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UNCORRECTED TRANSCRIPT OF ORAL EVIDENCE To be published as HC 194-i House of COMMONS MINUTES OF EVIDENCE TAKEN BEFORE HEALTH COMMITTEE
MS SOPHIA CHRISTIE, SIR LEN FENWICK and DR ALISON JONES HILARY WHITTAKER, PROFESSOR KAROL SIKORA and DR JACKY DAVIS Evidence heard in Public Questions 1 - 148
USE OF THE TRANSCRIPT
Oral Evidence Taken before the Health Committee on Members present Mr Kevin Barron, in the Chair Sandra Gidley Dr Doug Naysmith Dr Richard Taylor ________________ Witnesses:
Ms Sophia Christie, Chief
Executive, Birmingham East and Q1 Chairman: Good morning. Could I welcome you to what is the first evidence session of our inquiry into top-ups and improving access to medicines. I wonder if I could ask you, for the record, if you could give us your name and the current position that you hold. Ms Christie: Sophia Christie; I am the
Chief Executive of Sir Len Fenwick: Simon Fenwick; I am the Chief Executive of the Newcastle-upon-Tyne Hospitals NHS Foundation Trust Dr Jones: Dr Alison Jones; I am a medical oncologist and here for the Royal College of Physicians. Q2 Chairman: Thank you, and once again welcome. I have got some general questions, and we will start with general questions to all three and then some of my colleagues will get on to specifics to individuals in a few minutes. Why was the Richards Review of patient access to unfunded drugs commissioned? Was it a reaction to pressures from the lobbying of patient groups, the pharmaceutical industry or parts of the media - or a mixture of all three? Ms Christie: I think there was some general emerging confusion in the system around what the rules governing access to drugs were to the point where, at all levels in the system, there was beginning to be confusion and patients were getting very mixed messages about what they could and could not have access to, so it was probably timely to have something that set out more clearly what the rules were. Sir Len Fenwick: I think the first point has something to do with it. There were clearly sound voices across the media, and in part that was understandable. I think what we need to strive for is consistency and transparency across the National Health Service, and the report endeavours to bring that about. Dr Jones: I agree. I think also that there has been a mismatch
between what we can deliver in healthcare and patient expectation, and I think
we need to look at how we provide more realistic information to patients about
what they can expect from treatments. I
think one of the things that has also fuelled this is a sense of inequity
amongst patients across the country, where there is different access to
different elements of healthcare. So the
lack of consistency has fuelled it and perhaps lack of parity with Q3 Chairman: Could I ask each of you: what are the strengths and weaknesses of the Richards Report, in your view? Ms Christie: I think it has reiterated and reminded people of the rules governing access to the National Health Service as a publicly funded service and where the boundaries on that sit with the right to privately spend one's own money. I think the area of particular concern from a commissioning perspective is the suggestion that came out of it that NICE might raise its threshold for considering what represented value for money and cost-effectiveness. That element did not sit within the original terms that I think people were expecting from the review, and that does hold out some real hostages to fortune in terms of safe use of public money and the sort of messages that we give to patients. Sir Len Fenwick: I think in very good part the report is to be commended. The key recommendations all have a great deal of mileage to bring about the consistency that we seek. I think it has tremendous strengths right across the report, with perhaps the exception of how can we deal with matters of separation between the NHS and the private care streams. I think that is still highly problematical, and the report does highlight that. The report does not give us solutions, but I think the 14 key recommendations do provide the agenda to take things forward. Dr Jones: I think the report, in principle, is useful in that it allows patients to have access to a wider range of, in my case, drugs. I think the report has problems in the detail, in the implementation. The concept of separateness is difficult. The concept of billing - because it has to be an episode of private healthcare - which is not only the drug acquisition costs but the costs associated with that, and I suspect neither the media nor the public who would be paying realise how much the administration costs are and, professionally, there are potential difficulties in that, within the Code of Private Practice, one cannot engage in a consultation with a patient about private healthcare and yet the report is almost inviting us to do so. Professionally there are difficulties in that we would wish to maintain holistic care for patients within the team and, if they wish to have the drug as an episode of private care, there needs to be separateness in terms of how we have the discussion and our professional responsibilities. Q4 Chairman: Are there any issues you think that the report has not addressed satisfactorily, in your view, any of you? Dr Jones: I think the report looks at addressing a problem that we have because there is not access to as wide a range of drugs as there should be, and, obviously, it was not within the remit of the report why we were in the position of needing the report in the first place. Ms Christie: I think it has perhaps side-stepped the issue on whether access is always a good thing. There is an underlying assumption that it is bad to say no to certain drugs and that really what we need to do is make as much as possible as freely available as possible, and that seems to side-step a very real issue about public investment and the health gain that we should be getting for that investment and, on a personal level, whether we are really being honest with patients about the outcomes that they can expect. There has been a lot of discussion in the literature about the particular risks that face patients with poor prognosis, where they are hanging on to a hope that there is going to be a magic bullet that can save them. The reality is that many of the drugs we are talking about will offer maybe six weeks, three months of extra life: that will be life that will continue to be characterised by suffering from a very major disease, with hospital attendances, discomfort and, potentially, a real risk that in extending treatment we are not offering people appropriate palliative care and the opportunity to really plan for their end of life, for where they want to die. We know that over 65% of people express a desire to stay at home, but at the moment, certainly in my patch, we are only managing to achieve 20% of people exercising that choice. That is generally because they have an unplanned admission as part of an extended treatment where there has not been a real conversation with them or their family about the fact that they are now in their final stages of life, and it seems to me there are very real risks underlying the report of a failure to have those conversations and respect people's right to make real choices at the end of life rather than buying into a belief that one more drug is going to make the difference. Q5 Chairman: Is it not the case that that has always been a bit of a weakness in our healthcare system? It is not something that has been highlighted by the Richards Report. Ms Christie: Absolutely, that is a very fair assessment, but we are in the middle of quite an extended public debate now about how do we improve end of life care. It is a major one of our priorities at a local level. One of our major sources of investment last year was: how did we extend palliative care beyond cancer? Historically, we have tended to think that only people who die from cancer need to have proper end of life support, which seems a little unfair for the rest of the population, and it has not been a service that a huge amount of attention has been paid to. We are much more comfortable with the idea of active treatment and rescue, but the reality is that at some point we are all going to die, so we would like to make that as positive an experience as possible. Sir Len Fenwick: I must say, I am from the North East and we found the report tremendously helpful. We have achieved a great deal in the last three months in respect of both cancer and other top-up treatments, and we have already brought together protocols, standards, better information and, in fact, we are cited in the Richards Report. I think Richards met the objectives that were set and, of course, that is why we are here today - this is on the public agenda; it has been debated in a very meaningful way with good information - but, of course, perhaps he could have extended into the NCPOD findings, published late last year, where only 35% of received care was judged as good. There is quite a bit of rhetoric in the NHS in respect of expectation and policy. I come from the old school of evidence-based practice and I always commend that and, I think, in taking this issue forward, we need to rise above some of the rhetoric and look at good, evidence-based practice. What might work well for one community in one part of the country may be different for another. In very good part, we deliver good services and we can do better. I think my concern is getting back to the need for transparency, consistency where there is fragmentation and we need to move quickly if the options and the choice is going to be available to patients. I hear a great deal, as my colleague on the right, about care in the community and what we can do at home. I have seen a recent experience of care quality with a relative in the NHS, where choice was expressed by the patient and the family but it was the wrong informed choice and the patient suffered accordingly. So it is not all good in the secondary care sector, we need to get more common pathways, and I think Richards directs us there. I think Richards has done the job; it is now for us all to build the arrangements, the protocols and the good governance to bring consistency about. It will not be perfect, but we can certainly do a lot better. Chairman: Let me tease out the issue of communities versus the individuals in this session. I am going to move on to Doug now. Q6 Dr Naysmith: I think, Sir Len, you will find that all of us on this committee are in favour of evidence-based medicine and practice wherever we can find it. One of the things that seems to have come fairly clearly out of the Richards Review: talking about the separation of the National Health Service and private treatment, the decision seems to have been made that patients will be allowed to have both National Health Service and private care in parallel, if they can afford it. The reaction to that decision, which is one of the clearest things that comes in Richards, has been different with different people. Some people have called it the end of equity in the National Health Service and some people have said it is merely a restatement of existing rules which have not been very clear. Which do you think: because you are obviously an enthusiast for Richards? Sir Len Fenwick: I am not a great enthusiast
at all. In fact, this issue is not
something that bedevils my organisation.
I have one of the largest National Health Service trusts in the country,
serving the North East of England and beyond with a range of tertiary and
specialist services, and in the main, because we have critical mass, because we
innovate, because we are involved in research, many of the issues of the novel
treatments and the options that are available we are able to accommodate
without fuss, with opportunity, through working with primary care commissioners
and the resources that we have to hand.
I have got a long time running big hospitals. I have been the leader of the Q7 Dr Naysmith: There cannot possibly be equity for everyone: some people are going to be able to afford to pay for additional treatment side by side with other patients who cannot pay for that treatment. How can it be equitable? Sir Len Fenwick: I think that in very, very good part I find that the professionals advise what the expected benefits and what the likelihood of the treatment outcome will be if they wish to opt for a differing pathway of care and treatment, and it is rare that with good communication or with experience and support that difficulties arise in that arena. Q8 Dr Naysmith: I do not want to trespass into some questions that are coming later, but different PCTs have different levels of resources and sometimes they just cannot find their way to provide the extra money. You are saying this is merely a restatement of existing rules, but, clearly, you were doing it anyway, you were fudging anyway and providing the means for that to happen. Sir Len Fenwick: I certainly would not fudge. I could give you some case examples, if you wish to test me on them. When you talk about resource, primary care trusts in my region underspent: they sent money back. Q9 Dr Naysmith: That is not the evidence we get from some PCTs? Sir Len Fenwick: I can only speak from experience on the ground. I find that primary care commissioners in the North East of England are well informed, they are working together and working on choice, and what we do with clinicians and related professionals across our region through the networks that we have, we have protocols and decision-making trees that ensure a consistency, and it is not so much an issue for the North East as it would appear to be for other parts of country, and I think there are lessons to be learnt in that respect. That is not to say that the top-up is not there, but it is a rare experience in my organisation. I have done some research and over the last six months we have not had a top-up. Q10 Dr Naysmith: Are you saying that in your organisation the situation has never arisen where someone can get a drug in another PCT and not in yours? Sir Len Fenwick: Not in the North East. The difficulties that I have found, working with practitioners and others, is the parallel working with the private sector, where part of the treatment may begin in the private sector and then it moves into the NHS and where we have had to use multi-disciplinary teams and improved governance between the two streams to bring a greater, more governed, more consistent approach, and I think that is beginning to improve. Q11 Dr Naysmith: Sophia and Alison are both indicating they want to say something. Ms Christie: Can I pick up two points from that? The first one is about the evidence-based practice. As commissioners we are responsible for the wise investment of public money to get health gain, and we pay very real attention to whether commissioning a particular drug or intervention is likely to offer real benefit in terms of outcome, given that anything that we spend money on creates opportunity costs. So if we choose to spend money on a cancer drug that might extend life by six weeks or three months, we do not have that money available to create appropriate palliative care in the community for the six weeks later when that person does die, or we do not have the money available, perhaps more importantly, to invest in the most effective new radiotherapy facilities that might mean earlier intervention and better outcomes for patients. So there is a real issue about what choices the NHS, through commissioners and critically through NICE, makes and what gets into the list for funding. It is each of our individual rights to make bad personal choices, but as public servants we do not have the right to make inappropriate investments. So the decisions about NHS expenditure are very challenging; we have to make, at times, very fine judgments about where we might place limited resources against a whole range of pressures for intervention. The role of private medicine is there so that, if someone wants to make a personal choice about spending their own money on something that might have limited evidence of effectiveness, that choice still exists for them. However, just because they have made that choice does not mean that we should distort public money in picking up those bad, relatively poor choices going forward. So there are some real issues. If a patient has initiated treatment as a private patient of a drug that has not passed the test of cost-effectiveness for public funding, if they then run out of money or discover that whilst they can afford to pay for the drug they cannot afford to pay for the additional outpatient attendances that might need to go alongside that very toxic substance and they are looking for NHS money to support it, then we are potentially investing money very unwisely at the expense of other choices that we could make, and that will have been judgments that have been distorted by individuals exercising choice about their own finances that then has an impact on, potentially, the public health. So I think there are some real issues here as to being clear about what we mean by evidence and cost-effectiveness evidence and the role of the public sector versus the role of individual choices that we may or may not be in a position to exercise. Q12 Dr Naysmith: Do you think the Richards Report makes things clearer or makes them more difficult? Ms Christie: I think on one level it
makes it clearer. I think it reiterates
that division between the public responsibility for cost-effectiveness and the
private right to exercise one's own resources however one chooses. However, it does raise two issues associated
with that. One is the sort of situation
that Sir Len was referring to, where someone may have initiated treatment
themselves on the private route and where they then get into difficulties
maintaining that treatment and expect the NHS to find a way of picking it up
and maintaining it, even though it is not a treatment that has been prioritised
for public investment. Once we have a
situation where people believe that they have the right to co-fund, to initiate
their private treatment alongside the public, I think there are increasing
risks that there will be a perception that, if that drug is being administered,
surely it is a drug that should be available to all and will create a sense of inequity
in the local system if some people are receiving a drug and other people are
not. I am not sure there is much of a
solution to that problem, but it does feel like a continuing problem. The bigger issue is the one I referred to
earlier around the proposal to lift the level of what is perceived to be an
acceptable ceiling for quality adjusted life years in Q13 Dr Naysmith: We are going to come to one or two of these things later on. There are a lot of things listed. Dr Jones: The report really is about patients paying for additional drugs, over and above their NHS care, and separating the provision of that drug and the associated costs with that drug from their care. So all patients who are thinking of embarking on this should be in the context of a multi-disciplinary team, looked after by a consultant they know with a team around them, and that should not be broken if patients wish to pay for additional drugs. So I think their underlining care---. I take the premise of this starting as an NHS patient if they find a drug that they wish to have. It may have been deemed effective, because it may have a European license and be deemed effective, it may even be deemed effective through the NICE process; what it has not been deemed is cost-effective in terms of our costing system. It does not mean the drug does not have activity; it just means in this climate in the NHS we cannot afford for that patient to have that drug. I think if they wish to have it, they should be in a position to continue their NHS care but pay for the drug and the associated costs of that drug, with the clear understanding that they would not be in a position, if they run out of money, to have it picked up by somebody else; but they should not lose access to the palliative care and the team that they are in. If it is going to be set up, it needs to be done with continuity of patient care in mind. I am on the sharp end of this - I am not on the sharpest end but I am not a patient and they are really on the sharp end - but I do have these discussions on a daily basis with patients about life expectancy, how long they have got to live and what I can do to prolong that. It is not a choice between supportive and palliative care and a new drug; the two things should run in parallel; so any patient in this position should have access to end of life care while this is going on. None of us know how long the end of life is going be and we should help people do it as they wish. Q14 Dr Naysmith: But there are some drugs that extend life by merely two or three months, on average. Do you think it is really worthwhile spending lots of resources on that? Dr Jones: We are not expecting on this report the taxpayer---. It is a question whether the patient wishes to spend a lot of money. For example, if you take a drug that gives a medium survival of three months, that means some patients will die a lot before that and a few patients will benefit, and the other side of this is if we have more investment in identifying which patients benefit from which drugs--- Q15 Dr Naysmith: Is not that what Sophia was saying, that if people can afford to pay for it, the expectation will spread and it needs to be supplied to everyone? That is what you were implying, is it not, that if it is accepted for private patients--- Dr Jones: I live in the south of Q16 Dr Naysmith: We are going to have to move on because this is taking a long time. Can I ask you all a couple of very quick questions? Can you see any practical difficulties, and some of them you have hinted at already, but can you see any as being really important and can you see any potential abuses arising from the changes? Dr Jones: I think absolute clarity about how the conversation is initiated and whether this is a private episode of care in relation to the consultant and the whole process or just for drug delivery. My preference would be that it is just in relation to the drug delivery and the rest of the care of the patient and the consultation process takes place in the context of the NHS, so it is not forcing people who do not want to do it into doing private practice, for example, because I do not think one could do that. The inequities potentially arising from it are not just the drug costs, it is if the patient has a completely different stream of care that is consultant driven rather than perhaps being within the generality of the NHS. Absolute clarity about that and the concept of separateness is going to be difficult in some NHS hospitals that do not have a private facility in which the drug could be administered, in which case it is not realistic to assume there is a separate time of the day or week. We are usually running flat out all week. Q17 Dr Naysmith: Do you think that will produce pressure to set up a private wing? Dr Jones: No, there would not be enough to do it, and that raises risks to patients in transferring care at a vulnerable stage. Sir Len Fenwick: The inter-professional tensions that this can bring across a multi-disciplinary team, where there are many senior clinical practitioners who simply do not get engaged or wish to contemplate any aspect of private practice, can cause difficulty in communication and attitude. I think that is a fundamental issue to be addressed as part of this requirement for separation. I think, in relation to cancer in particular, it is a little naive to believe that there would be complete separation. It is simply not possible. Whether in respect of the therapy administration, the support that is provided in the hospital or in the community, the various disciplines that need to come to work together, there is some difficulty there and it is not straightforward. It is that element of fragmentation that I would believe is something that requires greater tension. There has been comment expressed in relation to documentation - the records and access to the records - if there is more than one provider. If an NHS provider and a private provider are running in parallel, there is a recipe for difficulty there, it is less than ideal, but I think in relation to billing and the documentation, certainly from my experience, my organisation is just a few months away from having any record. We are pursuing a new record outside of the Connecting for Health programme that will support the Connecting for Health programme, and I am confident that this year we will be demonstrating a great deal of integration, and that can include billing - and not just for billing, but also for cost control and awareness and to help primary care colleagues in relation to when they place the order are they getting good value, et cetera. It is the pathway of care and that disjointed break-down in communication and tension that can arise that would worry me. Ms Christie: I think you have hit the nail on the head with that issue of the multi-disciplinary involvement. It is very difficult to separate paying for a drug from the additional work load that then creates for the NHS. If we do not clearly separate the private episode of care from the public episode of care, we will be, by definition, cross-subsidising private care for some people. I absolutely hear the practical issues that have been raised, but I think that was really the purpose of the report: to clarify that if people are exercising the choice to spend their own money on treatments that have not been deemed good value by the public purse, then there is a very real cost associated to that and they are making a very real choice about a different pathway of treatment. The previous comments perhaps highlight why we needed the Richards Report, which is that clearly there has been cross-subsidisation taking place, driven by the best possible motives on the part of clinicians, but with the effect that people have been benefiting from a range of NHS resources for treatments that they ought to have been paying for themselves. Q18 Dr Naysmith: Do you think there is potential for abuse in that? Ms Christie: I think what it is going to do is raise---. We will probably have a difficult 12 months as people get used to the separation. It will make it much clearer where there is a private episode of care being initiated and maintained, and it will require much clearer conversations about where are private patients appearing in the system and what services should they have access to, which is anything that they would routinely get as an NHS patient, but where they require out-patient attendances, or in-patient admissions, or diagnostic tests associated with an additional private treatment, then those costs sit with the private treatment. Q19 Chairman: If somebody was in a hospital ward having a top-up as a part of in-patient treatment, what is the bed that they are in? Is it a private bed or an NHS bed? Ms Christie: I think that is probably a question that Len is more qualified to respond on. I am not sure it is that helpful to think of the bed. It is about the episode of care. The patient is a private patient. The point was made by Dr James that just because someone is having private treatment does not mean they should be excluded from the relevant NHS care. They should still have access to whatever they would be entitled to within the NHS, but for those elements of the treatment that are driven by the private elements---. It is a little known reality that someone having the breast cancer drug herceptin needs to have four out-patient attendances in cardiology because it is a highly cardio toxic drug. In the period before herceptin became widely available, there was a lot of lobbying for inpatients to pay for the drug. They did not want to pay for the four out-patients attendances in cardiology, but they were entirely driven by the administration of that particular drug. They ought to form part of any private treatment. I think that is where we will begin to see some of the tensions, trying to map out which elements of treatment are driven by the private care and which elements should be routinely available as part of NHS care. Q20 Sandra Gidley: If somebody has side-effects from a drug that they buy privately, which is quite a common occurrence, who pays for the drugs they need to cope with the side-effects? Dr Jones: It is very difficult with
somebody with advanced cancer to attribute some symptoms to a specific drug or,
indeed, the underlying disease, and it would be a very vexed question to try
and tease it out because they would be experiencing a number of cancer-related
symptoms. In this situation they may be
having a drug as an NHS drug and, on a separate day, having a private drug, and
I certainly would not want to be the person who tries to attribute and pin down
a specific side-effect to a specific drug unless it was absolutely clear. If a patient is in the private sector and
they have treatment in Q21 Sandra Gidley: If it is easy to attribute, what then? That was quite a political answer. Dr Jones: It is not always easy to attribute. Q22 Sandra Gidley: No, but there may be a case--- Dr Jones: There may be. If you have got a drug that only turns people green and they go green, then it is obvious. There will be times when you can do it, but a lot of the time it will be a really grey area. Q23 Sandra Gidley: You have just highlighted the case of somebody perhaps having treatment in one part of the country, then going to another, falling ill and being picked up by NHS care anyway. What are the difficulties with regard to continuity of care? This committee has already looked at the NHS IT project, which is difficult enough within the NHS. When you are adding in the private sector as well, are there problems there? Dr Jones: I think there are problems with continuity of care, which is why if a patient opts for a top-up drug and its associated costs, it would be ideal that they would stay within the same team that had been looking after them. It is not just the consultant; it is the nursing staff and supportive staff within that team and their palliative team, so their care should be in the same team. We have this all the time with patients falling ill and not necessarily going into the hospital where they had treatment, and that has been highlighted, as Len pointed out, in the NCPOD report and the NCEP report that patients often turn up with complications anyway, about 20% of patients, where they are not being treated, and that highlights a communication issue that is generic and not just specific to this problem. Q24 Sandra Gidley: Is there not possibly a bigger problem? If somebody is going to a private hospital down the road for their episode of privately funded care, how does that information get back to the NHS? Dr Jones: That is a two-way exchange. It is absolutely critical that there is a system whereby it does. If they are having one drug on the NHS and the other privately and the drugs have got to be linked in some way to a specific blood count and other supportive drugs, that would be extremely difficult. You have got two prescriptions for one patient; I think the issues in terms of data transfer are really difficult to maintain safety. Q25 Sandra Gidley: Are you saying that the private sector should be plugged into the NHS IT system? Dr Jones: I do not think the NHS IT system is entirely plugged into itself. Q26 Sandra Gidley: No, but let us try not to get into that. Sir Len Fenwick: Speak for yourself. There are some who are plugging in. Q27 Sandra Gidley: Are there any other practical difficulties with regard to continuity of care? Dr Jones: I think it is maintaining the holistic care of the patient with their team. The question is where they get the private care. If you do it in the same hospital in a private wing, it is going to be relatively easy because it will be one data set. If they had it out of hospital, then they could do it with a home care provider, in which case there is very good paper transfer of data back in and that works quite well for patients anyway. Q28 Sandra Gidley: Does it? Dr Jones: I have had patients who have wanted to do it for one reason or another. It can work, but it is a problem that we have anyway that patients do have elements of care outside. I think the main one is transfer of information and maintaining the whole team, knowing what is happening with the patient as well as the consultant, but I think data is very problematic. Q29 Sandra Gidley: Another practical question. If somebody has to have a mixture of drugs, one of which they are paying for themselves, the other is paid for by the NHS, it is best to give them at the same time. How do you split the difference between the private episode and the NHS? Dr Jones: There are a few schedules where there is a time dependency and a schedule dependency for drugs. That is going to be, practically, very difficult to organise if one drug is available on the NHS and another privately if they are having them on different sites. There will be the issue of putting the cannula in to give the drug, whose responsibility is that, depending on which drug is given first, and, potentially, removing patients between one site and another to receive two elements of care for the same condition. That is a very realistic practical issue. Sir Len Fenwick: It is a challenge across the NHS where there has been good investment in recent years in modern infrastructure and an environment for this client group. In my trust we are just opening a new cancer care centre where the majority of the facilities are single, private rooms for the NHS patients. This will not be an issue for us but, going back to the team working, we are getting so worried about the technical support, the clinical support. For the patient it is all about the personal contact and confidence and communication where you can get fragmentation. A lot of the good work is done, not on the technical side and the administration of the drug, but the support and the ability to work with people, family and carers in a very, very challenging environment, and that is where there can be a breakdown in continuity. Q30 Dr Taylor: If you will allow me, Chairman, I am going to go back a little bit before going on to my questions; I am very conscious of the time. I have been absolutely staggered by this so far, because to you, Len, and to you, Alison, it really has not appeared to be a major problem. Can I clarify? To take a concrete example, you have been funding Sinitinib for patients. Dr Jones: I do not actually treat renal cancer; I am a breast cancer oncologist, so I would get asked about different drugs. In my practice I have been asked about drugs that are not available and I have had conversations with patients about what is available, what the realistic benefits of non available drugs are, and I have not had to have that conversation very often. Q31 Dr Taylor: So is the problem rather less with breast cancer than with some other cancers because breast cancer has such a high profile? Dr Jones: I think the problem changes month on month, year on year, depending on the availability of new drugs and the time that they take to go through the approval process. At the minute we have, as it happens, a lot of kidney drugs under consideration. Another year the drugs move on so quickly that it will be a moving field as to which tumour type. I suspect pressure at the minute will be in relation to kidney drugs and bowel drugs, but that pressure could change and it could be a different tumour type another year. Part of it arises if patients have expectations that they are really missing out on something. If you have a consultation with a patient where you explain their options and their realistic outcome in a fashion that they and their family can understand and they understand what is happening and what their life expectancy is, they sometimes make a decision not to opt for a drug that is very expensive or, if they do, they are doing it on the basis of full information. But there are quite a lot of treatments that are available for people on the NHS, and if you explain the relative merits of different treatments carefully (and it is a time-consuming business) I think people feel perhaps less disenfranchised than they do. Q32 Dr Taylor: Have you been providing Sinitinib? Sir Len Fenwick: Yes, we have and in very good part, but, again, I come back to critical mass. This is not about cross-subsidy. We spend about six million a year on all of these agents out of a drug bill of over 60 million. So it is 9% of our spend this year in Newcastle, it will be 10% of our spend on drugs, and that is for an organisation with a turn-over in excess of 700 million; so it is not really big beer at the end of the day to my organisation. I think last year, on 107 occasions we sought exceptional circumstances support. Nine out of ten of the requests were moved very, very quickly through our primary care organisations with understanding and support based on the recommendation of the clinician across a range of criteria, but where you have an innovative, very large unit with drug trials running and other opportunities and you are bringing people on to trials, then it is a much easier and informed set of circumstances, and that is what I have said. I come down from the North East. We are well orchestrated in terms of the issue; we now publish those drugs that are not available either through our assessment criteria or through NICE and it is made very, very clear. I do accept Alison's view: good communication and information to the patient and their carers at the beginning, and if there is not a vested interest to promote something - because that is still with us and it is a great issue - then this is not a real issue, from my experience. If you wanted to talk about other materials, such as implants, pacemakers and knee joints, that is probably a bigger ticket issue for the coming years, because people are getting much more well informed about the performance of an implant or other support device that can help continuing quality of life, never mind end of life. Q33 Dr Taylor: Because I am going to ask Alison some questions, I have to own up to the fact that I am a fellow of the same college, for the record. A very general question: Is the College happy with the recommendations? Dr Jones: The College sent this out to consultation to the specialist committees and patient and care association, and I think the range of views expressed through the College were as wide as the range of views expressed in the media. There are people who are polarised against it and people who are in favour of it but, overall, most probably broadly in favour of it, provided the issues of continuity of care for the patient, the clinical governance issues and the care and the issues of professional responsibility and liability are carefully considered. Q34 Dr Taylor: You have already said that a tremendous amount of information needs to be shared to explain to patients how little the benefits actually are of certain things? Dr Jones: I think there are different situations. With the kidney drugs I think the benefits are tangible and quite long for some patients, but there is an assumption, because of the perception of rationing and cost containment, that any drug that is not approved is being withheld for cost reasons, and I think we have to sometimes be more transparent about why drugs are not approved. At the end of the day, if somebody wishes to pay for a drug and they have got full information, the feeling is that they probably should be allowed to do so, provided it does not disenfranchise other patients, the ground rules are very clear and it does not disenfranchise patients either in terms of withdrawing, perhaps, consultant time to be doing this. Q35 Dr Taylor: Len said there are some clinicians who will not contemplate private work. Probably there are quite a number in oncology like that. Is that so? Dr Jones: I think it was probably about 50:50 in oncology, some of whom will do private work and some who will not. Q36 Dr Taylor: What will they do under these circumstances? Dr Jones: There are two options in this. If this is regarded as private care and private prescription, then patients would have to transfer to another clinician who did private care. The other option is to say that you are having a consultation with the patient about care anyway, and if this was not regarded as private care for the doctor, it was just private administration and we did as part of caring for the patient, it would be a lot easier. I possibly would not want to bill for this as a private patient. Q37 Dr Taylor: Is that not a fudge really? Dr Jones: Yes, it is, but it is difficult, because you could run into a situation where, if the doctor regards this as private care and some doctors are not doing it, then you are going to get a transfer of patients and their care to different consultants and different teams, which is not good for the patient and, if you do private practice, then you might get overwhelmed by a lot of patients receiving a drug because you are the only person who does it, and that could mean that you were not doing other things that you would wish to be doing. Q38 Dr Taylor: Although Mike Richards has fallen over backwards not to say so, is not this really the establishment of a two-tier system? Dr Jones: Patients with cancer in private care do receive palliative care in the NHS and. if they run out of funding. their care transfers back to the NHS. What they cannot do at present is have some elements of care privately and NHS. It creates a situation where some people are getting drugs that are going to be of very limited benefit to them as an individual. The situation where there is a problem is where the drug does have a very overt benefit over a long period of time, which I think would apply to some of the kidney drugs, and I think one of the other risks in this is, if it is used widely, we would not want to take our eye off the ball professionally in pressing for more of the drugs to be available for more patients anyway to avoid the problem in the first place. I think that is where professionally our responsibilities should be. Q39 Dr Taylor: Will doctors need additional training to carry this out? Dr Jones: I think if you asked me what my core skill as a medical oncologist is, it is probably communication. That is what my core skill should be. I do not do technical things; I speak to people. I think understanding the data in relation to new drugs as they come through and what it means in the real world: because you have to bear in mind that patients who provide the evidence base are fit patients in clinical trials; they are not the same patients who I necessarily see in the clinic. Only about 10% of patients can go into clinical trials because of the entry criteria; so the patients receiving these drugs are not necessarily representative of the whole population, which is a problem, I think, in its own right. Sir Len Fenwick: I think that is one of the biggest challenges, and for a hard-pressed service practitioner it is also the time that is required in a clinic setting to do these things. Dr Jones: There needs to be some extra communication training in terms of not how we talk to patients, because hopefully we have done that already in our qualification in getting our CCST, but possibly we will need to develop some guidelines for new drugs as they come through as to what the real meaning of that drug is for individual patients. Chairman: I perhaps should have said earlier that I am an Honorary Member of the Royal College of Physicians. There is no causal effect; I just thought I would mention it. Q40 Stephen Hesford: It is to Len really. These are my words, so do not adopt them if you do not feel comfortable with them. In summing up your position, is it that this kind of whole issue is some kind of PR exercise and a Daily Mail lifestyle issue, because ordinary folk up north are just getting on with things and it has not really made any difference? Sir Len Fenwick: There are parts of this country still where there is great pride in public service and there is great belief in what local authorities and the NHS can provide and the way that they go about it and the confidence that they have, and I have got to say, in the North East that gives us a head start. We also have, in my view, some excellent provision of services, good communications and networking between the key professionals. As a Chief Executive, I do not apologise: patients first, bureaucracy second. In all my years, if the senior professionals in healthcare believe that we must do something for a patient and their supporters which will bring benefit, it is my responsibility to ensure the resource and the facility is there to deliver that, and I do that, and that is when I am either working within or without the rules, and I believe that brings success. There are exceptional circumstances. The Daily Mail, yes, there have been siren voices, but there are siren voices always. Going back to the two-tier thing, amenity beds - and Dr Taylor will know this - go back to 1948. I have never seen amenity beds run for many years, but there are still some in hospitals. That is a two-tier system. You come into a maternity department and, if you pay an extra few pounds, you get a nice private room, but you are still on the NHS. That is two-tier. That was in Bevan's NHS in 1948, so we should not kid ourselves about this. There are the siren voices, and I think some of the case histories that have appeared in the media have been rather dramatic and hyped, and I think in others there has been a case to call, hence the Richards Report has come about. The great thing is we have got focus on this. It has been debated in the public arena, I think, in a very well structured and well informed manner, and this will lead, I believe, to a stronger National Health Service and it will not be a two-tier service. Q41 Stephen Hesford: Is that a kind of yes? Sir Len Fenwick: It is a yes, yes. Stephen Hesford: Thank you very much. I think my questions have been covered by Len elsewhere, so, time pressing, let us move on. Q42 Dr Taylor: This time it is mostly Sophia because it is about the practical implications for PCTs with the changes of the NICE appraisal scheme. You have already said that life is going to be extraordinarily difficult if the threshold goes up, so it has come across very clearly: life is more difficult for commissioners than providers. Yes? Ms Christie: I think the NICE threshold
potentially makes life more difficult for the entire system. We have been in a very luxurious position in
the NHS in the last five years. We have
seen unprecedented levels of growth and investment. It has allowed us to significantly raise
expectations amongst the public, patients and clinicians of what might be
available and what we are able to provide free at the point of use. There have been huge developments in
productivity and improvement during that time, but even in that context of 9-10%
growth each year, every year has been a struggle to match the demand and the
expectations with the reality of delivering a balanced budget. I am in the interesting position of presiding
over a £1.2 billion turn-over, and on 31 March at midnight each year I
have to have precisely zero pence in my bank account. It is a fine judgment to make it all add up,
and the sort of pressures that are exerted are significant, and cancer drugs
has been one of the areas that has disproportionately, in my view, in terms of
the health gain it offers, taken the bulk of investment over the last five
years. In each of the previous three
years over 50% of our growth in specialised services has gone exclusively on
cancer drugs in the whole of the range of activity across specialised
services. It is very difficult to see
the extent to which that has really contributed in health gain. The point was made earlier that we do see
variation across the country. We see
variation across the country because need varies across the country. I used to work in Q43 Dr Taylor: If we were allowed to discuss rationing, the terrible R word--- Ms Christie: It is not a terrible word; it is a very sensible word. Q44 Dr Taylor: It is a sensible word; well said. Are there things that could fall off the bottom? Have you examples of things that you would like not to have to pay for? Ms Christie: I think the issue about rationing and the reason it feel difficult is because what we are talking about is relative value. If only it were as simple as being able to say: that is absolutely useless; we should never even consider it. We are always looking at a package of interventions in which there are always good arguments for just about anything that you could do, but what we are trying to do is get a sense of the relative value that they will give. So it is a prioritisation process; it is more about saying where do we focus the investment than, "We will never ever spend money on X". Len has already made the point, in individual case discussions you can get exceptional circumstances where something counter-intuitively looks like, in these circumstances, a reasonable approach, but we do have to go through that process of prioritisation. Last year we sat down with a list of 120 things, all of which had value, but when we had worked through them in terms of how many people were going to benefit, at what level were they going to benefit, to what extent did it contribute to achieving the kind of life to years and years to life agenda, we drew a line at about number 18, and that was a process that clinicians, managers and patients worked through together. We did some work as the Cancer Network earlier this year on a deliberative event, which was entirely members of the public, working through with them a prioritisation process. In each of those events many of the sort of drugs we have been talking about today were the ones that consistently came at the bottom; not that they confer no value - obviously, if you are dying three months seems like a long and positive time - but that they did not confer the same level of value as something that was going to have more prolonged benefits at lower cost. We have talked about some of the sorts of interventions but, going beyond cancer, the ability to really get good at acute treatment of stroke and have the right rehabilitation over the following six weeks that mean that people return to full functioning rather than end up severely disabled for another ten years, the ability to enable people to die a dignified death in a place of their choosing, with full pain control 24 hours a day seems like a very important investment to be making - the ability to reach out to sections of the population that historically have not made good use of services. We have a telephone-based assertive care management service for people with long-term conditions. It has reduced utilisation by 50%. In hospitals people have better clinical outcomes and symptom control and there is 99% patient satisfaction - fantastic use of money, but not something that has ever been prioritised by NICE. Q45 Sandra Gidley: One of the tensions is between decisions made by PCTs and national guidance. We have a system of 152 PCTs, all making different decisions using varying evidence bases, and there appears to be no consistency. Is there a need for rationalising that process? Dr Jones: I think if we are going to
have a system of top-ups, then one of the things we have to do is exclude any
other route of funding for the patient before they go for self-payment, which
means if you do not have a level playing field across the country in relation
to funding either through NICE or a consistent approach between PCTs, then it
might prove cheaper to move to get your drug than in a PCT that has a more
liberal view than not. So there does
need to be consistency, and that has been a big problem, and I think that is
where a lot of the tensions have arisen.
There are attempts to do that.
Within Q46 Sandra Gidley: Sophia, you are in charge of a PCT. Why is the one down the road doing different things to yours? Is there any attempt between PCTs to have more consistency? Ms Christie: The reason the one down the road might be doing different things is they might have a different population profile. Q47 Sandra Gidley: I am talking now about decisions made on treatment. You cannot wriggle out of it that easily. Ms Christie: No, that is about decisions made on treatment. A treatment happens within a context of the whole population spend. Q48 Sandra Gidley: No; it is supposed to be evidence-based. Are you telling me somebody in Ms Christie: No, I am not. I am saying that the profile of disease in Q49 Sandra Gidley: So it is not about effectiveness then? Ms Christie: Yes, it is about effectiveness. There is a first test, which is effectiveness, there is a second test, which is cost-effectiveness, there is a third test that is relevance to the local population, "Is this an intervention that is going to make a big difference here?", there is a fourth test that is about acceptability, "Is it an intervention and a treatment that is really going to resonate with patients and that offers a good personal experience for patients as well as a clinically effective treatment?" It is not a simple, kind of, yes/no issue. As I was saying earlier, that test of effectiveness is crucial, but that is not sufficient. They are effective but not affordable. Q50 Sandra Gidley: Most decisions are turned down on the basis of effectiveness or cost-effectiveness, and so all around the country you have three or four people, sometimes self-selected, it seems, with varying degrees of expertise purporting have great wisdom in these things coming to wildly different decisions on effectiveness and cost-effectiveness. How can that be justified? You cannot wriggle out of it by saying the local needs of the population are different. Ms Christie: I do not think that is
wriggling out of it. In terms of
collaboration, we need to improve collaboration. There is a number of initiatives ongoing at
the moment to do that. There is a
network of the consultants in public health that is looking at how we can share
the workload. Typically a PCT might just
have a couple of public health people who are trying to assess all of the
evidence on what in many cases is very technical information, and we are
looking at using the network to be able to share that workload, so we publish
for each other the findings and share those.
PCTs already collaborate in all parts of the country for a range of
specialised services and in many parts of the country at a more local level. In Q51 Sandra Gidley: That is all right for cancer, but there are sometimes drugs involved in these decisions that are not necessarily drugs for cancer. Ms Christie: For that we have an individual cases panel. That is a panel that is made up of clinicians, chaired by a lay member ---- Q52 Sandra Gidley: Who usually know little about the subject they are judging. Ms Christie: I think that is a strong generalisation. Q53 Sandra Gidley: Sometimes. Ms Christie: They are highly educated, experienced clinicians who are involved in assessing the merits of the case before them. We receive advice from the referring clinician who is a specialist in the subject. We are paying attention to ---- Q54 Sandra Gidley: Who frequently ignore it, I find. Ms Christie: -- the published evidence. Q55 Sandra Gidley: They frequently ignore the advice of six consultants who might know a particular patient, because these people, who have no expertise in the subject they are deciding on, decide something different. Are you saying that does not happen? Ms Christie: I cannot comment beyond the area for which I am responsible. In my panel we pay the best possible attention to looking at the evidence in front of us, both in terms of the clinical evidence and the specific patient evidence that is presented by a clinician, and often we have cases referred by clinicians who say, "I don't think this person is going to benefit from this but they're giving me a lot of grief about it, so please can you consider it." There are huge mixed messages in the system and I am hopeful that one of the things that the Richards Review will do ---- Q56 Sandra Gidley: I think you had highlighted very well that the system is a complete mess. Ms Christie: The system is a system of human beings. It is about people who are desperately trying to do the best they can, as a patient for themselves or for their family or as clinicians for the patient in front of them or as commissioners in terms of wiser spend of public money. Yes, it is a messy system. We are talking about life and death. It is a pretty messy process. Q57 Sandra Gidley: Sir Len has to pick up the process of this dog's breakfast, because he has two people being treated by the same consultant, who live in different areas and have different decisions made. Sir Len Fenwick: What do I do? We treat the patient. The real action in the
NHS is at my level. That is where the real accountability rests in terms of
quality, cost, and performance. When you
are a foundation trust, be assured, the buck does stop with the foundation
trust. The NHS is improving rapidly, and
your questioning is very, very relevant.
In the North East - and the Committee may wish to interview and
cross-examine the clinicians who are involved in this - across the PCTs, there
is a Cancer Drug Approvals Group which gets rid of a lot of this sort of
difference between the PCTs - and there are 12 subscribing to this - and then
there is a Treatment Advisory Group for treatment, drugs and other treatments
outside of the cancer therapy regimes.
The great thing about the initiatives taken is that they are healthcare
professional lead, they are not led by bureaucrats. That is what brings it together and that is
what gels the conference. Step-by-step,
patients who are trying to step outside of the evidence-based practice and the
appropriate regimes are given good, constant information. Whether they are in Q58 Jim Dowd: Could I first apologise to the witnesses and to the Committee Chairman for a conflicting constituency engagement which meant that I missed the first part of your submission. I hope what I am about to say has not been covered. Does the exchange just now not highlight the intractable tension between local commissioning and uniform provision? It is not just a question of cost-effectiveness between people suffering from a similar condition; it is making decisions about people suffering from entirely different conditions. Dr Jones, you were alluding to people moving. I presume the line between the two is that they really should move to areas where there are more people like them, and therefore with the conditions that they have. People have been doing this to find schools for their children for generations. Dr Jones: I think people go to Ms Christie: I think that is a good setting out of the process. In relation to your point about is it an inevitable tension, I think the answer is yes. We get ourselves into difficulties when we think of it as a problem to solve. I think it is just a tension to manage. There is always a tension between the strategic and the local, between the individual and the population, and that is part of the reason we have a system that helps to recognise that and manage that tension through: the role of government, the role of local commissioners, and the role of local providers. In many ways it can be a healthy tension because it allows for the debate, it allows for the challenge, but we are not going to solve it. There is not a simple answer, other than an exceedingly bureaucratic system which would draw up a list of 100 things that you are allowed to have on the NHS and under any circumstance, if you fall out of those, nothing else is available. If we start to get into absolutely rigid rules we really will struggle to meet local needs and local priorities. Having said that, in response to the earlier question about do we need a more rational approach, that is what NICE was created for and actually it has done a pretty good job in very difficult circumstances, which is why I am particularly worried about the lifting of the threshold, because I think it will make it very difficult for them to continue to have credibility as making any sort of judgment on cost-effectiveness. Effectiveness in the NHS, as a publicly funded system, cannot be separated from cost-effectiveness. Any spend on one activity has a disproportionate impact on everything else. To pretend that is not the case is disingenuous. Q59 Jim Dowd: I thought you wriggled out of that very well indeed. Ms Christie: Thank you. Q60 Chairman: Sir Len, unfortunately constraints of time will make it difficult us to bring your clinicians group down here, but could you pass as a note about how the North East Cancer Drug Approvals Group works and the spread of membership. Dr Jones: There is one in Ms Christie: And in Q61 Chairman: Could you send that in? We would be more than happy to have a look at the information and see how this PCT interaction works with the local NHS. The last question we have in this particular session is directed to you, Sir Len. It is on the issue of foundation trust private income cap. Do you think there is anything that is going to challenge the boundaries of this private income cap by the introduction of this scheme. Sir Len Fenwick: I think the answer rests with your good self as the legislators. Q62 Chairman: We are overseers. We are not legislators. Sir Len Fenwick: But through the
Committee. There is a cap, and
foundation trusts, if you like, are more under the collar on this one than the
non-foundation trusts. From the point of
view of my organisation, this again is relatively small beer in respect of a
private cap. It is not an issue for me
in the North East, but it could well be a major issue, and I am sure that it
is, for a number of the foundation trusts elsewhere in Q63 Chairman: Why is that? Is that because they interact more with the private sector? Sir Len Fenwick: The cap is 1% of the income stream. It is set very low indeed. But that is the licence that was accorded to us through our regulator and our regulator is tough to deal with. It is a very disciplined approach and I would applaud that. Q64 Chairman: There has been no debate to your knowledge of lifting that cap due to the Richards' proposals? Sir Len Fenwick: With the monitor, the independent regulator, there has been extensive consultation, and the outcome is that it stays as it is. Chairman: I would like to thank you all three of you very much indeed for coming along and helping us with this evidence session this morning. Thank you. Witnesses: Professor Karol Sikora, Cancer Partners UK, Dr Jacky Davis, and Hilary Whittaker, Chief Executive, Beating Bowel Cancer, gave evidence. Q65 Chairman: Good morning. Could I welcome you to this session and ask you to give your name and the current position you hold. Dr Davis: I am Dr Jacky Professor Sikora: I am Karol Sikora, Professor
of Oncology at Ms Whittaker: I am Hilary Whittaker. I am the Chief Executive of Beating Bowel Cancer charity. We provide education, awareness and support for bowel cancer patients, for health professionals and the general public. Thank you very much for giving me the opportunity to come and give evidence today, particularly this week as this is our biggest public awareness campaign week: Be Loud, Be Clear. I hope I am going to be able to put the patients' perspective in a Be Loud, Be Clear way. Q66 Chairman: Thank you very much. You are probably aware that some of us were supporting the campaign here in Parliament last week. Could I ask a question to all three of you. How do you ensure your independence from the interests that fund you or can you ensure your independence from the interests that fund you? Dr Davis: We have very little funding from anybody and the funding that we have comes from the people who support us. The Keep Our NHS Public campaign is supported by people who sign up to the campaign. Union branches, for instance, give us money and we have had a small amount of money from one union, I believe, but we are supported financially by supporters. The NHS Consultants' Association is only doctors who work in secondary care, and again that it is only supported by people who belong to the association. Professor Sikora: Obviously, I belong to a
commercial concern and have a vested interest in improving cancer
services. I feel that the only way to
improve, to bring our cancer care in line with Ms Whittaker: We get just short of 90% of our funding from general donations and grants and legacies and other general means of people providing money to us through events and activities. The remainder, just over 10%, we get from the pharmaceutical industry. That is normally made up of a variety of companies, which can vary year on year. A lot of that funding really comes to us for public awareness campaigns, and maybe campaigns that are centred usually around symptoms and early diagnosis of bowel cancer. Q67 Dr Taylor: I have an extremely broad question which you could all talk about for the whole morning, so, please, a very quick answer because we will be going into the detail. The very broad question is: Do you agree with Professor Richards' recommendations? Really I am looking for a yes and a very quick reason or a no and are very quick reason, because we are going to go into the detail later. Dr Davis: I think he has had a jolly good stab at it. He does say we should not have top-ups. He does recognise the threats to the NHS. For our liking, he does not go into alternative ways of doing this. We have heard this morning from two people that this is a very small problem and it seems to us that we are taking a sledgehammer to a walnut here and there are better ways of doing it. Q68 Dr Taylor: Commendably brief. Professor Sikora: I agree. Q69 Dr Taylor: Even better! Ms Whittaker: We broadly welcome it too. We liked the fact that it was broader than just top-ups, that it did look at the access to drugs for NHS patients. We welcomed the recommendations on exceptional funding and the recent announcement subsequently on high-level principles regarding national guidelines. Of course we want to see how that is going to be interpreted at PCT level. We were very encouraged by the importance given to the end-of- life treatments. This is particularly appropriate for bowel cancer patients, where there have been a number of drugs where these have not been readily available. We liked very much the spirit of the report, which is to have a flexible and open approach to how we deal with these issues going forward. Of course, speeding up the whole NICE issue was something that we welcomed. Q70 Dr Taylor: Are there sufficient safeguards to ensure that the patients who cannot afford the additional private treatment are not disadvantaged? Dr Davis: That is not so easy to answer very briefly, I am afraid. We feel that once you have people who are NHS patients but who can receive different treatments, you have a two-tier NHS and that it is almost impossible to introduce safeguards against that. Then you have to wonder how you are going to deal with those patients, what the psychological effects will be, what the clinical effects will be, what the knock-on effects will be of the inevitable shifting away of NHS funds into dealing with this problem. We heard this morning of the administrative costs of this, the policing costs of this, the time of clinicians. There are not that many oncologists around. There are not two sets waiting to deal with these patients, private and NHS. A lot of the time it is going to be the two people. The knock-on effects of people who cannot move out of the National Health Service will be great and the problem is that we simply do not hear from those people. The people we hear from, naturally, of course - and I would not want to disparage these people - are the people with end-of-life problems, with the cancers. We do not hear from the people who are going to be disadvantaged if the NHS becomes a two-tier system. They are the poor, they are the elderly, they are the inarticulate. I work in a hospital where the information sheets are printed in 27 languages. I suggest that we are not hearing from those people who speak those 27 languages about what they would feel when they could not afford these treatments, and I think it is a huge issue. Professor Sikora: I think we are making a bit
of a meal on the logistics. The Richards
report is not about how to implement the logistics of top-up payments. That is the next step after the public
consultation phase. I think it can all
be accommodated. None of us wants to see
a lady with a Barclaycard machine following the ward round around, giving a
menu of options, and then you give your credit card out and take that. That is not how it can work. Safeguards have to be in place and the paper
I submitted talks about the sort of safeguard.
Again, the logistics are not that complex. Let us take Erbitux, because you will no
doubt be telling us about Erbitux in a moment on - cetuximab is its generic
name - it has side effects. You can cost
those side-effects not so much in an individual patient but on an average, so
you can add a percentage of the drug's cost to manage side-effects. Whether they pitch up in Ms Whittaker: There are points there with which I also agree. I think the top-up debate is a complete distraction, which I do not want to talk about today really, because I think that for bowel cancer patients particularly the important issue is access to the drugs. That is the real core. Within the process we are going through at the moment there are very, very few people who are going to be able to afford to have top-ups. This is a minority of people. This is a lot of money people will have to secure to be able to go ahead. We are spending an enormous amount of time talking about something that is going to apply to very small numbers. In fact, I think Len said nobody had applied for a top-up in six months, so it put it into some sort of perspective. I think we have to keep that uppermost in our minds. It is a last resort for people. I think that continuity of care is a huge issue which patients have too: how this is going to work. They have all sorts of concern around that. Q71 Dr Naysmith: The evidence of what has emerged from Richards is that the guidance allows patients to receive both private and National Health Service care in parallel. People have interpreted this change in different ways, and I suspect that we have two people who take opposite views sitting in front of us here. Some people have said it is the end of equity in the National Health Service and therefore is a real and significant change. Others say it is merely a restatement of existing rules and fudging practices that were going on anyway. What do you think, Professor Sikora? Professor Sikora: I think the latter: it is
fudging. It has always gone on. The rich get better care than the poor, the
educated get better care than the uneducated - and that is a fact in the
NHS. The biggest single survival benefit
outside drugs and radiotherapy is your socio-economic class in terms of cancer,
and it is not just late stage of presentation but it is how you respond to
treatment, and it is because of a whole range of factors within the NHS. In the long term, the biggest weakness in all
our arguments is why can we not delivered comparative services to Q72 Dr Naysmith: We will come to that later on. Professor Sikora: Okay. Q73 Dr Naysmith: I do not know how much you heard of the previous session ---- Professor Sikora: I did. Q74 Dr Naysmith: -- but there was a PCT Chief Executive sitting there saying how difficult it is to balance cancer care against care for somebody with a long-term, disabling disease at home, and the money has to be found for their care as well. Cancer drugs are very high profile, as you will know very well. How do you balance that kind of judgment? Professor Sikora: You are absolutely right, it is an impossible task. The argument that Sophie gave about local needs is very valid: there are going to be different local needs. You cannot do the balance without having a rapid assessment from NICE to tell you the cost‑effectiveness - and we have problems there and I am sure we will come to those. More importantly, if you have top-up, if you allow top-up - which I guess is a foregone conclusion, we are going to allow some form of top-up - it focuses the mind. It focuses the mind of all of us on how can we get the same service for more people so that we diminish the need for top-up. Q75 Dr Naysmith: But it is on cancer drugs. Professor Sikora: I agree. Q76 Dr Naysmith: There are all the other things that the National Health Service has to provide. Professor Sikora: I quite often get accused by my colleagues at Hammersmith of stealing their budgets for cancer, because over the last 20 years we have seen a tremendous rise in cancer compared to other aspects of health care. One of the problems is that the NHS is based on the people, what the people want, and all the surveys show that cancer treatments are what people want. HIV was a great model from two decades ago: it was something people wanted and it achieved the goal. Things like mental handicap, adolescent care, drug abuse programmes suffer because of this. I think that is where you, as politicians, have to guide the decision-makers to make sure there is no suffering there. Ms Whittaker: Cancer is going to affect one
in three people, as we have heard already, so in itself it is something which
we are all concerned about. We all know
somebody who has cancer. Bowel cancer is
the second biggest cause of cancer deaths, so we are talking about big numbers
for the patients I represent. Looking at
the proportion of spend on cancer drugs in Q77 Dr
Naysmith: Ms Whittaker: But that is what it is at the moment. I can only base it on information that we currently have and that is the information that is available at the moment. If you think of the number of people who are affected by the disease and the spend, whilst there are all sorts of dilemmas in how money is determined across a PCT and all the different demands on the different disease groups, cancer still in this country does not get its fair share of spend. Q78 Dr
Naysmith: Jacky, I am sure you do not agree with these
previous statements. Q79 Dr Naysmith: We still have National Health Service patients and private patients side by side in dentists' surgeries under the National Health Service. Dr Davis: I do not think anybody sees dentistry as an ideal model for the way we are going, so I agree with you but I do not think we would want to end up there, with everybody with rotten teeth who could not afford their treatment. As for the proportion of money going to cancer drugs, I was struck this morning, when listening to the three people who came before us, by a sort of consensus that the top-up issue was really quite a small one. They did not seem to think it was very big. The issue that seemed to be coming out was the way that the cost of cancer drugs is really skewing the whole NHS budget. Why would it be right, if you had a child who was going to face their whole life with some problem, to see that money being lost to somebody who is spending that money on the last three months of their life? These are huge issues for society, not for us here this morning. It seems to me that that is the debate we need to be having and that the top-up thing is a distraction, in a sense. Those patients absolutely have to be dealt with who are having their NHS care taken away, but it is a distraction. I did not hear anybody this morning, for instance, talk about bringing the price of drugs down. That is something we really have to look at and that is one of the ways that we can avoid this problem altogether. Q80 Dr Naysmith: Professor Sikora, you made reference to the national insurance system. Of course our National Health Service is not really a national insurance system, as it is taxation that pays for it. Do you think this change makes it more likely that we will have to move to some kind of proper health insurance system? Professor Sikora: No, I do not think so. One of the things, listening to everybody, is
that we are not alone with this. It is
not just the NHS, it is not just Q81 Dr Naysmith: Do either of the other witnesses want to comment on insurance systems as opposed to being funded from general taxation? Dr Davis: Professor Richards said in the report very specifically that he was not swayed by the minority who wanted to go down the insurance way, but it was interesting that, very soon after it was announced that top-ups would be allowed in some sense, there was an article on the BBC website describing the insurance companies absolutely dancing with delight and saying, "This is a pivotal moment for us. There's a bigger market here than there is in the private health market thus far." Whether we want it or not, they are pretty savvy and they see that this is going to be a big opportunity for people to buy insurance. There will be people who can pay for the extra treatment, there will be people who cannot buy for it out of pocket but who can buy the insurance for it, and there will be people who cannot pay for either of those, and so they are going to fill that gap. Of course, once you are diagnosed with cancer you will not be able to afford that insurance, so those people will be out of that picture. The argument that we cannot afford everything and therefore we have to have insurance I always find a strange one, because, as I understand it, the NHS is the cheapest way of doing things. We might not like many aspects of it, but it is the cheapest way of doing it, and therefore any other way we go is going to be more expensive and so why not just invest that extra money in the NHS. Ms Whittaker: We have called for the last four years for there to be a lot of debate between the Department of Health and the pharmaceutical companies on the pricing of drugs, cancer drugs for bowel cancer, and to find innovative ways around that to bring the prices down. We continue to call for that and I know there is some movement in that area for patient access and risk sharing schemes and so on which is welcome. The outcome we really want is that these drugs become affordable and that they are readily available on the NHS. Then they would be available for everybody and it would not be a matter of insurance. Q82 Stephen Hesford: Professor Sikora, could I ask you the Debbie McGee question. Given that you are associated with CancerPartnersUK, which is a private sector organisation, Pharmacia Corporation ---- Professor Sikora: I worked for them in 2000, yes. Q83 Stephen Hesford: They are a private sector company. Professor Sikora: They are a big multinational pharmaceutical company. Q84 Stephen Hesford: And Bioscience plc. Professor Sikora: Yes. Q85 Stephen Hesford: When did it first occur to you that the NHS should really provide a core service and that independent providers should ".... bid for contracts to supply a top-up service to cancer centres"? Professor Sikora: I think that interaction
between the private and the public sector is very interesting. If you go around the Hammersmith at the
moment, 60% of the staff are private sector employed, although doing tasks for
the NHS. Okay, it is all in hotel and
cleaning services, nurse agencies and other agencies. In the long term, delivery of care has to be
done in the most efficient way, and in some cases the private sector is
effective in doing that. The topping up
debate in cancer really came at the beginning of 2005, when a whole range of
drugs were licensed in Q86 Stephen Hesford: It was just a coincidence that in your evidence to us you used "top up" as a phrase. Professor Sikora: Also, in my experience with pharmacy - I was head of R&D for cancer globally, based in three places - one of the questions for the pharmaceutical industry is "Can you lower the price of the drug?" and the answer is "No, not for a single country because they are global products." It is like airline tickets: they are global products. You cannot say, "Because we like you and we like the NHS we will lower the price for you." That is part of the problem. Over the last two years we have seen imaginative schemes of trying to get to value-based pricing, but they do not lower the price of the drug: you either get a refund or something back if it does not work after a certain period of time. The price of the drug to the wholesaler is the same. That is sort of because it is a global business, and I cannot see any way out of that. Q87 Stephen Hesford: In 1997 the NHS budget was somewhere in the region of £35 billion a year. It is now approaching £100 billion a year. Does that not suggest that there is a move forward to reach European levels and that the NHS, by itself, without any kind of nudging or carping from the private sector, is going to get to where we need to go as long as people all sign up to it and support it? Professor Sikora: I think there is huge inefficiency - and that is part of the trouble - within the public sector. It needs reform. Both the previous administration and this administration have attempted to do those reforms. I would say they have not gone far enough. There is a lot of efficiency savings to be taken out that could result in these drugs. I think the top-up argument is focusing our minds on how to get more efficient. Whether we use the private sector or do it in-house I do not think matters. We will achieve the same endpoint. Q88 Chairman: Jacky, do you agree with that? Dr Davis: I am very much with you, of course, because that is where I am coming from. Q89 Chairman: Do you mean with the question but not the answer? Dr Davis: Perhaps you would put the question to me again because I was so busy listening to the answer. Q90 Stephen Hesford: I cannot really, because you are not in the private sector. Dr Davis: No. Chairman: Let us move on. Q91 Jim Dowd: I was tempted to ask Professor Sikora whether the inefficiencies in the public sector match those in the banking sector. Professor Sikora: That is not public sector, of course. Q92 Jim Dowd: Most of it is now. I remember when we wanted to nationalise the banks because they had money. Now they want our money! It is amazing how the world changes. You mentioned the involvement of the private sector in the NHS. This Committee some years ago did an inquiry into the role of the private sector, and of course it goes far beyond the estate or the buildings. The pharmaceutical industry is hugely involved in the private sector. The difference there though is that that is the involvement regulated at the organisational level. With top-up fees, we are talking about contributions made at the individual level for private care. Do you not see that as a considerable change in the aesthetic of the NHS? Professor Sikora: I think it is relatively small. If you take drug top-ups, is it going to be a separate model, so that the patient goes to a private sector provider, either at home, delivered to them, or at a private hospital or private care unit that is specially set up to do this, or are they going to go down to the pharmacy in the hospital, get the drug, and be given it in the NHS? If one goes down the separatist route, then somehow private sector facilities have to be put in in the traditional private practice type setting to cater for those patients. If it is going to be integrated within the NHS hospital, then it is less of a problem, but even still there may be a need to have a private sector partner that comes and delivers the top-up care. As we have heard, it is going to be small. It is not going to be more than, I would have thought, 5% of all cancer patients who would want to get a top-up drug. Q93 Jim Dowd: As you have said and as we all know, one of the successes of recent times is increasing longevity, and therefore cancer becomes an ever increasing issue across time and will come to affect more and more people as a proportion of the population. There is no sign that that will ever end until we start losing longevity again, which of course is at a different time. It will come to affect more and more people over time. Professor Sikora: Absolutely. There are three drivers which you cannot
reverse: ageing populations; that there will be new drugs beyond the ones we
are talking about today and beyond the ones for bowel cancer that we have
heard; and also - which I think is the most powerful driver - the equalisation
of information. There are 300 million
websites on Google for cancer. You
cannot hide in a clinic the fact that these things exist. When I began as a registrar in oncology
at Q94 Jim Dowd: If it is cyanide, of course, that is probably true. Moving on from there, do you see practical difficulties in separating private and NHS care over time? If so, how would you overcome that? Professor Sikora: The logistics can be sorted out. I think the key thing is that there is no
conflict of interest. If I am sitting in
the clinic seeing a patient and I want to give them Erbitux or Avastin and they
want to have it or they have come asking for it, I cannot say, "Come to the
Sikora Clinic around the corner" and charge a lot of money and make profit out
of it. That would be wrong. I think what Alison was saying this morning
is very interesting, and it is the way I would envisage it. The patient remains under the care of the
same multidisciplinary team The decision
to give the drug, the decision that it is of some benefit to them, maybe not
NICE approved, comes from the doctor who looks after the patient but does not
charge the patient as a private patient.
The money for the drug with the side-effect costs are added to it, and
the NHS, the hospital trust, gets the benefit from that. There is no separate moving to another
clinic. The current model in Q95 Jim
Dowd: Sure.
Before I come to Ms Whittaker and Dr Davis, you mentioned Professor Sikora: That is my understanding. What happens is the top-up drugs are not given within the Birmingham Trust but they are given a mile down the road, so the Birmingham Trust can easily say, "We're not giving the drugs" but the patients that are getting the top-up, including sunitinib, the drug for kidney cancer that we have heard about, go down the road and get it. The consultant who does the prescription does not make a private charge for the top-up drug. It is a local arrangement which has worked for about three years now. It is one option, but that is the separatist model. It is ethical because there is no profit made by the consultant, so he or she has no vested interest in pushing top-ups to the patients. It is also not using NHS resources. Q96 Jim Dowd: At what stage is that suggested to the patient? Professor Sikora: Do you mean when they have chemotherapy? Q97 Jim Dowd: Yes. Professor Sikora: Most of the top-ups are drugs that are given with a course of chemotherapy for matters developed with cancer that has spread. At the inception of the chemotherapy, often the families come with internet printouts and say, "I've read about this drug" - and Erbitux would be an example if you have colorectal cancer - "can we have that?" The answer in the NHS is no, but you can have it privately. It has to be given with other drugs, so the other drugs can be given within the NHS at the NHS hospital and the Erbitux can be given in the private hospital. That would be the model. The drugs have to go together in that case. The oral drugs are given on their own, and so it is less complicated. Q98 Jim Dowd: Dr Davis, on the question of separating private and NHS care? Dr Davis: One of the problems we all seem to be suffering with here is that we simply do not know the scale of this problem and how much it would cost to address it. I have been struck, listening to the difficulties of having a true separation as recommended in the report, by how much this is going to cost on a rather individual basis around the country, because some of these will be for patients where there will only be one here and one there. It would be really worth knowing whether the cost of having true separation, as described in the Richards Report, would be greater than the cost of giving those patients the drugs on the NHS because it is possible that that is the case. I suspect that this true separation simply will not be possible for all the reasons we have head this morning: the difficulty of interrupting the multidisciplinary teams looking after these very complicated patients, the difficulty of giving the drugs separately, the difficulty of costing these thing into separate issues, the complications that arise from being transferred into the private sector. For issues of geography and availability of clinicians, what will happen is that in a lot of hospitals people will just be put in another room and a line will be drawn around it and that will be the private area and the doctor will deal with them: "I'm wearing my NHS hat now, and then I come down the corridor and I put on my private hat and I oversee you having your private treatment." I am sure the two will just drift together because of all the practical difficulties we have heard of this morning and then we will be down that route of two different treatments in the NHS. Everybody will start out on this with the best possible intentions - and I admire this report and I think he has done a terrific job - but the practicalities of it mean that is where we will end up. I really do think it is worth looking at whether the cost of doing this in the way that he recommends is going to be so great for PCTs in terms of doctors' time, premises, paperwork, multidisciplinary teams looking after everybody, that it will just be easier to stump up and give the patient the drugs. Q99 Jim Dowd: Is not the danger of that that you then let the private sector dictate the pace at which drugs become available? Dr Davis: That is another danger of going down the top-ups route. Once PCTs who are under pressure see that there are mechanisms being set up for drugs to be given to patients under these circumstances, more and more stuff will be pushed into that category. We have not gone down that road of discussion this morning but it is towards the core service model of the NHS, with people having a core service and then there is all sorts of bolt on stuff that you can get, and that will be the temptation. As has been pointed out by your colleague this morning, the NHS has managed to cope with the increasing costs so far. That is really a decision for society to make, we believe, rather than something that just edges in through the backdoor - which is what we are looking at at the moment. Ms Whittaker: I would like to put this in the context of the patient for a second. From a patient's perspective, they already have the trauma of dealing with a very serious disease and they are probably aware that they have a limited lifespan. They will be exhausted, having gone through the exceptional funding route first, because all of those avenues have to be exhausted. I think there needs to be lots of clarification on what that means. They are then confronted with this situation, which from a patient's perspective must be utterly confusing. I think it is very important that this is made very clear, the clarification of what top-ups mean, and, going back, some colleagues this morning mentioned that, even though it might be something that would extend their life for a short period of time, it might not be appropriate for everybody to have top-ups, even though it could perhaps give them some benefit. But patients are going to need an enormous amount of guidance and support - and that has to be a very important part of this process - in order for them to even make a decision with their families about whether they would take a top-up. If they do, one of the big issues is going to be what their belief is, their ethical dilemmas: Do they believe in private care? Are they prepared to pay? Do they want to go into a private hospital? What does continuity of care mean? Clinicians as well are going to need a great deal of help and support in order to be able to explain all of this situation to a patient. I think there is an enormous amount of issues around that which hopefully we will get a lot of clarification on as this unfolds, going forward. Professor Sikora: In the NHS clinic, time is of
the essence. You have a set number of
patients, a set time to do it, and the clinic gets taken over after lunch by
another consultant. The top-up debate in
certain areas is so time consuming. I
share a clinic with a consultant who does a kidney clinic and when he is on
holiday I have to see the kidney patients.
There is no doubt that you spend a lot of time going through the
costs/the benefits of these drugs. Not
only that, we have a map on the wall of the clinic that tells you which PCT
allows it easily and which does not allow it easily. If you are in Dr Davis: Nobody has mentioned, from a
clinical point of view, that as a doctor we have never had to discuss with NHS
patients whether they can afford something or not. We are a terrifically lucky generation
of doctors since 1948. I work in a part
of Q100 Jim Dowd: The conflict there is between equity at the lowest level and people who can exercise this choice. You say that because not everybody will be able to, nobody should be able to. Dr Davis: No. I am saying that that is a tension that we all recognise. When my colleague here says, "We will look at it from the patient's point of view," she is talking about particular patients, the cancer patients with these very desperate end-of-life requirements, the people who are not sitting here this morning. But we are all patients in this country. There are however many millions of us - everybody in this room - who are potentially going to be disadvantaged by these arrangements, so it is citizenship versus consumer, personal choice versus equity. Q101 Jim Dowd: De facto, any decision you take closes off further options. Dr Davis: Absolutely. I suppose I am saying that we always recognise that tension, and that there is nobody speaking for those patients whom I have already mentioned who speak 27 languages but not one of them English and who cannot be here today saying "What are the disadvantages to me if you go down this route?" Q102 Chairman: We heard in the earlier session about the potential associate costs of the National Health Service of this top-up system. I know side effects are a very difficult thing to predict. Is there a comprehensive list or an exhaustive list in terms of what the potential associate costs to the NHS is? Dr Davis: Not that I know of. Professor Sikora: You can obtain it from the
literature and looking at experience in other countries where the drugs have
been licensed and in use. The problem is
that clinical trials are not a good way to look at the true cost of giving a
drug because they are in very particular circumstances. For Erbitux, which is used I think ten-fold
more in Q103 Dr Naysmith: One of the things that this whole debate has focused attention on that maybe was not there quite so much before is end-of-life treatment. That has been illustrated this morning with a number of questions that have been asked and answered. I am sure you will all be familiar with the new NICE appraisal system which uses a different cost per QALY threshold. Do you think that this change which means that they have a different threshold for end-of-life drugs is fair? Can it be efficient? Can it be properly cost-effective? Professor Sikora: It is a horrible word, that is all I can say, "end-of-life". Q104 Dr Naysmith: We have been in clinical situations when doctors have talked about it and it clearly has been very much part of the debate. Professor Sikora: But we are all dying. Everyone is dying. It is a matter of relativity: How long is it that you have? As we heard from Alison earlier, a lot of cancer patients are going to live essentially in an end-of-life state - the disease has spread, so by definition they are not going to be cured of their disease - for ten or even 20 years. The longest I have had is 22 years. These people are living a normal life and they are accumulating all the morbidities that you accumulate when you get into your 70s and 80s and become frail. The end-of-life drug: it is difficult to define at what point you come to the end of life? Q105 Dr Naysmith: Somebody is defining it because they are using the different thresholds. Is that a valid decision to make? Professor Sikora: We have not seen how it is going to be used in practice. I think most oncologists are a bit concerned about this. The cost per QALY is enshrined in how NICE does its assessments. Are you really going to have differential costs per QALY when someone is, you predict, within three months of death? These are the sorts of things that are very difficult to do. At the end of the day, if one just added inflation to the cost per QALY that is allowed from 1997, when NICE started, to 2009, one would find one would be at the reasonable range for most of the drugs we are talking about. The end-of-life concept, to me, is a very tricky area to go down. Ms Whittaker: On the end-of-life that they are looking at now, which is benefiting "small patient population", we wanted to have some clarification on what they mean by small patient population, and whether this is to do with the number of people who were diagnosed or whether this is to do with the number of people who would benefit from the end-of-life treatments. Obviously that is a very different area. For bowel cancer patients it would certainly fall into the small patient population for end of life, because of course as a disease it is very large, with 36,000 diagnosed, and half of those are dying, but it would still come into that small patient population, the ones who would benefit from the end-of-life treatments. I do agree with the point that if inflation was added on to the existing 30,000 level over the period of time since it was set, that would be a new parameter for perhaps looking at the QALY measurement. Obviously how it is going to work in practice is another key issue because there are a lot of grey areas in small patient population and how that will be interpreted. It has to be interpreted equally and fairly across the whole of the NHS, so that we do not get the situation occurring again where some patients can get access to the drugs and some patients cannot through what we call the postcode lottery. I think that is terribly important when they are looking at the NICE system. Also, we welcome NICE speeding up the whole process but, again, we want to see that in practice and see how that is going to resonate. Q106 Dr Naysmith: Dr Davis, does not the whole situation arise because some of these drugs are quite toxic, the end-of-life drugs, and not effective? Not even the manufacturers would claim they cure the condition. Dr Davis: That is the difficulty. I think NICE rejects 5% of drugs. I saw a figure that the QALY for some of them is £370,000 a year, so they are obviously very unpredictable and very expensive. As I think Alison said this morning, they do work for perhaps a small percentage of people - we do not know which ones. If they start to be given outside the remit of the NHS, the true NHS, then we may not be able to even monitor how they do, if we start using them for more patients. The other thing is that there will be pressure from the drug companies to push these drugs outside the NICE parameters. I understand that has happened already, that somebody has not submitted their drug to NICE because they understand that it will not be accepted. Now that NICE is admired across the world, to be rejected by NICE will have incredible repercussions, so there will be drug companies who start to bypass NICE and go straight to patient groups, for instance, and put pressure on them to ask for the top-ups outside the NHS. It is a very slippery road to start going down. The other issue that I have referred to before is that it seems to me that end-of-life and cancer drugs in general are really skewing the NHS budget. They are skewing it in an unfair way. It may be that some PCTs have five patients with a condition and another PCT has no patients with that condition, and we should not be denying the patients those drugs. It did occur to me that perhaps if we had some national fund for these drugs, we would not have all this patchy differentiation across the country, with some PCTs saying yes and some PCTs saying no. They are hugely expensive. It was very striking this morning listening to the lady who was sitting in my seat saying, "Do I want to spend this money on a very expensive end-of-life intervention or do I want to spend it on mental health where it will be much more money spread around?" I have just thought of this: take that wretched money out, put it in some national pot, and then have it given out. Then it would be much easier for the PCTs to balance their budgets when they know they are not going to have to face up with somebody like that appearing on 30 March and saying, "I need these drugs." Q107 Dr Naysmith: I will open up another whole area here that started with a quotation from Professor John Black, President of the Royal College of Surgeons. He was quoted in The Times as saying, "The importance of surgery seems to have been forgotten at some levels. The common cancers that have a one-in-five chance of killing any of us are dealt with by surgeons. There is a reasonable input from radiotherapy but the input from all these anti-cancer drugs, which cost vast sums, is very marginal." Do you agree that more work needs to be done to explore the use of radiotherapy and surgery, not to the total detriment of cancer drugs but that the balance has become all wrong? Professor Sikora: In terms of where cancer research is going, we all realise that the only way to go beyond local control of a cancer with surgery or radiotherapy, is that you have to have something that goes right round the body, so it has to be a drug. The thesis of modern cancer research is about trying to find differences between cancer cells and normal cells to allow you to develop a drug. The future is likely to be more drug-oriented, as it has been in diseases where we have developed drugs: testicular cancer, lymphomas. The problem is that where the drugs work really well, for those sorts of cancers, it is a relatively small proportion, as you say, of overall cancers. Breast, lung, colon, prostate make up nearly 65% of all cancers, and the drugs there work but they do not work as well as they do in the rarer forms of cancer. I think that all one can do is see where technology takes us. I suspect over the next 20 years it will take us down a more drug-oriented route and the drugs will be much better than the ones we have now, and therefore NICE will be happier with the product, and so it will move forward in alignment. Q108 Dr Naysmith: That is probably looking towards drugs like Herceptin that go for a specific histotypes. Professor Sikora: Exactly. The thing about Herceptin that is interesting is that it began as an end-of-life drug (using the modern parlance). It was used in women who had disease that had spread to the liver, to the lung, to the brain. That is where it was first tried, it was effective, NICE approved it in that indication. Then two years ago data came showing that it worked early on, after surgery had removed the breast tumour, and so it then came out of the end-of-life box into the active treatment box. That may well happen to many of the drugs we are talking about today, that they are not really end-of-life drugs. They are now, but they will be proven to have benefit earlier in the disease. Q109 Dr Naysmith: The point I am trying to get at is that there is huge pressure to develop these new drugs from pharmaceutical companies - which is what their business is about. No-one criticises them for that. There are huge improvements possible nowadays in terms of therapy. We heard from one of the witnesses this morning that the radiotherapy department, half of it, is clapped out and needed replacing. Standing beside that - which I know is not true everywhere but happens in some places - we are spending lots of money on developing new drugs. Is that a sensible use of resources? Professor Sikora: I am a radiotherapist myself and I would agree. The problem you have, if you take the total cancer budget, is where would you spend it? That is what Mike Richards has been doing with the cancer plan over the last decade, trying to find out where to get the most benefit from a certain amount of money. The problem is that the public understand a drug. If you have kidney cancer and there is a drug that you cannot get, you become obsessed with wanting to get it. Whether you have a fancy type of precision-based radiotherapy compared to normal conventional radiotherapy for your prostate cancer does not have the cachet about it. Q110 Dr Naysmith: We are supposed to be in favour of evidence-based treatments in the NHS. Professor Sikora: Exactly. I think the future is about trying to use the technologies to the maximum and, as they improve, to look at the improvement. NICE is the way forward, there is no doubt, to assess all these technologies, but they have problems all the time: delays, suspension of appraisal for radiotherapy, for example. It is not a smooth transition. We need to get into a smooth transition. Q111 Dr Naysmith: Dr Davis, we have all this focus on drugs purchased by the pharmaceutical companies, and there are other ways, according to some experts, of treating some cancers that get left behind in the priorities. Dr Davis: I guess these are the patients I was talking about this morning, the patients whose voices are not being heard at the moment. If your radiotherapy department is clapped out and you are the patient who is relying on that, who is speaking for you? It seems to me there has been an emphasis on these very dramatic patients. As Karol said, they have become obsessed with drugs. That is one of the problems. It may be that they need protection from a lot of the publicity that goes out about drugs. The media. It is very easy to take up these patients, they are very emotive people, but it may be that somebody else looks at that and thinks, "Oh, that might do good for me." Who is going to advise these patients if the top-up thing goes mad? The cancer argument has skewed things. We need to step back from it a bit and say, "What about everybody else?" Q112 Dr Naysmith: Do you think that we need to spend more money to explore public attitudes towards whether the funding of expensive treatments that give patients a few extra months to live is a good use of NHS resources? We hear what the papers say, pushed by all sorts of people in the newspapers, but what are the attitudes of the patients in the National Health Service? Is it a good use of resources? Dr Davis: When people answer those surveys they always answer as individuals. The letter that was included in the Richards Report was a very telling letter. It was the only letter, I think, that he did include and he included almost all of it. It was written by a patient who had terminal cancer and who said, "I could not afford these drugs myself, I know I could not, and I ticked the box saying 'Should other people be able to buy them?' and I felt very martyred about it and good," and then he said, "but I went away and thought about it a bit and I thought how miserable all the people would be who could not afford those things." He was a bit unusual, he answered the question in a citizen sense, he did not answer it in a consumer sense, but when people answer those things, they think: "What would I want?" Perhaps it is right that people answer that, but I think people like you perhaps have to sit back and say what is best for society here. Q113 Dr Naysmith: There are ways of designing questionnaires that can get at people's views, even, sometimes, when they do not think they are putting them down. Ms Whittaker, do you have a view on this? Ms Whittaker: I think that asking patients their views of these things would be excellent. The more evidence base that you have for making decisions going forward would be welcomed. Q114 Dr Naysmith: This was not so much asking patients but asking the public. Ms Whittaker: Asking the general public is equally valuable. We hold a lot of market research on issues around bowel cancer, awareness of it, and how people would like to go forward and would they accept treatments and so on. I would absolutely welcome it. If I could go back to the previous question for one moment, our aspiration for bowel cancer patients is that they would not need end-of-life drugs. That would be the perfect solution because that would mean that the 50 people a day who are dying from bowel cancer are not. Surgery is usually the first place that a patient will go in terms of treatment for bowel cancer. The advancements on laparoscopic surgery have been absolutely tremendous for bowel cancer patients. Now, where there are centres where laparoscopic surgeons are doing, in some cases, 80% of their surgery for bowel cancer by laparoscope, a patient can be out of the hospital within three days, rehabilitated at home within two weeks, back at work and contributing and for all intents and purposes well. In bowel cancer cases, 90% of patients, if caught early enough, can be successfully treated. I think surgery is still the most important treatment for bowel cancer patients. That would be a wonderful place to be with end-of-life drugs not required for bowel cancer patients. But we have a long way to go, of course, before we are there and so we have to address some of those other issues. Professor Sikora: The largest study that has
been done was Cancer Backup two years ago - it is on the web, it is published
-looking at attitudes not to top-up but to attitudes to cancer drugs and
information. The bottom line was that
people want all the information, they do not want things to be hidden from
them. If they ask me about a drug, they
do not want me to deny the drug exists.
They want me to be honest with them, even if they cannot afford to buy
the drug for themselves. That
transparency is something about the whole consultation process that we cannot
take away. It does not matter whether it
is in the private sector or the NHS, that is key to good medicine. The question then is: How much would people
be willing to spend for a top-up? They
did ask a few questions, and that is where it gets a bit different: from social
class 1 you get a very different answer than from social class 5. It was of about 3,000 people. It was a donation from the MORI poll
people. It is worth looking at that
study and I can send the reference for it to Q115 Dr Naysmith: Asking people to understand what it means if you say to them, "There is a one in ten chance that it might be effective in your case" or "There is a one in hundred case it might be effective in your case," with the clinician sitting down and explaining that to a patient, must be a terribly difficult task. Professor Sikora: Other studies by my colleague
Maurice Slevin here in Q116 Dr Naysmith: But then you have to add in, "You might have terrible side effects for a while and it may not work, so you have to weigh up." Professor Sikora: Absolutely. Dr Naysmith: It is difficult. Q117 Dr Taylor: I am still grappling with the extent of the problem. I wonder if we could be given any idea of the cost of funding drugs for a patient with bowel cancer who is turned down. What sort of figure are we talking about? Ms Whittaker: I probably do not have that information to hand. I can have a look and see if I can source that information for you, or there may be others who would know what that figure is. I suppose the clinician's choice is so different for the whole process. Somebody will have worked out, I am quite sure, some measure by which there will be an average, but I do not know what it is. Q118 Dr Taylor: The Richards Report - correct me if I am wrong - guesses at £8,000 as the basic cost without all the extras. If you add the extras, one is going to be talking about £15,000 or £20,000. Ms Whittaker: Probably, yes. Q119 Dr Taylor: That comes back to the previous point: however many people are there who can afford that who are not going down the fully private route. Professor Sikora: The other problem is that the reason it is relatively low - relatively - is because a lot of patients fail. In other words, after three months the drug is not working, so you can stop, and so they have only had three months' supply. What do you do with someone who has a dramatically good response? However bad the situation, you get one or two patients who have dramatically good responses, so they are going for a year or maybe a year with the drug, and there the figure could be much greater than that £8,000. I it could be double, because that £8,000 is just an average, and they run out of money. How do you deal with that group of people? That has to be thought of here. Again it can be insured for. The way round it, if you sit down and work it out, you say, "Let's balance out what the average is and let's increase that a bit to pay for insurance, to pay for the people who are going to go two or three years down the line and start having to pay for a drug" - which is essentially what the NHS is doing. It is the insurance function of it. Q120 Dr Taylor: Is there an absolutely huge hidden problem, in that there are a lot of people who would never even dream about affording this amount of money, who are there who would really benefit from some of these drugs? I am talking specifically about the end-of-life drugs that really are proven to have quite a benefit. With the renal drugs particularly it is pretty definite now that they can prolong life. Are there thousands of people who would never even kick up a fuss because they know they cannot afford it at all? Have we any measure on that sort of problem? Dr Davis: I think part of our problem is that we simply do not know the size of the problem we are dealing with. To come back to your question: What is the average price? I would suggest again that if you add in what it is going to cost the National Health Service to run a parallel system for those patients, it may well be that the problem is small enough so that, cost-wise, it is not worth running that system because of the cost of administering the drugs. The number of those patients who have failed, according to the Richards Report, is very small - I think the Exceptional Cases Committee accepted something between 65% and 75% of cases, the average was £8,000, the overall number in the country was 15,000. Somebody needs to sit down with a calculator and say, "It would have cost this to fund those patients. How much is it going to cost us to administer the system that he is advising?" By the time you have factored in all these different doctors doing things and premises and paperwork and multidisciplinary teams, crossing the divide, perhaps it would cost less money to give the patients the drugs. Q121 Dr Taylor: Does this number of people who go into Exceptional Case panels probably cover the whole range? Dr Davis: I do not know. Professor Sikora: It does. Q122 Dr Taylor: Probably. Professor Sikora: It would cover the whole range. Q123 Dr Taylor: You have mentioned better information, should one of our recommendations be that we suggest to NICE that when they turn down a drug they produce a relatively detailed explanation aimed at ordinary people to explain almost in words of one syllable why they have turned it down so that most people could make up their own minds? Professor Sikora: And you could translate it into 27 languages. The idea would be that there would be three categories: (1) acceptance for widespread NHS use; (2) acceptance that the drug has value and is probably being used in European systems and there is evidence of benefit but it is not cost-effective used within the NHS; and (3) a recommendation that it is not worth touching with a bargepole, that it has no real benefit, and therefore do not even go and buy this drug. With a NICE approved drug there is a public leaflet that comes out. You just need to do the same process for the other two categories. Q124 Dr Taylor: Would you agree with that? Dr Davis: I think it is going to be necessary to protect patients from predatory drug companies. That seems like a way to do it. As said earlier, if there is a 1% chance patients will take it, but those choices need to be made very explicit. I would really like to see us aiming to offer all drugs that have clinical effect to patients who can benefit from them, like Europe apparently does, and to look at ways in which we can do that rather than through the top-ups. There was a very interesting letter in the BMJ about three months ago saying that if Europe approached this as a body - and of course we could through the EC - and looked at these very expensive drugs and said, "Europe will buy this drug if you make it value for money, if you bring the price down," then it may be that a lot of these drugs would start to fall within the price range where we could offer them to everybody, and, as Hilary said, we simply would not have the problem any more because we could deal with it. Q125 Dr Taylor: If prices came down what could we give up so that we could afford all these things? Dr Davis: Where could we save money in the NHS? Q126 Dr Taylor: Yes. Dr Davis: I believe there is a paper out where we are already identifying places to save money. Q127 Dr Taylor: Better Care, Better Value. Dr Davis: That is right. Q128 Dr Taylor: Which is hopelessly under-used. Dr Davis: Exactly. We could look at that. I am told by people who understand the pharmaceutical industry that we could, by negotiating with a drug company, bring the prices down. I know Michael Rawlins was quoted as saying that some of these drugs could be sold for one-tenth of the price, so there is a lot of scope there. Of course, coming from where I come from, I would say that a lot of money is being spent in the National Health Service - management consultants, bringing in the private sector and all that kind of thing - where it could have been sent to looking after patients. Dr Taylor: Thank you very much. Q129 Stephen Hesford: You argue that the NHS spends less on drug treatments for cancer than some European countries. How robust is the evidence for and should we be suspicious of it when its production is funded by the international pharmaceutical industries? Professor Sikora: The report comes from the
Karolinska Institute in Ms Whittaker: I think it is clear that for
bowel cancer the drugs are readily available in Q130 Stephen Hesford: How do we know that they are cost-effective and that they have any real difference on outcome? Professor Sikora: They have all been approved
by the FDA in Q131 Stephen Hesford: You said before that you could give a drug for, say, three months and then realise it is not having any effect. Professor Sikora: Yes. Q132 Stephen Hesford: Is that not a waste of money? Professor Sikora: No. It is good oncology. You give a drug, you have what is called some sort of marker of response - so it may be an x-ray, it may be a blood test, it may be some other investigation - you repeat it after three months, and you see if it has got better, in which case the drug is working, or if it has got worse. If it has got worse, you stop at that point. Most of these drugs take about three months before you can do the assessment. If you could do it the next day after giving it, it would be wonderful, but you cannot. You usually have to wait three months. Q133 Sandra
Gidley: In terms of outcomes, money spent, survival
rates, extension of life, what evidence do you have that Ms Whittaker: The figures I can refer to
are the 2002 figures that I currently have at the charity, in terms of five
year survival rates comparing the Q134 Stephen Hesford: But that is 2002. Ms Whittaker: Yes. I understand that for part of Mike Richards' review there is going to be an investigation into some more up-to-date data on those comparisons which of course will be extremely interesting for us to see in due course Q135 Stephen Hesford: It will be helpful to you when dealing with your client group to have that up-to-date conversation. Ms Whittaker: The more information we have
about what is going on in the rest of Q136 Chairman: Is that wholly due to the availability of these drugs or is there something else behind survival rates, in terms of being able to find out earlier when somebody has bowel cancer? Ms Whittaker: As with all things, it is probably an element of a number of different things, but there is no doubt that if you can get treatment that is very effective early on then the outcome is going to be to your advantage, and there are no other measures that we have that are saying it is any different from that. Q137 Chairman:
Would
you say that investigating and screening is good in the Ms Whittaker: We welcome screening in the Q138 Jim Dowd: I heard last week at the reception that it is the second biggest killer. Are you saying that it kills more people than breast cancer? Ms Whittaker: Yes. More people die from bowel cancer than breast cancer. It is second only to lung cancer. It depends which data you are looking at, but about 16,500 people are dying every year from bowel cancer. Q139 Jim Dowd: Setuximab was mentioned previously - I am not sure what the other name for it is. Ms Whittaker: Yes. Q140 Jim Dowd: Is that what it is called? Professor Sikora: Erbitux. Q141 Jim Dowd: Is that now generally available? Ms Whittaker: No. No. Q142 Jim Dowd: Not at all. Ms Whittaker: It is not available. Q143 Jim Dowd: I had a case with a constituent five years ago over this. Ms Whittaker: It is about five years ago that it was licensed, and we are still having this discussion. Avastin was probably four years ago and we are still having this discussion. Q144 Jim Dowd: And they are still not available. Ms Whittaker: They are still not available. In fact, under the exceptional funding possibilities to PCTs, there were about 46 applications for Avastin over a 20 month period finishing in October 2008, of which 41% were positive. There were about 106 for Erbitux and 41% were positive. So even for people going forward for acceptable funding more than half of them are turned down, and of course during that process patients are going through the most traumatic and difficult and stressful time, having to appeal through this exceptional funding process which can be lengthy and very distressing for patients and their families. Q145 Jim Dowd: I was fortunate five years ago with my constituent because the PCT did agree in the end. Sadly, he died before the first course was supposed to begin. Ms Whittaker: This is something, of course, at Beating Bowel Cancer we hear on a daily basis. Jim Dowd: Thank you, Chairman. Q146 Chairman: Does the new PPRS scheme which was renegotiated last year represent a good deal for patients on the NHS? I know you have covered this area in many answers to questions in the last hour, but who would like to have a shot at that? Is it a good deal for patients and the NHS? Professor Sikora: It is a complex fudge, I think. The difficulty is how is it going to affect the price overall of, say, Erbitux, as we are talking about it? Is it really going to make it cheaper or not? I suspect that in the negotiations on both sides, one side think they have got away with not lowering the price and the other side thinks they have got a big price reduction. I get the feeling that we just do not know - and you will not know until it has been operational. Value-based pricing, which is the other way of doing it, is a better way forward, if one is being logical. If you buy a better car, you expect it to last longer and not to need so many repairs, so you are paying more money to get that. Why does the same not apply to a drug? The difficulty in cancer is that very few cancers can be measured very precisely, so the first value-based pricing model was with a disease called myeloma, with a drug called Velcade. We measured the blood protein level. If it fell below 50% of its start level, you paid for the drug. If it did not, you got the drug for free. That is the ultimate in value-based pricing. That model is still in application. For breast cancer or for bowel cancer it would be very difficult to get such models. Not only that, it requires a bureaucracy to monitor that, how you are going to do it and get the refunds for the drug, so there are hidden costs in that. I am a bit sceptical about the PPRS. It is the most complex scheme and we are talking about a global market all the time. If you take Pfizer or Merck, they are not interested in British sales, they are interested in global sales. To them, this is unimportant. I think that is the problem with the whole thing. Q147 Chairman:
What
do you say to that comment in and around the OFT report in 2007 that the issue
of prices and PPRS was important to the rest of Professor Sikora: I think value-based pricing would affect the price more than the PPRS. The PPRS is a local agreement, looking at local assets of pharmaceutical companies and not allowing them to make so much profit beyond a certain level and then bringing down the cost. Value-based pricing is how we are used to dealing with the consumer world and would seem to be a much better model for the future - but you have Alan as the expert on this. Q148 Chairman: Do you think the reason we have drug companies raising prices is "to get profits up so their executives can get better bonuses" and that "the prices the pharmaceutical industry charges are what they think the market will bear". You know who I am quoting on this. Professor Sikora: There is definitely an
element of what the market will bear. I
was involved 25 years ago in the pricing of a drug for cancer - and I will not
tell you what it was. The way it was done was just to look across Dr Davis: Not being a person who
prescribes, that is what I have been told by people who understand the drug
industry. One of the important reasons
the NHS must stay as a coherent body is that it gives us much greater
bargaining power with the pharmaceutical industry. This lies at the heart of resolving this
problem. I do not think we are going to
resolve this problem in the way that has been suggested in this report. I think
we are going to resolve it by bringing drugs prices down, bringing those
patients within the Health Service, and getting rid of all the problems we have
discussed this morning. Karol says they
are interested in the global industry, certainly looking at it on a
European-wide basis and saying, "Okay, we are Ms Whittaker: I agree with Jacky. The key here is to get the prices down. The pharmaceutical companies should be working with the Department of Health; the Department of Health should put pressure on them to bring the prices down so that all the drugs can be available at affordable prices where clinicians feel they are appropriate for a patient. Chairman: You are all agreed that value-based pricing is the way forward and not the scheme that we have now. I do not know how that works on a European scale. Professor Sikora: Difficult. Chairman: Yes. Could I thank all three of you very much indeed for coming along and helping us on this, our first day of taking evidence in the inquiry. |