Medical Technology

Successful development and commercialization of digital therapeutics

By Dr. Mario Weiss, and Lukas Grabner

Nov. 8, 2021 | Q&A | 7-minute read

Successful development and commercialization of digital therapeutics

Digital therapeutics are on the rise and new routes for access and reimbursement for innovative solutions have emerged across countries in the recent years. Germany-based GAIA was an early player in this field and has focused on the development of evidence-based, safe and accessible digital therapeutics for many years–well before real pathways for digital therapeutics exist. I sat down with GAIA CEO Dr. Mario Weiss for a conversation on how digital therapies make a positive impact on patients’ lives, how to address adoption barriers and a broader outlook on the industry.


Lukas Grabner: Digital health and especially digital therapeutics have seen a lot of activity in Europe in the past year and GAIA is evidently one important player in this space. Can you give us a quick background on your organization and your visions?


Dr. Mario Weiss: We see ourselves as an R&D company with the mission to develop digital therapeutics that offer physicians, therapists, payers and patients the same effect sizes, similar safety profiles and equal levels of convenience as found in well-developed pharmaceutical solutions. Today, we have about 200 employees and are present in Europe and the US. GAIA was founded 20 years ago by a group of practicing physicians who were increasingly stretched due to a growing patient demand and their inability to meet those within their working hours. We asked ourselves, “What can we do to support our patients outside office hours or when we are not available?” Today, we offer several fully automated digital therapeutics for the treatment of anxiety, depression, RA, Oncology and MS-related fatigue.

“A partnership between a digital therapeutics organization and a pharmaceutical company can be very powerful if you have synergetic products”

Dr. Mario Weiss, CEO, GAIA AG

Lukas Grabner: There have been important developments in Europe regarding digital health–most notably DiGA in Germany but also innovation pathways in other countries such as the U.K. and funding through traditional medtech pathways in some instances in France. What is your perception of the state of the digital health landscape and maturity in Europe today? What does it mean for manufacturers like GAIA or pharma and medtech organizations that are trying to introduce digital solutions?


Dr. Mario Weiss: If you have a good product with compelling evidence, you will find a way to get funding or reimbursement. Obviously, not all countries are at the same stage with formalized reimbursement pathways. Therefore, the responsibility is also on companies to build great products supported by robust evidence. That way, governments are forced to review and reimburse our products. Because in the end, what alternatives do governments have? Due to the aging population, the demand for care keeps on growing. We either need to digitize or accept that we won’t be able to provide sufficient care to the entire population. For example, the recent introduction of DiGA was fueled by the increasing body of evidence of the clinical value of digital therapeutics. I think some countries will flip sooner than others, but ultimately governments will realize that you can only keep the level of care high and costs reasonable by embracing digitization.


Looking across Europe today, how well do evidence requirements that payers care about align across markets? How much country-by-country tailoring is needed and what does it mean for companies in the space?


Dr. Mario Weiss: Evidence is evidence. Robust evidence is generally recognized globally. There are of course exceptions, like Japan, which may require locally conducted clinical trials. Before launching in some markets, you may also want to make sure that you have a representation of the larger ethnicities in that country in the trial. However, these considerations are not unique to designing a clinical trial for digital therapeutics, but also true for any pharmaceutical product. We have become really good at conducting efficient clinical trials. The benefit of digital therapeutics is that the trial typically only lasts one to two years and if you see that the product isn’t working, you can quickly decide to stop the trial and move on.


Lukas Grabner: Let’s talk about adoption once a therapy is approved and funded. Adoption for several digital health solutions is often slow and not as widespread as the national access and reimbursement coverage might suggest (a top example being some of the DiGA in German). Reasons could be anywhere from physician awareness and comfort to patient interest and long-term adherence. What do you see as key barriers that manufacturers need to overcome? What are ways to bridge this gap?


Dr. Mario Weiss: Patient compliance is probably one of the biggest challenges and something you need to manage well. Taking a pill is easier than sitting in front of your computer for 30 minutes. On the other hand, pills have much more side effects then our digital interventions. For us, compliance is a functionality of the software. Managing critical compliance, i.e. sufficient engagement to ensure treatment benefits, is something we have become good at. Today, our compliance rate is comparable to that of drugs with good safety profiles at around 60-70%. We also often see that a patient becomes more compliant with a drug if they are prescribed our digital therapeutics as well. In addition to patient compliance, there was initially a resistance amongst physicians toward our solutions. Physicians hate digitization because it has always been a burden to them. Any new IT system or digitization generates more data demands for the physician. I suspect that there are also country-specific differences in attitudes toward digitization. The skepticism is probably more pronounced in Germany than say in the US, where physicians are overall more open to new technology.


Lukas Grabner: Do you see differences across specific therapy areas or types of conditions?


Dr. Mario Weiss: Psychotherapists were initially skeptical to us. Partially because they overall tend to be conservative, but also because they feared we would replace them with our technology and because they are simply not used to prescribing. Therefore, adoption of or solutions for anxiety and depression was slow in the beginning. However, in oncology, adoption of and acceptance of our solutions have been much faster for two reasons: First, they recognize that we can help them reduce their workload without the fear of us “replacing” them, and second, they are very familiar with prescribing drugs to patients.


Lukas Grabner: How do you see the role of partnerships (for example, with pharma) when it comes to achieving scale and ensuring adoption of new solutions in the market?


Dr. Mario Weiss: Reaching physicians is obviously a challenge for digital companies like ours without a massive salesforce. This is where collaborations can fit in well. We have partnerships with pharmaceutical companies, but less so with medtech companies. Our partnerships with pharmaceutical companies are currently around mainly marketing and sales. R&D partnerships would be very powerful: Software can boost the effects of drugs and vice versa. We are definitely open to exploring opportunities with strong R&D companies.  In addition, a partnership between digital therapeutics and a pharmaceutical company can be very powerful if you have synergetic products, for example, what we currently have for opioid addiction. However, a partnership with pharmaceutical companies may not be the best path for all digital therapeutic companies. If we find a pharmaceutical company interested in collaborating, that is great. Still, there can be other viable ways to launch our solution and reach doctors than partnering with a pharmaceutical company. We are a digital company. We are experts in changing the behavior of humans digitally. We think digital first also in marketing and sales. I must say that physicians are to some extent normal humans: their prescription behavior can be changed to a significant extent also digitally. Our first approaches are quite promising.


Lukas Grabner: To conclude something a bit more “future looking:” What are your projections for the digital therapeutics market in 2025 in Europe? What are your hopes? And how do you see the market landscape in DTx with pure players like GAIA, larger pharma and medtech organizations?


Dr. Mario Weiss: I think GAIA will continue to grow. We have several promising products in the pipeline which we aim to launch internationally, and we will continue to develop innovative solutions, now at a higher pace as we have established true expertise in how to develop products and set up and run clinical trials efficiently. I believe pharmaceutical and medtech companies will become more open to digital, often accelerated through partnerships with digital and tech native organizations to bridge capability gaps. More broadly, I expect a continuation of the rise of digital health for the aforementioned reasons, like the aging population, increasing cost pressure on payers and technological innovation.

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