Box 1. Box 1 What is NICE and how does it work?

NICE was set up in 1999 to introduce national standards for deciding what drugs would be reimbursed on the NHS. Before its inception, it was the responsibility of local health authorities to decide what they would pay for, leading to huge discrepancies from one area to another. Since its formation, NICE has given its stamp of approval to drugs that have added a cumulative total of £1.2 ($2.4) billion per annum to the NHS medicines budget, according to the UK Department of Health

NICE does not study the cost-effectiveness of every drug. Nor does it decide which to review. That responsibility rests with the Department of Health (DOH), which scans the market to pick out drugs that are likely to be controversial because they are expensive or act differently from existing treatments and consults the public, before referring a list of potential products to ministers for final selection.

Once a referral is made, NICE and the DOH work together to agree on the scope of the assessment. NICE then invites patients' groups, manufacturers and clinical experts to submit their evidence and views on why a drug should be paid for and allows other groups, including manufacturers of competitor products, to comment on the documents that have been submitted.

An independent academic group is then charged with analyzing all the published information and preparing an assessment for comment by the interested parties, leading to the production of an evaluation report. This is then studied by an independent appraisal committee, which also hears testimony from clinical experts, manufacturers and patients groups. The result, the appraisal consultation document is then open for further comments, before NICE makes its final appraisal determination.

After it received criticisms over the length of time taken to carry out appraisals, in 2006 NICE introduced a fast track special technology assessment (STA) to speed things up. In the STA process, NICE aims to start looking at a drug at the same time as the file goes for marketing approval, so a decision on whether or not to reimburse is made at the same time as a drug is licensed. Typically assessments take around 12 months.

NICE's remit is not limited to drugs, but covers procedures and diagnostics as well. It has been recently been handed a remit to root out ineffective treatments and interventions.

In a review carried out in 2003 at NICE's request, the World Health Organization (WHO) concluded, "NICE has developed a well-deserved reputation for innovation and methodological development that represents an important model for technology appraisals internationally."

WHO added, "Published technology appraisals are already being used as international benchmarks—an obvious recognition of their credibility."NM