Select Committee on Health Minutes of Evidence

Examination of Witnesses (Questions 540 - 559)



  540. How do you then reconcile that position with optimising devolution in the Health Service, if what you are really going to say to every health authority is, you can do what you want as long as you produce the same amount of drugs?
  (Lord Hunt of Kings Heath) The establishment of NICE alongside the Commission for Health Improvement and the financial service frameworks allows us to devolve more. The whole problem of the NHS, or one of problems—apart from the lack of resource for many, many years and the lack of capacity—is this huge inconsistency. If through NICE, if through National Service frameworks, if through the reviews of the Commission of Health and Improvement we can ensure that when it comes to clinical services there is a consistency of approach throughout the NHS then you can afford to devolve many more decisions to the local level. You probably know the Secretary of State in a speech about three or four weeks ago spelled out his vision in which, first of all, setting up these national bodies, then making them independent, as we have done, you can then allow much more freedom of movement at a more local level. The fact that we are requiring NHS bodies to finance the cost of NICE guidance is a small price to pay for that.

  Chairman: I should keep off that speech if I were you, Minister.

  Mr Burns: The Chairman is not very keen on it!

Dr Naysmith

  541. Those two answers, Minister, raise the question, how is it that NICE decides on which topic to appraise? There are some cynics who suggest it must be something to do with the pressure from drug firms or it may be to do with certain diseases and certain things that you hear about in the press. Could you tell us how that is done?
  (Lord Hunt of Kings Heath) Let me make it clear that, first of all, it is the Department of Health and ministers who decide in the end the work programme of NICE and the particular technologies that they would appraise or the guidelines they develop. That was only done after a very careful programme of work. We have Birmingham University undertaking horizon scanning, which is trying to pick up new developments and new technologies that are about to come on stream. Other organisations, as we have heard, are invited to put forward suggestions. All those are very carefully considered. We seek expert advice as well to advise us on the likely impact and actually the practicality of whether in a particular technique there is enough evidence in order for NICE to make a decision. A very careful process is gone through before ministers make the final decisions.

  542. You talk about innovations and innovating techniques, personally I am aware of a number of long existing techniques, and we have heard on this Committee about the wisdom of the National Health Service, do they get sufficient push from somebody to urge that they be appraised, some of them for the first time ever?
  (Lord Hunt of Kings Heath) There is a balance here in relation to new technologies and existing technologies that for one or other reason need to be given the NICE Review treatment. We will try and keep the balance there. I have already intimated that over the next five to 10 years the expectations that we will reach a position where any significant new technology where there was likely to be any doubt or controversy over cost-effectiveness and clinical effectiveness would be reviewed by NICE after launch or within a short period of time after launch. I also wish to see that over that time period we will pick up existing technology where, again, there is significant concern or a difference of view and where there is controversy. That is certainly our aim. The difficulty is we cannot fit everything in in each work programme and unfortunately some are having to be held back.

  543. Do you think process is transparent enough, the selection process? Is there anything that could be done to make it more inclusive and more transparent?
  (Lord Hunt of Kings Heath) We are consulting at the moment on the consultation process. There are a number of things we are doing, we want to make it easier for organisations and individuals to put forward ideas for possible considerations, that is the first point towards transparency. We have a Technologies Advisory Group within the Department, at the moment it is mainly staffed by officials in the Department and the National Assembly for Wales, and we want to extend that and bring in more people from the NHS and patient groups and, indeed, industry. It is bringing outside people in. We are also suggesting that we give fuller information on the rationale for the topics that we suggested. I hope that with those changes which, as I say, are subject to consultation, people will feel it is a transparent process, with ministers ultimately making the final decisions.

Julia Drown

  544. One of the roles of the Institute is to promote innovation and ultimately is there not some tension between promoting innovation and maximising health gains at a minimum cost? One of the bits of evidence we have had is a concern that when decisions are coming out and when topics are selected by the Department it is not clear whether that is being done because of patient issues or whether there is an issue there about promoting innovation, ie new drugs. Can you comment on that?
  (Lord Hunt of Kings Heath) Promoting innovation is very important. For instance, if we are talking about drugs particularly, this country has a very strong R&D industry and 23 per cent of all commercial R&D investment in this country comes from the drugs companies, so it is clearly a very important issue for this country that we have a climate in which innovative R&D takes place. Traditionally, the NHS has been very slow on the uptake of new medicines. Comparative work that we have done comparing this country with other countries shows that Britain is particularly slow in doing so. I think you can argue from that that NHS patients do not always get the benefits of medicines that might prove to be both clinically effective and cost effective. We want to get to a position where any significant new drug where it looks like there might be doubts about it in the NHS as to whether it is cost effective or not is appraised at a very early stage. If you could do that—and that is our aim—then you are likely to see a much faster uptake of those drugs which are cost-effective and on which NICE's advice should be taken, so I think we can get over some of those problems.

  545. But it is important that patients see NICE as independent not only of government but independent of the pharmaceutical industry. Is there a concern that as long as the promotion of innovation (which can, equally, be interpreted by some as promoting pharmaceutical companies) is in there as a role for the Institute, then patients are going to be suspicious that what is going to be pushed here is pharmaceutical interests and not the interests of patients? A physiotherapy treatment, by contrast, is not going to have much clout and be able to push its way forward in the way that pharmaceutical companies might.
  (Lord Hunt of Kings Heath) But innovation and the industry's role is not just about drugs. I just used that as an example. I mean innovation as innovation throughout the whole clinical—

  546. But you accept that pharmaceutical companies have much more clout and many more resources to push their case than others?
  (Lord Hunt of Kings Heath) I have to do that. I sit listening to the industry talk to me about these matters and I have to say they are not enthusiastic exponents of NICE so I guess NICE has got the balance right. To go back to drugs, we do want to get good, new drugs which are going to be clinically and cost effective. We want to get them out into the NHS quicker than we have been able to do before. I believe patients gain from that. I also believe that the processes that NICE have should ensure that they protect patients from drugs coming into the NHS because NICE would not find them cost effective and clinically effective unless there was robust evidence to support that. In the end you go back to the evidence base. The whole point of NICE is to make judgments on the basis of the best evidence available.

  547. Sure, but to make that crystal clear, should not NICE be under the part of the Department responsible for quality of care and for public health, rather than the part of the Department responsible for the health of the pharmaceutical industry?
  (Lord Hunt of Kings Heath) Whichever way you cut the cake, you are always going to have to balance these different viewpoints and interests. I do not think, frankly, that having NICE where it is placed in the Department at the moment is any inhibition or leads to any particular favouritism for the pharmaceutical industry. If you were to ask the pharmaceutical industry, they would probably say that they have concerns that their interests have been suborn to those of NICE. From where I sit, because I have to deal with both sides (if we are talking about sides) I believe we can take a very robust, balanced approach.

  548. Can I come back to one issue about the national versus the local tension. We have had the example of herceptin brought up and health authorities having to decide in advance of NICE guidance whether or not they should be recommending to their commissions that it should be prescribed and whether or not they fund that. If local authorities are having to make that decision, is there not a case for being more public about x pounds per QALY? We know herceptin costs £2,600 for the first 12 weeks and then some on-going costs past that. If they are trying to mirror what is going to be coming out from NICE do they not need to have those guidelines in order to make their own decisions?
  (Lord Hunt of Kings Heath) I do not think that is for the Department or the Government to do. I think methodology as far as NICE is concerned is very much up to NICE. Obviously one of the things that we have said to NICE is that we want them to be more open about their methodology and the kind of factors that bring them to make such decisions. Perhaps I could ask Mr McKeon to answer specifically on that.
  (Mr McKeon) NICE routinely put their appraisal documentation in the final documents. We have seen the final cost per QALY or other relevant measures—cost per life gain, or whatever seems appropriate for the particular drug or treatment concerned. Also, of course, Sir Michael Rawlins has gone on record with his own appraisal of NICE's track record. I think he did this at the NICE conference, which has been quite widely publicised, and talked about the kind of considerations that NICE have and the sort of cost per QALYs that were emerging. That has been there for the NHS to see.

  549. These are the ones you have approved so far but he has not created a situation that says, "this is the slice point where we think that is worth it, that is not worth it".
  (Lord Hunt of Kings Heath) No, he has very clearly said that there is not a threshold and that seems to be right, there is not a clear threshold for saying yes or no. You have to look at the circumstances of every individual case rather than saying it "X cost per QALY and it would definitely be no". He has given an indication that if it goes above a certain level then serious questions have to be asked about it.

Julia Drown

  550. That exposes the issue that it is difficult for people on the ground to make those decisions. There are going to be those local tensions because some health authorities will be saying X to one QALY and another will be saying Y to another QALY, depending on their particular regimes.
  (Lord Hunt of Kings Heath) I think we can recognise there is very much a tension there between a local implementation and a national one.

Sandra Gidley

  551. I apologise for not being able to be here for the early part of the meeting. Either I have misunderstood or there is a certain amount of disingenuity here. I thought the Minister just said that the quality of life and the cost effectiveness was a NICE decision, but surely if NICE's remit is affordability —
  (Lord Hunt of Kings Heath) No, it is not.

  552. Professor Rawlins said yesterday to a briefing of MPs that NICE's remit was affordability.—it is certainly in many of our briefing papers that NICE has to look at affordability—
  (Lord Hunt of Kings Heath) No.

  553. You had better tell NICE that because they are going round with a different story. How can NICE assess affordability if they do not have any input from the Department of Health?
  (Lord Hunt of Kings Heath) Let me make it clear that their judgment is whether a technology is clinically effective or cost effective. It is our job to deal with affordability issues—clearly because it is our job to fund the National Health Service. Obviously we can write to you further about that but that is the broad principle that we have agreed.

  554. We are not all singing from the same hymn sheet at the moment, I am afraid. I also have other questions. I would also like to be pick up on the issue of openness. NICE itself does seem to be reasonably transparent. Where the whole process appears to get a bit murky is when you try to assess the interests of groups that feed in and advise NICE. I was delighted to see the consultation paper on the Technologies Advisory Group yesterday. We have been trying to find some information on the interests of the people who are currently at NICE and it is incredibly difficult to get hold of. Will the new, more transparent system make sure that all interests are declared and they are actually placed on the NICE website so that everyone can see who is influencing who? We also have a problem at the other end of the scale, where we have the assessment centres and it is not always clear where those particular universities and centres are getting their funding from. Again, where is the transparency round those fringe elements? Where is that going to be?
  (Mr McKeon) TAG, the Department's Committee which is predominantly comprised of civil servants.

  555. That is what I would like to know, who is on it if they are advising?
  (Mr McKeon) There is a registered declaration of interests of those on the Committee, but you would not find that on NICE's website. That is the Department of Health. The assessment centres are effectively funded by the NHS fund and R&D budgets, they are not funded by NICE, they are funded by us.

  556. I realise that, but the same assessment centres also receive certain pockets of funding from drug companies and anywhere else, they have to these days because of the under funding of universities. Where are we going to find out who is funding those assessment centres? I am told it is usually fairly obvious which of the six assessment centres the technology is going to be allocated to?
  (Lord Hunt of Kings Heath) I think as far as the assessment centres are concerned that is very much a matter for the assessment centres concerned. The whole point about the NICE process, surely, is this, ultimately, that you need as robust a process as possible, as we have got, to make sure that their decisions are based on the evidence that is available. As far as the question of the selection of topics is concerned that is for ministers to decide. Of course we seek advice, and that is what the Technologies Advisory Group is all about, essentially it is an internal group within the Department which looks at the proposals that come forward and then makes some judgments and recommendations based on essentially whether there is likely to be enough information available in order that an appraisal can be conducted effectively and then based on decisions to do with priorities within the Department and looking at the shape of the whole programme to see whether there is a balanced programme. I think that in terms of the priorities of the process I am satisfied that it is a perfectly appropriate process and one which, at the end of the day, these ministers decide on which appraisals should be done by NICE.

  557. Yesterday's consultation document says, "We propose to re-establish TAG so that it includes wider representation for NHS frontline bodies, patients, professional groups and industry". What I am asking you is how the public and how politicians know exactly where those people are coming from and what onus will be put on those people to declare their interests so that the process is transparent?
  (Lord Hunt of Kings Heath) That is clearly a matter which we need to consider in relation to the consultation process. We put this out to consultation and will be seeking views, and we will be considering issues like that as we come to conclusions. Obviously we want this to be a process in which people have confidence. Where it is right that people should declare interests obviously we will want those to be declared. The Department has its own clear rules on declarations of interest. I do not think that should be a problem, it is certainly something that we will look at.

  558. We will all know where to find those interests should we wish to?
  (Lord Hunt of Kings Heath) We need to see the end of the consultation to see what we are going to do and the way we are going to prepare this. We will look at the issue of the declaration of interests. Again, I would say that it is in all of our interests to make sure that the process has as much integrity as possible because so much is riding on this being a thorough, comprehensive process.

  Dr Naysmith: It is very difficult to find any scientist or a laboratory in which the work is not getting some sort of funding from some market or organisation or other, not necessarily pharmaceutical. The point I wanted to pick up was what Sandra said when she started asking questions, I was at the same meeting and I do not believe the reference was to afford ability, I think he said cost-effectiveness.

  Sandra Gidley: I was talking about the lung cancer drug.

  Chairman: There we are!

Dr Naysmith

  559. Certainly talking about cost-effectiveness is very much part of the process.
  (Lord Hunt of Kings Heath) On the other point that you raised in relation to the number of experts who one way or another have connections with the industry, that is a feature which is apparent. NICE has, I think, described to you the way in which that is dealt with within the Committee process, which seems to me be an acceptable practice.

  Dr Naysmith: On that topic, attributing it to where it came from, it came from Mrs Thatcher's government, when she insisted that independent institutions, of which we had a great number, all had to seek grants in the same sort of way as other institutions, often from commercial sources, which means there is no such thing as a truly independent scientific government and scientific institution.

  Chairman: Who sponsors you, Doug?

  Dr Naysmith: Nobody sponsors me.

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