National Institute for health and Clinical Excellence (NICE)
pharmafile | October 1, 2010 | News story | | NICE, National Institute for health and Clinical Excellence
The National Institute for health and Clinical Excellence (NICE) is a UK cost-effectiveness body that assesses a drug’s cost against clinical trial data presented to it by the manufacturer.
Its assessments are not legally binding and it does not have the ability to ‘ban’ a drug. Instead, it will recommend, partially recommend or not recommend a drug to be paid for by the NHS based on evidence of its effectiveness against its cost. It uses its own ‘quality-adjusted life years’ (QALY) measurement as a formula with which to assess a drug’s cost-effectiveness.
If NICE has failed to recommend a drug, individual strategic health authorities or primary care trusts can decide to fund that drug under extraordinary circumstances.
NICE cannot directly assess a drug’s efficacy and does not have the remit to remove a drug from the market. Drugs are assessed for cost-effectiveness once the EU regulator the European Medicines Agency has approved them.
The body was established in 1999 by the Labour government and as well as health technology assessment, it provides guidance, sets quality standards and manages a national database to improve people’s health and prevent and treat ill health.
NICE is currently in a state of flux as it prepares to make way for a new system of value-based pricing that will see it become an advisor to newly created NHS boards, set to come into place from 2014.
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