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it is not the drugs that have been judged not to be cost-effective when compared with rival treatments, it is the patients who are being condemned as not cost-effective to society.
The assumption of distributive neutrality (ie individual considerations are not taken into account) that underlies the QALY frequently violates societal concerns for fairness in the allocation of healthcare resources. For example, in general, society does not consider a unit of health gained by a severely ill individual to be of equal value to a unit of health gained by an individual who is less severely ill.
In evidence to the Select Committee inquiry, Dr. David Anderson, from the faculty of old age in the Royal College of Psychiatrists, told us that experts often did not understand how some QALY-based decisions were made, and that they believed the process to be somewhat arbitrary. He told us:
When clinicians hear about health economic analyses many of them see it as made-up stuff. You just take some data and create an equation that is based on assumption after assumption... You fiddle about with an equation and come out with a number. If you want you can fiddle about with it some more and come out with a different number.
Other witnesses argued that the use of QALYs could lead to bias against treatments for long-term chronic conditions. Lower cost per QALY and therefore greater likelihood of NICE approval were claimed to be associated with treatments for acute conditions. Steve Winyard of the Royal National Institute of Blind People told the Committee:
Drugs that extend life will always achieve higher values...The use of QALY values puts people with long-term conditions at a disadvantage over people with life-threatening conditions.
NICEs cost-effectiveness threshold has also attracted much controversy. For instance, an article in the British Medical Journal last year by Professors Appleby, Devlin and Parker strongly criticised the way in which the threshold operates. It said that the threshold that it has used since its inception of £20,000 to £30,000 per QALY
has no particular basis in either theory or evidence.
It suggested that the threshold may be too generous and that, as consequence, NICE may have recommended too many new technologies. That would also mean that when primary care trusts implement NICEs guidance, resources may be diverted from other health care services that give better value for money. Indeed, it points to evidence suggesting that there is a mismatch between NICEs threshold range and that apparent elsewhere in the NHS. The average primary care trust spends about £12,000 to gain an extra QALY in circulatory disease
and about £19,000 in cancer. In contrast, an analysis of NICEs decisions suggests that its threshold is in practice even more generous than it admits, being closer to £45,000.
The article posits two possible approaches for setting a cost-effectiveness threshold. The first is to decide the worth or value of a QALY and set the NHS budget so that all health care is provided at a cost at or below that value. The second is to decide how much we wish to spend on the NHS, and let the value of a QALY emerge from the decisions made by NHS purchasers. It also asks why NICE should be required to set and defend what is an NHS-wide cost-effectiveness threshold. That is of course something that the Committee itself has questioned.
The BMA article suggests that the NHS should have a threshold committee with a similar structure to that of the Monetary Policy Committee; and NICE, primary care trusts, and other NHS purchasers should be required to adopt a common NHS threshold. I question whether simply creating another bureaucratic arm is necessarily the way forward.
Sandra Gidley: We all like to get hung up on the question of thresholds, but surely the hon. Gentleman saw the evidence, as I did, that there seems not to be an automatic cut-off, and that, for the rarer drugs to treat rarer conditions, there is no hard line that must be passed; instead, decisions are made about whether, in the absence of other treatments, we should pay a little more. There is no pass or fail magic number, and the thought of a British Medical Association committee sitting to make that decision fills me with horror, because there may be unintended consequences that are not seen now.
Dr. Stoate: I accept the hon. Ladys point, which underlines the great difficulty that we had in making some of the decisions. However, she will have heard the evidence that it is assumed, particularly by drug companies, that if a drug comes in below the threshold, it will pretty much get through without much argument, if it is in the middle the company has a bit of a fight on its hands, and if it is over the top it does not have much chance, unless, as my hon. Friend the Member for Norwich, North (Dr. Gibson) said, it is an ultra-orphan drug, which would be treated slightly differently. Whether or not we stick hard and fast to the thresholds, they are widely accepted and used in practice. The question is whether NICE is the right body to make the decision: should it set the threshold?
As I mentioned, the threshold has not really changed since NICE was set up, and it is about time that we had another look at it, to decide whether it is appropriate and whether a much wider body of NHS experts and users should be involved in making the decision. I merely put the question whether it is time for a rethink about the basis on which the process is carried out. Certainly, NICE gets a lot of criticism now, much of which I think is unwarranted. Nevertheless it has to take it. The question is whether it should be part of a bigger mechanism, so that others in the health service, including users of the service, get a say.
My point is that if the public could fully understand the process by which decisions are made and could have a better idea of how much the drugs and procedures
cost and a flavour of the level of competing claims, they might feel more empowered and able to make decisions affecting their lives in a more rational way. Everyone accepts that we cannot have everything. What is not accepted is the obscurity about decisions, and difficulty in understanding how they are made.
I could say much more, but many colleagues want to contribute. My final point is that it is now time for a much more in-depth look at how such decisions are made throughout the world. We can learn from other countries, in the same way that, as my right hon. Friend the Member for Rother Valley (Mr. Barron) said, other countries study NICE to see how we do things in this country. That would lead to a much more grown-up decision-making process, to ensure not only that the health service delivers for patients, but that it is seen to do so.
Mrs. Maria Miller (Basingstoke) (Con): It is with a little caution that I rise to speak after the hon. Members for Dartford (Dr. Stoate) and for Wyre Forest (Dr. Taylor), because I have no medical experience. The report, however, raises many issues that affect my constituents and businesses in my community. As the right hon. Member for Rother Valley (Mr. Barron) has said, the work of NICE is about ensuring that constituents get a fair deal from the NHS, which affects us all.
NICE has a vital role to play, and I commend the Select Committee and its Chairman for their work on the report and for giving us an opportunity to air our views today. It is right that the decisions on which drugs are available in the NHS are made by clinicians and not by politicians, and I respect the independence of NICE. The NHS budget is not infinite, and difficult decisions must be made, whether by what is called rationing or in other ways, but NICE was established to ensure that there is equity in the system. The report points out that the current situation falls short in many areas. I want to raise three important issues for me and some of my constituents, namely the evaluation process, the issue of non-statutory guidelines and the role of NICE in the future of the UK pharmaceutical industry.
Other hon. Members have already touched on the evaluation process. The report stresses that the speed of technological appraisal is of great concern, and that there are long periods between the licensing of a medicine and the publication of NICE guidelines. None of us can dispute the fact that that is fuelling a postcode lottery throughout the country, and some think that that is leading to problems for the NHS in keeping its universal promise that treatment should be available to all in accordance with their need. Some clinicians can prescribe during the period between licensing and the issuing of guidance, and some cannot because of the rules and regulations of their primary care trusts. Because the process is speedier in Scotland, drugs are available far more quickly there.
I have come across two examples of such difficulties in my three years as an MP. First, Tarceva was prescribed for lung cancer by consultants in my local hospital during the limbo period between licensing and the issuing of NICE guidance. Cases were referred to the
PCT for approval and an experienced consultant, who had the trust of the patients and families concerned, sometimes decided that benefit could accrue to a particular patient if the drug were used. In some cases the PCT agreed, but in others it did not. To the consultant, it seemed that those decisions were not always made for the same reasons.
So where did that leave the patients and their families? In the case of one of my constituents, the request for funding was rejected, and they were left in a very difficult situation. Was that because the finances of the PCT were too tight, or was it because the medic got the assessment wrong? I am aware that, in at least one case where the PCT rejected a request for funding, the family of the patient felt that they had no alternative but to pay for the drug privately. Where does that leave us with regard to the concept of a universal NHS?
I will briefly give another example. About four years ago, a drug to deal with the problems caused by mesothelioma was launched by a pharmaceutical company in my constituency, Eli Lilly. Although that drug was approved by the Scottish Medicines Consortium in July 2005, it took 1,000 days of NICE appraisal to get NICE approval, which eventually came through in January this year. Even now, more than three months later, there is evidence that one or two PCTs are still not providing funding for that critical medicine. In the meantime, people who are suffering from a truly dreadful disease are simply dying. We should continue to reflect on the slowness of the evaluation process, because it causes anguish, anger and other problems for families.
Dr. Gibson: First, does the hon. Lady think that fastness is not always associated with accuracy of information, and that a slow and steady approach, getting there with all the data, is better than a political knee-jerk reaction? Secondly, with Herceptin, which the hon. Lady has not mentioned, there was plenty of good scientific evidence that some individuals benefited from it because of a certain gene expression while other individuals did not. How can we get that information over to the public, when newspapers are running campaigns, saying that, In Scotland, they get it, but down here you dont get it and everybody should get it, because it makes you better.?
Mrs. Miller: I thank the hon. Gentleman for raising those points. I will discuss the length of time that should be taken for examining drugs, and he is absolutely right that it is not a question of rushing the process. Surely, however, there are ways in which we can try to truncate the existing process to benefit patients. He is absolutely right to raise the role of the media. However, the examples that I have given today were about situations in which the judgment of highly qualified medics was, I suppose, challenged and questioned by PCTs, rather than about the inaccuracies or misinterpretations that can sometimes come through media reports. Having said that, he is right to express caution about those instances of media inaccuracy.
The hon. Lady is touching on an important wider point for the health service, and perhaps she will share her thoughts on it. There is a difference between a clinician deciding for an individual patient and a PCT looking at the health assessment for its
entire population and reaching a conclusion about the best health investment for the moneys that it has. Clearly, mismatchesto put it politelyoccur. How does she see the gap between an individual assessment for a patient and an assessment for an entire population by a PCT being closed?
Mrs. Miller: The Minister has raised an important point. Presumably, what she as a Minister in the Department of Health wants to see is some consistency in the way in which our health care system deals with people. Many of the problems involve PCTs being put in a position where they have to make choices, and different PCTs obviously have very different financial arrangements, depending on the way in which the budgeting process hits them. I fear that many people in my constituency, and indeed in other parts of the country, feel that that situation does not always result in an equitable response, which is my response to the Ministers question.
On obtaining a shorter period of evaluation, the Committees report suggests adopting shorter and less in-depth evaluation at an earlier point, followed by a larger-scale appraisal, perhaps similar to the approach of the SMC. I have some concerns about that approach, although I applaud the Committees desire to try to truncate the all-too-lengthy process.
Using a lower cost-effectiveness threshold, as proposed in the report, could result in medicines being rejected by NICE at launch, which would leave no clinical practice on which to develop cost-effectiveness evidence, with patients also perhaps being denied new treatments altogether. I do not know whether the Select Committee Chairman has any thoughts about that, but it would certainly concern me that, if we were to follow that approach, we might be in a perverse situation in which the uptake of new medicines would be slower than it is today rather than quicker.
My hon. Friend the Member for South Cambridgeshire (Mr. Lansley), the shadow Secretary of State for Health, has put forward another possible approach, which is that NICE should conduct its appraisal of new drugs and treatments at the same time as such drugs and treatments are licensed by the Medicines and Healthcare products Regulatory Agency. That approach would help to speed up the assessment process without undermining in any way the quality of that process, which the hon. Member for Norwich, North expressed reservations about when he intervened on me earlier. As the Committee also suggested, there could perhaps be more collaboration between the SMC and NICE. That would seem to make common sense, in terms of the work that both bodies do.
It is difficult to believe that the current situation is what was intended when the system was set up. I am sure that the Minister, in her response today, will pick up on that point, because I am also sure that it cannot be her intention that families, such as those whom I have met in my constituency, should be in a state of distress because of the present situation.
My second point concerns the implementation of non-statutory guidelines. The Select Committee report noted widespread dissatisfaction with the sometimes limited implementation of some clinical guidelines and that health care authorities respond to guidance at different rates. Indeed, the Audit Commission has highlighted the problems of financial planning around
NICE guidelines, and the Government response highlights the point that additional support is in place to help local authorities with implementation.
I am grappling with the realities of the way in which the system works on the ground in my constituency. Taking the issue of in vitro fertilisation, the Government made a proud statement just before the last general election that everybody in the country would be allowed to have three cycles of IVF treatment within a certain age period. I must say that many people in my constituency were glad to hear that announcement. However, they were less glad to hear how it was to be implemented in our part of the world by what was then North Hampshire PCT and what is now Hampshire PCT. People were only able to get one cycle of IVF treatment, and that was only when they reached the age of 35, which, as anyone who has been in that situation knows, is obviously not an ideal way to go forward.
Although the Government have clearly put a lot of thought into the issue and procedures and processes have been put in place, when it comes to the practical realities for constituents on the ground, those constituents are still finding it difficult to get the non-statutory guidelines realised in practice. Again, I would be interested if the Minister were to clarify how the situation will improve in the future.
My third and final point concerns NICE and the pharmaceutical industry. The report refers to involving NICE in developing the new system of value-based pricing for medicine. In the evidence that it received, the Committee uncovered concerns about how the new system, which will replace the pharmaceutical price regulation scheme, will work.
Obviously, we need to keep pressure on costs in the sectorI fully endorse thatand the evidence suggests that the Government have been successful in driving down costs. However, the pharmaceutical industry is a complex and international industry, and by its very nature it requires long-term stability. It also keeps a keen eye on the broader international situation.
The Select Committee Chairman raised the issue, which the media recently covered, about the decision to scrap the current pricing agreements halfway through the five-year period. I fear that that decision did little to foster good relations between the Government and the pharmaceutical industry. I was interested in the Ministers intervention on the right hon. Gentleman, when she tried to imply that that decision was some kind of negotiation technique. I want to highlight to the Minister the fact that the pharmaceutical industry can choose to locate in many different countries in the world. We must foster a good relationship with it, if it is to continue to invest in research and development, as well as manufacturing, in this country.
There is already evidence of a brain drain from this country in respect of pharmaceuticals. The Minister will be aware of recent research undertaken by the Confederation of British Industry, which suggests that the UK is becoming an unfavourable place for the pharmaceutical industry to do business. If she has not seen the research, I would be happy to forward it to her. I hope that she will comment on the implications for employment and the future of that important sector in the UK.
Dawn Primarolo: I was at the annual dinner of the Association of the British Pharmaceutical Industry only last week. A slide was put up that showed how important the UK is and will be to the international pharmaceutical industry now and in the future. The UK represents 40 per cent. of its members world trade and sets the price for their products worldwide.
Mrs. Miller: I thank the Minister for that. I am sure that what she has said is right, but when UK pharmaceutical industry people were asked how confident they felt about doing business in the UK, 58 per cent. of them said they were not very confident at all. Perhaps she needs to take note of that research.
I hope that the Minister will respond to some of those points, which are incredibly pressing for people in my constituency. Again, I commend the Select Committee Chairman on the report and applaud his work in that area.
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