed on the single market in the European Economic Area. The CE mark certifies that a product has met EU consumer safety, health or environmental requirements.

Centre director

The director of the Centre for Health Technology Evaluation is responsible for the delivery of the Technology Appraisal Programme. The director is also responsible for ensuring that appraisals are done in accordance with the published appraisal process and methodology.

Clinical effectiveness

The extent to which an intervention produces an overall health benefit, taking into account beneficial and adverse effects, in routine clinical practice. It is not the same as efficacy.

Clinical expert

In technology appraisals, clinical experts act as expert witnesses to the appraisal committee. They are selected on the basis of specialist expertise and personal knowledge of the technology and/or other treatments for the condition. They provide a view of the technology within current clinical practice, and insights not typically available in the published literature.

Commentator

An organisation that engages in the appraisal process but is not asked to prepare a submission. Commentators are invited to comment on the draft scope document, the assessment report and the appraisal consultation document (ACD). They receive the final appraisal document (FAD) for information only. These organisations include relevant comparator technology companies, Healthcare Improvement Scotland, relevant National Collaborating Centres, related research groups and other groups as appropriate.

Commercial in confidence

See 'in-confidence material'.

Committee papers

The committee papers that are issued and published with an ACD or a FAD include all of the evidence seen by the appraisal committee. They are made up of the technical report, ERG report, written submissions, and the personal statements of patient experts and clinical experts, as well as comments received on the technical report. For second and subsequent committee meetings they will also include consultation comments and responses.

Company

The company that manufactures or sponsors either the technology being appraised, or the comparator technology.

Comparator

The standard intervention against which the intervention under appraisal is compared. The comparator can be no intervention, for example best supportive care.

CONSORT statement (consolidated reporting of clinical trials)

Recommendations for improving the reporting of randomised controlled trials in journals. A flow diagram and checklist allow readers to understand how to carry out a study and assess the validity of the results.

Consultation

The process that allows stakeholders and individuals to comment on draft versions of NICE guidance and other documents (for example, the draft scope) so that their views can be taken into account when the final version is being produced.

Consultee

An organisation that takes part in the appraisal of a technology. Consultees can comment on the draft scope, the assessment report and the appraisal consultation document (ACD) during the consultation process. Consultee organisations can nominate clinical experts, commissioning experts and patient experts to present their personal views to the appraisal committee. All consultees are given the opportunity to appeal against the final appraisal document (FAD).

Cost effectiveness

How well a technology works in relation to how much it costs.

Decision problem

A clear description of the interventions, patient populations, outcome measures and perspective adopted in a health technology evaluation, relating specifically to the decision(s) that the evaluation is designed to inform.

Decision Support Unit

The Decision Support Unit helps the technical team at NICE to meet the information needs of the appraisal committee. This is achieved by providing support, as needed, to the technical team and the evidence review group. The objective of the Decision Support Unit is to enhance the delivery of robust information to support appraisal committee decision-making. The Decision Support Unit is a multidisciplinary team, expert in methods of health technology assessment and capable of providing advice and high-quality analyses to decision-makers within very tight deadlines.

Department of Health and Social Care

The Department of Health and Social Care is responsible for standards of healthcare in the UK, including the NHS. The Department sets the strategic framework for adult social care and influences local authority spending on social care. The Department is also responsible for promoting and protecting the public's health, taking the lead on issues such as environmental hazards to health, infectious diseases, health promotion and education, the safety of medicines, and ethical issues.

Economic model

An explicit mathematical framework that is used to represent clinical decision problems. It incorporates evidence from a variety of sources so that the costs and health outcomes can be estimated.

European Medicines Agency

A decentralised agency of the European Union responsible for the scientific evaluation of medicines developed by pharmaceutical companies for use in the European Union.

Evidence

Information on which a decision or guidance is based. Evidence is obtained from a range of sources, including randomised controlled trials, observational studies and expert opinion (of clinical professionals and/or patients or carers).

Evidence review group (ERG)

An independent assessment group commissioned by the National Institute for Health Research Health Technology Assessment Programme to produce an independent assessment of the evidence submitted by the company with a technology being appraised within the standard technology appraisal process.

Final appraisal document (FAD)

The FAD sets out the appraisal committee's final recommendations to NICE on how the technology should be used in the NHS in England.

Guidance executive

A team comprising the executive directors and centre directors at NICE who are responsible for approving the final appraisal document before publication.

Health-related quality of life

A combination of a person's physical, mental and social wellbeing.

Health technology

Any method used by those working in health services to promote health, prevent and treat disease, and improve rehabilitation and long-term care. Technologies in this context are not confined to new drugs or medical technologies.

In-confidence material

Information (for example, the findings of a research project) defined as confidential because its public disclosure could have an impact on the commercial interests of a particular company or the academic interests of a research or professional organisation, or the policy interests of government.

Incremental cost-effectiveness ratio (ICER)

The ratio of the difference in the mean costs of a technology compared with the next best alternative to the differences in the mean outcomes.

Indication

The defined use of a technology as licensed by the Medicines and Healthcare products Regulatory Agency (MHRA) or the European Commission.

Lay member

A lay member is a committee member with a patient, service user, carer or community background. The lay member's role is the same as other committee members, and additionally includes contributing a lay perspective and highlighting patient and carer issues.

Marketing authorisation

An authorisation from the Medicines and Healthcare products Regulatory Agency (MHRA) or European Commission to market a medicinal product.

Medicines and Healthcare products Regulatory Agency (MHRA)

The Executive Agency of the Department of Health and Social Care. It protects and promotes public health and patient safety by ensuring that medicines, healthcare products and medical equipment meet appropriate standards of safety, quality, performance and effectiveness, and are used safely.

National Institute for Health Research – Health Technology Assessment Programme

The National Institute for Health Research – Health Technology Assessment (NIHR HTA) is part of the NIHR Evaluation, Trials and Studies Coordinating Centre (NETSCC) based at the University of Southampton. The NIHR HTA coordinates the Health Technology Assessment Programme on behalf of the NIHR. The aim of the Programme is to ensure that high-quality research information on the costs, effectiveness and broader impact of health technologies is produced in the most efficient way.

Outcome

A measure of the possible results of a treatment with a preventive or therapeutic intervention. Outcome measures can be either intermediate or final end points.

Patient Access Scheme Liaison Unit

The Patient Access Scheme Liaison Unit (PASLU) at NICE advises NHS England on the feasibility of patient access scheme proposals. When assessing a patient access scheme proposal, the PASLU considers the key principles for implementing patient access schemes in England and Wales as outlined in the 2014 Pharmaceutical Price Regulation Scheme.

Patient expert

Acts as an expert witness to the appraisal committee. Patient experts have used the technology either personally or as part of a representative group. Patient experts attend as individuals; they may be either somebody with personal experience of the condition, and if possible the technology, or a member of a patient and carer organisation for the condition being appraised.

Pharmaceutical Price Regulation Scheme (PPRS)

The 2014 PPRS is a non-contractual voluntary scheme. The parties to this agreement are the Department of Health and Social Care and the Association of the British Pharmaceutical Industry (ABPI – the trade association for more than 90 companies in the UK producing prescription medicines for human use). The scheme aims to ensure that safe and effective medicines are available on reasonable terms to the NHS.

Public Involvement Programme (PIP)

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. The PIP public involvement adviser also supports the lay members of the appraisal committees.

Redacted

If documents contain confidential information, it must be redacted, that is, academic-in-confidence and commercial-in-confidence information should be replaced with asterisks and then highlighted in black.

Remit

This is the brief the Department of Health and Social Care gives to NICE when it formally refers a technology for appraisal. Typically, the remit outlines the disease, the patients and the technologies that will be covered by the appraisal.

Scope

Provides a detailed framework for the appraisal and defines the disease, the patients and the technologies that will be covered by the appraisal. The questions the appraisal aims to address are also part of the scope.

Technical engagement

A period of 28 calendar days when the technical report is sent to consultees and commentators and experts to seek their views on the judgements made by the technical team and to specify any remaining clinical uncertainties.

Technical report

A report created to provide the preliminary scientific judgements of the technical team to the appraisal committee. It is created following consideration of the company submission, the ERG report, consultee and commentator and expert statements and any discussions with the company or experts about the appraisal.

Technical team

A team comprising members of the NICE appraisal committee (including the committee chair or vice chair) and NICE staff, who are responsible for considering submissions and providing preliminary scientific judgements and advice to the appraisal committee.

Technology appraisal

The process of developing recommendations on the use of new and existing health technologies within the NHS in England.

Technology assessment

The process of evaluating the clinical, economic and other evidence about the use of a technology and to formulate guidance on its use.

Terminated appraisal

The standard technology appraisal process relies on companies submitting evidence, in line with NICE's specification. Occasionally, they do not make a submission or the submission does not meet the specification. The appraisal is therefore terminated and NICE asks NHS organisations to take into account the reasons why the company did not make an evidence submission when making local decisions on whether to offer the treatment.

ISBN: 978-1-4731-2918-4