The National Institute for Health and Care Excellence (NICE) is an executive non-departmental public body of the UK Government's Department of Health and Social Care.
As the national health technology assessment body of England, it is responsible for judging the cost-effectiveness of medicines and making them available on the NHS through reimbursement, with its judgements informing decisions in Wales and Northern Ireland. It also provides a range of clinical guidance to the NHS in England and Wales, which are considered by Northern Ireland.
History
Organisational history Set up as the National Institute for Clinical Excellence in 1999, on 1 April 2005 the Health Development Agency was abolished, with their functions passed to NICE. Following the Health and Social Care Act 2012, NICE was renamed the National Institute for Health and Care Excellence, still abbreviated to NICE, on 1 April 2013 reflecting its new responsibilities for social care, and changed from a special health authority to an executive non-departmental public body (NDPB).
NICE was established in an attempt to end the so-called postcode lottery of healthcare in England and Wales, where availability of treatments depended on the NHS Health Authority area where the patient lived, but it has since acquired a reputation internationally as a role model for the development of clinical guidelines. One aspect of this is the explicit determination of cost–benefit boundaries for certain technologies that it assesses. NICE also plays an important role in pioneering technology assessment in other healthcare systems through NICE International, established in May 2008 to help cultivate links with foreign governments. NICE International has received financial support from the Bill & Melinda Gates Foundation and Rockefeller Foundation.
Policy history The notion of an Institute to determine the effectiveness of clinical interventions first emerged at the end of John Major's Conservative Government as moves elsewhere were being made to set professionally agreed standards for clinical care. In 1997, the UK National Screening Committee (NSC) had been established by Sir Kenneth Calman and Muir Gray (now Sir Muir Gray) by the Policy Team led by Timothy Riley for the Department of Health. The NSC aimed to ensure that evidence-based medicine informed policy making on what national screening programmes were approved for funding and what quality assurance mechanisms should be in place. This was a timely action as screening quality in breast cancer screening services came under question at Exeter in 1997 and followed in the wake of the 1995 Calman-Hine Report.
The idea of what was originally called the National Institute for Clinical Excellence took root when Labour came to power in 1997. Frank Dobson became Secretary of State and was supported by a team of Ministers keen on introducing clinical and health outcome measures to achieve improvements in the quality and delivery of care. The team included Alan Milburn, Baroness Margaret Jay, and Tessa Jowell. The name and mission was agreed in a meeting between the Ministerial team, Timothy Riley and Felicity Harvey shortly after the election and it was agreed that NICE should be described in the first policy white paper, The New NHS: Modern, Dependable 1997. Timothy Riley led the team that developed the policy and for NICE and which managed the legislation through Parliament in addition to implementing the new institute as a Special Health Authority. Timothy Riley joined Sir Michael Rawlins (the then recently appointed Chair of NICE) at the Health Select Committee in February 1999 where questions were raised as to whether NICE was just a means to "ration" healthcare. Sir Michael Rawlins and Timothy Riley presented a compelling case that positioned NICE as a standards setting body first and foremost. However, the reality was that although NICE was principally aimed at aligning professional standards through clinical guidelines and audit, the acceptability of drugs, devices and technological interventions in defining those standards, could not be ignored and so the concept of a "fourth hurdle" for drugs accessing the NHS market was invoked. This controversial policy shift meant that NICE was critical for decisions on drug reimbursement. Indeed, the first drug appraisal by NICE was on the drug Relenza which was turned down amidst criticisms from Glaxo-Wellcome that the appraisal had been fast tracked.NICE put on defensive as ruling on Relenza ends in row over 'leaks' Health Service Journal, 7 October 1999 Later, this policy development whereby the criteria for decision making, the role of costs, and the degree to which decisions of NICE and the secretary of state would be binding on clinicians was analysed by Andrew Dillon, Trevor Gibbs, Timothy Riley, and Trevor A. Sheldon.Milbank Quarterly, September 2001 As of 1 February 2022, its chief executive is Samantha Roberts, who succeeded Gillian Leng.
Guidance NICE publishes guidelines in four areas: the use of health technologies within England's National Health Service (NHS) (such as the use of new and existing medicines, treatments and procedures) clinical practice (guidance on the appropriate treatment and care of people with specific diseases and conditions) guidance for public sector workers on health promotion and ill-health avoidance guidance for social care services and users.
These appraisals are based primarily on evidence-based evaluations of efficacy, safety and cost-effectiveness in various circumstances.
Technology appraisals Since January 2005, the NHS in England has been legally obliged to provide funding for medicines and treatments recommended by NICE's technology appraisal board. This was at least in part as a result of well-publicised postcode lottery anomalies in which certain less-common treatments were funded in some parts of the UK but not in others due to local decision making in the NHS.
Before an appraisal, the Advisory Committee on Topic Selection draws up a list of potential topics of clinical significance for appraisal. The Secretary of State for Health and Social Care must then refer any technology so that the appraisal process can be formally initiated. Once this has been done NICE works with the Department of Health to draw up the scope of the appraisal.
NICE then invites consultee and commentator organisations to take part in the appraisal. A consultee organisation would include patient groups, organisations representing health care professionals and the manufacturers of the product undergoing appraisal. Consultees submit evidence during the appraisal and comment on the appraisal documents. Commentator organisations include the manufacturers of products to which the product undergoing appraisal is being compared. They comment on the documents that have been submitted and drawn up but do not actually submit information themselves.
An independent academic centre then draws together and analyses all of the published information on the technology under appraisal and prepares an assessment report. This can be commented on by the Consultees and Commentators. Comments are then taken into account and changes made to the assessment report to produce an evaluation report. An independent Appraisal Committee then looks at the evaluation report, hears spoken testimony from clinical experts, patient groups and carers. They take their testimony into account and draw up a document known as the 'appraisal consultation document'. This is sent to all consultees and commentators who are then able to make further comments. Once these comments have been taken into account the final document is drawn up called the 'final appraisal determination'. This is submitted to NICE for approval.
The process aims to be fully independent of government and lobbying power, basing decisions fully on clinical and cost-effectiveness. There have been concerns that lobbying by pharmaceutical companies to mobilise media attention and influence public opinion are attempts to influence the decision-making process. A fast-track assessment system has been introduced to reach decisions where there is most pressure for a conclusion.
Clinical guidelines NICE carries out assessments of the most appropriate treatment regimes for different diseases. This must take into account both desired medical outcomes (i.e. the best possible result for the patient) and also economic arguments regarding differing treatments.
NICE has set up several National Collaborating Centres bringing together expertise from the royal medical colleges, professional bodies and patient/carer organisations which draw up the guidelines. The centres are the National Collaborating Centre for Cancer, the National Clinical Guideline Centre, the National Collaborating Centre for Women and Children's Health, and the National Collaborating Centre for Mental Health.
The National Collaborating Centre appoints a Guideline Development Group whose job it is to work on the development of the clinical guideline. This group consists of medical professionals, representatives of patient and carer groups and technical experts. They work together to assess the evidence for the guideline topic (e.g. clinical trials of competing products) before preparing a draft guideline. There are then two consultation periods in which stakeholder organisations are able to comment on the draft guideline. After the second consultation period, an independent Guideline Review Panel reviews the guideline and stakeholder comments and ensures that these comments have been taken into account. The Guideline Development Group then finalises the recommendations and the National Collaboration Centre produces the final guideline. This is submitted to NICE to formally approve the guideline and issue the guidance to the NHS. To date NICE has produced more than 200 different guidelines.
In October 2014 Andy Burnham said that a Labour government could reduce variation in access to drugs and procedures by making it mandatory for commissioners to follow NICE clinical guidelines. "We need to look at how you strengthen NICE. Where they have said something is effective and affordable, on what basis does a local commissioner withhold that from somebody? I’m not comfortable with that. I don’t support that."
NICE has a service called Clinical Knowledge Summaries (CKS) which provides primary care practitioners with a readily accessible summary of the current evidence base and practical guidance.
In 2022 PricewaterhouseCoopers did a study for the Association of the British Pharmaceutical Industry of 13 medicines recommended for asthma, kidney disease, stroke prevention and type 2 diabetes. They found that 1.2 million patients had not received the drugs which could have given them the equivalent of 429,000 extra years in “complete good health” which could have translated into £17.9bn in “productivity gains” for the British economy.
Social care guidance Under the Health and Social Care Act 2012 NICE was given responsibility for developing guidance and quality standards for social care, using an evidence-based model. This was delivered by the NICE Collaborating Centre for Social Care (NCCSC), hosted by the Social Care Institute for Excellence (SCIE) and four partner organisations - Research in Practice, Research in Practice for Adults, Personal Social Services Research Unit and the EPPI-Centre. Over a five-year period, the NCCSC developed social care guidelines and supported the implementation of both the guidelines and social care quality standards.