Kennedy report podcast
Sir Ian Kennedy talks about his new report on the value of new innovative health technologies and what he is recommending for NICE.
This podcast was added on 22 Jul 2009
Sir Ian Kennedy Interview Transcript – 15 July 2009
In January 2009, as part of its process of constantly updating and improving the methods it uses to evaluate new health technologies, NICE commissioned Professor Sir Ian Kennedy to carry out an independent study into how NICE values innovation in its appraisals of health technologies.
The study involved evidence submissions and the use of a series of workshops involving the healthcare industries, patients and the wider public, together with representatives of the NHS to explore this issue. Professor Sir Ian Kennedy, emeritus professor of health law, ethics and policy at University College London led the study. In this interview Sir Ian explains the aims of his study and what conclusions he came to.
Interviewer –Philip Ranson: So what were the key aims of the study?
Sir Ian Kennedy: Well, the study arose because there was a report by Sir David Cooksey who advises the government and treasury. He was concerned about industry generally, pharmaceutical industry and bio-engineering and bio-science, and the need for that industry to receive incentives because it was an important part of the UK economy. And the view was expressed to him, and he to a degree endorsed it, that NICE was (in the language used) a fourth hurdle. There were three hurdles to pass before a product could be licensed and NICE represented a fourth hurdle and because of that stood in the way of innovation, progress, improvement - I’m overstating it but just to make the point. And therefore he suggested, he recommended that there be a real root and branch study of the role that NICE plays in the architecture of healthcare and then a more particular study of how NICE deals with the notion of innovation and whether it encourages it sufficiently. The government rejected the larger root and branch study but Sir Michael Rawlins, Chairman of NICE, asked me if I could conduct this rather smaller study as I say, about how NICE responds to the notion and deals with and incorporates reference to innovation, not least because it is required to do so by its regulation.
PR: Well that seems like a huge subject to tackle, how did you go about answering this question
IK: Obviously such a study as this invites you to paint on a rather broad canvas and in terms of process, I resorted to what I’m used to which is the first thing you do is you ask anybody who wants to give you a view to give you a view in written submissions or whatever, and then you read them and you try to pull out what people’s primary concerns are and largely we were getting……. , or I was getting, representation from industries, some of academics and patient groups - didn’t get much from government or whatever - but public sector, commissioning bodies which is rather disappointing and having got all those themes together we then organised some workshops where we had fairly, fairly heated sometimes, and very interesting exchanges on various themes we’d picked out and then that added to my understanding. Then there was a meeting with the PIN (Patient Involvement Network) group where I attended their meeting and they gave me some views and put in a submission and there was a meeting of the Citizens Council where the sort of questions that I was dealing with I was able to hear their responses after two days and that was helpful and then I went away and worked at it.
The size of the project was in part a function of what I quickly came to see as the need to expand the terms of reference somewhat, not just to talk about innovation but to talk a little bit about the background of how NICE is seen by the Pharmaceutical Industry and others and how it sees itself and also benefits which Pharma, if I can use that term, were quite anxious to put on the table in addition to innovation benefits which they said NICE didn’t currently take account of and which were important for patients. And lastly in this rather long answer to your question about the scope of it, what was interesting to me and challenging was you had to operate, or I had to operate at a series of levels, the most abstract level being a kind of political philosophy of NICE as being established by government to do a specific job - namely to allocate resources against the background of a fixed budget - and pharma, to a degree driven by American models of healthcare, seeing the consumer as king, and if patients or a consumer wants it then it ought to be made available and that clash between two political philosophies was a thread running through, as was the challenge, the tension between the idea of UK Plc needing a vibrant, effective, Pharmaceutical industry for the sake of the economy and NICE being really not part of that UK economic philosophy but rather a mechanism to allocate scarce resources, and there was a tension as well.
PR: So what were your main findings?
IK: There were lots of findings, first of all I gratuitously took it upon myself to make some observations about NICE and Pharma. About NICE, I thought that it really is very often on the back foot in terms of explaining what it does and its role in society, I didn’t think it was too effective in explaining what it did and it’s too easily and too often characterized or even caricatured standing between some poor person who needs a particular drug and preventing that happening, whereas in fact we know it’s designed so as to make sure that we attend to the person we don’t know about as much as the person we do know about and to balance that. And I also thought that NICE was to a degree was somewhat complacent in its appraisals - we’ve cracked the problem; if you don’t understand then it’s your problem, rather than having an obligation to continue to explain beyond the front foot. Pharma I characterise by saying, hang on you know, you have to play the game in England according to the British rules which are: we have a philosophy of collectivism of resource allocation, it’s not just the market place or the consumer and I also ask questions about how Pharma put R&D costs into their calculation and how they globally spread those costs, details like that. Having set that scene, I then said ok, are there certain benefits, as it was said by many manufacturers that NICE doesn’t take account of and which are important or which could be called health gains? and I took the views that there were some and they ought to be taken account of in the cost effectiveness analysis to which of course people inside NICE say “we always do that”, to which I say, but you do it in a way that isn’t clear enough and isn’t transparent enough, so you’ve got to make the process transparent so that everybody can see that you are taking account of these and you may actually have to take account of rather more things than you currently do on this health gain bit as we guard the wider things that some people making submissions argued for - namely the importance of a product to enable people to work or productivity increase or people will be liberated to enter the workforce, so-called social values. I argued that they should not be included in NICE’s appraisal because of the difficulty of calculating them in themselves and also setting them off against other aspects of the public purse to work out what’s wining and what’s not, but I did say further work should be carried out if you can model how you might be able to take account of. That’s just regards to those benefits other than innovation.
As regards to innovation I took the view that there was an opportunity here for NICE to give incentives to the pharmaceutical industry and others to concentrate on innovation. I defined innovation very tightly. Innovation is one of those things that everybody talks about and everybody is in favour and nobody identifies what they mean, and so I identified it as being something to do with a step change involving a product which meets a need which currently isn’t met and which is effective to a degree something close to 70% and has gone through a process where it can be of stratification and the use of bio-markers so that we know the population is going to work rather than currently very often it only works on 30% but we don’t know which 30%, so you buy it and you waste money, and if all those criteria are met I suggested there might be as an incentive to Pharma to concentrate on that rather than other things, you might allow it to bust the threshold a little bit and you might allow it to do that for a limited period of years, let’s say 3 years and then fall back in. So Pharma’s got an incentive to focus on. Another criteria of what innovation might mean is that it actually (the product) meets the needs of the NHS as declared by the NHS and Ministers so that they’re focusing on what we need as an incentive, but it must be real innovation now. As regards innovation which is promised - the so called incremental innovation of - oh well we need to be encouraged to do this now, I rejected that argument of special privilege for that on the grounds that we don’t know whether it currently will be an innovation and a significant development. It’s a bit like saying I have a glass of water here, if you give me time it will turn into wine, to which I say, until it turns into wine it’s still water and that’s what you’re going to get rewarded for. That said I did say there was a strong case, another incentive to Pharma, if you’ve got something that might hold promise, to conduct research and collect data and currently we’re not very good in this country. Pharma’s got no incentive sometimes to collect that data because it might prove that it wasn’t promising and we don’t regard that in some parts of the department as properly researched so we need to find creative ways of allowing further research and collection of data between NICE and Pharma and Universities and whatever and there are some schemes for doing that. And then I said that of course all of this is to concentrate on what is called the demand side; the side of the people who are, as it were, representing the purchaser or the user. But the attention of Pharma, of the government and so on should not only be concentrating on the demand side but also on the supply side. There’s a limit to what NICE can do on the demand side and NICE can’t do anything about the supply side but it need s to be addressed and fortuitously.
PR: When you were putting your report together, were there any surprises?
IK: There were some surprises as I went along which were intriguing. One of them was, the separation out of the difference between the pharmacological technologies and psychological technologies , and how the argument in psychological therapies was all about evidence and what constituted something which you can rely upon whereas that argument didn’t go in pharmacological, in drugs, because the randomised controlled trial was well established. So it was intriguing to me to find a way forward because I’m very interested in developing psychological therapies that can be shown to work and ultimately you’ve got to find a way that does actually show them to work and I make a recommendation that NICE should collaborate with academic health science centres and others because mental health to me is a very significant priority in this country. Another surprise, right at the other end of the spectrum - it doesn’t go to content but to culture - I was quite taken by some of the submissions and certainly some the workshops by the … , you can almost taste a kind of state of undeclared war between Pharma and NICE and I was surprised and what I’ve tried to say in the report is that we need some detente here, we need some mutual understanding and we need to lower the temperature, not least because Pharma needs to understand that NICE is doing a particular job and it’s not doing another job it wishes to do and NICE needs to, in a sense, work so as to encourage and provide incentives to Pharma to produce things which are what we need in this country and at the cutting edge. So that was a surprise to me. And then the third surprise was how absolutely complex the processes of NICE are, and how many pieces of guidance and so on I had to read and attempt to understand. So I was operating at the plane of a kind of political and philosophical approach on the one hand and also then on the other trying to work out what a FAD meant.
PR: You touched on some of the recommendations, are there others that you wanted to highlight?
IK: well I mentioned already a lot of the recommendations; I think I’m quite anxious to refer to recommendations about the supply side as well as the demand side. I am also anxious to perhaps point out a couple of recommendations about innovation, that it’s for NICE’s Board, my report goes to NICE’s board, and if they don’t like the notion of,if you like threshold busting, then that is for them. And secondly, if they do see that there is an argument in favour of promoting real innovation as I define it through offering some financial incentive then they and the Government and the NHS must realise that that will come at a price because if you bust the threshold too much in too many cases you destabilize the cost effectiveness system and you do that at precisely the moment where public finances are about to go over a cliff, so the NHS will not have the same amount of money or will have the same amount of money but inflation will increase, and in those circumstances Pharma and the government and the office of life sciences may have to comes to terms with the fact that to have an increased threshold for some, might have a consequence of NICE lowering the threshold as regards to everything else that doesn’t qualify as an innovation, and that needs to be digested.
PR: Is there anything else you wanted to add about how the report will effect NICE, or how important it is to NICE, in terms of the way it works?
IK: Yes I mean if I were asked whether this report were important, whether to NICE or to the wider world, I would say that doesn’t rest with me to say. Obviously NICE has asked me to do it, and I hope what I’ve done will be of assistance. Clearly there are those who are not entirely content with what NICE does, either because NICE exists, or the methods that NICE uses are not to their liking because they’re frustrated or disappointed in certain circumstances. That being the case, I think it’s entirely appropriate for NICE, to bring in someone who as outsider – no axe to grind – and say what do you think of the picture and then look at that, so that’s part of NICE’s constant attempt to engage with the wider world and to examine what it does and I think that’s welcome. Whether it will have any wider implications I don’t know. It’s part of the jigsaw about how we manage the architecture of the NHS and the money that the NHS has got, and how we respond to the changing nature of people’s…of the demographic circumstances, and people’s illnesses. I would say one thing, that it was quite clear to me that cancer, particularly cancer at the end of life, had, and I use a rather aggressive term but I hope I’m understood as trying to make a point, had elbowed its way onto the middle of the stage here, and particularly with the end of life provision which I think could well constitute a Trojan horse for the whole of NICE, unless it’s controlled. And I think I’ve said some quite strong things about those in the oncology area, to say hang on a sec, I know you’re very interested in your patients and I know your patient groups are very concerned or very vocal but 1.2 months of further survival is accompanied by a lot of other sequelli may be set against other things, like whether someone has a health visitor or whatever whatever, needs to be understood that you shouldn’t necessarily have your way and prevail, and to the extent that I can help that debate, which is a debate that NICE in my view has not adequately orchestrated, because it is represented by patient groups as some kind of ogre, denying a chance of life, well that I think is a pastiche of reality and it doesn’t really come to terms with the fact that we don’t see the elderly person over there, or the young child over there, that’s not getting the care that he or she needs, because the PCT has been required to allocate his money elsewhere.
PR: So how would you expect NICE to move forward as a result of this report?
IK: What do I expect NICE to do in my report is first I suppose read it carefully, we mean the Board, read it carefully, and I will be there to speak to it on July the 22nd when they meet,. I expect the board to read it and then I’ll be there to answer questions and explain, and thereafter I think what the normal procedure is that they will go out to consultation on what they think is worthwhile for what I’m saying, and then see how it coincides with larger parts of government policy, particularly the report to the Office of Life Science, which has recently come out, and then it will be onwards and onwards and onwards.
PR: Does the recent Office of Life Sciences report to some extent negate what you’re recommending in your report?
IK: Well, the report of the Office of Life Science which has recently emerged is much larger than…concerns much larger than NICE. It’s about the whole nature of industry in life sciences, which is identified by the Prime Minister as one of the important parts of the UK economy, and there aren’t many of those right now. That being the case, NICE is a bit player. But that said there is a proposition about the development of something called an innovation pass whereby the need for NICE appraisal and approval is bypassed. Some could say that that is the thin end of a wedge to undermine NICE. I don’t think it need be, particularly as it’s recommended it be managed by NICE, it be piloted, the money shouldn’t come from…the money associated with these products which will have the pass, shouldn’t come from the National Health Service, but an earmarked ring- fenced fund, and that it be piloted for only a year and then reviewed, and that the money isn’t a great deal anyway. So, it’s a kind of toe in the water way of determining how you can provide incentives to get drugs to patients which are cutting edge drugs, and I’m…I think…I derive some comfort from the Office of Life Sciences saying in the report that they are committed to the notion that the NHS requires products which are cost effective. That’s what NICE does.
Thank you very much, Sir Ian Kennedy
This resource should be used alongside the published guidance. The information does not supersede or replace the guidance itself.
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