DiGA Fast Track Isn’t That Fast, Is It? Digital Health Interviews: Alexander Voigt

Before we start the new episode of Digital Health Interviews, it’s essential to remind you about the importance of supporting Ukraine in any way possible during these challenging times. Our nation greatly relies on the assistance and solidarity of the international community.

We’re excited to introduce today’s guest: his name is Alexander Voigt. His expertise and insights in the field of digital health promise to provide us with a wealth of knowledge and valuable perspectives.

Introduction:

Alexander Voigt: Principal at Digital Oxygen, Healthcare Innovator, Digital Health Expert. Combining a strong dedication to patient and HCP needs with regulatory expertise, he supports providers of innovative DTx products with their launch in Germany. His competence includes regulatory and commercial matters on digital healthcare applications (DiGA/ DiPA) and diabetes technology: “I have a background in broader digitalization. When I started my career, I worked at a consultancy that helped media and tech companies transform themselves and develop great digital products. I joined Digital Oxygen almost five years ago when the company was founded. I took my learnings from what I’ve seen in other industries that are yet further ahead in terms of digital transformation and brought them to the MedTech sector in Germany.”

We started our conversation with the revolutionary reimbursement program. What are Alexander’s thoughts on how this journey has been developing for Germany thus far? “The DiGA Fast Track procedure in Germany is unique. I think it is a great success if we take a step back from all the day-to-day discussions and news broadcasted through online channels around how things are not good and could be improved. I think if we look at it from a broader scale, it is quite a success: today we’ve already had almost 50 DiGAs and applications that can help patients in everyday situations, where they might be underserved or receive not as much care as they need. There are always things that can be improved and always things that can go better. If we take the effort to understand what is not perfect today, we’ll also see what can be improved in the future. Everybody is learning the DiGA game. Some payers have not yet reimbursed digital applications on a broader scale. Some prescribers and medical officers have not yet dared to talk about those digital products because they were not part of an officially proven scheme like the DiGA Fast Track. Some manufacturers have not been in direct contact with prescribers as much as they now need to be. There are also policymakers and authorities such as the Federal Institute for Drugs and Medical Devices, who have not needed to take the effort to look into digital healthcare products as much as they need now with the DiGA Fast Track. There are a lot of things that we can all learn if we listen well enough to each other in terms of process: how you can become a DiGA, how the DiGA can be brought to the HCP, how DiGA can be brought to the patient and how patients can work with the DiGA successfully and not lose the interest halfway through. But it’s also about the products themselves: how a digital healthcare product and a digital application for healthcare should be structured and designed in the best way, so it can bring the full potential to the patients and be close to the unmet need.”

There are around 50 already approved applications. What about DiPA? Are there any applications approved in the care space? “Unfortunately, there’s none yet. But you also need to be honest and say: the digital care application procedure has only been around since the beginning of this year, while the DiGA Fast Track has already been around for two and a half years now. If you compare both products, you can see some differences that make it much more complex to launch a DiPA product than a DiGA one. For example, the missing option for a preliminary listing is also more complex as well as how you can bring the product to the market to the people needing care. There is also a different way how you prove evidence and benefit from your product. All of those things are not yet as far developed as you would see them in the typical therapeutic area, where DiGAs apply. That makes it very difficult for a lot of manufacturers. Right now, there’s no DiPA listed, and I would be surprised if we see a DiPA listed than 2025. Maybe, there will be one or two, but there won’t be a huge wave.”

In the interview with Sebastian Vorberg, we talked about DiGa starting and launching super fast but the speed slowed down a lot since that, and lots of hidden difficulties appeared. In the opinion of Alexander, what are the reasons for that? “I think back in the days when it was launched, there was a full focus on and commitment to the digital transformation of the German healthcare system. Between 2020 and today there was a change in the government and the newly appointed healthcare minister, who said they want to take a step back and analyze what is all needed on a broader scale than just talking about individual healthcare and digital healthcare measures. There was a little bit of a lack of momentum in that sense. There was not that political push anymore, especially for the DiGA topic. What you can see now — and that is quite positive — is that when the digital transformation strategy for the German healthcare system was presented last month, there were also aspects in their benefiting the DiGA and the DiPA and all of the digital healthcare products topics. Those were aspects that were for too long asked for by many stakeholders but not expected to make it into that digital healthcare strategy.”

It’s always tough to be an early bird. Now other countries are using the German model and adopting the best practices in their countries trying to avoid mistakes. “There are a few examples that have committed to introducing a comparable pathway, and you can see that France is currently launching this. It’s called PECAN. It is comparable, but not in every aspect. If we look at it at a broader scale, the idea was in November in 2021 to create comparable policies all across Europe. So if you are listed in one country, the authority in the other country would acknowledge you. As a manufacturer, you would be able to scale and bring your products to other patients in other markets. I see that as a great ambition and vision, but I don’t see that happening either in the short or midterm, since there are healthcare systems that are very individual in each of European countries. That makes it very difficult to adapt one product to other regions as well as to acknowledge the evidence that has been created in another country. Let me give you a very specific example: in France healthcare and MedTech products of Class 3 will be allowed to become a digital reimbursable application. That is not the case in Germany.”

There is also a problem of low conversion of digital prescriptions. A patient is prescribed some digital app, but one of three only installs that application and starts using it. Why is this a problem? What should be done to improve that? “I think there are different reasons for that. First of all, it’s a lack of integration into a broader digital healthcare ecosystem. The DiGA is great as it is, but it doesn’t fulfill its full potential only by being there on its own. I think it is not ideal, not for anyone in that area, not for the HCP, who wants to help the patients, not for the patients who need to take a lot of effort to understand how this process works since it’s brand new and is implemented nowhere in other areas of the healthcare system so they are unfamiliar with it. It’s not to the benefit of the manufacturer who needs to take a lot of effort to lecture the patient on how the process works. I don’t think it’s also not to the benefit of the insurers who need to pay for that product because patients who might be seen as eligible for reimbursement by the HCPs might not even make it to the stage where they get the product. So it’s a very good first start and an opportunity for all of us to learn how it could be improved but I don’t think it’s yet the end of the innovation on how this could happen. There are a lot of items where you could see that DiGAs could fulfill greater potential if they interact with different ends in the healthcare system. For example, superb integration into the electronic patient record, so you can create a better understanding of the patient and a better care in therapeutic approach inside the DiGA.

When you think about how many manufacturers have tried to become a DiGA, you could see that there was a real wave at the beginning. Many manufacturers heard of DiGA, at our Digital Oxygen company we even had requests from South Korea, so it really was a buzz in the industry and an area where Germany was avant-garde in terms of digital health and it still is. But you also can see that that has slowed down over time and also with the broader learning about how complex the process is despite it being called Fast Track. It’s always a relative comparison to what is fast. It certainly is not a “hockey stick” business model that you can run through when you become a DiGA. It’s a highly competitive yet regulated market, and you could see that the manufacturers, who have gone down that road, would say: “If I had known beforehand how big the challenge was I would not have started it. But now, as I have gone through all of this, I’m happy that I have actually crossed the start line with my listing as a DiGA — and now I can become successful on the market and help patients directly since being listed, but I had not expected that upfront to be that effortful.”

Let’s speak about the Digital Oxygen company and its help to digital health startups in Germany. “We’re consulting manufacturers of digital healthcare products on how to enter the German market. When you approach us with your creation, we can consult you and guide you on which market access path might be the best for you, and it is always a very essential question. From our point of view, it should be answered quite fast and at an early stage. We help manufacturers to make it to the start line of the market when you say: “This is now the product in our life in the market.” We also help together with our network beyond that. We are not a development company, but we have the network in our background, and we have the expertise that can guide you through the complex way into the German healthcare system.”

Digital Oxygen helps a product to understand which path to take. Since DiGA appeared, is the out-of-pocket strategy very popular? “It depends. If you want to become a DiGA, it’s quite obvious that it will be an expensive endeavor at the beginning. If you are not coming from a corporate background but have a startup one, you need some resources, especially financial ones, to invest in that DiGA project. There can be two ways: either you’re already generating revenue out of pocket to bootstrap that DiGA development or you’re doing it again through other ways. So you can prove against potential investors that your team understands the market. So I wouldn’t say out-of-pocket has ended. In certain cases, it might also be the more beneficial way: it depends on how your product is, and what it does. Also, especially in the care sector, it’s quite common that you first need to spend the money and then it will be reimbursed.”

Digital Oxygen was awarded “Best Consultancy” for five consecutive years. “I think we have a great team, and we are committed to creating real value. A lot of consultancies have the image that they just create slides — and then they’re gone. That’s not our understanding of how we can help our clients. In contrast, we are always trying to not only create new findings but also to help to transform them into real products with real value. The other thing is a quite broad mix of perspectives that we have in our team and backgrounds. We have led to a more holistic understanding of the challenges of our clients and potential solutions.”

How does the digitalization of the healthcare sector impact the German healthcare market, both in terms of challenges and opportunities? “I believe that we already have a very big crunch in the German healthcare system in terms of human capacity. Digitalization is the key to many problems, and that includes data, products, and digital knowledge. If you think about the healthcare system and how it will develop, we will not be able to even keep up the standard that we have today in the future to help patients. That will still become a bigger problem in the future because we’re not even talking about improving the standard of care, we’re just talking about keeping up. You can already see that today in the psychotherapy area in Germany people need to wait six or more months to get treatment and appointments. In those situations, for example, patients do turn to Dr. Google, because that’s just their first and most convenient way to find information, but that is maybe not the best way to find it. I believe it is very important to provide solutions that can help patients there. That could be telehealth, digital products, or online libraries with proven content where people can find information that can help them at that moment when they are in need and not three months later. If we had that kind of mindset in our heads, it helps us to innovate a lot and bring up new products. The other area is data. We’ve seen that during the COVID pandemic, a lot of policymakers and politicians needed to make decisions based on a blurry understanding of what the reality is out there, not downtown in the capital but maybe 100-200 kilometers away in very rural areas. And that was not always as we’ve seen now very decision-based.
Could we make better decisions as a community or could we improve that also for the future? Not talking about pandemics but preventing other diseases that we can already detect at an earlier stage than we do today. All of these things tie back to how big, and good is our understanding of the challenge, and if we don’t take it, we won’t get to the best solutions. In Germany, we also always think that we have the best healthcare system in the world, and now there’s slowly a discussion evolving, or maybe it’s not that good anymore. That is because we’re lagging on digitalization: we’re having maybe the best analog healthcare system but not the most digital one.”

What does Alexander think is the future of digital health in Germany, what should we expect? “In the near future, we will see that the digital healthcare strategy will be put in the legislation over the summer, and we’re looking forward to seeing that transformed into actions, more than a strategy. The strategy is only as good as its implementation. Once we will be there, we will already see the next iteration: we will see things that might be approved again. If we’re thinking about healthcare and digitalization, we must take the effort to do things — and then learn to improve on it instead of always pushing for the most premium and well-defined solution at the beginning, because we will never be able to pull that off. We should not always expect from the healthcare system that their healthcare products and the solutions for digital healthcare are always the most well-advanced in the first generation, but we should take the effort to just get started.”

Let’s wrap up our great conversation with some of Alexander’s recommendations to digital health startup founders in Germany and around the world: “Be aware that the healthcare market, especially in Europe, is very well-regulated and competitive. If you want to help patients, you need to have long-term motivation, and you might be familiar with the lifestyle sector. However, you will be able to help many patients here that are in need and that are in growing need. Being aware of the challenge always helps at the beginning to understand how you should adjust your plans and your strategy. Also, at the very beginning, you should understand what is the actual unmet need to target with your product for the patients in the very first instance, before even thinking about medical officers. What is the unmet need of the payers? If you’re building a great product that helps patients but that does not deliver any measurable and valued benefit, you will not be able to keep that thing running in the long term. You need to make sure that you find and collect all of the perspectives, while you’re still designing your product. That is very different from how other digital products industries work, where you can just easily iterate on your product. That is not the healthcare case, because in healthcare you need to have a sort of a certificate that doesn’t allow you to just basically and fundamentally change your product. Also, you will need to provide evidence, and also after you’ve created evidence, you can’t just change that. I think that this sounds quite obvious for a pharmaceutical product: nobody would dare to change the ingredients, mixture, and dosing of such a product after you’ve done with your study, but with digital products, the desire to do that is a little bit bigger. I think those are two things: understanding that it’s a long-term effort and understanding that you need to comprehend the market at the very beginning and collect a lot of perspectives before you’re closing your product development.”

Our previous episode was with Anna Erat: Preventive Healthcare. Doctor's Opinion