Select Committee on Health Minutes of Evidence



Examination of witnesses (Questions 20 - 39)

THURSDAY 4 FEBRUARY 1999

PROFESSOR SIR MICHAEL RAWLINS, DR GINA RADFORD and DR TIMOTHY RILEY

  20. In your document you mentioned procedures for dealing with situations where there is no sponsoring company. There will often be a sponsoring company, especially if it is a drug, but you deal with what if there is no sponsoring company. In relation to patients I have gone through and underlined everywhere you have mentioned patient groups and you mention them a lot, to be absolutely fair, but what about a situation where there is not a patient group? How do you then ensure that patients at large have some sort of influence if they want it? I appreciate that it is a terribly difficult question. The Committee faces it in a lesser way when we look to have in our inquiries the involvement of the users of services. It is easy if there are groups but what if there are not?
  (Professor Sir Michael Rawlins) Easier anyway.

  21. How far will you be making your possible appraisals and things like this public so that people at large can write to you and that kind of thing?
  (Professor Sir Michael Rawlins) Certainly the draft appraisal reports that we produce will be public. It is all very well putting it on the Internet but there are lots of people who will not be able to access it. I am not sure how we can get right down to where we need to go. I would take some comfort from the fact that 25 per cent of the Partners' Council will comprise of patient advocates and patient groups who might be able to help us reach much further down than has hitherto been possible. I think I would very much want their help and assistance on how to get down to exactly what you are talking about, individuals who may not be organised as a pressure group or some sort of self help group. Dr Radford, you might have a better idea.
  (Dr Radford) There are two issues. One is about ensuring that when any work of NICE is being undertaken-we are concentrating on the appraisal here-that the right questions are being asked, in other words that there is a consciousness that is recognising a patient perspective. That is one important function of patient groups, to make sure that it is not, as Sir Michael has said, just a clinical end point that has no relevance to quality of life or other issues. Then there is the second issue about how do you ensure that the appraisals do also take account of those who have the condition or have some understanding of it because they are carers. We have said within the document that we are consulting on that. We recognise that this is a developing, evolving process. The process itself will not necessarily be mature on day one and we need to learn these techniques. Everyone who is trying to ensure proper patient or user representation does struggle with making sure that it is appropriate and that we do get the best representations. NICE will not be unique in that. There is a real commitment and the real involvement of patient representatives within the Partners' Council will ensure that commitment to making sure that user/carer views are represented through the totality of NICE's work.

  Audrey Wise: Finally on this issue, part of this seems to me to depend on how much the public at large becomes aware both of the existence of NICE in the first place but also what NICE has in mind to do. What the Committee does when it is looking for opinions is it throws its bread on the waters with as many announcements as possible and people, stray people as it were, do get in touch with us.

  Chairman: Lots of stray people.

Audrey Wise

  22. How far do you think you will publicise what you are undertaking? Do you feel you can do that without sending too many shockwaves which might be picked up by the media along the lines of "doubts about X", especially if they are existing interventions or treatments? How will you reconcile those two things, making it known what you are doing so that people can respond, people that you do not know about, as against causing too much turbulence and questioning which might be detrimental?
  (Professor Sir Michael Rawlins) I very much appreciate your point. It will be part of the skill of the communications role of NICE. It is envisaged that NICE will have at board level a Director of Communications. This is not spinning, this is to do with actually getting the results of the conclusions out to people because unless NICE can communicate effectively with health professionals, patients, patient groups, health authorities and so on, it is a complete waste of time.

Mr Austin

  23. On that point, have you given any consideration to your links with Community Health Councils or had any discussions with the national associations at this stage?
  (Professor Sir Michael Rawlins) I have not had an opportunity to meet them yet but I have fixed an occasion when I will be able to meet them. I would very much like to engage them in the sort of dialogue we are having now. Yes, I think they could be very helpful.

Chairman

  24. Can I just come back to a point that struck me when you were talking about the example of the one million pound treatment. This might be a question for Dr Radford rather than yourself. What procedures are currently in place whereby an expensive treatment is evaluated in a wider format above and beyond your own Department? We were discussing Clozapine a while ago, an expensive treatment for schizophrenia, which needed to be evaluated not just in respect of what it costs the Department of Health but the savings that may be made as a consequence of using this, apart from human suffering, in the wider issues of savings to the penal system, the hospital system. It struck me that if you had a patient with a million pound drug, if that saved that person from burning down a school or something, to use an extreme example, it would be worthwhile paying a million pounds for that treatment. How does the Department currently evaluate the wider cost implications of an expensive drug where they may well not be savings within the Department of Health's remit but certainly in wider societal terms there will be huge savings. Does this happen in any way and how does this permeate through to the Treasury or not as the case may be?
  (Dr Radford) We do have the Health Technology Assessment Programme that is set up to look at certain technologies and assess the evidence around that. From my limited knowledge, and I must say I do not pretend to have expert knowledge in this area, I am not an economist, I am not aware that all the possible costs to society are necessarily considered in all of the Health Technology Assessment Programmes.

  25. From what you know of existing procedures, if through NICE or wherever a drug was evaluated that clearly would have huge cost savings in budgets of other Government departments. How do we develop a dialogue with the Treasury or other departments, such as the Home Office, to get them on board in supporting investment in new drugs that would have huge cost savings within their remit?
  (Dr Radford) Well, within the consultation document, as you can see, that we are proposing the cost basis on which NICE could be appraising its new technologies which include NHS direct costs, personal social services costs, I think this is for discussion, I really do, and I think it would be very useful to have that discussion about the wider costs. We have floated one idea within this consultation document and there is an opportunity within the consultation period to have that wider discussion.

  26. Do you, Professor Rawlins, see a role for NICE in this process of broadening out the debate?
  (Professor Sir Michael Rawlins) Yes, quite clearly NICE cannot second-guess the total allocation of resources in the Health Service, but what I think it can do is it can, as it were, be an advocate for what health gain and what costs the nation would get if adopting a particular new strategy or a particular new technology and what you would get for various patient categories and I think that might help the argument and the discussion so as to have a very clear idea, an authoritative and robust idea, of what you would actually get for your money.

Audrey Wise

  27. Following on the same point, I am very keen on the concept of social audit which is part of what comes in here, but I must say the way things are done never seems to me to actually encompass social audit. Looking at your paragraph 19 about what you would like evidence of, and this is the paragraph that Dr Radford was referring to, they would look at net NHS costs associated with this health gain, where appropriate, any associated government-funded personal social services costs, and that is "government-funded", I notice, and of course most personal social services costs or a great many of them are government-funded, but it rather suggests that if it is going to be a saving to anybody else, you do not care, and then it has got other things which are different. Then there is a sentence which says, "A wider range of costs and benefits may be relevant in particular circumstances" and my question is: do you have any gleams in your eye about what kind of particular circumstances and what kind of wider range of costs and benefits? If you have, what are they? If not, are you asking anybody specifically, for instance, other government departments and are they being asked to comment on the impact of this? Could I also make a suggestion which is that one obvious area, and the Chairman's point touches on this, where wider cost and benefits must be surely entertained is in the whole field of mental health because there is a huge impact on the community at large there, so that is one I would suggest for your wider range. Do you have anything in mind and are you asking anybody specifically?
  (Dr Radford) Certainly that last sentence really did try to address particularly some of the issues around mental health and some perhaps of the more chronic conditions which may have other impacts outside the direct healthcare sector, recognising that on occasion they may need to be considered, but clearly we are putting out a broad proposal not just around specific issues, and we are consulting and clearly we would be interested in people's comments on this. We will clearly be consulting quite widely with both experts in the field in terms of the academic side who are the economic experts and do understand the issues better than I could ever pretend to on the issues of costs and benefits and how those analyses can take place, so yes, we are consulting with those and are grappling with these issues at the moment about whether this does make a sensible package on which NICE can then undertake its appraisals.
  (Professor Sir Michael Rawlins) There is a technical problem in that particularly with a new technology, the wider you go, the more difficult it becomes and the more you have to start making not estimates, but guesstimates about the likely impact and this is a real problem in this sort of cost-effectiveness appraisal. I cannot speak for the Department, but I am sure they would like to have the Committee's views on how and when and why and where they should go further and that would be very valuable.

Dr Stoate

  28. Just for information, I thought I was the most expensive GP in the country. I am very impressed by your £1 million doctor. The most expensive patient I had was a mere £150,000 a year and I thought I was pushing the boat out, but clearly not! I wish to take up a few points around the cost-effectiveness because it seems that for the first time NICE will be, and quite rightly, bringing in a proper debate about where drugs and other interventions can have an economic impact. Is that a fair comment to make?
  (Professor Sir Michael Rawlins) I think that is exactly right and I am intensely anxious that it should be very transparent and that everybody should know what the issues are and what the difficulties are about taking various lines, absolutely.

  29. Well, you will appreciate of course that this puts obviously some particular people in difficulty. I want to pick up something that particularly the industry is interested in which is the so-called fourth hurdle, this idea that drugs have up to now not had to pass this cost-effectiveness test to get their licence, and to quote a paper from one of the leading industries, "A central issue is that economic data is not currently required as part of the licensing process for medicines", and they go on then to explain why they think it would be quite difficult. They are, I think, being quite responsible in saying that they are very worried about the lack of data, so do you feel there is enough data around to make decisions of that sort?
  (Professor Sir Michael Rawlins) Well, first of all, as a member of the Committee on the Safety of Medicines for nearly 20 years and Chairman for six years, I spent my life vigorously avoiding a fourth hurdle and any time any member even opened their mouth and mentioned money, I had to tell them to wash it out with soap. It is absolutely right that the licensing process both in Britain and in the European Union does not take cost-effectiveness into account, nor does it take really comparative efficacy into account, so these are things that are increasingly being required by reimbursement agencies across Europe, by the Australian and New Zealand Governments, so although they are not licensing requirements in many countries, in fact the recognition that cost-effectiveness and comparative cost-effectiveness as well as clinical effectiveness is increasingly recognised by the pharmaceutical industry and actually they already make many of these calculations for other reimbursement agencies and government authorities elsewhere in the world, so they are by no means ignorant of the principles and they are actually quite skilful and some of them have very large teams of people who are pursuing this area. Now, it is true to say that if you wanted to go the complete route of looking at all the issues that Mrs Wise was mentioning earlier, then you need to collect that information at the time you are probably doing the clinical trials if you want to find all the societal costs, but, nevertheless, you can make reasonable estimates of the health gain, the costs that are going to be accrued by a particular strategy and the cost-benefits, if you like, in relationship to the other demands on the Health Service and on the personal social services relatively easily. Mrs Wise talked about the technical difficulties of going wider and wider, but it can be done up to a point and it is being done quite extensively.

  30. What would be argued though from the other side is that these things often take a very long time to work up the true cost-effectiveness of many interventions, not just drugs, but interventions as well, for example, to take the surgical analogy, the cost-effectiveness of a coronary artery bypass grafting versus using long-term medication as an alternative for the treatment of heart disease and those arguments sometimes take many, many years to reach maturity. How can you in the time available to you, and you talk about a twelve-month proposed consultation period, begin to make that long-term decision?
  (Professor Sir Michael Rawlins) Well, of course many of these things can be resolved if the economic aspects are included in the clinical trials starting way back and so as NICE becomes more mature and as the industry becomes more accepting of the need for this sort of additional data-gathering, which is not actually all that expensive, then I think that with the passage of time, this issue will be relatively resolvable. There will be a difficulty in the short-term and one will have to use modelling and so on and so forth but I think things like the coronary artery bypass grafting is actually a wonderful example of why something like NICE and the R&D strategy is needed because surgeons did them for years and years with absolutely no evidence that there was any benefit whatsoever. If we started off with a few randomised control trials we would have got the answer very quickly, which we did not get.

  31. I entirely agree with that. We have got a new organisation called the Commission for Health Improvement which is working to some extent alongside you and they will be scrutinising the uptake of your guidance in local areas. Are you confident that there are effective mechanisms in place to ensure that your advice is implemented?
  (Professor Sir Michael Rawlins) In terms of the results of appraisal we can see very quickly really whether that is being implemented. In terms of the guidelines I think it is more difficult. Dr Riley might want to comment.

  (Dr Riley) Thank you. I think in terms of the clinical guidelines there is an issue about how far the uptake goes, and whether people understand them. As Professor Rawlins has already said there is an issue about whether people understand guidelines and have access to them. They (guidelines) can be large tomes which are not something you can readily glean an answer from. They are about patterns of practice in particular areas. I think that one of the issues in the past has been that whilst, as has already been mentioned, there are a wide range of guidelines for a particular condition ,in many cases these often are not linked to that robust audit methodologies to then enquire and re-audit what has happened as part of professional self-regulation. I think this is a terribly important component of what is being called clinical governance within trusts. That will include primary care trusts in due course. I think it is terribly important that we actually continue to build this with out hoardings; that we actually look at what sort of uptake there is of guidelines, making them more readily available, not just to doctors, nurses, health professionals, but also to managers and the public and then looking at the audit to see what is actually being achieved against that, what is the compliance? Where are the situations where it has been prudent to go further than the guidelines for a particular clinical presentation? I think it is really about having a clear audit track about what is happening within the service, what is happening with individual health professionals, and being able to continue to develop clinical practice against emerging and developing guidelines.

  32. The trouble is there are already some very well established guidelines on certain conditions, for example the British Thoracic Society guidelines on the treatment of asthma. There are very clear guidelines now about the use of statins in people with existing heart disease. There are very clear guidelines now about the application of Helicobacter in people with duodenal ulcers. Those are very well established and I think most doctors and other clinicians in the country would accept those as being reasonable and yet the uptake of them is very patchy and in some cases dismal. What makes you think that your guidelines from NICE are going to be any better followed than the ones we already have which are backed up by guidelines and which are largely agreed by the professionals and yet for some reason they are very badly taken up overall?
  (Dr Riley) I think there are a number of reasons why a lot of people find it difficult to either access the information for guidelines, they may be reluctant to use them or indeed they may actually not know where to find the information.

  33. Those ones I have mentioned are in the folklore, I do not think you would find very many GPs and other consultants and so on who have not got a pretty good knowledge of those and yet they are not being followed particularly well across the country. They are in some areas but they clearly are not in others.
  (Dr Riley) I accept that. I think that is why, through NICE, we want to link national audit methodologies to national guidelines because one of the issues has been that there has not been a comprehensive expectation to participate in audit with appropriate methodologies linked to specific guidelines. There have been very good guidelines readily accepted across a wide range of disciplines and conditions but there have not actually been the means and the approaches consistent across the country to audit what is actually happening. There are patchy responses; there is very little consistency between what people are learning, and there is very little ability to develop comparatively practice so that it is part of the ongoing development process rather than being something that is up to the enthusiast locally.

  34. Most of those protocols have developed over the years but how will you ensure that your guidance is kept absolutely up to date?
  (Professor Sir Michael Rawlins) What you raise is a very important and critical issue because there are all sorts of interventions that we know are effective-anticoagulants in atrial fibrillation-yet well under a half, a third or a quarter or twenty per cent are receiving them. Only a third of patients with high blood pressure are getting adequate treatment for high blood pressure. Every medical student in the first year knows how to do it. We really do need to find out how to engage doctors better. I do not have an easy answer. I am very conscious that we have to do so and that is one of the reasons why we need a Director of Communications, to find out how to engage doctors' attention into guidelines, what format most persuades them to use them, what things they find uneasy, unacceptable about them and generally pursue right down to the single-handed doctor in wherever to try to make sure everybody understands the merits, the reasons and the benefits of use.

  35. Just a final question. What would happen if NICE recommends a particular protocol or drug that turns out to be extremely expensive? I will give you an example which may not be a genuine one. A drug like Taxol. Say, for example, that you were to evaluate Taxol and find that it really was the only first line drug to use in ovarian cancer, what would you do if health authorities then said "we cannot afford this drug"? What would be your response?
  (Professor Sir Michael Rawlins) Quite clearly before we got that far we would have to discuss with the wider Department as to whether the use of Taxol came within the priorities on which the Department wished to spend its resource. If it did then it would be implicit in that that the resource would be available and so we would, as it were, stop this terrible business of patients lying in adjacent beds receiving different treatments because they come from different health authorities.

Audrey Wise

  36. I take that point very much. For years this Committee has tried to get the Department to show more interest in outcomes and perhaps less in whether you are seen within ten minutes. I am saying this in a very friendly way. It does seem to me that there is a possibility of easy slippage from the term "excellence" in the title, which I very much approve of, to actually having your evaluations unduly modified by questions such as my colleague's last question. When you said "within the Department's priorities", what about the population's priorities? Are you conscious of any worries about this?
  (Professor Sir Michael Rawlins) Yes, but I am also conscious that NICE does not have a responsibility for the total allocation of financial resources with the National Health Service. NICE ultimately has to temper its advice in relationship to the people's elected representatives in Parliament and in Government.

  37. But is there not a danger there in the way you put that? Should not your real absolute be the excellence bit and then if other people want to say "we cannot afford it", it should be really clear who is saying we cannot afford it and you are saying this is good?
  (Professor Sir Michael Rawlins) Absolutely. I have no doubt at all that where NICE believes that a new technology or a new guideline, even if it is expensive, has a real health gain it will be an advocate with the Department, like there has not been before, it will be robust, it will be given by clinicians and if necessary we will, as it were, bully the Department into seeing things our way. It will be quite clear that we regard treatment with Taxol in ovarian cancer as clinically effective and the most clinically effective agent around.

  38. It is that separation.
  (Professor Sir Michael Rawlins) Exactly.

  39. I am pleased about that.
  (Professor Sir Michael Rawlins) To be fair, it has been made very clear to me by ministers and senior officials in the Department that is exactly what they expect NICE to do.


 
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