National Institute for Health and Care Excellence
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).
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 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. 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.
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.
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.
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.
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.
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.
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. Treatment for fertility problems are approved but not always funded by clinical commissioning groups and they may cap the number of rounds.