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The efficacy of treatments is not an obvious subject for politicians. It could be regarded as a medical debate between cardiologists and surgeons about whether the use of stents is preferable to keyhole or bypass surgery; whether metal stents work better than drug-coated eluting stents or genetically engineered stents; about when and where they should be used, or about the short and long-term effects of each therapy. The side effects and the psychological, physiological and social
effects of each therapy can be discussed, and issues have been raised about whether the research into the effects and powers of various treatments has been adequate.
Ordinarily, this serious debate would be a matter for research journals, such as The Lancet, rather than Westminster Hall, if it were not for the fact that public money is involved. When spending public money, we must ask ourselves which treatments work better and, therefore, whether we are using public money as best we can; we then ask policy makers to form a view. In most circumstances, we are reluctant to give clinicians a completely free hand, because we recognise the pressures on themfor example, from drugs companies. Furthermore, they have vested interests. Contributors to this debate have mapped out the vested interests of surgeons as opposed to cardiologists. We are also reluctant to give patients a completely free choice, because cost and clinical outcomes can be uncertain.
In an age when medical treatment was much of a muchness and much of it unsuccessful, we could be fairly relaxed about value for money. However, things are not so easy in an age when medicines are high-tech, and when there are significant differences in the price of treatments. In a sense, therefore, we need a body such as NICE, whose primary job, as I understand it, is to separate therapies that deliver value for money from those that do not. It does not provide regulation; it does not forbid anything. It provides guidance. It does not outlaw procedures, but suggests which ones offer better value for money. Primary care trusts and other health care providers can then respond accordingly.
I attended a session at which NICE considered a particular drugnot one related to cardiology or heart complaintsand I was quite impressed by the exhaustive nature of the process. Patients suffering from the complaint under investigation were present during the assessment and it was robustly chaired. I am reluctant to venture a counter-opinion to the flow of the general debate today, but without proviso, I can say that NICE does a very workman-like and thorough job. However, demonstrablythis is illustrated in debate after debateit does not end arguments, as is the case here. That is probably because value-for-money judgments in the medical world differ from those in other contexts.
I serve on the Public Accounts Committee and am familiar with debates about value for money, but by and large, we look at public expenditure and policy. We do not debate whether a policy is good or bad; however daft we consider it to be from the point of view of value of money, its objectives are normally relatively clear. It is fairly simple, therefore, to consider how efficiently a certain policy or programme of expenditure delivers on its objectives.
The objectives of medical therapies, drugs and other treatments are not as clear and are often quite diverse, as seems to be the case with stents. They can fulfil a number of objectives: they can avoid the need for surgery, prolong life and diminish pain. I understand that there are differences in how far different stents diminish the pain from complaints such as angina. They can also complement other therapies such asmost obviouslyangioplasty and reduce patient
anxiety. Furthermore, we must consider how much they can evade side effects or forestall subsequent treatment.
Different evaluations ride upon how those objectives are weighted. Behind that, there is another debate about how NICE should prioritise legitimate medical objectives, such as pain relief, as opposed to cures and clinical efficacy. There can be uncertainty about such clinical priorities, and disputes about the objective of therapies and medicine, which engineers controversies that have been aired today. That will be true especially if the real time effects are questionableI am talking about the Liverpool research. There is no infallible pope to help the medical world.
Frank Cook: I am the first to agree with the hon. Gentlemans statementof course, no assessment is infallible. However, does he agree that in making a more realistic assessment, it would be better to use information from 2007-08, rather than from 2004-05?
Dr. Pugh: I accept that point, except that a number of people have made legitimate criticisms of the processes that NICE uses to do its job. I am arguing that there are weaknesses in the process, but it could be, and has been, argued that it has not made the best fist of the process as it is customarily run.
NICE gives guidance and, presumably, works under a constitution, which it has to establish in advance and through which it conducts its own procedures. There is no evidence that the guidance that NICE works with is less contentious than the guidance that it gives. That creeps into other issuesfor example, in connection with Alzheimers drugs. With those drugs, what it criticised is not so much what the research is saying but what research NICE allows to be taken into account in the first place.
I do not think that it can be plausibly argued that quality added years, which NICE awards therapies and which are the basis for its recommending them, follow through an irresistible, logical, conclusive process from the research that NICE commands and surveys. It just aint that simple.
At the end of the day, no mathematical calculation can simply produce the right or appropriate number. No mathematical calculation can substitute for a degree of human judgment, and no human judgment is completely uncoloured by unstated preferences and values. None the less, despite saying all that, I must acknowledge that NICE aspires to giving a dispassionate verdict and that, if NICE is not perfect, there does not seem to be a better tool currently available.
I think that the hon. Member for Stockton, North has made a very convincing case about why NICE should examine its verdict on stents again, not only because he says that it should, but because he is speaking on behalf of the thousands of patients whose lives depend on NICE getting this judgment call right.
I should like to join other hon. Members in congratulating the hon. Member for Stockton, North (Frank Cook) on securing this important debate and introducing it in such an articulate and informed way. He detailed the medical procedures; he quite rightly highlighted his personal experience, the benefits of which we all heard today in his articulate and passionate introduction, and he was speaking not only on his own behalf but on behalf of the many thousands of people who have benefited from those procedures in the past.
The hon. Gentleman comprehensively set out the issues regarding the different types of stent, including the all-important drug-eluting stents that we are discussing this morning. Importantly, he also highlighted the complexity and disparity of medical opinion regarding the cost-effectiveness of drug-eluting stents, and it is that opinion that NICE must make difficult judgments about. I am sure that he would be the first to acknowledge the difficulty of making those judgments.
We then heard from the hon. Member for Brighton, Kemptown (Dr. Turner), who made an extremely informed contribution to the debate. He set out the international comparison and the international dimensions, which are very important. He also highlighted the importance of restenosisin other words, the likelihood of recurrence of such problems, which would be made more prevalent by the use of bare metal stents, and the ongoing cost to the NHS of that procedure. He also highlighted his view that both the research base and the analysis on which NICE seems to be making its judgment were flawed.
NICE, in my experience, is extremely thorough in all its investigations. It needs to be acknowledged that NICE is, correctly, an independent body and that it must make very difficult judgments and decisions. However, I think that I am right in saying that those at NICE who are involved in making those decisions will read this debate avidly and will take on board the information from the various comments that have been made.
Before I go on to the specific issues, I just want to set out the context of this debate. The Conservatives are extremely supportive of the NHS, which is why we have promised to match the Governments spending, as outlined in the comprehensive spending review. We have three specific priorities for the NHS: first, we want it to be patient-centred, based on information; secondly, we want it to be based on outcomes, not on centrally processed and driven targets; and thirdly, we want much greater emphasis to be placed on public health. We want to empower patients to be at the centre of the NHS, and we want the NHS to look outwards and not, as it currently does, upwards.
The Conservatives are also extremely supportive of NICE, and we respect its independence. It is right that decisions about the guidance on which drugs are made available by the NHS should be made by clinicians and other experts, rather than by politicians. We support the Government in establishing NICE. In a moment, I will come to some of our recommendations to improve the procedure of NICE. However, such judgments should be made as freely from political interference as
possible; otherwise, the power of lobbying groups will end up dictating which conditions and treatments should receive approval and which should not.
It is right that patients have access to treatments that are judged to be cost-effective and clinically effective for their condition. There should be no reason for variances in national access. However, there are areas in which NICE could be improved and we have made a number of suggestions to that end.
Currently, there are long delays before drugs and treatments are approved by NICE, which has caused significant regional variations in prescribing and legal challenges to those variations. Before the decision by NICE, individual primary care trusts set prescribing criteria. As we all know from our constituencies, those criteria can vary widely, both between primary care trusts and within individual primary care trusts.
Such variation in access to drugs and treatments causes a great deal of uncertainty and angst for patients and their families, and it reinforces concerns about a postcode lottery. It also gives the impression that NICE is hindering clinical guidance and clinical betterment, rather than enabling it, and that impression needs to be changed. That is one of the reasons why the Conservatives have pledged to allow NICE to begin its assessment of new drugs and treatments as the drug licensing process begins, rather than afterwards. That would reduce the period of uncertainty between licensing and the completion of NICE guidelines.
The Minister of State, Department of Health (Dawn Primarolo): If I may just help the hon. Gentleman, that is already the case; NICE starts its procedures at that point. As yet, he has not raised anything that would lead to a change in procedures. So, before he tries to advance a point that he thinks is new, let me reassure him that that is precisely what NICE does as licences come up to be agreed.
Mark Simmonds: I am intrigued by that intervention from the Minister. If she will bear with me, I will move on to a couple of other points. However, she will also be aware that that is not what happens in practice at the moment. We need to speed up the process of the appraisal of drugs and medical treatments, because there is a lot of uncertainty.
Dawn Primarolo: The hon. Gentleman knows that an absolutely crucial part of NICEs determination process, which my hon. Friend the Member for Stockton, North (Frank Cook) rightly wants clarified today, is the consultation period and then the time for appeal against its initial determination. That is the pressure on the length of time that NICE takes to complete its procedures. Which one of those two things does the hon. Gentleman suggest that NICE should jettison to shorten the exercise?
In our recently published Bill on NHS autonomy and accountability, we propose a statutory and expanding role for NICE, to give it greater independence and
establish it as a statutory body, rather than as a special health authority, as it currently exists. To pick up a point that the hon. Member for Brighton, Kemptown made, we also need to analyse the quality adjusted life years method. We must carefully consider whether the threshold should be adjusted, whether it should take into account wider societal costs, where appropriate, and the complete cost to the national health service of particular treatments and whether NICE should approve them in guidelines. NICE should also play a wider role in producing evidence-based commissioning guidelines on standards of care to encourage best practice and the achievement of outcome objectives.
The hon. Member for Stockton, North quite rightly mentioned that patient groups, including people at high risk of restenosis, such as those with small blood vessels, long narrowings or diabetes, and some clinicians have voiced concerns about the decision potentially to allow treatment with only bare metal stents. Those patients account for about 40 to 55 per cent. of all patients undergoing angioplasty. I shall summarise the arguments that NICE must consider while it fully assesses all the available information to make a decision about potential guidance by the end of the year.
There is an argument that the decision would represent a step backwards in the clinical treatment of heart disease. Unlike most situations in which NICE has denied a treatment for drug-eluting stents, bare metal stents have previously been approved, and there is a suggestion that that decision may change, so I can understand why that issue is causing such angst and concern.
The hon. Member for Brighton, Kemptown was absolutely right that more patients will require repeat procedures if they develop restenosis. Studies have shown that drug-eluting stents reduce the necessity of further intervention by between 60 and 80 per cent., which is a significant amount. Not only could repeat procedures be detrimental to the patient, but they will be more expensive for the NHS to provide in the long run, according to the British Association of Cardiac Patients. The British Cardiovascular Society has calculated that, if NICE recommendations do not change, more than 5,000 patients will require a repeat procedure that they might not have had to undergo if initially given drug-eluting stents. NICE needs to consider that information in full.
Clinicians might also have to refer more patients for open-heart surgery instead of angioplasty, as the risk of restenosis in certain patient sub-groups, such as those with diabetes, is so highcurrently, 24.9 per cent. It is obvious that surgery carries more risk to the patient, and it is more expensive in both treatment cost and length of recovery. The combination of more repeat procedures and more surgery could also increase waiting times, as surgeons will have more and longer procedures to undertake. As the hon. Member for Brighton, Kemptown highlighted, drug-eluting stents are widely used elsewhere in the world, and the guidance against their use in the UK could send an unhelpful message to those developing new technologies and treatments.
The British Cardiovascular Society has claimed that the NICE assessment process for drug-eluting stents was flawed in three further ways. I am not saying that I
agree, but these points need to be considered when decisions are made. First, the process was based too much on a local audit from a single intervention facility. Secondly, the figures that NICE uses to calculate cost-effectiveness are inflated compared with the true costs that hospitals actually pay, making the stents appear less cost-effective than they truly are. Thirdly, the BCS is concerned that patients with complex conditions who are turned down for surgery may well have no treatment at all, as bare metal stents might not be appropriate in their individual cases. That needs to be considered carefully.
The decision must ultimately be for NICE to take. It is right that, as an independent body with specific clinical expertise, it considers such complex and difficult matters. It is not for politicians of any party, without the necessary expertise, to have a definitive influence. Decisions about clinical effectiveness and cost-effectiveness should be decided by NICE. However, we urge it to ensure that its assessment process is rigorous, fair and takes into account potential costs to the national health service, as well as the quality of life of the individuals involved. We want Britain to have the best health service in the world, with outcomes equal to or better than those of other European countries. For that to be achieved, we must offer the most innovative and effective treatments and ensure the best possible outcomes for patients and their families.
The Minister of State, Department of Health (Dawn Primarolo): I begin by thanking my hon. Friend the Member for Stockton, North (Frank Cook) for raising this important issue and, as others have said, for his detailed consideration of how best we can improve clinical care for people with heart disease. His personal reflections on the care that he has received from cardiac specialists provide a powerful backdrop to the debate. If I may say so, he stands as an impressive testimony to the great strides forward in modern medicine that the NHS has made in recent years. I pay tribute to him for the energetic role that he plays in the House on a wide range of matters and for his commitment to improving care for other people affected by heart disease.
The Government, too, are committed to developing a world-class service for heart disease that prevents ill health, saves lives through better treatment and improves the quality of life of people living with heart diseaseall the main points that my hon. Friend touched on. We have already made great progress: deaths have fallen, long waits are a thing of the past and we have invested in more staff and modern facilities to deliver state-of-the-art treatments. The pace of medical progress means that we are continually offered new opportunities to treat more people in different ways with an ever-broadening array of drugs and devices.
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