Interview with Dr. Stefan Walzer
What is a DIGA?
Why is Germany so important for DIGAs?
Nowadays, there are a couple of available apps being used in several countries that collect user information, such as heart rate combined with algorithms that calculate certain health risks that the user may be vulnerable to. What differentiates these apps from the apps listed in the DIGA registry?
In today’s episode, Dr. Stefan Walzer and I discussed the goal of the Digital Health Application.
Stay tuned and listen while we talk about the following points:
- What are some of the risk classifications?
- How does the process work to get a DIGA on the list of reimbursed?
- What is required to get a DIGA on this list?
Listen to this episode and share this with your friends and colleagues!
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. Furthermore Dr. Walzer is the Editor in Chief of the German Journal of ClinicoEconomics (www.germanjournal-clinicoeconomics.de) and the lead author of the book chapter “Vergütungshöhe und Preissetzung” [Reimbursement value and pricing] in Business Planning in Health Care (http://www.springer.com/de/book/9783658081850).
DIGA at BFARM
Dr. Stefan Walzer’s podcast: https://marketaccess-pricingstrategy.de/en/map-podcast/
Alexander: You’re listening to The Effective Statistician Podcasts, a weekly podcast with Alexander Schacht, Benjamin Piske, and Sam Gardner designed to help you reach your potential, lead great science and serve patients without becoming overwhelmed by work. Today, I’m talking with Stefan about apps on prescriptions paid by the government.
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Welcome to another episode of The Effective Statistician, and today I’m talking with Stefan Walzer. Hi Stefan, how are you doing?
Stefan: Hi Alexander, very well. What about yourself?
Alexander: Very good, It’s a rainy dark December morning.
Stefan: Yeah, it’s happening here, but it’s still quite darkish I would say.
Alexander: We are talking about topics that are pretty new and I think it will be really important for the future. In other areas, I think this digital landscape has already reached many different things. In our Healthcare, regulated healthcare environment, it’s something pretty new. I think it’s because of all the regulations, there’s always a little bit of a slower move here, but before we dive into this let’s introduce yourself first. So, what’s your background? How did you get into Healthcare?
Stefan: Yes, perfect. Thank you, Alexander. I mean, thanks also for inviting me to The Effective Statistician. I’m actually an economist. I liked to have statistical courses a long time ago, obviously, but from my background, I’m an economist. I have a Ph.D. in health economics and also a post-credit diploma in clinical trials. So I think that was probably the kind of path already bit into Health and Health Economics, but at the end of the day, it was really the kind of path that I was starting consultancy where I was working for the Pharmaceutical Industry for Medical Device Parts, we are doing quite a lot of modeling to health economic modeling, obviously, in those days, it was primarily for the UK, which I think they were always the forefront before I was then moving, let’s say into more probably more strategic roles when I went into the Industry. And since now roughly nearly 10 years, I’m running my own company. We’re focusing on the german-speaking markets and here really broadly for Pharmaceutical for Medical Devices. And obviously, I think the topic we’re in today, as well for digital Health applications, even though I have to say, DiGA, which is, I think today the topic is just one part of the Digital Health Solutions, right? There are also other parts of Digital Solutions, which might not be part of the definition of the DiGA but that’s also what we for example cover.
Alexander: Interesting. Yeah, so you just already mentioned the word DiGA which is an abbreviation for a German word. So what is DiGA actually?
Stefan: Yes, a very good question. At the end of the day, I think you also I think pointed out already. It is an abbreviation of a German word, right? It’s Digitale Gesundheitsanwendungen in German, which I think can be translated like a Digital Health Application. But that last word, the application is sometimes a bit misleading, right? It’s not always about apps. I mean, we always have a lot of discussions, questions. Do we need to have an app in order to be a Diga? Which is not the case, right? I mean, that’s the definition and an app could be. But you could, for example as well. Let’s say develop your DiGA as a let’s say using a functional something that you can just access via a browser. But at the end of the day, I mean we have a different part of the definition, I think the very first one is coming from the regulatory side, which is you need to have a certification obviously and it needs to be medical device class 1 or 2A, that’s really very important because at the end of the day depending which digital Health Solution you have, you might also end up in a class 2B right? Which is then not the DiGA pathway to get reimbursement in Germany. But that is then another pathway which leads directly through the joint Federal Committee in Germany, the GBA, which then the method of operation is not part of our discussion today, too complex, and complicated.
That’s the first one, right? So it’s just class 1 or 2A, so you need to take that box. If that is ticked, then the second point is…
Alexander: Let’s stop there for a moment. So what are Class 1 and Class 2A?
Stefan: To make it really simple, it basically just says that, let’s say the risk classification is quite low, right? It is not harming the patient to make it very simple, right? They’re very specific definitions of that. I’m not a regulatory expert but mean, there are very specific definitions and that’s where you can then classify that. The more you’re going up 2B and 3. I don’t want to say you can endure, let’s say you do automatically harm the patient. I mean, that’s not the case, right? Same when we speak about drugs, right? There are side effects, and let’s say complications maybe, but that’s not saying that you’re harming the patient, right? But, that’s a given risk behind and that’s what you need to take into consideration when you think about risk classes for medical devices. So the lower the risk in a way, obviously, the more you have than the kind of definition of a risk class 1 or 2A.
Alexander: Okay, so if I think about Medical Devices that are riskier would be kind of stands or things like this, more invasive stuff, and not something that has a browser or app for things like these.
Stefan: In general, yes, but I think what we need is to keep an eye on for example, going to artificial intelligence or so, where you say you have a program, which might have an impact and effect on a recommendation what to do with the patient, right? In terms of treatment. It also goes up in terms of risk class right? Automatically, you just say there might be an impact on the patient. If it’s rather something like you’re calculating, there may be a probability of a progression where you just say, please go to your doctor and get an appointment and the doctor will further check, then there’s always that let’s call intermediate. Right? Which is the physician before the next treatment step arises. That brings obviously the risk class again, but down.
Alexander: Yeah, so that is interesting. Let’s talk a little bit about what would be the aims of such applications? I think there are a couple of different areas that this could play in. It could be a kind of help or maybe even provide diagnostic decisions. I guess it can help with monitoring the severity of the disease or side effects or things like that. It can help you, as you just said, trigger certain kinds of monitoring discussions with Physicians. Are these the typical areas where these things will play a role?
Stefan: I think you have probably already mentioned a lot of those areas, absolutely. I think monitoring is the first thing that probably everybody has in mind, right? If you have a disease and you basically can, let’s take the simplest case. I mean, we all know the Apple watch, right? And they can now as well collect your information on blood pressure or the heart rate. If you take that and combine it with an algorithm that could calculate let’s say risk for heart failure, etcetera. This would be as well an application, right? But you just say that’s a collection of data. Then there’s a digital component of it, which is calculating the algorithm behind it. And then there might be an alert, right? Which could be on your watch, could be with the caregiver, which could be even with the Physician, which might be a bit tricky. Speaking about DiGAs, this is the kind of ultimate pathway. You’re totally right, I think not to forget we have quite a good number there called psychoeducation, right? I mean, it’s very clear what to do in which ways etcetera, and there we have already as well. Different DiGAs are available. Also in the Insomnia area, for example, and a couple of other quite interesting areas where we also know that there’s quite a good development. But in general, you’re totally right. As you described it, I think these are probably the areas where most of the developments at least I think are currently being done for DiGAs and beyond DiGAs.
Alexander: So it could also be that a DiGA is not only the diagnostic and kind of measuring but it could also be some form of intervention. Yeah, so that it’s kind of, as you say, psychoeducation, or maybe some intervention in terms of Insomnia things like this. But plays music that helps you get asleep faster or helps with the lighting in the room whatsoever. So there are all these other kinds of things that you could think of as well.
Stefan: Exactly. No, absolutely. And I think probably the most prominent one is, let’s say working in the area of depression, for example, right? You just covered that, right? It could also be a therapy, right? It always depends, however, what the underlying, let’s say, rationale is, we always need a scientific basis for that. I think, as long as you could, for example, translate let’s say, a therapy, which can be mimicked in a way from a physical person. So from a physician or therapist into a digital application, then it could also be therapy, absolutely. I mean, everything else is probably more. We need to be careful with the word monitoring, right? Because monitoring might go already to a Class 2B or at least could end up in a tool for the physician which is just in the definition of DiGA and it’s to be used by the patient. If you’d rather have a physician tool that could be seen with most of the monitoring, then it’s no more DiGA as well. So that’s also where I’m a bit careful to use the word “Monitoring” but in general, I agree with you.
Alexander: Okay, and now this one really interesting thing and that is the kind of German specific situation, which I think is pretty unique. So what’s so unique about Germany?
Stefan: Yes, I think interestingly we even have, let’s say, press coverage across the various countries. Also the U.S. The U.S. Is also looking now into Germany on how they really implement Digital Health solutions. I think this week there was a title in this Swiss newspaper, kind of watch out for Germany. They are overruling and getting up to speed in terms of Digital Health. Which was very interesting to see when you just compared it two years ago. Right? Well, I think it was at least seen as a bit difficult, but just coming back to your question. What is so unique, right? I think it probably has different components. First of all, I think, the most important thing and that is probably what I would say, the system has also learned from the pharmaceutical process I would say, is that the product could be available to let’s say it’s registered within the so-called DiGA registry. So it’s one pathway, you go to the so-called BfArM, which is the registration body, you basically show them what you have in your hands and they apply the rules. So especially the definition for the DiGA, right? I mean if that all applies and you have as well, at least a kind of proof of concept I would say for the DiGA then you would be included at least preliminary into that DiGA registry. And from that moment the DiGAs included in the registry, could be used by the patient, and importantly it’s even being reimbursed by the insurance funds. I think this is probably a very unique situation, but that’s the first one, right? Because you could just say first it is preliminary, but secondly, I just said it’s proof of concept why they only approve, right? I mean, it’s just too simple in a way. No, no. What happens then is that the BfArM in the system basically allows the DiGA companies to develop within a timeframe of 12 months, to develop the evidence to space. let’s say the evidence to prove your concept in a way, write the proof of concept, but while you already have reimbursement, and think this is a very unique situation. All right, I would say a bit more than an idea, you have shown that it works, then you can go on the market. You get the money from the house insurance company at the same time, you basically develop your evidence in order then to be registered finally, and permanently into the DiGA registry. I think this is probably the kind of combination of uniqueness.
Alexander: That is really interesting because it means that you can gather real-world evidence data during these 12 months of preliminary approval to collect much more kind of information on how it works. Yeah, user experience, all kinds of different things to go back to the regulator. So that makes it very unique and also very different from Pharma approval. Yeah, only after you have proven that it works, is safe, and is high quality then it gets reimbursed.
Stefan: Yeah, I think I would say exactly, but we need to keep in mind, real-world evidence could be a component of your evidence package, right? You need to be sure, depending on what you submit obviously, the BfArM will, as well, unless he needs to agree with you on the final evidence package, and that means only it needs to still be let us say comparative, right? It could be in a real-world evidence area that could happen, right? But I think it’s important that they want to have as well, the evidence obviously, the German environment and within the 12-month period, which is sometimes a bit difficult. We had a discussion, for example, on let’s say in the area of Asthma. And obviously, if you think about those kinds of events, but see the exacerbation, etc. They don’t really happen so often, if they do happen, it’s very severe, right? But if they don’t happen then, so or rather say, a more rare event. So you need much more patience there. So how do you do the power calculation? How could you redo that in 12 months, right? And also at the same time, do not have hundreds of different sites and study sites based in Germany right? Because you need to have German data, why? Because the DiGA is basically communicating with the patient, right? So, you have it in writing, or a video, or whatever else in German because it jumps patients. So that’s also one of the difficulties, right? If you have proof, for example, by randomized control trial somewhere in the US, or in France, or somewhere. You just need to prove to the BfArM that this is really transferable into the German contact with a lot of discussions, especially the very early beginnings and a lot of times it’s rather more. I, you know, that language, validation.
I think the BfArM is also changing. I think they’re getting a bit more pragmatic, used to the cases. But it’s not that easy, but I agree with you that it’s at least very unique. But that’s again going back to what we had a couple of minutes before in the risk class, right? The lower the risk class the less likely you harm patients. And so the more you could as well go with such a pathway.
Alexander: Yeah, that’s interesting. So that means that either way you get into the registry the first time, you need to have a very clear plan already. Yeah, so to make sure that you can meet the 12 months timeline, for refiguring adults are, after is probably a bad idea because 12 months can pass by pretty fast.
Stefan: Exactly. I think that’s also what the BfArM tells you when you go to consultation, which is also a possibility, right? You could even discuss with them in detail, protocols. I’m with you, I think the time when you are part of the DiGA registry so that you launch in a way, right? That’s where the latest DiGA study. If you need to prove that I need to stop because 12 months is a really short time period at the end of the day. Important, maybe a quick asterisk in there. You could let sit or prolong during that period, not only at the start right? You cannot just say, you know, I take six months longer, please approve it, that’s not possible. You need to plan for 12 months, meaning in the 12th month, the data and the new application need to be with BfArM, right? This does not mean January to December is the trial, then you do the analysis, then you do the report, then you submit. No. This needs to be all put into those 12 months, but you can expand it for the first three-month period. And for a second, third month, period as well in exceptional cases, so you need to explain why right? Difficulty in recruitment. I mean, cover it. It’s probably already an old story, but, you know, those kinds of things, right? I mean, sorry, we have already 80% recruited, we need another three months. That’s not an issue, right? But you need to plan it ahead of time. And I think that is very important as what you have said.
Alexander: Yeah, so when we dig a little bit deeper into the requirements, if I think about a diagnostic tool, then I need to show how this diagnostic tool works in real life. Is there some kind of gold standard?
Stefan: Yes, exactly. I mean it probably has different components, right? Because it is digital, you also have all of those IT requirements, which is quite a lot, right? I mean, IT security, IT safety, data security, whatever else. I mean, it is quite a lot of stuff as well as the company to think about it. Somehow this is also unique to Germany, and we’re seeing that with a couple of companies, they already had a product and other countries, and they had sold to change it at least in some components, in order to meet the BfArM I requirements. I think that’s the first part right? The second part is if you then have your product and you need to support think obviously in to show how this obviously compares against the German. Let’s call it standard of care which is maybe a bit different also to the Pharmaceutical area. But, a lot of times you have another drug or so. I mean currently, you could probably end in some cases just look for those patients who don’t have a digital application yet. So we just compare it against patients who do not have that, it’s kind of a placebo, right? What do you always want me to think and have in mind? I think that’s also where you probably have a good background. I mean, a lot of times companies are also running crossover trials, where that object is falling towards recruitment, right?
I mean, how do you want to satisfy patients if they say, Yes, I agree, I attend to or let’s say, I jump into the study and I see obviously because you can apply it, right? I mean you cannot just have a placebo DiGA, you have either the DiGA or nothing. So what is the incentive then for the patients who do not get the DiGA to stay in the study, right? So that is why a lot of times that crossover comes as well to affect, you could also get saved. We only analyze the first part, right? But that’s just for all the discussion with the BfArM, also from a methodological perspective, how do you best do that right?
Alexander: Yeah, with crossover trials, you can have all kinds of different complexities. And one of the safest things is just looking into the first period. Yeah. And have that power appropriately that maybe you don’t need the second period.
Stefan: I would go with that. Yes.
Alexander: Okay, very good. There are a lot of references already that you can use to learn about these and also which is nice. Lots of these are provided also in English, so not only in German but also in the German BfArM from the German regulator you can learn about these things on the respective home pages and we’ll link these in the show notes. There’s one other resource that I would like to mention as well. And that is Stefan’s podcast that he is also running for some time. Tell us a little about this and what’s the target audience? And what’s usually the content?
Stefan: Yes. Thank you, Alexander. The podcast was born out of the idea that we got a lot of times. Let’s see obviously very similar kinds of questions around Market Access, reimbursement, pricing, Health Economics. A lot of times people as well, just say we trust you because we have known you for a long time, but it would still be good to have maybe the opinion of one of the other stakeholders within the system, right? And that is where we started quite, let’s say lower based in a way, and where we had the first discussions with different experts. It’s almost in the area of Market Access out to the economics pricing. It’s not always in Germany or Switzerland, Austria will obviously take our heads on. I mean we have also, for example, upcoming episodes for Digital Health Applications in the US that will have a kind of discussion with the Canadian expert, where we just compare the upcoming U-joint HD assessment with the Canadian system when they integrated that. But we have obviously as well because we have just discussed the DiGA pathway. We have as well had for example discussions with responsible persons from the BfArM, which are just currently in the making. Also with the current head of the arbitration Board of the DiGAs. He’s also the former head of the AMNOG Arbitration Board, but I think that you could probably really get quite some parts out of it. We have small more General episodes, which is maybe going to negotiations more, where I think you can as well, get quite a lot out of it, even though a lot of that experience when we had the discussions is based on our drug experience, but the frame, when you have a look on the DiGA price negotiation frame, and the frame for the drugs is very similar in Germany, right? So, I mean just watch it out. I mean, the name is a very simple MAP map Market Access Podcast and it covers a lot of different areas. But especially obviously for Market Access Health Economics Pricing.
Alexander: Yeah. So for all those Statisticians that work more in the later phases of the development and want to learn a little bit more about how to launch a product. Not just getting it approved, but actually, bringing it to patients and making sure that it’s covered through the different systems around the world. Check out this podcast to learn more about these kinds of things, and listen to stakeholders say, live and breathe this kind of system.
Thanks so much, Stefan, that was awesome to have a discussion about Digital Health Applications, specifically to Germany. And I’m pretty sure this topic will be becoming a more Hot Topic in the future as well. There are so many possibilities and opportunities. And as you said there are a lot of other countries that look into what is happening in Germany and potentially, copy and adapt from Germany. So that will be interesting to see in the future.
Any final Learning said he would give to the listeners?
Stefan: Yes. I think it is very important, probably, whoever wants to come into the German DiGA World in a way. I think that’s quite a clear plan for your submission in your Market Launch. It sounds so simple but probably consulted early on by BfArM. You can even do that in English. I think you just mentioned that that’s a big difference to the drug area as well. You can submit your consultation request in English, you have the consultation meeting in English, which is much easier, especially, when we think about companies from outside of Germany. That’s the very first and most important, listen carefully to what they tell you. I think when you run your clinical trials, I think it is probably for, I guess most of your listeners as well. Probably call it a no-brainer that you have a protocol. In a statistical analysis plan, we had companies where we needed to explain in a clinical salary report. This is mandatory, I mean, how else could an institution really check what you have done and interpret the results carefully. So these are probably the two most important learnings that would say, one go and listen to the BfArM the institution there, speak with them and discuss with them. And the second part, if you can run or if you have already studied, please have your documentation up and ready. I think those are probably the most important things.
Alexander: Awesome. Thank you so much Stefan and stay tuned to learn more about Market Access through his podcast.
Stefan: Thank you, Alexander.
Alexander: This show was created in association with PSI. Thanks to Reine who helps with the show in the background, and thank you for listening. Reach your potential, lead great science, and serve patients. Just be an effective Statistician.