[2] As the national health technology assessment body of England, it is responsible for judging the cost-effectiveness of medicines and making them available on the NHS through reimbursement, with its judgements informing decisions in Wales and Northern Ireland.
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.
[11] 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.
Frank Dobson became Secretary of State and was supported by a team of Ministers keen on introducing clinical and health outcome measures to achieve improvements in the quality and delivery of care.
[14] Timothy Riley led the team that developed the policy and for NICE and which managed the legislation through Parliament in addition to implementing the new institute as a Special Health Authority.
Sir Michael Rawlins and Timothy Riley presented a compelling case that positioned NICE as a standards setting body first and foremost.
[18] NICE publishes guidelines in four areas: These appraisals are based primarily on evidence-based evaluations of efficacy, safety and cost-effectiveness in various circumstances.
Since January 2005, the NHS in England has been legally obliged to provide funding for medicines and treatments recommended by NICE's technology appraisal board.
[citation needed] An independent academic centre then draws together and analyses all of the published information on the technology under appraisal and prepares an assessment report.
An independent Appraisal Committee then looks at the evaluation report, hears spoken testimony from clinical experts, patient groups and carers.
[26] 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.
[28] 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.
[30][31] 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.
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.
These could include tailored versions of guidance for specific audiences, costing and commissioning tools and even training and learning packages.
As with any system financing health care, the NHS has a limited budget and a vast number of potential spending options.
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.
[35] 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.
Those treatments with lowest cost per QALY 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.
[41] The 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 trusts (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.
NICE is often associated with controversy, because the requirement 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.
[citation needed] Treatment for fertility problems are approved but not always funded by clinical commissioning groups and they may cap the number of rounds.
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.
[44] 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.
[46] NICE responded that they did follow the standard GRADE approach, and evidence from unblinded trials with subjective outcomes was appropriately downgraded.
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.