national institute for health and care excellence national institute for health and care excellence the national institute for health and care excellence (nice) is an executive non-departmental public body of the department of health and social care in england that publishes guidelines in four areas: the use of health technologies within england's national health service (nhs) and nhs wales (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. national institute for health and care excellenceexecutive non-departmental public body overviewformedapril 1999 (1999-04)headquarters2 redman place, london e20united kingdomminister responsiblewill quince, minister of state at the department of health and social careexecutive non-departmental public body executivesamantha roberts, chief executiveparent departmentdepartment of health and social carewebsitewww.nice.org.uk these appraisals are based primarily on evidence-based evaluations of efficacy, safety and cost-effectiveness in various circumstances. it serves both the english nhs and the welsh nhs. it was set up as the national institute for clinical excellence in 1999, and on 1 april 2005 joined with the health development agency to become the new national institute for health and clinical excellence (still abbreviated as nice). following the health and social care act 2012, nice was renamed the national institute for health and care excellence 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 in which the patient happened to live, but it has since acquired a high 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 clinical effectiveness of 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 dr tim riley and latterly sir charles nightingale 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 termed a 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, dr tim riley and dr 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. riley led the team that developed the policy for nice and which managed the legislation through parliament in addition to formalising the new institute as a special health authority. 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. rawlins 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. 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, tim riley, and trevor a. sheldon. as of 1 february 2022, its chief executive is samantha roberts, who succeeded gillian leng. technology appraisals since january 2005, the nhs in england and wales 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 (acts) draws up a list of potential topics of clinical significance for appraisal. the secretary of state for health or the welsh assembly 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 is being delivered by the nice collaborating centre for social care (nccsc), which is 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. nice receives referrals for social care guidance from the department of health and the department for education, and commission the guidance from the nccsc. nice, along with the nccsc, carries out a scoping exercise with a scoping group and with input from key stakeholders, at both a workshop and a public consultation, to ensure the guidance to be produced is focused and achievable. a chairperson and members of the guidance development group are appointed, and pose review questions which will enable systematic evidence reviews to take place, thus delivering the guidance and subsequent recommendations. service user and carer involvement takes place throughout, as well as public consultation on the draft guidance. the guidance development group then finalises the recommendations and the nccsc produces the final guideline. this is submitted to nice for formal approval and publication. the entire process from pre-scoping to publication takes approximately 24 months. the guidance is then available to nice standing committees to develop a quality standard on the topic. the quality standard is developed using the guidance and other accredited sources, to produce high-level concise statements that can be used for quality improvement by social care providers and commissioners, as well as setting out what service users and carers can expect of high quality social care services. the nccsc is unique within nice, in that it is the only collaborating centre to have responsibility for the adoption and dissemination support for guidance and quality standards in the social care arena. drawing on the expertise of scie and their partners within the sector, each of the guidance products and quality standards have a needs assessment carried out to determine the requirements for tools to help embed the guidance and quality standards within the sector. these can include tailored versions of guidance for specific audiences, costing and commissioning tools and even training and learning packages. as of august