Stoate participates in debate on NICE

Dr. Howard Stoate: The hon. Gentleman will appreciate that there is a great difference between time-honoured and evidence-based. Just because we doctors have done something for a long time, it does not necessarily make it worth doing.

Dr. Howard Stoate: I shall start by paraphrasing Kryten from the TV series “Red Dwarf”. There are two problems facing every health care system in the world: first, it is impossible to meet every need and, secondly, it is impossible to meet every need. I realise that, technically, that is only one point, but it is such a good one that it is worth making twice. The fact is that no system in the world can ever meet every competing need; indeed, if it did, that would prove that it was failing. One of the drivers of change in the health service is the constant striving for improvement, for better value for money and for better patient care. That automatically implies that one must keep pressing for change and improvement. Always having to look over one’s shoulder to see what one can afford is one of the major drivers in that respect. That sounds a bit harsh, but it is important.

The hon. Member for Wyre Forest (Dr. Taylor) talked about rationing. One reason why I am not happy with the word “rationing” is that rationing is actually very easy, whereas health care apportionment is very difficult. Those in the room who are old enough to remember rationing—that does not include me, of course—will know that it is relatively easy to tell somebody that they can have one egg or one ounce of butter a week or that they can have a British standard loaf ever two days—that makes sense. It is easy to do that because the one thing that everybody in the world does that has a cost to society is eat. What makes rationing even simpler is that everyone has broadly the same nutritional needs, so the parameters are quite narrow. It is easy to say, “I have 1,000 kg of rice and 1,000 people, so they can have a kilo each.”

Unfortunately, it does not work that way with health care. Let us imagine that I have 1,000 people in the room and I have six replacement hips, 20 doses of penicillin and 30 doses of Aricept. First, those replacement hips might be completely inappropriate for those 1,000 people because none of them might need a hip replacement; alternatively, by luck, 100 of them might need one. In other words, it is far more difficult to work out who should get what. Furthermore, how do we compare a hip replacement and Aricept to decide which does the greater good? That is an extremely complex and delicate decision.

I agree with those who have said that we need a much wider public debate about how we make such decisions. Such things are not news to society; the concept of distributive justice has been with us for thousands of years, although we have not always called it that. If we talk about distributive justice or competing claims for resources, rather than simply about rationing, that will make it easier for the public to join the debate. They will begin to understand the complexities of how people make some of these extraordinarily difficult decisions about distributing resources.

Dr. Stoate: I pay tribute to my hon. Friend, who does a huge amount of work for cancer patients and who has quite an international reputation for standing firm, helping cancer patients through difficult times and helping to make rational decisions. It is difficult for the public to understand what an ultra-orphan drug is. It is also difficult for the Government to deal with them, because they sometimes have such a skewing effect on overall health budgets, particularly in a relatively small health economy. The problem therefore needs special attention, and I pay tribute to my hon. Friend for raising it.

In this country, we have settled on the idea of measuring health benefits and deciding how to distribute resources using the QALY. As everyone knows, the QALY is a cost-utility index that combines the duration and quality of life. In some ways, it can be used as a comparative index. Perfect health is the equivalent to a QALY of 1, death is a QALY of zero and the various health states in the middle can be worked out on a fractional basis. In many cases, therefore, estimates of cost per QALY can be used to devise an indication of the relative value of different treatments and interventions.

That method certainly has the merit of being extensively researched in Europe, north America and Asia, but a number of people have expressed quite a few reservations about the manner in which NICE has used QALYs. For instance, John Harris, the joint editor-in-chief of the Journal of Medical Ethics, argues:

      “There are two ways in which QALYS can be used...to determine which of rival therapies to give to a particular patient or which procedure to use to treat a particular condition, in short which of two different treatments is the more cost-effective, better for patients, better for society.... QALYS are also used, however, to determine not which of rival treatments to give to a particular patient or group of patients, but whether or not to offer any treatment at all to some patients, or whether to offer a particular treatment to some patients even when no alternatives are preferred.”

It is that latter approach which Professor Harris understandably objects to on moral grounds, and he exemplifies that by reference to the treatment of patients with Alzheimer’s disease. He claims that     

      “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.”

Meanwhile, Maurice McGregor of McGill university in Canada has said:

      “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.”

That is a complex concept, but it makes the point that QALYs can be applied in different ways and can mean different things to different groups of patients.

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”.

NICE’s 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 NICE’S 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 NICE’S 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 NICE’S 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.

Dr. Stoate: I accept the hon. Lady’s 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.

To read the full debate, please visit http://www.publications.parliament.uk/pa/cm200708/cmhansrd/cm080508/halltext/80508h0001.htm#08050854000254