"Digital health is happening and here to stay". One Year of DiGA Fast-Track in Germany

We are glad to resume our conversation with Henrik Matthies, Managing Director of health innovation hub (hih), who was our guest at Digital Health Global Blogs exactly a year ago when we discussed the launch of the DiGA application process.

Led by Henrik, health innovation hub is a Federal Ministry of Health think-tank which, among other projects, is coordinating the work on the famous Digital Healthcare Act (DVG) adapted in 2019 in Germany. One of the Act’s most discussed implications is the DiGA Fast-Track process that allows digital health applications to be approved for statutory reimbursement and available by prescription.

In this way, digital health startups that successfully go through the DiGA process get an opportunity to access the market of 75 million people who are enrolled across 105 public health insurance companies in Germany (read about DVG and DiGA in more detail here – editorial note).

Today we are looking at the first results and discussing further plans.

Henrik, before we dive into the facts, how are you feeling looking one year back?

First of all, we are extremely happy that we actually made DiGA happen, and I believe I can say that on behalf of the German Ministry of Health, BfArM (the Federal Institute for Drugs and Medical Devices that is in charge of approving DiGA – editorial note), us at health innovation hub and everyone else involved in the process.

When the first draft of this law became public a two and a half years ago, it received a lot of resistance from the very traditional part of the healthcare sector. We heard opinions that it was very unlikely for such a law to come through, that the physician was the only true institution to take care of health, and that digital health was not going to make a change.

Hence, I would say DiGA is a real breakthrough since we now have a clear path that any digital health application manufacturer needs to undergo in order to obtain the opportunity for reimbursement by a German health insurance.

In the meantime, we learned a lot, which is also great. We underlined from the very beginning that DiGA would be an agile process of mutual learning, and we have adjusted already to some extent in the past 12 months.

I’m particularly happy about the fundamental mindset shift of many healthcare providers that resulted from DiGA. We especially notice it in discussions with stakeholders of this very diverse healthcare sector: there is an understanding that digital health is happening and is here to stay. The question is no longer “do we need digital health?” but rather “how do we need to adjust our health system to the new digital reality?”

In my perspective, this shift in mindset is one of the biggest implications of the DiGA Fast-Track so far.

What is the current number of approved DiGAs and which therapeutic areas do they cover?

To date, we have 20 DiGAs in the registry. Especially interesting is that 75% of them are listed preliminary because they do not yet have all the evidence in place, but they have 12 months to present it to be listed permanently.

If we did not have the option for startups to generate the evidence while being listed, we would have a very limited number of DiGAs currently in the pipeline. Hence, it was a good move.

I’d like to note that the manufacturers which didn’t make it into the fast track were mostly rejected because their study design was not appropriate. Thus, the way they wanted to generate initial evidence was simply not sufficient. To me, it’s a very thorough argument that BfArM is making sure non-scientific evidence doesn’t infiltrate the health care sector.

Regarding therapeutic areas, we see quite a variety covering mental health, neurology, oncology, cardiovascular, and others. This diversity is exactly what we hoped for and expect to see even more variety in the future.

Around 30% of approved DiGAs are in the mental health area. What could be the reason for this significant share, in your opinion?

In Germany, patients typically have to wait an average of six months to see a therapist or psychiatrist. Hence, there is a big need for psychological help, so an app can be an effective support tool for bridging the gap between an initial GP diagnosis and the first expert visit.

Covid was also definitely a very important demand driver, but I believe the mental health industry already had a number of digital health applications in place, so they acted quicker than many other sectors.

What can you tell us about the actual prescription rate? According to a Research2Guidance white paper, DiGA manufacturers “see an immediate growth in downloads after DiGA listing, but the growth does not appear to be sustained in the mid-term”.

Unfortunately, there is no structured data generation around prescriptions. The figure we rely on is 20,000 DiGA prescriptions to date, which has a lot of potential, considering prescription rates are growing over time.

According to TLGG Consulting, for July 2021, the most prescribed apps were Vivira (orthopedics), Kalmeda (neurology), Zanadio (cardiovascular), and Somnio (sleep disorders) – editorial note.

What we’ve heard is that for the first half of the year, it was difficult for doctors to get any information directly from DiGA manufacturers. Doctors simply did not receive alerts from the startups. Consequently, it was challenging for doctors to try the apps because there were no healthcare professional test accounts.

Unlike pharmaceutical companies, which have a very established system for how to inform doctors, the DiGA startups simply didn’t have this practice of approaching HCPs directly. Many startups had never any direct contact with the healthcare system as such, so it took some time for them to build up those capabilities.

Nowadays, this has very much changed and there is not a single DiGA without a test account. DiGA manufacturers have learned that they need to educate doctors about this entirely new category of therapies.

And again, it has only been 12 months since the first applications were received, which means we do not even have a full year since the first DiGA was actually prescribed. Price negotiations with the startups will begin only after this first year. I would envision that prices will be lower – probably significantly lower – but volumes might then significantly increase. Thus, it is still a bit early to conduct a thorough analysis of prescription rates.

Let’s talk about international perspective around DiGA. Are there international DiGAs in the pipeline? Are there many countries interested in adopting similar processes?

Currently, all approved DiGAs come from German-speaking countries, but BfArM reports a growing demand from international DiGA manufacturers, including many outside of Europe. We have a lot of interest from the US, Canada, Japan, Australia, New Zealand, Singapore, China, and Korea. Hence, I would be surprised if 12 months from now, we don’t have a diverse mix of DiGAs in the registry.

Then, we are constantly getting requests from the countries that would like to learn from DiGA experience and replicate it – you do not need to reinvent the wheel each time you build a digital health process.

Together with several EU countries, we are now working on a broader alliance with harmonized digital health policies. It is a big step ahead for the startups targeting the EU market, which would mean that evidence needs to be generated only once, CE product certification needs to be received only once, and if approved by DiGA, approval in other countries is automatic.

hih is hosting the English-language “EU DiGA Con” on November 2^nd 2021 as part of their two-days “Digital Medicine Conference“. The DiGA Fast Track process will be explained in detail, and representatives from various EU countries will discuss their DiGA alike approaches and fathom harmonization possibilities.

It’s a very important and also challenging task. The good news is that the regulation of digital health is completely new for any healthcare system, which makes it more open to harmonization. Hopefully, we will be able to see the first results in the next 2-3 years. Obviously, the market potential of such an alliance would be significant.

Lastly, I would like your opinion on the role of DiGA, and DVG Law in general, in transforming the status quo of the healthcare system actors such as doctors, patients, pharma, and insurance companies.

If we look into the doctor-patient paradigm, so far, the majority of DiGA manufacturers have been focused on doctors because they are the decision makers who prescribe the app, and adherence is probably higher when the prescription comes directly from them. Conversely, I am curious if we will ever see DiGAs who approach patients and motivate them to contact either a doctor or health insurance company.

Ideally, we should allow patients to own the maximum information about their health, using electronic patient record (DVG Law also introduces the online consultations and electronic prescriptions into use – editorial note). In such case, we can expect that patients are also prepared to take their own actions around their health, which may include also directly approaching doctors saying, “I have this condition and would like to have this DiGA prescribed.”

We are still years away from having honest discussions about healthcare system roles. Most stakeholders somehow hope their daily business will remain the same, just with more digital solutions around it. This is highly unlikely. Roles will change significantly. The more information, power, and support we give patients in everyday life, the more transformation around the roles of healthcare professionals and health insurance we will observe.

Flash Poll: The Future of DiGAs

In order to provide you with more insights into the future of DiGAs, we asked Henrik to give a short comment on each of the theses, published earlier by TLGG Consulting: