Glossary

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Abstract

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

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Academic In confidence

See ‘In confidence material‘.

Active implantable medical device

Any active medical device which is intended to be totally or partially introduced, surgically or medically, into the human body or by medical intervention into a natural orifice, and which is intended to remain after the procedure.

Active medical device

Any medical device relying for its functioning on a source of electrical energy or any source of power other than that directly generated by the human body or gravity.

Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM)

A public administrative body which acts on behalf of the French Government to ensure patient safety by conducting assessments and acting as a decision-making body in the field of the regulation of health products.

AHSC

Academic Health Science Centre

AHSN

Academic Health Science network

All Wales Medicines Strategy Group (AWMSG)

The AWMSG is the Welsh health technology appraisal (HTA) body,  a statutory advisory Welsh Assembly-sponsored public body which aims to provide advice on medicines management and prescribing to the Welsh Government’s Minister for Health and Social Services in an effective, efficient and transparent manner.

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AMNOG

Arzneimittelmarkt-Neuordnungsgesetz – The Act on the Reform of the Market for Medicinal Products. AMNOG aims to limit the cost of pharmaceuticals by the statutory health insurance funds.

AMSCI

Advanced Manufacturing Supply Chain Initiative

Appraisal

See ‘Technology appraisal (single and multiple)‘.

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Appraisal Committee

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

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Appraisal consultation document (ACD)

Sets out the Appraisal Committee’s provisional recommendations to NICE.

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Area Drugs and Therapeutics Committee (ADTC)

Committees responsible for providing advice to the regional NHS boards on the use of medicines to meet the needs of the patients in that health board area. There are 14 regional health boards in Scotland.

Assay

A diagnostic test to measure the concentration or level of a particular analytic.

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Assessment Group

An independent assessment group commissioned by the NHS Research and Development Health Technology Assessment (HTA) programme to produce an independent review of the evidence for technologies being appraised within the multiple technology appraisal (MTA) process.

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Assessment Protocol

The assessment protocol is derived from the scope of the appraisal, taking into account consultation responses to the draft scope and comments from organisations attending the scoping workshop. It forms the basis of the assessment report during an appraisal following the MTA process.

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Assessment Report

A critical review of the clinical and cost effectiveness of a health technology or technologies being appraised within the multiple technology appraisal (MTA) process. It is prepared by the Assessment Group. To prepare the report, the Assessment Group carries out a review of the published literature and the submissions from manufacturers and sponsors.

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Association of British Healthcare Industries (ABHI)

The industry association for the medical technology sector in the UK.

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Association of the British Pharmaceutical Industry (ABPI)

The trade association for more than 90 companies in the UK producing prescription medicines for human use.

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ASTUTE

Advanced Sustainable Manufacturing Technologies

AWMSG – All Wales Medicines Strategy Group

A statutory advisory Welsh Assembly-sponsored public body which provides advice on medicines management and prescribing to the Welsh Government’s Minister for Health and Social Services in an effective, efficient and transparent manner.

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BBA

British Bankers’ Association

BGF

Business Growth Fund

BIS

Department for Business, Innovation and Skills

BRC

Biomedical Research Centre

British In Vitro Diagnostics Association (BIVDA)

The national industry association for companies with major involvement and interest in the in vitro diagnostics (IVD) industry.

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BRU

Biomedical Research Unit

Budget Impact Model (BIM)

A budget impact model measures the net cumulative cost of treatment with a particular therapy for a given number of patients in a specific population.

Carer

‘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.

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CCG

Clinical Commissioning Group

CE Mark

The manufacturer’s declaration that the product meets the requirements of the applicable EC directives. The actual words signified by “CE” have been disputed. It is often taken to be an abbreviation of Conformité Européenne, meaning “European Conformity”.

CE mark(ing)

Is the manufacturer’s declaration that the product meets the requirements of the applicable EC directives. The actual words signified by “CE” have been disputed. It is often taken to be an abbreviation of Conformité Européenne, meaning “European Conformity”.

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 conducted in accordance with the published appraisal process and methodology.

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CIMIT

Center for Integrating Medicine & Innovative Technology

Citizens Council

A group of 30 people drawn from all walks of life who bring the public’s views to NICE decision-making. The Citizens Council tackles challenging questions about values, such as fairness and need.

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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.

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Clinical investigation

Any systematic investigation or study in human subjects, undertaken to verify the safety and performance of a device under normal conditions of use.

Clinical investigation plan

A document that includes detailed information on the rationale, aims and objectives, design and proposed analyses, methodology, and conduct of the clinical investigation.

Clinical investigator

The person responsible for the conduct of a clinical investigation and who takes the responsibility for the health and safety of the subjects involved.

Clinical Specialist

In technology appraisals, clinical specialists 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.

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Commentator

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

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Commercial in confidence

See ‘In confidence material

Committee for Economic and Public Health Assessment (CEESP)

A specialist committee within HAS for the economical assessment of drugs, medical devices and care strategies. They issue public health recommendations and technology appraisals based on clinical and economic evidence as well as on other domains (eg ethics, organisation).

Committee papers

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

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Comparator

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

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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 conduct a study and assess the validity of the results.

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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.

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Consultee

An organisation that participates 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 specialists, 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 determination (FAD).

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Cost effectiveness

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

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CPRD

Clinical Practice Research Datalink

CRC

Clinical Research Centre

DA

Devolved Administration

DALLAS

Delivering Assisted Living Lifestyle at Scale

DAP

Diagnostics Assessment Programme

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.

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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 required, 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.

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Department for International Trade (DIT)

The department for international trade (DIT) is a UK Government department working with businesses based in the United Kingdom to assist their success in international markets, and with overseas investors looking to the UK as an investment destination.

Formerly known as UKTI.

Department of Health

The Department of Health 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 like environmental hazards to health, infectious diseases, health promotion and education, the safety of medicines, and ethical issues.

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Directorate of Social Security (DSS)

One of the main areas within the French Ministry of Health which elaborates the Social Security policy (Sickness Fund, pension, family). It is also attached to the Ministry of Finance.

Drees

The Directorate for Research, Studies, Evaluation and Statistics within the Ministry of Health.

Economic Committee of Health Care Products (CEPS)

The Comité Economique des Produits de Santé (CEPS) fixes the medicine price after negotiation with the medicine company. It is an inter-ministerial body under the joint authority of the ministries for Health, Social Security and Economy.

Economic evaluation

An economic study design that allows the consequences of different interventions to be measured against a single outcome, usually in ‘natural’ units (for example, life years gained, deaths avoided, heart attacks avoided, cases detected). Alternative interventions are then compared in terms of cost per unit of effectiveness.

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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.

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EI – Enterprise Ireland

Enterprise Ireland is the Irish leading state economic development agency focused on helping Irish-owned business delivers new export sales.

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EIS

Enterprise Investment Scheme

EPSRC

Engineering and Physical Sciences Research Council

EUDAMED: European Database on Medical Devices

EUDAMED will be an information system for exchanging legal information related to the application of European Union Directives on medical devices between the European Commission’s Enterprise and Industry Directorate General and the Competent Authorities in the European Union Member States. Its legal basis is laid down in Directives 90/385/EEC, 93/42/EEC, 98/79/EC and 2000/70/EC.

European Commission (EC)

The European Commission is the EU’s executive body. It represents the interests of the European Union as a whole and not individual countries.

The Commission’s main roles are to:

  • propose legislation which is then adopted by the co-legislators, the European Parliament and the Council of Ministers
  • enforce European law (where necessary with the help of the Court of Justice of the EU)
  • set a objectives and priorities for action, outlined yearly in the Commission Work Programme and work towards delivering them
  • manage and implement EU policies and the budget
  • represent the Union outside Europe (e.g. negotiating trade agreements between the EU and other countries)

European Economic Area – EEA

European Economic Area – This was established on the 1st January 1994. The EEA includes the countries of the EU (European Union) plus Iceland, Liechtenstein and Norway.

European Medicines Agency (EMA)

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/carers).

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Evidence Review Group (ERG)

An independent assessment group commissioned by the NHS Research and Development Health Technology Assessment (HTA) programme to produce an independent assessment of the evidence submitted by the manufacturer or sponsor of a technology being appraised within the single technology appraisal (STA) process.

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Evidence Review Group report

A critical assessment of the evidence submitted by the manufacturer of a technology being appraised within the single technology appraisal (STA) process. It is prepared by the Evidence Review Group.

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Final appraisal determination (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.

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French National Authority for Health (HAS)

Haute Autorité de Santé (HAS) is an independent public scientific authority with financial autonomy. Its key purpose is to improve the quality of patient care and to guarantee equity within the healthcare system. It does this through the:

  • assessment of drugs and medical devices
  • certification of healthcare organisations and accreditations of doctors
  • publication of guidelines (good practices, public health)

GBA

Gemeinsamer Bundesausschuss – The Joint Federal Committee (GBA) is authorized to set limitations on coverage. It is the highest decision –making body of the joint self-government of a second function of the G-BA is the definition of drugs, which are subject to fixed prices.

General Inspectorate of Social Affairs (IGAS)

The centre which controls, audits and evaluates structures and policies within the Ministry of Health.

GKV-SV

Association of Statutory Health Insurance Funds – being the central association of the health insurance funds at federal level in accordance with section 217 a of Book V of the German Social Code (SGB V).

Guidance Executive

A team comprising the Executive Directors and Centre Directors at NICE who are responsible for approving the final appraisal determination before publication.

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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.

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Health Technology Assessment (HTA)

The systematic evaluation of properties, effects, and/or impacts of health technology. It is a multidisciplinary process to evaluate the social, economic, organisational and ethical issues of a health intervention or health technology. The main purpose of conducting an assessment is to inform a policy decision making for a drug, medical device or clinical/surgical procedure.

Health-related quality of life

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

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Healthcare Improvement Scotland (HIS)

The national healthcare improvement organisation for Scotland. The SMC is part of HIS.

HIS has a key role in supporting healthcare providers to make sure that their services meet these expectations and continually improve the healthcare the people of Scotland receive.

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HES

Hospital Episode Statistics

HICF

Health Innovation Challenge Fund

HPRA

Health Products Regulatory Authority – It’s role is to protect and enhance public and animal health through the regulation of medicines, medical devices and other health products.

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HSC R&D

Health and Social Care Research and Development

HSCIC

Health and Social Care Information Centre

IMDA – Irish Medical Devices Association

IMDA aims to promote and support an environment that encourages the sustainable development and profitable growth of multinational and indigenous medical device and diagnostic companies.

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Implantable device

Any device which is intended to be totally introduced into the human body, by surgical intervention and which is intended to remain in place after the procedure. Any device intended to be partially introduced into the human body through surgical intervention and intended to remain in place after the procedure for at least thirty days is also considered an implantable device.

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.

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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.

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Indication

The defined use of a technology as licensed by the European Medicines Agency (EMA) or the European Commission as well as specific bodies in each country such as the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK.

Invasive device

means a device which, in whole or in part, penetrates inside the body, either through a body orifice or through the surface of the body.

IQWiG

Institute for Quality and Efficiency in Health Care – The Institute for Quality and Efficiency in Healthcare is a German agency responsible for assessing the quality and efficiency of medical treatments, including drugs, non-drug interventions, diagnostic and screening methods, and treatment and disease management.

IRAS

Integrated Research Application System

ISPOR

International Society for Pharmacoeconomics and Outcomes Research (ISPOR), an international organisation promoting the science of pharmacoeconomics and health outcomes research Includes a section: Pharmacoeconomic Guidelines Around the World.

KTN

Knowledge Transfer Network

KTP

Knowledge Transfer Partnership

Lead team

Members of the Appraisal Committee asked to introduce individual appraisals at Committee meetings.

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LSIO

Life Science Investment Organisation

Market Authorisation Holder (MAH)

The MAH stands for the company in whose name the marketing authorisation has been granted. This party has responsibility for all aspects of the product, including quality and compliance with the conditions of the marketing authorisation.

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Marketing Authorisation

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

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Marketing Authorisation Holder – MAH

Marketing authorisation holder – This is an EU term. The MAH stands for the company in whose name the marketing authorisation has been granted. This party has responsibility for all aspects of the product, including quality and compliance with the conditions of the marketing authorisation.

MAS

Manufacturing Advisory Service

Medical Device Liaison Officer (MDLO)

This person’s primary role is to encourage the effective reporting of adverse incidents.

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Medical devices

All products, except medicines, used in healthcare to diagnose, prevent, monitor or treat illness or disability. For example, a device might be a pacemaker, knee replacement, X-ray or blood pressure monitor.

Medical Devices Directive (MDD)

The Medical Device Directive is intended to harmonise the laws relating to medical devices within the European Union.

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Medical Innovation Briefing (MIB)

MIBs help support NHS and social care commissioners and staff who are considering using new medical devices and other medical or diagnostic technologies. They include a description of the technology, how it’s used and its potential role in the treatment pathway.

A MIB also includes a review of relevant published evidence and the likely costs of using the technologies. They are designed to be fast, flexible and responsive to the need for information on innovative technologies.

Medical Research Council (MRC)

The Medical Research Council is a publicly funded government agency responsible for co-ordinating and funding medical research in the United Kingdom.

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Medical Technologies Advisory Committee

An independent committee with 2 roles: selecting medical technologies for evaluation by other NICE guidance programmes and developing medical technologies guidance itself.

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Medical Technologies Evaluation Programme

A programme to identify medical technologies that could offer benefits to patient or the NHS. Manufacturers notify NICE about possible topics. The Medical Technologies Advisory Committee selects products for evaluation. It may carry out the evaluation itself or refer the topic to be evaluated by another NICE programme – usually technology appraisals, interventional procedures, diagnostics, and sometimes guidelines.

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Medical technologies guidance

Guidance produced by the Medical Technologies Advisory Committee on technologies that it evaluates. Medical technologies may also be evaluated by other NICE programmes, and usually result in diagnostics guidance or technology appraisal guidance.

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Medicines and Healthcare Products Regulatory Agency (MHRA)

The Executive Agency of the Department of Health. 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.

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MTEP

Medical Technologies Evaluation Programme

Multicentre investigation

means a clinical investigation, conducted according to a single clinical investigation plan, which takes place at different investigation sites.

National Assembly

The National Assembly for Wales is the democratically elected body that represents the interests of Wales and its people, makes laws for Wales, and holds the Welsh Government to account.

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National Committee for the Assessment of Medical Devices and Health Technologies (CNEDiMTS)

One of the 6 specialist committees within the HAS responsible for the assessment of medical devices and professional practices.

National Health Service (NHS)

The NHS is the name commonly used to refer to the publicly funded healthcare systems of the UK.

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National Institute for Health and Care Excellence (NICE)

A public body of the Department of Health in the UK which provides national guidance and advice to improve health and social care. NICE also develop guidance, standards and information on high quality health and social care.

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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 (HTA) Programme on behalf of the NIHR. The aim of the HTA 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.

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NESTA

National Endowment for Science, Technology and the Arts

NHS Scotland – National Health Service in Scotland

NHS Scotland is the publicly funded healthcare system in Scotland. Health and social care policy and funding are the responsibility of the Health and Social Care Directorates of the Scottish Government.

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NHSCB

National Health Service Commissioning Board

NIHR

National Institute for Health Research

NIHR i4i

National Institute for Health Research Invention for Innovation

NISCHR

National Institute for Social Care and Health Research

NOCRI

NIHR Office for Clinical Research Infrastructure

Notified Body

A notified body, in the European Union, is an entity that has been accredited by a Member State to assess whether a product to be placed on the market meets certain preordained standards.

NRS

NHS Research Scotland

NRS Permissions CC

NHS Research Scotland Permissions Coordinating Centre

ONDAM

The health insurance expenditure.

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.

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Palliative therapy

To relieve the pain and treat a disease as far as possible, but not cure it completely.

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Patient Access Scheme (PAS)

A schemes where an agreement is reached with a pharmaceutical company in order to reduce the costs of a medicine to the NHS and improve its cost-effectiveness, and enable patients to receive access to cost-effective, innovative medicines.

Patient Access Scheme Assessment Group (PASAG)

The Patient Access Schemes (PAS) advisory group in Scotland. PASAG review and advise NHS Scotland on the feasibility of proposed PAS for implementation. It operates separately from the SMC to maintain the integrity and independence of the assessment process.

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Patient Access Scheme Liaison Unit (PASLU)

The Patient Access Scheme Liaison Unit (PASLU) at NICE assesses whether patient access schemes (PAS) are feasible to implement, and produces advice to the Department of Health. When assessing whether a patient access scheme is feasible to implement, the PASLU considers the key principles for implementing patient access schemes in the NHS in England as outlined in the 2014 Pharmaceutical Price Regulation Scheme (PPRS).

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Patient Access Scheme Wales Group (PASWG)

The Patient Access Schemes (PAS) advisory group in Wales, which aids the reviewing process for PAS applications made to the All Wales Medicines Strategy Group (AWMSG) within the Health Technology Appraisal (HTA) process.

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Patient Experts

Acts as an expert witness to the Appraisal Committee. Patient experts have used the technology either personally or as part of a representative group. They provide a view on the risks and benefits of the technology from personal experience as a patient or carer, and an understanding of the wider range of patient and/or carer views.

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Pharmaceutical Price Regulation Scheme (PPRS)

The 2014 PPRS is a non-contractual scheme. The parties to this agreement are the Department of Health, acting on behalf of the health departments of England, Wales, Scotland and Northern Ireland, and the Association of the British Pharmaceutical Industry (ABPI). The purpose of the scheme is to ensure that safe and cost-effective medicines are available on the NHS in England.

Public Health Wales NHS Trust

Public Health Wales was established as an NHS Trust on 1 October 2009. The Trust incorporates the functions and services previously provided by the National Public Health Service for Wales, the Wales Centre for Health, the Welsh Cancer Intelligence and Surveillance Unit, and the Congenital Anomaly Register and Information Service for Wales. Its statutory functions cover a broad range of public health, health protection, screening, health intelligence and research services.

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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 and supplies the patient and carer group information for the ‘Information for the public’.

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R&D

Research & Development

RAE

Royal Academy of Engineering

Real world evidence (RWE)

Real-world evidence provides significant insight into how a drug or drug class performs or is used in real-world medical settings.

Redacted

If documents contain confidential information, it must be redacted. ‘Academic in confidence’ and ‘commercial in confidence’ information should be replaced with asterisks and then highlighted in black.

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Remit

This is the brief the Department of Health 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.

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RGF

Regional Growth Fund

RSA

Regional Selective Assistance

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.

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Scottish Medicines Consortium (SMC)

A consortium of stakeholders from NHS Boards and Area Drug and Therapeutic Committees (ADTCs) with representation derived from across NHS Scotland. The SMC provides advice to all NHS Boards and their ADTCs about the status of all newly licensed medicines, all new formulations of existing medicines and any major new indications for established products. All new products must undergo an SMC evaluation within 3 months of launch.

SEIS

Seed Enterprise Investment Scheme

SHTG

Scottish Health Technologies Group

SMAS

Scottish Manufacturing Advisory Service

SMEs

Small and Medium Sized Enterprises

SMEs

Small and medium-sized enterprises.

Social Code Book V – SGB V

German social code book, this section specialises in Health insurance.

Social Security Financing Act (LFSS)

The act set by the Ministry of Health for the general framework for social security spending and a national target ceiling for health insurance expenditure (ONDAM).

Sponsor

A sponsor is a pharmaceutical company who may not manufacture the technology being appraised but holds the marketing authorisation.

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SSCIF

Specialised Service Commissioning Innovation Fund

Statutory Health Insurance Funds (SHIs)

These cover healthcare bills for the insured population. Being insured is compulsory in Germany and 92% of the population are covered by the SHIs.

Summary of product characteristics (SPC)

The SPC provides information for healthcare professionals on how to use medicines safely and effectively. The SPC does not give general advice on the treatment of particular medical conditions.

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Surgically invasive

means an invasive device which penetrates inside the body, other than through an established body orifice, with the aid or in the context of a surgical operation.

Systematic review

Research that summarises the evidence on a clearly formulated question according to a predefined protocol. Systematic and explicit methods to identify, select and appraise relevant studies, and to extract, collate and report their findings are used. Statistical meta-analysis may or may not be used.

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TAP

Technology Appraisals Programme

Technology appraisal (single and multiple)

The process of developing recommendations on the use of new and existing health technologies within the NHS in England. A multiple technology appraisal will normally cover more than 1 technology, or 1 technology for more than 1 indication. A single technology appraisal covers a single technology for a single indication.

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Technology assessment

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

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Terminated appraisal

The single technology appraisal process relies on manufacturers or sponsors 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 manufacturer or sponsor did not make an evidence submission when making local decisions on whether to offer the treatment.

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Transparency Committee (CT)

Part of the HAS, the CT provide independent scientific advice concerning the usefulness, interest and good use of drugs when there is a demand by the pharmaceutical company to have the medicine enlisted on a positive list to be reimbursed.

TSB

Technology Strategy Board

TTO – Technology Transfer Office

Technology transfer, also called transfer of technology (TOT), is the process of transferring skills, knowledge, technologies, methods of manufacturing, samples of manufacturing and facilities among governments or universities and other institutions to ensure that scientific and technological developments are accessible to a wider range of users who can then further develop and exploit the technology into new products, processes, applications, materials or services.

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UKTI

UK Trade & Investment – See ‘DIT

VC

Venture Capital

WHSSC

Welsh Health Specialised Services Committee – is responsible for the joint planning of Specialised and Tertiary Services on behalf of Local Health Boards in Wales.

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