National Institute for Health and Clinical Excellence
What is the National Institute for Health and Clinical Excellence?
The National Institute for Health and Clinical Excellence (NICE) is an agency of the National Health Service charged with promoting clinical excellence in NHS service providers in England and Wales, by developing guidance and recommendations on the effectiveness of treatments and medical procedures.
The recommendations are issued in the form of "technology appraisals". These are based on a review of evidence of clinical and cost effectiveness for a particular technology, and give recommendations about whether and in what circumstances the technology should be used in the NHS. The majority of technologies assessed by NICE are pharmaceutical, but it has also considered surgical procedures, medical devices and screening technologies.
NICE also produces "clinical guidelines", providing wider guidance on the management of whole diseases or clinical conditions, which cover several different treatment options.
The Institute is also responsible for assessing the safety and efficacy of interventional procedures for diagnosis and treatment.
It is tasked with conducting assessments and drawing up guidelines by the Department of Health and the National Assembly for Wales.
NICE is constituted currently as a Special Health Authority, and is accountable directly to the NHS chief executive - the permanent secretary at the Department of Health - and the Secretary of State for Health.
With effect from 1 April 2013, the status of NICE will change from a SHA to that of an executive non-departmental public body. Its name will also change to the National Institute for Health and Care Excellence to reflect changes being made to its role and functions; the acronym will remain the same.
The current chair of NICE is Sir Michael Rawlins; his term of office expires on 31 March 2013.
NICE was first proposed by the new Labour government in its 1997 White Paper, "The New NHS". The purpose of the proposed body was to drive up clinical standards in the NHS, and make sure that improvements were consistent across the Service. Previously, medical technology appraisals were carried out by a variety of professional and academic bodies, at both the national and local levels. Work was duplicated, standards were variable and the status of findings was frequently unclear.
The Government had previously attempted to address this problem, introducing the Selected List Scheme, which listed obsolete or ineffective treatments, in 1986.
However, since that time, developments in medical technology had progressed rapidly, with vast numbers of new drugs becoming available. NHS clinicians found themselves unable to tell which new products were the most effective, leading to local variations in commissioning practices. This in turn had led to a situation where patients' addresses determined whether they were able to obtain particular treatments - the problem of "postcode prescribing".
It was intended that NICE would replace the old arrangements with a central, coherent and authoritative system of appraisal, and this role was detailed in the 1998 paper, " A First Class Service - Quality in the New NHS". NICE was established and began work in April 1999.
From the outset, NICE's work was controversial. In October 1999, the Institute recommended against the prescribing of the influenza vaccine, Relenza - only to reverse its position in relation to the vaccination of "at risk" people in November 2000, following vocal criticism from the pharmaceutical industry. In February 2001, the Consumers' Association's "Drug and Therapeutics Bulletin" gave advice contrary to the NICE guidance, citing weaknesses in NICE's appraisal procedures.
NICE's credibility was also challenged by its shift of position in June 2000 over the extremely expensive and clinically controversial multiple sclerosis drug beta interferon, this time primarily in response to patient pressure. In October 2002, NICE's proposed rejection of photo-dynamic treatment for age-related macular degeneration caused uproar amongst old age charities.
It was unclear at first whether NHS bodies were obliged to follow NICE's recommendations. Many complained that they were unable to pay for recommended treatments, and as a result the problem of postcode prescribing remained. In January 2002 the ambiguity was resolved, and the NHS was put under a duty to provide funding to cover NICE recommendations.
In September 2006, following a public consultation, the Department of Health published new guidance on the selection of topics for the NICE work programme. This stated that NICE would now be responsible for the administration of the early stages of topic selection and the Department of Health would remain responsible for the administration of the later stages of the process.
A single set of criteria would in future be used for the selection of both Clinical and Public Health topics and the Advisory Committee for the Selection of Topics replaced by new panels to better represent the needs of professionals and their patients. The timeline for selection of topics was also to be reduced.
In addition, a new programme of work was to be established by NICE to help the NHS "identify and stop ineffective interventions". It was stated that this would "potentially allow the NHS to reinvest millions of pounds on drugs and other treatments that improve patient care."
The judgements that NICE should apply when making decisions about the effectiveness of interventions, "especially where such decisions affect the allocation of NHS resources", are outlined in the current (2008) edition of 'Social Value Judgements; Principles for the Development of NICE Guidance'. This pre-dates the Equality Act of 2010 and NICE's approach to applying social value principles when considering legally protected groups is now governed by the requirements of the Act.
From April 2013, the role of NICE will be expanded to include social care and its name will change to the National Institute for Health and Care Excellence.
NICE has been highly controversial during its short lifetime, and has been criticised on a number of grounds. It is widely acknowledged that many of NICE's appraisals have been successful, and have driven up standards in the NHS - along with other elements of the quality agenda introduced since 1997. At the heart of the majority of criticisms of NICE, however, is the requirement that its decisions reflect the cost effectiveness of treatments: this, it is argued, means that its clinical recommendations are inextricably tied up with political decisions about value for money.
In June 2002, the House of Commons' Health Select Committee published its report on NICE, warning that it was not fully accepted by stakeholders, and urging it to improve the transparency of its methods.
NICE's clinical credibility was called into question by the Relenza affair, when the Institute's findings were challenged. This led to criticism of the procedures by which NICE contracted out its research work. Reforms undertaken since the Select Committee report have largely eliminated this complaint, as standards of procurement have improved. This lack of credibility led to a situation where NICE was working largely in competition with the alternative assessment bodies it was intended to supersede for some time.
The Institute also has a controversial responsibility for encouraging "innovation" in the pharmaceutical industry, and some of its decisions have led to concern about its independence from business. This led to calls from the Health Committee in its report for NICE to focus on winning the trust of NHS bodies and the public.
At the same time, however, the industry and patients have complained about a phenomenon known as "NICE blight" - whereby the NHS will not provide a treatment until it has been approved by the Institute. The more thorough an appraisal is, the longer the period of blight. This was particularly noted in relation to NICE's appraisals of cancer drugs: the huge backlog of technologies NICE faced on its launch led to new treatments becoming stuck in the pipeline for long periods of time.
The status of NICE guidance has also coloured its relationship with commissioning NHS bodies. Prior to the imposition of the requirement to fund NICE recommendations, many local bodies simply ignored them because they were unable to pay for the treatments recommended without cutting other services. The focus of NICE's work on the cutting edge of medical technologies has increased this tendency.
At least part of the problem has been poor communication between NHS bodies and frontline staff: the Health Committee report identified weaknesses in the dissemination of NICE guidance to practitioners.
However, local NHS bodies have expressed concern about the centralising effect exerted by NICE's guidance. The requirement that additional money be spent on services recommended by NICE, it is argued, reduces local services' ability to respond to specifically local needs. In response, NICE's supporters insist that variations in service quality make the imposition of national minimum standards necessary.
It has also been argued widey that NICE should have greater responsibility for selecting its own work agenda. The priority given to technology appraisals - focusing on one specific treatment - has been questioned over its narrowness; it has been argued that NICE should focus its attention on clinical guidance, which looks at the whole range of treatment options for a particular condition.
The highly controversial Health and Social Care Act 2012 included provisions to expand the role of NICE, establishing it as a body corporate to be known as the National Institute for Health and Care Excellence.
Although there appears to be a general consensus that NHS health care and social care provision should be integrated, there is disagreement on how this should be achieved.
Labour has said that "all options must be considered – including full integration of health and social care", but the Shadow Health Secretary also accused David Cameron of pursuing a "fast-track to fragmentation" rather than integration and of introducing privatisation into the NHS "at a pace and scale never seen before."
In the meantime the Department of Health has agreed an initial list of joint NHS/social care topics for NICE to begin working on as from April 2013.
These include:autism in adults and children; mental well-being of older people in residential care; the transition between health and social care, including discharge planning, admission avoidance, reducing readmissions and reducing unnecessary bed occupancy; medicines management in care homes; management of physical and mental co-morbidities of older people in community and residential care settings; domiciliary care; transition between children and adult services; child maltreatment.
NICE Technology Appraisal Decisions.
NICE classifies each decision into one of four categories:
only in research
From 1 March 2000 to 31 August 2012, NICE published:
108 single technology appraisals, and
155 multiple technology appraisals;
263 appraisals in total, containing
490 individual recommendations.
Six of the recommendations were subsequently withdrawn:
on three occasions where the regulator revoked the marketing authorisation due to safety concerns
on one occasion where the product was no longer produced by the manufacturer
on two occasions when a nationally funded-programme for a technology rendered the guidance obsolete.
Twelve recommendations could not be made in the absence of a submission from the manufacturer (‘non-submission').
Overall, 81% of decisions made by NICE (378 of 472) were recommended or optimised.
Source: NICE - 2012
“The Care and Support White Paper set out our plans to drive up the quality of care.
"NICE’s new quality standards on social care will be a key driver of this. They will help define what good care and support looks like for commissioners and care providers as well as people using services.”
Earl Howe, parliamentary under-secretary of state for quality - 2012
“It's important for health and social care services to work in tandem and the standards we develop will play a vital role in ensuring services are closely aligned to ensure effective, high quality patient care is consistently achieved."
Dr Gillian Leng, deputy chief executive and director of health and social care at NICE - 2012