Select Committee on Health Second Report


136. We welcome the introduction of NICE as an institution which can offer advice on treatments and interventions based, where possible, on strong, reliable evidence. We also recognise that NICE is a new organisation, and would wish to stress that our conclusions and recommendations are intended to support NICE in learning from its early experiences and developing its processes accordingly.

The quality and credibility of NICE's work

137. NICE has been expected to meet exacting delivery targets from its inception. As well as this, it has been obliged, by developing scientifically robust appraisal methodology and inclusive and transparent processes, to establish credibility with, and to ensure the engagement of, a diverse range of stakeholders. At just under three years old, NICE is a relatively new organisation, and it would be unlikely that its processes would be fully watertight. Our main recommendations in this area are intended to bring about improved processes for stakeholder involvement, a more robust appeals procedure, and improved transparency about its evidence and its decision-making. Our confidence in NICE is strengthened by the fact that it is already taking steps in many of the areas where we have highlighted room for improvement.

138. Rather than a conclusive assessment, this short inquiry should be seen as the first step in a continuous process of scrutiny and improvement, in which we intend to play an ongoing role. One of NICE's main challenges at this still early stage in its development is to establish itself with its stakeholders. Of these, the most heterogenous and daunting is probably the NHS, which is why it is perhaps unsurprising that NICE does not yet appear to have won the full confidence of those who work in the service, or to have wholly established the place of its work in relation to the multiplicity of other pressures and policies competing for priority in the NHS. We have recommended that NICE concentrate on improving its involvement of NHS trusts and strategic health authorities, and other recommendations concerning the focus of NICE's work and the selection of its work programme will support this. We hope that by the time we revisit NICE, these reforms, together with NICE's growing maturity as an organisations, will have enabled it to have fully imbedded itself within the NHS family.

139. The quality and credibility of NICE's work can only be as good as the evidence on which it is based. While we recognise the importance of using the best available evidence, we are also sympathetic to the numerous difficulties attached to procuring the highest quality information. Because of this, we have made several recommendations connected to enhancing the quality of information NICE is able to use in its work, covering:

140. The area within which NICE works is populated by many expert groups and organisations. Although these groups may have differing remits, interests and viewpoints, they frequently have similar levels and types of expertise to NICE. The fact that many of these bodies already have well established reputations in the clinical areas they serve means that it is vital for NICE to engage constructively with them, and where appropriate share expertise. In section I we have recommended that NICE works to strengthen its relationships with expert organisations, including the British National Formulary and the Drug and Therapeutics Bulletin. Further to this, we are aware that although much of NICE's role essentially involves quality-assuring the research evidence available to the NHS, NICE itself is not supported by any means of independently quality-assuring its own work, and we have therefore recommended that the Government should consider options for rectifying this.

The focus, organisation and implementation of NICE's work

141. The concept of NICE guidance has been broadly welcomed by the NHS. However, some of our witnesses felt that the reality of NICE had raised difficulties, many of which were outside NICE's direct control. Difficulties surrounding the timing of NICE guidance and the focus of its work programme can be traced to the variety of competing aims NICE has faced from its inception:

142. While none of these aims are mutually exclusive, it would not be reasonable to expect NICE to have achieved all of them in such a short timeframe, or within the confines of its current structure or capacity. Drawing on the concerns raised in our evidence, we have therefore recommended that the Government should refocus NICE's efforts in several respects.

143. Firstly, we have recommended that a significantly increased proportion of NICE's resources should be devoted to NICE's clinical guideline development programme, which should be extended to cover all major causes of morbidity and mortality, as identified by a new, more inclusive and more transparent topic selection process. These changes in focus are supported by NICE, and are broadly supported by government. However, we are concerned at NICE's ability to deliver them without a significant increase in capacity, and therefore we recommend that the Government should extend NICE's funding to fully support these activities.

  144. Alongside this, we have recommended that rapid 'interim' appraisals of all selected new treatments should be published to coincide with the launch of the relevant technology, with a proviso for later review where necessary. For a number of years there will clearly be a continuing need for NICE to appraise the backlog of existing treatments and interventions which suffer from inequitable provision, or are of questionable cost or clinical effectiveness. This function should be distinct from NICE's "new technology" function in order to ensure that both activities are occurring concurrently, and to raise confidence in the NHS that NICE is achieving a balance between them, and should be carried out as part of NICE's main clinical guidelines function.

145. To improve the clarity and impact of this refocused work programme, we have also recommended that NICE should develop clearer cross-referencing between technology appraisals and guidelines, clearer links with NSFs, and that the legal status of NICE technology appraisals and guidelines should be clearly communicated to the NHS by the Government.

146. The success of NICE's endeavour is critically connected to the thorough and systematic implementation of its guidance, which is again outwith NICE's direct remit. While the impact of the Government's recent directive in this area is not yet known, it is clear from our evidence that monitoring of implementation has not been rigorous. We have therefore recommended that the Government ensures that CHI (and later CHAI) is able to conduct appropriate monitoring of the implementation of NICE guidance.

NICE in its wider context

147. Many of the issues raised by this inquiry reach beyond the specific role of NICE, focusing on NICE's relationship with the Government and its place in the wider debates on funding and prioritisation within the NHS. Considerable confusion currently surrounds the role NICE plays in assessing the affordability of treatments in the NHS, and to this end we have recommended that the Government ensures that there is clarity about its own role in settling issues of affordability. NICE's methodology is obviously still evolving, and we hope it will continue to be subject to regular review and 'fine-tuning' by NICE itself. Cost-effectiveness is an issue subject to the difficult combination of being both emotive and little understood, and we feel that our evidence reveals a need for greater clarity about both the determinants of cost-effectiveness, and the attendant value-judgements these necessitate. We have therefore recommended a full-scale review of NICE's methodology, followed by the publication of clear criteria.

148. The Government's decision to fund further research on beta interferon under a scheme of risk-sharing following NICE's negative appraisal of the drug has also raised concern and confusion, pointing to the need for further clarification and development of the relationship between the Government and NICE. We have therefore recommended that the Government ensures that all its work on health technology research and pricing takes full account of NICE's work, and that any subsequent government decisions which could appear to run contrary to NICE recommendations are issued in collaboration with NICE to minimise the potential risk to NICE's credibility.

149. In addition to the clear value of its guidance to clinicians, patients and commissioners of care, NICE has generated great interest in its work because of the central position it holds in the highly charged debate about prioritisation within the NHS. NICE's role in prioritisation has come under even greater scrutiny since the Government directed that implementation of NICE's recommendations will be a mandatory requirement for health authorities, which means that NICE's decisions may now have a direct impact on spending priorities in local health economies. This makes the process through which topics are selected for NICE's work programme doubly critical. We have recommended that the transparency and inclusiveness of the Government's topic selection process is improved, and that topic selection should be informed by the total health benefit to all patients.

150. The mandatory funding of NICE recommendations also raises the question of how the NHS should value other competing calls on its resources which will not be assessed by NICE, including, for example, nursing services. While NICE has served as a focus for these difficult issues, we do not feel that this is a debate NICE is qualified, or should be expected, to lead unsupported, and we have therefore recommended that the Government should work to establish a broad framework of values to guide the NHS in its consideration of spending priorities. These values should also inform the Government's prioritisation of topics for NICE appraisal and guidance.

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