Executive summary of evidence from the British Medical Association on the National Institute for Health and Clinical Excellence (NICE)
March 2007
- Before the formation of NICE, there was little in the way of widely circulated pan-professional evidence based guidance. Although our written submission raises significant problems with the operation of NICE, the concept remains a good one. This inquiry is timely as it affords the opportunity to reflect on ways to develop the institute.
- Doctors in a wide-range of specialties have told us that a key flaw in the formulation of NICE guidance is the lack of involvement of front line clinicians in the evaluation of evidence and formulation of recommendations. GPs, in particular, have concerns around implementation. They feel disengaged from NICE because guidance is developed with acute care in mind and is divorced from their everyday reality. In some cases, for example ‘Improving Outcomes Guidance for Skin Cancers’, guidance goes against the grain of reform, in this case the aim of providing more minor surgery in primary care.
- NICE decisions are increasingly being questioned and, partly as a consequence, public confidence is failing because cost containment is thought to be the primary concern. A growing awareness of the different availability of drugs across the UK’s national health services is adding to this as are the reports of financial challenges facing the English NHS. All these reasons make it likely that NICE and its work will become more politicised.
- There is growing concern amongst hospital doctors that NICE is slow to produce guidance, particularly on the evaluation of new technologies. Patients and doctors are often clamouring to use new technologies long before NICE provides its advice. There have been several publicly exposed situations where NICE has yet to undertake an evaluation and in response to individual claims for guidance the Department of Health say this should be provided by PCTs in the interim. This lack of clarity makes the process unclear and frustrating for groups who are asking their doctor for a particular intervention. It also places a great deal of pressure on local decision makers who want better support form NICE and national policy makers.
- We believe that NICE guidance should be more transparent about the evidence it draws upon and how this was interpreted. Guidance should more clearly rank the degree of authority evidence has and, by association, the authority of recommendations.
- We are of the view that politicians generally and the government especially need to be more open about the financial challenges facing the NHS and provide political and financial support for NICE and the critical role it has to play in its analysis of clinical and cost effectiveness and recommendations for clinical practice.
1. The British Medical Association is an independent trade union and voluntary professional association which represents doctors from all branches of medicine all over the UK. It has a total membership of over 138,000.
2. In our written submission we raise a number of problems with the way NICE is working at present. However, before its existence there was little in the way of widely circulated pan-professional evidence based guidance, and though there are significant problems, the concept of NICE remains a good one.
3.This inquiry is timely as it affords the opportunity to reflect on ways to develop the institute.
On reasons NICE’s decisions are increasingly challenged
4. Doctors from a wide range of specialties have told us that a key flaw in the formulation of NICE guidance is the lack of involvement of front line clinicians in their formulation.
5. General practitioners, in particular, feel that they are not fully recognised within NICE guidance. As the first port of call for patient care and with a broad range of skills, NICE seems divorced from the daily of reality of specialist general practice. One GP used the phrase “ivory tower” to describe the gap between NICE and practice at local level. In secondary care too, hospital doctors feel that guidance is produced by academics and to improve, NICE needs to focus more on ways to help clinicians at the coalface improve the care of their patients by helping them to implement decisions, which are relevant to real world practice.
6. Doctors are sometimes put under pressure to ensure that NICE guidelines are implemented, but in some cases the guidance is not considered appropriate and there needs to be space for doctors to explain why, to feed back into NICE and aid the revision of guidelines. The following comment illustrates part of the problem.
"I recently challenged a respiratory physician over the NICE COPD guidelines. NICE think we in primary care should be monitoring, including spirometry, these patients up to 4 times a year. He could give me no evidence that this behaviour would improve outcomes. In my practice, 25-30% of my patients have CPD. How much time and resource would be wasted on this activity? And for what benefit?”
7. It would help clinicians if some of its material were not labelled ‘guidance’ or even ‘best practice’ when evidence is clearly inconclusive or weak. An acknowledgement that some areas need more evidence would improve the credibility of NICE. NICE reports should come with greater openness about the standard of evidence that has been used and the level of authority that should therefore be afforded to the review. Furthermore, it would help if the evidence on which NICE guidelines are drawn up was clearer. In particular, clarity could be achieved on how evidence was thought by making it public prior to guidelines being introduced to ensure that they are (a) sufficiently robust, (b) are appropriate to everyday practice and (c) aid a discussion of how they will be implemented.
On public confidence in the Institute
8. With the absence of any research it is difficult to know how the public feel about NICE. However, we feel confident that it will become better. This is because NICE will inevitably become further embroiled in debates about what the NHS can afford. Some have interpreted the recent report on public services – launched by Tony Blair and Gordon Brown – as a move toward the NHS setting out a core list of services the NHS will apply (go to reference 1). Of course, setting out what is available will involve decisions about what is not available.
9. If as many believe, the NHS will increasingly have to make difficult decisions about rationing, NICE will have to have the confidence of the public. This may be difficult and ultimately this process of setting priorities may have to be political, informed by the advice of experts.
10. NICE decisions are increasingly being challenged because of the perception that cost is an overriding issue. This is becoming increasingly apparent when the public and doctors believe that the evidence for effectiveness of any treatment is ultimately overshadowed by economic concerns. This will erode public and professional confidence in NICE.
11. One of the main difficulties for NICE is in trying to rationalise its difficult decisions on cost effectiveness. Who is to judge, for example, whether a certain period of additional survival in a terminal illness is cost effective, particularly if this is significant? For individuals and families – and the media that tell their story – any prolongation of life is seen as worth it. There will always be challenges in these circumstances.
12. Another dimension of public confidence – already being raised as a question in the Westminster Parliament – is increasing awareness of differences across the UK. In mid-March an English MP asked the Prime Minister ‘why only British taxpayers with a Scottish postcode’ were able to access a drug for sufferers of lung cancer.
13. Even within England, there is a widespread perception of a postcode lottery and this also undermines public confidence in NICE.
14. A further reason for reduced confidence is that decisions are often not given with enough explanation or that offered explanation is not easy to follow. When NICE’s decisions are overturned then confidence sinks even lower.
On NICE’s evaluation process, and whether any particular groups are disadvantaged by the process
15. Both hospital doctors and general practitioners express concerns that NICE’s evaluation groups are unrepresentative and lacking views of doctors at the coalface of practice whose working knowledge could be drawn upon. GPs feel particularly strongly that NICE guidance is produced, in the main, by secondary care doctors, who tend to be from highly specialist academic departments. There is a wish to see more front-line doctors represented on groups.
16. From a patient perspective, there is a concern that NICE does not have a strategy for undertaking race equality impact assessments on their guidelines. NICE needs to improve its process to ensure that its work has cross-cultural relevance.
On the speed of publishing guidance
17. There is concern that NICE is slow to produce guidance, particularly on the evaluation of new technologies. There have been several publicly exposed anomalies where NICE has yet to undertake an evaluation and the Department of Health respond to questions by saying that local PCTs should make a judgement in the interim. These gaps make the process unclear, are frustrating for groups who are asking their doctor for a particular intervention and place a great deal of pressure on local decision makers who want better support form NICE and national policy makers. Patients and doctors are often clamouring to use new technologies long before NICE provides it advice.
18. We accept, however, that the work of NICE necessitates careful evaluation and a reasonable time to complete this. It might be possible to speed this activity with greater financial support that would enable NICE to employ more evaluators. It seems that the political prominence of priority setting is increasing, as is the rate of new technologies, not all of which can be afforded. At the same time, the government is expecting NICE to do more whilst not supporting this with resources.
On comparisons with the work of the Scottish Intercollegiate Guidelines Network (SIGN)
19. The main concern of hospital doctors is the very slow speed in publishing guidance. The advantage of the Scottish Medicines Consortium (SMC) is that it provides a much more rapid response based on clinical and cost effectiveness data. We understand that NICE has had discussions with the SMC and intends to adopt some of its procedures for single health technology appraisals. That said, the multiple health technology appraisals that NICE undertake are valuable and this process clearly takes longer to complete.
20. The Scottish Intercollegiate Guidelines Network (SIGN) has been an invaluable way of ensuring that peer reviewed high quality evidence is synthesised into clinical practice guidelines. Its guidelines are used and methodology respected. Crucially, it grades evidence appropriately according to international standards. This means that the recommendations can be accepted by clinical professionals and by NHS organisations.
21. A major weakness of SIGN guidelines, however, is that they have no data on cost effectives. It is expected that in future, SIGN guidelines – now under the umbrella of NHS Quality Improvement Scotland should contain cost effectiveness data alongside recommendations.
On the implementation of NICE guidance
22. The issue of implementing NICE guidance is a huge bone of contention for doctors.
23. Guidance can be confusing and frustrating where it goes against the grain of general policy. At present, for example, an aim of the reform programme is to provide more care outside of hospital and into community settings. NICE guidance can be a major deterrent to this aim. Most recently, the NICE guidance on Improving Outcomes Guidance for Skin Cancers has been criticized for its potential to prevent minor surgery in primary care, if implemented as directed. A GP commented that:
“I carry out about 100 minor surgical procedures within my practice per year. My audit last year showed I excised 6 BCCs. To be able to continue to provide this service to my patients I will have to:
Become an accredited surgeon
Carry out 40 surgical interventions for expected skin cancer per year
Maintain a log book
Perform an annual audit of excision margines etc
Attend a skin course every 2 years
Attend 1 session per year of training with a consultants
Attend a minimum of 4 local skin multidisciplinary team meetings per year
So in effect this will stop all GPs performing this surgery unless they are GPs with special interests. The patients will have to travel further and cost the NHS more, for what gain?”
24. As stated, GPs are concerned that the secondary care slant within NICE guidance - and a failure to translate it to general practice - makes it difficult to implement NICE guidance in primary care. Because GPs are “gatekeepers” of NHS resources and navigators for patients, they are concerned with commissioning care and referring patients to appropriate services. There is a view within general practice that compelling NICE guidance on PCTs does not always lead to appropriate behaviour.
“The whole exercise has been a colossal waste of money and the best thing to do with NICE guidance is to use what is useful. It would be very helpful if the Select Committee were to recommend that NICE guidance should revert to the status of guidance rather than having protected status as holy writ, since it is inhibiting progress and leading to waste.”
References:
- Nicholas Timmins. NHS may be restricted to core services. Financial Times: 19 March 2007; www.ft.com
Email: parliamentaryunit@bma.org.uk