Are you curious about the current state of EU Health Technology Assessment (HTA) and the challenges it faces?

Wondering how upcoming changes will impact statisticians and the healthcare community?

Today, we tackle these pressing questions with the help of Stefan Walzer from Mars, an expert in market access and health economics.

Join us as we explore the need for agility and innovation in navigating these complex regulatory environments and discuss what these developments mean for the future of healthcare in Europe.

Key points:

  • EU Health Technology Assessment (HTA)
    • Current state
    • Significant challenges ahead
  • Stefan Walzer
    • Market access expert
    • Health economics
    • Over two decades of experience
  • European Joint Clinical Assessment (JCA)
    • Introduction and implications
    • Impact on pricing and clinical requirements
  • Healthcare Community
    • Agility and innovation
    • Navigating regulatory environments
  • Key Topics
    • Pressures on pricing
    • Clinical requirements
    • Future of healthcare in Europe

This episode provides crucial insights into the evolving landscape of EU Health Technology Assessment (HTA) and the significant challenges ahead.

Stefan Walzer’s expertise sheds light on the pressures on pricing, clinical requirements, and the upcoming European Joint Clinical Assessment (JCA).

If you’re involved in the healthcare industry or have a keen interest in market access and health economics, this episode is a must-listen. Don’t keep these valuable insights to yourself—share this episode with your friends and colleagues who can benefit from understanding these pivotal developments.

Tune in now and join the conversation on shaping the future of healthcare in Europe.

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Dr. Stefan Walzer

CEO, President & Founder at MArS Market Access & Pricing Strategy GmbH

Dr. Stefan Walzer has more than 15 years experience in payer strategy, pricing, health economics and reimbursement submissions and is the founder and general manager of MArS Market Access & Pricing Strategy GmbH based in Germany. He previously worked as a payer consultant for various global pharmaceutical and medical device / diagnostic companies, successfully launching their products across the world. Dr. Walzer was also the Global Payer Strategy Leader for various products and compounds of F. Hoffmann – La Roche AG, where he successfully developed early payer strategies as well as launching and maintaining the reimbursement process for top brands and early compounds. Dr. Walzer is experienced in the development of early payer strategies and the related evidence generation.

Furthermore he is also capable in translating the clinical and economic evidence into successful reimbursement submissions and pricing negotiations especially in Austria, Germany and Switzerland. Additionally he also teaches at the Master course of Consumer Health Care at the Charité in Berlin (Germany) and is a tutor in market access and health technology assessment at the State University of Baden-Wuerttemberg (Germany).

From 2018-2019 Dr. Walzer was the head of the committee “Inpatient care” of the German Health Economic Association (DGGÖ). Furthermore he is a leading member of the Special Interest group for Medicial Nutritions at the International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Dr. Walzer is also a member of the Austrian Health Economic Association (ATHEA) and the newly founded Swiss Health Economic Association. Additionally, he is also a member of the Access Advisory Committee of the Global Pneumonia Prevention Coalition.

Dr. Walzer received a Master of Science in Economics from the University of Tuebingen (Germany), a PhD in Health Economics from the University of Zurich (Switzerland) and a Diploma in Clinical Trials from the London School of Hygiene and Tropical Medicine (UK). He is co-author of more than 40 peer-reviewed scientific articles and more than 100 scientific abstracts.

Picture shows: Stefan Walzer


The Current State Of EU HTA: Large Challenges Ahead!

[00:00:00] Alexander: Welcome to another episode of The Effective Statistician. And today I have once again, Stefan Walzer here from Mars with me on the show. [00:00:10] Hi, Stefan, how are you doing? 

[00:00:11] Stefan: Very good, Alexander. Thanks for having me. And obviously it’s great to be back. 

[00:00:16] Alexander: Yes. So if you don’t know about [00:00:20] Stefan, he has been on the show already multiple times, has been part of conferences from myself, and so but still for [00:00:30] those.

[00:00:30] Alexander: Who doesn’t know you, maybe you can give a very short introduction on what you’re doing and where you’re currently up to. 

[00:00:37] Stefan: Absolutely. Perfect. Thanks. Thanks for that. So [00:00:40] I’ve been working in the area of Market Access Health Economics Pricing for more than 20 years. I was working in consultancy, have had as well, quite a good number of years in the industry.[00:00:50] 

[00:00:50] Stefan: And for a bit more than 11 years, I’ve been running my own consultancy. We have had. Bigger focus in the last years on the German speaking markets. So Germany, Austria, and [00:01:00] Switzerland, but nowadays I think also with all of those different language models and I, and AI kind of maybe just a height question mark, I think we have as well been moving a bit [00:01:10] more into, as we call it market access 4.

[00:01:12] Stefan: 0, but I think overall, and I think that’s probably what we have as well, but the the, the, the kind of a connection is for sure market [00:01:20] access is not only about, let’s say the economics of it. But it has a lot to do obviously with the clinical part, hence with statistics, with statistics, sorry, of [00:01:30] course, as well.

[00:01:31] Alexander: Yeah, yeah, definitely, definitely. And just scroll back in the episodes, you’ll definitely get some [00:01:40] insights about that, even though you might not work directly in this HTA area. So also if you work in phase one, two, [00:01:50] three, then you will definitely benefit from these things as well too. I don’t understand why certain things need to happen in development in a certain [00:02:00] way.

[00:02:01] Alexander: And that is actually getting more and more important. And that’s actually the topic of today. What is currently happening [00:02:10] within the EU HTA area? 

[00:02:13] Stefan: Yeah. I mean, I think we probably need to differentiate a bit, right? I think one thing is obviously what is happening in the individual [00:02:20] countries, but I think with also the kind of, let’s say difficulties around the economies, struggling economies, obviously, let’s say payers across those countries are looking [00:02:30] for cost savings, meaning trying to as well, bring further the prices down.

[00:02:34] Stefan: And the price is down obviously as well, always the question, how could you do that? Hence, they are also [00:02:40] trying to get even more strict. On the kind of requirements, especially from a clinical and statistical perspective. That’s one side, right? On the other side, we’re [00:02:50] obviously as well entering into a new era.

[00:02:52] Stefan: We will get into the so called European Joint Clinic Assessment which will start early next year. So it’s in the first quarter of next [00:03:00] year. And some of those indications which might be then launched after that, firstly need to go through that so called JCA which is especially oncology, rare disease [00:03:10] areas, the advanced therapy medicinal products, ATMPs, and also vaccines and antimicrobial agents as well.

[00:03:16] Stefan: So it’s a smaller kind of group. Interestingly, for me as [00:03:20] well, oncology, okay, I could maybe understand that it has a bigger kind of impact. But I mean, thinking about 18 piece and the kind of sample size kind of issues sometimes what you have, [00:03:30] it might get a bit tricky as well already on a pan European level before you would even enter into then the kind of real submissions, meaning the negotiations on a national [00:03:40] level.

[00:03:40] Stefan: That’s a current kind of, let’s say, big discussion, the hot topic probably across Europe.

[00:04:32] Alexander: Yeah, so European Union things are happening, so that means that does not [00:04:40] include the UK and England, which is nice, isn’t it? 

[00:04:43] Stefan: Exactly. Absolutely correct. I mean, due to Brexit, I think the UK is basically out of that component, [00:04:50] meaning, let’s see, the complexity might even increase when you are coming or when you are coming outside of the European Union, right?

[00:04:57] Stefan: I mean, if you are maybe US company and want to, let’s say, [00:05:00] concur the European let’s say environment, the different nations you have on the one side, you have the UK with the specifics on the regulatory side. And obviously then as well with UK nice, would you as well, just [00:05:10] said. As well with respect.

[00:05:11] Stefan: For example, the cost effectiveness, which is quite complex already. And then I think on the other hand, you have then the bigger European Union with now a [00:05:20] pan-European clinical assessment, firstly, which is then basically coming before you would need to submit still to the national agencies and some in some countries, even [00:05:30] on a regional and or local level.

[00:05:32] Stefan: So it’s getting, let’s say, a bit more complex potentially. We need to see, I think we still have a couple of question [00:05:40] marks. If potentially that kind of further layer might even make the life a bit easier, I think it could very well be, I think if we have spoken with some payers, [00:05:50] probably more from some smaller countries in the European Union with not so much manpower, for example, like Germany or France.

[00:05:57] Stefan: Then this could obviously help because then they would just [00:06:00] say, look, we wait for the European JCA, which is happening before their submission. And then we take that as a basis for the negotiation that could potentially speed up the timing until market [00:06:10] access, meaning a price agreement. On the other hand, obviously there are also, let’s say some critiques.

[00:06:15] Stefan: As people might just say, you know, it’s just another layer and you would still need [00:06:20] to obviously submit kind of further analysis, for example, for Germany, for France, for a couple of other important countries. And ultimately, if you maybe mix everything together, [00:06:30] why should maybe as well, the industry have an incentive to, for example, get an agreement with a small country, for example, with, I don’t know, maybe say Poland, which is [00:06:40] not so small, but still, let’s say smaller than, for example, France and Germany, maybe even with a lower price.

[00:06:45] Stefan: So I think the kind of order might still be the same as we now see, and that’s a bit the kind of [00:06:50] question mark. And I think it will be really interesting to see what is happening in the next two years. 

[00:06:54] Alexander: So just from a timing perspective, so what’s currently [00:07:00] happening is you more or less start with the HTA submissions around the time of the European [00:07:10] approval.

[00:07:10] Alexander: Yeah. So in Germany, for example it usually is a couple of weeks after, after the approval where you need to submit your [00:07:20] HTA dossier. How will that work in the future?

[00:07:24] Stefan: Well, that’s a very good one as well. At least a theory behind, right? Is [00:07:30] that, let’s say at the time of the positive opinion by the CHMP, companies should be able to submit the JCA dossier ready. [00:07:40] The reason for that is basically very simple. And you just laid that out with a different kind of timings, right?

[00:07:44] Stefan: If you want to be ready for national submission in at least Germany, for example, [00:07:50] very close to the actual approval, which is happening normally eight to 12 weeks after the CHMP opinion, you need to have the JCA dossier ready, let’s say those two, [00:08:00] rather three months before the actual approval already is being submitted as obviously also the agency, which is handling.

[00:08:06] Stefan: The the, the JCA on a European level needs as well a bit of time, [00:08:10] right? They need time to review, to give feedback, to finalize, to finalize as well a kind of recommendation, let’s say, that this can as well be used, and that’s the [00:08:20] idea, as a basis also for the national submissions. But this is then also a bit of the tricky question.

[00:08:24] Stefan: I mean, you as a statistician have been as well pretty much let’s say, involved as well in those early [00:08:30] stages, right? A lot is happening around, let’s say, the definition also of the label. And this is happening, let’s say, around the CGP opinion, right? So how could you really make Let’s [00:08:40] say everything ready, so close to the kind of actual submission of the JCA, meaning the actual kind of approval, not approval, sorry, the positive opinion [00:08:50] of the CHMP.

[00:08:51] Stefan: Everything’s happening basically around the same time. A lot of times this might not be an issue, right? This might just be small kind of changes, but just imagine the CHMP might [00:09:00] just open a subgroup. Instead of the ITT, which have been in the, in the trial, right? Or maybe they move a, a product rather in a later line or include a later line, which [00:09:10] might as well mean that you would need further analysis against additional comparators.

[00:09:15] Stefan: So that’s a lot of, let’s say, uncertainty around it. And that I think will be really, really interesting [00:09:20] to see how the industry, especially maybe smaller or mid sized companies will react to that. 

[00:09:25] Alexander: Yeah. Or maybe there’s only, you know so those will [00:09:30] depend on certain factors. Yeah. So maybe, you know, you have two doses in your study.

[00:09:35] Alexander: Yeah. And they say, well, we approve the lower dose for [00:09:40] these patients and the higher dose for these patients. 

[00:09:43] Alexander: Yeah. Perfect example. And then see, you basically need analysis, all the [00:09:50] analysis again, where you basically have two arms, so comparator, and then so to say a pooled [00:10:00] dose up, yeah? Where the, let’s say the lower weight patients gets a lower dose and the higher weight patients gets a higher dose.

[00:10:07] Alexander: Yeah. Imagine that might happen. Then you [00:10:10] would basically need to re-run all the analysis. Yeah. You basically need to be, you know, ready very, very soon [00:10:20] into agile with these kinds of things. Exactly. Anders, a fellow statistician on LinkedIn, talked about statisticians being [00:10:30] super heroes to achieve all these timelines.

[00:10:32] Stefan: Yeah, exactly. Exactly. No, I think you probably hit the, the, the. the right kind of [00:10:40] direction, right? I think everything would be super hectic probably around the kind of one, which it has been as well in the past, but I think the past is probably just Let’s see quite easy in [00:10:50] comparison probably to the to the near future if you want to still stick to those kind of let’s Say timelines you currently have used right?

[00:10:56] Stefan: Obviously, you can as well be a bit more relaxed If you just say we first do [00:11:00] the ctmp opinion then we prepare and submit maybe even four six eight weeks later to the, to the JCA, meaning that still they need some time to review. You get [00:11:10] the approval already somewhere between, then you wait for the kind of feedback and obviously then you just maybe further prepare the submission for the national agencies.

[00:11:18] Stefan: So it’s a bit of the question as well. [00:11:20] Just keep in mind, I think politicians or the idea of politicians on the European level in order to let’s say create that kind of GAC, what it was especially [00:11:30] also to to streamline the process in order to get the drugs faster to the patients across the various countries. If that will be achieved, I’m not really exactly [00:11:40] sure. 

[00:11:41] Alexander: Yeah. How far are we in terms of knowing exactly what needs to be submitted [00:11:50] and in which forms? 

[00:11:53] Stefan: Yeah, let’s put it that way. I think a couple of more question marks are probably Already a bit more answered. I think there’s [00:12:00] a template now available somehow, I would say, right?

[00:12:03] Stefan: For the dossier. I think at the last e spore in Europe, which was mid of [00:12:10] November last year, which is roughly five, six months from now, when we just speak. And roughly a bit more than a year before the actual JCA would come into effect. I think [00:12:20] as far as I remember, I don’t know exactly anymore the kind of exact number, but the feedback from some European responsible person was, yeah, you know, we have probably [00:12:30] already achieved somewhere around one third of the tasks we needed to do before the kind of actual launch of the JCA, which is to me a bit of a joke.

[00:12:39] Stefan: I mean, [00:12:40] you know, people, companies need to prepare and, you know, they just do it now within that one year. And I would bet that not everything is answered [00:12:50] when they try to launch it. If I would maybe want to say that in the first quarter of next year. 

[00:12:56] Alexander: So that means people can’t kind of [00:13:00] completely already now know, okay.

[00:13:02] Alexander: Yeah. Next year in 2025, we will need to do these kinds of different things. They don’t even know yet. [00:13:10] What they will be asked to fill in and what kind of formats on these kind of things. So you really need to be even more agile and more [00:13:20] flexible to then adjust to all these kind of different settings.

[00:13:24] Stefan: Yeah, no, absolutely. And you know, just, just as well, keep in mind, I think in most of the countries you also have [00:13:30] the opportunity to speak with institutions beforehand, right? Yeah. You have those early consultations, and this has just been put into place earlier this year together than with the [00:13:40] joint HDA, sorry, with the joint yeah, HA a kind of process with the GPA in Germany.

[00:13:44] Stefan: But keeping in mind as well, we already have a big backlog in the German assessment. [00:13:50] Let’s say process for the consultation with the GBA already, just with the general one, right? And you could just imagine they cannot just shift and put a lot of new people as well in that kind of process and just give a [00:14:00] small additional kind of feedback there.

[00:14:01] Stefan: So if you’re lucky, you have maybe already gotten a consultation on the European JCA level with the GBA. They do it on behalf, [00:14:10] right? If you’re unlucky, maybe you don’t have one now and you maybe plan a launch in early next year. It might get even more tricky, right? Because otherwise you get at least some kind of [00:14:20] feedback.

[00:14:20] Stefan: Even that, let’s say not everything is currently being planned for, it has been decided and knowing how the DBA let’s say personnel [00:14:30] is reacting. And I think that’s, that’s absolutely correct. They basically just tell you what is a hundred percent clear, a hundred percent defined in the various regulations.

[00:14:38] Stefan: If something is not [00:14:40] included there yet, they cannot give you an answer, obviously. So it’s not helping a lot at the end of the day, potentially. Right.

[00:14:46] Alexander: So at the moment, people really need to be [00:14:50] very, very agile. What are kind of resources that people should look out for kind of emails, maybe email [00:15:00] subscriptions, they should follow groups that should follow conferences they should attend. Where can people learn more from about the EU HTA process?

[00:15:09] Stefan: Yeah, [00:15:10] I think the most important thing is obviously, let’s say the European Commission and all the kind of related institutions around the JCA for sure, because they need firstly, let’s say, to do, to as well [00:15:20] define a lot of those kind of regulations, further templates, and I would also say further some of the processes even more clearly.

[00:15:27] Stefan: I think that’s, that’s, I think, number one. I think the [00:15:30] second thing is for sure, maybe as well check with some of the industry associations. I think they have as well, obviously, through their Kind of groups and kind of connections as well. [00:15:40] Sometimes a bit earlier one or the other kind of information for sure And finally, I think what I would clearly see I mean if I would be in the industry, I would clearly go to the ispo conference, [00:15:50] which is in november.

[00:15:51] Stefan: I mean, I could foresee that. Let’s say the vast majority of topics at that conference will be around the european jca. I think it was already a [00:16:00] lot last year in november But I think will be clearly not only the hot topic. It will be probably the You I don’t want to say only, but in a way it is the only kind of topic, which is really important for [00:16:10] most of the persons attending there.

[00:16:11] Stefan: So I think if you take all of that into account, try to speak, ideally still try to get maybe a consultation with the GBA to get some further [00:16:20] information, I think that’s probably the only thing what you can do. I mean, of course we all have information, let’s say experience from different other sources from, from different other [00:16:30] processes, but ultimately it’s not the one which.

[00:16:34] Stefan: has still to be defined within the European assessment. 

[00:16:38] Alexander: Yeah. In [00:16:40] November, there’s also another event that is happening. And that is actually not clashing with ISPOR and that is my conference. So at my 

[00:16:53] Alexander: Yeah. Anja Schiel already signaled to me that she will be there and she [00:17:00] sits quite directly in the center of all of that.

[00:17:03] Alexander: And she will definitely be able to, to update on that especially being herself a statistician [00:17:10] in that area. And she has been very, very informative in prior episodes on this podcast. And on other occasions [00:17:20] where she talked false. For example, also at the FSPI regulatory workshop. 

[00:17:26] Alexander: Either way, that will also happen in September in Basel. And. I’m pretty sure that at that time, there will also be discussions about that. I know from some of the organizers [00:17:40] of this workshop that EUHTA, like last year, will also be one of the key, key topics that they will talk about. 

[00:17:48] Stefan: Yeah, I think that’s a very good point, absolutely. [00:17:50] 

[00:17:50] Alexander: Yep. So, and by the way, regarding my conference, of course, you can just go over to the Effective Statistician homepage and check in the menu [00:18:00] for the conference and you can register there.

[00:18:04] Alexander: Now, you said this could be one of the [00:18:10] You know, or the only thing at the ISPOR, I think there will be one other thing. And that is a hot [00:18:20] topic that probably nobody can anywhere kind of avoid. And that is of course, generative AI. How do [00:18:30] you think generative AI will change how we approach H, HTA processes or how’s it already changing how we approach [00:18:40] HTA processes?

[00:18:42] Stefan: Yeah, that’s a very good one. Yes. I mean, as, as I said as well earlier, I think in my introduction, I think the, we are as well behind that, right? And I think [00:18:50] you, you probably mentioned a very important word, which is agility, right? You need to be agile, especially in those kind of even faster kind of processes.

[00:18:59] Stefan: [00:19:00] So I think the whole kind of, let’s say AI to me, I think will change. Everything would we currently do in market access in the next probably let’s say [00:19:10] two to four years Probably I think depends a bit how fast probably the industry is also adapting to that That’s I think to me the kind of key driver for everything But I think [00:19:20] when you just take the different processes there, right?

[00:19:22] Stefan: When you think about the let’s say kind of the the early planning of market access I mean you can already streamline a lot because Most of the information [00:19:30] is available, right? What we currently have done is basically spend a lot of time to basically streamline the information, put it into a good kind of frame, and explaining it.

[00:19:37] Stefan: But I think the, especially the first part, bringing [00:19:40] everything together, condense it, put it maybe in a kind of nice way that everybody, or at least the experts, can understand it, I think that can be probably done already. By a lot of those kind of let’s [00:19:50] say AI platforms or tools, which are available, that’s number one, right?

[00:19:53] Stefan: What we haven’t also discussed, I think a couple of months ago and probably continuously most also, let’s say a quite flexible system from a [00:20:00] statistical perspective, I mean, just take your example from before, right? If you have all of the data available and you have, let’s say, suddenly changed from the [00:20:10] CHMP, for example, I want only, let’s say a lower dose for one group and maybe a higher dose for another group, the data are there, right?

[00:20:16] Stefan: The kind of key issue so far was rather, okay, let’s go back to the [00:20:20] statistical kind of group, discuss it, plan the analysis, run the analysis, understand it, validate it, and then bring it back. Right. That is still the normal process, but I think if you can make [00:20:30] up a more kind of agile and more kind of easy to use platform and also plan for that early enough, Also, that one can streamline a lot of days, weeks, and [00:20:40] months to probably just a few hours, maybe a couple of days for sure, that this can as well be used then in that kind of process.

[00:20:46] Stefan: So you see already that you’re shrinking down as well as the kind of timelines a lot. [00:20:50] And what we have, for example, as well done now, we have now created a platform for dossiers. Where you can just upload the documents and then, which is then being pre filled, or pre-filling the [00:21:00] kind of different templates which are available just in a couple of minutes.

[00:21:02] Stefan: So also this one will help a lot when you just say, think about it, you’re approaching the kind of SHMP opinion. [00:21:10] Maybe this is changing their kind of mindset. Right? So you go back, get the kind of statistical analysis, maybe within a couple of days, get the statistical analysis in that kind of dossier [00:21:20] platform, get everything in there.

[00:21:22] Stefan: And then you are already in that kind of time frame where you can just still say, okay, now I submitted to the JCA. Yeah. Even think that further. Right. [00:21:30] I mean, the kind of time would you need now for the JCA dossier is also the kind of time would you then need for the national dossiers. But if you have an AI platform behind, [00:21:40] which can at least refill the majority of the dossier, then you can spend more time on strategy, on validation, on streamlining, all of that kind of stuff, which is still shrinking [00:21:50] your timeline tremendously down.

[00:21:52] Stefan: And this is just. Let’s say three examples, right? Not even thinking about what payers can as well do, right? Let everything checked in a much faster [00:22:00] way that you have a basis much faster So you could maybe even go into price negotiation a bit earlier That’s probably a bit more the future what I think but not not not as of now, right?

[00:22:09] Stefan: So you see a [00:22:10] lot of different applications Think about literature searches is the same thing, right? We spend a lot of time there in reviewing and analyzing and deciding and extracting data, [00:22:20] then further analyze it again, maybe do even a meta analysis, which takes months. And then we’re still not at the report level, right?

[00:22:26] Stefan: If we can shrink that down there and could it maybe [00:22:30] done in, let’s say two weeks and then write the report, or maybe even have a draft report ready by an AI, then we’ve done it maybe four to six weeks. 

[00:22:38] Alexander: Yeah. Yeah. I think [00:22:40] the the drafting of documents can be so much faster. 

[00:22:44] Alexander: And of course there’s a lot of kind of generic text in [00:22:50] there that can also be written by an AI.

[00:22:53] Alexander: Yeah. Exactly. So [00:23:00] I’m pretty sure that. Those companies that embrace that kind of technology and invest in that [00:23:10] will have a major advantage. So if companies, you know, I think kind of some of the big ones, they will try at [00:23:20] least to build it themselves. Yeah. But if people say, well, I don’t want to build that myself, there’s probably something better out there.

[00:23:28] Alexander: What should people do? [00:23:30] 

[00:23:32] Stefan: I mean, we did a screening. I mean, currently it’s not a lot out there to be, to be honest, right? I mean, there are, I think, four or five [00:23:40] platforms available where I know for systematic literature searches. I think there are a couple of more actually, but some are not, let’s say, promoting it really proactively.

[00:23:48] Stefan: So I would guess [00:23:50] we probably have seven to eight different. The systematic literature search AI platforms available. Some are a bit better than others, but I think at least they’re helping already quite a lot. [00:24:00] From a pricing forecasting perspective, there are also maybe a handful of those platforms available.

[00:24:06] Stefan: Most of those still rather small, and I think it’s still tricky to [00:24:10] really forecast the price, especially if you have something very new in your hand, but at least the kind of basis. I think can be done quite fast and you can as well react to different requests. Maybe also internally, right? So [00:24:20] those are probably let’s see pieces.

[00:24:21] Stefan: I would look out for the dossier we currently have on our own on the I mean I know that some companies are as well industry companies [00:24:30] are as well trying to develop it as far as I know what I have heard now, it is poor. They are also not yet there, but also there it’s probably a bit of the question of the expectation, right?

[00:24:39] Stefan: If you’re [00:24:40] looking for 80, 90 percent ready to see, I think we’re probably not yet. They are even with the kind of platforms and tools available yet. But as you said as well, to draft something, maybe the 50, the 60 [00:24:50] percent of the work, which is being done beforehand, I think that is already saving the three, four, five, six months of, of time, right?

[00:24:56] Stefan: So that’s, I think a very important component. And then I think everything around [00:25:00] it. We need to see but I think you can probably streamline everything but also there I think when at least thinking about the market access their area. I think the the statistical [00:25:10] one is obviously an important one It’s probably something to really watch out at probably the next two or three years sports I think there will be a lot coming out there and people speaking about it.

[00:25:18] Stefan: People are thinking at least [00:25:20] about it Some are still developing it. As you said as well, some are just using it maybe from somewhere else I think we have this all learnings from other areas You I mean, and that [00:25:30] kind of, let’s say overall areas just developing so fast. I think you have every, let’s say three, four, five months, you have something new, right?

[00:25:37] Stefan: Just earlier this week, [00:25:40] I just learned as well. I think you can basically have a, a, a, a, a speech and have your AI translating it at the same time to different languages, right? You don’t [00:25:50] need a translator anymore, even in Chinese. It was so great to see. It was just, oh, wow. So, you know, and then, you know, with that, I mean, you can probably do a lot, right?

[00:25:59] Stefan: This is just one [00:26:00] small kind of example. I’m not even thinking about, let’s say, different, I don’t know, statistical kind of analysis, which could probably be done as well from various angles. [00:26:10] 

[00:26:10] Alexander: Yeah. And so if people want to learn more about this please reach out to Stefan. Yes, he is he can definitely help with lots of these [00:26:20] different things and he’s working on these, these kind of different tools for himself.

[00:26:26] Alexander: And so reach out that will [00:26:30] definitely make your life easier. And this. actually quite frightening situations that we are facing, you know, with lots of, lots [00:26:40] of uncertainty coupled with very, very short timelines. So it will be very, very interesting. I’m, I’m kind of glad I’m not responsible for one of these [00:26:50] dossiers.

[00:26:52] Stefan: Yeah, yeah, yeah, yeah. Of course. I think that’s Yeah, I think if you’re responsible for that and you, you just get the timelines, right, do it. And this is the timeline. And [00:27:00] then obviously commercially is behind you. Clinically is behind you and regular chairs basically delivered. So I think it’s getting really, really even more tense, especially also in that area.

[00:27:09] Stefan: And [00:27:10] at the same time, we still, let’s say, have a scarcity of resources as well, right? Or manpower. So it’s a mix of everything. Which might [00:27:20] even let’s say get into a direction either that some pieces are delayed, submissions are being delayed, and or maybe the submissions are not at the highest quality.

[00:27:27] Stefan: Both are not good for the [00:27:30] success of companies. 

[00:27:32] Alexander: Yeah, yeah, absolutely. So, thanks so much, Stefan, for this awesome episode where we [00:27:40] talked about all the different things that are happening around the EUHTA process, where we are now that, yes, there’s some movement, but there’s still lots of, [00:27:50] lots of uncertainty.

[00:27:51] Alexander: We looked especially into the complexities around the timings which will be really, really challenging, especially with the. [00:28:00] Uncertainty around decisions from the regulatory side, and we also talked about which indications will be [00:28:10] first most affected, like oncology, rare diseases, and that there’s a couple of different occasions, including also my conference and [00:28:20] ISPOR in November of 2024 that will definitely be good places to attend. Thanks so much, Stefan. 

[00:28:28] Stefan: Thank you, Alexander, for your time. [00:28:30] Thanks for having me and thanks for the good discussion. 

[00:28:32] Alexander: And I’m sure this won’t be the last one. [00:28:35] Stefan: Absolutely. Thank you, Alexander. [00:28:40] Bye.

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