[Start! DTx Era]② "Overcoming Unmet Patient-Centered Needs Possible... Bold Fee Application Needed"

Challenges After 'First DTx Approval'
Urgent Expert Roundtable

Shin Jaeyong "Expand Coverage for Product Diversification"
Choi Yunseop "Time to Prove... Improve Usability"
Kang Seongji "Patient-Centered Care Will Be Possible"

[Asia Economy Reporter Lee Chun-hee] AimMed's digital therapeutic device (DTx, digital therapeutics) for insomnia treatment, 'Somz,' has finally become the 'first DTx' after receiving approval from the Ministry of Food and Drug Safety. However, since this is the first approval, there is no precedent on how to commercialize it yet, and the supporting system has not been established.

We listened to the diagnosis of future challenges through an urgent roundtable discussion with three experts who have consistently voiced opinions on the DTx industry. The discussion included Professor Shin Jae-yong from Yonsei University's Department of Preventive Medicine representing academia, CEO Choi Yoon-seop of Digital Healthcare Partners (DHP) from the investment sector, and CEO Kang Sung-ji of Welt from the industry.

Finally, the country's 'first' approved DTx has emerged. What are your thoughts from the perspective of those who have made various suggestions?

▲CEO Choi Yoon-seop= From the standpoint of introducing DTx long before it became known in Korea, it is a moving moment. There was little awareness or interest for a long time, so it is astonishing how rapidly it has grown in recent years.

▲Professor Shin Jae-yong= This is thanks to the considerable efforts of not only the DTx industry but also related agencies such as the Ministry of Food and Drug Safety, the Ministry of Health and Welfare, and the Health Insurance Review and Assessment Service. While not completely satisfactory, since this is just the beginning, I hope it develops well going forward.

▲CEO Kang Sung-ji= I think it is 'just the beginning.' As DTx takes a role as a pillar of Software as a Medical Device (SaMD), alongside AI companies like Lunit and Vuno, I expect AimMed and Welt to achieve results and grow in the DTx field.

Professor Shin Jaeyong, Department of Preventive Medicine, Yonsei University. Photo by Hyunmin Kim kimhyun81@

There is still confusion between 'therapeutics' and 'therapeutic devices,' and a clear definition of DTx is not easy. Regarding usage, whether doctors should prescribe it, pharmacists should guide medication, or it should be freely used as simple wellness products, discussions are needed.

▲Choi= The definition is clear. The official term used by the Ministry of Food and Drug Safety and the Health Insurance Review and Assessment Service is 'digital therapeutic device.' The Digital Therapeutics Alliance (DTA), the U.S. Food and Drug Administration (FDA), and others also regard it as a medical device, not a pharmaceutical product. The confusion seems to arise from lack of understanding or intentional distortion. There should be no further confusion.

▲Kang= Since it is a product with very flexible characteristics, such issues seem to arise. Because performance has been proven in clinical participants, it is necessary to select and guide users similarly to prescriptions. However, this seems to be a matter that can be regulated by the Ministry of Food and Drug Safety's authority.

▲Shin= From the perspective of 'improving medical accessibility,' it can be divided into multiple layers rather than a single one. If the industry ultimately aims for real-time feedback to change treatment methods, a doctor's prescription is definitely necessary. On the other hand, if it only provides simple medical information or lacks interaction, it could be considered similar to over-the-counter products.

For medical industries, insurance reimbursement is essential for products to be used. How should domestic reimbursement be implemented?

▲Shin= First, various products should be allowed to be used. Since patients are willing to pay if effective, non-reimbursed or selective reimbursement should be expanded. A voucher system could be introduced to exempt co-payments. Since proof of effectiveness is important, a provisional listing system should be established, and if proof is not provided, products should be boldly removed.

▲Choi= Recently, the government has continuously expressed support for digital healthcare, but if we truly want to lead the world, innovative improvements in the reimbursement system are necessary. A reasonable yet bold plan like Germany's Digital Health Applications (DiGA) is needed.

▲Kang= Since DTx products are flexible, pricing should also be flexible. If mismanaged, prices should be lowered, but as products improve, prices should increase to encourage evolution. However, standards that anyone can easily agree on, such as continuous usage rates and patient satisfaction, are also necessary.

Choi Yoonseop, CEO of Digital Healthcare Partners Photo by Digital Healthcare Partners

What benefits can our society gain through DTx?

▲Kang= Patient-centered healthcare will become possible. Services like predicting what a user will buy next, preparing it in advance, and delivering the product immediately upon order can also be realized in healthcare. I hope patients are better understood and receive personalized medical care, increasing treatment satisfaction.

▲Shin= It strongly addresses unmet needs that are essential but not fulfilled, overcoming them with minimal cost. As a father raising twins, I am not confident that general clinics can provide information on how to respond when children have a fever and cough at night. There is no fee for this, and even if there were, medical staff would likely prefer to see a new patient during that time. DTx is expected to fill this gap.

▲Choi= Ideally, it can deliver medical value safely and remotely to more patients at lower cost anytime and anywhere. Industrially, development costs are lower, and replication and distribution costs are close to zero. However, overseas cases show many patients drop out due to usability issues. The problem is more severe among elderly people with low digital literacy. If this is not resolved, the social impact could be greatly reduced.

What are the future challenges?

▲Shin= I think this year is very important. Regarding approval, DTx grades should be divided into prescription and non-prescription, and evaluation methods for each grade should be established. Regarding reimbursement, bold support such as vouchers for co-payments and transparent data analysis should be implemented. Some products may disappear, but I expect this year to instill belief and confidence that 'DTx is an essential product.'

▲Choi= Until now, development has been based on dreams, but now manufacturers must show that they can make money and realize actual value. If Korea truly wants to become a leading DTx country, the government must not stop at declarations but provide proactive reimbursement policies and support. It is important to remember that the medical industry can only grow up to the level of a country's regulations.

▲Kang= The industry must broaden its perspective. Instead of focusing on increasing market share domestically, everyone should collaborate to build a foundation for pioneering the global market. Just as Germany and Japan led the automotive industry during the internal combustion engine era, but the U.S. and China lead in the electric vehicle era, I hope for a future where the world comes to learn 'Korea's digital medicine.'

Kang Sung-ji, CEO of Welt [Photo by Welt]