Two-Cents In: FULL INTERVIEW

What definition of HTA do you subscribe to?

Mark: HTA is a term that is used quite loosely. It seems that the formal definition is to provide an assessment of medical technologies using different perspectives including clinical, economic, ethical and technical. But I think the meaning that it has developed in some parts of the world relates to its use in supporting resource allocation decisions, particularly when technology should be funded from available resources, so issues of reimbursement and determining an appropriate price for new technology. In Europe, there is an organization called Eunetha which is focused on HTA, but does very little in the way of economics. So the role of economics in HTA, when you talk about it and when you define it, seems to be variable. Some people might agree that it’s not a very helpful term. It’s very general and you should use terms that are a bit more specific to relate to particular meanings that are available.

Karl: The only thing that I’m interested in is that it is to inform decisions about healthcare that are taken on behalf of others. That is the nature of decisions in healthcare, we make the choice about what type of interventions, drugs and services are going to be available on behalf of other people and what we’re interested in is trying to inform those choices. I don’t really care what things are called, but I do care about how we do that and whether we do that in a way that is consistent with the things that really do matter and with the evidence and I would argue that you can’t inform decisions in a mechanical way that’s accountable to reason and to evidence without addressing the economics of those decisions. So I don’t care what the people call it, HTA, Pharmacoeconomics or economic evaluation. I don’t really like the term economic evaluation because it seems to suggest that there’s an evaluation of economics over here, and there’s another type of evaluation over here and we can just choose what type of evaluation we want. What we want in an evaluation should be relevant to making the decisions. And some of them are relevant and some of them aren’t.

So when you’re talking about HTA it’s about prior to decision making, but what about after the decision has been made? Will there be HTA afterwards, looking at policy and programs that has been implemented and to see whether it’s really working and it’s really value-for-money?

Mark: If you work on that principle to describe it as research to support decisions, then the question is when the decisions are made. For most types of resource allocation, there isn’t just one decision that is binding for the rest of time and indeed there is often flexibility on the part of health systems about how they make decisions overtime so it is entirely possible and indeed desirable to guide decisions overtime. So what we might consider as an initial decisions, perhaps when a proprietary technology tries to enter the market, the evidence of what we expect in terms of cost-effectiveness, we can say something about the uncertainty of that evidence and what additional evidence would be valuable for conditional research or it’s that process of whether that additional research is undertaken or not but one can envisage a sort of ituitive process that decisions are due once additional research is undertaken. And the process reiterates itself. So I wouldn’t accept the idea that you have a before and after assessment. It is a cycle whereby you are trying to assess at each timeframe, do we have sufficient evidence at this point to genuinely fund the technology, is additional research so valuable, how am I to get that research and keep reviewing that and recognize that off course other types of information emerge and that new technologies come into market, other things like, particularly in the space of new technologies, patents and things change as you go forward, so it’s a continuous process.

Karl: I would agree with that. It is certainly true. Certainly in the UK, NICE has been under a lot of pressure to make decisions about new drugs rather than drugs at large. So the focus just seems to be there, but that’s not all that NICE does. And Mark’s absolutely right, the process isn’t just a one-off at launch and they approve it or don’t approve it and that’s done. I guess what I would say though is the notion that, and the evaluation always looks forward, so the idea that in the future we might evaluate the decisions that we’ve made in the past to decide whether it was good or a bad decision, is not very useful. The truth of the matter is, we make the decision based on the evidence that we’ve had available at that time. We make that decision, and we might acquire more information that would mean that we have to reevaluate that decision and possibly make a new choice. It doesn’t mean that the previous decision was wrong, it just means that the uncertainty came out another way, a new technology may have come out, we found out more information and prices may have changed. So this process of continually considering whether we’ve made the right investments isn’t about judging those previous decisions in hindsight.

What do you think are the top priority methodological issues of HTA?

Karl and Mark

Opportunity Costs

There’s been huge amounts of work done globally on how we properly assess the benefits that intervention service that technology can offer. And we have gotten good globally on how to do that. And also likely costs taking into account future costs as well. But that’s not enough, we need to understand what health we could have gained had we not used those resources in that way to make it available for other uses. We need to understand the opportunity costs of the decisions that are on the table and our assessment of those have been relatively weak and I think that’s what’s starting to change. It’s probably the most important question, not just for high-income countries but for all countries. And in fact it’s a cross-cutting issue that’s relevant to all health-care systems, if anything, it’s even more important where resources are even more constrained because those health-opportunity costs are likely to be even greater. So I think that’s the key issue on both policy and methods agenda, as to how we can properly assess those health opportunity costs. And it’s not just relevant to choices about how we choose a particular technology. It’s also relevant to benefits package designs, it’s also relevant to prices that health care systems can afford to pay for technologies, so it’s very relevant to pharmaceutical pricing, tiered pricing, it’s also relevant to issues around development in the sense of apprising the right development, so unless you know how much you can afford to pay for the benefits that a development might have to offer, you don’t know the value of the investment.

Unfortunately, all of that is being called the threshold, but that’s not really what it’s about. It’s not about a decision rule, it’s not about comparing something to an ICER, it’s just about having an evidence-based view and trying to assess what the health opportunity costs are likely to be.

Issues of Uncertainty

Mark: How do we best inform decisions in the context of uncertainty? This has been a big area of work for our group as well. Off course when health care systems make decisions about medical technologies, the evidence is often highly immature and in many ways that’s getting more and more challenging as regulators, at least in Europe, I don’t know if that’s true in Asia.

Karl: Absolutely!

Mark: So it’s less evidence, and indeed worse evidence, poor evidence, not quality evidence as some have got. So apart from just saying, well it’s too uncertain, we can’t do anything, what should a decision making body say about uncertainty. How should we help a decision making body think about uncertainty? So part of that is about quantifying uncertainty appropriately. So that it’s part of the modeling framework used. We try to capture the uncertainty in not only the evidence that exists, but also in our understanding of the disease and the structure if you like, from a modeling point of view. And express that in a way that directly informs decisions, so that’s in part understanding if on-balance or on average, is this technology cost-effective. But we also want to be able to quantify the probability that that technology represents a cost- effective use of resources. So we can have something that’s cost-effective on average but there actually might be a marked likelihood that in choosing to reimburse or to finance a technology, that that decision will be the wrong decision. And that leads us to thinking, in principle, how would we reduce that risk of making that wrong decision by doing additional research. So that framework allows us to be able to quantify the value of the additional research being undertaken to reduce our uncertainty and to improve tomorrows’ decisions and future decisions. So that process of characterizing the uncertainty in the evidence, linking that formally  to a decision and quantifying the value of additional research can start to inform decisions about what should a decision maker do when the research is uncertain. Should they reject the technology? And is that the best way of getting additional research undertaken if the research is of high value? Should they undertake some sort of arrangement with the manufacturer whereby perhaps the manufacturer reduces the pricing in the short-term due to the uncertainty of the evidence behind the technology, with the potential agreement to undertake additional research? Should there be an agreement such as that for all patients or just patients who might be participating in the research project. So a series of structured approaches in thinking about the value of the technology will allow its use now and its cost-effectiveness, the value of additional research and also, what is the most likely means by which that research can be undertaken. So that whole process, that whole framework is a really important one. I’ve always been instrumental in developing that in many years. I’m beginning to see it gain traction with decision makers and policy makers as it’s particularly thought of these days as technologies become used, and become available to the system.

Karl: The only thing I’ll add to that is certainly in the UK, it’s generally true. Globally, there’s an increase in pressure to approve early with poor quality evidence, with more uncertainty and the promises made about collecting future evidence, is really about collecting observational data, so it becomes monitoring those who are on the drug. And in many respects, it may be a greater threat to overall patient outcomes than approving technologies where the price is too high. In the UK, there’s a lot of pressure for early approval on the promise of collecting observational data. The problem is that observational data that’s been envisaged is just approved registry. We won’t have the proper controls, we won’t actually know what works, and the magnitude of the effect and in a sense that’s a pretty major threat to patient outcomes and evidence-based medicine. So I think the more explicit the formal framework within which we can start to quantify the value of getting proper evidence and ways in which we lack proper evidence is important in that policy space to make sure that there is some accountability for the value that they are giving up if we let technologies into the system that we don’t really know whether they are the most effective or whether the scale of the effect justifies their cost. I’m quite concerned about the way in which people are imagining that so-called real world data can solve these fundamental problems, because it can’t, because data, without sufficient variation in treatment assignment, doesn’t tell you anything.

I think at the same time though, we need to be thinking about more innovative research designs, so some work can start to be done on those. There are traditional clinical trial designs of allocating randomly to Intervention A or Intervention B, isn’t particularly useful, it means that clinical trials tend to be unrepresentative of the target population, you need ethical approval and are quite more expensive to run. More innovative designs where you randomize people to either having what’s currently available, let’s call it intervention A, or randomized to a group where, well, you could have A if you want but you can also choose B, which is an option that you can choose. Those kinds of designs are things that could be run more easily and is effectively an observational study within a randomized design. I think with the pressure to approve early, there’s a real need to think about research designs which allow that to happen that don’t throw the evidence, which is the kind of way in which real world evidence is talked about effectively withdrawing away the evidence. We’re not going to get the evidence really.

Where does the pressure come from, the government, the industry or both?

Mark: The pressure for early approval. I suspect that’s somebody’s PHD thesis. These are complex, political relationships in many countries, including our own (UK), the pharmaceutical industry is very strong politically and they have a lot of influence. We have a reasonably large pharmaceutical research center in the UK. So governments are keen to encourage pharmaceutical companies to invest in the UK and often the theme of investment in industrial policy is conflated with health policy. Often the feeling is, if you don’t pay what the pharmaceutical industry wants for their new products, then they will relocate research and development outside of the UK. We try and couple these two things. It’s a very complex political relationship. And government itself is highly variable. You’ve got the department of health who will be focused on the main interest of the NHS and other parts of government will be focused on the industry or the strength of the British industry including the pharmaceutical industry. So it’s a complex way of management.

Karl: I think there’s another aspect which is unless we have a proper evidence-based assessment of who will have to give up health care and health benefit as consequence to these decision to approve technology at high prices and to approve early when we don’t know if it works. Until we have that, for politicians, it’s quite difficult because there’s all the pressure from those people who believe they can benefit from these new interventions and they want it now and they don’t care how much the health care system pays for it. So it is partly the manufacturers and their influence, but it’s also that unless we can really start to make these health opportunity costs real, there’s no counter pressure on the politicians. So that’s why I think assessment of health opportunity costs is so important. It’s not just important in a technical sense, but it’s also important in a political sense because it is a way in which we can communicate to a much wider population, to actually know, we can’t afford this drug and this is why and it’s because the people could benefit more and the real issue is how it’s priced. And I think it helps politicians make that argument. But it also means that there is accountability to politicians if they fail to account for that. So for example, the cancer drugs fund was supposed to be a vote winning exercise. Well maybe it was, but now we know that 400 Million Pounds per year spent on these cancer drugs is doing enormous harm to the NHS and we quantify that. And as soon as people start to understand that, journalists start to understand that. I’m not sure that it’s a vote winning exercise anymore. And I think it’s just starting to happen. The politicians are realizing, this isn’t necessarily going to win me a lot of votes when people can’t get access to basic care in the NHS or have to wait or an accident put an enormous arm under pressure but at the same time we’re willing to spend so much money on oncology drugs that may not be good. So these kind of technical matters called the threshold have a role in making decisions but it also has some consequences in that it changes the nature of the political debate. And it holds people to account in a way that can actually change the way in which these arguments get played out.

Coming back to the issues of uncertainty, as I understand, it has many levels – uncertainty in research and uncertainty in politics:

Mark: Well absolutely, the original question was about methodological and development in the context of decision making and in the context of doing research. What I was describing was, I think we feel that it has been a really important development and we’re just trying to characterize uncertainty and to quantify it and direct it specifically into how do we make better decisions or how do we make the best decisions in the context of uncertain evidence. It’s quite different when you think about it as to how standard-evidence based medicine, which is about uncertainty which is about generally speaking, making hypothesis and gauging whether the weight of new evidence is sufficient to take you away from what is a fairly arbitrary null hypothesis.

So your policy recommendation would then be several tiers, and you would recommend that because the evidence is uncertain, then they could have options in terms of making a decision such as approving the technology with future research, approving the technology or do nothing.

Mark: The nature of the decision options will vary depending on the decision maker but to the extent that the decisions that incorporate the ability to do additional research, the ability to delay decisions into the future. Or indeed whether there is some flexibility over price. It gives more scope for the decision making body to react to uncertainty.

So how is that research going?

Mark: The framework is there, it’s been written up into various forms, the question is, the extent to which decision making bodies are using it and doing it. In the UK NICE reflects it to a certain degree of how it thinks so it’s always had research recommendations. I think it now fully understands that its own decisions, decisions about adoption of technologies to formal guide of technology will have implication on research and whether further research gets undertaken, but I don’t think we’re there yet. We haven’t fully implemented the framework and it’s particularly relevant to how this review is going on in the UK called Accelerated Access which is again all about this idea that given the regulators there, coming up with at least provisional licenses for drugs much earlier for much poorer quality evidence, how should the NHS react? So we believe this framework banning that context, that’s ongoing at the moment.

Karl: I think there is a lot of work to do, in two respects. One is the value of how information works would originally develop and built alongside decision tree models, evidence synthesis. So before you even get to thinking about the value of evidence, you’ve got a huge investment in this edifice of quite complicated and time consuming work. One thing that we try to do, prompted by pre query is how we can apply these principles, very quickly, very easily, is the kind of thing that is readily available applied to results of standard meta-analysis, at least to get some feel for what the scale of what the health benefit of resolving what uncertainty might be. So that’s one way of how we pursued it, to make it something that is not so much owned by health economists or technical people but something that can be conducted as a routine part of any meta-analysis, that’s our vision for it. So that work’s ongoing, we’re using it, we did that for the query. We’re using it with the body that sets research priorities in the UK, which sets research for the NHS. So that’s one part.

The other part is how it integrates with policy. There again is a real challenge. Pressures have been to approve drugs that on the balance of revenues are not cost-effective early and require evidence. Whereas in actual fact, if we don’t expect them to be cost-effective, we should be withholding approval until we get that evidence. And in fact, even if we think it’s cost-effective, if we’re really uncertain, that we can’t get the evidence once we approve, then we should still be withholding approval to get the evidence. And you know for all reasons we’ve talked about, the political pressures, the pressure from those that have got interesting end-game for drugs that are widely used in the NHS.

HTA is being marketed as the path towards universal health coverage, to what extent do you think this statement to be true?

Karl: When it comes to benefit package design, the key questions are, what we think the benefits are likely to be of the various things that could be included in that package, what are the additional costs including system costs, and critically, that question of health opportunity costs, what else could we have achieved if we had used that money in different costs by putting other things in the benefit package or other investments that could have been made. And those are the key questions that, if you wanna call it HTA, economic evaluation, I don’t really care what you call it. But those are the key questions that need to be addressed so, I think HTA provides the tools, the fundamental building blocks of informing, not deciding or having a decision rule, but providing the critical pieces of information that are going to be required in making informed and accountable choices about what ought to be included in a benefits package. I think secondly, what’s very important is that those are the key pieces of information that are required to figure out how much we should be paying or certain things that are particularly branded pharmaceuticals. And by having the evidence about what healthcare systems can afford to pay the benefits that new drugs offer, we have a framework within which we could start to think about what would reasonable and sustainable prices and they will differ by health care systems and a move towards tiered pricing based on evidence of benefit and how much different healthcare systems can afford to pay for those benefits, would be hugely beneficial. At the moment, effectively with affecting the global price, health care systems ace a terrible choice between either approving a new technology and damaging their health care system or saying no to a new technology and not having access to the newest medicines that might be available. And that’s a terrible choice to face. Whereas with tiered pricing, if we can have mechanisms with tiered pricing, there’s no reason why we cannot have access to these medicines at a reasonable price that we can afford. It will be beneficial to manufacturers at the moment. Manufacturers abandon large sections of the world that can’t afford their prices. But with tiered pricing, they are able to get the entire area under that global demand curve. It’s actually a benefit to manufacturers and it’s a benefit to health care systems. This is because the manufacturer gets to sell their drug and even if it’s at a low price, as long as that price is above the marginal cost of production, as long as that price is above the generic price, they can still get some revenue from selling the drug.

The other benefits that flow from that are two fold, what it means that health care systems that can’t afford to pay very high prices, without tiered pricing are excluded from the market so their needs and their demand has no influence on the global market. With tiered pricing, even health care systems that can afford to pay a modest amount for new drugs, start to have some influence on global research and development decisions about made new pharmaceuticals, they enter the market, and they’re part of that influence. The second reason, the other reason why this is beneficial is there were gonna be health care systems, poor healthcare systems that may not be able to afford even the marginal cost and the generic price. That’s where assistance is required, if those heath care systems don’t have access.

What do you mean by assistance, do you mean external aid?

Karl: So the way I see it at the minute, is that financial donors are using donated resources are using it to compensate for the fact that we don’t have tiered pricing globally. And that is a real waste of those resources. Those resources should be targeted to situations where once we’ve got tiered pricing, those health care systems that are not even able to afford tiered prices, that’s where the assistance should be targeted.

So then you would start to be able to identify which countries don’t have even the basic or even the generic drugs and that’s where the aid should go.

Karl: Yes, if we can have a system of tiered pricing based on evidence of benefit and evidence of how much each healthcare system can afford to pay for the benefits. So I think that’s a really important move that will help the move towards universal health coverage. Because it has benefits for everybody, health benefits for healthcare systems and actually has benefits for manufacturers, because there are a number of manufacturers that want to see tiered pricing. And it has benefits for organizations responsible for ensuring that donated resources are used effectively.

But that is quite a difficult notion because, even within the aid community, all of them function under different organizational structures, different policies. So even to get them to come together and understand this notion might not be possible.

Karl: Yeah, I mean you can’t solve everything all at once. But there are bodies, first of all, the manufacturers are interested to establish tiered pricing. They will argue a lot about the cost-effective threshold are for different countries. And they might be quite upset about the reality of the evidence. We do have some bodies that have that role in purchases. So global fund has real interest in knowing what it should be paying. You have organizations like the Gates Foundation with similar interests and want to know what would be the value of the things that they are developing across a range. So we cann’t get everybody to agree to everything and implement everything tomorrow. But I think the important thing is that we understand the nature of the problem and we put in place, in principle the things that start to address it and I think we are doing that. I think globally, around the world, we have bodies like HITAP that are very good at assessing benefits and costs. We pretty much know how to do that. Sure we can improve things but, we’re pretty good at it. I think increasingly, we start to address these questions of what health opportunity costs are likely to be across health care systems. With those two things in place, we make these ideas about tiered pricing and mechanisms that we might put into place. They start to become real. So I’m reasonably optimistic.

What challenges do you see in exporting this area of study of health economics and HTA to low- and middle-income countries?

Karl: I suppose two-fold, but I don’t have a lot of experience on working in low- and middle-income countries. I’m fortunate enough to be able to work with other people like Paul Rebel and I try to learn a lot from their experience. What I understand is that there are some capacity issues.

Not just capacity of the technical experts, but in terms of the political and the public as well.

I think people like Paul and like yourselves who have that experience of understanding that the capacity issue is not just n technical capacity but it is capacity in terms of governance, in terms of accountability. And working with those decision-makers in that context, you want to move things forward incrementally. I think the same principles apply as they have in the UK which is focus on those decision makers who have a problem, who recognize they have a problem and would like to make an incremental difference. Those are the key people to be working with and that’s important. You can’t change everything all at once and make it the way that people might like it to be but if you have key people that have a problem they need to solve, who are open to thinking about ways in which that problem might be better solved and we can engage with them and help them with those specific problems in an implementing way, then that is the start of in a sense building that capacity, not just technical capacity but governance capacity.

I think maybe if you look at what we need to work on a little more is to make sure that we are able to properly reflect the range of constraints that are in low- and middle-income countries. It’s not simply a question of resources, there are many constraints which are ultimately tightly binding. We need to make sure that we conduct analysis that reflect that. If we don’t then we’ll be engaging with people who’ve got a problem, we’ll want them to listen to how we might help them with that problem. But if we fail to address the key constraints that they see, then we won’t be seeing it at all particularly relevant or helpful. So it’s very important that we do that. I think we have the tools to do that, and increasingly, we’re trying to develop those as well. It’s important that we do have those tools available to us, reflecting other constraints not just resources.

So currently, are there available tools to reflect on these constraints?

Karl: Well there are. So I guess another thing that I would argue is that it’s really important that there isn’t some arbitrary orthodoxy of wanting to do good HTA. If our purpose is to have informed decision making, in a way that is useful to decision makes within their timelines, in the context in which they’re having to make decisions, then we need to be responsive to that. How much we can do, how sophisticated our analysis is, that is on a sliding scale. There is no end to how much more sophisticated we could make the analysis, how much more data we would really want. There is not end to that and it’s quite a question of what is enough in the timescales available and the resource constraints available to improve things and help that decision to be a little bit better than it otherwise might be, so I think what we definitely shouldn’t do is to have some kind of set of rules about what constitutes good HTA. I think that is what we try to reflect in the reference-case that was developed with the Gates foundation, in which it was really important that, that wasn’t set out as an orthodoxy or a set of rules that have to be followed but rather a set of principles at how we might address those. How much you can do, just depends on the context, the timelines and resources available and the data available. So I guess that’s my take. Good HTA informs the decision maker on what is useful, is delivered in a time when the decision is being made. That’s what good HTA is.

Regarding VLM and ART drugs.

Karl: On that particular example, there isn’t a tradeoff in a sense, so from existing resources devoted to HIV, we want to introduce viral load monitoring (VLM), and then we will have to reduce the coverage of ART. So we will reduce overall health and we will increase health inequalities because a greater proportion of the population won’t even get access to ART, never mind VLM. So I think it would work in the same direction.

In terms of the tradeoff-between health equity and aggregate health, the key thing that any analysis ought to do is to make it absolutely clear what that tradeoff is. I’m not an economist that believe he ought to tell people what to do or how they should make the trade. I think what economics is there to do really is to expose the trades that will be made. They’re unavoidable and you have to expose them clearly so people understand when they’re making a choice.

Where do the social and political factors fit into HTA and establishing the threshold of cost-effectiveness?

 Karl: I really don’t like the word threshold. I try not to use it anymore. What we need to understand are what we expect to be the health opportunity costs of the decisions we are going to make and that’s just a factual question about what do we expect to happen elsewhere in our health care system, what are the health consequences? That’s not about individual or social preference, it’s just trying to estimate, what do we expect the health that we have to give up, what do we expect the scale of the health that we have to give up to be. It’s just telling it as it is as it currently is. Now, how much we’ve spent on healthcare and what the scale of those opportunity costs are as a consequence of social choices that we’ve made as a society about how much to spend on health care, how we’ve decided to organize our health system, what levels of accountability are in our system, so that’s just the way it is now and understanding that is key to having a proper debate about social choice, about do we want to spend more or not. Without knowing what that quantity is, we won’t have a sensible discussion about whether we should be spending more on health care.

Although people have described the threshold, not in that way but in terms of representing how much society does or should want to pay for health improvements. Now, I have a real problem with that. It’s first of all not what you need to know, what you need to know is not probably what you are getting, it’s the same thing. The second problem I have with it is, truthfully, I don’t know, how I would formulate what society should be willing to pay. You might say, it should be based on individual preferences, that we should go out and do an experiment and ask people, how much they are willing to pay. Well, maybe, but that’s just one view. I personally don’t subscribe to it. I don’t think social choice is the sum of individual preferences, I think there’s more to social choice than individual preference. So I’m not saying that knowing what individuals are willing to trade is unimportant. I’m just saying it’s not the key question to these choices. And I don’t believe it tells us what society ought to pay. I think, how societies figure out what they ought to do is quite nuanced and it’s through a social and political process.

It’s quite difficult to tell in this context because if you were paying for health privately, then the sum of individual preferences would be the demand, but in this case, because we’re not paying out of our own pocket, then it’s quite difficult to test that out.

Karl: Absolutely, I mean there’s lots of methods in terms of hypotheticals, kind of considering valuation and things that we could do and I think that stuff is kind of useful and interesting. Whatever the answer to that is, it doesn’t tell us whether or not we should implement this intervention tomorrow our existing benefits package. It doesn’t tell us the answer to that. Secondly for me, although I’m interested in that, that doesn’t tell me what society’s preference are because I don’t believe that social preference is just about the individual. I am an old collectivist you see.

Getting to the public debate might be a challenge for LMICs, so how can we use the results of HTA if we can’t even get to the public debate or the public to even debate about it?

Karl: I think in the past, we have not been very good at presenting things and providing things that allow that debate to take place properly, whether it’s in LMICs or in HICs. So I think, talking about ICERs and thresholds. We are now doing a reasonable amount of media interviews in the UK in radio and television. You can’t do an interview on radio or television and talk about ICERs and thresholds, you cannot do that. You can’t just talk about QALYs like everybody knows what it is. That’s just not going to work. It’s not going to work if you want to present those ideas. Because if it’s not going to work for you, it’s not going to work for the decision maker, it’s not going to work for a politician. So in a way, this has always been a view working with a body like NICE. It is other people who take our work and want to be informed by our work, who want to stand up and be accountable to others in the choices that they are making .And that means, they have to be able to explain what we’re telling them in a way that can connect with anybody in the street. If we cannot explain to policy makers, what this really means in a way that they could talk to a journalist and have it published in a paper so it could be read and understood by any of the citizens in that country, then we haven’t done our job. We can’t expect decision makers to be willing to take political risks unless they’re confident that they understand them and that they can express it in a way that can connect to people. So I think in the past we’ve maybe not done a great job of that. I think we’re getting better at it.

How so?

Karl: I think we are doing better at it by recognizing that what we are doing is simply comparing the health benefits to the health that we lose and for me that’s why this notion of health opportunity cost is so critical. It’s not just important in a kind of technical sense. It’s the foundation of being able to communicate what we do and why, of why it makes sense ethically and politically both to policy makers and ultimately to the wider population. What I found with the threshold work that I’ve done in the UK, armed with that, I am happy to do any debate on radio or to speak to journalists. Because I actually have the means to express clearly what this is about and why it makes sense, without it, you don’t have that.

Within the context of LMICs, we’re not even sure if the public care enough to have that debate, even if they find out that they’re health insurance won’t be able to cover something because there’s different interventions in the package. So we’re not even sure if the public will have an opinion about it.

Karl: I guess in that context, the key thing is the decision makers you are working with, you could think about accountability running in a number of different ways where you’ve got a population that are very engaged in political debate and these kinds of choices. In that way you’ve got an active press that are questioning politicians and holding them into account. You’ve got all that framework of accountability. In that context, really, the debate really kind of goes to the citizen. And you need to be able to communicate all the way down to the citizens because the debate is happening there. They are the ones that hold the decision makers into account. If that’s not the case for whatever reason, if there isn’t that process, if accountability isn’t coming from below, then the key thing is, the decision makers that you’re working with, that what we do, I actually believe that it is not just a technical job. I believe what we do is an important part of accountability. Even if it’s not getting in the press, even if it’s not brought up in a political debate. Even if people on the street don’t know about it, never heard of it or don’t really care about it, we’re still having an important role in making sure that there was some record. There is a record of what we’ve done and why and what information was available. And that’s the contribution to accountability that we make. And I think that’s all we can do, and we can do that in different systems which have different types and lines of accountability. I’m used to the UK where there’s a very active press and decisions are going to be brought on the radio.

Where health care is likely high on the priority list and political agenda.

Karl: But that’s just the experience in the UK, I think. We would still be doing the same things about making sure we did work, which meant there was accountability for these kinds of decisions, even if that wasn’t the case.

In terms of promoting HTA, what do you suggest for countries that don’t have this kind of system to move towards that stage?

Karl: I guess as I said before it’s about key people who’ve got important problems where we believe that we could help them or provide analysis that could help them work through those problems to identify those key people and demonstrating early the value of taking a systematic approach. I think that’s how you start to demonstrate value in the start for them to see that this might have a role in the broad sense. So that’s my view. That it’s specific and it’s practical. That’s the target. Specific problems where we might be able to make practical solutions, and if we can demonstrate that, specific circumstances in a small way and people feel that it is indeed helpful to them, and having seen this value demonstrated in a specific and small way, they will start to see the possibility of a much greater and wider value. I think we can have lots of abstract arguments about the value and utility of HTA, of hoe we need a big organization and how we need to spend loads of money in the process; that to me doesn’t sound like the right way to persuade people.

Do you think HTA institutionalization should be approached in a top-down manner or a grassroots bottom-up approach?

Karl: That’s a really good question and I think it depends on who’s got the problem; who’s got a difficult decision and whether that’s high-level or whether that’s at the grass-roots level, I think it depends on the context of the health system, on the context of which decision-makers have got really problematic issues to solve who are open to the possibility of being informed by the work that we do. Whether it’s high-level or low-level, I think it’s about identifying people who you have a key relationship with, who’ve got a real problem where we believe we could make a real practical difference.

Where do you think the future of HTA might go?

Karl: It’s been an amazing 15 – 20 years. It’s been quite incredible really. I only see it extending, not particularly because we’re good at selling an idea. But because the fundamental problems and fundamental choices are just not going away and they don’t go away with time. I think over the past 20 years I think we’ve demonstrated it in practical ways. In different contexts, making a bit of a difference. We’ve also done some work on how those practical things can be linked to global prices, reseeahc and development, choices about how much to spend. So what I hope is that we will be able to show practical value to real decision makers in real time and different contexts, in that sense the role of HTA will grow and that it won’t be specialized in a highly technical role with small number of centers around the world but will be much more diffused and will be prominent among healthcare systems. What I also hope is that we are able to persuade that this type of analysis helps inform a much bigger issues about global pricing, etc. I don’t see why not.

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