Abstract
From 1 April 2013, the National Institute for Health and Clinical Excellence (NICE) will be re-established under the provisions of the Health and Social Care Act 2012. Although its name will change to the National Institute for Health and Care Excellence, its acronym — NICE —has been written into the face of the Act. The new NICE will continue to provide the full range of guidance and other products with which the Institute has become associated. It will, though, have enhanced responsibilities in the development of quality standards and in the introduction of value-based pricing. In addition, it will be responsible for producing guidance for social care (hence the change in its name) and associated quality standards. The changes to the structure of NICE will not change its relationship with the professions and we are confident that it will continue to be relevant to all those working in the National Health Service.
Since its establishment in 1999, The National Institute for Health and Clinical Excellence (NICE) has existed as a ‘special health authority’. On 1 April 2013, it will become re-established, under the Health and Social Care Act 2012, as the National Institute for Health and Care Excellence.1 What does this mean for the Institute's status, independence and responsibilities?
The name
The Institute's title has been changed to reflect the fact that its portfolio of products is to include social care as well as health. Its acronym – NICE – will, however, remain intact and it appears in the face of the Act.
Independence
The independence of the Institute will, if anything, be enhanced by the new arrangements. As a ‘special health authority’, NICE was created under secondary legislation and, hence, could easily be abolished. As a body established under primary legislation, NICE could not be dissolved without another Act of Parliament. Furthermore, the Act specifically states (Chapter 237, Subsection 4) that the Institute's regulations ‘must not permit a direction to be given about the substance of advice, guidance or recommendations of NICE’.1 Although no minister has, in the past, attempted (or even threatened) to overturn any NICE guidance, this clause enshrines the Institute's independence in primary legislation rather than relying on custom and practice.
Current responsibilities
The Institute's current portfolio of roles and responsibilities remains unchanged. These comprise:
the development and publication of guidance for NHS health professionals and those with responsibilities for the wider public health (summarised in Table 1)
the preparation and dissemination of quality standards and metrics for those providing and commissioning care for NHS patients (summarised in Table 2)
a range of information services for the NHS and for those providing public health and social care services (summarised in Table 3).
NICE's guidance programmes.
NICE performance standards and metrics.
Information services provided by NICE.
Enhanced responsibilities: quality standards
Under the arrangements that are provided for under the Act, NICE's quality standards have an enhanced role.
The Institute launched its quality standards programme in 2009. These are a set of specific and measurable statements that define what high-quality care should look like in the prevention and treatment of particular conditions. They are based on high-quality guidance (especially NICE's clinical guidelines) and address all three dimensions of quality: effectiveness, patient safety and patient experience.
NICE's quality standards have assumed a central role in the Health and Social Care Act in order to ensure that the NHS is focused on delivering the best possible outcomes for patients. Although they are not mandatory, they will be used by:
patients, carers and the public to provide information about the quality of care they should expect to receive from the NHS
healthcare (and ultimately social care) professionals, as well as public health professionals, in monitoring and improving the quality of services provided for patients and the public
provider organisations to demonstrate, through their annual quality account returns, the quality of care given to patients by their own institutions
commissioning bodies to inform the configuration of services through the contractual process.
The quality standards will also support the NHS Commissioning Board (NHSCB) by informing their commissioning of products and in prioritising areas to facilitate improvements in the NHS Outcomes Framework. Quality standards will also inform the future development of indicators for the Quality and Outcomes Framework.
Enhanced responsibilities: value-based pricing
In late 2010, the government signalled its intention to adopt a ‘value-based pricing approach to determining the cost-effectiveness of new pharmaceutical products’. The details have yet to be announced but are likely to involve formally ‘weighting’ the quality-adjusted life year to take account of societal preferences. In this new process, the government has indicated that NICE will play a central role.
The change is not as dramatic as some commentators have suggested. NICE's appraisal committees already have discretion to take account of factors such as the severity of the underlying disease, and treatments that prolong life at the end of life, in making decisions about whether — on cost effectiveness grounds — a product should be available under the NHS. They have always done so but in a subjective, qualitative manner. The intention to capture these elements quantitatively, implicit in value-based pricing, is therefore an evolutionary step, although we do not underestimate the technical challenges that are involved.
The move to value-based pricing will not change the significance, to the NHS, of the implications of ‘positive’ NICE technology appraisal guidance. In these circumstances, the law (as reflected in a 2002 Direction to the NHS from the Secretary of State), as well as the provisions of the NHS Constitution, places an obligation on the service to make such products available. The government has confirmed that these arrangements will stay in place after the introduction of value-based pricing.
Additional responsibilities for social care
The Health and Social Care Act requires NICE to develop guidelines and quality standards for social care.
This is a significant addition to NICE's remit and follows the Institute's track record in developing robust, evidence-based guidance in healthcare and public health. The Institute welcomes this initiative, which will cover both adult and children's social care, because it will help break down the barriers that have for too long existed between these services.
In preparation for this new role, which can only formally begin next April, NICE has run a pilot of two topics:
the care of people with dementia
the health and wellbeing of ‘looked after’ children and young people.
The pilots will test NICE's methods and processes, explore the format in which guidance can most appropriately be presented and disseminated, and develop an approach for integration with the Institute's guidance for relevant aspects of healthcare.
Conclusions
Re-establishing NICE as a non-departmental public body, though necessary to enable us to engage with the social care communities, will not change the fundamentals in our relationship with the NHS. In order for the Institute to continue to be relevant in the NHS, it needs to ensure that its outputs are closely aligned to the decisions that health professionals need to make. The Institute must also create and maintain effective partnerships with the NHS Commissioning Board as it becomes, from next April, responsible (indirectly and directly) for the provision of most NHS services. NICE must also continue to innovate in the ways it presents its guidance and other products to its various stakeholders, so that its guidance and information services are available and accessible at the time they are required. And, finally, the Institute must continue to support the adoption of its guidance and standards so that patients and the public benefit from its work.
- © 2013 Royal College of Physicians
