HTA: Past, Present and Future

Ansgar Hebborn, Head of the Global Payer & HTA Program Policy at F Hoffmann-La Roche, joins Pharma IQ to analyse major trends and implications for the research-based pharmaceutical industry.

Pharma IQ: You'll be delivering a presentation at the event on HTA and value-based pricing in Europe, and arising major trends and implications for the researched based pharmaceutical industry. Who decides on what constitutes value in the various countries?

A Hebborn: In the end it’s payers that have to take decision, but in their decision-making they're obviously cannot be disconnected from the preference of those that they serve. So they have their expectations towards healthcare systems and the services that are in there, expectations raised by taxpayers, and obviously by patients, and somehow they’ve quite a challenging job. Payers have to bring these preferences in line with available budgets when they decide on new technology, so it’s payers that decide, but not without a feedback loop to the expectations of the day.

Pharma IQ: How can we align diverging evidentiary standards and expectations of different stakeholders in Europe and beyond as well?

A Hebborn: The first step is to understand, if you're a payer in a healthcare system is to understand more about the expectations, and this is, I think, the role of what HTA could be, and to some extent is. It’s about understanding needs, preferences, unmet need and the value of technologies that could address those.

The challenge for a globally acting pharmaceutical industry is obviously to align the various requirements and requests, which, to some extent, are driven by the local context and the local opportunities of a payer; to some extent also by the technology itself, and the evidence that exists on the technology, which may be more universally valid. If you think of clinical evidence related to a product, and that’s where it’s getting challenging for a researched based pharmaceutical company, which has to determine how a single global development programme should look like, what studies it should conduct, what endpoints should be considered for these studies, and there we face a multitude of expectations, a multitude of regulators, HTA agencies, payers, sometimes patients directly, and other stakeholders. I think that's really the challenge for the industry, to align this, and I think we are looking for formats and institutions to get to a better alignment of these requirements, to some harmonisation, while still being, and remaining, reasonable with the evidentiary standards so that innovation can still happen.

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Pharma IQ: You mentioned the word harmonisation. Is there a difference between harmonisation and centralisation? It seems at the moment in the HTA world things are going north and south. Some people are moving more towards a decentralisation, and others more towards a unified, standardised way of doing things. Where do you think the HTA world is going to end up?

A Hebborn: I think you're right. You see two trends. You see a stronger regionalisation, or even local hospitals doing something, which they consider HTA. On the other hand, you have high-level discussions in Europe, for example, or even globally, in professional associations, and other forums, to align some of these requirements. I think we will see different decision-making levels, or different harmonisation levels for different types of attributes of technologies.

Certainly if you want to evaluate the budgetary impact or how much a new technology, a new healthcare delivery system fits into the local context, you have to do certain assessments and decisions obviously locally. But if it's about certain more generalised attributes of a product, like the clinical benefit, in clinical trials, and eventually also under certain new world circumstances you could see some more harmonisation. We saw this on the regulatory side, where, in Europe you have had a long debate about what can be harmonised, you see some kinds of centralisation around standards, and there may be also opportunities here on clinical attributes, to think about harmonisation at a European level.

Pharma IQ: One of the major changes from the beginning of this year especially was Germany’s move towards implementing its version of value-based pricing, and that attached to the AMNOG Bill passed as well. Can we talk about that, and see how things are going towards value-based pricing in Germany?

A Hebborn: Value-based pricing is probably the contrary to things, which are more cost-based systems, which probably have existed in years back, where it was then the cost of producing a technology that would have a major determining impact in its price. The world has moved on here. It’s ultimately outcomes that payers want to see, and consumers want to see, and also what they would want to pay for, and it’s the value of these outcomes that's in the centre of discussions to establish systems, pricing and reimbursement systems, that people consider them value-based pricing systems, and if you ask payers in Germany, I would assume so also in France or in other countries, they would consider what they do some kind of value-based pricing, value-based reimbursement or value-based decision-making. I think sometimes the name, value-based pricing, doesn’t really focus on all the decision dimensions that are taken. Ultimately it’s about granting access to patients, based on the value that a product or technology or a process delivers.

Pharma IQ: How has AMNOG shaken up what's going on at the moment in pricing?

A Hebborn: You asked the question about Germany: yes, I think it would be interesting to see how the whole new system will play out in Germany. I think there is certainly the new element that products that were considered or not considered as stand alone products, products that are delivering a unique incremental benefit, will also go through dedicated price negotiations, which wasn't the thing in the past.

I think it will be seen, based on first decisions, and then based on a series of decision-making. The German tradition of HTA, which plays into this, is a rather short decision. IQWiG, which is the institute that was charged with this, has taken a number of decisions, but not that many, so it was quite difficult, and is quite difficult, to see how ultimately it will lead to a situation where serial assessments are done, in a rather short time, how this will play out. We'll need to see. And of course decision-making on price, which is the other new element in Germany, is something that we also need to see how it plays out.

The system allows quite some freedom for relevant decision-makers, which are at one level the physicians of the sickness funds, and the sickness funds, the sales representatives, but in the pricing end it’s only sickness funds, which, hopefully, will not only have their narrow budget focus in mind when negotiating price, which will be a challenge.

In other countries you have more governments directly negotiating prices, which is still a difference, I think. They have their system represented in a broader sense in these discussions, and sometimes even beyond the healthcare system, when you think of the discussion currently here in the UK to integrate more a societal perspective. That may be more challenging in Germany, where you have just sickness funds taking decisions or negotiating prices.

Pharma IQ:Let's talk about the UK then. Some fairly big changes are happening with regards to the role of NICE at the moment, and with regards to how the HTA is going to be regulated in that respect. How would you compare what is happening in the UK to what is happening in Germany, with regards to value-based pricing and progress?

A Hebborn:One of the big differences here in the UK is the long experience. So there's a long experience, with very formal health technology assessment methods and procedures and institutions, and I think it's interesting to see that the system is able to constantly look into how it performs and how it does compare to, for example, the expectations of those that are served by the National Health Service, and that's quite different from Germany, where the tradition is not so long there, with HTA.

It will be interesting to see here in the UK how the very quantitative approach to cost effectiveness will ultimately be able to adapt to some of the political requirements towards the new value-based pricing system. So interesting times ahead, and I think it's good that this is a broad dialogue that's now about to be started with a first round of feedback that is to be collected in March.

Pharma IQ: Picking up on something that you just said, how much can HTA be tagged on to politics? Is HTA necessarily a political document?

A Hebborn:I think HTA is an important set of tools, methods, to bring facts to decision-making. It’s not about taking the decision or pre-empting decisions, which I think is often not so clear, but HTA means Health Technology Assessment, and so it should provide and should maintain and should develop a set of tools that identifies the value of technologies, but also, in the first place, tries to reveal the expectations of patients, of those that pay for a system, to bring information to the table of the decision-maker, without being the decision-maker itself, which is a challenge. NICE was initially, for example, understood as an HTA agency, and has later presented, and also understood itself as a consumer of HTA, so the distinction between decision-making and assessment hasn’t always been clear in this system, and it’s always a challenge. Some of the methods that were applied, if you think of formal cost effectiveness analysis, they have a very strong decision-making pre-empting element, and obviously appraisal committees, people charged with decision-making, they expect a lot out of the assessment process in this direction, so is the Health Economist, for example, saying it’s cost effective? Yes and no. While I think one would also understand, in most jurisdictions, and also theoretically, to quite some extent, this as a question that's not completely up to the assessment. You can assess a cost effectiveness ratio, but the decision if something represents value for money is a decision in a slightly different context, and that's a difference, I think, that's currently being played out. There is a proposal to introduce additional dimensions of decision-making, like societal preferences, innovation, and other factors, which are more difficult to formally integrate in a full, quantitative framework of decision-making.

Pharma IQ: When we were putting the conference together, you spoke to me about an ongoing project that you were involved with, called Swiss HTA. Very briefly give us a description of what that project encompasses, and what you are aiming to achieve with it.

A Hebborn: Like many other countries, also in Switzerland there is a debate to inform decision-making on technologies, on procedures on care in, for example, chronic diseases, with more formal input, with formal information, and that role is something that HTA, Health Technology Assessments, could play. And then the question is how to introduce it, and what happened in Switzerland was that somehow it was possible to form a stakeholder-driven platform to discuss key aspects of introducing health technology assessment in Switzerland, in particular to learn from experiences abroad in other countries. Certainly the discussion in the UK is very widely visible, or the discussion in Germany is certainly very visible in neighbouring countries, to jointly digest the experience there, and to bring it in the context of local decision-making. What is relevant? Which kinds of information does it need, to take adequate decisions in healthcare? And I think this is the basic idea of the platform: digest and ultimately digest the experience from elsewhere, but then to reach consensus between various stakeholders, physicians, government, sickness funds, on a number of key principles on how HTA should be introduced or should not be introduced, in Switzerland. The whole thing is quite transparent, and there is a website, which is called swisshta.ch, where some of the public workshops are visible to a wide audience.

Pharma IQ: I would definitely, to our listeners, advocate that you do have a look at that. It is very interesting. Do you think this could possibly be a template for the way things should be done in the future?

A Hebborn:One of the basic ideas of this project is to make HTA methods relevant for local decision-making, so I think it's not just simply possible to take the methods or the set of principles one-to-one to another country, but what is interesting is the climate in which these discussions were possible. It's the idea that stakeholders, including providers of health technologies, could meet and discuss actively, and not just reactively, to each other’s proposals about introducing a better information basis for decision-making. I think this is the interesting element, which, hopefully, is something that could and will be seen in other countries as well. In many countries we have seen the introduction of health technology assessment, or elements of health technology assessment, more as a series of conflict, which has not helped anybody to take more informed decisions about, at times, very complex technologies. So it's certainly a benefit also for an industry to ensure that its technologies and the value of technologies is understood in HTA, which should bring us in a more constructive, proactive format to the table of discussing what is needed, what can be delivered, what is reasonable, in terms of establishing health technology assessment in a jurisdiction.

Pharma IQ: Finally, Ansgar, why did you choose to take part in the HTA forum in London, and to what are you looking forward?

A Hebborn: Interesting discussions on one of the key subjects of these days here in the UK, but not only in the UK, but in Europe in many countries, where people introduce value-based pricing or value-based reimbursement or value-based decision-making, and that's sometimes called a little different in other countries, but it's certainly an interesting debate, where this conference will contribute, or we’ll see some interesting contributions. And then of course it's to meet interesting people, and see some other quite relevant speakers presenting their perspectives on the future of health technology assessment and decision-making, not just in the UK, but globally.