The principles that guide the development of NICE guidance and standards
1. In 2005, NICE published a guide setting out the social and scientific ‘value judgements’ that informed our approach to developing guidance. The social value judgements document (Word, superseded) helped our advisory committees resolve uncertainty in the available evidence. It informed their judgement when developing guidance, by giving them a set of principles.
2. The social value judgements were originally designed to support decision-making in guidance on new technologies. NICE’s remit has grown significantly since then. We now produce guidance for local government and social care providers, which draws on a wider range of evidence. The original social value judgements document remains relevant to our work, and much of what it contains is included in our methods and process manuals.
3. This document, which replaces the social value judgements document, focuses on the key principles that are universal to all of our guidance and standards. Our independent advisory groups are expected to use it, along with our methods and process guides and the NICE charter, to inform their decisions. Our charter is a statement of purpose that describes who we are, what we do and how we do it. The NICE principles document, like the social value judgements document before it, goes beyond that, to explain the morals, ethics and values that underpin our recommendations.
4. When making decisions, NICE and our committees strive to balance the need to achieve the most overall benefit for the greatest number of people, with the need to ensure fairness and respect for individual choice. NICE advisory committees have to make judgements about the fair and equitable distribution of scarce resources, often in the face of uncertain evidence. When making judgements about what health and social care services should provide, it is important to be able to explain what informs those judgements.
5. NICE guidance aims to meet population needs by identifying care that is high quality, good value, and provides the best outcomes for people using health and social care services within the budget available. An important part of high quality care is enabling people to be equal partners in planning their care and making informed decisions about it. But in the best interests of the wider population, and because of limited resources, decisions have to be made about what options are publicly funded. This might be, for example, by focusing resources on interventions that have been proven to be effective or cost effective. NICE believes that overall population needs are paramount in determining the fair allocation of resources. But it also recognises that in some circumstances, in the interests of fairness, the needs of particular groups may override those of the broader population.
6. NICE’s advisory committees use their own discretion when developing guidance and standards. But their decisions are guided by the principles in this document, which are based in part on the following moral principles:
- People have the right to make informed choices about the care they receive. But not everyone has the ability to make their own choices, and not everything people might want will necessarily be available.
- Every intervention has the potential to cause harm and may not always benefit everyone. So it is important consider the balance of benefits and harms when deciding whether an intervention is appropriate.
- Resources need to be allocated appropriately and fairly. They must provide the best outcomes for the finite resources available while balancing the needs of the overall population and of specific groups.
The principles that guide NICE's work
How we produce guidance
Principle 1. Prepare guidance and standards on topics that reflect national priorities for health and care
7. NICE’s remit covers health, public health and social care, as set out in the Health and Social Care Act 2012. To ensure our guidance and standards appropriately cover this breadth of topics, we have several processes to prioritise our work.
8. We welcome topic suggestions from a range of sources. These include people using services, health and social care professionals, manufacturers and commercial sponsors, and horizon scanning by the National Institute for Health Research. We work with the Department of Health and Social Care, Public Health England and NHS England and NHS Improvement to select and prioritise topics that reflect the ambitions and capacity of the health and care system. We do this using criteria that include several aspects of a disease, condition or care need. These include impact on health and wellbeing, variation in current service provision, uncertainty about best practice, the available evidence, and the potential to reduce health inequalities.
Principle 2. Describe our approach in process and methods manuals, and review them regularly
9. NICE’s guidance can have a significant impact on people’s lives. So it is important that we are explicit about the approaches we use and allow others to comment on them. The NICE (Constitution and Functions) Regulations 2013 require us to have, and consult on, procedures for giving advice or guidance, and making recommendations. The principles of the NHS Constitution also highlight the importance of transparency and accountability in our decision-making processes.
10. All our guidance and standards programmes have detailed process and methods manuals. These go through rigorous review, assessment and consultation before being published. They are updated regularly. We are required to follow our documented processes and methods and are accountable for the decisions that we make. Sometimes it is appropriate to depart from the documented processes and methods for particular recommendations. When this happens, we clearly explain our rationale in the guidance or standard, or in accompanying documents.
Principle 3. Use independent advisory committees to develop recommendations
11. We use independent advisory committees to consider the evidence. This is to ensure that our recommendations are unbiased and objective, and that the evidence is interpreted in a way that is relevant to health and social care delivery in England. Even the best research evidence will never be complete and comprehensive, so it is essential that it is considered by a committee independent of NICE.
12. The credibility of NICE guidance depends on the committee making decisions using a process that is transparent and contestable. It is crucial that the reasons for the committee's decisions and reasoning are explained clearly. This includes explaining the available evidence, and how the contributions of experts and the views of people who responded to consultation have been taken into account.
13. Committees include people from the NHS, commissioners and providers of social care, local authorities, academia, relevant industries, organisations that represent people who use services and carers, and the general public. Committee members are selected for their knowledge and experience. They are each there in their own right and do not usually represent organisations they work in. All committee members, invited experts and any organisations nominating specialists or making written submissions, declare any relevant interests both annually and for each committee meeting they attend. They do this according to our policy on managing potential conflicts of interest.
Principle 4. Take into account the advice and experience of people using services and their carers or advocates, health and social care professionals, commissioners, providers and the public
14. NICE needs to ensure that the process for developing guidance and standards involves people who will be affected by it, to ensure their needs and priorities are reflected. We build in these perspectives through the membership of our guidance development committees. If this isn’t possible, we find experts to give testimony to the committee.
15. The people who work with us reflect the experiences of a wide range of people affected by the guideline. They don’t base their views solely on personal experience. All interested groups, including health and social care professionals and voluntary and community sector organisations, are involved in defining the scope of our products, may be invited to submit evidence to the committee, and have the opportunity to comment on draft recommendations.
16. NICE's Public Involvement Programme supports people who use services, their families, carers and the public to take part in our work. It promotes their involvement regardless of disability, language, or other potential barriers.
Principle 5. Offer people interested in the topic the opportunity to comment on and influence our recommendations
17. NICE recommendations are based on detailed consideration of the evidence by our committees, and it is important that a wider group of stakeholders are also consulted. This wide consultation helps ensure the validity of the final recommendations. The principles of the NHS Constitution also require us to be accountable to the public, and to make decisions in a clear and transparent way.
18. All our guidance and standards are therefore developed using a process that takes into account the opinions and views of the people who will be affected by them. Consultations are open to voluntary and community sector organisations as well as health and social care professionals, NHS organisations, industry, social care businesses and local government. As part of the consultation stakeholders have an opportunity to comment on the potential impact of our guidance on health inequalities, as well as on the content of the recommendations. Our advisory committees consider and respond to comments and make amendments if appropriate.
What we take into account
Principle 6. Use evidence that is relevant, reliable and robust
19. NICE’s guidance and standards are underpinned by evidence. So we need to ensure that this evidence is relevant, reliable and robust. To do this, we have processes to identify research evidence, determine whether it is relevant and assess its quality. We also work with data providers to ensure the information and data analytics that we use are high quality and robust.
20. For each piece of guidance, we consider whether the methodology used to produce the evidence is appropriate. We recognise the value of traditional ‘hierarchies of evidence’ but take a comprehensive approach to assessing the best evidence that is available to answer the questions we face. Our process and methods manuals set out the types of evidence that are generally appropriate for different types of question. This can include qualitative and quantitative evidence, from the literature or submitted by stakeholders. It can also include observational data and testimonies from experts.
21. Committees should not recommend an intervention if there is no evidence, or not enough evidence, on which to make a clear decision. But they may recommend using it in a research programme or alongside mandatory data collection, if this will provide more information about its effectiveness, safety or cost (see principle 11).
Principle 7. Base our recommendations on an assessment of population benefits and value for money
22. When NICE was established, the directions from the Secretary of State for Health made clear that we should take into account both the costs and benefits of interventions in our recommendations and encourage the effective use of resources. This was restated in the Health and Social Care Act 2012, which requires us to have regard to the broad balance between the benefits and costs of providing health services of social care in England. We must also take account of our commitment under the NHS Constitution to provide ‘the best value for taxpayers’ money and the most effective, fair and sustainable use of finite resources’.
23. If possible, NICE considers value for money by calculating the incremental cost-effectiveness ratio (ICER). This is based on an assessment of the intervention’s costs and how much benefit it produces compared with the next best alternative. It is expressed as the ‘cost (in £) per quality-adjusted life year (QALY) gained’. This takes into account the ‘opportunity cost’ of recommending one intervention instead of another, highlighting that there would have been other potential uses of the resource. It includes the needs of other people using services now or in the future who are not known and not represented. The primary consideration underpinning our guidance and standards is the overall population need. This means that sometimes we do not recommend an intervention because it does not provide enough benefit to justify its cost. It also means that we cannot apply the ‘rule of rescue’, which refers to the desire to help an identifiable person whose life is in danger no matter how much it costs. Sometimes NICE uses other methods if they are more suitable for the evidence available, for example when looking at interventions in public health and social care.
24. Interventions with an ICER of less than £20,000 per QALY gained are generally considered to be cost effective. Our methods manuals explain when it might be acceptable to recommend an intervention with a higher cost-effectiveness estimate. A different threshold is applied for interventions that meet the criteria to be assessed as a ‘highly specialised technology’.
25. NICE’s recommendations should not be based on evidence of costs and benefit alone. We must take into account other factors when developing our guidance. We also recognise that decisions about a person’s care are often sensitive to their preferences. We support personalised care and shared decision-making and provide information and tools to help with this in and alongside our guidance and standards.
What our guidance aims to achieve
Principle 8. Support innovation in the provision and organisation of health and social care services
26. The importance of promoting innovation in the provision of health services and social care is set out in the Health and Social Care Act 2012. NICE aims to support this innovation by encouraging interventions that provide substantial distinctive benefits that may not be captured by measuring health gain (that is, the estimated QALYs gained).
27. Innovation does not necessarily lead to better outcomes than existing practice. And if innovations come at an additional cost, they may divert resources away from existing practices that are better value for money. To mitigate the risk of an innovative intervention not performing as expected NICE’s committees can, in appropriate circumstances, recommend its use in the context of a managed access arrangement.
Principle 9. Aim to reduce health inequalities
28. The Health and Social Care Act 2012 states that the Secretary of State, NHS England and NHS Improvement and clinical commissioning groups must give ‘due regard’ to reducing inequalities. This provides the context in which NICE’s recommendations are implemented. So our guidance should support strategies that improve population health as a whole, while offering particular benefit to the most disadvantaged.
29. We think about equality in relation to the protected characteristics stated in the Equality Act 2010. We also take into account inequalities arising from socioeconomic factors and the circumstances of certain groups of people, such as looked-after children and people who are homeless. If possible, our guidance aims to reduce and not increase identified health inequalities. This may mean making recommendations for specific groups of people (see principle 10).
30. Some conditions, such as sexually transmitted diseases and drug dependency are associated with stigma. We do not consider this a reason to alter our normal approach to developing advice and guidance. However, stigma may affect people’s behaviour in a way that changes the effectiveness of an intervention and routine quality of life assessments may not capture the benefits of treatment. Our advisory committees should take both these factors into account.
31. We do not alter our normal approach because a condition may have been caused by the person’s behaviour. But it may be appropriate to take behaviour into account if it is likely to continue and to make a treatment less clinically effective or cost effective.
Types of recommendation
Principle 10. Consider whether it is appropriate to make different recommendations for different groups of people
32. NICE’s guidance aims to serve the interests of the population as a whole. But sometimes the available evidence shows differences in the effectiveness and cost effectiveness of an intervention for a particular group of people. Certain groups may also be at a disadvantage compared with others, including those covered by the Equalities Act 2010. In such cases, it may be appropriate for us to make recommendations for specific groups of people.
33. NICE may recommend an intervention for a specific group of people only if there is:
- enough relevant evidence that the intervention is more effective or cost effective in the subgroup, or
- a legal requirement to act in this way, or
- other reasons relating to fairness for society as a whole.
Principle 11. Propose new research questions and data collection to resolve uncertainties in the evidence
34. NICE examines the available evidence when it produces guidance. This often highlights unanswered questions. There may be uncertainties because there is no published evidence available, or the evidence is conflicting, insufficient or not robust. We make recommendations for research in areas for which resolving uncertainties could affect future recommendations. We liaise with the research community to ensure they are addressed.
35. We have processes and methods for committees to make recommendations for research. We share these recommendations with researchers and funders including the UK Research Councils, research charities, and industry. We work closely with the National Institute for Health Research Evaluation, Trials and Studies Coordinating Centre (NETSCC) to prioritise the recommendations.
36. If there are uncertainties about an intervention’s effectiveness, safety or cost that can be addressed by collecting more data, committees may recommend using the intervention:
- only in a research programme, or
- if explicit conditions are met for collecting data to resolve the uncertainties, for example, through a managed access agreement.
This is helpful for interventions showing promise of being better than existing alternatives, but for which the evidence is limited.
What we do after making recommendations
Principle 12. Publish and disseminate our recommendations and provide support to encourage their adoption
37. NICE’s guidance and standards will not have any impact if they are not used by the health and care system. When implemented effectively, they can support local improvement initiatives, improve outcomes, reduce health inequalities and reduce variations in practice across the country.
38. The NICE (Constitution and Functions) Regulations 2013 require us to publish or disseminate our recommendations. Our implementation strategy supports adoption of these recommendations by:
- producing guidance and standards that are fit for the audience’s needs
- ensuring relevant audiences know about our recommendations
- motivating and encouraging improvement
- highlighting practical support to improve local capability and opportunity
- evaluating impact and uptake.
We work with strategic partners to reinforce NICE’s recommendations in national and regional initiatives. We support personalised care, including shared decision-making, in all our work to help people implement our guidance and standards.
Principle 13. Assess the need to update our recommendations in line with new evidence
39. NICE’s guidance and standards need to be up to date to ensure people receive the best care and advice, and to be credible for health and social care professionals, commissioners and providers. The NICE (Constitution and Functions) Regulations 2013 require us to review and revise, as we consider appropriate, all our advice, guidance and information.
40. We regularly assess the need to update our guidance and standards. New evidence might change conclusions about the benefits and risks of an intervention, and so the extent to which it represents good value for money. We may review guidance if we find evidence that might change our recommendations, or if there are changes in the health and care system. We normally consult with relevant organisations on a proposal about whether guidance needs updating and, if so, how to do the update.
- The 2008 edition of Social value judgements: principles for the development of NICE guidance (Word, superseded), which this document replaces
- NICE Citizens Council reports available on PubMed Bookshelf.
The legislative and policy requirements that apply to NICE’s guidance are set out in these documents:
- The 7 principles of public life (also known as the ‘Nolan principles’)
- Care Act 2014
- Department of Health and Social Care’s outcomes frameworks
- Equality Act 2010
- Health and Social Care Act 2012
- Human Rights Act 1998
- NHS Constitution
- NICE (Constitution and Functions) Regulations 2013
- NICE charter
- NICE Patient and Public Involvement Policy
- Sustainable Development Unit’s sustainable development strategy