Select Committee on Health Minutes of Evidence

Examination of Witnesses (Questions 300 - 319)



  300. Can I take you on to the next question, which is the issue of selection of topics. Clearly one of the areas where there are suggestions that you are not independent is the fact that Ministers select the topics that you examine.
  (Professor Sir Michael Rawlins) Yes.

  301. Are you happy with that arrangement? Are there areas of selection that cause you problems or where you may have expressed concern to Ministers about the specific topics which are being proposed?
  (Professor Sir Michael Rawlins) Yes. I mean, I think the fact that the final decision rests with Ministers is inevitable in a service which is publicly funded, when NICE's conclusions could impose very considerable costs to the health service. I think those powers are appropriate in a publicly funded service. The proposals that go to Ministers are drawn up by a group that is called the Joint Planning Group, which is jointly chaired by myself and Andy McKean, a senior official in the Department, and we have a lot of input into the agenda setting process and to what goes forward. That has changed since NICE was first set up. When NICE was first set up, there was a Departmental committee that made these decisions and we had very little input into it. In response to remonstrations from us, the Department, the Government, changed the process to give us a much more robust say in what counts. Nevertheless, I think the process is still somewhat opaque and obscure. I think it could be more open and transparent, I think it could be more inclusive. As we say in our submission, I would like the health service generally to have an input into what we do because I think there are wonderful ideas out there that we probably have not thought of, where guidance is needed and would be extremely helpful. I also think that it should be pro-active. We will no doubt come on to this later, but we should be appraising new treatments, new technologies around the time they launch. We have had to do a catch-up programme up to now but we have got to overcome that catch-up period and become much more pro-active.

  302. Do you detect, in terms of your wish to have more say in the determination of topics, a willingness by the Government for a move further in this direction?
  (Professor Sir Michael Rawlins) I think so, yes. We have not had any suggestions that this is not an appropriate way forward. There is a draft consultation paper, I understand, coming out shortly. I do not know what the content is, but I understand it is coming out in the next week or two.

  303. That is on your procedures, is it?
  (Professor Sir Michael Rawlins) On the topic selection process.

  Chairman: I understand.

Sandra Gidley

  304. There have been a number of submissions that have raised questions about this. I am glad that you have said that it is opaque and obscure. I think it might be helpful to us if you could describe what sort of protocols you use to decide which drugs are going to be prioritised. And, once you have decided, have there then been ministerial decisions which have said, "No, we do not think this is appropriate, could we change it" and what the reason for that has been?
  (Mr Dillon) Essentially it is a three-stage process. The first stage is identification of a pool of potential topics that NICE might consider. Of course these topics stretch well beyond pharmaceuticals because the Institute looks at pretty much any intervention that the NHS might use in clinical practice. That pool is filled, essentially, from a number of sources, but primarily from work that is done by what is called the Horizon Scanning Centre at the University of Birmingham. The Department of Health and the National Assembly of Wales have a contract with the people at the University of Birmingham who do what the title of their unit suggests, which is to look for emerging technologies and to refer them to a committee, which is the second stage of the process, called the technologies Advisory Group. That group consists of people from the Department and the National Assembly of Wales and also people from the NHS, people from the NHS Research and Development Programme, and the Horizon Scanning Centre, sitting together with representatives of NICE, looking at the potential pool of technologies and selecting out those of particular significance. There are the criteria which are used to select technologies that were published by the Department of Health at the time NICE was established. The third stage is a final review of that topic list by the group which Professor Rawlins referred to, the Joint Planning Group, jointly chaired by Mike Rawlins and a senior official from the Department, a much smaller group with some representatives from the Department and the Assembly and some from NICE, which signs off, in effect, a final recommendation to the Minister. The Minister would consider the topics that have been put forward and make the final selection decision for publishing and for consultation.

  305. If we can go back to the beginning, the Horizon Scanning Centre, who is actually on that and how are they appointed?
  (Mr Dillon) Those are members of an academic department, so the arrangements for their appointment would be the responsibility of the appropriate academic department at the University of Birmingham. Although I do not know any details, there would be periodically a bidding process for the contract for Horizon Scanning. The Institute itself was not involved the first time round the contract was let, although we would be involved in the future, so I am not aware of the fine details of the contract specification, but the individuals, as academics, would be appointed through normal processes by the University of Birmingham.
  (Professor Sir Michael Rawlins) The Horizon Scanning unit is actually funded by the NHS R&D programme; it is not part of the virtual institute of NICE.

  306. Would there be ministerial input at that level or not?
  (Mr Dillon) No, I do not think so, not in terms of the Horizon Scanning Centre doing its work I am quite satisfied that they independently do the scanning work and then they present that information to the Department and the Assembly.


  307. Can I come back on the issue of independence. A number of witnesses have talked about conflicts of interest on the issue of independence of your body. You may have seen the evidence that Helen Marlow from Croydon Health Authority presented to the Committee, in which she talked about conflict of interest and went on to talk about the absence of a robust procedure for declarations of interest within NICE. Is this fair comment or not? Would you care to respond to the concern she has expressed?
  (Professor Sir Michael Rawlins) We do actually have a very clear code of practice that applies to members of all our advisory committees as well as the staff. (I think it is an annex in the evidence we submitted to you.) In essence this requires members of advisory committees to declare their interests annually, to declare them at the start of each agenda item, and these are minuted and published in our minutes on our web site. So I think we are actually pretty open about this and we take very seriously this whole question of conflict of interest.

  308. So you would refute very strongly any implication that some of your decisions may be influenced by interests within NICE.
  (Professor Sir Michael Rawlins) Very much so. As I said, we do publish all members' interests, and if they have a personal specific interest they take no part in the proceedings. I mean, they are not even present in the meeting.

John Austin

  309. There will be a number of interests which will want to seek to influence your processes. I think we would all agree that it is important that the voice of patients and patients' organisations is heard. It is suggested sometimes that some patient organisations may have a fairly cosy and perhaps not too healthy relationship with the pharmaceutical companies. I would like to ask: Do you seek to ensure any declaration from any patient organisations that are making representations?
  (Professor Sir Michael Rawlins) I should explain that I never go to the Appraisal Committee meetings because I have to remain independent to hear appeals. Mr Dillon will explain what happens.
  (Mr Dillon) The process that we have for inviting submissions from all stakeholders asks them to identify any potential conflicts of interest that they might have. Specifically, and most importantly, when clinical experts and patient experts are invited to attend the Appraisal Committees themselves, which they are for every technology, they are asked before the beginning of each item to formally declare any interests they consider appropriate and those interests are recorded in the minutes and published on the web site.

  310. And that is a requirement.
  (Mr Dillon) That is a requirement.

  311. Since the time that we first met you, have you learned anything in respect of the way various interest groups operate? Have you in any way changed your procedures to take account of this learning process?
  (Professor Sir Michael Rawlins) I think so. When we started out, we produced interim guidance. We were starting out on a venture, nobody had ever done it before, and we produced interim guidance for manufacturers and anybody else who was submitting evidence to us. At that time I do not think we made it quite clear what sort of evidence would be most helpful to us and, indeed, professional organisations and so on, as a result of the early experience, we have now laid out much more clearly the process and what manufacturers can do, what professional organisations can do, what patient/carer organisations can do as well. Andrew Dillon was particularly involved in that and may want to amplify it.
  (Mr Dillon) In order to get the appraisal programme running rapidly, we wrote very quickly procedures and methodology in order that we could start. The first people appointed at NICE arrived in the middle of July. We launched our first programme at the beginning of August. We had to move very quickly. What we committed ourselves to almost at the same time as launching the programme was a formal review of all of our processes for the appraisal programme and we completed that and published new process documents and new methodology documents early last year. In preparing the document that guides patient organisations in submitting to NICE, we sat down with patient organisations themselves, both those that had had experience of the Institute's appraisals and those that had not, talked through with them the best ways to present to them our thoughts on how they could best contribute to the appraisal process, and the resulting document was published in February last year.

Dr Taylor

  312. I do not envy you your job at all because in some way you have to balance clinical effect and cost. In your submission you say that you should have regard for available resources. We would like you to expand a bit about what that means and how you know what resources are available.
  (Professor Sir Michael Rawlins) In general terms, we look at the clinical effectiveness in relationship particularly to clinical need and other sorts of treatments that are available and we look at cost effectiveness by methods that are reasonably well accepted internationally, and we look at each of the technologies or treatments in that light. The Institute also calculates the net budget impact; in other words, if this advice is taken up, how much is it going to cost. This does not play a part in the appraisal or process itself, but clearly it is of considerable interest to the Government and the Treasury and Parliament. But it is not part of the appraisal process. I have often used an example, and it might be helpful. It might be that at some future date a company comes along with a treatment for lung cancer that produces a 95 per cent two year survival, which would be riches in the context of everything we have got at present. If that costs £10,000, that would be roughly £5,000 per life-year gained. That is fine, that would be cost effective of the order of routine mammography in breast cancer. But there are 50,000 patients a year with lung cancer. The cost to the country would be £0.5 billion. NICE cannot suddenly commandeer £0.5 billion from the Treasury and quite clearly it becomes an affordability issue for Government and ultimately for Parliament as to whether or not they are prepared to fund that sort of thing, and, if they are, how they are going to find the money, increased taxes, borrowing or whatever. That seems to me a very clear distinction between affordability, the £0.5 billion it would have cost the nation, as opposed to the clear evidence of clinical effectiveness and cost effectiveness in relationship to what we do. We would go as far as the clinical and cost effectiveness; ultimately it is you who have to do the affordability bit—which I do not think is actually any easier than what we have to do.

  313. No. This is not how it is coming across to health authorities and purchasers. One example that has been quoted to us which I think is probably one of the best is the implantable cardiac defibrillators. One of the local trusts knows that four of those is exactly the same as four extra nurses in A&E, and for the trust the four extra nurses in A&E is far, far more important, but they have been faced with this, which is coming down with pretty considerable power, that this is what they should do. Is this not skewing local priorities?
  (Mr Dillon) But this is a choice that has existed for years. As Chief Executive of St George's I remember signing many orders for implantable defibrillators and having to do that in the knowledge that there were a whole series of local priorities, local demands for resources, that there simply was not enough money to meet. The guidance that the Institute gives is guidance on topics that are important to every local health community but we know they are not the only important priority, we know they are not the only demand that is made on local resources in the NHS. We are aware of that. But the point of establishing NICE is that, if we are given the right topics, topics that the NHS collectively regards as important aspects of clinical practice on which it wants consistent service to be provided for patients, on which it wants consistency of access, then we are in a position to give that advice to the service. I think the service that is looking to deal with these difficult and unacceptable issues of significant geographical variations, has to take and accept and has to regard that as a major priority and in effect a first call on the resources which are available locally. That does not mean to say that nurses in the Accident and Emergency Department or Outpatients or on the wards or anywhere else are unimportant; they are clearly very important, but the fact of NICE existing and providing guidance at a national level has not created a new dilemma for local organisations to deal with. What we are doing is providing clear information that helps to resolve difficult funding decisions about aspects of clinical practice that would otherwise be provided variably across the service.

  314. It has given them an entirely new dilemma, because now they are faced with what is in fact coming out as a directive, that this has to be bought or has to be provided, and they do not have the funds to do both. The expectation of patients is: "If NICE has said so, I'm going to get it" and they will make a tremendous fuss. The comments from patients who do not get it ... I have got a superb letter—and I am an Independent, so I can say exactly what I like in this Place. Some people regard this—and I am not criticising you—as really a way to ration health care and to be a Teflon coating for the Government. Is this another example of Mr Milburn devolving decisions that he ought to have responsibility for?
  (Mr Dillon) I remember a discussion I had with cardiologists at St George's Hospital some years ago, before NICE was announced, about effectively the rate at which we should be stenting, the rate of using stents. It was put to me by the cardiologists that our rate should be around 85 per cent. I asked them for the evidence for that. It would have meant spending about £60,000, a significant sum at the margin for even a large organisation. The evidence they gave me was, "That is what the Royal Brompton does." In the end we had a long discussion about it, but I was presented with no better evidence than, "That's what the Royal Brompton does, and so that is what we should do." When I went to NICE and we were asked by the Department and the Assembly to look at the use of stents in CH18 March 2002 and to go through the process of finding the evidence, of exposing that to extensive appraisal and consultation and coming up with clear guidance, I remembered those discussions, and, whatever problems it might create for the local NHS, if that guidance had been available to me and the cardiologists of St George's at that time we would have been in a far better position to make good quality decisions about resource allocation than we were at that stage.

  315. Do not think I am criticising the desire to get evidence, because that is absolutely essential. What I am having difficulty with is who is meant to balance four nurses against four implantable defibrillators and how you square patients' expectations. Slightly on that, one other thing: several people have mentioned that they feel that you should have some ethical input. Is that something that has been raised with you?
  (Professor Sir Michael Rawlins) We certainly recognise that some of our decisions or the basis upon which they are made requires value judgments. We fully recognise with those value judgments that we are no more competent than anybody else to make them. That is why we are in the process of establishing the citizens' council, composed of ordinary men and women around the country, to help us make those value judgments, because they are probably better then the three of us at coming to that sort of conclusion. I am not quite sure whether that is ethical; at least it is seeing how out there people think we should be approaching some of these difficulties.

  316. There are well established ethical committees because every research project—
  (Professor Sir Michael Rawlins) Yes, I have chaired one for a number of years, as you might imagine. This is a rather different endeavour than the somewhat amateur ethics that we used to conduct in my ethics committee.


  317. Can I pursue that question Richard has raised about the issue of determination and choices at a local level? Mr Dillon, you had been in a key position in the health service before you came to NICE. Have your experiences of being involved in NICE given you any ideas as to how you may make different arrangements for local choices within the health service? This is slightly askew from the direction of travel with this inquiry, but I have asked one or two of our witnesses, when we are talking about limited resources how best we can ensure that the kind of choices that Richard has talked about are made with citizens' councils locally, never mind within NICE or some other body, where we genuinely reflect the views of the local users of the service. Have you come up with any brilliant ideas in your time in NICE which may move us on in this respect?
  (Mr Dillon) I think the reality is, certainly my experience has been, that the opportunity for choice just exists at the margins for most NHS organisations. Most of what is committed every year in the NHS is pay. Around 70 per cent of what we spend in the NHS is on pay. There are choices to be made there. Changes occur every year in relation to the kind of people that are employed in the service and the numbers of people that are employed in particular functions in each local health economy, but essentially we are stuck with this huge bulk of expenditure long term. Beyond that, most of the rest of the expenditure is pretty much long-term as well, in conventional clinical practice. Sometimes that practice is challenged. NICE provides the NHS with an opportunity to challenge, to challenge constructively, what we do at the moment, and we would very much like to get from the NHS, and we are not at the moment, ideas for topics that look at topics or aspects of clinical practice where there is a prima facie case for considering whether or not what we are doing and what we are spending money on really is the best way to treat patients with that particular condition. So we would like more of that. If anything, my experience at NICE has been that if we can start to engage more actively with the service in topic selection for the Institute, we will get those proposals coming through, and the NHS will start to see us less as an entity that is providing us with the sort of challenges that Dr Taylor referred to. We already have got difficult decisions, we have very little flexibility and now there is a national organisation that is effectively reducing that flexibility by virtue of indicating how we should spend some of the money. I think if we can move to a position in which we are working with the NHS on topics that provide the opportunity to redirect investments to more effective treatments, then we will feel that our contribution to the service, which we already regard as being substantial, will increase.

  318. Sir Michael, you talked about your citizens' council. Without going into detail about how you select Citizen Smith to serve on this, how do you see, in practical terms, this body operating?
  (Professor Sir Michael Rawlins) We would operate it very much along the lines of citizens' juries, where they meet for two/three days at a time and they hear witnesses. They are facilitated, not by me but by experienced facilitators, and they come out with a report at the end. The citizens' juries that have been conducted—and the King's Fund have sponsored quite a number—have produced extraordinarily sensible conclusions at the end of it. That is the sort of model we hope to get and we hope to include a real cross-section of people to take part.

  319. What kind of issues would they be looking at?
  (Professor Sir Michael Rawlins) Just to give you one example, when we calculate these quality of life adjusted years, life-years gained or whatever it is, we multiply the quality of life by the number of years in which you are going to enjoy them. That gives a huge advantage to children relative to the elderly because they have got fewer years left to enjoy. It is actually mathematically quite simple to change that from a straight line to any old curve you like. So one of the sort of things is: How much should we be giving emphasis to children and how can we ensure that in some way we do not deprive elderly people of the benefits of modern treatment? It is that sort of broad-based type issue that we are anxious to pursue with the council.

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