Select Committee on Health Minutes of Evidence

Examination of Witnesses (Questions 400 - 419)



  400. So if something was discussed—I am just trying to get a handle on the process—at a meeting and you needed some evidence how long would it be before it would be looked if that was provided the next week?
  (Professor Barnett) The answer to that question is two-fold. One is how easily available that information is, and of course we have to take advice on that from whoever is answering the question. The second is how easy it is to make committee time. My view and the view of the Committee members is that we will spend as much time as is necessary on the day we meet in order to achieve our goals. We will do everything we can to make space for an urgent request as much as we possibly can, but all committees work to timetables, all committees have certain agendas which they have to fulfil. Where we might be fulfilling the agenda for a particular technology, somebody else will be missing out. That balance is a very difficult one.

  401. So on average, if you assumed that nothing was that urgent?
  (Professor Barnett) A present appraisal which we are doing, which does not need to be mentioned, requires additional information. That was decided at the Committee meeting last week and we will review it again in one month.

Jim Dowd

  402. I want to follow this Herceptin issue for a moment. This Committee received a very strong submission last week that there had been an inexplicable six-month delay (and "inexplicable" was the word used) in the assessment being published. First of all, that rather seems to contradict your view that all those involved were fully informed, and the assertion we got was from a range of individuals, not just one. It also in my mind creates possible confusion between the view you have of how you relate to your stakeholders and how they understand your performance. I am not quite sure whether you are both equally misinformed or whether you both think you are doing the right things on your side of the equation, but it is just not communicating to the other. Was there a delay, this six-month "inexplicable" delay, in Herceptin, because it was put to us quite forcefully, if not quite directly as near as makes no difference, that women were dying because of the failure to use this drug? That was clearly the import of what was said to us.
  (Professor Barnett) There are two components to this and I think that the process issue and the issue about the timings perhaps Andrew would like to comment on first.
  (Mr Dillon) All the stakeholders involved in the appraisal, as David said, are told—and this is true for all appraisals—if there is any variation to the process that we have previously published in the standard appraisal process that we have. In the case of this appraisal it was the consultees themselves who encouraged us to look for, or rather to look at, further evidence, essentially a case series that they considered was appropriate evidence for the Appraisal Committee, so it was at the request of consultees that we had to consider whether or not we should plough on with the standard time line for the appraisal and not give the Appraisal Committee the opportunity to look at the evidence, or to take the time to do that. We decided that it was appropriate in the case of this appraisal that we looked at the further evidence that we were being directed to see. To enable us to gather that evidence we had to suspend the time line for the appraisal, so we had to give ourselves sufficient time to find out where the data was, to get the data evidence supplied to us in order to enable us to present that data in a form that could be used by the Appraisal Committee. Once we had taken that decision we made sure that all the consultees were aware of this, and furthermore we put the information on the Institute's web site. Anybody who seriously wanted to know what the new time line was, why the Institute had to change the original projected timetable, could find out either by looking at the web site or by reading the letters that we sent to the consultees or simply by getting in touch with us.

Dr Naysmith

  403. I want to move to another area now. We are interested in the appeal process. Can you tell me what are the grounds for appeal?
  (Professor Sir Michael Rawlins) There are three grounds by which the Institute is directed to hold appeals, and these are the directions of the Secretary of State. The first is that the Institute has acted unfairly in the way it has conducted the whole process; secondly, that its findings are perverse, that they are so unreasonable that no reasonable Appraisal Committee could possibly have come to that conclusion, are the words the lawyers use; and, finally, that the Institute is acting beyond its legal powers. It is these three things, and it is very similar to the appeal in the criminal or civil courts.

  404. What happens next?
  (Professor Sir Michael Rawlins) Any of the consultees may appeal except the Health Authorities and the Technology Board for Scotland, and we can come back to that a bit later. The Department of Health can appeal, and manufacturers, professional organisations, patient bodies, have all appealed at one time or another. The consultee or groups of consultees request an appeal. It comes to me. I invariably seek legal advice and those appeal requests that meet the legal criteria for an appeal are granted. There is an oral hearing with myself or another non-executive director in the chair. There are always two or three non-executive directors, one independent member from the industry and one individual representing patient and care organisations. The proceedings are inquisitorial, not adversarial.

  405. You say the appeals come to you first of all?
  (Professor Sir Michael Rawlins) Yes.

  406. Can you turn them down?
  (Professor Sir Michael Rawlins) Yes, on two occasions—

  407. Only on legal advice?
  (Professor Sir Michael Rawlins) On two occasions. Neither appeal was on grounds on which we could hear appeals and the legal advice was that we should not have an appeal and the appellants said, "Thank you very much" and went off.

  408. How many appeals have there been?
  (Professor Sir Michael Rawlins) We have had 13 that have been allowed, four have been upheld and nine have been rejected.


  409. Where your advice was that the appeals did not meet the criteria, did you feel in fairness that perhaps the criteria could be changed in future at some point to reflect a genuine grievance? Are you happy with the criteria?
  (Professor Sir Michael Rawlins) I tended to veer the other way and there have been a number of occasions when, on strictly legal grounds, probably it was not necessary to hold an appeal because there really were not appropriate grounds, but on the other hand it did seem to me that this was an opportunity to allow the particular organisation, which in one case was actually a patient organisation, to explain what their problem was and we could explain what our problem was and I think they were reasonably satisfied. Although the specific appeal was rejected I think they were satisfied that their point of view had been put and we had explained why we could not meet their demands.

  410. Do you feel the criteria are appropriate, the three points?
  (Professor Sir Michael Rawlins) I think they are. The industry have made suggestions that criterion two, this business about perversity, ought to be widened so that the whole case could be re-heard. I do not think it is appropriate for a new trial as it were to happen. We would have to assemble a panel that replicated the original appraisal committee with all the range of expertise and then what do you do if one group disagrees with another? The Board then have to make a decision. The industry draw analogies with the Medicines Act and appeals before the Committee on Safety of Medicines that go on to the Medicines Commission. Having chaired the CSM for six years I am very familiar with that process. What of course happens at the end of the day is that it is not the Medicines Commission overruling the Committee on Safety of Medicines. The licensing authority, the Secretary of State, has to decide which committee's advice he is going to take. I think that it would just end up in a more difficult situation even if we could assemble another appraisal committee to consider it all again.

Dr Naysmith

  411. It has been suggested to us that the number and variety of successful appeals throws a bit of doubt on the credibility of your organisation. What do you say to that? Is it fair?
  (Professor Sir Michael Rawlins) When I chaired the Committee on Safety of Medicines 40 per cent of the decisions that we made were appealed against. We are seeing something like a similar number.

  412. How many of those were as a result of new evidence being brought?
  (Professor Sir Michael Rawlins) On this occasion none, at NICE.

  413. But on the other occasions there were quite a lot?
  (Professor Sir Michael Rawlins) I cannot remember off hand. The fact that appeals are going to the Medicines Commission is never in the public domain.

  414. I do know that sometimes fresh evidence is brought.
  (Professor Sir Michael Rawlins) Oh yes, sometimes it is, but I cannot tell you how often.

  415. Would that be allowed in this system?
  (Professor Sir Michael Rawlins) In this system if there is fresh evidence that is clearly relevant we would ask the Appraisal Committee to re-examine their conclusions in the light of this fresh evidence.

  416. Has that ever happened?
  (Professor Sir Michael Rawlins) Yes, it has.

  417. What happens if you get to a situation where you cannot really make a decision? I know there are one or two recent cases where that might be the case. What would you do in that situation? What would you say? This is before the appeal stage and you get to a situation where the Appraisal Committee cannot make a decision. The company would be entitled, would they not, to make an appeal against that kind of situation? What would you do?
  (Professor Barnett) There are several possibilities that the Appraisal Committee have. One is to come to a decision yea or nay. Another is to say that the evidence base on which they are basing the decision is inadequate and they wish for further evidence, and that has happened on a number of occasions, or that it is obvious that new evidence is appearing at the time during which the appraisal is going on which would mean that a delay in the appraisal process is appropriate. I have to point out that trying to convince the Chief Executive of the organisation that that is an acceptable way of going is very difficult because he takes quite seriously the importance of keeping to our time lines. Therefore, if that is necessary, we will do that. We will move it appropriately. It is not usual that we would leave it in the air. There would be a forward move of some sort.

  418. I wonder if the need to take the availability of finance and the cost effectiveness into account comes into this at all. I say that because scientifically you are probably very rarely going to come to the wrong conclusion, unless we are talking about really big shifts, so the number of appeals that are successful purely on scientific grounds I would suggest would be lower than you are reporting now, but the fact that you have to bring cost effectiveness into it, does that often constitute grounds which help the appeal to be successful?
  (Professor Sir Michael Rawlins) It is certainly an element of the appeals that the Committee had been perverse in their interpretation of cost effectiveness data and sometimes it has been alleged that the Committee has adopted a threshold of cost effectiveness. The Committee Chairman comes to all the appeals and explains what the Committee's thinking has been and whether this has been asked about. It is always hotly denied that they have adopted a particular threshold. The cost effectiveness does contribute but it is really not a matter of re-hearing evidence. It is a matter of seeing whether they were making a reasonable decision, not necessarily a judgement we might make but whether it was reasonable in the light of the prevailing circumstances and evidence.

  419. How much discussion of all this is there at the appeals procedure?
  (Professor Sir Michael Rawlins) They last two or three hours or, in the case of beta-interferon, it lasted a whole day, the second appeal.

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