Select Committee on Health Minutes of Evidence

Examination of Witnesses (Questions 460 - 479)



  460. Briefly.
  (Mr McKeon) The process is fully set out in the scheme document which is on our web site and we can make available to you which will set that out.

  461. What is the position?
  (Mr McKeon) It is not a trial in the normal sense of the term.

  462. What is it?
  (Mr McKeon) We are going to monitor the progress of a cohort of patients, rather a large cohort of patients, about 9,000 or so, providing we can get the numbers, for about ten years to assess the disease progression and whether the effect of the drugs is as calculated to give a certain benefit over those without treatment. The price of the drugs will be adjusted accordingly and so on. That is rather different from a clinical trial.

  463. It sounds like a trial to me.
  (Mr McKeon) It is not a small cohort, and indeed the intention is that once the numbers who are being specifically monitored for that purpose—

  Mr Burns: One minute.


  464. Go on, Mr McKeon.
  (Mr McKeon) Once the numbers of the people who are being specifically monitored in order to assess the cost effectiveness of the drug have been brought into the scheme then all other patients who meet the ABN guidelines will also be treated but they will not be subject to that specific monitoring, which is again rather different from a trial, which is on a small cohort of patients, that you were putting forward.

Mr Burns

  465. How many people do you estimate suffer from MS in this country, roughly?
  (Mr McKeon) Probably about 60,000.

  466. As a result of any other NICE decisions has this programme been adopted?
  (Mr McKeon) No. They did not recommend that we did actually explore these facts with its broader pricing and so on with the companies.

  467. Sorry, who did not?
  (Mr McKeon) NICE did not.

  468. No. The Government decided to.
  (Mr McKeon) No. There was a specific recommendation in the provisional appraisal document that we should do that, we should look to see whether there was a way in which the drugs could be acquired on a cost effective basis for the National Health Service. We therefore entered into discussions with the companies, and indeed with the ABN, the Multiple Sclerosis Society and so on, in order to see if that could be done, and ultimately this scheme emerged.

  469. What measures do your Department take to verify independently the quality of the work that NICE does?
  (Lord Hunt of Kings Heath) I think I explained that we set the framework in which we expect NICE to operate. We have set that very clearly. I think it is in our evidence. It is around the robustness of the processes. It is around the ability of those who are concerned to have an input into it. NICE also of course uses a number of academic centres and there are four universities at the moment involved in work on the appraisals. They have been commissioned through the NHS Research and Development Directorate. In addition, particularly in relation to guidelines, there will be collaboration with I think six of the medical and nursing Royal colleges. In that sense there is a strong connection between NICE and centres of academic excellence. I believe also that the very nature of the NICE process, the fact that provisional appraisals are sent to stakeholders who are enabled to comment on them, they then have to be considered, there is the same process in terms of final appraisals with the ability of those involved with an interest in a particular appraisal with to appeal; in other words, the combination of its own rigorous processes, the use of reputable academic centres and the appeal process, combine to give you assurance as to the quality of the work they have undertaken.

  470. Finally, do you think that NICE has sufficient in-house expertise to understand and critically review the advice that is given and to act upon it appropriately in the wider context of the NHS?
  (Lord Hunt of Kings Heath) I certainly hope so. I think that is really a matter for NICE themselves to answer rather than the Department. My understanding is that they do have some high calibre staff. It should be a partnership between in-house staff and work commissioned from outside academic departments. One of the issues that I have discussed with NICE is the availability of expertise int his country for this kind of work, for instance, issues as to whether we have got enough health economists in this country to support all that is necessary. One of the points in the last appraisal of NICE is that I have encouraged them to talk to universities generally about planning in terms of the number of students coming through ind the future so that certainly I would expect and hope that they do have the right in-house expertise, but I also expect them to ensure that there are people coming through in universities who will be able to help them either in-house or working for other academic units.
  (Mr McKeon) There is an important point about the appraisal committees themselves and the membership of those committees, some 40-odd members of the appraisal committees, who provide a lot of the expertise quite apart from anything that NICE has through their own employees.

Dr Taylor

  471. Minister, one of the things which rather staggered me in our inquiry so far was that the two publications that are really carried in every doctor's pocket, the BNF and the Drug and Therapeutic Bulletin, have become so divorced from NICE, and there seems to be so much antipathy between them and, as somebody who was a practising doctor until relatively recently, I just fail to understand that because these two publications have years of experience and respect behind them and I would have thought that the first thing they should be doing is building on a relationship with those two highly respected publications.
  (Lord Hunt of Kings Heath) Of course I have read very carefully the transcript of the evidence NICE gave to you and I know that the Committee had a full discussion of those matters. My understanding is that NICE, if they had not already, have responded to you on some of the specific criticisms that have come from the BNF and the other bulletin that you mentioned. Let me say from my point of view that I would encourage NICE to enter into close dialogue with those organisations and indeed other organisations who have a part to play here. I think I have said already to the Committee that my expectation is that NICE will be inclusive in its consideration of criticisms and discussions and will wish to engage in constructive dialogue with the organisations you mentioned.

  Chairman: I think it is better to clarify, Richard, that we did write to the Chairman of NICE after the session that we had with their witnesses. We have not yet received a reply to some of the points that were raised. We understand that we will have them fully by the end of this week.

Dr Taylor

  472. I am pleased you are going to encourage that co-operation. Just going back to beta interferon, as an outsider it appeared to me, and I am sure it did to lots of people throughout the country, that the Government had a tremendous lot of pressure on it when NICE put a block on beta interferon and it appeared that really they struggled and thought hard about how they could get round a decision that did not really go with what so many of the people wanted.
  (Lord Hunt of Kings Heath) I certainly agree that there has been considerable interest in the beta interferon appraisal right from the start, no question about that. The point is that the issue about the Government's discussions with the drugs companies concerned arose from a fairly early stage when the provisional appraisal was first published by NICE. All that we have done stems from that original recommendation which was confirmed in the final appraisal.

  473. So you started work before they made the final decision?
  (Lord Hunt of Kings Heath) No. We carefully looked at the provisional appraisal and we certainly started some informal discussions with the drug companies in terms of whether, if that were the conclusion, we would be able to reach some agreement. We worked to do that until NICE produced its final guidance.

  474. Do you think in the long term it may bring down the price?
  (Lord Hunt of Kings Heath) Certainly we are in it for the long term because this is a programme, as Mr McKeon has said, which goes over ten years, so it has obviously had a positive impact on the price that the NHS is going to have to pay.

Dr Naysmith

  475. Pursuing that line, beta interferon and MS is very interesting in terms of lots of things to do with NICE and perhaps its future development. It is clear that the initial report of NICE and MS was not very positive, shall we say, and it would have probably indicated that it would not have recommended it for widespread use. It was also clear that there was confusion, partly because it was a progressive, degenerative disease that we were looking at and it was difficult to get a clear and final answer, apart from the fact that it works on a proportion of patients and not on others. The point I want to explore is that eventually a very ingenious solution was arrived at to enable it to stay on the table and be further examined over a period. In the light of what you were saying before about NICE appraisals not necessarily taking place at the same time as things go on the market, (a) there is this ingenious way of doing things, is it likely to apply to other drugs and treatments in the future, and I have forgotten what I was going to say for (b).
  (Lord Hunt of Kings Heath) Clearly that is an important consideration as to whether this is a precedent for the future. That very much goes back to the advice that NICE gives to the Government. We would not have gone down this path had not NICE said in its provisional appraisal that they recommended that the Government talk to the drug industry about whether it was possible to reach some kind of agreement, so that in the end if you like it goes back to NICE and the integrity of their process. This is very hypothetical but one would have to deal with each appraisal on its merits. I do not think you can draw many general principles from what happened with beta interferon.

Mr Burns

  476. If it has been very difficult to assess beta interferon by clinical trials why should a maintenance arrangement give any better evidence?
  (Lord Hunt of Kings Heath) I might ask Mr McKeon to come in on the specifics of that but perhaps I can make a general point. In relation to the consultation that we have just issued we have recognised that there may be certain diseases where it is difficult to come to a definitive view at the time of launch or shortly after the time of launch. It is certainly in our view sensible but we are asking for comments on whether, when we go through the process whereby recommendations are made to ministers as to which appraisal should be referred to NICE or not, it should be referred immediately or whether you should delay it in time for further clinical trial work. That is one of the issues that we are consulting on at the moment.
  (Mr McKeon) Essentially we are doing different things. Clinical trials, which are essentially there for licensing purposes, are conducted over a relatively short period, say two years, compared with the length of the disease itself and the progression of the disease. Most of the impact of the clinical trials was on the effect of numbers of relapses and so on rather than on disease progression, and it is disease progression which has the biggest effect upon the quality of life measures.

  477. Why were there not clinical trials on that?
  (Mr McKeon) Because the period of the clinical trials before it was licensed was not such as to be able to measure what the overall impact of the disease progression was over a ten-year period, which is precisely what the scheme is intending to do. It is also is not intending to have a regulatory absolutism that the clinical trials require. This scheme is essentially looking at how much should the NHS pay in the light of the impact of the drug on the disease progression and that is not something that a clinical trial would ever look at.

  478. It is just those 9,000 people who—
  (Mr McKeon) Who are being monitored intensively.

  479. Is that not a bit rough on the remaining 51,000, or is it a moveable feast?
  (Mr McKeon) No. The 60,000 do not all qualify for treatment under the ABN guidelines. It is only a sub-set of people with multiple sclerosis for whom treatment with beta interferon and beta acetate(?) is recommended by the ABN. It is about 10,000.

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