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All things Pharma

An interview with: Professor Sir Michael Rawlins

At the start of 2007, the head of the National Institute for Health and Clinical Excellence (NICE) told a national newspaper that the NHS could run out of money for the best drugs if, as expected, the government slowed the rate of spending on health. As Chairman of NICE, Professor Sir Michael Rawlins is no stranger to controversy. This month, Pf brings you an exclusive insight into the inner workings of NICE and the philosophies that have made it such an important organisation for the modern pharmaceutical industry.

What are the major challenges currently facing the UK pharmaceutical industry?

The main challenge for the industry is to provide the NHS with value for money with its new products. In Britain, as in all countries, we need innovative products, but we don’t have a bottomless pit of money to pay for them. We are about to enter a lean period in terms of NHS funding, where money for new interventions is not going to be as freely available as it might have been in the past six or seven years.

Coincidentally, there is a leanness too in the pipelines of pharmaceutical companies.

Are these challenges confined to the UK market?

There is no doubt that all healthcare systems face the very serious challenge of trying to meet the demands of their populations with the resources that are available, while making the most of the opportunities enabled by new advances. Everybody has got this problem. The industry, and its investors, need to understand that healthcare systems are going to be looking increasingly at new interventions to make sure they represent value for money. This is not just in Britain, it is becoming a global movement.

How does NICE approach this?

We endeavour to do this in as fair a way as possible, and in a manner that promotes and supports real innovation, but that doesn’t deprive other people of cost-effective healthcare. In other words, if you spend a huge amount of money on a cancer drug that means patients with other conditions will receive less care, we have to prioritise. These are tough decisions to take, but nowadays everyone accepts that someone has to take them. That’s why NICE has cross-party support, because it is a serious attempt to resolve some of the problems and inequalities in our healthcare system.

What is the role of NICE for pharmaceuticals?

NICE is actually nothing to do with pharmaceuticals in one sense. What it’s really trying to do is to establish an affordable standard of healthcare for the NHS. As in many other healthcare systems, within the NHS there is an inappropriate variation in the quality of care, for all sorts of reasons. NICE is mandated to try to ensure that the standard of healthcare in England, Wales and Northern Ireland is as high as we can afford. Pharmaceuticals is one small part of it. The appraisals programme, which has always generated a lot of heat, is only one part of what NICE does. In some ways, a more important component is its Guidelines programme.

How does the Guidelines programme work?

The programme looks at the management of conditions. This obviously involves drugs, but it also involves other sorts of care; procedures, referrals to secondary or tertiary care, and all the other factors that are important when looking after patients. For example, when should clinical psychologists or occupational therapists be used? How quickly should a patient get up out of bed after an operation? And so on. It’s a pathway of care and is not specifically about products.

Back to the appraisals process, how are the recommendations NICE makes enforced and policed?

There are no penalties on doctors who fail to follow recommendations, and it would be difficult to do that. However, when it comes to technology appraisals, the direction given is a legal requirement, so Trusts are legally required to provide a particular drug if NICE has said it ought to be available on the NHS. If it is not recommended, they can still provide it, but in fact they probably won’t. Whether Trusts conform to NICE recomm endations and the funding direction is part of a particular enquiry by the Healthcare Commission.

The Commission requires that all Trusts declare annually whether they are compliant with NICE guidance on technology appraisals. In the most recent report, around 90% of them said that they were.

How do you respond to suggestions that NICE is about cost-effectiveness, rather than clinical effectiveness?

To some extent the suggestions are true – it is about cost-effectiveness a lot of the time. I’m unashamed about that. The more thoughtful analysts accept that we have to make the money that we devote to healthcare go as far as it can. in fact, a recent article in the national press talked about how NICE has an obligation to look at costeffectiveness as there is an increasing realisation that we don’t have an open-ended chequebook.

The message is also beginning to drift through to the general public. Each year we commission a poll into the public perceptions of NICE. Last year around 35% of the public knew about NICE and what it did. A politician would probably die for 35%! Around two thirds of those who were aware of NICE considered it was doing a good job. We are making progress.

How best can NICE build relationships with patient groups?

We have a special unit dedicated to doing this. The Patient and Public Involvement Unit is designed to liaise with patient organisations and help them to make submissions to us. NICE Guidelines are produced by groups of around 15 people, this group normally includes two patients or ‘service users’. The Patient and Public Involvement Unit recruits them through patient organisations and then provides them with training – it can be very daunting if you are a patient sitting around a table with some very distinguished professors. The training is designed to give them confidence so that they feel able to make a contribution.

How do you handle angry patient groups?

In the same way we handle anyone else that is upset with us: we listen to what they have to say.

All our recommendations are first produced in draft form and everyone has the opportunity to look at them. Patient organisations do, of course, come to the HTA committee meetings and make their case. We look at their comments and review them. Sometimes they make some very good points and decisions are changed, but we can’t allow ourselves to be bullied by vested interest. I understand patient groups want to do the best for their members, and they have a right and responsibility to do so. But equally, we have a right and responsibility to look at the interests of other patients who use the healthcare system. What I am critical of, however, is patient organisations that are acting on behalf of pharma companies. I am not alone in complaining about them.

So do you think there is now widespread acceptance of NICE?

Most pharma companies, with one or two exceptions, accept that all countries are gradually moving in the direction that the UK is going with NICE.

They may wish it had never happened, but there’s no going back. NICE is not going to be abolished with us going back to a funny free market, it is here to stay.

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