Select Committee on Health Minutes of Evidence

Examination of Witnesses (Questions 340 - 359)



  340. Who is on the NCCHTA? Who decides who goes on that board? There are panels and boards all over the place. I am getting slightly confused as to who overlaps with whom and who appoints to which group. It is all becoming very incestuous almost.
  (Mr Dillon) No, I do not think it is. In fact I think the fact that NICE operates in the way that we do—the example of the external commissioning of our evidence—is an example of the robustness that is built into the process. NCCHTA consists of staff who are employed by the NHS Research and Development Programme. The office is led by Professor Kent Woods at—

  341. They are the same people as run the Horizon Scanning Group.
  (Mr Dillon) No. No, they are a different group. They are quite different. The Horizon Scanning staff have academic contracts at the University of Birmingham and they work on the basis of a contract that they receive from the NHS Research and Development Programme.

  342. Yes. I am sorry, that is where I was coming to.
  (Mr Dillon) Yes, that is the link.
  (Professor Sir Michael Rawlins) The Health Technology Assessment Units are also all part of the NHS R&D Programme, so in one sense are a free good to NICE.

Dr Naysmith

  343. We were told by a representative from Glaxo WellcomeSmithKline that industry pharmaceutical firms are out to check original technology assessment reports. It must be part of that procedure you first outlined. Are you entirely happy with this? Could it be done better by independent people such as the people who run the British National Formulary or the Drugs and Therapeutics Bulletin.
  (Mr Dillon) I am not quite sure I follow the introduction to the question. We do not expect the industry to—

  344. Let me say a little bit more. They are going to look through it. Do they always confine themselves purely to factual errors—numbers in the wrong place, decimal points, perhaps—or do they ever make comments on other things in the report?
  (Mr Dillon) They have exactly the same opportunity as any other stakeholder to make whatever comments they want but generally their comments fall into three categories. The first is where they believe there are factual errors, and that might be numbers that are misquoted—

  345. Not just factual errors. That can be a chance to comment on other people's comments.
  (Mr Dillon) The second category is where they may say that there is evidence which exists and which has not been included, and they draw the attention of the Institute to that. The third is where they believe that the way in which the evidence has been laid out is unhelpful. But they are perfectly entitled to make any and all of those observations, and it is a matter for the Institute and the Appraisal Committee to decide whether or not to take them into account.

  346. So it is actually much more than checking.
  (Mr Dillon) Yes. We do not attempt to constrain them, because to do that might potentially lead to some genuine error or omission in one of the assessment reports not being drawn to our attention which would clearly disadvantage the appraisal.

  347. Purely statistical or factual or scientific mistakes could be looked at and corrected by some other body, could they not?
  (Mr Dillon) Well, they already are. If they get through to that stage, then it means that they have been missed by the authors, they have been missed by the peer reviewers and they have been missed by the National Coordinating Centre for Health Technology Assessment. So the number of occasions when that occurs are actually quite small, and it is really at that stage that if factual errors have crept in we want to make sure that we know about them, because we are very close at that stage to the Appraisal Committee seeing the document for the first time.

Andy Burnham

  348. I would like to take forward Dr Naysmith's line of questioning, to think about the original data set and evidence base that you get provided from the pharmaceutical companies themselves when you originally submit data on a technology or a treatment. Sir Iain Chalmers, who is a fairly eminent commentator on these matters, has stated in evidence to the Committee that "important data having been withheld from NICE by companies whose interests would not be served by submitting it". Do you think that happens?
  (Mr Dillon) When we invite companies to make submissions, we ask them to sign a declaration that they have submitted to us all relevant information. If they sign that declaration, we accept it. We have no means of challenging it. If we ask someone a question and they give us an answer, unless we are presented with clear evidence from whatever source that that declaration is wrong then we have to operate on the basis of trust that we have received all the relevant information.

  349. Might I suggest that that might sound a little too trusting. Sheila Bird, the statistician on your own Appraisal Committee, said in evidence "NICE is not afforded full access [to information] by all pharmaceutical companies". It seems that this is something that people are suggesting to us, and yet when we put this point to the ABPI last week they categorically said it does not happen. Why the difference in view?
  (Mr Dillon) I do not think it is a difference of view. I think the reference that you are quoting there was a reference to the appraisal that we conducted on the beta-interferons and glatiramer acetate for multiple sclerosis. As I think the Committee knows, we commissioned an additional economic model as part of that appraisal. We asked a consortium of British universities to construct independently an economic model. They would have preferred to have had access to what is described as "patient level data"; in other words, the original data which resulted from the clinical trials conducted by companies which is then summarised and presented into the public domain. The companies we asked for that information from decided not to release it to us. Their reasons for doing so were that it was confidential information; that to release it to us, in their view, would breach the confidentiality agreement that they had in effect entered into with the patients who were the subject of those clinical trials.. They also argued that the data was not relevant to the inquiries that we were making or the process of constructing the economic model.

  350. Were you happy with those arguments?
  (Mr Dillon) No. The view that was being put to us by the consortium of universities doing the modelling was that they would have preferred to have had that data and so on that basis we would have preferred that the company supplied it.

  351. Has Sir Iain Chalmers made these concerns known to you?
  (Mr Dillon) Yes, I had a conversation with him at the Institute's conference in December and he said that he had heard that things had been said that led him to suspect that this was the case.

  352. Have you taken any action on that?
  (Mr Dillon) Unless we are presented with very clear evidence that effectively challenges the statements that are made by companies that they have submitted all relevant evidence, I cannot take action. I have to have the name of the appraisal and the name of the company and the details of the data that the individual who is expressing the concern thinks has been withheld from us. If I am supplied with that information, then I will make inquiries with the company concerned.

  353. When you say presented, could you not go out and seek that? If people suggest that there is a problem, could you not, rather than waiting—
  (Mr Dillon) If I am provided with the details of the appraisals and the companies concerned, I will make those inquiries. But I cannot just randomly approach companies and say, "Have you done what in effect you have already told me you have done by virtue of the declaration that you have made?"

  354. Do you think there might be a flaw in the system here that it is taken on trust, that there may be the situation where one side is saying one thing and one another? Would you welcome greater powers to be able to take information, if you deemed it was necessary to the work you were doing?
  (Mr Dillon) In one sense we are in the same position as the licensing bodies for pharmaceuticals, who seek all the relevant information from the companies and they seek commitments from the companies that they have provided that information. But I think it is the case—Professor Rawlins will know better than I—that in the case of the Medicines Control Agency that request is backed up with the force of statute. The Institute's position is different. Our request is not backed up with the force of statute.

  355. Would you welcome that?
  (Mr Dillon) Yes, it would obviously be better if it was.

Julia Drown

  356. Some forms of therapy and some patient groups do not have the lobbying capacity that the pharmaceutical companies do that we have just been discussing. How do you make sure that their views are fed in and are regarded in your processes?
  (Mr Dillon) By making sure, first of all, that we do what we say, that we act what we set out as being the way in which the Institute approaches taking evidence; that is that we regard the evidence submitted by all of our stakeholders as of equal value and equal value also with the assessment report that we receive, as we have discussed, from the independent academic organisations. I mentioned earlier that we worked with patient organisations to identify not just the best way in which they can engage with the Institute but also the nature of the evidence that they can supply to us. It has been the case that patient organisations have expressed concern since NICE was established about two things . . . or perhaps three. One is that they are uncertain about what we want to get from them, what is it that they know and that only they know, in other words, that we do not get from the work done by the academic organisations or from other sources that we need to have, specifically that the Appraisal Committee needs to have, to interpret the evidence. Secondly, how do they get involved? How can they be certain that the Appraisal Committee is taking what they have said into account? They attend part of but not all of the Appraisal Committee meeting. They can go to the Committee and talk through their evidence, they can enter into discussions with committee members, but there is a point at which they withdraw to allow the committee to consider the evidence further and to debate. How can they be certain that their evidence is being taken into account in that part of the committee meeting? Finally, they are concerned about resourcing. Some of the patient organisations we work with are very small, they have very limited resources, and they are concerned about the cost of engaging with the Institute, particularly where we are looking at a series of appraisals in which they might be interested. We have worked with them to try to deal with as many of those concerns as we can, partly through the process, partly through supporting them when they need it directly, when they come and ask us for assistance in understanding our processes, partly by making a decision to provide some financial support to their work—it is only a small contribution, in effect a contribution to the costs they incur, £400 per organisation per appraisal. It is the best that we can do with the money we have got available, but we recognise that there is a need for it and we have tried our best to help them. We have tried to reassure them that what they provide us with is used every time particularly to inform the way in which the committee interprets the other evidence that it has received.

  357. Particularly with regard to the patient groups, why can they not sit through the whole process, so they can see if their particular points are being raised and continued through the whole process?
  (Mr Dillon) Partially, because we take and use evidence which is submitted to us as commercial in confidence.

  358. What if they were willing to sign up to the same commercial in confidence criteria that you have to sign up to?
  (Mr Dillon) The way in which the Institute operates at the moment is on the basis that if companies come in complete confidence and give us data on which they may already have decided on a publication strategy for or on which they have decided that, for whatever reasons, they do not wish to release into the public domain—and, as the owners of the data, they are entitled, it seems to me, to do so- then we having given them a commitment that we will respect the confidentiality of that data and expose that in relation only to working of the Appraisal Committee. Unless in some way that can be changed . . . it is a limiting factor in terms of the extent to which we can expose the work of the Appraisal Committee to the general public. But the members of the patient organisations that come to Committee meetings themselves see the data that is submitted to the Institute, so there is a distinction here between the general public having access to the committee and patient organisations, who are formal consultees, who have signed a confidentiality agreements. Those patient and clinical representatives sit with the committee for a significant proportion of the discussion, but there comes a point at which the committee needs to have the time to consider everything that it has heard, including all the representations that have been made directly to it, and to consider its decision This is a short period out of the whole appraisal.
  (Professor Barnett) I want to reinforce what has just been said. First of all, I made a career of listening to patients, which is what I do in my day job, and I think we try to make it abundantly clear to the patient and carers who arrive, that we will do so and that is exactly what we do. They are also present, as Andrew has just pointed out, for a substantial proportion of the time during which that technology is being discussed. They engage directly with committee members; they ask questions and are asked questions of. I think that is something of which most of the patient and care organisations who engage with us are fully aware and quite happy with.

  359. We have heard it was the cancer charities who felt they did not have evidence that their views had been fed in, that they had been dismissed, and they personally had not had that feedback to know why they had been overridden.
  (Mr Dillon) Part of the problem there—and we began to realise this in the past as a result of the discussions that we were having with patient organisations and also other stakeholders—was that after the first meeting of the Appraisal Committee, where the draft guidance is prepared (it was called a provisional appraisal determination), we set out the evidence that we received, we describe the technology and we write the draft conclusions in the form of the draft guidance, and what we realised we were not doing in the earlier appraisals effectively in the document was connecting the two things; in other words setting out in writing how the evidence that we put in the document allowed us to reach the conclusions that we set out in the guidance. What we have started to do is to write a section that we call "Consideration". It is in that section that we describe how the committee has interpreted the evidence and that gives us the opportunity to describe how patient evidence influenced the conclusion.

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