‘We’re not playing God’ – an interview with NICE chairman Professor Michael Rawlins

Last month, we asked you to send in questions for us to ask Professor Sir Michael Rawlins, the chairman of NICE.

We got a great response and lots of thought-provoking ideas, so here’s the interview we carried out, in full, completely unedited.

There’s also a full transcript further down the page too.

• Download as mp3 (11.6Mb)

Thanks so much for all your questions, we hope you enjoy the results. If you have any further comments, questions or thoughts, please use the comments box at the bottom of the post,

Henry

Transcript

Sally Staples, Cancer Research UK: The National Institute of Health and Clinical Excellence – known as NICE – makes recommendations to the NHS new and existing medicines, treatments and procedures, and it makes recommendations on treating and caring for people with specific diseases and conditions.

Sir Michael Rawlins has been chairman of NICE since its formation in 1999. A pharmacologist, he’s also an Honorary Professor at the London School of Hygiene and Tropical Medicine, University of London, and Emeritus Professor at the University of Newcastle upon Tyne.

Today, he’s kindly agreed to answer some questions sent into Cancer Research UK by members of the public, on the role that NICE plays in relation to cancer.

Our first question comes from Hazel Dodge, via Facebook:

Why should we have an organisation that plays God and decides which drugs should be funded and which shouldn’t?

Professor Rawlins: Well, we’re not playing God. But we live in an environment – in a healthcare system – here there’s a finite amount of money for healthcare. Under the NHS, which provides 95% of all healthcare, parliament votes money each year for healthcare – for the NHS – and the NHS has to live within its means. And there are always more demands on its services than there is capacity to provide. And if we spend a lot of money on a few patients – doesn’t matter what condition they have – we’ll deprive others of cost-effective care. We have to take cost-effectiveness into account.

And the money we spend in healthcare in Britain is very much on a par with other countries in Europe. And countries spend what they can on healthcare – it’s closely related to their Gross Domestic Product.

So we’re not playing God – we’re trying to be fair to everybody who needs the NHS, remembering, as I’ve already said, that if we spend a lot of money on one group of people, we’ll have much less money to spend on others.

Cancer Research UK: Do you find that’s a frustration in your job – that because of cost restrictions you have to say no sometimes?

Professor Rawlins: Well it’s an inevitable consequence, really. Every healthcare system has to say no sometimes – even ones like the United States, which is primarily based on insurance (although there is actually quite a large public component through Medicare)… but 20 per cent of American citizens have no access to regular healthcare at all! So what we’re doing in Britain, I think, is a far far fairer way than is done in America – which is just that poor people don’t get access to healthcare.

Cancer Research UK: Our second question comes from Teresa Wilford, also via Facebook:

Early diagnosis is crucial in cancer. What does NICE have to say about improving cancer diagnosis, and where do you see things in 5 years time?

Professor Rawlins: Well, it’s quite correct to say that early diagnosis is critical. And so what we have done is to provide doctors – particularly GPs – with guidance on early referral (i.e. when they should suspect and therefore when they should refer [people] early) and within our guidelines, for particular individual cancers, we’ve also given advice to doctors as well.

So I hope that’s going to start making a difference, because we don’t diagnose cancers early enough in Britain, and we need to start doing better.

Cancer Research UK: Our next questioner asks about an area where I think policy has changed, although people may not know this, and it comes from Concetta Mesiti Harrington, via Facebook:

Why have people been stripped of their total NHS cancer care because they paid with their own money for a drug which is available in other countries, but which NICE won’t fund?

Professor Rawlins: Yes, that was the situation until 15 or 16 months ago, when a change was made. In actual fact, this business of so-called ‘topping up’ has been around for years and years and years – when I was a kid and had my eyes tested, and I didn’t like the NHS spectacles, I could have the NHS lenses put into ones my mum bought me. If you have IVF, you might have it privately but then the baby is born in the NHS.

So in a sense, topping up is no new thing, and Professor Sir Mike Richards, who is the National Coordinator for Cancer, proposed a modified scheme, so that people who did top up, in the way your questioner has asked, nevertheless can have access to the drug and still have access to the rest of the health service.

Cancer Research UK: Our next question is from Moyra Cosgrove, via Twitter:

How will NICE dramatically speed up appeal process if they reject a cancer drug?

Professor Rawlins: Well the appeals process is as swift as we can make it. And actually, a lot of the delays – we’re talking 4 to 8 weeks – are because the various parties want to have time to prepare for the appeal.

I mean, we could do appeals in days if necessary. But the stakeholders – the appellants – which sometimes are patient organisations, sometimes manufacturers, sometimes vocational bodies – sometimes all three – they all want time to prepare, they don’t want a quick hearing – they want time to prepare.

And of course we also have to remember that when we undertake appeals, that is the last chance, as it were, unless the appellants want to go to the High Court and take us to Judicial Review. So we’ve got to get it right, and we’ve got to be fair to everybody.

Cancer Research UK: So do you think that when people do complain that patients are being left in limbo over this process, that’s the minority?

Professor Rawlins: Certainly the minority, yes.

Cancer Research UK: The next question comes via Beata Ciepal, via our blog:

NICE’s cost limit is about £30k per one year of good quality life. If a drug is more expensive, like Avastin for breast cancer, it’s not available on the NHS. Has NICE ever considered co-funding these drugs with the patient? So if one year treatment costs £42k, the patient would have to pay £12k, pro rata.

Professor Rawlins: We wouldn’t have powers to do that – that would require primary legislation to introduce some co-payment of that sort, and it’s not within our powers.

But I would like to emphasise that this figure of £30k is a guideline, it’s not an absolute rule, and we have gone much further than that – in some cases as high as £60k. So it’s not a strict rule – it’s a tool.

Cancer Research UK: When you say you’ve gone as far as £60k, is that common or rare?

Professor Rawlins: It’s relatively rare – the problem being that if we spend £60k, then that means the people are going to have to be denied care. It’s very hard. When we said ‘yes’ to Herceptin in breast cancer, I know of one primary care trust that had to suspend its domiciliary palliative care service. It hadn’t got the money to do both. And it has to provide Herceptin. So it emphasises that we can’t do everything. We haven’t got enough money.

Cancer Research UK: I’d like to ask a question about ‘patient power’ in NICE decisions. When Sutent was being turned down there were a lot of stories in the media – a lot of kidney cancer patients made the headlines – and I wonder how powerful that is when you come to reassessing a drug – because Sutent was finally approved.

Professor Rawlins: Well we listen to people, but we don’t allow ourselves to be bullied. And sometimes, patient organisations, when they make a lot of noise – as they have every right to do – are funded by the pharmaceutical manufacturer to do so. Covertly. We know this. We know that PR firms will provide pro bono help to certain patient groups.

Cancer Research UK: Some people will be upset to hear this.

Professor Rawlins: Of course, they may well be upset to hear it, but we know it happens. Now, they have every right to do that, I’m not complaining about that, I’m just drawing attention to the fact that it happens. But I’m also drawing attention to the fact that, yes, we listen – but we’re not going to allow ourselves to be bullied by one group, who’ve got a powerful voice, when we also have other groups of people with other conditions that don’t have anything like that sort of powerful PR lobbying behind them. We’ve got to be fair to everybody. It’s hard…

Cancer Research UK: There must be patients who actually aren’t financed by the pharmaceutical companies, who actually feel very aggrieved when they can’t get a drug.

Professor Rawlins: Oh yes of course there are, very aggrieved, and I understand that. But as I keep on saying, the problem is that we only have a finite pot of money for healthcare.

Cancer Research UK: The next question comes from Navin Sewak via our blog:

Do you believe that the Cancer Drugs Fund undermines the work that NICE does?

Professor Rawlins: No. I think it’s a perfectly reasonable extension to the existing arrangements for exceptional circumstances, for example when NICE haven’t yet completed an appraisal for a drug because it’s only just come on the market.

So we’ve already had these arrangements for exceptional circumstances – this is just another way of looking at exceptional circumstances, but on a regional basis. I think that’s perfectly right and it’s certainly not undermining NICE.

Cancer Research UK: Next is Clive Stone, via our blog:

NICE costs the taxpayer a lot of money to support. Why cannot NICE now concentrate on working with pharma companies to create a robust database of differing cancers (including rarer types) as to where they occur geographically/socially so that a more focussed approach for a cure may be made. Those of us with rare cancers like my renal cancer need the option of sequential drug treatment. Will NICE adopt a “can do” approach and increase the cost limit which was set in 1999 and should now be about £47k with inflation?

Professor Rawlins: I think there are several questions there. The first that, of course, the pharmaceutical companies themselves research extensively into where the unmet need is, they don’t need us to tell them, and we all know.  We do help pharmaceutical companies and we do provide scientific advice to pharmaceutical companies – it’s a service we started providing about two years ago. And it’s warmly welcomed by manufacturers to help them develop the evidence that might be able to persuade us to say yes to a particular product.

The question of the threshold, as I’ve already indicated – it’s not an absolute threshold at all, and it’s always a comparison: we’re looking at how much additional benefit you get for how much additional money. So the comparators will also have increased in price over time. So that’s one of the reasons why we haven’t increased the threshold  – because it’s a comparison all the time: A vs. B – A is the old drug, B is the new drug – the price of A has increased over the years in line with inflation, so the difference remains the same.

Cancer Research UK: The next question is from Sue Law, via our blog

With the imminent shake-up of the NHS looming, do you sense a change to your structure on the horizon? Also, as GP’s will apparently have more control regarding money spent within the NHS, does this mean that they will play any part in your decision making?

Professor Rawlins: Well there IS a big change to NICE [on the way], NICE is currently established as what is known as a Special Health Authority, under secondary legislation, and its being re-established, as part of the new Health Bill going through parliament now. So our legal position changes very substantially, we become actually much more independent of Government.

And we are actually having our role extended to incorporate social care as well as healthcare. Healthcare and social care have always been two disparate silos, and I very much welcome the opportunity to try to bring the two together, by producing advice in social care alongside advice in healthcare. So there are changes.

The question of GP involvement: GPs always have been involved, very very closely, in all we do. The decisions at NICE are not made by me, they’re made by the members of our advisory bodies, who are drawn from the health service – and who always include GPs, even if it’s in rather specialist areas, because GPs tend to bring what you might call ‘an element of common sense’ to the discussions, which sometimes my more specialist clinical colleagues sometimes… lose sight of.

Cancer Research UK: So GPs act as a sort of touchstone?

Professor Rawlins: They’re a very useful touchstone, because they understand what it’s all about and they can remind everybody what it’s like in the real word and it’s ‘not going to quite work like that’. So they’re very very important.

Cancer Research UK: So you welcome the new plans, that GPs will have so much more control?

Professor Rawlins: Oh I’m quite comfortable with that, yes.

Cancer Research UK: The next question comes form Pauline Crawte, and it comes via our blog:

NICE says that it doesn’t monitor whether guidelines are being met. When the NICE guidelines for cancer treatment are not met in practice, what is the point of having guidelines at all?

Professor Rawlins: Well, I think we need to make a separation between our guidelines – our clinical guidelines, which cover the treatment of diseases or conditions  – and our appraisals, which cover individual drugs.

Where NICE say a drug is clinically and cost-effective, in our appraisals programme, there is a legal obligation on the NHS to provide it – it’s enshrined in the NHS constitution.  And anyone who’s not been able to access drugs that we’ve said ‘yes’ to, and that their oncologist or doctor feels is appropriate, then the NHS is acting illegally. And anyone who’s in that position only has to whisper the words ‘Judicial Review’ to make the Primary Care Trust or hospital immediately change its mind, because they will know that if they go anywhere near the law courts, they will be hammered.

Our clinical guidelines – covering the whole pathway of care for a condition – well you can’t really do that. They’re often quite complicated to introduce -sometimes you have to have extra equipment or extra infrastructure.

What I think the NHS can be asked for, is, OK, you can’t introduce this in three months, it’s not like buying a drug off the shelf, but how long are you going to take? And that’s certainly the approach, not that we take, but the Care Quality Commission take, because they’re the inspectorate. And they inspect organisations in relationship, in part, to their adherence to NICE guidelines. And it’s the sort of ‘test’ that they use. But it can’t be done immediately; it may take a year or two – or even three years, to be able to introduce a guideline, because of the infrastructure requirements that are going to be necessary.

Cancer Research UK: Jack Searle, via our blog asks:

Do you think mass media coverage of health issues ever has an effect on the formation of guidelines? Who sits on the panel that formulates new guidelines? e.g what’s the ratio of doctors/managers etc.

Cancer Research UK: You’ve mentioned a little bit about GPs, but I think we’d all be interested to know, when you have clinicians and health economists sitting together, who wins?

Professor Rawlins: Oh, they have to reach some sort of consensus, at the end of the day. And to be fair to health economists, they’re not trying to be cruel to anybody – but they want to see the money used in the most effective way. But we have specialists in the particular area, we have GPs, we have nurses, we have one or two managers, one or two health economists, one or two statisticians.

But with our guidelines, we also always have two patients – or ‘service users’, as they like to be called. And we’ve done that right from the beginning. When we started off and included patients, we were accused of being politically correct, and they didn’t have any role, and that we were just massaging the whole thing. Now, everybody accepts that the patient representatives – service users – play a critical role – they remind people what it’s really like.

Now we understand that for service users taking part, it can be quite a daunting task , to find yourself facing a dozen famous professors of oncology… so we help them a lot. We have a unit here at NICE that helps service users understand what’s happening, understand what people are talking about when they’re talking about ‘randomised controlled trials’ and this sort of thing. So they get a lot out of it too, and they contribute hugely. We did a survey about it not long ago of the chairmen of our guideline groups, asking them, ‘did the patients make a real contribution’ – and every single one said the patients make a critical contribution.

Cancer Research UK: Do the patients have a vote?

Professor Rawlins: If it’s necessary to have a vote, they have a vote, yes.

Cancer Research UK: How often is there a vote?

Professor Rawlins: Well, you can’t really write guidelines with votes, because there are so many different steps along the way – it’s a consensus. But nobody’s ever come out and said, ‘I thought that was terrible guideline and I completely disagree with it’.

Cancer Research UK: Jack Searle goes on to ask, how long does the average guideline take to be processed?

Professor Rawlins: Well a clinical guideline can take up to two years. A clinical guideline is a huge piece of work, and it involves what we call ‘systematically reviewing’ the relevant literature.

So, for example, when we did a guideline on lung cancer, the first trawl of the literature, produced 64,000 relevant scientific articles to consider. You can’t go through those in a week or two – or three, or four. It takes time – it actually takes about a year to produce.

And then we deliberately go through a whole series of consultation steps, to find out what people out there think of it – have we got it right? Have we misinterpreted the evidence? And then we bring it back and review it. But it takes about two years.

Cancer Research UK: Do you think it’s a fair criticism that the public in general seem to have – that everything does take so long with NICE?

Professor Rawlins: Well, if we didn’t take this time, first of all, we would not do patients justice.

Secondly, unless we were this thorough, then the medical profession wouldn’t trust us. They trust us hugely now, because they know how thorough and robust our processes are.

And one of the surprising things to me was, because I never thought it would happen at the time, how much international interest there’s been in our guidelines. We know, for example, that our schizophrenia guideline has been translated into Spanish and used throughout Spain, translated into Italian and used throughout Italy, and, well, not ‘translated’ into Australian but it’s used there… and it’s even used throughout the state of California in the US.

So we can’t do it right and thoroughly, and do it quick. We have to take the time. And the time we take in developing our guidelines is actually no real difference to the time taken by other guideline development groups in the US and Europe.

Cancer Research UK: Our last question comes from David Waldock, via our blog:

Does NICE feel its expertise is being undermined as politicians seek to influence the way money is spent irrespective of the evidence?

Professor Rawlins: No, I don’t actually. Because we have a nationally funded healthcare system, funded from taxation – politicians have the responsibility to decide on the scope of the healthcare arrangements, and then let us, NICE, work out the details of how it might be implemented.

So, for example, it was a political decision to decide to have fertility treatments on the NHS. That’s right, that shouldn’t be my decision; it should rightly be a political decision. Having decided that fertility treatments would be provided by the healthcare system, NICE was asked to produce a guideline on how it should be done and under what circumstances. And I think that’s the right division of labour, if you like.

And these political decisions aren’t really based on ‘evidence’, they’re based on an awareness of what is perceived to be the desires of the people and what seems right to be done. And those are political decisions that are rightly made by politicians.

Cancer Research UK: And you’ve been in this job now for what, twelve years? Your term of office comes to an end when?

Professor Rawlins: Well, I think my term of office will ultimately come to an end at the end of March 2012. That’s when the new organisation will be created, so my job will become vacant and I’d have to reapply. But I think after 13 years it’s someone else’s turn to have a go. It’s been a wonderful 13 years, but someone else should have the opportunity to enjoy it.

Cancer Research UK: Will you miss it?

Oh dreadfully! When I started off at NICE it was just me! So of course I’ll miss it – it’s been the most wonderful, exhilarating, rewarding – sometimes exasperating – part of my professional career, and I’m very lucky to have had the opportunity to do it.

Interview conducted on 18th Feb 2011 by Cancer Research UK press manager, Sally Staples