National Institute for Health and Clinical Excellence - Health Committee Contents

Examination of Witnesses (Questions 720 - 739)



  Q720  Sandra Gidley: At the time I am not sure that the drug had even been licensed.

  Dawn Primarolo: There was a great deal of discussion around it and the Secretary of State was making clear what the policy of the Department is. I would absolutely stress that it is not the role for ministers to contradict, override or directly seek to influence a process where NICE are already engaged in consideration.

  Q721  Sandra Gidley: So no minister at the time tried to influence NICE to speed up a decision or bring anything forward?

  Dawn Primarolo: Not as far as I am aware, no, and if you have any evidence to the contrary please do let me know; but not as far as I am aware, no.

  Q722  Sandra Gidley: How would you see the relationship between NICE and ministers developing in the future because I know from having lobbies that they have had slightly different approaches—I do not want to name names here—and some have been completely arm's length and some have seemed more willing to have discussions with appropriate people. What would your approach be?

  Dawn Primarolo: What do you mean by "appropriate people"—that is my question?

  Q723  Sandra Gidley: At NICE. As we all know, some decisions are controversial or looking as though they are going to be controversial.

  Dawn Primarolo: Indeed, and as a minister—certainly in terms of Members of Parliament and organisations wanting to speak to me directly on issues regardless of considerations being undertaken by NICE—I could not refuse to see people and I doubt if my predecessors would on the basis of, "Sorry, I cannot talk to you at the moment, NICE is considering." But within the process it seems to me that when the priorities have been agreed and NICE has undertaken its work then the Department of Health, including ministers, falls back into a position of being one of many stakeholders who will have views about what NICE is doing and may or may not express those views to NICE. But there is not a route to directly try and circumvent or change the decision that NICE in its independence—quite rightly, because that is the strength of the organisation—both nationally and internationally is doing with its expert analysis. Again, going back to the Chairman's first point about how do you manage expectations, where is the dialogue, what is the engagement, unless you are suggesting to me that I should say to you the next time NICE is considering something that you want to speak to me about, I say, "No, hang on, wait until NICE has finished and then I will talk to you," I think that would be unacceptable. So I think we have to be careful, but let us be clear: there is no way that a minister can override, circumvent, force NICE to come to a conclusion that is not the conclusion of NICE based on their expert analysis—no way—nor should there be.

  Q724  Dr Taylor: Good morning, Minister. I am very pleased to hear that it is not policy to contradict NICE but there do seem to be two examples of conflict. The first one on recommendations for alcohol in pregnancy, and the second one the Department's working group on VTE and the NICE recommendations, which do seem to be pretty different. We heard from the Chair and Chief Executive of NICE earlier that regarding the VTE one the Department's recommendations were really meant to be interim before NICE gave its actual ruling, but as they came out at exactly the same time it is very hard to see how they were interim ones.

  Dawn Primarolo: Can I say on the VTE, they came out very closely together, within about a week actually, although they had different timeframes and originally different expectations. For instance, the Chief Medical Officer's expert working group was looking at recommendations for inpatients in the medical sphere and was also looking very specifically at summarising practice in time for the implementation and particularly when NICE's work came through. I certainly asked this question in preparing for this Committee today—in the discussions that inevitably occurred between NICE and the Department we need to find a way of managing slightly better when the Department is undertaking work because it needs to be giving guidance to the health service in the interim and what that relationship is with NICE. To be honest, in the end there is not a contradiction between the two; they were looking at slightly different focuses. But obviously now that NICE has been asked to go on and complete a fuller position it will be clearer. I think the question was one of handling rather than contradicting in the different pressures in giving advice to the NHS and NICE looking at an area.

  Q725  Dr Taylor: So if the expert panel's report had been labelled as interim guidelines rather than definitive ones and had been brought out when it was actually completed—because it appears that it was delayed by six to nine months at least—that would have helped. Again, what clinicians are bothered about is when they get two subtly different bits of advice.

  Dawn Primarolo: Indeed.

  Q726  Dr Taylor: So should the Department not be either retracting something that it has put out, if it is not the same as NICE? What solution should there be?

  Dawn Primarolo: This is a really complex area. There was guidance being sought from the Department, and I believe this Committee, in fact, looked at the issue. In 2005 the Chief Medical Officer was taking forward the proposals about in the here and now and clarification on practice. If I could answer your question, the essential question is how do we manage the process of making sure that the NHS has, when it needs it, and the Chief Medical Officer recommends, the guidance on practice at the present time, particularly in this area of medical inpatients and NICE's work. I was not a minister at the time but, as I understand it, although there was discussion among the experts as the issue was being developed, and I absolutely concede that it was not a contradiction, the Department is looking very carefully at how it managed that and whether it would be possible to avoid it.

  Q727  Dr Taylor: We were all incredibly impressed with the speed with which the Chief Medical Officer did respond but then completely perplexed when the interim report, or whatever it was, was ready and it was not actually published for months and months so it came out at the same time as the NICE guidelines. Then when you get two things which are subtly different people do not know what to do. All I am pleading for is that this does not happen again and if the Department does put out something that it views as interim guidelines then it is made absolutely clear that those no longer stand when NICE comes out.

  Dawn Primarolo: We will consider that very closely. As I am not medically qualified, I am just a little hesitant in that the advice to me was that the guidance was important. The experts in the field are perfectly capable of distinguishing between the subtleties, as you have put it; that is why they are experts. The essential point that you are making about the need for care and clarity and the relationship between advice, whether it be expert group, Chief Medical Officer or NICE, is certainly one that I think is well taken. I would be pushed to find a reason to disagree with you, and I am not going to.

  Q728  Chairman: Could I ask on that about the issue of the advice to pregnant women. The Secretary of State has been making some very relevant comments in terms of health in terms of life chances at birth, as it were. Here we had advice initially from the Department saying that pregnant women should abstain completely from alcohol during pregnancy, but then NICE guidelines came out to say that they should just limit their intake to less than one and a half units of alcohol per day. If it is so crucial to people's lifestyle in terms of when you are born, as it were, why are we having this contradictory evidence from these two cathedrals that people look to for advice in terms of how they should rule their lives? Who is right?

  Dawn Primarolo: They both are. In May 2007 the Chief Medical Officer made two essential points. First, that pregnant women, or women trying to conceive, should avoid drinking, and I wish the evidence was much clearer because it would make the discussion around alcohol consumption generally easier, not just for pregnant women, but then he went on to say that if they choose to drink they should really try and minimise risk by not drinking, I think it was, more than one or two units once or twice a week. Then NICE put out their guidance which was basically no drinking, or very little. They are in the same area. What will be best is when we have the final guidance from NICE. Both of these areas that you have touched on are areas that are difficult anyway, particularly the issue with drinking. Maybe we should go to a precautionary principle with recommendations for women drinking who are pregnant, or trying to conceive, which I think is what the Americans do, which is just say "don't", but at the moment we are still trying to work through this evidence. I suppose in these contested areas these views will emerge but NICE's final guidance will be final.

  Q729  Chairman: That is likely to be more evidence-based than the CMO's position.

  Dawn Primarolo: I think it will be very helpful when we have a synthesis of the point so that it is absolutely clear to pregnant women or women who are trying to conceive.

  Q730  Mr Syms: We have had several years of large increases in cash for the National Health Service and yet a lot of the NHS cannot afford to implement a lot of the guidance produced by NICE. We are now going into a period after the CSR of rather more modest growth levels and that is going to throw up a number of challenges. How is the Department and the National Health Service going to cope with the situation?

  Dawn Primarolo: First, the role that NICE performs is one of not creating more money in the Health Service but of helping in the most effective and efficient way. In terms of affordability, as you will know the National Health Service has a statutory duty to fund the implementation of the technology appraisals, and that is factored into the spending plans and allocations to the primary care trusts. It is not ring-fenced and we do not hold it centrally but we do our best in knowing the work that is being undertaken by NICE to make those allocations available. Clearly there are always going to be pressures but you are talking about the pressures that the National Health Service itself faces: do we concentrate on giving ever more expensive drugs or do we concentrate more on services, or do we try and strike the balance about what is most effective and the best outcomes. So we try and ensure in the devolving of the monies to the primary care trusts that that puts them in the best position to do that and has the two locked together, the requirement to implement within three months under normal circumstances and the way we try and work out the funding for the primary care trusts.

  Q731  Mr Syms: Clearly we have had a lot of money going into the service, I think we all acknowledge that, and people see NICE guidance being produced, they have an expectation they are going to get a particular drug, but inevitably things are going to get tougher in the next few years. What I am really trying to find out is what is the Department going to do about this? Are they going to put more pressure on NICE maybe to reduce the cost per QALY threshold? How are you going to manage? The gap between expectations and resources is there now and it is going to get bigger.

  Dawn Primarolo: There is not an easy answer. If you accept the proposition that our view as potential patients of the NHS is that we have unlimited expectations, I have already tried to answer that by saying that is a complex web of interactions. Certainly my experience as a constituency MP is that when put to individuals, "Well, we need to have what is effective, not who shouts the loudest", they understand that. That is one set of issues. On the other set of issues, and you mentioned the use of QALY by NICE, you need lots of cold towels, it seems to me, to work through the economics, the methodology and the understanding of how NICE balance this and come to the particular ratio that they do, and they use a great many experts to do that. I take advice on the basis that the consensus is that the methodology currently used by NICE is right, nobody has been able to come forward and say that it is not. That is reinforced by the review, which I presume you might have touched on, that NICE undertakes every three years or so, and there is a consultation to start quite soon in looking at that. That is the other pressure point. The final point is yes, you are right, there is always pressure in the Health Service, but it is true in any health system, whether it is insurance-based, private-based or tax-funded, as ourselves, which is expectation and cost, what is possible in the most advanced technologies and drugs, can be extremely expensive and how do you decide which ones you use. This comes back to my first point that we try and do that in as expert and transparent a way as we can removed from ministers about the optimal use and effect.

  Q732  Mr Syms: We have been told that an independent body should set the threshold used by NICE and the rest of the NHS. Would you agree with that? Do you think that is a reasonable way to go forward?

  Dawn Primarolo: That presupposes there is a better way to do it in the sense of how NICE, through its technologies, and it is a methodology and it is independent, is consulting, is there to take these decisions and make those judgments. It does have support mechanisms to look at that. If there is a proposition that there is a much better way to do this and it can be demonstrated to us then, of course, why would we not want to engage in that discussion, but I need to see where that is as opposed to just a straight proposition that somehow the current system does not work.

  Q733  Sandra Gidley: You said a few minutes ago that the PCTs basically should be forward planning, the money was given to PCTs so that they could implement the technology appraisals guidance. Some of the evidence we have received is that PCTs are under some pressure to implement guidance and effectively by doing that they have to reduce money in other areas of spend which may be more cost-effective. What would your response to that be?

  Dawn Primarolo: What, the PCTs said they are more able to decide on cost-effectiveness rather than the full body of NICE and all its expert panels?

  Q734  Sandra Gidley: No. We are talking about here you have a drug which has to be prescribed and in any area of treatments there are non-drug treatments, so the PCT will possibly have to cut back on those non-drug treatments or even public health measures in order to implement the technology appraisal guidance. Do you believe that having to implement within three months is a good idea given that context?

  Dawn Primarolo: We have a National Health Service and what we ask NICE to do is look at the claims of the drugs, that is basically the exercise they would undertake, assess it against the evidence, compare it against what the National Health Service is currently doing and using, and then it advises on the therapeutic gain. It is basically talking about optimum use. If, having come to that conclusion on something, then they said, "But we're not going to guarantee access through each PCT", would we not be open to a challenge that we were not providing a National Health Service?

  Q735  Sandra Gidley: But is the three months fair because PCTs do have to undertake financial planning? It is difficult to predict, and I know NICE try to help them. It is difficult for a PCT to predict exactly what the spend will be.

  Dawn Primarolo: Under some circumstances it can vary. Perhaps I should ask Felicity to come in here.

  Dr Harvey: There is a waiver system and that is if, when NICE has completed its appraisal, it comes forward to the Department to say, "We think there is a reason why the NHS would not be able to take this forward within the three month funding direction", then there is an opportunity for ministers to be advised by NICE to say, "We think a waiver, either a full waiver or a partial waiver, might be used". Those have not been used in terms of costs of drugs. On the occasions those have been used, and it is not very many occasions, it is usually around a technology that has implications in terms of staffing or reconfiguration of the way a service is delivered. An example of that was surgery for obesity. There have been a few examples but there are not very many. It is not just when it is just utilised for a drug. Is it worth just mentioning that not all NICE technology appraisals on pharmaceuticals are actually driving up cost. For example, a technology appraisal that we had on statins, which was the evidence-base that fed into the Better Care, Better Value indicator for the NHS, said that actually in terms of statin provision there is evidence to indicate for the majority of people you should start treatment on a drug that has a lower cost rather than one of the drugs that is now generic, and it is only if that is not effective that you then move up. Particularly with multiple technology appraisals and, indeed, the clinical guidelines that NICE provides, it is providing advice to the NHS that is helping them utilise the resources in delivery of services in slightly different ways. As I think you were discussing slightly earlier with Sir Michael and Andrew Dillon, they are now publishing their optimal practice reviews where there is evidence drawn from their guidelines and technology appraisals to help the NHS realise the sorts of interventions that are going to be effective and better help them utilise their resources.

  Q736  Sandra Gidley: Sometimes they are not directly competing services that have to go though. For example, in a previous inquiry on NICE we were told that various recommendations for cardiac payments meant that they could not afford the cardiac nurses to provide rehab and various other things and, given the choice, they might have felt that was a better use of resources. What assessment has been made of these perverse impacts?

  Dr Harvey: If you are talking about a technology appraisal, that is why NICE would on occasion advise ministers that, in fact, they think a technology appraisal should not be supported by the three month funding direction. If it is around a clinical guideline, also as Sir Michael and Andrew Dillon said earlier, those are not mandatory in the same way that technology appraisals are and that is because different parts of the NHS would be at different positions in terms of the model of the services they are currently delivering. Some may be very close to what the guideline is suggesting is the best way of providing a service and others might have a further distance to travel. That is why, as they were saying, the expectation is on those occasions that a PCT would look at what a guideline shows, where their practice currently is and how they might move to that over a period of time.

  Q737  Sandra Gidley: A change of tack slightly. Some PCTs play the system quite well and there will be something they have to implement and to tick the box they provide a small amount of funding for a particular treatment but that funding will only treat half or even a quarter of the patients who could benefit. What levers does the Department have to investigate those cases where patients are being denied a treatment simply because they are too far down the waiting list?

  Dawn Primarolo: Can you give me an example before I answer the question?

  Q738  Sandra Gidley: I can give you an example. The drugs for rheumatism. This is a local example. The PCT would only fund for 12 patients but the consultant had far more on his list. We eventually got the strategic health authority involved but it took a lot of time, persistence and energy to tackle that. It must be happening all around the country in a similar way to restrict in a finite way what is potentially not a finite demand.

  Dawn Primarolo: In the circumstances you have touched on, although you said it was extremely difficult to get the strategic health authority to focus on it, where the Department is involved through the strategic health authorities they would be looking at the PCTs that they might consider to be "outliers", and then get the strategic health authority to engage with that PCT and produce an indication over what time period they would come up to where they should be or where the expectation was. If you have a particular example, particularly given my period in post is only four months, from your experience with your PCT and strategic health authority about the operation of that, I would be happy to look at that. That is the interaction between the Department and the strategic health authorities trying to work with the PCTs to bring them to the position where they should be over an agreed period of time.

  Q739  Dr Stoate: Minister, I want to talk about the PPRS. It has been around for about 50 years and, generally speaking, I think it has served the country very well, and broadly speaking your predecessors and industry alike seem to think it is not a bad system. However, it is quite a blunt instrument and one of the side-effects of it is that companies that produce the most useful drugs are not effectively rewarded any more than companies that do not produce necessarily the most useful drugs. The question I want to ask is how can you justify that? Do you think that needs to be looked at to encourage more innovation?

  Dawn Primarolo: Certainly the Government has indicated through the work that Lord Ara Darzi is doing that the role of innovation and the speed at which both technologies and drugs are available and get to the market is something that is crucial and needs to be looked at. The Health Innovation Council which is going to be established is designed to do that. Its interaction with the current fora where the Government discusses, whether it be with diagnostics, with the drug industry, will have to be part of that. If I can put that to one side, Felicity is leading on that and if you want to ask more specific questions on that perhaps we could come back to it. On the question of the PPRS itself, as you will know, I hope, the Department is shortly to commence negotiations with the industry, the pharmaceutical industry, and we are hoping to achieve a voluntary agreement that will replace the agreement we have now. We have laid out the principles we want to pursue, which is delivering value for money, encouraging and rewarding innovation and providing stability, sustainability and predictability in that whole very difficult area which I suppose we touched on right at the beginning of the questions on rationing. I am not able to explore that discussion any more but it is an important interaction around the availability point that you are making here. I am not quite sure how I can keep the Committee informed of developments but I am happy to try and do that through my officials. At this particular time, as we are on the eve of engaging, it would be a bit remiss of me to lay out our negotiating position now.

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