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{{Redirect|NICE}}
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[[File:Evidence-informed-health-policy-4---Case-descriptions-of-organizations-that-support-the-use-of-1748-5908-3-56-S8.ogv|thumb|thumbtime=1:42|A six-minute video documentary of NICE from 2008]]
The '''National Institute for Health and Care Excellence''' ('''NICE''') is an executive [[non-departmental public body]], in England, of the [[Department of Health and Social Care (United Kingdom)|Department of Health and Social Care]]
* the use of [[Health technology|health technologies]] within [[National Health Service (England)|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)
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It serves both the English NHS and the Welsh NHS.<ref>{{cite press release | title = The National Institute for Clinical Excellence (Establishment and Constitution) Order 1999 | url = http://www.opsi.gov.uk/si/si1999/uksi_19990220_en.pdf | date = 1999-02-02 | access-date = 2009-09-18 | publisher = [[Office of Public Sector Information]]}}</ref> 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).<ref>{{cite press release | title = The National Institute for Clinical Excellence (Establishment and Constitution) Amendment Order 2005 | url = http://www.opsi.gov.uk/si/si2005/20050497.htm | date = 2005-03-07 | access-date = 2009-09-18 | publisher = [[Office of Public Sector Information]]}}</ref><ref>{{cite press release | title = The Special Health Authorities Abolition Order 2005 | url = http://www.opsi.gov.uk/si/si2005/20050502.htm | date = 2005-03-07 | access-date = 2009-09-18 | publisher = [[Office of Public Sector Information]]}}</ref> 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 [[NHS special health authority|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.<ref>{{cite book | title = Health Technology Assessments by the National Institute for Health and Clinical Excellence | url = https://www.springer.com/public+health/book/978-0-387-71995-5 | last = Schlander | first = Michael | isbn = 978-0-387-71995-5 | year = 2007 | page = 245 | publisher = [[Springer Science+Business Media]] | location = New York | access-date = 2008-11-13}}</ref> 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.
==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 [[Kenneth Calman|Sir Kenneth Calman]] and [[Muir Gray]] (now Sir Muir Gray) by the Policy Team led by Dr
The idea of what was originally
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|Glaxo-Wellcome]] that the appraisal had been fast tracked.<ref>NICE put on defensive as ruling on Relenza ends in row over 'leaks' [[Health Service Journal]], 7 October 1999</ref> 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,
==Technology appraisals==
Since January 2005, the NHS in [[NHS England|England]] and [[NHS Wales|Wales]] has been legally obliged to provide funding for medicines and treatments recommended by NICE's technology appraisal board.<ref>{{cite journal | title = National Institute for Health and Clinical Excellence (NICE): How does it work and what are the implications for the U.S.? | url = https://www.scribd.com/doc/8737637/National-Institute-for-Health-and-Clinical-Excellence-NICE-How-Does-it-Work-and-What-are-the-Implications-for-the-US-Executive-Summary | access-date = 2009-09-18 |author1=Sorenson, C |author2=Drummond, M |author3=Kanavos, P |author4=McGuire, A | publisher = [[National Pharmaceutical Council]]}}</ref> 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.<ref>{{
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.{{cn|date=December 2022}}
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.{{cn|date=December 2022}}
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.<ref>{{
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.<ref>{{cite news | url = http://news.bbc.co.uk/1/hi/health/5063352.stm | title = Herceptin: Was patient power key? | date = 2006-06-09 | access-date = 2008-11-13 | last = Berg | first = Sanchia | work = BBC News}}</ref> A fast-track assessment system has been introduced to reach decisions where there is most pressure for a conclusion.{{cn|date=December 2022}}<ref>{{Cite journal |title=Risk assessment of fast-track projects: a systems- based approach |url=https://www.researchgate.net/publication/332442110_Risk_assessment_of_fast-track_projects_a_systems-_based_approach |journal=researchgate.net}}</ref>
==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.<ref>{{Cite journal |last= |first= |last2= |first2= |last3= |first3= |last4= |first4= |date= |title=Factors affecting therapeutic compliance: A review from the patient’s perspective |url=https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2503662/ |journal=Therapeutics and Clinical Risk Management |volume=4 |issue=1 |pages=269–286 |issn=1176-6336 |pmc=2503662 |pmid=18728716}}</ref>
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
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 trial]]s 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.{{citation needed|date=April 2014}} To date NICE has produced more than 200 different guidelines.<ref>{{cite web|url = https://www.nice.org.uk/guidance/published?type=guidelines|title = Guidance List|access-date = 8 October 2014|website = nice.org.uk}}</ref>
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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.<ref>{{cite news |title=The Primer: Hunt's fix for 'rogue system' of NHS and DHSC |url=https://www.hsj.co.uk/daily-insight/the-primer-hunts-fix-for-rogue-system-of-nhs-and-dhsc/7032443.article |access-date=30 June 2022 |publisher=Health Service Journal |date=16 May 2022}}</ref>
==Social care guidance==
{{unreferenced section|date=September 2013}}
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
NICE
The Guidance Development Group then
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 work|social care arena]]. Drawing on the expertise of SCIE and their partners within the sector, each of the guidance products and quality standards
As of August 2013, NICE and the NCCSC had scheduled guidance delivery for five topics: [[Home care|domiciliary care]], older adults with long-term conditions, transition between health and social care settings, transition from children's to adults' services and [[Child Abuse and Neglect|child abuse and neglect]].
==Cost–effectiveness==
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Theoretically, it might be possible to draw up a table of all possible treatments sorted by increasing the cost per quality-adjusted life year gained. Those treatments with lowest cost per quality-adjusted life year gained would appear at the top of the table and deliver the most benefit per value spent and would be easiest to justify funding for. Those where the delivered benefit is low and the cost is high would appear at the bottom of the list. Decision makers would, theoretically, work down the table, adopting services that are the most cost effective. The point at which the NHS budget is exhausted would reveal the [[shadow price]], the threshold lying between the CQG gained of the last service that is funded and that of the next most cost effective service that is not funded.
In practice this exercise is not done, but an assumed shadow price has been used by NICE for many years in its assessments to determine which treatments the NHS should and should not fund. NICE states that for drugs the cost per QALY should not normally exceed £30,000 but that there is not a hard threshold,<ref name="Quality Adjusted Life Year">{{cite web|url=http://www.nice.org.uk/newsroom/features/measuringeffectivenessandcosteffectivenesstheqaly.jsp%7ctitle=News%7cwork=nice.org.uk%7ctitle=News%7cwork=nice.org.uk%7ctitle=News%7cwork=nice.org.uk|title=News|work=nice.org.uk}}</ref> though research has shown that any threshold is "somewhat higher" than being in the range £35,000 - £40,000.
The [[Health Select Committee|House of Commons Health Select Committee]], in its report on NICE, stated in 2008 that "the ... cost-per-QALY it uses to decide whether a treatment is cost-effective is of serious concern. The threshold it employs is not based on empirical research and is not directly related to the NHS budget, nor is it at the same level as that used by [[primary care trust]]s (PCTs) in providing treatments not assessed by NICE, which tends to be lower. Some witnesses, including patient organisations and pharmaceutical companies, thought NICE should be more generous in the cost per QALY threshold it uses, and should approve more products. On the other hand, some PCTs struggle to implement NICE guidance at the current threshold and other witnesses argued that a lower level should be used. However, there are many uncertainties about the thresholds used by PCTs." It went on to recommend that "an independent body should determine the threshold used when making judgements of the value of drugs to the NHS."<ref>{{cite web|url=https://publications.parliament.uk/pa/cm200708/cmselect/cmhealth/27/27.pdf|title=House of Commons Health Committee: National Institute for Health and Clinical Excellence - First Report of Session 2007-08|website=publications.parliament.uk}}</ref>
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Approved cancer drugs and treatments such as [[radiotherapy]] and [[chemotherapy]] are funded by the NHS without any financial contribution being taken from the patient. Where NICE has approved a treatment, the NHS must fund it. But not all treatments have been assessed by NICE and these treatments are usually dependent on local NHS decision making. In the case of cancer the [[Cancer Drugs Fund]] was set up in 2011 after complaints about NICE decisions on new and expensive cancer drugs with limited benefits.{{citation needed|date=October 2014}} Treatment for fertility problems are approved but not always funded by [[clinical commissioning group]]s and they may cap the number of rounds.<ref>{{cite web |url=http://www.hfea.gov.uk/fertility-treatment-cost-nhs.html |title=NHS IVF and Fertility Treatment – Funding Options |publisher=Hfea.gov.uk |date=2015-01-06 |access-date=2015-09-05 |url-status=dead |archive-url=https://web.archive.org/web/20130127204213/http://www.hfea.gov.uk/fertility-treatment-cost-nhs.html |archive-date=2013-01-27 }}</ref>
NICE has been criticised for being too slow to reach decisions. On one occasion, the [[Royal National Institute of Blind People]] said it was outraged over its delayed decision for further guidance regarding two drugs for [[macular degeneration]] that are already approved for use in the NHS. However the Department of Health said that it had 'made it clear to PCTs that funding for treatments should not be withheld simply because guidance from NICE is unavailable'.<ref>{{cite press release | title = Media release (14 June 2007) | url = http://www.rnib.org.uk/aboutus/mediacentre/mediareleases/media2007/Pages/mediarelease14jun2007.aspx | date = 2007-08-08 | access-date = 2008-11-13 | publisher = [[Royal National Institute of Blind People]] | archive-date = 13 June 2011 | archive-url = https://web.archive.org/web/20110613112739/http://www.rnib.org.uk/aboutus/mediacentre/mediareleases/media2007/Pages/mediarelease14jun2007.aspx | url-status = dead }}</ref>
Some of the more controversial NICE decisions have concerned [[donepezil]], [[galantamine]], [[rivastigmine]] (review) and [[memantine]] for the treatment of [[Alzheimer's disease]] and [[bevacizumab]], [[sorafenib]], [[sunitinib]] and [[temsirolimus]] for [[renal cell carcinoma]]. All these are drugs with a high cost per treatment and NICE has either rejected or restricted their use in the NHS on the grounds that they are not cost-effective.
A statement published by the Royal College of Physicians expressed concern that the 2021 NICE guidelines for ME/CFS did not properly evaluate or recommend graded exercise therapy and cognitive behavioral therapy for the treatment of ME/CFS.<ref>{{cite web |date=29 October 2021 |title=Medical leaders sign joint statement in response to NICE guidance on ME/CFS |url=https://www.rcp.ac.uk/news-and-media/news-and-opinion/medical-leaders-sign-joint-statement-in-response-to-nice-guidance-on-mecfs/}}</ref> A study by 49 academics argued that the dissonance between the 2021 guidelines and the previous guideline was the result of deviating from usual scientific standards of the NICE process.<ref>{{cite journal | url=https://jnnp.bmj.com/content/early/2023/07/09/jnnp-2022-330463 | pmid=37434321 | date=2023 | last1=White | first1=P. | last2=Abbey | first2=S. | last3=Angus | first3=B. | last4=Ball | first4=H. A. | last5=Buchwald | first5=D. S. | last6=Burness | first6=C. | last7=Carson | first7=A. J. | last8=Chalder | first8=T. | last9=Clauw | first9=D. J. | last10=Coebergh | first10=J. | last11=David | first11=A. S. | last12=Dworetzky | first12=B. A. | last13=Edwards | first13=M. J. | last14=Espay | first14=A. J. | last15=Etherington | first15=J. | last16=Fink | first16=P. | last17=Flottorp | first17=S. | last18=Garcin | first18=B. | last19=Garner | first19=P. | last20=Glasziou | first20=P. | last21=Hamilton | first21=W. | last22=Henningsen | first22=P. | last23=Hoeritzauer | first23=I. | last24=Husain | first24=M. | author25=Huys AML | last26=Knoop | first26=H. | last27=Kroenke | first27=K. | last28=Lehn | first28=A. | last29=Levenson | first29=J. L. | last30=Little | first30=P. | title=Anomalies in the review process and interpretation of the evidence in the NICE guideline for chronic fatigue syndrome and myalgic encephalomyelitis | journal=Journal of Neurology, Neurosurgery, and Psychiatry | volume=94 | issue=12 | pages=1056–1063 | doi=10.1136/jnnp-2022-330463 | s2cid=259502526 | display-authors=1 }}</ref> NICE responded that they did follow the standard [[GRADE approach]], and evidence from [[Blinded experiment|unblinded trials]] with subjective outcomes was appropriately downgraded.<ref>{{Cite journal |last=Barry |first=Peter Walter |last2=Kelley |first2=Kate |last3=Tan |first3=Toni |last4=Finlay |first4=Ilora |date=2024-07-01 |title=NICE guideline on ME/CFS: robust advice based on a thorough review of the evidence |url=https://jnnp.bmj.com/content/95/7/671 |journal=Journal of Neurology, Neurosurgery & Psychiatry |language=en |volume=95 |issue=7 |pages=671–674 |doi=10.1136/jnnp-2023-332731 |issn=0022-3050 |pmid=38418217|doi-access=free }}</ref>
A Conservative shadow minister once criticized NICE for spending more on communications than assessments. In its defence, NICE said the majority of its communications budget was spent informing doctors about which drugs had been approved and new guidelines for treatments and that the actual cost of assessing new drugs for the NHS includes money spent on NICE's behalf by the Department of Health. When these were added to NICE's own costs, the total cost of the technology appraisal programme far outstrips the cost of NICE communications.
A report from the [[University of York]] Centre for Health Economics written by [[Karl Claxton]] in February 2015 suggested that the maximum threshold, currently around £30,000 a year, for judging a medicine cost-effective should be more than halved. They found that any intervention costing more than £13,000 per [[quality-adjusted life year]] risked causing more harm than good by denying cost effective treatment to other patients.<ref>{{cite news|title=Expensive drugs cost lives, claims report|url=http://www.ft.com/cms/s/0/d00c4a02-b784-11e4-981d-00144feab7de.html#axzz3ldCBJUxL
The institute's approach to the introduction of new oral therapy for [[hepatitis C]] has been criticised. [[Sofosbuvir]] was approved in 2015. It costs about £30,000 for 12 weeks treatment. [[NHS England]] established 22 Operational Delivery Networks to roll out delivery and proposes to fund 10,000 courses of treatment in 2016-17. Each has been given a “run rate” of how many patients they are allowed to treat. This is the NHS’ single biggest new treatment investment this year.<ref>{{cite news|title=NHS England rollout of ground-breaking drugs 'changes role of NICE'|url=http://www.hsj.co.uk/topics/policy-and-regulation/nhs-england-rollout-of-ground-breaking-drugs-changes-role-of-nice/7003752.article|access-date=14 May 2016|publisher=Health Service Journal|date=4 April 2016}}</ref> In the North East London network patients with [[cirrhosis]] or [[fibrosis]] go to the front of the queue and three new patients at the Grahame Hayton Unit at the [[Royal London Hospital]] start treatment each month. Those without such complications may faced considerable delays before they start treatment.<ref>{{cite magazine|title=Philip Christopher Baldwin: "We need better access to treatment for gay men living with HIV and Hep C"|url=https://www.gaytimes.co.uk/life/36173/philip-baldwin-need-better-access-treatment-gay-men-living-hiv-hep-c/|access-date=14 May 2016|magazine=Gay Times|date=11 May 2016|archive-date=12 May 2016|archive-url=https://web.archive.org/web/20160512120121/https://www.gaytimes.co.uk/life/36173/philip-baldwin-need-better-access-treatment-gay-men-living-hiv-hep-c/|url-status=dead}}</ref>
==See also==
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* [http://vimeo.com/4796083 The Price of Life, BBC Documentary about NICE]
* [https://www.thetimes.co.uk/article/the-unbearable-cost-of-living-rkl2bh50pmm The Unbearable Cost of Living, Sunday Times (London)]
* [http://www.niceconference.org.uk/ NICE Annual Conference] {{Webarchive|url=https://web.archive.org/web/20200809133306/http://www.niceconference.org.uk/ |date=9 August 2020 }} organised by [[EMAP|i2i events group]]
* [https://www.youtube.com/watch?v=nDY4SoU20mI Video, 9:19 minutes]: "What is the NICE threshold?", Centre for Health Economics, University of York
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* {{Official website|http://www.nice.org.uk}}
{{Department of Health
{{Evidence-based practice}}
{{authority control}}
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[[Category:Health education organizations]]
[[Category:Health in the London Borough of Newham]]
[[Category:Health policy in the United Kingdom]]
[[Category:National agencies for drug regulation]]
[[Category:Non-departmental public bodies of the United Kingdom government]]
[[Category:Organisations based in the London Borough of Newham]]
[[Category:Organizations established in 1999]]
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