Select Committee on Health Minutes of Evidence

Examination of Witnesses (Questions 320 - 339)



Julia Drown

  320. I am interested in the set up of NICE which said NICE is required to be "sympathetic to the longer term interests of the NHS in encouraging innovation". What do you understand by innovation?
  (Professor Sir Michael Rawlins) I think there are a number of aspects to it. The first is that we would be very anxious for innovative new treatments that are clinically cost effective to be made available to patients and that the patients could benefit from them. I have to say—and I do say with some regret as a clinical pharmacologist—that British doctors are probably the most conservative in the western world and are the slowest to take up new treatments. There is a therapeutic conservatism in British medicine that goes back 100 years to William Osler and previously and we are unquestionably almost the slowest. There has been evidence for this recently published in the Wanless report and the PICTIF report and so on. One of the things we wish to do is really for new innovative treatments to become available to patients as quickly as possible. I think that is the first part. The second part of it is that we are anxious to ensure that new treatments are looked at in a way that, if there are any doubts about it, we should default in the interests of patients. There are a number of individual appraisals, which we could go into if you wish, where there has been some doubt—it has not necessarily been beyond reasonable doubt but on the balance of probabilities—that patients would be advantaged by having access to a particular medicine, and so I believe that in encouraging innovation we should encourage that sort of use of treatments. The third thing is that there are a number of occasions when we have felt that innovative new technology needed further studies, and so we have promoted clinical trials or other sorts of investigations to make sure that the potential new treatment really does fulfil its promise.

  321. You said in there that there were some cases where it was not absolutely clear but you thought in order to benefit patients you would recommend that particular treatment. That is also, in benefiting the patient, benefiting the particular company that is pursuing that treatment. Could it also be argued that having that particular recommendation there that you have to encourage innovation is intrinsically building in a benefit to drugs companies, to other companies, to develop new products.
  (Professor Sir Michael Rawlins) I think it would and I think if the company produces a new product that is clinically cost effective then it is perfectly reasonable for it to have the rewards of its original investment. It applies not just to pharmaceutical products but it also applies to procedures and surgeons who have introduced new procedures, for example.

  322. Can you say whether or not having that criteria has changed any of the guidance that you have given out, that had that criteria not been in there you would have had a different position.
  (Professor Sir Michael Rawlins) Can I ask Professor Barnett, who chairs the Appraisal Committee.
  (Professor Barnett) I think innovation is only one component. It is certainly very important. It is very important obviously for new innovative therapies to be made available, if they are clinically cost effective, as soon as possible, but innovation also means innovation in the way which we apply the guidance. An example would be total hip replacement. There is a huge number of possible hip replacements. We have heard evidence from a variety of individuals—clinical experts, patients themselves, from manufacturers—on the wide range of possible hips that are available. It seemed to us that the guidance encompasses the concept of innovation by setting a benchmark which has never been set before on the basis of clinical effectiveness. A new hip achieves, if you like, its licence on the basis of the fact that it has certain criteria in its manufacture, not because it reaches a benchmark in clinical effectiveness, which is what patients want (namely, that it lasts long enough, it is not too difficult to put in, "It's effective for me"). So the NICE guidance identifies a benchmark which new hips, new innovative ideas, would have to achieve: to be as good as that which we already have. There is an example of innovation, if you like, for something which is kind of old.

  323. Can you be absolutely clear: When you encourage innovation, it might be a drug, it might be a new technique, but it might also be an old technique, like physiotherapy or something like that?
  (Professor Sir Michael Rawlins) It could easily be. It could easily be, yes, most certainly.

  324. And you are comfortable with those criteria being your guiding criteria.
  (Professor Sir Michael Rawlins) Yes. I think, as Professor Barnett says, it is just one and has to be taken in the context of the overall judgment that needs to be made.

Dr Naysmith

  325. I was struck by something Mr Dillon said in the earlier part of that exchange. We were talking about the fact that the resources could be redistributed in the National Health Service if current treatments and so on were demonstrated not to be effective. Now most of the examinations that have been carried out by NICE have ended up recommending virtually every technology that you have examined. I was under the impression when NICE was set up, I hoped it would be, that many existing techniques would be examined and found to be wanting and replaced with better techniques. The best example I can find of that that has happened is impacted molars, in saying that they should not be removed if they are pathology free. I remember myself 25 years ago having an argument with a dentist about my impacted molar, saying it was not giving me any trouble, and he was very anxious to do something about it. I won in the end: I have still got my impacted molar and it has never given me any trouble since. That is the kind of thing that is going on in a number of other areas of the National Health Service. What can we do to encourage more examinations by NICE of these kinds of thing? I know you are not supposed to make the recommendations but perhaps you can give us some advice on how to seek to make that happen.
  (Mr Dillon) We would genuinely like more of those topics to come through to us. We think the best way to do that is to engage actively with health professionals and those who support them because those are the people who know, either directly because of the work they have done in their overall health communities on the way in which interventions are used or because of what they have read, of the potential topics that we could look at. Not all of them may be suitable for the kind of appraisal that we do but clearly some of them will be, and so what we have been asking the Department of Health and the National Assembly for Wales to do is to expose the process of selecting topics to the NHS and to engage actively with the service. We genuinely believe that if that happens then two things will result. One is that we will get more of those sorts of topics coming through. Secondly, I think the service will be more confident that the guidance that we eventually produce will be on topics that they regard as being important in their local health communities, that, regardless of the array of other priorities they have, what the service in effect which owns NICE will be asking them to do will be the things it regards as being important.

  326. How did the pathology-free impacted molar study get onto your agenda? Have you any idea?
  (Mr Dillon) When NICE was first established we published, the first list of technologies that was given to us, the Department and the Assembly wanted it to display the range of potential technologies that NICE could look at and, indeed, apart from aspects of health promotion, which might be regarded as a technology, they were all present in that list. But the reality was at the time we were established that there was a significant backlog of pharmaceuticals that were already subjected to substantial geographical variation in use, and it was clear that the Department and the Assembly wanted us to deal with those as quickly as possible, which is what we have done.
  (Professor Barnett) With respect, the concept that it is all or nothing is a narrow view of what we do, and I know that we discuss in committee in great detail the issue about targeting an innovation or an intervention because by so doing you actually do, if you like, identify the correct use of the funds and therefore reduce inappropriate expenditure. That does not perhaps come out quite so clearly because part of the appraisal will be to target the technology appropriately.

  327. You say you are doing that all the time.
  (Professor Barnett) Absolutely.

Sandra Gidley

  328. The Committee has received a number of submissions which worryingly describe NICE guidance as being flawed or even perverse. I refer particularly to the submissions on the Drugs and Therapeutics Bulletin, which is highly regarded in medical circles, which highlighted six technologies where they felt the guidance had been flawed or perverse in some way. Does this not actually give you cause for concern, that such a well regarded body is picking quite large holes in the guidance that NICE provides?
  (Professor Sir Michael Rawlins) I am disappointed in how they perceive us. There are both general points that I would like to make and more specific ones. The general points are that we do not believe our guidance is flawed. It is constructed to a very robust process, probably more robust, open, transparent than any analogous type of activity anywhere in the world. I have been involved with the licensing of drugs: I chaired the Committee on the Safety of Medicines for six years and was vice-chairman for the previous six years, I have been involved in the European Medicines Evaluation Agency; and the World Health Organisation, and the robustness of the way NICE goes about it and the way it is open and transparent is very different from, for example, the regulatory authorities. We also challenge and dispute that we contradict the Summary of Product Characteristics. We do not. All our guidance to date has been entirely in accordance with the indications in the Summary of Product Characteristics that has been produced by companies but with the approval of the regulatory authorities. So we would dispute that. It has also been suggested that we should incorporate a complete account of the use of a particular technology within each appraisal guidance. We do not expect in our guidance to replicate what is already in the Summary of Product Characteristics for the pharmaceutical industry any more than we would expect in our guidance to instruct an orthopaedic surgeon on how to fit a new hip. That information is quite separate. For drugs it is contained in the Summary of Product Characteristics and that is the proper place for it. Nevertheless, we do refer to specific sentences from the SPC where it is appropriate. The other point I think is that sometimes our guidance should have covered another technology—and that particularly applies to the criticisms of our appraisal of methylphenidate. We are of course asked to look at particular technologies in relationship to current best practice and methylphenidate we were asked to look at it because there was a lot of controversy about its use and that was the whole reason for its referral to us. So, in general, I reject the notion that our guidance is flawed, and we have prepared a detailed commentary on all the individual pieces of guidance that are criticised by the Drugs and Therapeutics Bulletin. If you want to question us on those, that would be very welcome, but we have prepared it in written form and we will send it to you early next week.


  329. So you contest every one of their assertions?
  (Professor Sir Michael Rawlins) Certainly, Chairman.

  330. Every one of them.
  (Professor Sir Michael Rawlins) Certainly.

  Sandra Gidley: It would have been useful to have had that here today, actually, I have to say, so that we could have looked at it before we spoke to you. Why was that not provided? We have had all this load of stuff which I doubt all of us have had a chance to read.

  Chairman: Have you not read it? What have you been doing today!

Sandra Gidley

  331. What would have been useful would have been that rebuttal.
  (Professor Sir Michael Rawlins) We were advised that we should send it after we had given our evidence.

  332. Who advised you of that?
  (Professor Sir Michael Rawlins) I think that is right.
  (Member of the audience) We made our submission on the 4th, which is the information you have there, in line with the Committee's—


  333. I am not sure we can take evidence from a member of the audience. I am sorry about this.
  (Mr Dillon) We are sorry, Chairman. We had prepared it. If we have been misinformed, then I apologise for that.

  334. OK. But you are prepared to supply us with the detailed information.
  (Mr Dillon) Absolutely.

Sandra Gidley

  335. I just want to come back on a couple of the points you raise. You mentioned methylphenidate, which is perhaps a good example of something we covered earlier. The fact that it was not looked at in comparison to dexamphetamine has been picked up as problematic. With all technologies would it not be useful for the future to look at them in a broader sense? Is it not actually causing problems—and it is not a problem necessarily NICE is making—that everything is looked at in such isolation?
  (Professor Sir Michael Rawlins) When it came to methylphenidate, we did actually consult with professionals as to whether we should extend the guidance to dexamphetamine and they said, "No, we hardly use dexamphetamine. We do not regard it as an appropriate form of treatment for most patients and what we really need to know about is your views on methylphenidate (Ritalin) because it is a very highly controversial topic. There have been a lot of adverse comments from some sources and we would really like a robust and authoritative guidance on its use in our practice." That is what we did. The health professionals involved have been very pleased at having such authoritative and robust advice from us and have made comments positively, as have many patient groups as well.
  (Professor Barnett) Can I just concur with that. The appraisal process meant that we had to engage with clinical experts, with patient care organisations, with in fact the parents of/the carers of patients with the problem and the use of Ritalin. We had to deal with the evidence base that was available and the lack of, if you like, head-to-head comparisons directly in the evidence base between dexamphetamine and methylphenidate. In addition, what is perhaps most important and which has not been referenced in this particular appraisal is the comparison between the use of Ritalin with non-pharmacological approaches to the control of this condition. It is pretty obvious that the evidence base suggested quite dramatically that actually behavioural therapy did not stand up too well against the drug therapy. If you will look at our advice, it was, as the evidence was presented to us, that waiting for behavioural therapy before commencing Ritalin was actually an inappropriate thing to do. So we did make comparisons to the alternative approaches to the management of this condition. Leaving out dexamphetamine was a separate component of that.

  336. What about the allegations that, say, for the anti-diabetics you have actually recommended a use which was not in the data sheet at the time.
  (Professor Barnett) I do not think our guidance does go contrary at all to what the data sheet says. What our guidance is intended to do is to give pragmatic and practical advice based upon the licensed indications—

  337. You actually recommended a use that was not licensed at the time, according to the Drugs and Therapeutics Bulletin.
  (Professor Barnett) I refute that. We have given advice based upon the licensed indication for medication in a practical way to achieve what the experts requested of us as to how they should best use this medication in clinical practice. We could go into the details if you wish, but I would suggest that might be better in a written form.

  338. It would be useful to have that. If I could just go back to this robust, open and transparent. You are very bullish about this in your submission to us. Quite a few of the submissions have said that there seems to be an inconsistency between the six different centres that are performing the assessments. There appears to be certainly a very strong feeling out there in the medical community that you are not necessarily getting the same standards from the six centres. How would you answer that allegation that has come forward?
  (Mr Dillon) By looking at how those assessment reports, as we describe them, are commissioned. I think it is the assessment reports that are provided to us by one of now six universities in the UK that form part of the evidence base that the Appraisal Committee looks at. They are commissioned on our behalf by the National Centre for Health Technology Assessment, which is part of the NHS Research and Development Programme. They are not commissioned directly by NICE but we set out what it is that the Appraisal Committee needs. Once we do that, the commission is done by the National Centre for Health Technology Assessment and the National Coordinating Centre for Health Technology Assessment. They commission the reviews from independent academic department. Those departments themselves produce reports to standards that they agree jointly with NCCHTA. Those assessment reports are peer reviewed before they are received by NCCHTA; they are reviewed by the Centre for Health Technology Assessment before they come to the Institute; they are reviewed again by the Institute's technical staff. In the new process that we have got, they are then sent out to all the consultees, who have the opportunity to read them and to comment on them and to correct any factual errors which from time to time do, perhaps inevitably, despite all of those quality checks, creep into the report. They are then subjected to another, in effect, peer review process, because they go to the Appraisal Committee. There is then a further opportunity for consultees to comment again if there is anything left in the documents that they feel unhappy about. So there is a whole series of stages in the process that these documents go through where they are exposed to clear opportunities for all consultees to identify any errors, any missing evidence or anything that might mislead the Committee. I cannot think of a process that parallels that in the NHS that secures quality in the same way.

  339. Has that always been the case?
  (Mr Dillon) Yes, that which I have just described. The only thing that did not exist until recently, when we put our new process in place and, only applies to appraisals that were initiated after 6 February 2001, the only element that did not exist was that it was not until the new process came in is that we send the assessment report out to consultees before the Appraisal Committee sees it. But all the other checks that I mentioned have been in place right from the start.
  (Professor Barnett) The Appraisal Committee themselves are a highly political bunch, and we spend a lot of time looking through the assessment documents and in our committee discuss the concerns that may have been raised. We are very grateful for the quality checks that go on.

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