Diabetes UK is one of Europe's largest patient organisations. Our mission is to improve the lives of people with diabetes and to work towards a future without diabetes through care, research and campaigning. With a membership of over 175,000, including over 6,000 health care professionals, Diabetes UK is an active and representative voice of people living with diabetes in the UK.

EXECUTIVE SUMMARY

—  The decisions of NICE may increasingly be challenged as a result of perceptions that their primary objective is measuring cost effectiveness.

—  In addition there is concern that the views and experiences of patients and the public are marginalised in the consideration of evidence and the decision making process.

—  These in turn will have an effect on public confidence, as will the increased media attention over cases such as Herceptin.

—  Deviations from NICE recommendations may be a legitimate decision by a practitioner based on the best interests of an individual patient.

—  Increasing transparency of its decision making processes and why it has reached its decisions should assist in maintaining its credibility as an institute, particularly when decisions are altered.

—  The willingness to alter decisions is a positive provided the process behind this is fair and transparent.

—  Whilst NICE has taken steps to increase patient and public involvement, concerns still exist that patient experiences are not given enough consideration in the evaluation process.

—  Implementation of NICE recommendations whether guidelines or technology appraisals, are affected by the funding available locally. If funding is not made available and the recommendations not implemented as a result, this again will impact negatively on public confidence.

—  NICE guidance can be misinterpreted resulting in an unfair restriction in access to services required, for example in the case of access to insulin pump therapy.

1.   Why NICE's decisions are increasingly being challenged

  1.1  The concerns highlighted to Diabetes UK overwhelmingly concern two key issues; the role of NICE in measuring cost effectiveness and the extent to which patient experience and wishes are adhered. These issues have increasingly affected the credibility of the Institute in the eyes of some healthcare professionals and patients alike and has encouraged people to challenge the decisions of the Institute. The concerns are that there is an increasing bias towards considerations of cost effectiveness when decisions are made regarding technologies/treatments in particular. For example, as an organisation we have been involved in the consultation regarding inhaled insulin. The initial recommendations were clearly restricting access to people with diabetes based on considerations of cost despite the benefits in quality of life that could be attained for some people with diabetes. There is recognition that the remit of NICE which straddles both clinical and cost effectiveness can create this conflict of interest creating tensions in their role. In addition, opinion suggests that the decisions reached are based predominantly on the outcomes of Randomised Control Trials and a hierarchy of the evidence base where patient experience and other qualitative evidence is marginalised. This was again reflected in the initial decision made by NICE regarding inhaled insulin.

  1.2  Challenging decision is a healthy part of ensuring transparency and that checks and balances are in place. The fact that NICE has altered previous decisions, as with inhaled insulin, not only shows that they are willing to reconsider decisions but that people are able to challenge NICE. However NICE must ensure that their decision making process is clear and transparent and that this is communicated effectively, otherwise, paradoxically, any changes to earlier decisions could be viewed as evidence of a weak organisation that is vulnerable to ill considered decision making.

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

  2.1  The media have an interest in sensationalising stories and media distortions of some NICE decisions will have an affect on the general public's perception of NICE. Undoubtedly, the increased awareness of NICE and its role through recent media coverage has encouraged scrutiny. This, in turn, can be a positive force for engaging more members of the public in the work of NICE.

  2.2  Decrease in public confidence may also be the result of misdirected frustration. NICE make decisions in terms of cost effectiveness as well as examining the evidence working within the financial parameters of a tax based NHS. Funding is central to the question of confidence in NICE. This relates to the implementation of best practice with regards to clinical guidelines and access to new medicines and technologies that improve patients' health and quality of life. NICE guidance is not always implemented at a local level, particularly where there are increased costs involved or savings to be made. We are concerned, for example that NICE recommendations regarding blood glucose monitoring testing strips is being misinterpreted by PCTs in a manner that has restricted or prevented the supply of these testing strips to people with Type 2 diabetes, as evidenced by the level of anecdotal feedback we are receiving about this issue as an organisation. In addition, despite the existence of guidance, local areas are also not providing pump services in a consistent manner.[73] Public confidence then may be waning as they find NICE guidance is not being implemented locally by their PCTs.

  2.3  Some people have expressed concern regarding the lack of transparency regarding NICE and its decision making process in relation to how it communicates this with the wider general public. By ensuring they communicate clearly and behave transparently regarding their decisions and why they have reached particular conclusions, NICE may improve public confidence and recover potentially lost credibility.

  2.4  Clinicians will make decisions based on the best interests of their individual patients and may not always follow NICE guidance as a result. This may have the effect of reducing confidence in NICE from patients who disagree.

3.   NICE's evaluation process, and whether any particular groups are disadvantaged by the process

  3.1  We are aware NICE has made progress in its attempts to better engage with the public and patients, and is also looking at how their guidance can also be better tailored to incorporate matters affecting people from groups traditionally labelled as "hard to reach". However we are also aware that in practice, as mentioned in paragraph 1 the views of patients and the public may not always be given as much weighting as the more traditional sources of evidence.

4.   The speed of publishing guidance

  4.1  There is recognition that although the speed of publishing guidance is slow, this is due in part to the complexity and depth of the task at hand. The length of time can be explained as it enables wider stakeholder consultation and an understanding that patient organisations for example will have their own consultation process with their membership and stakeholders in order to provide a representative response to consultations. However this must be tempered with the need to ensure that guidance is published fast enough to enable patients to take advantage of innovations and receive best care as soon as possible. It is also important so that guidance maintains relevance and that evidence used in the review is not quickly superseded with new evidence making the NICE guideline out of date.

  4.2  This is also important in relation to the length of time before guidance is next reviewed. The gap between reviews can be too long. For example confusion has been caused regarding cholesterol levels as a result of the length of time between review of guidelines. The National Prescribing Centre has had to clarify that despite the new evidence identified in the JBS2 guidelines that existing guidance must be followed until NICE have the opportunity to review this new evidence.[74] Out of date information in a NICE guideline can create a conflict between PCTs and practitioners, and there is the potential for the guidelines to be ignored as a means of restricting access to technologies or medications on the basis of outdated guidelines. It would be helpful if parts of guidelines are reviewed in light of new evidence.

5.   The appeal system

  5.1  The appeal process can be an unfair one and there is concern that decision making is swayed in relation to who is able to create the most vocal demonstration.

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

  6.1  It is difficult to draw comparisons between NICE and SIGN as people tend to have experience of one body or the other.

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

  7.1  The difficulties of implementation in relation to cost have been mentioned in paragraph 4. However there are a number of connected issues relating to costs that affect the ability of NICE guidance to be implemented. Funding is required not only for the material resources such as treatments or technologies but also implementing clinical guidelines through the staff, facilities and training required to implement recommendations effectively. For example insulin pump therapy requires specialist input from competent staff who themselves require training who in turn need the protected time to adequately educate the person receiving the pump and then be available to provide support to the person as they begin to use it.8 Our recent survey in relation to cuts in specialist services has highlighted that in many cases all manner of specialist diabetes services are being cut in various guises such as the cutting and freezing of specialist posts and the redeployment of staff on to general wards. In addition we are aware that time allowed and funding for continuing professional development is also being slashed.[75] In this environment of deficits it is important that the quality and availability of excellent care is not compromised. Having NICE recommendations that cannot be implemented undermines the existence of NICE as a body representing health and clinical excellence.

  7.2  The recent commissioning toolkits developed by NICE may help the implementation of NICE guidance. However Diabetes UK is concerned with the lack of engagement with patients and patient organisations in relation to their development. For example Diabetes UK would have welcomed the opportunity to have been involved with the "Foot care service for people with diabetes" commissioning guide. We hope that when this is reviewed we will be able to offer our assistance. We believe that all appraisals and guidance should be accompanied by clear implementation and commissioning guidance. We welcome NICE's plans to do this and look forward to being involved in this in the future.

  7.3  NICE lacks the power to ensure implementation of its guidance and causes problems for patients when they are unable to access the services and treatments to which they are entitled. The technology appraisal over structured education is a case in point. Despite the ministerial funding direction regarding NICE guidance in January 2006[76] which places a responsibility on PCTs to show that they at least have a plan in place for the delivery of structured education that meets the agreed criteria with clear timescales in place, we are aware that some PCTs will not be able to meet this target and as there is not a strong enough impetus to do so prioritisation of this direction is unlikely. This is compounded by the issues mentioned in paragraph 12 regarding costs for training, development and delivery of such programmes whilst ensuring they are sustainable and that funding is not later withdrawn.

  7.4  We are aware that NICE recommendations can also be misinterpreted to restrict the level of provision of certain technologies. This can mean arbitrary decisions are made regarding for example the number of insulin pumps bought in any one year by a PCT. The decisions are made based on the NICE estimations despite the local level of need.[77] There are inherent difficulties with the position of NICE as their recommendations are neither mandatory but neither are they insignificant in their weight. Therefore there will always be the opportunity for recommendations to be used both positively to seek best care for patients but also negatively to restrict without good reason access to best care and this can hinder the recognition by healthcare professionals of more recent clinical evidence that may contradict NICE guidance. However there would be no merit in arguing that NICE recommendations become entirely mandatory or lose their weighting as this is likely to hinder the delivery of best care to some patients.

Stella Valerkou

Diabetes UK

March 2007

http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_072777

http://www.diabetes.org.uk/Professionals/Information_resources/Reports/Cuts-in-Diabetes-Specialist-Services/

http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_4138033

74   National Prescribing Centre; Boyle, R (2006) Copy of DH statement following National Cardiac Networks Meeting National Policy on Statin Prescribing. Back

75   Diabetes UK and National Diabetes Support Team (2007) Insulin Pump Services Department of Health Back

76   Diabetes UK (2007) Cuts in Diabetes Specialist Services-A Report Back

77   Information on the funding direction for structured education programmes for people with diabetes Back