House of COMMONS



HEALTH committee






Thursday 8 November 2007



Evidence heard in Public Questions 639 - 773





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Oral Evidence

Taken before the Health Committee

on Thursday 8 November 2007

Members present

Mr Kevin Barron, in the Chair

Charlotte Atkins

Jim Dowd

Sandra Gidley

Dr Howard Stoate

Mr Robert Syms

Dr Richard Taylor


Witnesses: Professor Sir Michael Rawlins, Chairman, and Mr Andrew Dillon, Chief Executive, National Institute for Health and Clinical Excellence, gave evidence.

Q639 Chairman: Good morning, gentlemen. Can I invite you to our sixth and final evidence session on our inquiry into NICE. I know you have been here before but, for the record, I wonder if I can ask you to introduce yourselves and the positions you hold, please.

Professor Sir Michael Rawlins: I am Michael Rawlins and I am the Chairman of NICE.

Mr Dillon: I am Andrew Dillon and I am the Chief Executive of NICE.

Q640 Chairman: NICE have been around for seven years now and I wonder if you can share with us how you feel the environment in which NICE operates has changed since its establishment?

Professor Sir Michael Rawlins: I think in a number of ways. There has been greater emphasis in the Health Service on commissioning. Recently there has been the review of the PPRS by the Office of Fair Trading and Sir David Cooksey's review, which is relatively recent. There are conditional licensing arrangements in the European Union now which came into force at the beginning of this year. Of course, most recently of all there has been the increased budget for health research, all of which have impacts. On commissioning, we have started to develop commissioning guides to accompany our clinical guidelines. This is advice to commissioners on what service provisions they should be contracting for with their providers. As a pilot we have developed five or six and we plan to do more next year. In principle, we would like resources, God willing, to expand that role. They are very popular with commissioners and we think they are making a useful contribution. On the PPRS OFT report, there is the possible involvement of NICE in determining value for money, the early availability of innovative new medicines, we have to think about how NICE could accommodate those sorts of arrangements. The increased budget for health research, which, as you might imagine, as an academic, I more than welcome, gives greater opportunities for our research needs to be met from public funds.

Q641 Chairman: Can I ask you what have you done to respond to the recommendations contained in the Cooksey Report?

Professor Sir Michael Rawlins: There are a number of elements to that. We are discussing with other interested parties, particularly the MHRA, how they envisage the conditional licensing arrangements will work and, consequently, what sorts of arrangements we might have to put in place to enable us to look at the cost-effectiveness of drugs at an early stage. I do not think this is at all impossible and there are examples of really early drugs which we have looked at in the past where we have found it possible to do this, perhaps being a little bit more imaginative about the approaches we take. Glivec was a very good example where we used historical controls in relation to looking to see not just how the Philadelphia chromosome came off so easily, but whether that increased longevity, which we found it did. I think there are approaches like that which we can take.

Q642 Chairman: In his report, and I will quote it, it says: "...new ways of bringing drugs that address UK health priorities to market faster without compromising patients' safety". Are you comfortable with that phrase and take it on board?

Professor Sir Michael Rawlins: One has to accept that the longer a drug is around and available, the more one knows about its safety profile. Of course, this is a matter for the drug regulatory authority, not for us, but as a former chairman of the CSMI, I watch with interest. There is a risk about early availability of drugs but, of course, the conditional licensing arrangements are pretty limited. It has to be a serious or life-threatening illness or it has to be in response to some urgent public health problem, I am particularly thinking of pandemic flu, or it has to be for an orphan drug. It is not across the board, but one does have to be very careful about conditional licensing and making sure that safety is taken fully into account.

Q643 Dr Stoate: Professor, we have been told by PCTs that they sometimes find it quite difficult to meet the QALY threshold you have set. Should you set a threshold which is more affordable for PCTs?

Professor Sir Michael Rawlins: I think maybe you are thinking of the evidence which Professor Peter Smith gave some months ago. Since then he has produced another report, which we have seen in draft form, where he has looked much more widely than he originally did. Originally it was just cardiovascular disease and cancer, but he has now included other conditions, particularly diabetes. His conclusion, and I quote from his August report: "Our cost estimates are not out of line with the threshold of 30,000 per QALY often attributed to NICE for the acceptance of new technology". His more recent and more extensive work indicates that we are in about the same sort of ballpark.

Q644 Dr Stoate: How did you come to that figure in the first place? How did you work out that was affordable?

Professor Sir Michael Rawlins: It is not based on empirical research, there is no empirical research anywhere in the world, it is really based on the collective judgment of the health economists we have approached across the country. There is no known piece of work which tells you what the threshold should be. There have been ex cathedra statements. For example, the World Health Organisation says it should be somewhere around your GDP per person, but why the GDP per capita? It is elusive.

Q645 Dr Stoate: Are you happy that NICE is the right body to make that judgment or do you think there should be an independent body to assess the right level?

Professor Sir Michael Rawlins: My own view is an independent body would have exactly the same difficulties we have had. They would have to use judgment about it because there is no empirical basis. We have commissioned research about this, and that is reporting towards the end of the year, which may inform us further. The truth of the matter is if we halve the broad threshold, we would have declined as cost-ineffective most of the new drugs we have looked at and I do not think that is what people want.

Mr Dillon: I think that is right. As Michael has said, when NICE was established in 1999 we drew together those who would be in a position to advise us on how we should approach the business of designing a threshold range. Of course, there is not a cut-off point, there is no ceiling that we operate to, it is a range. Our advisory bodies have discretion to establish cost-effectiveness within that overall range. We talk both to health economists and clinicians in the NHS who have been involved in objective decision-making based on economic assessment on a regional basis in the NHS decision-making world as it existed before NICE was established. We talked pretty much to everybody who was in a position to give us advice but, as Michael said, there was no one source that one could go to which definitively laid out both the process of establishing the threshold range and, at any one point in time, putting a value on it.

Q646 Sandra Gidley: Some eight years later we have had relatively low inflation, and I am sure the Prime Minister would like to take some credit for that, but there does not seem to have been an increase in the cost per QALY. Why is that?

Mr Dillon: Partly because we operate a range. Clearly if it was a ceiling, if it was a fixed point to certain fixed pounds per QALY, there would be an immediate case for saying, "That ought to be reviewed every year". Every three years we have gone out to consultation on the methods we apply, including the arrangements for the range which we operate, and we are doing the same thing at the end of this month for three months. Those who believe there is a case for taking account of general inflation or, some argue, NHS specific inflation have got the opportunity to say, "Over the years that you've been operating these things have changed" and, indeed, the NHS has had real terms increases over and above the level of general inflation anyway. Theoretically, the system has become wealthier, so it ought to be able to afford more and all of these things ought to have an influence. As we do every time we go out to a public consultation on our methods, we will genuinely take all that into account. If there is a strong case for making a change, then we will consider that and discuss it with our colleagues at the Department of Health.

Q647 Charlotte Atkins: Do you think people's expectations of what the health system can provide are too high?

Mr Dillon: Speaking personally, as somebody who uses the National Health Service, when I am ill, when any of us are ill, our expectations are unlimited. Our ambition is simply to get access to treatment which will improve the position we are in, ideally to offer a cure, at the very least to help to improve our quality of life or to extend life. At a personal level, it is entirely understandable that our ambitions are almost limitless. Stepping back into the role that we have at NICE, we have to recognise that as much as the Health Service is having significant increases in funding as it has over the years, in the end there is a limit on what the service is capable of providing. Where that is the case, as indeed it is in every healthcare system around the world, it is important that we have objective processes which allow people to see how decisions are made at the margins when we take into account, and we have to take into account, what the service can afford. Our general expectations of what should be provided are increasing. It is entirely understandable and entirely appropriate that the health system is pushed all the time to do as much as it possibly can. As that pressure increases, it is evermore important the way we make decisions is as objective and as transparent as possible.

Q648 Charlotte Atkins: How effective do you think NICE has been in bringing about more rational rationing, something which people can understand objectively, even people who are expecting to get the treatment they need?

Mr Dillon: I think we have done reasonably well in engaging with the NHS in that. Sometimes our decisions are very controversial, and however much people might understand the methodology and might appreciate the objectiveness with which we do it, there will always be decisions which, individually, people have great difficulty in accepting. I am not sure we have been as successful in engaging the general public. As much as we try to do that, every time we publish something, we engage very actively with the media to explain the basis of the decision. Of course, we are always doing that and quite often we are doing that with the most controversial of decisions that we take. We are doing it in circumstances where emotion is often very high, there might be considerable disappointment at the decision we have taken, so we are trying to explain why these decisions have to be taken, often in difficult circumstances. I think there is a case for a wider discussion to take place which has to go beyond just NICE engaging with the public on why NICE exists in the first place and why it does what it is asked to do.

Professor Sir Michael Rawlins: The problems facing the British National Health Service are reflected precisely elsewhere in the developed world. Every single developed country has got the same problem, and they all recognise it is going to get more difficult because of the increasing ageing population, which at my age is something to be welcomed, technological advances of one sort or another, which, again, is to be welcomed, and the expectations of the public. Every country in the world is struggling and that is why we have had such a lot of interest in what we are doing on a global scale. We get invitations every week to go almost everywhere to talk about what we are doing and how we are doing it. Surprisingly, in some ways it has even caused great interest in America, although it is slightly irritating when a presidential candidate starts talking about the quality of care in the British National Health Service and, of course, it is socialised medicine. I was very pleased to see the Secretary of State for Health rebutting him properly; I thought that was brilliant.

Q649 Charlotte Atkins: I think we were all happy to see that. If we take a case like, for instance, Herceptin, where there was a huge local and national campaign, particularly in my part of the world in North Staffordshire, in that situation do you feel the ministerial involvement in that decision with North Stoke PCT was helpful or unhelpful?

Mr Dillon: I think, perhaps, it was surprising to make that comment because the scientific basis for Herceptin being effective and safe in early cancer had not been demonstrated in the public domain. The only information was on Investor website of the pharmaceutical company and the Invester website is not the most reliable source of objective information about safety and efficacy of new products. Added to which, at that stage the company had not even made an approach to the regulatory authorities, it had not made an application, so it was a surprising remark from a Secretary of State.

Q650 Charlotte Atkins: Is "surprising" rather like the word that a civil servant might use to a minister "brave", ie not what people would recommend?

Professor Sir Michael Rawlins: Not being a civil servant, I have never been brought up with that sort of language, but I think I will leave it at "surprising".

Q651 Charlotte Atkins: The other issue is clearly - again, being in the area of North Staffordshire - when one looks at the cost of the marginal benefits of Herceptin in those circumstances, it was a very high cost which I think many people did not recognise locally. There was a huge publicity campaign which was very difficult for, for example, a politician to resist, either national or local, and in that situation the expenditure on Herceptin could easily crowd out expenditure on things like hip replacements and such like.

Professor Sir Michael Rawlins: I fully sympathise with that view and that is why at NICE we had to look at it very carefully and look at what we did think was the incremental cost-effectiveness ratio, the additional cost per QALY. We did think it was cost-effective; it was around about 22,000 per QALY. Although Herceptin is very expensive, one also has to remember it does not just prolong life for a month or two or three, it actually prevents cancer recurring. Because it prevents cancer recurring, it saves the misery of late stage cancer and it saves the huge expense we often undertake in treating people with advanced cancer. It is a curative treatment which, in some respects, is cost-saving because it prevents you having to spend a lot of money later on. There are problems with introducing it, not least of which is the need for three-monthly echocardiography to make sure the patient does not develop any heart problems. In my hospital in Newcastle there was a three month waiting list for routine echocardiographs anyway. We are very sensitive to these sorts of things and we understand them but, nevertheless, in this particular instance, we deemed it as being cost-effective as well as clinically-effective.

Q652 Charlotte Atkins: But in other circumstances, particularly in terms of NICE's clinical guidelines, the take-up by PCTs is rather patchy, is it not? If you are looking at something like IVF, for instance, many PCTs do not take up your clinical guidelines. I know that they are not mandatory but how do you feel about that because it seems rather odd that NICE will put out guidelines then the expectations of the public are raised that they are entitled to this particular treatment, but then it is extremely patchy in some parts of the country.

Mr Dillon: That is true but we have to remember, of course, that for any particular disease or condition for which NICE might issue a clinical guideline - and here, of course, we are making the distinction between clinical guidelines as a type of guidance from NICE and the technology appraisals, the drug evaluations amongst them that form a different kind of guidance - individual parts of the NHS start from very different positions. For any disease or condition one part of the NHS might, for all sorts of reasons - because it is the local clinical champion and the decision was taken many years ago - be much closer to broad concordance with our recommendations when we publish a piece of guidance that in other parts of the NHS, which has not made that investment and has a much longer road to travel in implementing our recommendations. So it is actually inevitable that it will take some parts of the health service longer to get to the point of implementation of our recommendations. What seems to me to be important, though, when we publish a piece of guidance as an organisation that is serving patients, people who use the NHS and those who are providing services in the NHS, is that PCTs and hospitals say, "We are up for this; this is where we should be; this is the distance we have to travel and this is how we are going to get there." That allows those who live locally with a particular disease or condition, who have that expectation that NICE has produced guidance and they should get that standard of service, some ability to understand what they are going to get and when and some ability to measure the progress of their local health service towards that.

Q653 Charlotte Atkins: But if you are talking about something like IVF time tends to run out for women and clearly they do not have years to wait. Are you suggesting, therefore, or would you suggest that it would be a good idea that your clinical guidelines should be mandatory but over a period of time?

Mr Dillon: I think it is difficult to do that because a guideline might contain 30 or 40 recommendations and could involve for individual parts of the NHS very significant changes; and, as I say, for other parts of the health service much less in terms of additional resource and organisational adjustments to the current arrangements for providing services. It is very difficult, I think, for the Department of Health in that situation to mandate and say that everybody has to get to broad concordance with the recommendations by this date. I think they would have to be quite cautious about where they pitched that date in order to take account of that variation in the starting point for different parts of the NHS. I know it is repeating it but I do think it is very important that if it is not possible to mandate in that way that there is a clear expectation that every part of the health service has a clear plan about how they are going to get there and that they stick to it.

Professor Rawlins: Could I add two things to that? One is that IVF - I know the guideline has caused a lot of public and parliamentary interest - is a very special case, in fact, and most of our guidelines have been - and I am sure that Dr Taylor will want to cross-examine us about this a little bit later - very well accepted by the profession and by PCTs. Things like, for example, our schizophrenia guideline, which was the very first one, the psychiatrists all say that it has had a major impact on the management of patients with schizophrenia in all sorts of different ways. So I think that generally speaking our guidelines are something we should be proud of and we should fully continue to support. One other thing, guidelines are guidelines; they cannot cover 100% of patient interactions. We estimate that about 80% of patient interactions can be covered by a single guideline. People are all different and you have to take into account their individual differences, so mandating it is not a practical proposition, also for that reason I would say.

Q654 Dr Taylor: Can I go further into healthcare rationing, briefly? Andrew, you said that one would have to take the healthcare rationing debate wider. How did you mean; how would you do that; who would you involve?

Mr Dillon: I am not sure we have enough of the basic strategies for a broad engagement with the public but, as I said a few minutes ago, it is illustrated most obviously to me when I have to go and present a controversial recommendation on national television or radio or to the newspapers. I am trying to do two things at the same time and it is very difficult. One is to explain the basis of a decision that many people find very difficult to accept, and at the same time explain why that kind of decision has to be taken. So what I would like is that somehow we separated those two things. I am always going to have to present the difficult decisions and that is fine, but I would quite like NICE to contribute to a broader debate about why it is necessary sometimes for those controversial decisions to be taken, and I think that has to be a debate that involves government with its stewardship responsibilities for the health service; and amongst all the other messages that it wants to communicate about change and improvement, all of which are entirely appropriate, to also talk about the realities of decision making too.

Q655 Dr Taylor: How far are you getting with removing some of the fairly useless sort of treatments and some of the less vital therapies, which would release money? Are you having time to do any of that?

Mr Dillon: Yes. 18 months to two years ago we agreed with the Department of Health that we would make a very specific effort to provide the NHS with tools to do just that. What we launched then, internally inside NICE, was quite a comprehensive research programme to identify all these topics, all these things, all these interventions that everybody says are there and are obvious cases for stopping and saving lots of money. We went, for example, through the entire Cochrane database and we searched with Cochrane to try and find those topics. The fact is that they are just not there in the way that people think they are. The health professionals do not indulge routinely and profitably in things that have absolutely no value whatsoever, to a level that would make it possible for us to say that there is a whole raft of things that should be stopped altogether. What we find is that there are interventions which, in some circumstances, have value but maybe being over-used and we can start to tackle those.

Q656 Dr Taylor: If the government's pay for better care better value indicators really did raise the two billion that it promised, if that came to you would you then be able to put up your cost per QALY so that things like Wet AMD and some of the cancer drugs would be more likely to be affordable?

Mr Dillon: There are two things on this. The thing about good use of resources is much more to do with how we organise the delivery of services than it is to do with the use of useless individual interventions, and there is a lot of work to do on that and there are organisations like the NHS Institute for Innovation and Improvement that have a big contribution to make to supporting the health service getting better organisational services. If you could put another 2 billion into the health service what would you want to do? Would you want to introduce ever more expensive products into specific aspects of service or would you want to broaden the range of services that are currently offered. Would one, for example, want to implement Lord Layard's ambition for comprehensive access to cognitive behavioural therapy, which many people, including NICE, believe can make a substantial contribution? Or would we want to introduce very expensive new pharmaceuticals? In reality what we would end up doing is trying to do something of both, so whether that would mean NICE changing its threshold range substantially or making adjustments at the margin is something that we would have to consider at the time.

Q657 Dr Taylor: This is why we desperately need a wide public debate on the whole subject. Coming to public health, in your evidence you have given us public health guidance on the promotion of good health and the prevention of ill health is now one of your tasks, and you have issued guidance on four public health topics and you have another nine public health interventions and eight public health programmes in development. What changes do you need to allow you to concentrate on public health more because public health and prevention in the long-term is going to be the biggest saver of money, so what do you need to be able to concentrate on this more?

Mr Dillon: We have a well-resourced public health programme as it stands and we certainly have the capacity in place to deal with the topics we have agreed so far with the Department of Health. As with almost anything that NICE does you could expand the rate at which we produced these recommendations by expanding the size of the programmes, but to the extent that topics have been prioritised so far we are able to deal with them.

Professor Rawlins: We also have to be careful about the implementation because this is not just the health service, this is a much wider audience we are addressing, so we cannot expect guidance to schoolteachers coming out every month - it just would not be practical. So we have to be careful that what we produce is directed at the target audience in a way that they can assimilate and adopt, which means we have to prioritise the public health topics.

Q658 Dr Taylor: Do you do cost per QALYs for public health intervention as well?

Professor Rawlins: We do, yes.

Q659 Dr Taylor: By and large are those really usually pretty low?

Professor Rawlins: Yes.

Q660 Dr Taylor: Very low?

Professor Rawlins: Very low.

Q661 Dr Taylor: Is it your responsibility to make sure that the cost effectiveness of public health interventions is improved or do ministers still refer things to you, or are you now able to choose what you do more freely?

Professor Rawlins: Ministers refer things to us but the topic selection process gives us an opportunity to engage with the Department about the sort of things that should be referred. One of the great problems in public health - and this is not a criticism of Britain, it is global - is the dearth of research into public health. The evidence base for public health interventions is often very much weaker than it is for anything else, and this causes us some difficulties because we do not want to ask the country to spend lots of money on things that we are not pretty sure are going to give a good return. This dearth of research in public health has been a real problem for us and it is one of the reasons why we are very pleased with the Chancellor's promise for more money for health research generally and in particular public health because in the future our successors, as it were, will have a much better chance of picking up the things that are really going to make a difference.

Q662 Sandra Gidley: We went up to Scotland to look at what they do and the SMC evaluates medicines in half the time NICE takes and the decision is different on a handful of occasions. Is there a benefit in being shorter and sharper and what would you say the advantages were of taking longer?

Mr Dillon: You can compare NICE and the SMC and there a number of things that one has to look at in making a judgment about the desirability of using one system or another. Looking at the total timeline there are two bits to it really: there is the process of selecting topics, deciding what one is going to do; then there is the time it takes once you have decided that you are going to do something to produce the guidance. The SMC process operates on the basis of an application from a company usually, although they can invite a company to make a submission, and they start the clock from the point at which the company makes a submission and pretty much the ambition of the SMC is to look at all the new drugs that are introduced, all the new - significant anyway - licensed extensions. NICE, by contrast, does not look at all drugs so there has to be some process for deciding which ones to look at; there has to be some arrangement for prioritising the topics. So simply that difference means that it takes longer for the referral for a particular drug to come to NICE because it is not simply just based on a company application. In looking at the process for actually doing the evaluation itself there are two quite important differences between the way NICE operates compared to the SMC. That is that NICE in circumstances where we look at a new drug and we think that there is an argument for targeting its use in some way, we go out to public consultation. That has been a fundamental aspect of the way that NICE has operated; it has right from the start been part of the basis on which we enable people to engage with what we do. In those circumstances it adds about two months to the timeline. Secondly, right from the start - and this is written into a statutory instrument - we allow an opportunity for a formal appeal once we have completed the appraisal itself, and in about 30% of our technology appraisals our consultees take up the opportunity to appeal, and that extends the timeline by a number of months for the appeal itself. Then, of course, if the appeal is upheld the advisory committee has to review the position and it adds further time. Finally, on your point that the decisions are the same, yes and no. Yes, if you look at on the face of it was the decision broadly supportive of use or negative, as it were, on the face of it there is a great similarity. But the fact is that what NICE does is to identify precisely the circumstances in the form of the clinical advice that we offer that the drug should be used in. So we would identify specific populations, we would identify specific features of the way that the drug should be administered and the circumstances in which it should be used. That just takes longer to do and the more detail that you put into your decision there is more to talk about it to those who are affected; there is more that they need to consider; there is a greater need for that consultation that we put into the process to be undertaken. The SMC's documents, if you set them side by side for the same product with NICE's, are shorter statements of the desirability or otherwise of a drug being listed for use in Scotland. It performs a different function. So simple comparisons side by side do not work because we have a different process and we are producing a different product.

Q663 Sandra Gidley: What about the benefit to the patients? Yours takes longer. I know that patients are not supposed to be denied medicines during the NICE process but we all know that happens. Do you not have concerns that your process takes so long?

Mr Dillon: Yes. I am concerned for any delay, however it is introduced into the business of producing advice for patients and for the NHS, and it is our job, along with the Department of Health's and the departments involved in the topic selection process, to minimise this as much as we can. I am sure that there is more that we can do to achieve that but in the end, however efficient the process for doing that topic selection, which we have to do and the SMC do not, and however much we try to be efficient in the way we do the appraisal there will always be circumstances where it is the right thing to do to go out to public consultation and it is the right thing to do to offer the opportunity to appeal, and there will be circumstances in which our consultees will want to appeal. When those things happen it will just take a little bit longer than if you have a process that does not require you to do any of those things.

Professor Rawlins: Can I just add to that? If you compare the process without appeals, without consultation, NICE's takes five and a half months and the SMC four and a half months, so it is just a month different. It is because we have these processes of consultation; it is because we have this very formal appeal mechanism that it takes longer. One could abandon them but I do not think that people would want that. Just to add a quantitative point to what Andrew was saying, we have looked at the 73 treatment condition pairs that we have all looked at and we have come to the same conclusion as the SMC on 34 of them but different conclusions on 39 of them. So it is a different process and it is sometimes getting a different answer.

Q664 Sandra Gidley: They claim there were only five differences, so you are talking about fine tuning rather than a yes or no?

Professor Rawlins: Sometimes we are less restrictive; sometimes we are more restrictive than the SMC. So of the ones where we gave different guidance, 39 of them out of the 73, 16 were less restrictive, 23 were more restrictive. It is a different process and it does not necessarily produce the same answer.

Q665 Mr Syms: You undertake evaluations of only a small proportion of drugs introduced each year. Would NICE have the capacity to carry out a brief evaluation of all drugs, which would be shorter and cheaper than the current STA, at launch; and would that be a fairer system?

Professor Rawlins: I will start off but Andrew might want to follow on that. We have the ambition of trying to make sure that the NHS has advice around about the time of launch - it cannot necessarily be at launch, but within a month or two or three, and that is our ambition. It is really the moment one starts. I think a quick and dirty answer would be unfair and wrong both for the National Health Service and the patients it seeks to serve. You could get it wrong both ways that way. We rely and depend on the rigor of our system not just to withstand the law and all that type of thing but to actually make sure that we are fair to everybody who uses the National Health Service, because saying yes to something that is cost ineffective will deprive other people of cost effective care, and saying things that are cost ineffective when they are cost effective really will have the opposite effect and that would be wrong to. Andrew, do you want to add to that?

Mr Dillon: The test in thinking about the answer to that question is to go back a couple of years when we consulted on the shorter of our two processes - what we call our single technology appraisal process - and there our ambition was to telescope the process that we had in operation at the time, which we used both for very complicated technology appraisals as well as very simple ones where there was just a single drug for perhaps a single indication. So for those single new drugs being introduced we wanted to do something much more rapid, the sort of thing that you have described. The best that we could get in consultation with everybody who has an absolute vested interest in making it as short as possible - the professional groups, the patient organisations, the manufacturers of the drugs and other interventions themselves - the very best that we could do was in total seven and a half months from the point at which we invite a submission from a company to the point at which we issue guidance, and that assumes that there is no public consultation because we are broadly supporting the use of the technology, and nobody appeals. Yet pretty much since we put that process in place our stakeholders have been looking for additional opportunities to engage with us all of which, of course, would have the effect of extending the process. So I doubt whether we could do a credible appraisal that would stand the test at an appeal and that would satisfy those who we quite reasonably have to satisfy in terms of transparency and objectivity - I doubt we could do it more quickly than that.

Q666 Mr Syms: Could NICE work with the SMC to evaluate all drugs at launch? Could there be more cooperation with our friends north of the border?

Professor Rawlins: That would involve not just new active substances but new formulations and so on and I am not sure that the health service wants that in England. New formulations of old products, I think local arrangements are often perfectly satisfactory for that; so I think that would not be necessary and I think it would be unnecessary in fact. When it comes to new drugs, there are about 20 or 30 new a year on average - there has been a bit of a dip - and then of course there are major new indications, and if we were to do all new drugs and all major new indications I think we would need to have a rather larger outfit than we do at present.

Q667 Dr Stoate: I want to expand on something you touched on earlier, which is the quality of evidence you have to work with. We have heard from various sources that the quality of evidence on which you have to base your judgment is sometimes fairly poor. What do you think could be done to improve the quality of evidence and particularly that provided by the manufacturers?

Professor Rawlins: I think there are two things about manufacturers in relation to clinical effectiveness and then to cost effectiveness. When it comes to clinical effectiveness the evidence of manufacturers is generally reasonable although there are three particular difficulties. The first difficulty is that traditionally manufacturers have not collected routinely health rated quality of life data, which would be very important, and they understand that now. We do have a problem with comparators; we have to compare a new drug against best supportive care and most drugs are licensed on the basis of placebo-controlled trials. What we have to try and do is to use indirect comparators; we have to try and assess it that way. It is not easy but it is not completely out of order either, there has been some quite good work from Oxford about use of indirect comparators and with caveats they are valid. But there are difficulties sometimes, so that is the second difficulty. The third difficulty we have is very specific to anti-cancer drugs, and drug regulatory authorities - and as a former CSM chairman I have to hold my hands up - the requirements for cancer drugs have been lesser than any other branch of medicine. Cancer drugs have traditionally - not just in Britain, this is right across the world - been made available on much less evidence of effectiveness and efficacy than any other class of drug, for reasons that in retrospect I do not really understand either.

Q668 Dr Stoate: There is published evidence that a negative study is five times less likely to be published in the journals ---

Professor Rawlins: We are very conscious of the publication biases, yes.

Q669 Dr Stoate: So is there a system whereby, for example, you could grade the evidence you have produced and publish the results on the quality of the evidence that you have?

Professor Rawlins: We do comment, not in a quantitative term, but we do comment in our appraisals about how reliable, how fit for purpose the evidence is. The much greater problem we have actually than all of that is the cost effectiveness, and the problem with cost effectiveness, to be honest with you, is that companies have not had experience of having to do sophisticated cost effective analyses, and they are on a steep learning curve. I am confident that over the next year or two or three the pharmaceutical industry will become very adept at health economics. Traditionally when new things have been imposed on them there has been a learning curve. Twenty years ago, when they were all asked to undertake in vitro genicity testing there was a bit of a shambles for a year or two but very quickly they produced fantastically reliable results, and I am sure that is the same. We are going through a learning curve at present.

Q670 Dr Stoate: My worry still remains though that an awful lot of negative studies simply never see the light of day and I think that could have quite a bearing. For example, if you do ten studies, nine of which are negative that you do not publish, and then the tenth one that shows something positive you do publish that rather skews the evidence.

Professor Rawlins: We do expect companies to provide that sort of evidence for us, and sometimes we get it in a different way and the most important example we have had was the use of antidepressants in children, where to their enormous credit the MHRA put on their website the results of these trials that had previously been unpublished, most of which were not just negative but they were obviously clearly harmful to children.

Q671 Dr Stoate: What about if we made compulsory registration, effectively, of all clinical trials, would that be a way round it?

Professor Rawlins: There is increasingly registration of clinical trials. I do not think it goes as far as it should go because I do not think there is still let out for companies who do trials and then do not market the product and do not get a marketing authorisation. Those trials may well never see the light of day.

Q672 Dr Stoate: That is my point. If they had to register all those trials at least there is that data.

Professor Rawlins: The difficulty is, I think, is passing that law because there would have to be a global arrangement. You would have to talk to Congress and all the rest of it.

Q673 Dr Stoate: That could be arranged!

Professor Rawlins: Good!

Q674 Dr Stoate: A small matter! You would like to see it happen?

Professor Rawlins: Absolutely.

Q675 Dr Stoate: The other thing I would like to ask about, you do not seem to have automatic access to all data relating to medicines at the moment and the MHRA does and it seems that you do not. Would that improve things?

Professor Rawlins: It is quite clearly knowing what trials have been done but to be fair the European Medicines Evaluation Agency publish a scientific discussion which describes and enumerates all the studies they have taken into consideration. So if a company's application does not include some of them we spot it very quickly now.

Q676 Chairman: If you have a situation where you believe it is on the edge between getting approval and not, do you have the ability to go to the MHRA or to the manufacturers and get further evidence?

Mr Dillon: Yes.

Q677 Chairman: Do they share it with you - they will not share it with the world, as it were, but would they share it with you?

Mr Dillon: Yes, in general, although we have sometimes had to have conversations to work our way through to it. We have always got to the point where we have been able to put into the public domain enough information about the data that is put in front of the advisory body to enable people to understand why a decision is being made. We do understand that there are circumstances in which data supplied to us is commercially in confidence and a much smaller number of circumstances where it is academic in confidence.

Q678 Chairman: You are not denied that knowledge even if you cannot publish it and will not publish it? You are not denied it?

Mr Dillon: No.

Professor Rawlins: They would say it is academic in confidence, yes.

Q679 Sandra Gidley: Would it be a better use of your resources if you compensated the collaborating centres for loss of intellectual property and actually allowed the pharmaceutical companies access to the economic model?

Mr Dillon: The way we have approached this has always been on the basis of looking at economic models and indeed all the other evidence used by advisory bodies is that those who have an interest in what we do as registered stakeholders or as consultees in our guidance producing processes should be able to see what it is that the advisory body is seeing, unless it is commercially in confidence. So what we do is to ensure, when we are dealing with the economic analyses, that the consultees see the information that the advisory body sees, and they are in a position to comment on it. In fact in the case of economic models we go further because, typically, we do not put all the spreadsheets in front of our advisory bodies when they are meeting, we develop a synthesis for the committee so that they can understand what the models are telling them. But we do make the models available so that all the numbers can be seen by those consultees who want to see them.

Q680 Sandra Gidley: But it is not clear how those conclusions have been arrived at and I think that is the fundamental problem.

Mr Dillon: It is.

Q681 Sandra Gidley: So there is a top level set of data which is available but it is not very transparent.

Mr Dillon: No. The companies get all the spreadsheets. What they cannot do is to put the numbers in they want to see how that would change the conclusion that they want.

Q682 Sandra Gidley: What is the problem with that?

Mr Dillon: Because if they want to - and indeed they do - they produce their own models constructed on the assumptions that they think are appropriate.

Q683 Sandra Gidley: I do not see why that is a problem.

Mr Dillon: If they feel that there is something about the model that is not right or they do not understand they can come to NICE and say, "Can you run it in this way to see what the effect would be?" and we will do our best to comply with that and see what the outcome is. Or if they think that there is something fundamentally wrong with the model they can tell us and we will check it and we will correct it if it is.

Q684 Sandra Gidley: But the process relies very much on the Collaborating Centre distilling a huge amount of information and I would contend that all the members of the panel do not have the time or effort to read every single spreadsheet with which they are presented, and then they are hit with accusations that you have not taken social care into account or you have not taken some other aspect of a particular patient group into account, and nobody can prove that that is the case.

Mr Dillon: That is not so. Also, we have to separate typically the issue of exposure of economic models comes in our technology appraisal programme, so when we are looking at drugs rather than the clinical guidelines programme - although models are used there - the concern from some is that what they want is to get the model, to get the spreadsheets, to get the memory stick with the information on, which we supply them, and they can see every number in the model, they can see all the assumptions that are made, they get the full description of the model and what it means that goes to the advisory body - they get all that. What they cannot do is to go in and - although in reality if they wanted to reconstruct the model and to change the numbers in fact in practice they are perfectly capable of doing that -change the way the numbers work inside the model without reconstructing the model itself. But in every conceivable respect - and this has been tested by the Information Commission, it has been tested now in the High Court - they are put into a position where they can do what any of us would want to do in their position, and that is to comment constructively and critically on the information that is put in front of the advisory body, the basis on which NICE advice has been formulated.

Chairman: We will move on now. Richard.

Q685 Dr Taylor: Expert involvement. You have already hinted that we would be coming to the VTE and you know only too well that we have had criticisms from haematologists and thrombosis experts about the lack of involvement in producing the guidelines on VTE. You have probably seen the journal of the Royal Society of Medicine this month with an editorial written by two psychiatrists, starting with the rather derogatory title "A NICE mess".

Professor Rawlins: I have seen worse!

Q686 Dr Taylor: One of the paragraphs in this is about fairness, and I am going to mention the anti-dementia drugs but I do not think I am straying on to the sub judice sort of things, but they do point out that the NICE appraisal panel for anti-dementia drugs did not include any geriatric psychiatrists amongst 32 members, and it lists some of the other members like neonatal paediatrician, nephrologists, anaesthetists. They rather pooh-pooh the idea that having experts on such a panel can lead to conflicts of interest and therefore sway the result, when they make the point that people in other specialities could want to sway the result in favour of their specialities. My question is if you had had experts closer involved with the VTE thing do you think it would have changed the guidelines and do you think it would have avoided the backlash that followed, because the backlash has come from some of these experts.

Professor Rawlins: Can I answer in two points? When you are talking about the drug we are not allowed to mention, the Alzheimer's drug, that was an appraisal. The appraisal committee always has at its meeting experts who are not members, not voting members, they are there to help the committee understand the issues, but the committee itself makes the decision and it has to be like that really. Our professional colleagues tell me that clinical experts will come along fighting for their patients - and that is right, I am glad they do - but when it comes to the issue of having to look right across the board and look at everybody's interests they do accept that a broader based committee that has to do this week in, week out is an appropriate way. When it comes to the VTE guidelines I am afraid you have been seriously misled. There were 11 members of the guideline group, five were doctors; they included an orthopaedic specialist, Mr Simon Carter, who was appointed to the GDP with the agreement of the British Orthopaedic Association, and we have the correspondence confirming that that is the case. It also included a haematologist, Dr John Luckitt, who is a member of the group. There were additional medical experts consulted during the course of the guideline development and they included a general surgeon, a urologist, a neurosurgeon, two vascular surgeons, a transplant surgeon, who also happened to be President of the Royal College of Surgeons at the time, and a general practitioner. And outside statistical experts were brought in to peer review the approach taken in the mixed treatment effect model; in other words a large range of experts were involved in this guideline. The British Orthopaedic Association was a formal registered stakeholder; it was invited to comment at the start, it commented on the draft guideline. The guideline development group responded in 17 pages to the comments of the British Orthopaedic Association and at a recent meeting earlier in October the current President, at a meeting with Professor Littlejohns, our clinical director, said to him that they were 95% to 98% happy with the guideline, only 2% really concerned them.

Q687 Dr Taylor: So you would justify your conclusions even though they differ from some of the other guidelines across the world?

Professor Rawlins: The guideline development group looked very carefully at all the other guidelines across the world and did not think they were appropriate to use; firstly, because it was very unclear as to what sort of literature review they had untaken and secondly almost none of the guidelines looked at cost effectiveness.

Q688 Dr Taylor: Could you explain why your recommendations differed from the Department of Health's expert working groups?

Professor Rawlins: The Department of Health's expert working group in essence looked at the existing guidelines; they did not look at the primary research data. Our guideline development group - and the guideline is the full guideline - runs to hundreds and hundreds of pages. The original literature search drew 21,000 articles of which 560-odd are quoted and used in the evidence analysis. So this was not the sort of methodology that was adopted by them.

Q689 Dr Taylor: Coming back to your comment about experts advising the appraisal committee, which is obviously rather like the role of our expert advisers sitting at the back over there on this committee.

Professor Rawlins: They are not allowed to answer questions!

Q690 Dr Taylor: Not at this point I am not! Rule me out of order if I am out of order on this but some of us went to sit in on an appraisal committee meeting some time ago and there were three experts sitting there and, to be honest, I was horrified how little input they actually had to that particular appraisal committee meeting. Whether that was unusual or ---

Professor Rawlins: Sample of size problem? I do not know.

Q691 Dr Taylor: There were three experts sitting there.

Professor Rawlins: That is one meeting, that is what I mean.

Q692 Dr Taylor: So I got a false impression, did I, that they were not really very involved?

Professor Rawlins: Andrew sits in them more often than I do.

Mr Dillon: When the experts are actually in the routine they are routinely involved in the dialogue. I do not know which particular meeting it was, but it is difficult to know why it might be that you had that impression. Certainly my experience is that (a) the chairs of the committees involve them directly, and (b) the experts themselves are not shy at coming forward and informing the discussion.

Q693 Dr Taylor: So unlike our experts they are allowed to chip in all along?

Mr Dillon: Yes, they do; they sit at the table and they are involved in the debate and the discussion.

Q694 Chairman: Can I ask on that: is that in every case?

Professor Rawlins: Yes.

Q695 Chairman: Every guideline that is produced is produced with these people available for comment even if they are not there for decision-making, in every case?

Professor Rawlins: Absolutely and many organisations register as stakeholders in guidelines. In the VTE one there were over 200 organisations registered as stakeholders.

Q696 Dr Taylor: One final point, we are told that your earlier terms of reference said that you should always provide a single source of information for the NHS. Is this no longer your remit?

Mr Dillon: Single source in what sense?

Q697 Dr Taylor: Let me read the information we have been given. Your earlier terms of reference stated that NICE should provide a single source of information for the NHS. If this was still your remit could the situation with VTE be different?

Professor Rawlins: I think the intention for the VTE guidance was for it to be interim guidance until such time as NICE had produced its full guidelines. It was instituted because of your vigorous cross questioning ---

Q698 Dr Taylor: The inquiry we did here.

Professor Rawlins: So the Chief Medical Officer set up a group to produce, as it were, interim guidance.

Q699 Dr Taylor: I have never understood why it was delayed by months and months just to come out literally almost at the same time as yours.

Professor Rawlins: Nor have I.

Q700 Sandra Gidley: I just want to clarify. Professor Rawlins mentioned the 17-page document that you had clearly received from the BOA but in our evidence Professor Roger Atkins said, "I wrote a 17-page document of commentary, including the latest evidence, and received no reply." I am fairly sure you clearly said that you have replied, but Roger Atkins goes on to say, "We emailed the chairman of National Collaborating Centre for Acute Care on a number of occasions and received no reply." So were they writing to the wrong people? I do not want to blame the Royal Mail here but are you able to clarify what happened?

Mr Dillon: Yes, I think I can. The process that we have when we go out to consultation on a clinical guideline offers the opportunity to anybody, including our registered stakeholders, to comment on every aspect of the guideline and the British Orthopaedic Association did that. The responses to all those comments in a tabular form is put on our website when the guideline is published. So I think what Roger Atkins is saying that at the point at which they put in that submission they may well have expected to get, as it were, an immediate response to those comments, but we get sometimes thousands of them. So the way we try to handle that fairly for everybody is to make sure that we have a response to every comment that comes in, but to put it on the website at the point at which the guideline is published; we do not go back individually to individual stakeholders during the course of the development of the guideline.

Q701 Sandra Gidley: So there is never a point where you would consider that there was a fairly key stakeholder and that they deserved an individual response; that just would not happen?

Mr Dillon: I think we would have to be careful about labelling individual stakeholders in that way because all our stakeholders regard their input as being extremely important. There are some circumstances where we think it is appropriate - because now we have a single public consultation for our guidelines - where there is a very controversial issue, as indeed there was with our intrapartum care guideline when it dealt with place of birth, which is a very controversial issue, we felt it was appropriate to go back out for a second time on the basis of the comments that we had received. It is a judgment we make on a guideline by guideline basis, so we do have the opportunity in exceptional circumstances to go back and say, "All your comments have indicated that there is something fundamentally at issue here, so we want to hear from you all again." But typically we go out for a single consultation, gather in all the comments, make sure that they are all taken into account by the advisory body, log all the responses and put the responses on the website when the guideline is published.

Q702 Sandra Gidley: Thank you for that clarification. We have been talking about VTE and you referred earlier to forward planning and how you selected drugs. I gather that there are two oral treatments coming out to treat this problem, both being licensed at the same time, one has been chosen and weighed 15 and the other one has yet to be determined. Would it not make sense to be joined up and discuss the two at the same time? I know occasionally in the past you have changed your mind, Wet AMD being one example.

Professor Rawlins: If we have a single drug we get a single manufacturer to provide the information; if we have two and we have to compare them then we cannot use that approach, we would have to use the older approach to do it. Quite clearly an oral equivalent of Heparin would be extraordinarily helpful; nobody doubts that. There was one that we were all anxiously waiting for and then it got killed off at the last minute by the Food and Drug Administration in the United States. Quite clearly we are very keen to look at it the minute it becomes appropriate and possible for us to do so because the implications for the health service are potentially very important.

Q703 Sandra Gidley: Another drug that has the same efficacy but works in a different way, should that not be assessed as well?

Mr Dillon: Typically we would and so what we could do, if you want, is to look specifically at those cases. There would have been some reason for us separating them.

Q704 Sandra Gidley: I do not want to go too much into great detail.

Professor Rawlins: We do have mechanisms if something really important comes along for us to revise the guideline. We did it, for example, in the treatment of hypertension where a very important trial, the ASCOT trial came out, suggesting that really our previous advice - which had only been out for nine months - should now be changed as a result of the ASCOT study, and we did.

Q705 Dr Stoate: Professor, we have already mentioned that sometimes PCTs seem to struggle to implement some of your guidelines and technology appraisals and yet few PCTs seem to be involved in the process. Do you think that involving PCTs more in the process might actually lead to a result that might be better suited to their needs?

Professor Rawlins: Yes, Andrew has been looking into this.

Mr Dillon: We want the NHS to be directly involved in the development of all of our guidance and in our technology appraisal programme, where we looked at individual drugs and at the treatments, we have for some considerable time invited two Primary Care Trusts in each case to become formal consultees and have the same rights as a manufacturer or as a professional group or anybody else. What we have discovered over the years is that the extent to which those PCTs actively get involved is quite low. That is disappointing and it is as much our responsibility as it is the community of PCTs to do something about that. We are concerned, as indeed is the NHS Confederation and the NHS Confederation has been extraordinarily helpful in thinking through potential solutions and is now actively talking to Primary Care Trusts about a specific proposal to put in place arrangements that would work more efficiently for them and more efficiently for NICE and we are very happy to collaborate with them in putting that mechanism into place and working with it.

Q706 Dr Stoate: So you are actively going to try and involve them more if you possibly can?

Mr Dillon: Yes. It is absolutely in our interests and it is the interests of good quality guidance and it is the right thing to do and we are very happy to work with the Confederation to make that work better.

Q707 Dr Stoate: That is certainly helpful. I just want to bring back Sir Michael to one issue about disinvestment. You mentioned the Cochrane studies and so on, but there is very little evidence to support effectively stopping a drug or a technology completely and yet from my many years of general practice - and I am sure you will be aware - the majority of things that we do in general practice are still lacking a good evidence base. What can we do to try and put that right because GPs up and down the land are using time honoured methods of medicine, many of which have never really been subject to a proper evidence base at all.

Professor Rawlins: Yes, and of course in the real world a lot of what we do has never been subjected to randomised control trials and actually some of the things ought never to be randomised control trialled - it is just plain, blind obvious that thyroxin for myxedema is effective, it is all those sorts of things. I am very optimistic that with the new arrangement of funding healthcare research we will include general practitioners in research programmes to a much greater extent than we have in the past. There are difficulties because many general practitioners have found it not very easy to devote the time to doing clinical trials, but it has been done in the past and we should do much more in the future. On the disinvestment, a lot of it is not saying that you should never give an antibiotic to a child with a sore throat; it is defining the circumstances much more precisely than anyone with a sore throat or a sore ear comes and gets an antibiotic.

Q708 Dr Stoate: We all know that we are still using antibiotics in a pretty haphazard fashion in general terms.

Professor Rawlins: It is really a matter of identifying when you should and when you should not. It is not saying that antibiotics are useless in all streptococcal sore throat infections; it is defining when is the most appropriate moment to do it.

Q709 Dr Stoate: My concern is that this should actually be more of an urgent problem because if we are spending literally billions of pounds on medicines which probably do not achieve the benefits, particularly in the patient groups we are using them for, that is money that could be used far more effectively. So surely this is a matter of urgency, is it not?

Professor Rawlins: Up to a point. As I said, it is not a question of there are useless medicines out there - there are not. The BNF has a few things that it does not recommend any longer but there are things that you and I or Richard have not prescribed for years and years and years anyway.

Q710 Dr Stoate: Let us just say that they are not being used in the most cost effective fashion and possibly being used in patient groups which may not benefit from them, let us put it that way.

Professor Rawlins: Exactly. That is much the more important area and that is what we are trying to identify and move into. For example, we are looking at grommets at the moment.

Mr Dillon: Also antibiotics in children, so that particular topic is one that we have identified where there is the potential for issuing guidance which would guide practitioners to optimal use and therefore where there is inappropriate prescribing reduce that.

Q711 Dr Stoate: All I am saying is should this not be further up your agenda rather than something you would like to get done eventually; is it not something that you should be cracking on with?

Mr Dillon: It is already there. We have the capacity; when we can be confident that when there is a substantive question to be addressed a useful guidance issue will do it.

Professor Rawlins: As you are probably aware, there is a large MRC trial looking at tonsillectomy, which could be very, very important rather than just the rule of thumb of five in two years and you have your tonsils out.

Chairman: Thank you for the confessions of a GP! We will move on to Robert.

Q712 Mr Syms: Can you see the merit in NICE being involved in drug pricing?

Mr Dillon: We are intrigued at the possibility that we might; of course, it is entirely a matter for the government to decide whether it wants NICE to direct its evaluative capacity in that way and the government is in the process of considering its response to the OFT's recommendations where this has most recently been rehearsed. As we have indicated to the OFT, and indeed to the Department of Health, what we do in evaluating, in assessing the therapeutic value of drugs, if you were to use therapeutic value as the basis of pricing it can be done, you can use it that way. We have views, I suppose, on the circumstances in which it would be most desirable to do that but it is absolutely a matter for government to decide rather than for NICE.

Q713 Mr Syms: Could NICE use the levers relating to pricing to improve the standard of evidence that you get?

Professor Rawlins: I think it is not easy because the pharmaceutical industry is a global industry and we only represent 3% or whatever it is of it, so actually although people say, "You are a monopoly purchaser," our negotiating position is not all that strong and some pharmaceutical companies have admitted that, "It is worth losing the whole of the UK market rather than halving our price for you because we would have to halve it for the rest of the world and we would rather lose you and keep the business with the rest of the world." There is a reality about this one has to face - our bargaining position is not as strong as people think it is sometimes.

Q714 Dr Stoate: So you do not think that if this happened it would lower the price of medicines?

Professor Rawlins: I think the price of medicines has to be looked at more than one level and I talked about this last time. The problem of the negotiated price is this business about the knock-on effects elsewhere in the world.

Chairman: Could I thank you both very much indeed for being with us again this morning.

Witnesses: Rt Hon Dawn Primarolo MP, Minister of State for Public Health, Dr Felicity Harvey, Head of Medicines, Pharmacy & Industry Group and Dr Sunjai Gupta OBE, Deputy Director, Public Health Strategy, Social Marketing and Sexual Health, Department of Health, gave evidence.

Q715 Chairman: Good morning and welcome to our sixth evidence session on our inquiry into NICE. Minister, you will be pleased to know that it is the final evidence session on this inquiry as well. For the record, could you introduce yourselves and the position that you hold?

Dawn Primarolo: My name is Dawn Primarolo and I am the Minister of State in the Department of Health for public health.

Dr Harvey: I am Felicity Harvey, Head of Medicines, Pharmacy & Industry Group within the Department of Health.

Dr Gupta: I am Sunjai Gupta; I am Head of Public Health Strategy, Social Marketing and Sexual Health in the Department.

Q716 Chairman: Welcome again and welcome Minister, especially in your new role with the Health Select Committee. We have been told that people's expectations of the National Health Service and what it can afford are just too high. Do you think there should be a more public discussion about rationing?

Dawn Primarolo: Can I answer that in three quick points? Firstly can I say that I do not accept the concept of rationing if it means and if it is used to mean that what the National Health Service will do is to provide a minimum package of care on offer to an individual and nothing else? But in a cash limited system we clearly cannot pay for absolutely everything so there needs to be an approach which attempts to prioritise on evidence what is available. NICE has a role to play in that in starting to shift the debate on to a more robust footing that is about what the evidence tells us rather than who shouts the loudest, and I am sure you will want to go further. I think because of the role, which is very important, of local commissioning, when we look at the Primary Care Trusts as well we need to be sure that they are engaging with our local communities in very clear understandings of what the need is and what the evidence is; how they set the priorities within that identified need; and what outcomes they expect, and NICE has a crucial role in some elements in advising on that. So in a sense it is about the management of the resources, it is a trade-off in terms of services and what is available within the cash system. Forgive me, you asked me to encompass basically how the National Health Service works very briefly.

Q717 Chairman: I accept what you are saying but from the perspective of the consumer, from the patient, NICE is often challenged - it is challenged by patient groups all the time in your postbag, like the rest of us - and is the public's expectations of the National Health Service far ahead of its ability to be able to provide for them? My instinct is that it is probably yes and the question then is what do we do about this? How do we have dialogue with the public and potential patients about lowering expectations, if that is what we think they have, that not everything that is available in medical and clinical care is available for them through our national system?

Dawn Primarolo: I think that has to be achieved through transparency and engaging. I think all of us would agree that at the point at which we are ill or very ill we would want anything that we believed and how we came to that decision was made immediately available to us. What we have to do in the health service, whether it is NICE, the Primary Care Trusts, the government, the professional bodies is to look the clinical evidence and what will be the optimal effect of choosing between different drugs or treatments and trying to make sure that the patient gets the best at every opportunity, and that is an incredibly difficult discussion to have. So we set the general dialogue and try and have that discussion all the time, but at the point where that patient absolutely needs or believes that they need a particular treatment then that obviously is almost impossible to have. So it is about managing expectations and that is why the way of ensuring that, for instance, Primary Care Trusts are more explicit in understanding the needs of their local populations and therefore how they set the priorities and the outcomes and that that should be an engagement at that point, is an attempt to manage that very difficult dialogue.

Q718 Chairman: Is there any methodology on how this engagement takes place or should take place with PCTs in other parts of the National Health Service?

Dawn Primarolo: No, I do not think there is at the moment, Chairman, and I think it is slightly outside of my remit as a minister. But I think the perennial challenge for the health service, in whatever structure it is, is to make sure that as best we can we ensure that people understand the choices that are being made for the resources that are available. I think what is really important is the absolute trust that underpins the relationship between those who use the health service and the clinician that they interact with, whether that be their GP or a practice nurse and that that, if you like, family of the NHS has a role to play as well. But there is never a simple answer; we can give advice and try and encourage but in the end it has to be about discussions and as much transparency as possible, in my view.

Q719 Sandra Gidley: In the past ministers have undermined NICE's work by directly intervening - Herceptin is the classic example as being refused by a PCT on the grounds that it had not yet been evaluated and then the Secretary of State intervened very publicly, or tried to. Do you think this is likely to happen again in the future?

Dawn Primarolo: I actually do not see it quite in the way that you are suggesting about an intervention. What the Secretary of State was doing at that time was reiterating the existing policy - and the policy which exists now as well - which is to say that PCTs need to ensure that they have the evidence of the new drug before they take a decision on it. They should not take a decision simply on cost, and that is the position now and continues to be the position. Obviously in the question of Herceptin it was very high profile and the NICE appraisal was expected very shortly. Ministers have been and I will ---

Q720 Sandra Gidley: At the time I am not sure that the drug had even been licensed.

Dawn Primarolo: There was a great deal of discussion around it and the Secretary of State was making clear what the policy of the Department is. I would absolutely stress that it is not the role for ministers to contradict, override or directly seek to influence a process where NICE are already engaged in consideration.

Q721 Sandra Gidley: So no minister at the time tried to influence NICE to speed up a decision or bring anything forward?

Dawn Primarolo: Not as far as I am aware, no, and if you have any evidence to the contrary please do let me know; but not as far as I am aware, no.

Q722 Sandra Gidley: How would you see the relationship between NICE and ministers developing in the future because I know from having lobbies that they have had slightly different approaches - I do not want to name names here - and some have been completely arm's length and some have seemed more willing to have discussions with appropriate people. What would your approach be?

Dawn Primarolo: What do you mean by "appropriate people" - that is my question?

Q723 Sandra Gidley: At NICE. As we all know, some decisions are controversial or looking as though they are going to be controversial.

Dawn Primarolo: Indeed, and as a minister - certainly in terms of Members of Parliament and organisations wanting to speak to me directly on issues regardless of considerations being undertaken by NICE - I could not refuse to see people and I doubt if my predecessors would on the basis of, "Sorry, I cannot talk to you at the moment, NICE is considering." But within the process it seems to me that when the priorities have been agreed and NICE has undertaken its work then the Department of Health, including ministers, falls back into a position of being one of many stakeholders who will have views about what NICE is doing and may or may not express those views to NICE. But there is not a route to directly try and circumvent or change the decision that NICE in its independence - quite rightly, because that is the strength of the organisation - both nationally and internationally is doing with its expert analysis. Again, going back to the Chairman's first point about how do you manage expectations, where is the dialogue, what is the engagement, unless you are suggesting to me that I should say to you the next time NICE is considering something that you want to speak to me about, I say, "No, hang on, wait until NICE has finished and then I will talk to you," I think that would be unacceptable. So I think we have to be careful, but let us be clear: there is no way that a minister can override, circumvent, force NICE to come to a conclusion that is not the conclusion of NICE based on their expert analysis - no way - nor should there be.

Q724 Dr Taylor: Good morning, Minister. I am very pleased to hear that it is not policy to contradict NICE but there do seem to be two examples of conflict. The first one on recommendations for alcohol in pregnancy, and the second one the Department's working group on VTE and the NICE recommendations, which do seem to be pretty different. We heard from the Chair and Chief Executive of NICE earlier that regarding the VTE one the Department's recommendations were really meant to be interim before NICE gave its actual ruling, but as they came out at exactly the same time it is very hard to see how they were interim ones.

Dawn Primarolo: Can I say on the VTE, they came out very closely together, within about a week actually, although they had different timeframes and originally different expectations. For instance, the Chief Medical Officer's expert working group was looking at recommendations for inpatients in the medical sphere and was also looking very specifically at summarising practice in time for the implementation and particularly when NICE's work came through. I certainly asked this question in preparing for this Committee today - in the discussions that inevitably occurred between NICE and the Department we need to find a way of managing slightly better when the Department is undertaking work because it needs to be giving guidance to the health service in the interim and what that relationship is with NICE. To be honest, in the end there is not a contradiction between the two; they were looking at slightly different focuses. But obviously now that NICE has been asked to go on and complete a fuller position it will be clearer. I think the question was one of handling rather than contradicting in the different pressures in giving advice to the NHS and NICE looking at an area.

Q725 Dr Taylor: So if the expert panel's report had been labelled as interim guidelines rather than definitive ones and had been brought out when it was actually completed - because it appears that it was delayed by six to nine months at least - that would have helped. Again, what clinicians are bothered about is when they get two subtly different bits of advice.

Dawn Primarolo: Indeed.

Q726 Dr Taylor: So should the Department not be either retracting something that it has put out, if it is not the same as NICE? What solution should there be?

Dawn Primarolo: This is a really complex area. There was guidance being sought from the Department, and I believe this Committee, in fact, looked at the issue. In 2005 the Chief Medical Officer was taking forward the proposals about in the here and now and clarification on practice. If I could answer your question, the essential question is how do we manage the process of making sure that the NHS has, when it needs it, and the Chief Medical Officer recommends, the guidance on practice at the present time, particularly in this area of medical inpatients and NICE's work. I was not a minister at the time but, as I understand it, although there was discussion among the experts as the issue was being developed, and I absolutely concede that it was not a contradiction, the Department is looking very carefully at how it managed that and whether it would be possible to avoid it.

Q727 Dr Taylor: We were all incredibly impressed with the speed with which the Chief Medical Officer did respond but then completely perplexed when the interim report, or whatever it was, was ready and it was not actually published for months and months so it came out at the same time as the NICE guidelines. Then when you get two things which are subtly different people do not know what to do. All I am pleading for is that this does not happen again and if the Department does put out something that it views as interim guidelines then it is made absolutely clear that those no longer stand when NICE comes out.

Dawn Primarolo: We will consider that very closely. As I am not medically qualified, I am just a little hesitant in that the advice to me was that the guidance was important. The experts in the field are perfectly capable of distinguishing between the subtleties, as you have put it; that is why they are experts. The essential point that you are making about the need for care and clarity and the relationship between advice, whether it be expert group, Chief Medical Officer or NICE, is certainly one that I think is well taken. I would be pushed to find a reason to disagree with you, and I am not going to.

Q728 Chairman: Could I ask on that about the issue of the advice to pregnant women. The Secretary of State has been making some very relevant comments in terms of health in terms of life chances at birth, as it were. Here we had advice initially from the Department saying that pregnant women should abstain completely from alcohol during pregnancy, but then NICE guidelines came out to say that they should just limit their intake to less than one and a half units of alcohol per day. If it is so crucial to people's lifestyle in terms of when you are born, as it were, why are we having this contradictory evidence from these two cathedrals that people look to for advice in terms of how they should rule their lives? Who is right?

Dawn Primarolo: They both are. In May 2007 the Chief Medical Officer made two essential points. First, that pregnant women, or women trying to conceive, should avoid drinking, and I wish the evidence was much clearer because it would make the discussion around alcohol consumption generally easier, not just for pregnant women, but then he went on to say that if they choose to drink they should really try and minimise risk by not drinking, I think it was, more than one or two units once or twice a week. Then NICE put out their guidance which was basically no drinking, or very little. They are in the same area. What will be best is when we have the final guidance from NICE. Both of these areas that you have touched on are areas that are difficult anyway, particularly the issue with drinking. Maybe we should go to a precautionary principle with recommendations for women drinking who are pregnant, or trying to conceive, which I think is what the Americans do, which is just say "don't", but at the moment we are still trying to work through this evidence. I suppose in these contested areas these views will emerge but NICE's final guidance will be final.

Q729 Chairman: That is likely to be more evidence-based than the CMO's position.

Dawn Primarolo: I think it will be very helpful when we have a synthesis of the point so that it is absolutely clear to pregnant women or women who are trying to conceive.

Q730 Mr Syms: We have had several years of large increases in cash for the National Health Service and yet a lot of the NHS cannot afford to implement a lot of the guidance produced by NICE. We are now going into a period after the CSR of rather more modest growth levels and that is going to throw up a number of challenges. How is the Department and the National Health Service going to cope with the situation?

Dawn Primarolo: First, the role that NICE performs is one of not creating more money in the Health Service but of helping in the most effective and efficient way. In terms of affordability, as you will know the National Health Service has a statutory duty to fund the implementation of the technology appraisals, and that is factored into the spending plans and allocations to the primary care trusts. It is not ring-fenced and we do not hold it centrally but we do our best in knowing the work that is being undertaken by NICE to make those allocations available. Clearly there are always going to be pressures but you are talking about the pressures that the National Health Service itself faces: do we concentrate on giving ever more expensive drugs or do we concentrate more on services, or do we try and strike the balance about what is most effective and the best outcomes. So we try and ensure in the devolving of the monies to the primary care trusts that that puts them in the best position to do that and has the two locked together, the requirement to implement within three months under normal circumstances and the way we try and work out the funding for the primary care trusts.

Q731 Mr Syms: Clearly we have had a lot of money going into the service, I think we all acknowledge that, and people see NICE guidance being produced, they have an expectation they are going to get a particular drug, but inevitably things are going to get tougher in the next few years. What I am really trying to find out is what is the Department going to do about this? Are they going to put more pressure on NICE maybe to reduce the cost per QALY threshold? How are you going to manage? The gap between expectations and resources is there now and it is going to get bigger.

Dawn Primarolo: There is not an easy answer. If you accept the proposition that our view as potential patients of the NHS is that we have unlimited expectations, I have already tried to answer that by saying that is a complex web of interactions. Certainly my experience as a constituency MP is that when put to individuals, "Well, we need to have what is effective, not who shouts the loudest", they understand that. That is one set of issues. On the other set of issues, and you mentioned the use of QALY by NICE, you need lots of cold towels, it seems to me, to work through the economics, the methodology and the understanding of how NICE balance this and come to the particular ratio that they do, and they use a great many experts to do that. I take advice on the basis that the consensus is that the methodology currently used by NICE is right, nobody has been able to come forward and say that it is not. That is reinforced by the review, which I presume you might have touched on, that NICE undertakes every three years or so, and there is a consultation to start quite soon in looking at that. That is the other pressure point. The final point is yes, you are right, there is always pressure in the Health Service, but it is true in any health system, whether it is insurance-based, private-based or tax-funded, as ourselves, which is expectation and cost, what is possible in the most advanced technologies and drugs, can be extremely expensive and how do you decide which ones you use. This comes back to my first point that we try and do that in as expert and transparent a way as we can removed from ministers about the optimal use and effect.

Q732 Mr Syms: We have been told that an independent body should set the threshold used by NICE and the rest of the NHS. Would you agree with that? Do you think that is a reasonable way to go forward?

Dawn Primarolo: That presupposes there is a better way to do it in the sense of how NICE, through its technologies, and it is a methodology and it is independent, is consulting, is there to take these decisions and make those judgments. It does have support mechanisms to look at that. If there is a proposition that there is a much better way to do this and it can be demonstrated to us then, of course, why would we not want to engage in that discussion, but I need to see where that is as opposed to just a straight proposition that somehow the current system does not work.

Q733 Sandra Gidley: You said a few minutes ago that the PCTs basically should be forward planning, the money was given to PCTs so that they could implement the technology appraisals guidance. Some of the evidence we have received is that PCTs are under some pressure to implement guidance and effectively by doing that they have to reduce money in other areas of spend which may be more cost-effective. What would your response to that be?

Dawn Primarolo: What, the PCTs said they are more able to decide on cost-effectiveness rather than the full body of NICE and all its expert panels?

Q734 Sandra Gidley: No. We are talking about here you have a drug which has to be prescribed and in any area of treatments there are non-drug treatments, so the PCT will possibly have to cut back on those non-drug treatments or even public health measures in order to implement the technology appraisal guidance. Do you believe that having to implement within three months is a good idea given that context?

Dawn Primarolo: We have a National Health Service and what we ask NICE to do is look at the claims of the drugs, that is basically the exercise they would undertake, assess it against the evidence, compare it against what the National Health Service is currently doing and using, and then it advises on the therapeutic gain. It is basically talking about optimum use. If, having come to that conclusion on something, then they said, "But we're not going to guarantee access through each PCT", would we not be open to a challenge that we were not providing a National Health Service?

Q735 Sandra Gidley: But is the three months fair because PCTs do have to undertake financial planning? It is difficult to predict, and I know NICE try to help them. It is difficult for a PCT to predict exactly what the spend will be.

Dawn Primarolo: Under some circumstances it can vary. Perhaps I should ask Felicity to come in here.

Dr Harvey: There is a waiver system and that is if, when NICE has completed its appraisal, it comes forward to the Department to say, "We think there is a reason why the NHS would not be able to take this forward within the three month funding direction", then there is an opportunity for ministers to be advised by NICE to say, "We think a waiver, either a full waiver or a partial waiver, might be used". Those have not been used in terms of costs of drugs. On the occasions those have been used, and it is not very many occasions, it is usually around a technology that has implications in terms of staffing or reconfiguration of the way a service is delivered. An example of that was surgery for obesity. There have been a few examples but there are not very many. It is not just when it is just utilised for a drug. Is it worth just mentioning that not all NICE technology appraisals on pharmaceuticals are actually driving up cost. For example, a technology appraisal that we had on statins, which was the evidence-base that fed into the Better Care, Better Value indicator for the NHS, said that actually in terms of statin provision there is evidence to indicate for the majority of people you should start treatment on a drug that has a lower cost rather than one of the drugs that is now generic, and it is only if that is not effective that you then move up. Particularly with multiple technology appraisals and, indeed, the clinical guidelines that NICE provides, it is providing advice to the NHS that is helping them utilise the resources in delivery of services in slightly different ways. As I think you were discussing slightly earlier with Sir Michael and Andrew Dillon, they are now publishing their optimal practice reviews where there is evidence drawn from their guidelines and technology appraisals to help the NHS realise the sorts of interventions that are going to be effective and better help them utilise their resources.

Q736 Sandra Gidley: Sometimes they are not directly competing services that have to go though. For example, in a previous inquiry on NICE we were told that various recommendations for cardiac payments meant that they could not afford the cardiac nurses to provide rehab and various other things and, given the choice, they might have felt that was a better use of resources. What assessment has been made of these perverse impacts?

Dr Harvey: If you are talking about a technology appraisal, that is why NICE would on occasion advise ministers that, in fact, they think a technology appraisal should not be supported by the three month funding direction. If it is around a clinical guideline, also as Sir Michael and Andrew Dillon said earlier, those are not mandatory in the same way that technology appraisals are and that is because different parts of the NHS would be at different positions in terms of the model of the services they are currently delivering. Some may be very close to what the guideline is suggesting is the best way of providing a service and others might have a further distance to travel. That is why, as they were saying, the expectation is on those occasions that a PCT would look at what a guideline shows, where their practice currently is and how they might move to that over a period of time.

Q737 Sandra Gidley: A change of tack slightly. Some PCTs play the system quite well and there will be something they have to implement and to tick the box they provide a small amount of funding for a particular treatment but that funding will only treat half or even a quarter of the patients who could benefit. What levers does the Department have to investigate those cases where patients are being denied a treatment simply because they are too far down the waiting list?

Dawn Primarolo: Can you give me an example before I answer the question?

Q738 Sandra Gidley: I can give you an example. The drugs for rheumatism. This is a local example. The PCT would only fund for 12 patients but the consultant had far more on his list. We eventually got the strategic health authority involved but it took a lot of time, persistence and energy to tackle that. It must be happening all around the country in a similar way to restrict in a finite way what is potentially not a finite demand.

Dawn Primarolo: In the circumstances you have touched on, although you said it was extremely difficult to get the strategic health authority to focus on it, where the Department is involved through the strategic health authorities they would be looking at the PCTs that they might consider to be "outliers", and then get the strategic health authority to engage with that PCT and produce an indication over what time period they would come up to where they should be or where the expectation was. If you have a particular example, particularly given my period in post is only four months, from your experience with your PCT and strategic health authority about the operation of that, I would be happy to look at that. That is the interaction between the Department and the strategic health authorities trying to work with the PCTs to bring them to the position where they should be over an agreed period of time.

Q739 Dr Stoate: Minister, I want to talk about the PPRS. It has been around for about 50 years and, generally speaking, I think it has served the country very well, and broadly speaking your predecessors and industry alike seem to think it is not a bad system. However, it is quite a blunt instrument and one of the side-effects of it is that companies that produce the most useful drugs are not effectively rewarded any more than companies that do not produce necessarily the most useful drugs. The question I want to ask is how can you justify that? Do you think that needs to be looked at to encourage more innovation?

Dawn Primarolo: Certainly the Government has indicated through the work that Lord Ara Darzi is doing that the role of innovation and the speed at which both technologies and drugs are available and get to the market is something that is crucial and needs to be looked at. The Health Innovation Council which is going to be established is designed to do that. Its interaction with the current fora where the Government discusses, whether it be with diagnostics, with the drug industry, will have to be part of that. If I can put that to one side, Felicity is leading on that and if you want to ask more specific questions on that perhaps we could come back to it. On the question of the PPRS itself, as you will know, I hope, the Department is shortly to commence negotiations with the industry, the pharmaceutical industry, and we are hoping to achieve a voluntary agreement that will replace the agreement we have now. We have laid out the principles we want to pursue, which is delivering value for money, encouraging and rewarding innovation and providing stability, sustainability and predictability in that whole very difficult area which I suppose we touched on right at the beginning of the questions on rationing. I am not able to explore that discussion any more but it is an important interaction around the availability point that you are making here. I am not quite sure how I can keep the Committee informed of developments but I am happy to try and do that through my officials. At this particular time, as we are on the eve of engaging, it would be a bit remiss of me to lay out our negotiating position now.

Q740 Dr Stoate: I appreciate that. I do not expect you to be able to answer things that you have not yet negotiated and obviously there are commercially sensitive issues around it as well. What I want to get at is the drive of Government to try and improve innovation, to try and ensure those companies that are most innovative and produce most value to the NHS are the ones that will be able to reap the benefit of that more so than others. Is that a fair direction of travel?

Dawn Primarolo: Yes, it is. The specific role of the Health Innovation Council will be about engaging the NHS not only in order to get the most cost-effective treatments and ensure that we have got world class methodologies for achieving that, but recognising the area of devices as well as drugs, getting the availability as quickly and as promptly and the costs, are all a discussion that needs to be had. There are ministerial consultation structures now with the different aspects of the industry but they will be integrated and the Ministerial Industrial Strategy Group will continue, but on the Health Innovation Council the pharmaceuticals and the device industry and NICE will be represented and be part of that wider group that is seeking to advise the Government specifically on how we go about achieving the points you have made, which is we have got a range of things we do now, is there more, what is it and how do we make sure we carry on providing an opportunity for the development of innovation here in the industries in the UK.

Q741 Dr Stoate: Obviously the OFT's criticisms of the PPRS are well-known and you are obviously looking at the OFT report at the moment. What I am really asking is when do you anticipate publishing your full response to the OFT's suggestions?

Dawn Primarolo: We have given our interim response and it would be inappropriate for me to go further because of the negotiations starting on the PPRS. I feel I am caught here between a rock and a hard place.

Q742 Dr Stoate: That is why you are the Minister.

Dawn Primarolo: That is my job, yes. I am not trying to be unhelpful, I am saying I can only lay out the principles. I am acknowledging the points you are making but we now need to proceed with those detailed negotiations.

Q743 Dr Stoate: You cannot give us a timescale as to approximately when you might respond in full? That is too early, is it?

Dawn Primarolo: When we have the agreement. As quickly as we get that we will be in a position to clear quite a lot of issues and you will be able to see the context as well then.

Dr Stoate: Thank you very much, that is fine.

Q744 Chairman: Following on from what you have just said, are we are likely to see more transparency in the future than we have in the past as far as pharmaceutical pricing is concerned, or is it a "don't know" at this stage?

Dawn Primarolo: I think it is worse than a "don't know". We would certainly like to but it depends on what is negotiated and what is commercially confidential, as always. Going back to where we started, Chairman, with the questions you asked me on rationing, we constantly have a pressure on us, quite rightly, as a Department to be as transparent as possible in how we take the decisions we do. We do not try and hide it away but there are a large number of pressures here. Can I just say I will do my best.

Q745 Chairman: That is fine. We are moving on to a section now headed "risk sharing schemes".

Dawn Primarolo: Excellent.

Chairman: You have been through yours and now I am going to call Richard.

Q746 Dr Taylor: I think we all understand and approve of the scheme with Velcade, the multiple myeloma drug, where it appears that the firm is only going to charge for patients who respond to treatment. This seems to be the ideal if we could extend this to everywhere else, that you only have to pay for it if it actually works, that would be superb. I am afraid I am very confused about what has happened in Sheffield with the work on the evaluator of the cost-effectiveness of some of the treatments for Multiple Sclerosis because I understand that the manufacturers came to an agreement with the Department where the drug could be used as part of a long-term trial because its cost for QALY is very high at 36,000. That seems to have faded into the background and we do not really know what is happening to that. The first thing is , when will the Government publish the full report of the Sheffield experience? In the interim, before the publication, what has the Government learnt from this evaluator?

Dawn Primarolo: A lot about the complexities and the difficulties of both the science and the methodological challenges of trying to come to particular conclusions in the absence of clear markers to determine patients' response to treatments would be what we have learnt and the officials can better understand that and progress. Where we are in terms of the report, the data from these risk sharing schemes have been collated, managed and analysed. We are informed that the first preliminary analysis of the data completed, that is the Independent Scientific Advisory Group which is meeting to consider it, will be early next year.

Q747 Dr Taylor: So we could expect some of the results early 2008?

Dawn Primarolo: Yes. You can expect the first analysis to be early next year.

Q748 Dr Taylor: I think it is a ten year trial, so this will be just for the first part of it, will it?

Dawn Primarolo: Yes, it will not undo the time period, it will be the first.

Q749 Dr Taylor: We have to wait for that, you cannot give us any clues?

Dawn Primarolo: No, not because I will not but I do not have them myself. If I had some clues I would certainly give them to you.

Q750 Dr Taylor: Would you support further use of risk sharing arrangements so that we should pay more money if treatments actually work?

Dawn Primarolo: I certainly hope that the negotiations with the industry on the PPRS around the principles that we have identified to date will help us further advance the necessity or not for risk sharing arrangements. I cannot say any more than that.

Q751 Charlotte Atkins: Good morning. Would you accept that the implementation of NICE guidelines, particularly its clinical guidelines, is slow and patchy?

Dawn Primarolo: It does take a time but I think that is necessary for the steps that we clearly require NICE to undertake, particularly its consultation and appeals procedure.

Q752 Charlotte Atkins: No, I am sorry, I am really talking about the implementation of NICE guidance rather than NICE itself. It is really the implementation by PCTs that I am speaking about.

Dawn Primarolo: These are the development guidelines?

Q753 Charlotte Atkins: Yes.

Dawn Primarolo: Do I accept it is clunky and slow? Well, the very nature of the development guidelines, and we touched on that earlier, can be very challenging because it depends where the PCTs themselves are in their experience. What the Department continues to do is improve that process in dialogue with the primary care trusts recognising that they hold the budgets and are setting the priorities. It still comes back to the balance between local priorities and maintaining some core issues, some guidance, on progress, and particularly around the developmental standards there is still quite a lot for us to learn about how we engage and roll those out and inevitably that will develop over time as well.

Q754 Charlotte Atkins: Earlier on you were talking about the crucial role of NICE is to make sure it is not just about who shouts loudest who gets the treatment, but in a situation where a PCT is not implementing NICE guidance you could get that situation again very easily because someone is not shouting about a particular treatment. I had quite a difficult conversation with a constituent just last night about sleep apnoea, which is not funded locally, and he was obviously very frightened and considered his life was at risk - he had been told by his clinician that was the case - but the PCT had adopted three fairly tight criteria which the PCT interpreted that he did not meet. In that situation there are a number of people waiting for sleep apnoea treatment but he is not going to make a huge impact unless, of course, he goes to the press, which he may do, and makes a lot of noise. Is that not unfortunate, that someone who is very frightened about a situation should actually find that his own recourse is to parade his particular case in the press to try to encourage his local PCT to give him the treatment he thinks he needs to maintain his life?

Dawn Primarolo: I would certainly regret that. That is not the position we would want to be at. Yes, it is a challenge in working through the strategic health authorities to the PCTs to ensure that on developmental standards of particular services we understand clearly the timeframe from where the primary care trust starts, where they will move over time and that is not an absolutely perfect process, and cannot be because of the priorities that are set. I recognise the point that you are making and anything the Committee says on this I will look at very closely. It is a bit difficult in trying to maintain the balance about local priorities and national direction, and developmental standards fall very clearly within that about the pressure points we have to speed up to a standard that is across the whole country. I acknowledge the point you are making.

Q755 Charlotte Atkins: I note that Dr Harvey was in the room when the NICE leadership were giving evidence on the whole issue about mandatory implementation of clinical guidelines. At the moment there seems to be an imbalance between clinical guidelines, which are not mandatory, and obviously technology appraisals which are. How do we get that right because otherwise we get a mismatch here?

Dr Harvey: Going back to the point that Sir Michael and Andrew Dillon were making, the difficulty you do have with a clinical guideline is that you have delivery at different positions in different parts of the country and, therefore, were you to say that it is mandatory that would have very, very different effects. It is a bit like when do you have a waiver for a technology appraisal. Some parts of the country may be a long way away from being able to reach that standard whereas others might be there already, so it is very difficult. With a technology appraisal I think the issue is slightly different because you are dealing with a pharmaceutical or medical device that is being introduced and that is around saying there is evidence to show that this single technology is clinically cost-effective and, therefore, you will get good patient outcomes if you are utilising it. We have many, many more clinical guidelines and there is a debate about whether, in fact, for clinical guidelines you have a library of them, so it is down to commissioners to say what it is that they need to commission, and NICE is helping with that as well now by providing commissioning guides based on their products, what it is they want to commission and what is the best service they could commission. The guidelines is a very difficult issue as against the single technologies that we deal with.

Q756 Charlotte Atkins: We have targets on everything in the NHS, why do we not have targets on that issue as well, or would you suggest that the strategic health authority should have more of a role in this respect? I think a lot of people do feel that they are hitting their head against a brick wall on a number of issues, and I have mentioned sleep apnoea but obviously there are things like IVF as well, and clearly in that situation time is definitely running out, and time is probably running out for my constituent with his sleep apnoea problem. People do get very concerned about the timeframes involved. Would not a targeted approach, if we are not willing to have a mandatory approach, be a way forward?

Dawn Primarolo: I hesitate because I am not sure how you are using the word "targeted" or "target" in ---

Q757 Charlotte Atkins: Targets.

Dawn Primarolo: --- in the way it has been used in the Health Service, and it is quite clear that we are moving to less targets. What I would say to you is I would need to consider and discuss with my officials whether there is an enhanced role that the strategic health authorities might be able to play in addressing the timeframe problem that you are identifying. I do not know whether that is possible. What I do know is that in some senses we have gone through the different discussions this morning: should we ration, should we not; should we direct, should we not; should we have local decision-making, should we not, and those are all the principles that we are balancing, and to get to effectiveness. To be perfectly honest, I would need to give more consideration about whether there are other things we can do that we are not doing or whether what is supposed to happen is not happening and, therefore, we need to put pressure on the system.

Q758 Charlotte Atkins: How would you define the role of the SHA at the moment in this field?

Dawn Primarolo: Well, as I understand it, the SHA is supposed to be engaged with primary care trusts through their development plans, their priorities, their evidence-base, on how they have a staged approach to deliver these developmental guidelines. If the point you are making is either it is not working or it is not enough, I am saying at the moment I cannot distinguish this morning between whether it is not enough or it is not working and both require further consideration on my part and on my officials' part.

Dr Harvey: I wonder whether I might just add to that. As you are aware, the core standards, which are the technology appraisals, are actually looked at by the Healthcare Commission, and have been, and we have been through a whole process, those have been scrutinised and we have final results for the 2006-07 year. As you probably also know, the developmental standards for the first time this year have been looked at in a pilot, and that includes not only the clinical guidelines but ---

Q759 Charlotte Atkins: Looked at by the Healthcare Commission?

Dr Harvey: By the Healthcare Commission. This is not just for the clinical guidelines but also the public health guidelines. These have been looked at and this year we are at the stage of doing a self-assessment by trusts. The self-assessment of those trusts for the pilot showed that on clinical guidelines 90% said they had good, excellent or fair implementation, and similarly on the public health it was about 88% assessing themselves as good, excellent or fair. Clearly this is the first year, this is a pilot looking at developmental standards, but the Healthcare Commission has been looking at what is happening to the clinical guidelines, these developmental standards when they go to primary care trusts and, therefore, there is a role for the strategic health authorities in understanding where their primary care trusts are in terms of taking a view as to how they implement this guidance. Clearly, as the Minister said, that is where we are at the moment, it is at the pilot stage, and they are expecting to do as they do on the core standards, which is verify that data and look at 20% of the returns in far more detail and take far more evidence on those. That is what is happening at the moment with the developmental standards.

Q760 Charlotte Atkins: Dr Tim Crayford of the Association of Directors of Public Health made the point that he felt that PCTs sometimes "fudge" their responses in respect of the measures of implementation. Perhaps they are indicating that their implementation is somewhat better than it actually is. Would you see that as being true or not?

Dr Harvey: I think it is difficult for me to comment on that. In terms of the core standards, that data has been verified and the Healthcare Commission has looked at further evidence on this. This is only a pilot at this stage for developmental standards but I know that the Healthcare Commission are intending to roll this out as they have with the core standards.

Q761 Dr Taylor: I would agree with NICE that guidelines as a whole cannot become mandatory because they are just guidelines and recommendations. What I want to ask if you would consider is certain bits of guidelines should be mandatory. I am only going to pick out one particular bit. In the guideline on venous thrombo embolism the absolute essential bit is the risk assessment and if somehow that sort of thing could be highlighted as that is the bit of the guideline that was going to be assessed by the Healthcare Commission rather than leaving it to self-assessment, I wonder if you would consider pushing that on to NICE, and I see they are listening avidly so I am very pleased.

Dawn Primarolo: Ever helpful as NICE are, I am sure they would be prepared to look at anything. Can I reflect on that because we are expecting some more advice? Given that the focus was specifically on the Working Group as well on risk assessment for particular patients, I bow to your expertise. I think that is a reasonable proposition to put to me.

Chairman: We would be more than happy to accept further correspondence on that issue, as we have done with IVF quite recently.

Q762 Dr Stoate: Minister, a lot of the discussion in the last half hour or so has been around the difficulty of PCTs affording, implementing or bringing in these technologies, some of which are quite expensive and you understand the reasons why they find it difficult. One of the problems is that many of the NICE new technology appraisals are around high cost drugs and, therefore, they are excluded by the high cost exclusion from the payment by results tariff. That means that the financial risk for these drugs falls entirely on the PCT. The question is, if those drugs were included in the payment by results tariff, would that not share the risk and make take-up more uniform?

Dawn Primarolo: I would certainly be prepared to consider further how best the tariff could be used to support implementation. The final roll-out does not cover all specialties until 2007-08. Obviously that could include high cost drugs and it could give greater certainty to PCTs. Overall it would not increase the funding. This is something, bearing in mind the roll-out finally through 2007-08, we are prepared to keep under consideration.

Q763 Dr Stoate: The reason I ask is because Sandra has mentioned a PCT that is only going to fund, for example, 12 doses of TNF blocking drugs for rheumatism because they are able to do that, but if the rheumatoid tariff included the cost of the drugs it would mean overall that the costs would be shared out amongst a wider pool and the PCT would have far less opportunity to say, effectively, "We are limiting it to 12".

Dawn Primarolo: As I said, we will consider that and as we go through 2007-08 it is something that we can actively consider.

Q764 Dr Stoate: At the moment, as you probably appreciate, there is every incentive for hospital clinicians to want to use these expensive drugs because they are outside the tariff and, therefore, that effectively means extra money from the PCT to the trust. There is this rather perverse incentive arrangement at the moment for clinicians to be desperate to use these new drugs and PCTs desperate about the effects of what might happen if they do.

Dawn Primarolo: Indeed.

Q765 Dr Stoate: You are prepared to at least concede that there is something to look at?

Dawn Primarolo: Yes, of course. We are not quite there yet in terms of the continued roll-out. The issue that you identify clearly needs to be considered and there are possibilities there.

Q766 Dr Stoate: As I am always being accused of being a horribly frank general practitioner, one of the difficulties we have in general practice is that NICE guidelines come in in separate documents, separate publications, which are extremely difficult to store away in your brain when you are trying to remember where the particular NICE guideline was filed when a patient comes in. What can the Government and the Department do to help GPs with better technology so they have got that stuff on their screens rather than having to hunt around in their room for where the particular NICE guideline was last filed?

Dawn Primarolo: Felicity?

Q767 Dr Stoate: That is not the right answer!

Dr Harvey: Within the national programme of IT, decision support is being looked at in terms of looking at how you will get prescribing systems in hospitals and also you have prescribing systems at the moment in general practice but the issue is, is there something we should be moving towards. The issue around decision support and how you make sure the right evidence is available is something that is being considered at the moment within the national programme of IT.

Q768 Dr Stoate: We need to make sure that information is literally tied to the patient records so that when, for example, I type "hypertension" on to the screen the system will recognise that that is a 35 year old Afro-Caribbean and it will come up with the NICE guideline as to what I should do next. That is what I am asking for. Are you telling me that the programme for IT might deliver that?

Dr Harvey: I am saying ---

Dawn Primarolo: Think about it!

Dr Harvey: --- in terms of the evidence-base that supports decisions, this is something that is being looked at. Clearly it is a bit different to do provision support in terms of an individual prescribing event as against immediately pulling up the key points of a clinical guideline. It is an area that people are looking at and that is probably as much as I can say at the moment.

Q769 Sandra Gidley: As part of the inquiry we went to Scotland and looked at what the SMC were doing. They tend to approve medicines, or not approve them, rather more quickly, although the system is somewhat different. Has the Government had a look at what they are doing in Scotland and are there any lessons we can learn from what they do there?

Dawn Primarolo: The particular pressure in terms of time for NICE, as I touched on before, is with regard to their public consultation and their appeal stage on determinations. That is where we get the difference on the whole. It is a slight difference but it is the major difference between NICE and the SMC. I suppose you would expect me to say this, but we, as ministers, prefer the process of NICE, we think it is more robust, transparent, it is being improved with certain considerations moving to public session and it is respected, therefore, internationally as the right way to proceed. We could, if we wanted to, come in line with the SMC but it would be the appeals and consultation process that would come under pressure. Is there an issue about speed? Yes, and everybody recognises that. There are discussions on that about what can be done, but it cannot be done by cutting short the public consultation or the appeal procedure and that is where the big time is.

Q770 Sandra Gidley: You have just mentioned transparency and one of the constant themes throughout the inquiry has been, yes, transparency is great to a certain level but when it comes to drugs that perhaps have social care impact, the transparency about how much of that is taken into account a lot of people feel is not there. How would you like to improve that process and improve the public's perception of that process?

Dawn Primarolo: NICE have a huge amount of information both on their websites and increasingly moving to public sessions. Unless you are going to put a specific proposition to me in terms of transparency, what else is it that you feel NICE needs to do given the evidence it is working with and it is taking from expert groups. What do they need to do that they are not?

Q771 Sandra Gidley: It is not clear how much evidence is given to some of the softer, non-health benefits, that does not seem to be transparent. We have had a lot of submissions saying that a working model of the costing assessments would be useful rather than the final version they are presented with.

Dawn Primarolo: I think we can look specifically at what we ask NICE to do and then we can look at their methodology and consultation which will be for public consideration and consultation, I think at the end of this month, showing exactly how they undertake things. Some of these things are contested and it is very difficult when we ask them to follow the evidence that we make sure they do that. I am perfectly prepared to look at that if you have propositions that it could be more transparent. I understand that some of the decisions are very controversial because I get it as a Minister in my mailbag and from Members on the floor of the House, but I do not see in those controversial areas at the moment what is missing in greater clarity. Some of the deliberation committees are going to be done in public because people are saying, "How did they get to that?" and now they will be able to see the deliberation of how the expert group got to a particular point. Over and above that, please do say if there is something else but it is not immediately obvious to me at the moment what could be done on the advice I am getting.

Q772 Chairman: The Minister has just tempted me to say that one of the areas we took evidence on, both written and verbal, was the methodology in terms of how you get to a QALY, particularly around the issues of the costs of caring or potentially costs of employment or unemployment, as it were, of somebody being denied something because they believed the methodology was wrong on the basis that the full costs had not been taken into account in terms of how it impacts on that individual. Do you have a different instinct between being a constituency MP as opposed to being a Minister? Mine has been pretty consistent throughout about this.

Dawn Primarolo: As a constituency MP I am like everyone else, I would want everything that suits my constituents. What we are setting NICE to do is a specific task on the effectiveness and the consultation that will be available for comment later this month will touch on those issues and they qualify, and can qualify, the criteria in terms of how the QALY operates. There is a real issue and a debate to be had, and I agree with you, on whether in our desire to ensure that all the costs are taken into consideration, somebody being unable to go back to work or the costs of care, and we need to be careful that we do not skew decisions away from certain groups within our community towards others. Nobody has the answer as yet, unless the Committee does, as to how we balance that to make sure we are using a methodology that is for the entire population and focuses on specialist groups when NICE considers that necessary. If we required them to consider the costs of not returning to work, would that skew away from the elderly and the long-term chronic diseases where people have no chance of returning to work because of their conditions, it seems to me that is the essential challenge and it is raised in other issues as well, such as the cost of care. It is difficult.

Q773 Chairman: Thank you for that. Amazingly, we are finishing a minute earlier than we planned. Can I thank all three of you very much for your involvement today.

Dawn Primarolo: Thank you for that minute!

Chairman: Thank you.