The NHS Confederation is a membership body that represents over 90% of all statutory NHS organisations across the UK. Our role is to provide a voice for the management and leadership of the NHS and represent the interests of NHS organisations. We are an independent organisation.

  The NHS Confederation welcomes the opportunity to give evidence to the Health Select Committee on NICE. This evidence sets out our views, based on feedback from a cross section of our member forums.

EXECUTIVE SUMMARY

—  The NHS Confederation supports the role of NICE and regards it as a successful organisation that has proved responsive to the view of stakeholders and has a high reputation for the quality of its work.

—  Many of the issues relating to NICE are less about the Institute itself and more about associated government policy. This includes the selection of topics and the mandating of funding of NICE decisions.

—  There seems to be a view in some quarters that NICE is able to provide a solution to the difficult problems of how resources should be allocated and how new technologies and treatments can be afforded and prioritised. This was not the intention and it is not reasonable to expect NICE to be able to do this.

—  There are a number of measures that could be taken to support organisations in implementing guidance and ensuring effective uptake.

1.   Why NICE's decisions are increasingly being challenged and 2. Whether public confidence in the Institute is waning, and if so why?

  1.1  NICE has raised the public understanding of how health interventions are introduced into practice. This includes understanding of the need to consider treatments according to their effectiveness.

  1.2  NICE does appear to have made genuine efforts to engage all stakeholders in reaching its recommendations.

  1.3  NICE have approved more treatments than they have refused. This has received very little coverage and the media have tended to portray NICE as a rationing body.

  1.4  Even so media coverage at the time of newly published NICE guidance can be associated with concerns from professional /care provider agencies, and may create a perception that NICE exists to ration care rather than make judgements of cost-effectiveness. MORI polling suggests that the public are not sympathetic that access to drugs should be restricted on the basis of cost and some are even not clear that effectiveness should be a criteria. The problem therefore, may be less about NICE and more about how the public perceive the issues.

2.   Whether public confidence in the Institute is waning, and if so why?

  2.1  There has been some coverage showing that post code differences in the uptake of NICE appraisals guidance have persisted—albeit that the level of variation has been reduced. This is not in fact NICE's responsibility but reflects the problem of the diffusion of changes in clinical practice. The existence of NICE has certainly reduced the overall level of this problem.

3.   NICE's evaluation process, and whether any particular groups are disadvantaged by the process and 4. speed of publishing and 5. the appeal process

  3.1  Our members do not question the quality of NICE's appraisal processes, however, there are a number of aspects of the way that NICE is currently required to operate that do cause some concern.

  3.2  At present NICE examine individual treatments or technologies referred to them by the DH. The assessment is made difficult by a lack of good quality cost effectiveness data. Even where it may do this NICE is not mandated to make judgements about how best to allocate limited resources to the new treatment. Many of the treatments that NICE examined have been at the margins of cost effectiveness. As a result the paradox arises that NHS funding is mandated for a marginally cost effective drug and local NHS organisations may have to achieve this by not spending on treatments which may be very much more effective and could benefit more people.

  3.3.  The development period for NICE Clinical Guidelines and technical appraisals has been lengthy. We recognise the very technical nature of the process and the need for complex models to be developed or validated. Delays can be absolutely legitimate, for instance where the development process is suspended if the scope needs to be redefined.

  3.4.  The more recent faster technology appraisals seem a sensible approach to dealing with concerns from patients and NHS for guidance on new interventions immediately after market availability. There is however, a trade-off to be made between speed and the availability of reliable data creating the risk that decisions will subsequently be reversed. Rapid appraisals are more likely to have to rely on data provided by the developer than more independent sources,

4.   The appeal system

  4.1  The appeals process is clear and appears to be effective.

5.   Comparison with the work of the Scottish Intercollegiate Guidelines Network (SIGN)

  5.1  The Scottish Intercollegiate Guidelines Network (SIGN) established in 1993, has concentrated on the development of Guidelines considered by each of the seven specialty subgroups. There is an emphasis on not duplicating any work already commissioned by NICE.

  5.2  Although topics can be submitted to NICE from a range of sources (eg professionals, public, NICE), the recommendations made by the consideration panels are submitted to the DH, to make the final decision on which topics are referred to the NICE work programme.

  5.3  In contrast, topics that are submitted to SIGN are considered by an Executive team for appropriateness, before a full proposal and scoping process commences. Proposals referred to the appropriate clinical subgroup are prioritised and included within a list of potential topics for the Programme Advisory Group. The SIGN Council ratifies which topics are selected.

  5.4  It seems the topic selection process adopted for NICE TAs & CGs is potentially more influenced by DH priorities compared to the CG model adopted by SIGN.

  5.5  More thought needs to be given to how the areas that NICE should be examining are chosen. This is a genuinely difficult area as the knowledge of what areas would replay examination is not widely spread. Some investment in investigating new methodologies to improve the selection of candidate would be useful. At present this is not NICE's responsibility and it might be appropriate if they were involved in developing such methods.

6.   The implementation of NICE guidance, both technology appraisals and clinical guidelines (which guidance is acted on, which is not and the reasons for this).

  6.1  NICE has concentrated on decisions about whether to start using new technologies and much less on which treatments could be stopped although there are new measures to improve this. It may be that some of the expectations that this will lead to large scale savings are over stated.

  6.2  There is a general problem that the methods for dissemination and implementation of guidance are not as well understood as they might be and work and NHS management would benefit more research on influencing clinical practice.

  6.3  Recommendations frequently involve several provider agencies/teams, which can delay progress with the implementation of service specific and/or overall implementation. Departmental expectations of implementation for NICE products needs to consider how organisations such as a NHS trust and its PCT partner(s) can prioritise which guidelines and within individual guidelines which recommendations to implement first and where business planning is required to progress new or additional resource.

  6.4  There is an understanding that the clinical guidelines are developmental in nature and that organisations will therefore need time to plan resources for and to implement any one of them, but given the number of different guidelines now available some direction about how to look at them as a group and to prioritise within them overall might be helpful.

  6.5  The Interventional Procedure Programme (from 2003) supports healthcare professionals involved in the introduction of new procedures and patients themselves, by publishing guidance on the safety and efficacy of the procedure. Trusts take these NICE recommendations and integrate within local policies for implementing new procedures which is vital for local ownership of changes in practice but can also appear as a delay.

  6.6  The DH requirement to fund NICE treatments may lead to in-year financial pressures flexibility becomes increasingly limited. The publication of NICE appraisals throughout the year does not fit with the annual allocation of resources to NHS organisations although NICE have introduced a forward planner which can assist with this. The introduction of fast track appraisals could potentially reduce the ability of PCTs to plan for significant NICE recommendations. The DH policy of developing contingency funds could assist with this.

  6.7  The argument made by Ministers in the past that this is good for patients or that it eliminates post code prescribing may not fully reflect the reality of how decisions are implemented. By definition insisting on funding a less cost effective treatment will be at the expense of other patients who would have benefited more. It may eliminate post cost prescribing in the treatment that NICE have examined but, as the funding government provides for NICE decisions is in general allocations and not earmarked, different NHS organisations will find the money in different ways producing variation elsewhere.

RECOMMENDATIONS FOR ACTION

—  NICE has been successful and should be supported in its role. Further work on opportunities for disinvestment and advice on cost minimisation is required. NICE will need access to data on utilisation and research on health technology assessment in order to do this. Unsurprisingly, manufacturers do not tend to sponsor research which produces data that can inform this.

—  Methods for topic selection could be improved. It is welcome that NICE has been given more responsibility for this. Developing new methods for doing this might be of value.

—  It is not reasonable to expect NICE to provide the answer to the difficult question of how to allocate resources. This is a decision for PCTs, and NICE can assist with this. An expansion of the NICE programme would help this. However, there is a need for a debate with the public about some of the difficult resource allocation decisions that need to be made, how priorities are set, and how scarcity should be managed.

—  The policy of mandating of funding of technology appraisals should be evaluated in terms of its impact on other services.

—  There would be merit in further research and tool development for the dissemination of appraisal and guidelines. Making these available on the desk top of NHS clinical computer systems would be helpful.

NHS Confederation

March 2007