Introduction

The consultation papers A first class service: quality in the new NHS and Putting patients first: quality care and clinical excellence made clear the government's commitment to enhancing the quality of patient care in the NHS by a variety of means, including

• setting clear standards of service
• ensuring local delivery through professional self-regulation, clinical governance and lifelong learning
• monitoring of performance against standards

One particular strand in the consultation documents is the need for a coherent programme of activity to develop guidance on clinical and cost effectiveness. This will be the particular responsibility of the National Institute for Clinical Excellence (NICE).

NICE will develop a variety of clinical guidance "products". Some of these will focus on the treatment of specific conditions and will bring together all the evidence relating to the various available treatment options, including pharmaceuticals, surgical interventions, lifestyle advice and so on. Guidance of this kind ("clinical guidelines") can be regarded as a kind of summation of the state of knowledge on a particular condition at a particular time.

However, as para 2.13 of the A First Class Service made clear, the government also believes that there is a need for timely guidance on individual treatments and products, in particular clinical innovations. Very often, at the time new treatments are introduced into general NHS practice, evidence of clinical and cost effectiveness is ambiguous or incomplete. The result can be

• slow uptake even of innovations of great benefit to patients
• different judgements in different parts of the country on the interpretation or significance of the evidence, resulting in variations in access for patients to the new treatments and the widespread perception of inequity
• wasteful use of resources as treatments are used outside the range of circumstances in which they are clinically cost-effective, at the expense of alternative uses of those resources which could give greater benefits to patients

A First Class Service: quality in the new NHS (Department of Health, London, June 1998).
Putting patients first: quality care and clinical excellence (Welsh Office, Cardiff, July 1998)

As well as guidance on significant new treatments, the government intends as soon as practicable to extend similar principles to the appraisal of the most significant of , especially those for which there is evidence of wide differences in clinical practice or inappropriate use.

NICE is ultimately accountable to the Secretaries of State for Health and for Wales. It will however be responsible for developing its detailed methods of working, for the appraisal of individual interventions as for its various other functions, within any broad guidance which the Secretaries of State may from time to time lay down.

The purpose of this paper is to set out, as a basis for wider discussion, how NICE will address the appraisal function. We would greatly welcome views on the best way of establishing a practicable system which will enable NICE to issue clear and timely guidance, without placing disproportionate burdens on those who are developing clinical innovations for use in the NHS or risking delay in the effective introduction of those innovations offering worthwhile benefits to patients.