Closing the curtains on the first DTx Asia which was held in Seoul on Tuesday and Wednesday, Korea Biomedical Review pulled aside three experts in the DTx space to discuss the growing interest in DTx technologies and its outlook for the APAC region.

Head of Welt USA Danny Kim, Click Therapeutics Director of Business Development and Alliance Management Sarah Jackson and Digital Therapeutics Alliance (DTA) Megan Coder all shared their industry specific insights into the relatively young field of DTx.

From left, Head of Welt USA Danny Kim, Click Therapeutics Director of Business Development and Alliance Management Sarah Jackson and Digital Therapeutics Alliance (DTA) Megan Coder talked to Korea Biomedical Review about DTx industry trends at DTx Asia in an interview on Wednesday.
From left, Head of Welt USA Danny Kim, Click Therapeutics Director of Business Development and Alliance Management Sarah Jackson and Digital Therapeutics Alliance (DTA) Megan Coder talked to Korea Biomedical Review about DTx industry trends at DTx Asia in an interview on Wednesday.

DTx from an industry perspective

Samsung spin-off company, Welt, based in the U.S. and Korea, started extracting digital biomarker data from wearables to promote healthier lifestyles, said Kim. However, with the emergence of DTx, the company started incorporating lifestyle recommendations in its smart belt to help improve user’s gait patterns, speed and other health issues.

“Now our company is focused on integrating digital biomarkers collected via smartphone wearable sensory technology to create that second wave of digital therapeutics that's more personalized,” he said.

Jackson also introduced Click Therapeutics, saying it focuses on software prescription medical treatments which started off with a smoking cessation project.

However, the company’s lead programs are in depression and schizophrenia, and also has a varied pipeline for indications in oncology, multiple sclerosis, chronic pain, fibromyalgia, rheumatoid arthritis, diabetic neuropathy and irritable bowel syndrome, Jackson said.

Click Therapeutics affected behavioral change with its smoking cessation digital therapeutic program and will advance its pipeline in the prescription (Rx) category which is more highly regulated, she added.

“As a company, we want to translate traditional psychotherapy into engaging digital formats while also maintaining efficacy and discovering novel mechanisms of action (MOAs) that are not possible in traditional face-to-face medicine,” she said.

DTA’s Coder also chimed in from a non-profit organization DTx perspective saying, DTA was first founded five years ago to understand the value of DTx and how to assess them for optimal implementation.

“We are also focused on bringing DTx companies together to work with regulators, payors, decision making bodies, and patient groups to better help them navigate this ecosystem,” Coder said.

Alluding DTA to the World Health Organization (WHO) in the DTx space, she drew some similarities, “As it is a fairly new field, we provide thought leadership like the WHO, through different publications on digital therapeutics involving regulatory and reimbursement pathways, health technology assessment and more but we really want to translate this into meaningful action across markets in low-, middle- and high-income countries.”

 Danny Kim, Head of Welt USA, speaks at the first DTx Asia in Seoul on Tuesday. 
Danny Kim, Head of Welt USA, speaks at the first DTx Asia in Seoul on Tuesday. 

Status of DTx in APAC region

Commenting on the status of DTx in the APAC region, Welt’s Kim said launching the first DTx Asia in Seoul was a big step for the industry in the Asian market.

Particularly, he noted that Korea also has the support of the government to accelerate development and adoption of DTx through the regulatory guidelines presented on Wednesday by the Ministry of Food Drug and Safety (MFDS) and the DTx reimbursement guideline scheduled to be published by the end of the year.

“Hosting this DTx Asia conference provides the opportunity to really see what's happening both inside and outside of Korea which mutually motivates all gathered here,” Welt USA head said.

“Most of our pipeline assets are supported by government entities in Korea like the Ministry of Science and ICT, Ministry of Trade Industry and Energy and the Seoul Metropolitan government, showing the governments active interest in this area.”

Kim also mentioned that Japan and China are starting to develop DTx reimbursement and regulatory guidelines and also in Southeast Asia, as Indonesia’s Chief Digital Transformation Officer of the Ministry of Health Setiaji Setaji acknowledged the need for digital therapeutics in the region to better to serve the population using limited resources.

Overall, Jackson noted that there was a growing interest in DTx over the last 12 to 18 months from pharmaceutical companies but admitted that seeing action from these discussions may take some time.

Challenges facing the DTx industry and solutions

When asked to elaborate on the biggest challenges facing the DTx industry, Coder stepped in saying, “There's currently a lot of interest in bringing these DTx treatments into patient care settings but each entity across every state and nation are individually making their own requirements which makes it difficult for DTx companies to expand as they have to meet different requirements.”

In this regard, she suggested that the only way to solve this problem is for the DTx industry to work closely with the decision makers and agree upon standard requirements to give companies more confidence in bringing products into this space.

The DTx field is very unique, she explained.

“As a pharmacist, I never had to worry about language barriers when dispensing medication, but digital therapeutics is different and needs to be customized for a Spanish speaking population, with the right cultural references and engagement factors and above all, still needs to demonstrate safety and effectiveness via clinical trials,” she said.

In response to a comment made earlier in the conference about “piggy-backing” on similar clinical trials to speed up the regulation, she admitted that to some extent this is true but it's still important for each product to do their own clinical trials because although a product might be using the same cognitive behavioral therapy (CBT), the MOA can still be implemented in different ways which still need validation.

WELT USA Head added, “I think that DTx can benchmark some aspects of conventional biopharmaceutical clinical trial design and end points regarding specific inclusion and exclusion criteria.”

Advice to start-ups in DTx

Offering advice to young DTx start-ups, Jackson stressed establishing robust clinical evidence upfront for prescription digital therapeutics.

“Aside from regulatory approval, you need to provide a full clinical dossier containing long term efficacy, real world evidence and data on healthcare resource utilization and health economics to really prove the impact of the DTx and convince all stakeholders,” she said.

“Based on your available resources, you may not be able to tackle that full dossier, but at the very least, creating a roadmap to get there is key for a successful launch,” she shared.

Despite the young DTx industry, there are 15 trials that's been approved by the MFDS and many more companies are trying to enter digital therapeutics.

However, Welt U.S. Head pointed out that while excitement for this industry is good, it’s important not to claim to be a digital therapeutic company simply because of the investment funding or increased media attention.

“The industry is young so we cannot risk muddying the DTx definition which can confuse not only other manufacturers but stakeholders outside digital therapeutics that are just learning about this product characterization,” Kim said.

Benchmarking models and future plans for the DTx industry

While policymakers are prone to harmonizing the regulatory pathway and determining what makes a good digital therapeutic, the reimbursement decision is more sensitive and each country has their sovereignty when it comes to determining what should be covered depending on each population's need, he explained.

“Similarly, just because one reimbursement scheme works well in one country, doesn’t necessarily mean that Korea needs to do the same,” he emphasized. “However, I do advocate for best practices regarding health economics outcomes like a cost versus benefit ratio which could be factored into the reimbursement decision.”

On that note, he highlighted Germany’s Digital Health Applications (DiGA) reimbursement scheme as it solves the chicken or eggs problem regarding whether the health economics modelling or payment model should come first.

Germany provided a preliminary listing status which first gives temporary reimbursement and subsequently requires you to prove the cost and medical benefit within a year to renew your listing status, he said.

In this regard, Kim also noted that Korea’s Health Insurance and Review Assessment (HIRA) have published a study investigating different reimbursement models outside Korea.

Lastly Coder revealed immediate goals of DTA to move towards harmonizing expectations around the quality of digital therapeutic products to make sure that they actually are legitimate DTx products intended to serve patients in the right way to provide policy and decision makers with the appropriate insights for wider DTx adoption.

Midterm, she expressed commercial scaling of DTx products so patients can have access to these products in a way that they can really engage with them and understand the value it can provide in their lives.

Long term, DTA’s goal is to achieve patient acceptance of digital therapeutics as a standard of medical care across all chronic and medical conditions just like pharmaceuticals are seen as standards of care, Coder said.

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