NICE process and methods
How to use this manual
This manual explains how NICE does health technology evaluations. It includes both the processes we use – that is, what steps happen, when, and who is involved – and the methods – that is, how different types of evidence are collected and considered, and the principles and considerations that go into making recommendations. The processes and methods are presented throughout the manual, to show what happens and how throughout the evaluation process.
You can use this manual to find out how health technology evaluations happen either by reading it in full, or by exploring particular sections to find out in detail what happens at a particular stage, for a particular participant or for a particular type of evidence. The following sections describe where particular information can be found.
What the manual contains
This manual has 8 chapters:
1. Involvement and participation
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Describes who is involved in health technology evaluations, at different stages, and how they participate.
2. The scope
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Describes how we develop the scope for an evaluation – that is, what question it will answer, and what will and will not be included.
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Includes the steps that happen during the scoping stage, and what the scope document contains.
3. Evidence
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Describes the principles for how different types of evidence are collected, presented and considered.
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Includes all types of evidence (such as randomised controlled trials, non-randomised evidence, diagnostic test accuracy, qualitative research and expert evidence), as well as how evidence is combined (or 'synthesised') from multiple studies or sources.
4. Economic evaluation
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Describes the methods for evaluating the costs and benefits of health technologies in an economic evaluation, to understand its value for money.
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Includes different types of economic evaluation, including cost–utility analyses (which consider costs and health benefits measured using quality-adjusted life years) and cost-comparison analyses (which consider only the costs and effects on NHS resources).
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Where the manual refers to multiple programmes, the term 'value for money' has been used as a generic term to describe economic evaluation approaches.
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Presents NICE's preferred methods for economic evaluation (the reference case) and alternative methods (non-reference case), including which costs and benefits are included, how and over what period, how future costs and benefits are considered, methods for modelling and exploring uncertainty, and how the results should be presented.
5. Developing the guidance
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Describes the processes for making guidance.
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Includes the steps involved in the evaluation from start to finish, how information and evidence is collected, reviewed and handled, how committee meetings work, and the steps involved in commercial and managed access discussions in evaluations.
6. Committee recommendations
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Describes the methods that committees use to reach decisions and make recommendations.
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Includes how committees assess the strengths and limitations of evidence, the factors, considerations or 'modifiers' they take into account, and how they reach a decision based on the evidence.
7. Finalising and publishing the guidance
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Describes what happens after a recommendation is made, in order to complete the evaluation and publish the guidance.
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Includes the opportunities to challenge diagnostic and medical technologies guidance (termed 'resolution'). Appeals for guidance with a funding requirement are presented in the guide to the technology appraisal and highly specialised technologies appeal process.
Where to find information
The following table details where to find commonly used information. It is not exhaustive, and you should refer to the whole manual for full details.
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If you want to find out about… |
Look in… |
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How to get involved in an evaluation, how to become an expert, what experts do |
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How the scoping process works, what it includes, how to get involved, how scoping workshops work |
Section 2.4 – identifying stakeholders |
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Who can submit evidence and how, and what types of evidence are considered |
Principles and types of evidence: Chapter 3 – evidence How it is considered: Chapter 6 – (particularly sections 6.2 and 6.3) – committee recommendations Who can submit: Chapter 1 – involvement and participation |
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Economic evaluations – what they are, what they include, how they affect recommendations |
Chapter 4 – economic evaluation Chapter 6 (particularly sections 6.2 and 6.3) – committee recommendations |
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How committees make recommendations, how they think about comparators, clinical and cost evidence, and additional factors ('modifiers') |
Chapter 6 (particularly sections 6.1 to 6.4) – committee recommendations |
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The steps involved in an evaluation |
Chapter 5 (particularly sections 5.1 to 5.10) – developing the guidance |
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Confidential information – what is confidential and why, and how it is handled |
Sections 5.3 and 5.4 – information handling |
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Managed access – what it is, how decisions are made, what happens after managed access |
Section 6.4 – types of recommendation Section 5.9 – patient access schemes and commercial access agreements |
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What happens after an evaluation, and how NICE decides whether guidance needs to be reviewed |