In this Podcast episode, Dr. Stefan Walzer is reflecting on 1 year DIGAs

with the leading question whether the "fast track process" for digital health applications is successful?

Additionally, the two digital health experts, Prof. Dr. David Matusiewicz from the FOM Universtity and Dr. Anne Sophie Geier from the head association of digital healthcare SVDGV, will also discuss the status of digitalization in the German health care system.

Get into the latest digital health care discussions and let us know in case you might have any questions.

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For more information about MArS Market Access and Pricing Strategy visit: marketaccess-pricingstrategy.de

Dr. Stefan Walzer: Welcome to MAP, the bi-weekly Market Access Podcast provided by MArS Market Access and Pricing Strategy, which is your healthcare consultancy in the German-speaking markets. MArS makes it as easy as possible for you to get your pharmaceutical, medtech, or digital health product to the market, and of course, get the price it deserves. My name is Stefan Walzer. I'm the founder of MArS and a health economist by training and working in the fields of market access, reimbursement, pricing, and health economics already since 2004. Now let's learn about the market access and reimbursement systems around the globe. Digital health applications or generally digitalization in health care in Germany is obviously a very broad spectrum. In 2020, health care decision-makers have just implemented the so-called DiGA pathway. DiGA is basically the short abbreviation for Digitale Gesundheitsanwendungen, which is then DiGA.

Dr. Stefan Walzer: For that, the decision-makers have implemented a new pathway in order to get into the system into the regular care reimbursement as well, given two different core components. First component is quite clearly that companies would need to apply to be included in the so-called BfArM registry. That is, first of all, the registrational body which is taking care that all of the IT security, IT requirements are fulfilled, plus the fulfillment in order to have a patient benefit. For that patient benefit, you have basically then also two different directions. One is that you have already a full evidence package, which means that you are evidence-based. What you have should normally be a randomized controlled trial within the German-speaking markets, so ideally in Germany, but also Switzerland and Austria is basically accepted. That's what we have seen so far. Or that you basically have a hint that there's a patient benefit and that you have done as far already a clear evidence plan how to create that evidence within the first 12 months after you are included preliminary in the BfArM registry.

Dr. Stefan Walzer: Once the companies, better said DiGAs are included in the BfArM registries, those DiGAs can be used, prescribed by physicians, used by patients, and need to be paid for by the health insurances. Once the whole DiGA is then included permanently in the DiGA registry, there are then the price negotiations, which are then happening between the health insurance funds, the head association there, similar to the AMNOG process for drugs, and the companies. There are now a couple of opinions also how this process would really work. I think some, especially from the health insurance side think, ah, prices are still too high. The BfArM was maybe not strict enough. Others, for example, some in the industry think, ah, works quite well. It's a fast process. Other opinions, for example, also out of the industry just think, ah, we're still too complicated.

Dr. Stefan Walzer: Let's just see and listen what two core experts and stakeholders within the German system think about it. One is Anne Geier. She's at one of the core associations, the Spitzenverband Digitale Gesundheitsversorgung in Germany. She will report back what she has also heard and learned from her members in the first year of DiGA. Then secondly, we have also Professor Dr. David Matusiewicz. He is a key expert and leader, as well key opinion leader, in terms of digital health and digital health transformation in Germany. He's also the Dean and institute director of the FOM Hochschule in Germany. Let's just see and listen what they think about the first year of DiGAs and where Germany might go in terms of digital healthcare.

Dr. Stefan Walzer: Welcome, and thank you also for joining our podcast on Market Access. This time, one year DiGA. I think we can directly jump into the first question where I also think we probably get really the interesting insights from an association's perspective. What is your takeaway from one year DiGA from an association's perspective?

Dr. Anne Sophie Geier: First, thanks for having me. To my mind, we are still at a divining point in Germany. Strong concerns about privacy have long hampered efforts to digitize health care, but we have the chance to become a pioneer, which we are actually with the digital health applications. After one year, I can say DiGAs are part of the daily reimbursement routine, but is it still at its full potential? No. I think we still need to inform doctors and psychotherapists about this new type of therapeutics. We also need to establish some more important elements to make the whole process for patients and doctors easier, for example, such as the electronic prescriptions. For example, information-wise, as an association, we have built up a platform for CME-certified classes for doctors and psychotherapists. There, they can inform themselves about the whole reimbursement process, so everything that's connected to DiGA. In general, I can say I'm happy that we have DiGA now for one year in the routine healthcare system, but there's more to do from my perspective.

Dr. Stefan Walzer: I think that's obviously a very important point. Maybe just another question because you mentioned the physicians. I can obviously foresee that especially the companies in and around the associations, but also generally in Europe, I think see the reimbursement process with the DiGAs obviously as a core benefit, and I would fully agree with what you said as well beforehand. Do you see that physicians are also ready to prescribe DiGAs? We have now already a couple of DiGAs on the market. I think it is already a good success, but are they also ready to really use it?

Dr. Anne Sophie Geier: Yes. That's a very generous question. Some are, some are not. Like with every new process, and this is new for a health care system that exists for such a long time, one year is not a long time frame. As I said, in our webinars, we actually see a lot more physicians listening and coming to the webinars and being interested. We would definitely see it like a curve, increasing curve of interest. Have we reached everybody out there? I think this is also unrealistic, right? I think we are on a good wave. All physicians, at least, that we have spoken in our webinars, they are well prepared to prescribe a DiGA.

Dr. Stefan Walzer: That's also good insight. Moving a bit further, what are the benefits of the DiGA process? If you could quickly maybe describe it, but also obviously just probably focus a bit on the benefits from your perspective and also especially maybe in the areas where you don't see a benefit or maybe still some hurdles. I think you also mentioned that there are still some things to be changed or a movement to go. Where do you still see improvement in that process?

Dr. Anne Sophie Geier: First, I want to mention that the procedure itself, designed as a fast-track process, which means that within a three-month period, the BfArM assesses the DiGA and decides about the listing in the directory is, a big chance, because that means you can plan ahead as a company, and you know your time schedule better than you did in the past, where it was really hard to get reimbursed in the statutory health insurance at all. Actually, it's a challenge. The assessment includes 120 criteria that have to be fulfilled such as information of our product qualities, data protection, user friendliness, and the examination of the evidence of the positive health care effect. There, we have learned that this is a challenging part of the BfArM process. When I think in improvement, we have already some new rules coming into practice for the new law from the BMG, from Jens Spahn the DVPMG. For example, there are new rules about data security.

Dr. Anne Sophie Geier: My advice would be, specifically regarding the BfArM fast track, let's give this process a little bit more time and not start to change the next thing again. Because more importantly, for the manufacturers, it's the point that they know exactly what to do after meeting the BfArM, that they have continuity in the decisions of the BfArM, because this creates trust, and you can plan accordingly. I would say the whole process is good how we have it. Let's stick to it a little bit and see where it brings us and look at the rules that we have established are actually followed by everybody.

Dr. Stefan Walzer: That's I think a good point. I think the learning process and the learning system is good. I would agree maybe it's best as well to have already establishing at least some of the processes before changing. I would agree. I think that's also a good point. We're still obviously waiting for the frame for the price negotiation, which is still not yet 100 percent agreed on. Maybe besides that, I have spoken also with different persons from German payer organizations from the statutory health insurance funds. Some might even be a bit provocative and just argue that DiGAs might just be a hype and will be gone in a few years' time. How do you see that?

Dr. Anne Sophie Geier: I think that this won't be the case because DiGA have some big advantages. They can be used anytime, anywhere. This flexibility is something that not only young people appreciate, and especially because too doctors and patients have proved more open to trying digital healthcare products and services during the pandemic that we still have. DiGA have some other big plus. They have a very high standard of data protection. Once patients are aware of this, I think they would trust their DiGA more than any other not regulated app, for example. Actually, I'm very positive that DiGA will stay in our healthcare system.

Dr. Stefan Walzer: I would also agree with that. It just more obviously getting a bit of the provocation, which we might also face. Maybe this is also a bit more going to the direction of what some health insurance companies already argue, also in the public domain, that the prices, at least from their perspective, seem to be too high, but let's just see. I think this is probably as well the process to go. You have probably as well a couple of startup companies within the association. If you would be able to directly speak to a startup company maybe outside of Germany, which are the three core items you would maybe recommend what they should do in order to be successful in Germany?

Dr. Anne Sophie Geier: That's a good question. For one, I would say know your value story well in advance and plan your evidence generation accordingly, because this will help you then in the whole process of BfArM and the negotiations with the statutory health insurance funds. Then I would say, secondly, information of doctors is key, but not easy. That's what we have heard from all companies in our association. Then think in advance and try to find your ways with just your present channels you can and will use, and be probably also innovative there. Third, I think the extension from all this with other companies is crucial. We have learned in all our groups and channels, we work with Slack at the association that it is really helpful to get the right information fast and chat with others about their experience. This would be my three advices, what to do to be successful in the German market.

Dr. Stefan Walzer: I think that's good advice, especially with the last one. I think exchange of ideas, recommendations, learnings, et cetera, which might be really helpful. That might be maybe also different to established pharma companies, I would guess. Go a bit further international maybe as well. Have you been approached as well from other countries or maybe associations from other countries in order to learn as far what Germany has been implemented now in the last one year?

Dr. Anne Sophie Geier: Yes. There are, for example, conferences organized by other countries, and they are interested in our learnings from the DiGA process. I've also spoken with companies that are not based in Germany but want to come to the German market. I think there is a big interest in this new process. We are very open in our association to inform everybody about the process, about what we've learned. Yes, I can definitely say there's exchange also in other countries.

Dr. Stefan Walzer: That's perfect. Very good. Anne, thank you very much for your time. Looking forward to the next discussions.

Dr. Anne Sophie Geier: Thank you very much.

Dr. Stefan Walzer: Very good. Thank you Professor Matusiewicz for accepting also discussing today about digitalization of health care or the healthcare system in Germany. In general, you're very active obviously in the whole discussions in terms of digitalization of the German healthcare system. What would be your rating, also, maybe when you take into account maybe the differences between the outpatient and the inpatient setting?

Prof. Dr. David Matusiewicz: Thank you very much for having me. If you see the value chain in the inpatient and outpatient stay of the patients, there are differences on the one hand, but on the other hand, there are some quite similarities. In both systems, we have the digitalization, of course, but in both systems, we have a lot to do. Theoretically or political, there are a lot of nice things which will happen in the next years during the legacy, but if you go to the doctor-- every time I go to the doctor or to the hospital even, I see how big the lack between the theory and the practical use is in the field of the outpatient and inpatient stay. There's a lot to do. If you remember the Bertelsmann study two years ago, we were at the end of the chain, end of the 16 countries which were compared. Today, we are, in Germany, one of the first countries worldwide who have an app precription which you can get by your outpatient stay. We are on the good way, I think.

Dr. Stefan Walzer: I think you're summarizing that probably already quite good. I'm also pretty much impressed when I go to the doctor and still see the fax machines there. Keeping that maybe aside, you have already brought up an important new process. I think the DiGA process, what you just mentioned, the digital health application process was implemented roughly a year ago. What is your impression there? What is your opinion on it?

Prof. Dr. David Matusiewicz: It's the same topic, so I think it's very important and a very nice process. You get your app via smartphone at your doctor, but if I ask a doctor outside, do you know the DiGAs, the digital applications, do you ever prescribe one, there's often the answer no, sorry. I've heard about it. I read about it, but I don't use it. I ask as a health economist, why is it that way? I think the doctors must get more money for it, and we must implement that in the supply chain. There's a lot to do, but it's very important to me that there's an experimental field, so the startups can use their application for one year and then collect data to get later the proof via study for the health insurance companies. I think the system is quite good, but there's a lot to do in the communication and the marketing. I think that people as customers will do it also that way when their demand goes to the doctor, and they want this app better than the pill.

Dr. Stefan Walzer: That's a very good point. I think you also already mentioned incentives. Monetary incentives for physicians are probably also one important component. Maybe also, first and all, put the digitalization gears even up there. When I think about the whole digitalization, I always need to think about generally change management. Would you think that maybe as well something beyond maybe even the monetary incentives for physicians? Because I believe and I fully agree with you that obviously, the doorway through the physicians and the skepticism is probably as well one of the core maybe still breaks in the whole system.

Prof. Dr. David Matusiewicz: As a health economists, it's always the money question. When the money is good enough for the physician, so the compensation they get from the health insurance company must be very nice for them, so they change their behavior. Otherwise, they will use their fax the next years when they get more money for the fax. Like for the email, it's very easy on one hand. On the other hand, it's very complicated. I think besides the compensation topic, the young doctors, we have a lot of young motivated people out there. They learn about digital health in their study. When they finish their study, I think it's a new generation of physicians out there. They will use, of course, the applications because it's very fast. They can trick the process. The compliance is maybe bigger because they can also look inside if people use it or not. Today, we don't know if they use their pills or they interrupt the therapy. I think there's generation topic on the one hand, and on the other hand, the compensation topic.

Dr. Stefan Walzer: Very well said. Changing the gears, we have now spoken a bit on the outpatient setting, the DiGA process, prescriptions, et cetera, if we move into the hospital setting, just a couple of weeks ago, basically, the so-called Hospital Future Act was as well put into place. From your perspective, just generally before we come maybe whether this could help in terms of digitalization, what are the core benefits and drawbacks of that act from your perspective?

Prof. Dr. David Matusiewicz: It's very important. The so-called Krankenhauszukunftsfond, there are three billion euro inside and a lot of money for IT security. On the one hand, it's a very important act. On the other hand, I ask myself if the hospitals will really use the money. I think it's hard for them because on the one hand, they cannot call the money because they have not so much people working in the hospitals who have time to write the paper to get the money. On the other hand, I ask some managers of hospitals, and they tell me that it's also very important because they get money now from the government, but they must pay the processes after the Krankenhauszukunftsfond later on. They don't have the money to continue the process. It's now like a small money they get today, but tomorrow it's important that the money will continue, and that's very hard for them.

Prof. Dr. David Matusiewicz: On the other hand, we have some interesting projects. I think there are 11 tasks in this context. You have the B2C level about how to get an appointment, the therapy, the medication, the telemedicine. You have the system level, so you get the diagnostics, therapy, and after the hospital, and the digital pills and so on. You have data governance topic to talk about data repository or clinical repository. You have the B2B level, of course. You have regional structures or regional telemedicine networks from hospital to hospital or from inpatient to outpatient or even to the so-called Rettungsdienst - what is the English name?

Dr. Stefan Walzer: Emergency services.

Prof. Dr. David Matusiewicz: To the emergency rescue district. There's a lot of topics on that, but I am very surprised if the hospitals use the three billion euro or not.

Dr. Stefan Walzer: That's probably one of the core questions. I fully agree with you. Especially as they haven't had really a lot of time as well to prepare for the different reports and requests. I agree with that. Taking everything into account, the outpatient, inpatient, the different potential incentives or maybe the future, the young doctors, et cetera, what you have all said, where will the German healthcare system be in 10 years' time with respect to digitalization when you think about the year 2031?

Prof. Dr. David Matusiewicz: Thank you very much, Stefan. Very nice question. I think we are at the bottom of a big mountain, and we look on the mountain and see a lot of opportunities in the next 10 years. We see robotics, artificial intelligence, virtual reality, blockchain, 5G, 6G, and so on and so on. There's a lot of exponential technologies out there, a lot of startups with good ideas, and the health insurance companies who want also transform into management companies, the hospitals, the doctors. After corona, a lot of people are very positive concerning the digitalization of the healthcare system. There's a lot of the thing to do, and in my opinion, we must go in a very quick way because there are also other players in the US or in China. They don't sleep.

Prof. Dr. David Matusiewicz: We must be very keen, very hungry, and must be very fast, so we don't lose the global race concerning global health care. Because today when we talk about digitalization, everything is connected, and everyone wants to be the Amazon of the health care system of tomorrow. We have good incentives and a lot of good companies inside Germany, but maybe we must also see on the European which networks we can use, so we can get really good opposite concerning US and China.

Dr. Stefan Walzer: That was a good summary word looking forward to the future. Thank you again, David, for your words, for your thoughts, and also for your opinions. Looking forward to the future and also to further discussions with you. Thank you, David.

Prof. Dr. David Matusiewicz: Thank you, Stefan.

Dr. Stefan Walzer: Interesting insights from both stakeholders of the German healthcare system with respect to digital health and digital healthcare, and also with a special focus on the so-called DiGA pathway. What needs to be done? I think it's quite clear. Besides obviously, I would say, minor comments from and on the DiGA pathway, there are always opportunities in order to further strengthen such pathways, but at the end of the day, I think there are still two core components to be done. One is with waiting how the price negotiations would really work. I think we have seen and heard also in the press and the media that especially the health insurance funds, think that the DiGAs are by far too expensive. My opinion is a bit different, but let's just see how this would really work out in the next 6 to 12 months.

Dr. Stefan Walzer: Also, where it's also quite clear, what both also stakeholders just said, the DiGAs, the digital health applications in general have not yet really reached the market itself. There is still a pathway to go in order to reach patients, and also even probably more important to reach physicians, as obviously physicians need to prescribe it. If they don't prescribe it, "promote" the digital health applications, it might be very difficult as well that those digital health applications get really into the standard of care process for those patients. I think an unresolved issue is still what will happen not only with the DiGAs but generally with respect to digital healthcare in hospitals. There is now the Hospital Future Act, which was also being implemented in early 2021. One needs to see how this would really be when basically make as well an effect on the market in hospitals in order to really bring hospitals into the new era of digital healthcare. Still a long way to go. I'm sure we'll have other episodes on digital healthcare in Germany in the outpatient, but also in the inpatient setting. Let's just stay tuned.

Dr. Stefan Walzer: That was an episode of MAP, the Market Access Podcast provided by MArS Market Access and Pricing Strategy, which is your healthcare consultancy in the German-speaking markets. MAP is available every second week with a new episode, so watch out. In case you might have questions, contact me directly and or visit our website on www.marketaccess-pricingstrategy.de.