[DTx Asia] Japan Already Successful in Commercialization... Korea Evaluated as "Global Regulatory Leader"

Two Countries with 'Public Insurance-Centered' Healthcare Systems

Japan's 'CureApp' Launches Nicotine Addiction and Hypertension DTx
Jo Si-jun BD Director: "Japan Also Faces '5-Minute Consultation' Issue"
"Lifestyle Habit Correction Effective Through DTx"

Korea's Discussions on Reimbursement Still Insufficient
Regulations Evaluated as "Global Leader" Through Various Guidelines

On the 8th, Jo Si-jun, Global BD Director of CureApp, is giving a presentation at the '1st DTx Asia' held at Novotel Ambassador Hotel in Gangnam-gu, Seoul.
Photo by Lee Chun-hee

[Asia Economy Reporter Chunhee Lee] There is growing anticipation that the 'first digital therapeutic (DTx)' approval could be granted as early as within this year, but some evaluations suggest that this is just the 'beginning.' Due to the unique nature of the medical industry, where the consumer (patient) and the payer (insurance) are different entities, successful insurance reimbursement is essential for actual product sales to become possible.

This is why the case presentation by Shijun Jo, Global BD Head of CureApp, titled "Pathway to Market: Clinical Trials and Business Development (BD) in Japan," held at 'DTx Asia' on the 8th at the Novotel Ambassador Hotel in Gangnam-gu, Seoul, attracted significant attention.

CureApp has launched two DTx products, the nicotine addiction treatment 'CureApp SC' and the hypertension treatment 'CureApp HT,' after receiving approval from Japan's Pharmaceuticals and Medical Devices Agency (PMDA). It is the only company commercializing DTx in Japan. Notably, CureApp HT succeeded in gaining coverage under Japan's health insurance in September. CureApp HT is the first hypertension DTx to achieve reimbursement. Additionally, CureApp is developing DTx for alcohol addiction, non-alcoholic steatohepatitis (NASH), cancer, and chronic heart failure.

Japan CureApp's hypertension treatment DTx 'CureApp HT' (Photo by CureApp)

The significance of Japan's DTx commercialization for Korea lies in the fact that both countries operate their healthcare systems based on strong public insurance frameworks. In overseas markets where DTx commercialization is already widespread, the absence of a strong public insurance system often allows market entry through various private insurance schemes or individual negotiations with large corporations. However, Korea has a robust single public insurance system, the National Health Insurance (NHI). Since it covers the entire population, successful reimbursement can rapidly expand market reach, but the emphasis on publicness and universality means that without clear proof of cost-effectiveness, crossing the reimbursement threshold is difficult. Japan similarly operates a 'National Health Insurance (Kokumin Kenko Hoken)' system that covers all citizens.

CureApp's choice of hypertension as its second target indication also reflects a healthcare environment similar to Korea's. Jo explained, "In Japan, consultation times are so short they are called '5-minute consultations,' making it difficult for doctors to provide personalized advice to patients. It is estimated that 70% of hypertensive patients are untreated or undertreated, and patients find it hard to know how to modify their lifestyle habits."

CureApp HT helps achieve essential lifestyle modifications for hypertension treatment by providing education and motivation, assisting with exercise, weight management, and controlling alcohol and salt intake. Clinical results demonstrated that the group prescribed CureApp HT alongside standard of care (SoC) showed an average systolic blood pressure (SBP) reduction of 10.6 mmHg at 8 weeks compared to the control group receiving SoC alone. Improvements were also observed in secondary indicators such as body mass index (BMI) and weight.

CureApp Logo (Photo by CureApp)

Regarding costs, Jo stated, "Every year in Japan, 100,000 people die from hypertension, and related costs amount to $12.5 billion (approximately 17 trillion KRW)," highlighting the enormous social costs of hypertension. He emphasized that DTx like CureApp can bring significant cost savings. Currently, CureApp HT costs $10 for management and $59 per month for a 6-month program. He noted, "The lifetime medical cost based on existing treatments is 7.53 million yen (about 71.16 million KRW), but using CureApp reduces it to 6.94 million yen (about 63.56 million KRW), resulting in a lifetime medical cost saving of 590,000 yen (about 5.57 million KRW) per person."

Jo also mentioned that despite the Japanese government providing substantial support, such as shortening the approval period from one year to six months through a fast-track review system, there are still many shortcomings in Japan's system. He cited fixed reimbursement fees as the biggest challenge.

He also emphasized the operation of a platform considering doctors' reluctance to adopt DTx different from existing treatments during prescription. CureApp operates a prescription platform application called 'APS.' Jo explained, "The extent to which doctors adopt DTx is a global issue, not just in Japan. APS helps doctors prescribe more easily."

Jo added that, similar to Korea where integration with electronic medical records (EMR) is a major task for DTx commercialization, "One of the biggest efforts currently in Japan is electronic health records (EHR). We are requesting the government to allow our data to be linked with EHR systems."

Zero Commercialization Cases in Korea Yet... Government-Led Regulation to Lead Global Standards

Unlike Japan, where commercialization is already significantly underway, Korea currently has no commercialized DTx products nor any approved by the Ministry of Food and Drug Safety (MFDS). Policy directions regarding health insurance reimbursement have not yet been established. However, the Health Insurance Review and Assessment Service (HIRA) is hastening the preparation of DTx reimbursement guidelines, aiming for publication within this year. Nevertheless, Korea is recognized for leading global regulations by being at the forefront of establishing DTx-related regulations.

On this day, Youngmin Han, a digital health regulation support officer at the MFDS's Food and Drug Safety Evaluation Institute, introduced the current status of domestic DTx development, stating, "As of last month, 15 products have received clinical trial application (IND) approval and are undergoing clinical trials, including products for insomnia treatment and mild cognitive impairment (MCI) improvement."

On the 8th, Han Young-min, an officer from the Digital Health Regulatory Support Division of the Ministry of Food and Drug Safety, is presenting at the '1st DTx Asia' held at Novotel Ambassador Hotel in Gangnam-gu, Seoul. / Photo by Lee Chun-hee

Currently, domestic regulatory authorities such as the MFDS published the 'Digital Therapeutic Device (DTx) Approval and Review Guide for Applicants' in August 2020, followed by the 'DTx Safety and Performance Evaluation and Clinical Trial Protocol Preparation Guidelines' last year for insomnia and alcohol/nicotine use disorders. Additional guidelines for indications such as depression and panic disorder are planned for release within this year.

This initiative is highly regarded overseas as well. Since global DTx regulatory guidelines have yet to be firmly established, Korea is seen as leading the way. Megan Coder, Chief Policy Officer (CPO) of the Digital Therapeutics Alliance (DTA), which is working with the International Organization for Standardization (ISO) to develop global guidelines, praised, "The Korean MFDS was the first in the world to create DTx-related guidelines. Many countries refer to these, and Korea is leading global DTx regulation as a leader."

Officer Han also hinted that the regulatory framework is open to foreign DTx products that have conducted clinical trials overseas entering the Korean market. He said, "Under domestic regulations, submitting overseas clinical data is not prohibited. We are considering how to recognize clinical data from overseas products."