National Institute for Health and Clinical Excellence - Health Committee Contents

Examination of Witnesses (Questions 540 - 559)



  Q540  Dr Stoate: I thought it might be.

  Professor Devlin: Obviously, there is a difference between what NICE might say about its threshold—because what we have been discussing so far is the means by which it expresses that threshold—and what it actually does. They may be two different things. In the evidence we provided to the Committee reference was made to a study also done at City University. That study looked at the thresholds implied by NICE's own decisions. The results suggested that the actual threshold was considerably higher than £30,000 because of the number of special cases and decisions made in favour of drugs which were a lot higher than £30,000 per QALY.

  Q541  Dr Stoate: But whatever the figure is do you have any research evidence that other treatments are being crowded out because PCTs have to provide these drugs whether they like it or not? Is there any evidence that other treatments are being effectively sidelined, marginalised and pushed out altogether because of NICE's decisions?

  Professor Devlin: We were very interested in exploring this question. Methodologically, it is incredibly challenging because it is difficult to track through exactly what is crowded out as a result of the introduction of new products because of NICE-mandated decisions.

  Q542  Dr Stoate: Clearly, there must be some evidence of it. Obviously, there is an opportunity cost for every new drug that comes in. If you spend money on one thing you cannot spend it on something else. As PCT budgets are effectively ring-fenced, as is the entire NHS budget, there must be a squeezing out somewhere. If you have to spend £1 million on Herceptin, for example, you have to find that sum from elsewhere. What work has been done to find out where that money has come from and what effect it has had on the wider NHS?

  Professor Devlin: I do not think there is any direct evidence. You are preaching to the converted with respect to opportunity cost, and that would be an extremely interesting and important question to answer.

  Q543  Dr Stoate: Why do you suppose no one has looked into it before?

  Professor Devlin: I think that NICE guidance is part of a package of pressures that are binding on PCTs and include a wide range of targets and other imperatives that it faces. It is very difficult to disentangle any one aspect of that bundle of pressures and identify its specific impact.

  Q544  Dr Stoate: But it is essential that we do. For example, how can the public decide whether or not they want a particular treatment if they have not understood the implications of other treatments?

  Professor Devlin: What has to be foregone in favour of them? The only evidence of which I am aware in this context is anecdotal and it comes from consultants, reports in the media and things of that nature. As far as I am aware there is no hard evidence on opportunity costs associated with specific guidance.

  Q545  Dr Stoate: That is of concern to me. The other matter that concerns me is whether there has been any modelling of the effect of future NICE decisions. If NICE goes on making decisions in future at the rate it is now making them is there any modelling on what the effect may be on PCTs?

  Professor Devlin: Not to my knowledge.

  Professor Appleby: There is very short-term "modelling". The Department of Health would claim that it makes an estimate of how much NICE decisions will cost the NHS in the next year or two, so that is as far as it goes. The figures we have had for England over the past four or five years have been in the £300 million to £400 million range. What the Department says to PCTs is that when it makes its allocations part of the extra £300 million to £400 million is to cover this very issue, namely that NICE will be making recommendations and they will have to abide by them and commit funds to them. There is an opportunity cost in some sense, but existing services should not be stopped to fund new ones. That is the Department's argument. It is almost universally believed in the NHS that that is not the case and that money is not ring-fenced but is notionally in the big lump of money that PCTs get. In our research with NICE we interviewed directors of public health and their colleagues in PCTs. We asked them questions about the effect of a decision by NICE and so on. PCTs will not directly link a decision that it takes about NICE with something else that it does. Every decision seems to be separate. The only evidence is anecdotal evidence from directors of public health. For example, a particular director of public health was very concerned about a cessation of smoking clinic which was stopped. He felt that that was a cost-effective use of the PCT's resources, but it was all mixed up with the then current climate of deficits and the need to cut back a bit. This was seen as a bit of an easy target; it was not affecting people's health today and so on.

  Dr Stoate: The bottom line is that we do not know, and do not seem to have any method to find out, whether or not it is affordable. As a committee where are we supposed to go if we do not know whether or not NICE's decisions are affordable and do not appear to have any method of finding out? It is hopeless.

  Q546  Charlotte Atkins: For instance, a number of PCTs do not fund IVF treatment despite the fact that they have a NICE guideline to say they should. Is that being crowded out or is some sort of value judgment made by PCTs that that is not the kind of service they want to provide?

  Professor Appleby: I do not know what the decision of those PCTs is. NICE guidance is that it must be complied with. I do not know what excuse a PCT would have for not complying with that guidance.

  Q547  Charlotte Atkins: Certainly the ones that you have investigated or observed have not disinvested from that sort of treatment?

  Professor Appleby: Not as far as we are aware.

  Professor Devlin: There is also a very complex issue specifically around IVF because the provision of that service across the country was already uneven prior to guidelines being issued on it. You may well have some PCTs moving towards it from different directions. Amongst our sample we had some that had altered their provision of this service. It was not a question of whether or not IVF would be provided; there were more subtle ways to deal with it, for example in relation to the eligibility criteria but also the number of cycles that might be funded.

  Professor Appleby: Often decisions were not that they had been funding the service but they then decided not to fund it at all. A lot of it came within the phrase "managed access". Therefore, PCTs came up with criteria which perhaps changed the age range for eligibility for a service, the severity of the illness had to be at a certain level before they would agree to fund and so on. There was shaving around some of the services. The service still existed but in a slightly reduced form.

  Charlotte Atkins: My PCT has perhaps been slightly more honest in saying that it will not fund IVF treatment until it reconsiders it in the next financial year.

  Q548  Mr Scott: Do you agree that if services are squeezed out and patients do not receive the treatment and drugs they need—indeed, if there is even loss of life—it is fundamental that such a report should be produced to show the effects?

  Professor Appleby: I absolutely agree. The big assumption here perhaps is that everything the NHS currently does is absolutely great, is being provided efficiently and is of maximum benefits to patients. We should not assume that. Maybe some things are being crowded out because they need to be in that they are less value for money and so on. One cannot assume that all the NHS does at the moment is right.

  Professor Devlin: I agree that much more evidence is required around that. In general, there is inferior evidence about the cost-effectiveness of a lot of what the NHS does compared with the kind of evidence that exists on the new drugs at which NICE looks. I believe that that is part of the challenge faced by PCTs. The cost-effectiveness of a lot of what PCTs commission simply remains unknown, so it is extremely difficult for them to make decisions about what should be foregone when confronted with an imperative handed to them by NICE.

  Professor Appleby: That was reflected in another finding in our work. PCTs appear to spend an inordinate amount of time fretting about rather small amounts of money. They control hundreds of millions of pounds of NHS money, most of which flows straight to hospitals and other providers, yet PCTs set up exception panels to deal with individual patient cases and treatments because they have managed access policies and certain criteria have to be fulfilled. It needed almost all the time of a couple of public health officials to deal with that. Some of the decisions might involve perhaps £50,000 or £100,000 and yet behind them millions of pounds were flowing through the system. It was something that we knew about. It is really shocking that that happens. In part it is to do with their resources. They do not have the staff, skills and so on, but they also do not have the information about cost-effectiveness.

  Q549  Sandra Gidley: As a follow-up, has anybody looked at the cost of these panels and compared it with the cost of the technologies that they turn down? That might be quite an interesting study.

  Professor Appleby: Yes. Nobody has looked at it as far as I know. All the PCTs we looked at, I think, devoted considerable amounts of time to it.

  Professor Devlin: I believe that they are required to do so. There cannot be a blanket exclusion; there must always be a process around allowing exceptions. The management of that process is extremely time-consuming. We could perhaps talk of more general issues to do with the management of disinvestment generally. I absolutely accept what you say about the opportunity cost of NICE guidance which is crucial. There are also difficulties faced by PCTs in relation to disinvestment generally, not just what information should inform that, but also the sensitivities that surround any attempt to disinvest from any service.

  Q550  Sandra Gidley: How can NICE encourage more disinvestment decisions because it appears that is part of the equation that is not being dealt with very effectively by anybody?

  Professor Devlin: It can help inform those decisions. One of the aspects of PCT decision-making that we found was a desperate demand for information on what services were poor value for money, what should it be disinvesting from, what would be the appropriate responses to cost pressures and so on. We found instances of PCTs working together to try to create some sort of information and evidence base on which to do that. Clearly, there is scope to do that on a much greater scale to improve the information available to PCTs on services that are demonstrably poor value for money that perhaps they ought not to be funding. Perhaps NICE or some other organisation can play a greater role in that. PCTs simply do not have the analytical workforce to make that sort of effort and it would be ridiculous for each PCT to duplicate it. Maybe some sort of clearing house to assist in and inform those decisions would be a good idea.

  Professor Appleby: There is another bigger issue here about the state of commissioning within the system which is an apparent failure. I gave the example of PCTs worrying over relatively small amounts of money. One would hope they would be looking at their whole budget and making decisions on how to get the biggest amount of health and reduce inequalities with all the money they use. There is an issue about the inequality between the purchasers and providers in the system. The latter have a lot of power. Another issue to emerge from PCT decision-making was that cost-effectiveness might be a criterion but political acceptability was another. Could they get hospitals and others to change what they did? I believe there was a good deal of pessimism on the part of PCTs. They felt relatively powerless. They were the ones with the money which they handed over, but it was just flowing through the system as if they did not have much control over it.

  Q551  Sandra Gidley: NICE is supposed to be doing some of this but it has done comparatively little. Should it do more? Should any disinvestment recommendations have the same weight as a new technology that is approved? Would that be helpful?

  Professor Appleby: Yes. Relatively recently, they have set up or at least assigned some resource in terms of people and effort to look at disinvestments a little more thoroughly. It is much easier to introduce a new service or have more of something than to say it should be stopped, especially when the argument in the public mind is perhaps not that clear cut. The idea that if something is not killing you and may be doing you some good it is probably worth having is not how NICE or the NHS should operate. The area of disinvestment is a much more difficult area to go into, and that is why I believe PCTs need a lot more support. NICE could do more on that front, and I am sure it wants to.

  Professor Devlin: The answers to your question are yes and yes. I think PCTs would find it enormously helpful if perhaps they were empowered to make decisions by having an evidence base to support them, whether that is provided by NICE or some other organisation.

  Professor Appleby: NICE collects evidence but it is of an average nature and does not necessarily apply to a particular service in Colchester bought by a specific PCT. The cost-effectiveness evidence will vary from area to area and that is to do mainly with the way the service is provided. As we know, hospital efficiency varies. That is another issue for individual PCTs to grapple with. They may have evidence from NICE that something is cost-effective, but locally it may not be that cost-effective because of the way it is supplied. That means gathering data about the efficiency of local hospitals and so on. It is not simply a case of having a leaflet saying that it should buy this but not that. That is also where they need help.

  Q552  Dr Naysmith: A good number of our witnesses and the evidence we have received suggest that there should be a lot more public discussion in a broad sense about the rationing of healthcare, healthcare facilities and so on. Do you believe that that should happen more, and can you suggest mechanisms by which it may be achieved? We all know about things that have happened in the past, for example the ranking of services and creating lists with mental health ending up at the bottom and heart surgery at the top. How does one get an open discussion about resources in the National Health Service and what can be done with them?

  Professor Appleby: I absolutely agree with you. I hope we have made clear that the issue about the threshold is absolutely fundamental. I cannot think of a more fundamental issue to do with the NHS given the way it is funded and so on. It is not merely of academic relevance—I apologise for using that term pejoratively—but of absolute relevance to individuals in terms of the services they get and so on. It is their money, frankly, and they need to be involved in these things. I do not mean that necessarily they should be involved in decision-making in a fantastically detailed way, although there could perhaps be more room for that, thus bringing some of these issues to the fore, but they need to be aware of the decisions that the NHS has to take on their behalf. One idea at the back of our minds is the creation of an independent threshold-setting group. That would then bring these issues out into the open much more and lay out the trade-offs and difficulties. PCTs and the NHS are not bad people who are trying to deny treatment; they seek to do the right thing. NICE also tries to do the right thing in difficult circumstances, and people also need to understand that.

  Professor Devlin: The involvement of the public has perhaps been seen as rather difficult. The idea of a cost-effectiveness ratio is not necessarily the easiest concept for people to come to grips with; nor is the idea of a quality adjusted life year, but perhaps more effort needs to be devoted to trying to explain those concepts in easily accessible ways, engaging the public in what is acceptable value for money. These debates should be more explicit and there should be more discussion on very difficult decisions, for example on third line cancer drugs that extend life by a month. What exactly should society be prepared to pay for that? What is that health gain worth? There are ways to express these things so that people can become engaged. I believe that it would help tremendously to try to get the public to acknowledge that when a new drug is developed it can be purchased and it can be benefited from, but that something else is necessarily foregone as a result.

  Q553  Dr Naysmith: That is the crux of the matter, is it not? I quite liked Professor Appleby's earlier statement that NICE had almost a technical function to perform. It should say that something is value for money and its threshold for the value is such and such. There should then be another body that looks at it and decides that if that is to be paid for it will push out something else and not everything can be paid for. What should be the role of NICE in this rationing debate, if any?

  Professor Devlin: I suppose the response to that depends in part on whether one believes that the threshold should be decided by NICE or a body somewhat external to it. Certainly, everything that NICE does provokes and informs that debate and provides an opportunity to raise public understanding. Every time a new piece of NICE guidance comes out we receive calls from the media asking us to comment on what it means, what will be foregone and so on.

  Q554  Dr Naysmith: Part of the problem is that some of the evidence is not that easy to use for the purposes of decision-making. You mentioned end-of-life cancer drugs. They will not say that they will prolong life for a month but that on average they will prolong life by between a month and three years. Maybe a month is not of much use, but many argue for three years and yet you do not know which it will be for you. That is a very difficult decision on that sort of evidence.

  Professor Appleby: There is always uncertainty in these matters. There is an issue about what NICE looks at and what its agenda is, as it were. Why does it look at certain treatments and not others? Why is one treatment considered before something else? There may be an issue here about who sets NICE's agenda. In part, it is not just about individual treatments and cancer drugs, which are expensive and require decisions, but there are other things that go on in the NHS. For example, the dominant policy aim of this Government and previous ones has been to reduce waiting times. I am not aware of any figures to show how much money we have spent doing that, but it must run into billions over the past seven or eight years. That is a lot of health money to spend and it has an opportunity cost. I am also unaware of how many quality adjusted life years have been generated by that money; I have seen no research on that. There may be an issue here about at least demanding of government that in producing policy it also says something about the benefits and how much they will cost.

  Q555  Dr Naysmith: If one goes down that route one will end up saying that the answer is democracy. One lays out everything one knows and then says, "You want to do this and you want to do that." That is where it ends up.

  Professor Devlin: But that has to be facilitated by information and evidence.

  Q556  Dr Naysmith: We are all agreed that more information is needed, but how do we get the discussion going? I agree that evaluating the worth of some of the more political matters is very important but it is difficult.

  Professor Appleby: We have had cycles about the debate on rationing. For the past seven years it has gone a bit quiet. I suspect that that is because so much money has been coming into the NHS. There is perhaps a feeling that there is no need to ration; it has the money to employ people, to expand and so on. It will come back again. The NHS has a new settlement for the next three years, but it is less than half the real rate that it has received over the past seven years. That may focus some people's minds as well.

  Professor Devlin: It is a very difficult debate to get going in the current climate. A big policy theme within the NHS has been improving patient choice. Patients are encouraged to choose what treatments they get, where and when. That sort of theme around responsiveness and individualisation of treatment alongside a debate on rationing in the health service is somewhat uncomfortable, is it not?

  Q557  Dr Naysmith: Let me change the focus slightly to the level of the PCT. You will remember that Primary Care Trusts were set up to reflect local needs. Each Primary Care Trust would be able to use its budget to do what is best for its locality. NICE guidelines and directives remove that sort of ability and one ends up with a postcode lottery. Is there any way that we can incorporate NICE guidelines and advice and still reflect local needs?

  Professor Devlin: My colleague touched on this earlier. Any piece of advice that comes down from NICE is based upon a cost-effectiveness ratio with evidence around both costs and improvements in health outcomes. Clearly, there are opportunities to tailor that sort of data to local settings to reflect different cost conditions, different patterns and modes of delivery and different epidemiology in a PCT. That sounds quite ambitious. Knowing what we know now about the way PCTs go about making their decisions and the nature of the evidence they have at their disposal, the idea that evidence is either widely used or is tailored in that way is an over-optimistic description of what is actually done.

  Q558  Dr Naysmith: But if PCTs were obliged to explain their decisions to the local community and what evidence they used to make them and get feedback would it help?

  Professor Devlin: Yes, absolutely, and they should do so. Some work has been going on in the Department of Health over the past few years to collect and publish information on the amounts of money PCTs spend on different disease areas. The national programme budget project has produced some very interesting information, not the least of which is to show the enormous variation in spending between PCTs. Even when account is taken of different needs and areas one still ends up with two or three-fold differences in spending on different disease areas. I believe that PCTs are hard pushed to explain why they are doing this but they should explain themselves.

  Q559  Dr Naysmith: Should they have more local or public meetings or ask people how it should be done? They are appointed rather than elected bodies.

  Professor Appleby: You may have attended some public meetings of PCTs.

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