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Sir Michael Rawlins, M.D., Chairman of the National Institute for Health and Clinical Excellence

Tell us what NICE [National Institute for Health and Clinical Excellence] is, why it was created in 1999, and a little bit about what’s happened since.

We were set up in 1999 primarily to improve the quality of care that National Health Service patients get. In doing so, we were required to take clinical effectiveness into account, but also cost effectiveness into account and we’re particularly concerned with trying to reduce inappropriate variation in care. We have two main programs that address this.

First, we have a program that’s known as technology appraisals whereby we look at individual drugs, individual devices, individual procedures or groups of very similar drugs and we examine whether they are cost-effective and clinically useful in the National Health Service. The second program, which is in some ways more important, is a clinical guideline program; we are in the process of producing a series of clinical guidelines for the National Health Service to help doctors, nurses, and other health professionals provide their patients with the highest attainable quality of care. Again, we take clinical effectiveness into account but also cost effectiveness.

Are your recommendations binding as far as policy goes, or could the National Health Service say, “We simply disagree with that” for one reason or another?

In theory, the National Health Service could do that. We don’t have statutory powers to impose our guidelines or our decisions on the Health Service, but, by and large, our recommendations are fully accepted by the Health Service.

And are they fully accepted by the public?

Broadly speaking, yes. The public understands that we have a finite amount of money to spend on health care and, broadly speaking, the public does understand. There are sometimes occasions when a particular patient group feels aggrieved that particular products are available or can’t be made available because they’re too costly. But broadly speaking, the public understands what we’re doing. We’ve been doing public opinion surveys every year and 70 percent of the public think we’re doing a good or a very good job.

Some kind of budgeting system may need to be imposed on Medicare or Medicaid in the United States, which will then affect payments and that will affect treatment. How do you go about establishing a budget? Do you recommend a treatment and project the cost? Do you estimate how much it would cost for the nation, for the year, and recommend it to the political figures to fund, or do they set a number and come walking into the office?

Well, it’s neither of those. The Health Service has a budget each year set by Parliament and the Health Service has to operate within that budget. It’s approximately 100 billion pounds a year for the National Health Service. We look at whether or not treatments, diagnostic techniques, pathways of care give good value for the money. We look at cost effectiveness. We do not look at the budget; in fact, we’re specifically barred in our statutory instruments from looking at budgetary impact. We look at cost effectiveness. We’re looking at the value in relationship to the benefits a particular product brings in, in respect to the health benefits and the costs.

Pharmaceutical companies in the United States say that it costs them a lot of money to develop a new prescription. For example, a new drug for treating cancer may cost hundreds of dollars per pill and it requires dozens of pills per week and the final cost is in the hundreds of thousands of dollars.

Yes.

What does the National Health Service do in that circumstance?

Well, I fully accept that developing a new drug can be very expensive, but there’s more to it than that. Historically, many pharmaceutical companies have spent twice as much on marketing as they have on the research and development. Pharmaceutical companies’ investors have expected double-digit growth and pharmaceutical companies had to spend a lot of money, in part, because of the drug regulatory authorities and the demands that they have made. And if we’re going to have affordable drugs in the future, we’re going to have to look at all of those areas. We’re going to look at the cost of development. We’re going to have to look at the cost of marketing and we’re going to have to accept that investors can’t necessarily expect double-digit growth in the future. Unless we address all three of those issues, we’re not going to be able to afford – any of us, either in the United States or in Europe – the new drugs that the pharmaceutical industry wants to bring onto the market.

When you talk about the cost of development, does the kind of testing and analysis that NICE does help the manufacturer alleviate some of the cost involved in the testing?

Not really. No. We’re not involved with the regulatory process. There is a separate body now in Europe, the European Medicines Evaluation Agency, that is the drug regulatory authority for Europe. Just as in the United States you have the Food and Drug Administration, the FDA, that regulates the access of drugs to the market, my regulatory agency looks at quality safety and efficacy. They don’t look at cost. They are specifically barred from looking at cost and I think that’s right. I don’t think they should look at cost. I think that needs to be a separate decision about whether a product is cost-effective.

So, NICE doesn’t determine whether it’s cost-effective?

We have a number of advisory committees, so when it comes to things like pharmaceuticals, we have what we call the appraisal committee. In fact, we have three of them and we’re about to establish a fourth appraisal committee. They’re composed predominately of doctors, some nurses, some statisticians, some health economists, and patient advocates. They look at the evidence, they interrogate clinical experts, they interrogate patient experts, but ultimately they make the decision about whether something is appropriate in terms of cost effectiveness and sometimes clinical effectiveness because devices aren’t regulated in the same way as pharmaceuticals. And they have to take into account the fact that if you spend a lot of money on some patients, then perhaps other patients with other diseases, other conditions, are going to be denied. The appraisal committee has to think of everybody who seeks their care from the National Health Service and in Britain 95 percent of all health care is delivered by the National Health Service. The private sector is very, very small.

Let’s look at an example. Let’s say my heart surgery at the age of 62 was $150,000. At the age of 78, would it be seen as appropriate for me to have that bypass surgery or would that be seen as foolish, since I wouldn’t be expected to live much longer?

No, we wouldn’t deny you. One of the difficulties, in a sense, in making these sorts of decisions is that it’s not merely a technical decision. There are also social value judgments that have to be made and we recognized that very early on. So in order to capture social value judgments, we set up something called a Citizens Council – a group of ordinary men and women from Britain who meet for three days at a time, twice a year, and who really represent a sort of stratified sample of the British public. And we pose these difficult questions to them. And the one you asked me is one of the very early questions we posed. Should we take age into account when making these decisions? It’s a very important decision. We gave them two sessions to deliberate, so they actually spent six days discussing it and we also asked children via a separate process what they thought. The children and the Citizens Council came out with the same conclusion, having listened to all the evidence on one side, all the evidence on the other, and they had witnesses, too. Some very distinguished people came and talked to them about their views, often opposite views, but at the end they said, “No, you should not distinguish between people on the basis of age.” A year of life was just as precious if you were a child, a parent, or a grandparent.

Have you had any delegates from the United States inquiring about what you do?

Oh, we’ve had a lot of interactions with the United States. I’ve been over on a couple of occasions and talked at the Institute of Medicine about comparative effectiveness and what we’re doing and I’ve spoken at dozens of venues across the United States explaining what we do and how we do it.

And do you expect that the Obama administration will be knocking on your door saying, “Please help us”?

The technical things we do at NICE are relatively easy. You can do them in the United States probably better than we can. You’ve got huge knowledge and expertise and health economic statistics, clinical research, and so on. You don’t need our help in any of that. You can do it all. Any country’s problem is how to adapt those processes and insert them into their health care system. That’s a political activity; it’s a political decision and you got to make those political decisions yourselves.

How are you going to work with all of the aging citizens of your country?

We’re very conscious that we’ll have an increasingly elderly population in Britain, as you are in the United States. By the time you and I are 80, we will probably have three chronic diseases at the same time and we’re going to have to try to work out ways in which we can look after each other when we’re old and in a way that is fair and equitable.

Now, our health care system is rather different from yours. We have a National Health Service funded by general taxation which is based on a principle of social solidarity. We look after each other when times are hard, when we’re sick. In Britain, we spend 70 percent or more of our health care money on people who are elderly. That’s the time nowadays when you really get sick. All the miserable diseases of childhood have largely been eradicated: diphtheria, whooping cough, measles, tuberculosis. It’s the chronic diseases of the elderly that are now consuming our health care budget and your health care budget and we’re going to have to do the best we can. I want to live to be 100, just like you do.

The pharmaceutical companies in the United States go directly to physicians to increase the demand for the particular drug they’re trying to sell so that the physicians then put the pressure on Medicare or the insurance company that’s actually paying for it. The marketing is intense and pricy and when they’re thwarted, they claim discrimination, immoral behavior, unfairness, and so forth. Is it different in England?

Not entirely, no. And, as in the United States, it is complicated. There are, though, a number of differences. First, there is a restriction on the amount of money companies can pay for marketing in Britain. There are restrictions and there are price regulation schemes for pharmaceutical companies about marketing. So we don’t quite have what you might call some of the excesses that you have had in the past.

We do not have, for example, direct to consumer advertising. That is illegal in Britain. I know you have it. It’s very boring, too, whenever I watch your television. It’s all about Viagra and Cialis and erectile dysfunction and it comes after every news item again and again and again. It makes for terribly dull television. I’m surprised people continue to listen to it or watch it. We don’t have any of that. Of course, companies try to pressure physicians. There was a lot of that in the past before NICE was set up. It’s much less than it was, but clinicians often want to access drugs for their patients and they’ll often say to me, “I’m fighting for my patients; do you understand that?” And I say, “Yes, and that’s quite right that you should, but you also have to understand that it’s not just your patients that I’ve got to worry about; it’s other doctors’ patients, with other diseases, with other conditions and they’re not here today.” I’ve got to take everybody into account and a month later they’ll come up to me in a bar and say, “You know, I hope you don’t mind us fighting so hard for our patients. I know we didn’t win and you are probably right at the end of the day. Can I buy you a drink?” And it’s sort of by and large settled.

Probably the most difficult group is patient organizations and that’s made more difficult by the fact that a lot of patient organizations receive some funds from the pharmaceutical industry and I know that happens in the United States, as well. More sinister, in a way, is the fact that some patient organizations get covert help in public relations. Public relations firms will give them pro bono help and gosh, it’s the same public relations firm giving pro bono help that’s actually getting a contract from a drug company and that is not good. I’ve spoken about this very openly; I do not think this is a good idea. I do understand patient organizations may need money. I don’t, in principal, object to them getting money from pharmaceutical companies, but it’s got to be very explicit and the pro bono help system has to be very explicit, too. And we have to be able take those sorts of conflicts of interest into account. The other thing I always say to patient organizations is that you criticize NICE when we think something is too costly for the benefit, but why don’t you criticize the company for charging so much? And I’ve been very public about that, too, because it’s almost never happened that a patient organization has criticized a company for the price it’s charging.

How does private insurance work in conjunction with the National Health Service?

The private health care system is mainly elective surgery. Ten or 15 years ago, when we had very long waiting lists for hip replacement or cataract operations and so on, some patients elected to have private health insurance. That actually has declined because the waiting times in Britain have fallen so substantially that actually the private sector’s been damaged by it and people are going less to the private sector.

Many countries are looking to NICE for guidance. Is cost containment the most common goal?

It varies. Some come to us and say they want to establish a NICE-like organization and ask how we do it. They want to know if they can come and watch the committees. Can we help them develop the skills to do these sorts of things? Others of them want to borrow, beg, or, if you like, “steal” our guidance itself, particularly our guidelines, and they want help in adapting them for their own circumstances. For example, Columbia is very keen on using our guidelines to help form their basic health care package, but they also recognize that they can’t possibly afford some of the things in our guidelines. Columbia has approximately $250 per person per year to spend on health care. It can’t apply the same guidelines as Britain, which spends nearly $3,000 per person per year. And we can’t begin to spend what you guys in the States do. You spend $6,000 per person per year on health care. So countries have to cut our guidelines, cut the cloth, if you like, to meet what they can afford, and we all are going to have to learn to do this. We can’t regard health care as a bottomless pit. We’re all going to have to learn how to use our resources in the fairest way possible so that everyone benefits within the limits of what we can provide.

- This is an edited transcript of an interview conducted March 3, 2009.

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