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Taken before the Health Committee
on Tuesday 4 December 2012
Mr Stephen Dorrell (Chair)
Mr Virendra Sharma
Dr Sarah Wollaston
Examination of Witnesses
Witnesses: Professor Peter Smith, Senior Associate, Nuffield Trust, Professor Peter Littlejohns, King’s College London, and Professor Albert Weale, University College London, gave evidence.
Q67 Chair: Good morning. Thank you for joining us this morning. This is a reasonably brief session, before we meet the current chairman and chief executive of NICE, in which we want to explore in particular the points that were made by this panel of witnesses in written evidence about the relationship between NICE guidance and approvals and the commissioning process. That is the agenda for the next, roughly, 45 minutes. Could I ask the three witnesses briefly to introduce themselves? Who are you and where do you come from?
Professor Smith: My name is Peter Smith. I am a professor of health policy at Imperial College but I am also a senior associate at the Nuffield Trust. I am here to comment on the submission that the trust made to you.
Professor Littlejohns: Good morning. I am Peter Littlejohns. I am professor of public health at King’s College London. My research interests are around trying to improve the costeffectiveness of healthcare, with particular interest on the role of values in determining a fair allocation of resources. From 1999 to 2011, I was the clinical and public health director at NICE.
Professor Weale: I am Albert Weale. I am professor of political theory and public policy at University College London. I have worked for a number of years now on questions of social values and priority setting in healthcare and, together with Professor Peter Littlejohns, I have been working, with support from the Economic and Social Research Council, on a research programme trying to examine the role of social values in priority setting in healthcare.
Q68 Chair: If I may, I would like to ask what I think is the core question in this evidence session from our point of view. What do you think is and-probably just as importantly- what do you think ought to be the relationship between NICE guidance, NICE approvals and the practice of the commissioners in the shaping of healthcare services? We have had a fair amount of evidence that there is a disconnect between what NICE says ought to happen and what does in fact happen. Equally, of course, there is a tension the other way, which is the freedom of individual commissioners to decide their own priorities and, indeed, clinicians to reflect their own views about best interests of patients in a particular set of circumstances. It is that set of issues that we would like to explore. Perhaps I could start with Professor Smith.
Professor Smith: Thank you very much. The principle of costeffectiveness is one that has proved very hard to challenge. It arises from the desire to spend a limited budget as effectively as possible. That gives rise to the decision rule of costeffectiveness. The work of NICE, which is internationally recognised, has embedded that within our health system. At the same time we have had local administration of our health system, up until recently, by primary care trusts, which has had one superb outcome in one dimension, and that is the ability to keep costs under control. Those PCTs have proved very effective at that. There arises a difficulty in transmitting the general principles of costeffectiveness from NICE, which by their nature must be very aggregate and global, down to a local level, while also keeping costs under control locally.
We concluded in our report for the Nuffield Trust that to have excessively rigid principles of costeffectiveness applied at a local level might well compromise the necessary freedom of local commissioners to work within their budget and, of course, to respond to idiosyncrasies in their local populations and so on. At one extreme, you could envisage that NICE guidelines were absolutely mandatory everywhere, that it was absolutely mechanistic how patients were treated. That that would almost destroy the need for local commissioning and would also probably compromise cost control in the NHS. At the other extreme, we could have very loose and flabby guidance coming from NICE, which really didn’t influence local commissioning at all. Likewise, I think the outcome would be highly undesirable. The trick is going to be to find the balance between those two extremes.
Q69 Chair: You have defined the problem. I wonder if you would offer an opinion about the quality of the outcome. Do you think the tension you describe is fully or properly addressed, or do you think practice should stray one way or the other from where it is now?
Professor Smith: Where the evidence is strong on costeffectiveness, and where it is very clear which patients would benefit and which would not so that you can also specify clinical thresholds for who should receive treatment, the principle of national solidarity and the certainty in those sorts of situations should lead to a fairly clear mandatory requirement to follow that guidance. At the other extreme, where evidence is very insecure and, also, the capacity to benefit of different patients might be very different depending on things like their level of sickness, age and so on, then you have to start thinking about a more nuanced guidance at the local level, with information given to local providers but not necessarily making it mandatory. Nevertheless, whatever approach you adopt, we believe quite strongly that public reporting of what is done locally-so that variations can be explored, explained and justified-is absolutely central, whatever the degree of-I want to say "mandatoriness", but-
Professor Smith: Yes, compulsion. Thank you.
Q70 Chair: Can I bring in Professor Littlejohns?
Professor Littlejohns: The first thing I would like to say is that I view NICE as being absolutely crucial to the new NHS architecture. It will be the glue that holds this new model together. Historically, NICE guidance has been directed into different areas-public health guidance and technology appraisals around specific drugs that had a mandatory nature to them, certainly in terms of funding, and then the clinical guidelines. But, in the new world, all of that evidence and guidance has been distilled into national standards, be they clinical standards or the Quality Outcomes Framework and indeed public health standards. That will give an added bite to them because they will be within the context of clinical governance and governance of the clinical commissioning groups. But I think they will still remain aspirational. As Professor Smith has said, some of those standards are based on very good evidence of value for money and others will be based much more around the consensus from professionals of what they would like, not taking into account perhaps all the cost implications.
That means that the clinical commissioning groups are going to have to identify not only how close or far they are away from individual standards but be absolutely explicit with those to whom they are accountable-be it patients, the public or the National Commissioning Board-about where they are in achieving those standards. Historically, NICE has always been aware that the clinical guidelines were often a challenge, and Sir Andrew Dillon and the Chairman talked about having a conversation with the local population, from the PCTs to the local population and the professionals around that. I think it is very important to have that conversation, but, in the new world, there will need to be a much more open, transparent and robust way of identifying where you are against those standards and then how you are going to deliver on them.
It is inevitable, with the age of austerity that we are in, that the CCGs are going to have to make quite difficult decisions and they are going to have to prioritise one patient group against another. They may target children as opposed to the elderly, but, if you are in a particular area where children are being prioritised but you happen to be elderly, you still want to have the same service as if you are in another CCG that has a very elderly population and perhaps is targeting the services there. NICE, through its standards, does not define the balance of primary versus secondary care, whether it should be in hospital or whether it should be a nurse practitioner or a consultant, but the actual clinical care that is delivered. That is where the challenge would come.
Q71 Chair: You are putting a similar emphasis on it to that which Professor Smith did in his second answer on reporting-that it is assessing the performance of the commissioner or the delivery of care in a particular locality against NICE standards and reporting against those standards. Am I hearing you correctly?
Professor Littlejohns: Absolutely. There will be many standards, initially 150, and I suspect there will be a lot more over time. It is naive to think that any clinical commissioning group can deliver on all those standards. What it can say, though, is what standards it is going to concentrate on and which standards perhaps it cannot achieve in the short term. If I can give a very practical example, southeast London is trying to implement NICE’s guidance around obesity. NICE is very specific about the thresholds for treatments, for bariatric surgery, but that cannot be delivered on the current service. What southeast London is doing is not expanding its bariatric service but looking at different thresholds. It is saying that it understands that the thresholds are costeffective, but the overall cost impact is not that it wants to prioritise. Therefore, it is redefining the thresholds. I think that is very legitimate-it has made a decision-as long as that process of prioritisation is undertaken in a legitimate way. It is being very explicit. It has published its thresholds, which are different from NICE, and everybody can see and understand them.
Professor Weale: The question of the balance between national consistency and local commissioning is at the heart of the new system. I am probably going to echo much of what has been said already, but I see this as having two components. One concerns the difference between the way in which NICE implements the principle of costeffectiveness and the way in which CCGs will have to implement the principle of costeffectiveness. What NICE does with its threshold is take each intervention one by one and assess it against the threshold. In strict theory, that is measuring the opportunity cost of purchasing that intervention as against what that will displace, but it doesn’t seem like that when the decision is being made, whereas at CCG level they will in effect be operating within a global budget and so will know that, if they are commissioning one service, that will mean that some other service will not be commissioned. One of the ways of looking at that relationship is that CCGs are making explicit the opportunity costs that are implicit in the national decisionmaking process.
The other question is the issue about the role in which the commissioning outcomes framework standards will stand in relation to the local commissioning. There, I would simply want to echo what Professor Littlejohns has said. You would expect the configuration of services in Milton Keynes on the one hand and Worthing on the other to be different because they are different age populations. It is not clear that a young person suffering an eating disorder ought to get a less appropriate treatment in Worthing than they would do in Milton Keynes or that somebody suffering from dementia in Milton Keynes gets something worse than they got in Worthing. It is managing that particular configuration of being responsive to local population needs but also meeting appropriate standards at the individual level that is going to be the real challenge facing CCGs.
Chairman, you mentioned the question of reporting back. There is one other thing that it might be helpful to think about in this context, which is that, as part of our own research project, we have confronted potential members of commissioning groups with scenarios in which they make decisions. It is very interesting to see people wrestling with real problems. Of course, people can understand that there are reasonably different solutions to the same problem. If there were a mechanism by which people who are making what will be, I think inevitably, very difficult decisions can share, so to speak, their reasoning in a nonthreatening framework so that they can understand that reasonable people might take different views on the same evidence, that might be helpful.
Q72 Chair: In terms of reporting information, I suppose the question is whether commissioners-we talk of CCGs but, presumably, in the context of social care it also includes social care authorities-should be selfreporting their own view of their own outcome or whether there is a role for an external agency, probably the Commissioning Board, in moderating the information that flows from CCGs. That is one question. The second question is whether that information should focus more on outcomes, as we are always told, or on process. Are we interested in the outcomes achieved or are we interested in detailed compliance with NICE’s latest view about how to achieve an outcome in a particular locality?
Professor Weale: That is a very interesting question. It is quite interesting if you try and think through the bodies to whom-let us just talk about CCGs for a minute-CCGs will think themselves accountable, because they will obviously be accountable to the National Commissioning Board. They will certainly feel accountable to their local populations. They will have a sense of accountability to their professional colleagues. I am sure, if something goes wrong and your Committee is interested in finding out, they will feel themselves accountable to this body as well. They may well feel themselves highly accountable to their local press. I think that balancing off those questions of accountability to whom is going to be very difficult.
On the question of commissioning for outcomes as against commissioning for process, that is a very difficult one and I might defer to my colleagues here who know more about this than I do. I have been wondering how you would write a contract that included some of these process requirements, in particular how you would envisage the contingencies, were there to be a departure from those process standards. After all, things do go wrong, so to speak, for reasons beyond the control of providers. So there are some very difficult issues there. If we are concerned about transparency and accountability, people need to be able to understand both the process and the outcomes that are associated with that. Providing information sets that are meaningful to people is going to be very difficult.
Professor Smith: Could I say a couple of words about that? On the transparency, elsewhere there have been big discussions about the extent to which the accountability mechanism within the new NHS will operate well. It seems to me that the most important thing is that we have a common set of information that allows any reasonable observer to compare how their locality is performing relative to others. But then also, I think, there needs to be a narrative from the local CCG that explains why they have departed from national standards and why they are performing particularly badly on certain issues and so on. So I think it could have both.
In addition to the areas that Professor Weale has mentioned, I would also think that accountability through scrutiny of local government might be quite important in this area. Local government can develop an expertise in holding their CCG to account.
As to the use of processes or outcomes, I am very much a processes person, I have to admit, for the reason that outcomes have so many influences on them in general beyond the care delivered. Therefore, in general, standards ought to be specified in terms of processes. However, there is one big concern about that, and that is that you might be inhibiting new types of service delivery and treatment if you stick to a rigid process. Therefore-again, this is where good reporting mechanisms will come into play-we need to allow providers or commissioners to explain in narrative why they are not undertaking certain processes. One very good reason may be that they are doing research into new ways of delivery that might lead to greater efficiency or effectiveness.
Professor Littlejohns: I would add a few comments, Chairman. Obviously, we are all geared towards achieving the best outcomes for patients, but one of the key difficulties with monitoring a healthcare system on that is the timelines. Very few of the interventions, except for acute medical emergencies, are going to impact within a timeline of a business cycle. The national commissioning group will want to monitor on that basis.
The other point, as my colleague on the right just said, is the attribution of that outcome. We are emphasising discussing clinical commissioning groups, but of course they are commissioning from providers, and, in a sense, it is the providers that may well be in the best position to define exactly what processes are required within a clinical service, within a clinical pathway, to deliver.
The final point, I suppose, is that there will need to be a mixture. If there is very good evidence of the value of a certain process intervention where research has demonstrated that the implementation of that intervention leads to a good outcome, then it may well be that that is the best vehicle. As you are well aware, measurement of process and using that data routinely is much easier now.
Q73 Valerie Vaz: I was wondering what evidence you have of the takeup of the clinical guidance, which is quite an important part of NICE’s work. Do any of you have any evidence of how that is seen across the NHS? You mentioned the obesity clinical guidance, but that was drafted and implemented in 2006. How do you update that guidance?
Professor Littlejohns: There are a lot of questions there. NICE never had full responsibility for implementation, but it knew that its credibility depended on the implementation of its guidance and very quickly established an implementation support function within the institute. That group has worked very much with the local NHS communities and has been gathering evidence over the years. But you are right that there is variability in the uptake of guidance. Some guidance happens very quickly and there is research evidence to show that implementation of that guidance led to not only an improvement in quality but also a reduction in costs. An example of that is the head injury guidance.
I talked about the obesity guidance because it is not a question of its not being implemented but not being implemented as quickly as the local community would have liked. Part of the responsibility of the implementation group at NICE is to identify good practice. There are many examples of good practice that are collated and put on the website that are freely accessible. As I have said, I have left NICE, but my experience working within the local NHS is that NICE guidance is taken very seriously. Most providers will have a mechanism to receive NICE guidance, to prioritise it and to distribute it to the various clinical parties. That is seen as a very key component of the clinical governance mechanisms within local providers.
Q74 Valerie Vaz: I am not suggesting it is not good. I am actually suggesting that it is very good. I am just wondering why the uptake is so patchy across the NHS and how, if the obesity guidelines were drafted in 2006, we have an explosion of obesity. There is a problem, isn’t there? That should have been a key guideline to follow, shouldn’t it? Anybody can answer, not just you.
Professor Littlejohns: Obesity is a huge issue and it cuts right across society. NICE has produced guidance in the public health field and it is being implemented. But the expectation that you can change a whole society within a period of years is difficult to comprehend. The fact is that the local communities are now being very specific, certainly in the areas that I have come across in south London, that obesity and the implementation of NICE guidelines is not only the responsibility of the providers, but now the local authorities through their Health and Wellbeing Boards are putting NICE guidance as a priority.
Professor Weale: It may come back to the question about the distinction between what, in principle, is a costeffective intervention on the one hand and the fact that the hitherto PCTs are dealing with global budgets. If you are in a situation of having a global budget and find at the margin that you can’t afford everything, then something has to go. It is pretty well researched now and we know that one of the things that PCTs do is adapt their referral criteria in order to be able to keep within their budgetary limits. As to the logic of operating with global budgets, even with guidelines that seriously take into account a principle of costeffectiveness, there is a serious problem, I think.
Q75 Rosie Cooper: I am interested-and I was just writing down a comment for myself there-that you are very clearly distinguishing between clinical practice that is not costeffective and rationing. That is the line you are travelling down. I had planned to ask you about disinvestment in lowvalue services, the role that NICE might play in that process and how effective it has been. Perhaps I will put that bit to you, as to how effective you think they have been there, and then come back to you.
Professor Weale: Professor Littlejohns knows much more about this than I do, but I just have one comment on that. I think I said at the beginning that I had been working on these issues for a number of years and I can remember at one stage a number of people were very excited by the NICE "Do not do" list in the hope that that would target lowcost interventions. One has to be a little careful there-I am doing this from memory now and I have to check-because, for example, if you say, as NICE says on its "Do not do" list, that GPs should not be doing melanoma excisions for quality of care reasons, that is going to be passed on to the specialist services and will almost certainly be more expensive. So I think we ought not to confuse-
Q76 Rosie Cooper: It saved a few lives as well.
Professor Weale: Indeed, and I am entirely in favour of it. But one should not be over-optimistic about being able to scrutinise a "Do not do" list and think necessarily that that coincides with costsaving measures.
Q77 Rosie Cooper: Okay, but I suppose, for me, we are nibbling round the edges of what really is going on here. There is £100 billion being spent and little work being done to assess the costeffectiveness of treatments that are already funded. PCTs and CCGs are trying to do that. I know that my area, central Lancashire, has its own list and another authority would have another list. So we have everybody trying to do the same piece of work, doing it differently and coming up with a slightly different answer. We clearly have a postcode lottery. For a simple soul like myself, that is a waste of money, time and expertise, and perhaps NICE should be addressing that at the core.
Professor Littlejohns: Disinvestment or, as the Canadians are now calling it, reinvestment is a very difficult issue. There are a few points I would like to make. First, it is very difficult because there is very rarely evidence of cost-ineffectiveness. What you have is a lack of evidence of costeffectiveness. That means that you are into the realms of professional debate. Many of the interventions do benefit some people. It is not around lowvalue interventions but interventions that are, overall, useful for some patients but not for all.
Certainly, during my time at NICE, I was very sceptical about these lists. The lists tend to be the same lists, with slight variations, around interventions with a social value attached. In terms of varicose veins, is it for prevention of ulcers or is it for cosmetic purposes? What NICE has done over the years is to highlight within its guideline programme where there are opportunities for disinvestment. There are many. I forget what the figure is, but I think it was around 800. The issue is that it is not simple enough to say to a patient, "You can’t have this." What you have to say is, "You can’t have this but you can have this." It should be in the context of a pathway of care rather than specific items that can be taken out of the schedule.
Q78 Rosie Cooper: I see that Professor Smith will want to come in. I hear what you are saying, but, frankly, how anyone could put a cataract operation, the end result of which is a magnificent improvement in your life and an ability to see, on a list that could be deemed of low clinical or monetary value is completely beyond me. Shouldn’t NICE address those questions?
Professor Littlejohns: I agree that it shouldn’t be on the list. I don’t think there should be lists. What NICE has done is to define the appropriate criteria for when a cataract operation should take place. If there is variation, it comes back to Professor Weale’s point, that-
Q79 Rosie Cooper: It is rationing.
Professor Littlejohns: For whatever reason-and I suspect it is from cost impact-they have set their threshold for intervention at a higher level than another community.
Chair: Professor Smith wants to come in.
Professor Smith: My point is directly related to that, and I am glad you raised it. The key here, in my view, if you really want to make big rational savings, is to look at the clinical thresholds beyond which people will not receive treatment. At Imperial College, with colleagues, we have done research specifically in cataract surgery where we have looked at the criteria being used by PCTs for limiting access to that surgery, and found that the variation around the country was absolutely astonishing. There are a minority of PCTs that have no explicit guidance at all in this area. There are some PCTs that have rules to do with visual acuity. There is one PCT that said that cataract surgery will not normally be offered, and there are other criteria such as someone having to have had falls in their house before being offered cataract surgery. There is astonishing variation, which is absolutely unjustified, of course.
However, it is clear to me that there does have to be some limit. If someone has a very small capacity to benefit from a cataract surgery, to offer that on demand will somewhere in the system be denying some other patient elsewhere treatment for something for which they can secure greater benefit. So I do think there has to be rationing of access to treatment, or at least limits on access to treatment, and that will then secure the best use of the limited NHS budget. But that limited access has to be based on evidence and also it has to be systematically applied.
Q80 Rosie Cooper: Would NICE not be best placed to make those judgments and apply them right across?
Professor Smith: Assuming it has the resources to do this, in my view, NICE should, at the very least, be saying, "What are the expected quality-adjusted life year gains for people in different circumstances for requiring cataract surgery?", let’s say. They could then come to a view saying, at the national level, "This would imply that the following criteria should be applied." That is, "No one with a visual acuity worse than x should be denied treatment"-criteria such as that.
NICE has a fundamental role to play there. The issue for your inquiry is the extent to which that should be mandatory and that there should just be a "cook book" for local areas as to what they should be doing. For the reasons I gave at the beginning of this session, I would suggest that the provision of that information and maybe a statement as to what would usually be expected as the criteria for offering treatment are where the key decisions have to be made in terms of your inquiry.
Q81 Mr Sharma: Very briefly, what we are looking at here is using different terminology or phrases for the same thing. The decisions taken are financeled rather than clinical or needsled.
Chair: Professor Weale, it’s your territory.
Professor Weale: I think it is very important not to see the principle of costeffectiveness in treatment and care as purely driven by a financial concern. Clearly it is, and one can have an argument there about the amount of money that is devoted to healthcare. But, for me, there are two aspects that complicate that discussion. One is the point that has been made more than once, which is that in a situation in which someone is operating with global budgets they are confronted with opportunity cost decisions and so that does mean that resources devoted to one group of patients then become unavailable to another group of patients. The whole point of having a sense of a cost threshold, which you are very cautious about going beyond, is that you are aware that, if, for example, you finance new expensive pharmaceuticals, that will have a consequence. It will have a consequence, for example, upon how much commissioners, whether PCTs or CCGs, can finance outreach activities to people who are drug dependent in their communities or can deal with the burdens of mental illness in their communities and so on. That will feed through the budgeting system. So there is a real issue of fairness that is also involved in this costeffectiveness consideration.
The other thing that is quite important is that we shouldn’t confuse spending more money with better quality care necessarily. Again, this is something on which people reasonably disagree, and these are difficult issues. Think back, for example, to the "Child B" case a number of years ago, where the issue was of a child who was suffering from leukaemia; the specialists thought that what was required in the circumstance was palliative care but the parents fought the case for pharmaceutical intervention. The child did live for 10 months, so it really is right at the cusp of, "Do you regard that as an expensive but none the less worthwhile intervention or not?"
There is a genuine discussion to be had here about broadening out the discussion of social values beyond merely a concern for maximising costeffectiveness through QALYs and taking into account other considerations. I don’t think that automatically means finding room to fund the expensive therapies. I think it may go the other way.
Q82 Chair: Can I follow that up because I was struck at the beginning that Professor Smith said that the development of NICE has strengthened focus on costeffectiveness and a rational analysis of costeffectiveness in the system? But it is very clear that NICE intends, or tries, to balance other factors beyond purely the assessment of costeffectiveness by means of a QALY. Do you think NICE has been effective at holding the balance between costeffectiveness on the one hand and other considerations, in particular patient voice and patient engagement in the process? Do you think that has been a success or do you think there is still learning there?
Professor Smith: Both. Internationally NICE is recognised as being absolutely at the leading edge in trying to engage the public in these decisions. Nevertheless, we are in the foothills of understanding exactly what people want. My feeling is that NICE would be quite open-of course you will be able to ask the people involved very soon-to different criteria for making systematic rational decisions and guidance across the system. However, whenever one tries to introduce additional criteria such as, for example, a higher value for the end of life, for children and so on, you begin to see the political conflicts between all the stakeholder groups as to who gains and who loses.
In the end, NICE is a referee between these conflicting forces of the corporate sector, patient groups and other interested parties and taxpayers, among many others. I think that costeffectiveness has been very robust in answering the concerns of those groups. My own personal view would be that you would depart from costeffectiveness at your peril unless you felt there was really strong evidence for doing so. It would be a very good area for the National Institute for Health Research and other research-funding bodies to explore more strongly.
Q83 Dr Wollaston: On the issue of costeffectiveness, how important do the panel feel it is that the information on which they base those decisions should be in the public domain so that others can look at the work of NICE and make a judgment?
Professor Littlejohns: I think it is absolutely crucial that all of the information on which the deliberations are made is made public. Because those final decisions are often difficult and controversial, the assumptions that go into the interpretation of that evidence also have to be part of that process. That will be a challenge. NICE has attempted to do that over the years, but I think there will be an expectation from patients and the public that the clinical commissioning groups address that issue in exactly the same way.
Q84 Dr Wollaston: Yes. I think there has been some controversy, hasn’t there, about the amount of clinical study reports that are put in the public domain?
Professor Littlejohns: Yes.
Q85 Dr Wollaston: Certainly, I understand that about 60% of the data-the patient levels from stage III trials on Tamiflu, for example-still have not been given to NICE. Do you think NICE could take a more muscular approach as, say, IQWiG has in Germany in insisting that that data is available so that they and the public can make a judgment about costeffectiveness?
Professor Littlejohns: I should respond on behalf of myself as a researcher as opposed to NICE. As a researcher, all information should be freely available for deliberation. Not only is the onus on the commissioner of that research but the researchers themselves. I don’t think any research should be undertaken unless there is full agreement that all information, be it negative or not, is fully available.
Q86 Dr Wollaston: That should be implemented throughout the system, from the level of researcher right through to organisations like NICE, who are making decisions about costeffectiveness.
Professor Littlejohns: Yes.
Q87 Dr Wollaston: Thank you for clarifying that. Can I turn to another area that has interested this Committee, and that is about integration between health and social care? How effective do you think NICE can be in driving real integration, which has been such a difficult goal to achieve?
Professor Weale: I am going to have to be anecdotal at this point, I am afraid. As someone who has spent a reasonable amount of time in recent years visiting elderly relatives in hospital, the Dr Foster report did not come as any surprise to me this week. I have thought about this a lot. It is clearly true, in some sense, that we could get better integration between community services and hospital services. It is not good for elderly people who are recovering from a fall, or whatever, to be stuck in a hospital ward for a long time because there is no care into which they can be discharged. There are very wellknown problems across all countries, not just the UK, about how to implement integration across organisational boundaries. Those are very familiar issues.
The only thing that I would say is that the challenge of integrating healthcare and social care is going to be, so to speak, a challenge of evidence and the research skills required to be able to interpret that evidence as to how we get better coordination across social care organisations and healthcare organisations, because it is a different sort of problem from assessing the costeffectiveness of the pharmaceutical intervention, for example. I think probably Professor Smith knows more about this than I do. There are some interesting results coming out from the personal care budgets, but I think one has to be very careful about making an inference from trials as to what it would be like when implemented in practice. There is a lot of work to be done on it.
Q88 Dr Wollaston: Do you not think it is primarily about NICE assessing the evidence for whether integration works rather than recommending that there are pathways that could drive it?
Professor Weale: It is a challenge in itself to be able to identify what works.
Q89 Chair: Could I ask Professor Littlejohns and then Professor Smith to answer in conclusion on this and anything else you would like to add?
Professor Littlejohns: What you have raised is the issue around the evidence base. Where the evidence is around the clinical pathway, including the social care components, NICE has a very strong role to play. One of the difficulties, though, with integration is the interface historically between the primary and secondary care sectors within the health arena, and of course now with the social care environment and a whole new mechanism around local authorities. We need to develop the evidence base around what is working at that interface. NICE can only work if the evidence is there. It can bring the stakeholders together to get a consensus view, but, at the end of the day, it is a consensus. I think there is a requirement-very quickly actually-for the research commissioners on the social and the healthcare sides to encourage the natural experiments that are taking place all over the country in terms of new ways of reworking, to gather that information and make it freely available. The difficulty is that, if it sort of works, then it will get publicised. If it doesn’t work, then you don’t get that evidence. It is very important to get the evidence of where things don’t work.
Professor Smith: Integration is a critically important issue. The fundamental reforms that are needed in that area as a starting point are to reform the financing system so that the payment for people with integrated needs is made on a more integrated basis and also then the information base on which we can assess whether a good job has been done. This is where maybe one would want to move more towards measuring outcomes rather than the processes.
I say that for two reasons. One is that we do not know which processes are especially good for integrating care, and the second is that individuals, as the individual budget experiments have shown, have different priorities as to what should constitute their treatment. One would look more towards seeing the outcome of these packages of integrated care, what they have delivered, rather than the actual processes that have gone on. The role of NICE in that, I would suggest, would be to collect and assess evidence and, in particular, to integrate cost evidence into the effectiveness evidence, which is the usual type of evidence that is produced in this area. But I am not sure that the prescription of particular guidelines and standards is very well suited to integrated care.
Chair: At that point, we need to say thank you very much for joining us this morning. You have given us some food for thought and we need to move on. Thank you very much.
Examination of Witnesses
Witnesses: Sir Michael Rawlins, Chair, and Sir Andrew Dillon, Chief Executive, National Institute for Health and Clinical Excellence (NICE), gave evidence.
Q90 Chair: Good morning to you both. Since the purpose of this inquiry is to prepare our thoughts, in particular, for doing a preappointment hearing on a successor to Sir Michael when the Government makes a nomination, I don’t think I need to ask you to introduce yourselves. It is very clear to us who you are; you are very welcome.
I would like, if I may, to begin with a very specific question about the health technology appraisal process and to ask whether, within NICE, you monitor the extent to which approvals are taken up around the Health Service and whether there are any policies or levers available to you if you are concerned about what you find if you do.
Sir Michael Rawlins: We do not really have the resources to try and monitor it. The Information Centre is trying to do it and it has produced a report, although it admits that its report is experimental. But we do know-and I know from anecdotes-that, although there is a legal requirement for trusts to provide interventions that have had a positive NICE technology appraisal programme, it is observed in the breach and all sorts of tricks are played by trusts to avoid having to meet this legal obligation. When I have been asked by organisations how they can persuade a trust to change their mind, I have always said, "Threaten judicial review." That usually gets an immediate response. So there has never been a case brought to court, which is rather unfortunate.
Q91 Chair: Can I ask what your understanding of the law is? Is it the law that, once you have approved something on a health technology appraisal, the trust has an obligation to ensure that it is used in all circumstances defined in the guidance or does the law provide that if a patient asks for a particular treatment the trust is under an obligation to provide it?
Sir Michael Rawlins: If the clinician responsible believes it is in the interests of the patient and the patient agrees too, then there is a legal obligation. There is a funding direction, there is the NHS Constitution, and in the response to the Future Forums report the Government said, in relationship to valuebased pricing, "This means patients will continue to have the legal right to clinically appropriate costeffective drugs and treatments as set out in the NHS Constitution." It is pretty clear.
Q92 Chair: You don’t think this is a flaw in the law; this is a flaw in the application of the law.
Sir Michael Rawlins: No-I just wish somebody would go to judicial review, but all attempts have been at naught.
Chair: It is a fairly straightforward answer. Thank you very much.
Q93 Dr Wollaston: NICE has an international reputation for its rigour and its work in costeffectiveness, except perhaps in one area, and that is the area of transparency of drugs trial data. I have had sight of a letter that has been written to you and I wonder, Sir Michael, whether or not before you leave NICE you would be able to make a commitment that NICE will insist on not only seeing all the clinical study reports but putting them in the public domain so that people can make a clear judgment about the evidence base and be confident in it.
Sir Michael Rawlins: Yes. We do, in so far as is humanly possible, try and ensure that the evidence that underpins our guidance is in the public domain. All our guidance is usually backed by hundreds of pages of evidence reviews, the guidelines, the technology appraisals and so on. We assume that companies give us all the data they have; we assume they do. We have some reassurance because the European Medicines Agency indicate all the clinical trials that have been submitted to them. We can check with the EPARs-the European Public Assessment Reports-as to whether we have received all the information. But if a company conceals it from us we may not know it exists. I had this experience in another world when I was chairman of the Committee on Safety of Medicines, when Mr Dorrell was my Secretary of State, and companies did conceal information sometimes. The problem was that the British component of it didn’t know the existence of the data, so there was nobody that could be taken to court because we don’t have jurisdiction in the United States, Germany or Switzerland.
Q94 Dr Wollaston: Except, of course, you do have some levers, because you could refuse to say that it was a costeffective treatment if you couldn’t do it, and in fact lately you have done that.
Sir Michael Rawlins: I am not sure, to be honest, whether we would ever have the resources to do individual patient metaanalyses on every single thing we looked at. It is a big task to do that. What we do want to know is the summary statistics, the summary findings, the details of how the study was done and so on and so forth. For our purposes, looking particularly at the new products, necessarily always requiring individual patient data might be over the top.
Q95 Dr Wollaston: No, but there are other organisations, such as, for example, the Cochrane Collaboration, which is very concerned, just to take the example of Tamiflu, for which the NHS paid half a billion on NICE’s recommendation-
Sir Michael Rawlins: Yes.
Dr Wollaston: -that around 60% of the level III data is still not in the public domain.
Sir Michael Rawlins: Yes. I think that is a separate issue. Allegedly, they have not published a lot of the clinical trials or put them in the public domain. That is a bit of a different thing from the individual patient data.
Q96 Dr Wollaston: But the point is that when you are trying to make an assessment of the costeffectiveness of a drug, if you do not have access to everything-
Sir Michael Rawlins: Absolutely.
Dr Wollaston: -clearly there is real concern that a lot of these treatments that are being recommended-
Sir Michael Rawlins: I completely agree. We don’t really have a disagreement about this. I was a member of a Royal Society group that produced a report about six months ago wishing to see the publication of all scientific data irrespective, and we were not just talking about medicine; we were talking about tectonic plates moving the Antarctic and so on and so forth.
Q97 Dr Wollaston: Indeed, but there are organisations-for example, IQWiG in Germany-that take a much more muscular approach, don’t they, in that they refuse to say-
Sir Michael Rawlins: I would contest that. They don’t do individual patient metaanalyses all the time. It is a huge undertaking to do an individual patient metaanalysis.
Q98 Dr Wollaston: No, but there are other bodies that would want to undertake those metaanalyses and, therefore, you could come back and revisit the evidence.
Sir Michael Rawlins: Sure; the Cochrane do a great job and we use them extensively for all sorts of purposes, but they rarely do an individual patient metaanalysis. This is a metaanalysis based on the summary statistics.
Q99 Dr Wollaston: But they want to see the clinical study reports in the public domain, don’t they?
Sir Michael Rawlins: Sure, yes.
Dr Wollaston: That is what they are asking for.
Sir Michael Rawlins: Yes, that is what they are asking for, particularly in relationship to Tamiflu, as I understand it.
Q100 Dr Wollaston: Indeed. But would it not be possible for NICE to take an approach such as has been taken in Germany where they are refusing to give approval? You have various levers that you could help to apply to force pharmaceutical companies to behave ethically.
Sir Michael Rawlins: Certainly, I think I am right in saying that, if we had evidence that a company had concealed reports from us, we would refuse to appraise it until such time as we had got the full data-of course.
Q101 Dr Wollaston: For example, where you have evidence that Roche is still continuing to withhold data, could you not revisit that and use the powers and levers that you would have as an organisation to push Roche into behaving ethically?
Sir Michael Rawlins: We will have to look back, because it was some time ago that we did this, to see what information we were basing our conclusions on. We would need to go back over that.
Q102 Dr Wollaston: You would make a commitment to revisit that.
Sir Michael Rawlins: I have got to reply to Fiona Godlee’s letter by next week.
Dr Wollaston: Thank you. I know we don’t want to spend too long on this.
Q103 Chair: Can I ask a similar question to the one about health technology appraisals, about what the law is governing companies that have scientific data available to them about the effectiveness of their drugs that they don’t make public? Are they, in your understanding of the law, under an obligation to publish that material?
Sir Michael Rawlins: No, they are not under a legal obligation to publish that material. More importantly, they are not under a legal obligation to publish negative results. That is critically important. When things don’t work we need to know, and those are not necessarily published.
Q104 Chair: If something does not work and is not on the market, I suppose that is a matter for the-
Sir Michael Rawlins: The classic example is with the antidepressants in children, where we were trying to do a guideline and the guideline developers wrote round to all the manufacturers of these antidepressants saying, "Do you have studies in children?" Some of the manufacturers refused to reply. One or two manufacturers lied and said they had not done studies when it turned out afterwards that they had. Some manufacturers said, "Yes, and here are the results." We would have been in a terrible mess in that guideline had it not been for the fact that the MHRA was doing a study of this problem and published all the results online of all the studies. It was hugely important to us, otherwise we would have done terrible things with our guideline.
Q105 Chair: That was where I was going, with the MHRA as the regulator. If a product is on the market, is it a condition of an MHRA licence that all information, including negative information, is published as a condition of that licence, and, if it is not, should it be?
Sir Michael Rawlins: No. It would be wonderful if it was, but there are difficulties in the sense that most of these companies are multinational. A law can only be made, in my understanding-I am sitting among legislators, but it is difficult to legislate for America-
Q106 Chair: It is very clear where our limits run.
Sir Michael Rawlins: I think there might need to be other approaches. For example, if ethics approval globally, in the western world, refused to give ethics approval to any investigator who had done a study and not published the results at least a year later, after the end of the study, that would concentrate minds hugely, both in the industry and among my academic colleagues. My academic colleagues aren’t innocent in this either.
Q107 Chair: There are two separate lines of inquiry here, aren’t there? One is the law, where it is absolutely right that our writ stops at the English channel, but, equally, licences are issued for products to be sold in the UK and there can be conditions attached to those licences and applied in law.
Sir Michael Rawlins: There can be, yes.
Q108 Chair: That is one route. The other route is the professional obligation route-the ethical obligation route.
Sir Michael Rawlins: Yes. Part of the difficulty also is that most licences for new drugs are issued by the European Commission, and I am not sure about the Criminal Code and the European Commission.
Q109 Dr Wollaston: But I think there is also, surely, a point that, as an organisation, doctors are relying on your advice to make decisions. When I was prescribing medicines, I was relying on the advice I was getting from NICE, and what you are saying is that you are basing that advice on a sometimes absent data set. Could you not be more-
Sir Michael Rawlins: I don’t think it is fair to say that. We are, broadly speaking, basing our advice on the same information that has been provided to the regulatory authorities.
Q110 Dr Wollaston: Yes, but do you think there is any way in which NICE could take a more muscular approach in insisting that drug companies hand over their data in order to-
Sir Michael Rawlins: You are asking really difficult questions now. My chief executive-
Q111 Dr Wollaston: Are there any more levers that NICE could apply to persuade drug companies to behave in a more ethical fashion by making a clear statement that you expect them to hand over and put in the public domain all the evidence so that you can issue correct guidance to clinicians?
Sir Andrew Dillon: I suppose, as Mike has indicated, there is the legal route, the limitations of which we have just been rehearsing. I guess the alternative is to say that we are not going to issue advice, but to do that we would have to balance off the disadvantages to patients of not saying anything, with all the potential consequences of variability in the availability of a product, with the potential benefits of flushing out data that we think the company may not have provided us with. But that is the point. We would have to have a pretty good reason for believing that a company had not given us all the information.
That is the problem. We don’t know what we don’t know. We get the medical directors of pharmaceutical companies to sign a statement that indicates, to their knowledge, that they have supplied all the data that is relevant to the appraisal that we are undertaking. Once we have that, it is then very difficult for us to be able to make a judgment that that may not be the case. Clearly, if there is some indication from elsewhere that there is data that the company is not making available, then we already pursue the companies. We pursue it anyway. That is something that we would do as part of the normal course of the appraisal. In the end, if there was something that was absolutely fundamental to a robust and credible set of recommendations being formulated, based on data that was not being released that we had reasonable confidence existed, then we could halt the process until that data was made available and we could make the reason for halting the appraisal public.
Q112 Rosie Cooper: The Chairman has explored with you the legal parameters about full declaration, but, Sir Michael, you said that you assume you have all the data and information available. My very simple question is, do you actually require them to give you all the information? Do you ask them, "Do we have all the information?", to which they say yes or no? Therefore, it is a lie or they are telling you the truth.
Sir Michael Rawlins: The medical director.
Sir Andrew Dillon: Yes. When we invite companies to make a submission, we have a standard pro forma for them to do that. The pro forma requires companies to submit all the studies that they are aware of, not just those that have been published. In a sense, they are preparing the basic evidence base for us. So they must both identify those studies that are in the public domain that we would know about anyway and anything that they have that is not in the public domain.
Q113 Rosie Cooper: What action do you take when a pharmaceutical company knowingly has lied to you? Is there any sanction? Is there any way of dealing with that company? If not, that just encourages them to carry on that behaviour.
Sir Michael Rawlins: I don’t think we have ever had an instance where a medical director has lied to us, but if they did, we would take exactly the same action as we took when I was Chairman of the Committee on Safety of Medicines. We reported the doctor to the General Medical Council and he was struck off. That has been a huge lesson for medical directors of pharmaceutical companies.
Q114 Rosie Cooper: That means a nonmedical director would sign whatever it is that is coming to you, and they will find a way. What action is within your gift to try and influence the behaviour of pharmacy companies to make sure they tell you the truth? Unless there is a sanction, they will carry on doing whatever it is they are doing, and if you are already asking a direct question to which you find that they have told an untruth, there are serious questions there.
Dr Wollaston: It is very important. There are 123 trials of Tamiflu that remain unpublished, which is about 60% of patient data. That is shocking, isn’t it?
Sir Michael Rawlins: Yes. It should be in the public domain. I will be responding to the letter that you are referring to from Fiona Godlee.
Q115 Chair: There are two things being muddled up here. One is the specifics of the argument about Tamiflu and the other is Rosie’s question. I think I heard Sir Andrew say that the submission has to be signed by the medical director, who is a registered practitioner.
Sir Michael Rawlins: Yes.
Q116 Rosie Cooper: My apologies; thank you, Chairman. In that case I did miss that. Now that we are not mixing it up, in the case of Roche and Tamiflu or whoever it is, we will look forward to the medical director having to answer for whatever information he did or did not give you. Is that right?
Sir Michael Rawlins: It is much more complicated than that, because the medical director may not have known of the existence of some of these studies. This is the problem. That has happened to me in the past where the British company has been unaware of data that the American headquarters knew of. This is the real difficulty.
Chair: I think we are unlikely to get to the bottom of the Tamiflu issue in this hearing, if I may say so.
Q117 Rosie Cooper: Absolutely, but I would like to ask Sir Michael what he can suggest that would make pharmaceutical companies behave in the interests of transparency and their patients, and not in the interests of their profits. With Tamiflu we have been ripped off good style.
Sir Michael Rawlins: One needs to place considerable responsibility on the medical director and, in some senses, we have to trust him or her to act professionally and responsibly. I don’t know how one can produce a law that will resolve the problem. That is why I have been thinking about going down the routes of ethics committees, publication ethics, and those sorts of things, "You won’t get your paper published unless", and so on and so forth. It is going to be those sorts of routes, I think, rather than a legislative one.
Q118 Rosie Cooper: I was just going to say, in a business world, not in a clinical world-so I do understand that what I am about to say is very difficult-I would probably penalise that pharmaceutical company and not look at any of their stuff for a year. They would soon start to behave.
Sir Michael Rawlins: Yes, but in the process, of course, you might well damage patients.
Rosie Cooper: I understand that.
Sir Michael Rawlins: Because you are cross with Roche, you might refuse to look at Herceptin for women with breast cancer.
Rosie Cooper: That is why I said, "In a business world, not in a clinical world." It is really difficult.
Chair: The real problem, Rosie, is not what you do about it when you have found out that somebody has transgressed, but how you find out about the transgression.
Rosie Cooper: Yes.
Chair: Can I suggest we move on, otherwise we are going to spend all morning talking about it? There is one final question from Sarah on this.
Q119 Dr Wollaston: There is no doubt that there are other parts of the system that also need to respond to this, but surely NICE does have some role to play in this. We have seen, for example, in Germany, when IQWiG went back and insisted that they saw all the data on Reboxetine, that they were able to persuade the company to produce that data. So there are examples in other countries where organisations in an equivalent position have used levers.
Sir Michael Rawlins: Yes, and what we tend to rely on-and Andrew will correct me because he is closer to the details-is the European Medicines Agency’s report, which lists the clinical trials that they have looked at. Beyond that, I am in difficulties.
Q120 Dr Wollaston: But once it has been drawn to your attention that there is missing data, you have enormous levers. Again, that is what IQWiG did. They went back, revisited it and said, "Unless you show us the data that we now believe is missing, we will withdraw our support for your product." Do you think that is something that NICE could in future commit to doing?
Sir Andrew Dillon: We should applaud IQWiG for its persistence in securing data that it believed existed and that it did not have available to it. But we have done over 250 technology appraisals now. That is hundreds and hundreds of drugs, with engagement with pharmaceutical companies over nearly 15 years. In many cases, our dialogue with the company continues beyond the point at which the initial submission is put in. That initial submission, of course, is sent to an independent academic team to review, and at various stages in the process it can become apparent that there is more information that might be available. We are continuously talking to companies. We do not necessarily present that as being, "Clearly, somebody didn’t do what they should have done originally", and that is why we are having to go back. So we do go back to companies. The IQWiG example is an interesting one, but it is not an indication that we are not doing as much as we can within the current arrangements to pursue companies for the data that we need to make the decision.
Q121 Dr Wollaston: So you don’t think you have any levers where you could go back and force companies to behave ethically.
Sir Andrew Dillon: That is a very big statement-to "force companies to behave ethically". The job we need to do is to make sure that we have enough information to safely make a recommendation to prescribers in the interests of patients.
Q122 Dr Wollaston: Do you feel in the specific example of Tamiflu that you are confident that you have enough data to make the statements that-
Sir Andrew Dillon: We were confident at the time that we had enough information to make a recommendation. If it turns out that the data that is not published is likely to have a material effect on the recommendations-in other words, the data suggests that the original recommendations were unsound-then we would review the recommendation. But it may well be that the data does not do that. It may well be that it simply supports the recommendation that we had. That is not an argument for the company not publishing it in the first place. It is just a bit of information about how we would treat new information when it becomes available. That is what we do with everything. The evidence base for virtually everything that NICE has looked at matures almost from the day on which the recommendation goes out. So we are constantly testing it to make sure that it is up to date. We would do the same thing with Tamiflu.
Chair: I said one more question and we have had three. We will move on to Rosie, who was going to ask some questions about the patient voice.
Q123 Rosie Cooper: Thank you. How much weight is given to patients’ views when NICE is making assessments of treatments? The Committee has heard criticism that the role of patients in the appraisal process is not properly defined. I wonder whether you agree with that, and, if you do or not, do you have any plans to improve the ways in which patients and those who represent them are involved in those appraisals?
Sir Andrew Dillon: I don’t agree that it is not properly defined. It is very clearly set out in all of the programmes that NICE runs to produce guidance for the NHS, in the process documents and in the advice that we designed specifically for the patient organisations that we work with. The same is true in our public health guidance when we are working with a broader range of public advocates.
It is almost certainly the case that the experience of engaging with NICE by individuals who might sit on our advisory bodies, or by organisations that work with us across more than one piece of work, is not necessarily always as good as they would want. That is partly influenced sometimes by the nature of the outcome, but it is also influenced by the challenge of individuals, and indeed organisations sometimes with very substantial resources, engaging with what is, I quite understand, in some circumstances a complex and quite an intimidating process.
That is why, almost from the first year that NICE was established, we put in place a team that now has more than 10 people specifically to support the engagements that patient organisations and individuals have, either as witnesses or expert witnesses, at advisory committees or as members of committees. I am sure there is more that we can do. We don’t have a monopoly of wisdom on it. You heard Peter West say that we have an international reputation for working out ways in which we can ensure that the voices of those who are ultimately the beneficiaries of the guidance that we are producing can be heard in the development of the recommendations.
I doubt we always get it right. We are always looking for ways to improve it. The sorts of suggestions that Laura Weir of the Patients Involved in NICE group made in her evidence, for example, that we might do a review looking back over the almost 15 years that we have been doing this, to tease out lessons that we might not be applying completely consistently, would be a good thing to do. We talk to the PIN group all the time about ways in which we can improve their engagements, but we are very willing to do more, if we can, within the resources that we have available to change our processes where engagement is not clear or is not adequate and to do our best to support individuals when they work with us.
Sir Michael Rawlins: Can I add that it is important to remember that within our guideline programme we always have two patients-or service users, as they prefer to be called-as full members of the guideline development group? They play a critical role, and we provide them with training, because it is pretty intimidating if you are a patient to be surrounded by a dozen professors of psychiatry, or whatever-there is nothing wrong with psychiatrists. When we started doing this, we were accused of just being politically correct, but now everybody accepts that these volunteers make a real and important contribution to what we are doing in making sure the guideline meets patients’ needs as well as professionals.
Q124 Rosie Cooper: Sir Michael, would that be patients with particular conditions or would it be lay opinion from a healthy professional?
Sir Michael Rawlins: No. When it is the guidelines, it is people with the particular condition. The first guideline we ever did was on schizophrenia, and we had two people who had schizophrenia in remission as full members of the guideline.
Q125 Chair: Could I move on? There is a phrase that is much in discussion in the pharmaceutical world at the moment-valuebased pricing. I wonder if you had any clearer understanding than the rest of the world as to what the phrase means.
Sir Michael Rawlins: Shall I start? I have my own views, but I am not quite sure what is going to come out. In the past we have looked at costeffectiveness in relationship to the incremental costeffectiveness ratio-the increased amount of money you get in terms of the increased numbers of quality adjusted life years gained. We have had a threshold, but we have always encouraged our advisory committees to be flexible about the use of the threshold, and there may be circumstances when they feel they ought to be giving a positive recommendation even when things are above our threshold range. Endoflife care is an example.
This has all been subjective and it has not been objective. Maybe you could reasonably criticise us for not having tried to create an objective approach rather than a subjective approach, but I think part of valuebased pricing is to produce some objectivity into it. One would weight the QALY. One might weight double the value of the QALY for endoflife treatments, for example. That is one component to it and that is how I see valuebased pricing at that end.
The second component is what they call the economic perspective. When we are looking at costs and benefits, we look at it for the health service. That is because you, Parliament, in your statutory instruments, told us we could only look at the health service but we did include the personal social services. I hope you don’t mind, but that seemed sensible. There could be a case for going wider. One could take into account the benefits to carers more or time off work or unemployment. The perspective can be very wide. I am agnostic about this whole perspective business, because there are difficulties about how far you will want to go and when you have a lot of unemployment what is the sense of compensating that in a macro scale. So I am more neutral about the perspective. Is that any help to you?
Q126 Chair: I think it is actually. It is the most focused description of the difference between normal marketbased pricing and valuebased pricing that I have heard. I think what you are saying is that it is an opportunity to operate a different value tariff for the QALY.
Sir Michael Rawlins: Yes.
Chair: It is a more flexible value tariff for the QALY, fundamentally.
Sir Michael Rawlins: Yes, I think that is right, plus what sort of perspective Parliament wishes us to adopt.
Q127 Chair: Yes; that is where you move from science to art, I suspect. Then the question is, once having determined that you might operate more than one tariff for a QALY, whether that is only to apply to new drugs or to all drugs in the formulary.
Sir Michael Rawlins: My understanding is the intention is that it applies to new drugs only. That is right.
Q128 Chair: Presumably, if that argument applies only to new drugs, there will be a large number of people coming back to you asking you to revisit your opinions about existing drugs based on this new approach.
Sir Michael Rawlins: My understanding is that it would be unlikely for Ministers to refer such issues to us; otherwise we would be in continuous session.
Q129 Valerie Vaz: So the routine system is going to be operating then.
Sir Michael Rawlins: It is intended for the new system to operate in 2014 and all previous decisions will remain unless somebody thinks there is some very special reason to revisit it.
Chair: Does anybody else want to come in on that? If not, we go to Valerie.
Q130 Valerie Vaz: I am going to move on to the Cancer Drugs Fund. It will come to an end in 2014. It appeared to undermine all the good work that NICE was doing. Could I have your view on how it operated?
Sir Michael Rawlins: You are better on the Cancer Drugs Fund than me.
Chair: You might be freer, I suppose.
Sir Andrew Dillon: I don’t know an enormous amount about how it is operated. I know there is variability in the decisions that have been taken within the regions that have been established, which get a share of the total amount of money and can independently assess and make decisions on the requests that are made against them. It has always seemed to me that it is entirely within the Government’s responsibility and authority to choose to allocate resources to particular priorities, as Governments have done over the years that the NHS has been in operation, in circumstances where they think that that is appropriate.
The effect, I guess, of the Cancer Drugs Fund is that it has expanded the amount of money that the NHS has available to fund the exceptional treatment decisions that it makes all the time, both in relation to NICE guidance and circumstances where individual patients present and there is an argument put forward by the attending physician for access to a treatment that is not, on a straight reading of NICE guidance, indicated for that patient, and in other circumstances where, as a result of the local decision making, for some reason, particular treatments are not routinely made available. The Cancer Drugs Fund has expanded that and more patients are likely to have had access, through those exceptional treatment decisions, to treatments that either NICE has not actually made a recommendation on, either because we are still in the process of doing it or because it is not something that we have looked at anyway, or where we have made a recommendation but there is a strong case, in the view of the patient and their attending physician, to get access to the drug.
As to whether it undermines NICE, I don’t know. I suspect we would have to look systematically at the end of it to see where and on what basis the decisions were made and, in fact, ask, "Is this an indication of the full extent of the population of people for whom exceptional treatment decisions were made or does the cumulative effect of all the decisions made across all the regions in using that money add up to confounding the original recommendation from NICE?" But I don’t have access to that information.
Q131 Valerie Vaz: Is someone going to be monitoring the effectiveness of these drugs?
Sir Andrew Dillon: Did you say the effectiveness of the drugs?
Valerie Vaz: Yes.
Sir Andrew Dillon: Somebody will certainly be monitoring the impact for individual patients, yes.
Q132 Valerie Vaz: Is that not something that you would do?
Sir Andrew Dillon: No, it is not something that we have been asked to do or that would be appropriate for NICE to do. We are not resourced to conduct studies of that kind. I would imagine the Department of Health does want to know what the cumulative effect of the application of the Cancer Drugs Fund is, but NICE is not directly involved in that assessment.
Q133 Valerie Vaz: I think we heard evidence last week-I read-that it is not actually new money. It was money that was reallocated from different parts of the NHS. It was not actually new money that was coming through.
Sir Andrew Dillon: I don’t know where the money came from. There is never really any new money. It is only the money that is just there that would otherwise be allocated in some other way. But, clearly, yes the fact that that money was taken out for a period of time means that it is not available for the Department of Health to apply to other clinical priorities.
Q134 Valerie Vaz: Do you think it should continue beyond 2014?
Sir Andrew Dillon: Again, in a way it is not for NICE to tell the Government how to allocate their resources.
Q135 Valerie Vaz: But you have to look at costeffectiveness, don’t you?
Sir Andrew Dillon: Yes, we do, and in a way the Cancer Drugs Fund, in a sense, can only operate because the exceptional treatment decisions are being baselined against the guidance that NICE has produced. They can only be, in a sense, exceptional because they are beyond the ordinary, which might be characterised by the recommendation that we have made for that treatment. But I really think it is a matter for the Government and not for NICE to decide whether or not they continue it and what for.
Sir Michael Rawlins: Can I come in, because I won’t be around when all that happens? My understanding from the chair of one of the regional committees is that a lot of the money is spent on drugs that have not yet been appraised by NICE or are going to be used offlabel, offlicence, for another, nonlicensed indication. Frankly, I don’t think valuebased pricing will help resolve that either way. I also have to say-and here I go AWOL-that there are other rotten diseases apart from cancer. To limit it to cancer has always made me a bit uncomfortable, to be honest.
Q136 Andrew George: The last offpiste, as it were, response partly answers my question. Sir Andrew, when you were answering, you gave-how can I put it?-a minimalist, descriptive and slightly disdainful, in my view, perambulation around the Government’s decision to redirect the money in this way to one particular silo of pharmaceutical purchase. You may disagree with that or bridle at the use of the word "disdainful", but irrespective of that, it seems to me that there is a body of evidence coming through as to whether this was a wise decision or not and justified or not, for which NICE should be keeping a watching eye, a monitoring brief, and gathering the evidence from this spend in appraising both the effectiveness and the financial effectiveness of those decisions. I am rather dismayed that you are not monitoring it more closely than you seem to be.
Sir Andrew Dillon: I am sorry if I came across as disdainful. I in no way meant to criticise the Government because-
Andrew George: It was just the impression I got.
Sir Andrew Dillon: -genuinely, I think it is entirely a matter for Government to choose how to allocate resources. It must do it on whatever basis it thinks is appropriate and then justify it and account for it, ultimately. You suggest that we should be doing this. As you heard earlier on, NICE has never been resourced systematically to assess the impact of the guidance that we produce, and we would have to have huge resources to do that now, given the size of the back catalogue for guidance that we have. There is a lot of information, much of which we do collate and make available through our evidence services, about the way the guidance has been produced. But that is rather different from a deliberate and systematic approach to assess the impact of every recommendation. I suspect there are not enough patients being treated through the Cancer Drugs Fund for any individual drug to tell us enough additional information about the effectiveness of those drugs to have a material impact on our underpinning recommendations.
Aside from the fact that any application of public funds should be accompanied by an assessment, particularly in these circumstances, it is very important just at the level of the confidence of individual prescribers, clinicians or oncologists, who are using the treatments that are available for them, to know what the cumulative effect of all their individual exceptional treatment decisions has been over the period of time that the Cancer Drugs Fund has been in place. I entirely support what you suggested-that a review should take place-but we have not been asked to do it. If we were, we would have to have the resources to do it because it is not something that we would routinely do, given the brief that we have.
Q137 Andrew George: Putting it another way, do you not think perhaps it would be appropriate for you to suggest to Government, since they are directing resources in this way, that both the cancer networks that will be overseeing this deployment and also the pharmaceutical companies that will be benefiting through the sales of their drugs should monitor and assess the effectiveness of those drugs and feed the information back to you? In other words, that does not involve you in deploying your resources, but I think it is a reasonable expectation, given the redirection of finances going in that way.
Sir Andrew Dillon: You have encouraged me to find out from the Department what their intentions are, and I will certainly do that.
Q138 Valerie Vaz: Part of what this Committee does is to find the gaps, and you tell us where we need to fill them. We all want the same outcome in the end. Don’t worry, I didn’t take it as-
Chair: Disdainfully or otherwise, Valerie.
Valerie Vaz: I did not take it as disdainful. I took it as someone who is in an organisation that is on the back foot and is a bit worried about what is happening in the future. But, obviously, Sir Michael is in a different situation.
Can I move to the quality standards now? Could you update the Committee on where we are on these 150 or 180 quality standards and when do we get to the end of it? We have heard that it is not going to be completed until 2019. Is that right?
Sir Andrew Dillon: By the end of this financial year-so by the end of next March-we will have published 30 quality standards. At the current level of resourcing for the programme, we will be publishing 35 quality standards each year into the future until we have completed the library. It is possible that we could increase that rate of production up to about 45, though we would need to have additional resources. But, once we get to that level, we meet a rate limiter, which I am not sure we can do very much about because it was always the intention that the quality standards would be based on NICE clinical guidelines. These standards in fact are a synthesis of our clinical guidelines. They contain sentinel markers of good practice, which indicate the areas where we are conscious that there is variability in the way in which the NHS is delivering services or there is very strong evidence pointing to developments that the NHS has not consistently taken up. So they are very important for practitioners; they are important for commissioners. They are also very important, and they were designed and are presented, as things that we can all use when we are engaging with the NHS too. So they are important. But we need to be confident that they are based on a carefully assessed evidence base. The best we think that is available is the work that we have done through our clinical guidelines.
We have published just over 150 clinical guidelines, but there is not a precise match between the guidelines that we have published and the list of quality standards that the Department of Health has given us. It is almost inevitable, because we have been going for so long, that the priorities for the NHS now, in quality standard topics, are not necessarily the same as the priorities 10 years ago for clinical guidelines. There are clinical guidelines that we have never published that we need to develop. There are enough clinical guidelines for us, over the next couple of years or so, to publish 45 a year, if we have the resources as planned. But that would be the maximum that we could do. By the end of the 201415 financial year we might have something over 100 quality standards in place, but then the rate at which we can develop the rest of the library is dependent on the availability of the new clinical guidelines that we will be publishing.
Q139 Valerie Vaz: So you are actually writing clinical guidelines, because there is written evidence from Patients First that you are not. You are still writing clinical guidelines.
Sir Andrew Dillon: Yes, absolutely. What we are doing now is re-orientating or redirecting the capacity of our clinical guidelines programme so that it is precisely aligned with the library of quality standards. These two things, ultimately, will sit together. There will be a quality standard underpinned by a NICE clinical guideline.
Q140 Valerie Vaz: So long as there is a quality standard and a synthesis of the clinical guidelines, there would still be commissioning on certain conditions, would there?
Sir Andrew Dillon: It depends on what you mean by that. It is certainly the case that the guidelines already inform commissioning in its current form through the PCTs, but we have heard that there is variability in the extent and the pace of application of the guidelines. In the future, the NHS Commissioning Board, as we know from the Act, is expected to have regard to the quality standards in the engagement that they will have with clinical commissioning groups. We don’t yet know precisely how that signal is going to be translated into the practical currency that is going to exist between the Commissioning Board and CCGs, and then CCGs and their providers. But it is clearly going to be significant. Therefore, the influence of the guideline, through the quality standard, will be felt in the contracting relationship that CCGs have with their providers.
Q141 Valerie Vaz: Where do you fit in in that conversation between the Commissioning Board and the CCGs? You must fit in that conversation, mustn’t you? You would be talking to the Commissioning Board.
Sir Andrew Dillon: We fit in because we are supplying what we think is clinical core material in the contracts that the Commissioning Board will have with CCGs and then in the contract that the clinical commissioning groups will have with their providers. We are separately and in parallel entirely consistently engaging directly with clinical commissioning groups, with the clinical support units that are going to provide the business services to CCGs and, of course, directly to providers, because that is where the guidance goes, including the quality standards. So, hopefully, there is a neat effective pincer movement.
Q142 Valerie Vaz: Would that be upwards to the Commissioning Board?
Sir Andrew Dillon: No. It would be through the system precisely to the point at which clinical decisions are being taken.
Q143 Valerie Vaz: You won’t be talking to them separately.
Sir Andrew Dillon: To whom, sorry?
Q144 Valerie Vaz: The NHS Commissioning Board.
Sir Andrew Dillon: Yes, of course-absolutely, yes. That is a fundamentally new relationship that we already have.
Q145 Valerie Vaz: Yes, I was asking where you fit in in the conversation. I was trying to work out where you are in this triangle of activity.
Sir Andrew Dillon: Yes. We have a dialogue directly with the Commissioning Board. That signal is the start point of the journey through the contracting and commissioning process, but we also have direct engagement with those who are designing and providing services locally.
Q146 Valerie Vaz: How will you ensure that the quality standards will be taken up throughout the NHS?
Sir Andrew Dillon: We don’t have the executive power to require the guidance to be applied. Mike earlier talked about the particular force around technology appraisals through the NHS Constitution and the funding direction. Everything else that comes out of NICE is guidance. We had to argue the case for doing so with those who need to engineer it into their daytoday professional and managerial practice. That is what we have been doing through our implementation of services since about 2004. We provide a lot of tools that lay out the clinical and the business case for the adoption of the guidance and we pursue that directly with providers from a national level and through a small field team that we have, who are able to engage directly locally with providers and commissioners.
Q147 Valerie Vaz: So you are able to monitor the takeup.
Sir Andrew Dillon: No, but, again, as we rehearsed earlier, that systematic detailed monitoring is beyond the resources that we have available at the moment. But we have a whole array of what you might describe as diagnostics that will put us in a position where we are confident that, first of all, people know the guidance is there when it is relevant to their particular practice and enough sampling to know that the guidance is being used in practice, though we don’t know in every case systematically precisely how it is all going to be used.
Q148 Chair: Can I explore the relationship between your clinical guidance and the professions? There seems to me to be a danger, particularly at a time when there is a lot of talk about integration and deconstruction in order to reconstruct the way clinical services are delivered, that clinical guidance will reflect one view of how care should be delivered to a particular group of patients and other people may have different ideas within the profession. I wondered how you dealt with that.
Sir Michael Rawlins: Our guidelines are what you might almost call joint productions between us and the Royal Colleges. The Royal College of GPs, the Royal College of Physicians and so on and so forth have been extremely supportive. Our guideline groups contain experts but they also contain generalists. It is quite important to have generalists-GPs, for example, classically, and I am not saying that because Sarah is here-because they can sometimes see the wood for the trees rather better.
Q149 Chair: You might even have a social worker, since we are talking about integration.
Sir Michael Rawlins: Relations are really very good. One of the ways in which the colleges have helped implement our guidelines is that they incorporate material from our guidelines into their exams, into the MRCGP, the MRCP and so on. The kids go through our guidelines assiduously in case they come up in the exam. It is absolutely wonderful really; you couldn’t win it. The only trouble is that they then go and tell their consultants how they ought to be managing their patients and sometimes the consultants get a bit irritated with us. Andrew has had his ear bent about that once or twice and I have as well, but juniors have always been teaching their consultants, so there is nothing new.
Q150 Chair: There are two serious points there, aren’t there? One is that practice needs to evolve and, indeed, guidance needs to evolve.
Sir Michael Rawlins: Yes.
Q151 Chair: Once you have issued your guidance, it is a process and not an event.
Sir Michael Rawlins: No, and we have to review it, otherwise people will lose confidence in it, quite apart from the fact that it is dated. If they see it has been issued six years ago, doctors or nurses will think, "It can’t be up to date." We do have a programme of renewal, revision and re-looking at it on a routine basis.
Q152 Chair: When Mike Farrar says that what we should have is a care system with a medical adjunct, first, do you agree with that, and, secondly, if you do, is your guidance an important instrument in the delivery of that change?
Sir Michael Rawlins: Yes. I am sure he is right, and most auxiliary care is provided by nurses, in both general practice and in hospitals.
Q153 Chair: But also in social care.
Sir Michael Rawlins: And in care, yes. So our guidance is not directed at a particular professional group, very deliberately, because circumstances will be different in different institutions. In some places nurses will be able to do it and in other places only doctors, and so on and so forth. We are keen on getting that sort of horizontal integration into the care system.
Q154 Chair: Do you have social care expertise in those groups?
Sir Michael Rawlins: We are just about to start doing social care guidelines. We have done two pilots, one on looked-after children and one on dementia. We are busy recruiting a collaborating centre to undertake our social care work.
Sir Andrew Dillon: Yes. All the social care guidance and quality standards that will go with them are developed by people who are in social care. We apply the same principle as when we are producing clinical practice guidance for the NHS.
Q155 Chair: But there is something wrong, is there not, about producing guidance for the care of dementia patients as medical care and social care as two separate groups of guidance?
Sir Michael Rawlins: We are hoping to link our guidelines up in many instances because the dysfunctional relationships between healthcare and social care have been desperately damaging for older people and children,
Sir Andrew Dillon: When we published our original guideline on dementia, the Social Care Institute for Excellence worked with us to produce parallel advice, which was integrated and cross-referenced.
Q156 Chair: Parallel and integrated, but not the same.
Sir Andrew Dillon: No. The advice that you would give to a general practitioner or to a physician in practice in a hospital for an acute episode is not going to be the same, though it ought to be complementary to the advice that you might give to somebody who is looking after someone in a residential home or in a domiciliary care setting. We want to make sure that the range of advice to everybody who has some responsibility for looking after people with dementia is consistent. It is a spectrum of advice, because the needs that we might have when we are living with dementia vary, depending on the setting that we are in. We are trying to get settingspecific guidance.
Q157 Chair: I have one further question prompted by this clinical guidance issue. Do you think there is a danger that in preparing clinical guidance, for example, for dementia patients, and then separate clinical guidance for diabetes patients, that you are reinforcing the habit of treating conditions rather than people?
Sir Andrew Dillon: Yes, there is a real risk of doing that. One of the great things about being given now, or from next April, the responsibility to produce quality standards and guidance in social care is that we have built and have access to a resource that allows us to scope individual topics-whether they come from a clinical guideline route or a social care referral route-in the most appropriate way for the people who are going to use them. In future, it will change the way in which we can look at topics. We are going to take advantage of that as we review existing clinical guidelines and re-scope them and as we put together the new topics specifically for social care.
Sir Michael Rawlins: Just to add to that, what you are hinting at is one of the flaws in our guidelines, which is that they are single conditions, and by the time people get to 80 they say, "I will have five simultaneously." We have to produce guidelines that accommodate that. Nobody in the world has ever done this, but we are going to do it. We can’t cover every possible combination, otherwise it would take years to produce a single guideline, but what we can do is provide advice on, say, the three or four most common comorbidities that occur in someone with heart failure, such as chronic bronchitis, which is very common, and so on. It will be that sort of approach. NICE is going to be evolutionary, I hope, in the future and can’t just rest on what it has done in the past.
Q158 Dr Wollaston: Our last panel of witnesses were talking about the lack of evidence base there was for integration and how, for that reason, they did not want to be too prescriptive. But there are some features-if you can base it around the patient’s experience-that give patients a better experience of care. Is that the kind of thing you are hoping to achieve in issuing joint health and social care guidance in future?
Sir Michael Rawlins: Yes, and I would not expect the evidence to be randomised controlled trials. There will be observational evidence and studies and so on, which are just as valid as randomised controlled trials. There will be areas, I am sure, where there isn’t any evidence-there is just expert view-but, hopefully, that will stimulate research in social care so that the next time we won’t be relying on the frailty of expert opinion.
Q159 Dr Wollaston: Yes, so you feel that NICE can have a role in saying where the gaps in evidence are and-
Sir Michael Rawlins: That is exactly what I hope.
Dr Wollaston: -making recommendations for what kind of social care, integrated healthcare and research is necessary.
Sir Michael Rawlins: Exactly.
Q160 Dr Wollaston: Thank you for that. One area that is of great concern to people who have rare conditions is the issue around orphan drugs. I was wondering whether you could incorporate the assessment of treatments for rare conditions currently done by a separate body into NICE.
Sir Michael Rawlins: Yes. NICE has been asked to take on responsibility for the very high-cost low-volume treatments where there are only a few hundred. They are expensive, unquestionably, because the development costs will be not that much different from a common disease, and we recognise that, if the manufacturer is going to recoup his development costs, he is going to have to charge more unit price. We did a pilot about six or seven years ago on Gaucher’s disease, because the same idea had come up, and we came to the conclusion that the conventional approach was not going to work in the sense that if one looked at the cost per quality adjusted life year gained we were talking about £200,000 or £300,000. On the other hand, when we asked members of the public in our Citizens Council whether we should make exceptions for people with very rare diseases, they said yes, that we should. But, they said-two caveats-it must make a real demonstrable difference and, "Make sure you don’t get ripped off by the drug company."
Dr Wollaston: Thank you for that.
Q161 Chair: This leads into another bigger subject, doesn’t it, which is personalised drugs and how practical is the model that you have developed over the last 15 years going to prove to be in the next 15 years as drug companies focus more on more personalised compounds?
Sir Michael Rawlins: Yes. I don’t think there is a problem in the sense of the diagnostic linkage between a particular diagnostic test indicating a particular drug. Herceptin is a classic example where you only give it to one third of people with breast cancer who have the particular receptor on the cell’s surface. The principle and the appraisal are not a problem in that sense.
There might be a problem, looking at the other end, because it is now possible or beginning to emerge to be possible to be able to predict from people’s genes whether they are going to get side effects to particular drugs, which is a very interesting development. There is a particular mutation that increases the liability for clotting on oral contraceptives, for example. The costeffectiveness of doing those individual tests, though, starts becoming eye-wateringly awful because, very often, these genetic mutations are relatively rare, so 100, 1,000 or 2,000 people would have to be screened in order to detect one person. My vision of the future is that we will all have an electronic medical record, which will have real-time decision support based on NICE guidance, and it will have our human genome scan in it. That is what it will be like in 20 years’ time, I am sure. I am sorry.
Q162 Chair: That is an interesting piece of future gazing, but the evolution, as I understand it, in pharmaceutical development-
Sir Michael Rawlins: It is diagnostic, yes.
Chair: -is to smaller doses because they more accurately target conditions.
Sir Michael Rawlins: Yes, it is to a smaller population. It is perfectly feasible. The only worry we sometimes have is how good the national health service is at the diagnostic test. I don’t think the NHS came out very well on the Herceptin test. So that is the worry that is always at the back of our minds.
Q163 Chair: But, bringing Sarah back, presumably, if accurate use of diagnosis tests becomes progressively more important, that is one of the things the health service has to get better at.
Sir Michael Rawlins: It does.
Q164 Dr Wollaston: One of the criticisms that is sometimes made is the use by pharmaceutical companies of funding patient groups to lobby for treatments. How much do you think that is an issue and a problem? We saw that, for example, with Herceptin.
Sir Michael Rawlins: Yes. It was a problem and I was very public in criticising patient organisations for doing it. There was a television programme about it. I think it has stopped. I can’t be certain, but I think it has stopped. We no longer have riots outside our premises in High Holborn organised by a PR company funded by a pharmaceutical company.
Q165 Dr Wollaston: Yes, so you are confident that that practice has stopped.
Sir Michael Rawlins: I think I have shamed them into it, yes.
Q166 Dr Wollaston: You are confident that we are no longer seeing pharmaceutical companies funding patient groups to lobby for treatments.
Sir Michael Rawlins: I think they do resource patient groups, but patient groups are now much more explicit about it and we require them, if they are giving evidence to us, to tell us if they are funded by companies. The covert funding, I think, has stopped. I think so.
Q167 Chair: Sir Michael, my last question is very much directed to you personally because NICE to a large extent-and this is without prejudice to Sir Andrew’s position-is seen in the world outside as very much your baby. It is seen very much also as having been a success of British policy making. I wonder where you think your baby should go next and what priorities should be at the front of your successor’s mind.
Sir Michael Rawlins: First of all, it is not my baby; it is a joint baby. The only good decision I ever made was appointing a chief executive, and he has stayed with me all the time so it shows how resilient he is. In terms of my successor, there are three things that he or she needs to do. There is the whole business of managing the board, developing strategy and making sure that the executives are challenged-those sorts of typical classic board things. I am sure that the Secretary of State will find somebody who can do that sort of bit.
The second is that the current things we do must evolve. They are not perfect. We must be continually prepared to accept good ideas and make up good reasons for doing things slightly differently.
Thirdly, my successor needs to make sure that NICE is attuned to the changed architecture in the national health service-the importance of commissioners. There is more we could do to help commissioners. For example, a few years ago we did, on a pilot basis, produce some commissioning guides, which, at the time, everyone said were very helpful because an individual PCT could plug in its own population and gender and all that sort of stuff and pull out the numbers of referrals for endoscopy that they ought to be commissioning for. I think probably NICE should return to that and develop, on the basis of those, some sort of clinical commissioning group standards. We have to move forward in that direction as well as sustain what we have been doing in the past.
Q168 Chair: Thank you very much. Does anybody want to ask anything else?
Valerie Vaz: I would just like to say thank you for the work that you have done. I am sorry you are retiring.
Sir Michael Rawlins: Thank you; so am I.
Chair: Thank you very much.