The National Institute for Clinical Excellence (NICE)
The National Institute for Clinical Excellence (NICE) is a part of the UK’s National Health Service (NHS) and is run by the UK’s Department of Health. NICE produces three types of guidance for the NHS (technology appraisal, clinical guidance and assessments of interventional procedures). The technology appraisals assess new medicines as they are introduced into clinical practice. NICE will review a drug by examining its effectiveness and safety, its cost-effectiveness and the financial impact on the entire NHS. NICE will also recommend when and under what clinical conditions the new drug should be used.
Funding in the UK for health care is provided by the Government but distributed by local health commissioners to primary care, mental health and hospital services. When a new drug is approved by NICE, a business case for its use needs to be made to the local health commissioners. It is important to emphasise that just because a new drug has been approved by NICE, funding is not automatically released.
The decision by NICE to approve a new medicine is determined by a number of factors [1]. The incremental cost effectiveness ratio (ICER) should lie below € 28 000 to € 42 000 per quality adjusted life year (QALY). If there is uncertainty in the ICER, NICE are unlikely to approve the drug. If the therapy is unique, NICE is more likely to approve the drug than if there are (cheaper) alternatives. NICE will also consider the burden of the disease on society and its impact on NHS budgets.
References
1
Devlin N, Parkin D.
Does NICE have a cost-effectiveness threshold and what other factors influence its decisions? A binary choice analysis.
Health Economics.
2004;
13
437-452
3
Padkin A J, Goldfrad C, Young J D, Rowan K.
The prevalence of severe sepsis in the first 24 hours in the ICU, in England, Wales and Northern Ireland.
Intensive Care Medicine.
2001;
27
S252
4
Bernard G R, Vincent J L, Laterre P F. et al .
Recombinant human protein C Worldwide Evaluation in Severe Sepsis (PROWESS) study group. Efficacy and safety of recombinant activated protein C for severe sepsis.
New England Journal of Medicine.
2001;
344
699-709
5
Vincent J-L, Bernard G R, Beale R, Doig C, Putensen C, Dhainaut J-F. et al .
Drotrecogin alfa (activated) treatment in severe sepsis from the global open-label trial ENHANCE: Further evidence for survival and safety and implications for early treatment.
Critical Care Medicine.
2005;
33
2266-2277
6
Davies A, Ridley S, Hutton J, Chinn C, Barber B, Angus D C.
Cost effectiveness of drotrecogin alfa (activated) for the treatment of severe sepsis in the United Kingdom.
Anaesthesia.
2005;
60
155-162
7
Wright J C, Plenderleith L, Ridley S A.
Long term survival following intensive care - Subgroup analysis and comparison with the general population.
Anaesthesia.
2003;
58
637-642
8
Drabinski A, Williams G, Formica C.
Observational evaluation of health state utilities among a cohort of sepsis patients.
Value in Health.
2001;
4
130
9 Towse A. What is NICE’s threshold? An external view. In: Devlin N, Towse A (eds) Cost effectiveness thresholds: economic and ethical issues. London; Kings Fund/Office for Health Economics 2002
