Chief Executive National Institute for Health and Clinical Excellence (NICE), UK.
Along with the expected complexities of working in and on behalf of a rapidly changing health system, it has been an interesting year in the evolution of National Institute for Health and Clinical Excellence’s (NICE) work programme. The NHS is constantly striving to make tactical and strategic alterations to its structure in order to adapt and to operate as effectively and efficiently as possible, and the organisations that exist to support and advise it need to do the same. An important change took place in 2005 that saw the core functions of the Health Development Agency (HDA) transferred to the National Institute for Clinical Excellence, to form a new organisation: the National Institute for Health and Clinical Excellence (which will retain the abbreviation NICE).
The decision to merge NICE and the HDA, taken as part of the government’s arms-length bodies review, has been seen by some as controversial, principally due to the predictable accusation that it is about cutting costs and nothing more. But this is not a marriage of political convenience, and anyone who was familiar with the work of NICE and the HDA will see huge potential benefits from the merger.
The role of the new organisation is to produce guidance for health professionals, patients and the wider public in three areas of health:
Across all three programmes for work, NICE’s task is to produce intelligent and well-resourced guidance that informs healthcare professionals and the public of the best way in which to improve and protect health.
Decisions about the total resources available for healthcare are the responsibility of parliament and inevitably compete with other demands such as education, defence and transport. Within the allocations made by parliament, the resources for the NHS are finite, and the use of cost-ineffective, or less cost-effective, interventions in one area of practice will deny the availability of more cost-effective interventions in another.
The Institute’s preferred approach to the economic evaluation of clinical interventions is cost–utility analysis. The principal measure of health outcome adopted by the Institute is the Quality-Adjusted Life Year (QALY). This embodies the important social value judgement that to count only gains in life expectancy, without considering the quality of the additional life years, omits important dimensions of human welfare. Value judgements embodied in health-related quality-of-life measures can be reasonably captured in terms of physical mobility, ability to self-care, ability to carry out activities of daily living, absence of pain and discomfort, and absence of anxiety and depression. QALYs are underpinned by an extensive body of empirical evidence1 and have been shown to be appropriate for a range of conditions, including mental health2.
The use of cost–utility analysis in resource allocation has aroused a substantial debate. Charges of discrimination against children, elderly and disabled people, and people who are terminally ill, have led some to conclude that the use of QALYs leads to impermissible trade-offs in setting priorities. Nevertheless, most bioethicists and political philosophers are generally prepared to accept cost–utility analyses provided they are used to inform, rather than direct, decisions about setting priorities, and that other considerations are available to constrain morally offensive trade-offs. The Institute’s own position is that while it endorses the use of cost–utility analysis in the economic evaluation of particular interventions, such information is a necessary, but not sufficient, basis for decision-making. Its advisory bodies have discretion, informed by advice from the Institute, on how to take the outcome of economic assessments into account in formulating their recommendations.
The audiences for the new public health guidance products extend beyond the NHS to local government and education, the public utilities, the private and voluntary sectors. Audiences also include a range of central government departments and their delivery arms with responsibility for taxation, benefits, roads, transport, housing, criminal justice and other aspects of services that contribute to the health of the public. NICE guidance will support evidence-based decision-making by public health physicians, medical and dental general practitioners, nurses, community practitioners, other NHS staff, local authority employees, employees of public utilities, teachers and others working in relevant fields.
Examples of recent public health guidance include interventions on smoking cessation and physical activity, as well as a clinical guideline on the prevention, identification, assessment and management of overweight and obesity in adults and children (More details of which can be found on the NICE website at http://www.nice.org.uk/guidance/CG43). Public health programme guidance is also being developed for primary care and employers on the management of long-term sickness and incapacity(http://guidance.nice.org.uk/pageaspx?o=350209&c=296726) and on personal, social and health education focussing on sexual health and alcohol(http://guidance.nice.org.uk/page aspx?o=350208&c=296726).
The Department of Health document Standards for Better Health published in 2004 set core and developmental standards for NHS organisations. The implementation of technology appraisals guidance and interventional procedures guidance is a core standard, whereas the implementation of other types of NICE guidance is a developmental standard. The recent introduction of the Healthcare Commission’s Annual Health Check should help ensure NICE guidance is implemented more quickly throughout the NHS. The Annual Health Check will require NHS bodies to declare whether they comply with the Department’s standards, which includes compliance with NICE guidance. The audits carried out in line with The Annual Health Check will explore how new guidance from NICE is being managed and introduced within trusts. Assessing the implementation of NICE guidance is a high priority for the Healthcare Commission in its role of encouraging improvement in the provision, safety and quality of patient care.
Due to the sensitive nature of our work, NICE is rarely out of the headlines. The quid pro quo of inclusiveness and consultation means that NICE guidance often takes longer to produce than stakeholders would like3. We are however acutely aware of this, and have responded accordingly with the aforementioned STA process. We have also been flexible in terms of updating recently published guidance where new evidence has emerged. This was seen in our clinical guideline on Hypertension, where the subsequent emergence of the highly significant ASCOT trial findings resulted in an amended version of our guideline being issued before the official review date.
We are also continuing to provide support to the NHS as it applies our guidance. Our implementation support programme now offers a range of tools and resources for most of the guidance at the time of, or soon after, its publication. Our aim is to do everything we can to make sure that those whom our guidance is intended to benefit are able to do so.
1. Rasanen P, Roine E, Sintonen H, Semberg-Konttinen V, Ryynanen OP, Roine R. Use of quality-adjusted life years for the estimation of effectiveness of health care: A systematic literature review. [Review] [17 refs]. International Journal of Technology Assessment in Health Care 2006;22:235-41.
2. Canadian Coordinating Office for Health Technology Assessment. A clinical and economic evaluation of selective serotonin reuptake inhibitors in major depression. 1997. Ottowa, Canadian Coordinating Office for Health Technology Assessment (CCHOTA).
3. The Department of Health has however made it clear to the NHS in guidance that it is not acceptable to refuse a treatment simply because NICE guidance does not yet exist. The NHS must make its own assessment based on available evidence.