National Institute for Health and Care Excellence
The National Institute for Health and Clinical Excellence or NICE is a special health authority of the National Health Service (NHS) in England and Wales. 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).
NICE publishes clinical appraisals of whether particular treatments should be considered worthwhile by the NHS. These appraisals are based primarily on cost-effectiveness.
NICE was established in an attempt to defuse the so-called postcode lottery system of healthcare in England and Wales, where treatments that were available depended upon the NHS primary care trust area in which the patient happened to live. However its role in rationing treatment has led to NICE becoming a controversial body, which has gained a high profile internationally as a potential role model for the explicit prioritisation of health services[1].
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 is at least in part as a result of well-publicised postcode lottery scandals in which certain less-common treatments are funded in one part of the UK but not in another.
If a technology is to be appraised by NICE then it must be referred to them by the Secretary of State for Health. 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 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[2]. 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 have set up several National Collaborating Centres who draw up the boundaries of the guideline, i.e. what it will cover. The National Collaborating Centre then appoints a Guideline Development Group whose job it is to work on the development of the clinical guideline. This group will consist of medical professionals, representatives of patient and carer groups and technical experts. They work together to asses 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 who then formally approve the guideline and issues this guidance to the NHS.
Cost effectiveness
NICE attempts to rationalise for the NHS the trade off between spending money on different forms of treatment and when and when not to treat. It attempts to weigh up factors such as how much benefit the treatment gives, how long the benefit of the treatment will last for, and how much it costs. Once it has done this it will make recommendations about which treatments can be given and in which circumstances in order to maximise the delivery of care within the available budget.
Quality-adjusted life years
NICE utililises the quality-adjusted life year or QALY to measure the benefits of a treatment quality and the quantity of life delivered by a given treatment regime. One interpretation of QALY would be how much lifespan a person would be prepared to give up to deliver one year of perfect health from the current state of ill health. By comparing QALY values before and after treatment one could calculate the benefit delivered by a given treatment to a given person[3].
Cost per quality-adjusted life year gained
The cost of a treatment may be relatively easy to calculate but because people may be at different ages when they receive treatment, the gain may be different according to age. A heart operation on a small child may deliver many more years of quality of life than the same operation on a 76 year old man. By taking the cost of treatment and dividing it by the years gained an overall cost benefit ratio can be determined as the 'cost per quality-adjusted life year gained' or CQG.
Basis of recommendations
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 which 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[4]. However research has shown that any threshold is "somewhat higher" than this[5].
Criticism
 | This article's "criticism" or "controversy" section may compromise the article's neutrality. |
The work that NICE is involved in attracts the attention of many groups, including doctors, the pharmaceutical industry, and patients. NICE is often associated with controversy, because the need to make decisions at a national level can conflict with what is (or is believed to be) in the best interests of an individual patient. Decisions not to fund expensive treatments or those with no proven benefits are necessary to ensure that public funds are used wisely. From an individual's perspective it can sometimes seem that NICE is denying access to a potentially life-saving treatment but the denial is only effective as far as the use of public resources are concerned. Treatment may be available if the patient can find the resources to pay for treatment in the private sector and a doctor willing to administer it.
NICE has been criticised for its over-reliance on evidence-based medicine, which it is argued privileges certain kinds of econometrically derived types of studies over others. NICE has also been criticised for being too slow to reach decisions, especially when compared to the equivalent body for Scotland, the Scottish Medicines Consortium. On one occasion, the Royal National Institute of Blind People accused NICE of incompetence over its delayed decision to approve a drug already approved for use in Scotland[6].
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 which NICE regards as too expensive relative to the improvements in health they bring. In effect NICE is saying that the money could and should be better used to treat other patients and deliver even greater benefits to the community overall.
References
- ^ 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.
- ^ Berg, Sanchia (2006-06-09). "Herceptin: Was patient power key?". BBC News. Retrieved 2008-11-13.
- ^ Appleby, John (2007-12-05). Searching for local NHS cost effectiveness thresholds: A feasibility study (pdf). Manchester. Retrieved 2008-11-13.
{{cite conference}}: Unknown parameter|coauthors=ignored (|author=suggested) (help) - ^ NICE - Measuring effectiveness and cost effectiveness: the QALY
- ^ Devlin, N; Parkin D. "Does NICE have a cost effectiveness threshold and what other factors influence its decisions? A discrete choice analysis" (pdf). City University, London. Retrieved 2008-11-13.
{{cite journal}}: Cite journal requires|journal=(help)CS1 maint: multiple names: authors list (link) - ^ "RNIB accuses NICE of incompetence - risking blindness for 10,000 people" (Press release). Royal National Institute of Blind People. 2007-08-08. Retrieved 2008-11-13.