The UK's Life Sciences Strategy: opportunities for clinical pharmacology.

The UK's Life Sciences Strategy provides UK clinical pharmacologists with a unique opportunity to enhance the impact of their discipline on patients and the NHS as well as the pharmaceutical industry. The full benefits of electronic prescribing systems, supported by artificial intelligence, will require clinical pharmacological expertise. Similarly, the Strategy's support for 'healthy ageing' will only be realized if clinical pharmacologists are able to use their expertise in promoting the safe and effective use of medicines in older people. Furthermore, their needs to be an active - and continuing - collaboration between clinical pharmacologists in the NHS and the pharmaceutical industry in general as well as with the discipline of pharmaceutical medicine.

National Institute for Clinical Excellence: NICE works.

The National Institute for Clinical Excellence was established in 1999. Its original remit was to undertake technology appraisals of (mainly) new interventions and to develop clinical guidelines. In providing both forms of guidance, it was required to take into account both clinical and cost effectiveness. After a difficult first few months, it gained the confidence and trust of the professions. It subsequently gained additional responsibilities with a commensurate increase in its staffing and budget. It is, moreover, the only one of the National Health Service organisations established in the late 1990s and early 2000s to have not only survived but grown. This paper describes not only the National Institute for Clinical Excellence's early years but also, in the author's view, the features of its guidance programmes that led to its success and (in retrospect) some things it could have done differently.

Evidence, values, and decision making.

BACKGROUND: The evidence supporting the use of new, or established, interventions may be derived from either (or both) experimental or observational study designs. Although a rigorous examination of the evidence base for clinical and cost-effectiveness is essential, it is never sufficient, and those undertaking a health technology assessment (HTA) also have to exercise judgments. METHODS: The basis for this discussion is largely from the author's experience as chairman of the national Institute for Health and Clinical Excellence (NICE). RESULTS: The judgments necessary for HTA to make are twofold. Scientific judgments relate to the interpretation of the science. Social value judgments are concerned with the ethical principles, preferences, culture, and aspirations of society. CONCLUSIONS: How scientific and social value judgments might be most appropriately captured is a challenge for all HTA agencies. Although competent HTA bodies should be able to exercise scientific judgments they have no legitimacy to impose their own social values. These must ultimately be informed by the general public.

Clinical pharmacologists in pharmacoeconomics: what is their role?

Clinical pharmacologists have three distinct contributions to make in the economic evaluation of new and existing pharmaceutical products: they should play a significant role in promoting the principles of "opportunity costs" in healthcare; they need to have a broad understanding of the methodology of economic evaluation in healthcare; they have a critical role in bringing their specialist knowledge, skills and experience in decision-making. In fulfilling these essential roles clinical pharmacologists may find themselves outside their conventional "comfort zones". Nevertheless, clinical pharmacologists need to rise to the occasion if they are to meet their obligations to patients and to society as a whole.

Crossing the fourth hurdle.

The fourth hurdle, the requirement that pharmaceutical manufacturers can demonstrate that their new products represent good value for money as well as being of good quality, effective and safe, is increasingly being required by healthcare systems. In crossing this 'fourth' hurdle, companies will usually need to demonstrate that their products are more effective than relevant comparators and that the increased cost is offset by the enhanced benefits. Decision makers, however, must draw their conclusions not only on the basis of the underpinning science but also on the social values of the people they serve.

Quality, innovation, and value for money: NICE and the British National Health Service.

The National Institute for Health and Clinical Excellence (NICE) was established as a part of the British National Health Service in 1999 to set standards for the adoption of new health care technologies and the management of specific conditions. In doing so it was required explicitly to take into account both clinical effectiveness and cost-effectiveness. This article describes how NICE has responded to the challenge and considers whether its experience of balancing quality, innovation, and value for money holds policy lessons for the United States.