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NICE publishes guidelines in four areas: the use of health technologies within the 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; and
guidance for social care services and users.[5] These appraisals are based primarily on evaluations of efficacy and cost
effectiveness in various circumstances.
NICE was established in an attempt to defuse the so-called postcode lottery of healthcare in England and Wales, where
treatments that were available depended upon 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 costbenefit boundaries for certain technologies that it assesses.[6] 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.[7][8]
Contents [hide]
1 Policy history
2 Technology appraisals
3 Clinical guidelines
4 Social Care guidance
5 Costeffectiveness
5.1 Quality-adjusted life years
5.2 Cost per quality-adjusted life year gained
5.3 Basis of recommendations
6 Criticism
7 See also
8 References
9 Further reading
Policy history
[edit]
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[where?] were being made to set professionally agreed standards for clinical
care. In 1996, 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.[9] 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 concerns over
screening quality had emerged in breast cancer screening services came under question at Exeter in 1997 [10] and followed
in the wake of the 1995 Calman-Hine Report.[11]
The idea of what was originally termed a National Institute for Clinical Excellence took root when Labour came to power having
in 1997. Frank Dobson became Secretary of State and was supported by a team of Ministers keen on introducing clinical and
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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.[12] 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. Sir Michael Rawlins presented a
compelling case that positioned NICE as a standards setting body first and foremost.[13] 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.[14] 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.[15]
Technology appraisals
[edit]
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.[16] 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 invite 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 costeffectiveness. 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.[17] A fast-track assessment system has been
introduced to reach decisions where there is most pressure for a conclusion.
Clinical guidelines
[edit]
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 have 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 Guidelines Centre for Acute and Chronic Conditions, the National Collaborating
Centre for Women and Childrens Health, and the National Collaborating Centre for Mental Health.[18]
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
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submitted to NICE who then formally approve the guideline and issues this guidance to the NHS.[citation needed] To date NICE
have produced more than 200 different guidelines.[19]
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? Im not comfortable with that. I dont support that."[20]
The National Institute for Health and Care Excellence (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.[21][22][23]
[edit]
This section does not cite any references or sources. Please help improve this
section by adding citations to reliable sources. Unsourced material may be challenged
and removed. (September 2013)
This article needs more links to other articles to help integrate it into the
encyclopedia. Please help improve this article by adding links that are relevant to
the context within the existing text. (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 is being delivered by the NICE Collaborating Centre for Social Care
(NCCSC), which is hosted by the Social Care Institute for Excellence (SCIE) and 4 partner organisations - Research in
Practice, Research in Practice for Adults, Personal Social Services Research Unit and the EPPI-Centre.
NICE receive 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, carry 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 who then formally approve the guidance and publish it. 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 2013, NICE and the NCCSC have scheduled guidance delivery for 5 topics: 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.
Costeffectiveness
[edit]
As with any system financing health care, the NHS has a limited budget and a vast number of potential spending options.
Choices must be made as to how this limited budget is spent. Economic evaluations are carried out within a health technology
assessment framework to compare the cost-effectiveness of alternative activities and to consider the opportunity cost
associated with their decisions.[24] By choosing to spend the finite NHS budget upon those treatment options that provide the
most efficient results, society can ensure it does not lose out on possible health gains through spending on inefficient
treatments and neglecting those that are more efficient.
NICE attempts to assess the costeffectiveness of potential expenditures within the NHS to assess whether or not they
represent 'better value' for money than treatments that would be neglected if the expenditure took place. It assesses the
costeffectiveness of new treatments by analysing the cost and benefit of the proposed treatment relative to the next best
treatment that is currently in use.[25]
NICE guidance supports the use of quality-adjusted life years (QALY) as the primary outcome for quantifying the expected
health benefits associated with a given treatment regime. By comparing the present value (see discounting) of expected
QALY flows with and without treatment, or relative to another treatment, the net/relative health benefit derived from such a
treatment can be derived. When combined with the relative cost of treatment, this information can be used to estimate an
incremental cost-effectiveness ratio (ICER), which is considered in relation to NICE's threshold willingness-to-pay value.[24]
As a guideline rule, NICE accepts as cost-effective those interventions with an incremental cost-effectiveness ratio of less
than 20,000 per QALY and that there should be increasingly strong reasons for accepting as cost-effective interventions
with an incremental cost-effectiveness ratio of over a threshold of 30,000 per QALY.[26]
Over the years, there has been great controversy as to what value this threshold should be set at. Initially, there was no fixed
number. But the appraisal teams created a consensus amount of about 30,000. However, in November 2008 Alan Johnson,
the then Secretary of State, announced that for end-of-life cancer drugs the threshold could be increased above 30,000. [27]
The first drug to go through the new process was Lenalidomide. And its ICER was 43,800.[28]
Criticism
[edit]
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See also
[edit]
References
[edit]
1. ^ Great Britain: Parliament: House of Commons: Health Committee (2013). National Institute for Health and Clinical Excellence:
Eighth Report of Session 2012-13, Vol. 1: Report, . The Stationery Office. p. 7. ISBN 978-0-215-05239-1.
2. ^ "The National Institute for Clinical Excellence (Establishment and Constitution) Order 1999" (Press release). Office of Public
Sector Information. 1999-02-02. Retrieved 2009-09-18.
3. ^ "The National Institute for Clinical Excellence (Establishment and Constitution) Amendment Order 2005" (Press release).
Office of Public Sector Information. 2005-03-07. Retrieved 2009-09-18.
4. ^ "The Special Health Authorities Abolition Order 2005" (Press release). Office of Public Sector Information. 2005-03-07.
Retrieved 2009-09-18.
5. ^ "About" . nice.org.uk.
6. ^ Schlander, Michael (2007). Health Technology Assessments by the National Institute for Health and Clinical Excellence . New
York: Springer Science+Business Media. p. 245. ISBN 978-0-387-71995-5. Retrieved 2008-11-13.
7. ^ "NICE International: what we do" . www.nice.org.uk. Retrieved 8 Oct 2014.
8. ^ Cheng, Tsung-Mei (2009-09-15). "Nice approach" . Financial Times. Retrieved 2009-09-18.
9. ^ "History of the UK NSC" . screening.nhs.uk.
10. ^ "Breast Cancer Screening" . Hansard. November 1997.
11. ^ http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_4071083
12. ^ The New NHS: Modern, Dependable . Department of Health.
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Further reading
[edit]
Official website
NICE annual conference and exhibition
The Price of Life, BBC Documentary about NICE
The Unbearable Cost of Living, Sunday Times (London)
NICE Annual Conference organised by i2i events group
Video, 9:19 minutes : "What is the NICE threshold?", Centre for Health Economics, University of York
v t e
[show]
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