[Exclusive] Korea's First Digital Therapeutics Prescription Starts on the 16th... Seoul National University Hospital and Severance Launch 'Somz' for Insomnia

Started 11 Months After MFDS Approval
Non-Reimbursable Cost 200,000~250,000 KRW... Cheaper Than Cognitive Behavioral Therapy
Opportunity for Digital Therapeutic Device Industry Advancement

The first domestically produced digital therapeutic device (DTx) for insomnia, 'Somz,' will begin official prescriptions for patients on the 16th. The first clinical prescription of Somz is expected to serve as a catalyst for the advancement of the domestic digital therapeutic device industry and the expansion of the related market.

Aimmed's digital insomnia treatment device 'Soms'
Photo by Aimmed

A representative from AimMed, the developer of Somz, stated on the 5th, "On the 16th, the first prescriptions of Somz for insomnia patients will be made at Seoul National University Hospital and Severance Hospital." They added, "Samsung Seoul Hospital, Korea University Anam Hospital, Yongin Severance Hospital, and Wonju Severance Christian Hospital have also completed all related procedures, including review by the Institutional Review Board (IRB), and plan to begin actual prescriptions within this month." These medical institutions are participating in the innovative medical technology research that AimMed is conducting for the commercialization of Somz. Furthermore, starting in April, when the next phase of innovative medical technology, the 'clinical care' stage, begins, primary care institutions such as local psychiatric clinics will also be able to use Somz for insomnia treatment. Somz has been proven in clinical trials to statistically significantly improve the severity scale of insomnia in the experimental group compared to the control group.

DTx refers to "software medical devices that provide evidence-based therapeutic interventions to prevent, manage, or treat medical disorders or diseases." Insomnia patients install the Somz DTx app on their smartphones according to a doctor's prescription and undergo six weeks of sleep habit education and behavioral interventions at home as part of the treatment. Compared to traditional cognitive behavioral therapy received through direct hospital visits, this method saves time and costs, and allows doctors to continuously monitor the patient's condition.

Initially, insomnia DTx prescriptions were limited to psychiatry departments, but ahead of the prescription launch, the Ministry of Health and Welfare removed the restriction on medical specialties, allowing prescriptions across all departments. This is also expected to help expand the related market. However, since it is still early in the prescription phase, AimMed plans to supply the device only to psychiatry departments for the time being.

In February last year, Oh Yu-kyung, Commissioner of the Ministry of Food and Drug Safety, held a briefing regarding the approval of the country's first digital therapeutic device for insomnia.
[Image source=Yonhap News]

This prescription comes 11 months after Somz was approved by the Ministry of Food and Drug Safety in February last year. Following this, Welt's 'Welt-i' was approved as the second insomnia DTx. In October last year, the government introduced a 'DTx provisional listing plan,' which opened the way for commercialization. The government granted DTx developers the option of 'selective reimbursement,' which covers either non-reimbursed costs or 90% of the patient's out-of-pocket expenses under health insurance.

AimMed chose the non-reimbursed option. A company representative explained, "We judged that medical staff prescribing DTx prefer non-reimbursed options," adding, "We believed that non-reimbursed coverage is more appropriate initially to broaden the base." The price was set at around 200,000 to 250,000 KRW for one treatment cycle of six weeks. This is lower than the approximately 300,000 KRW patient out-of-pocket cost for six weeks of existing reimbursed cognitive behavioral therapy, aiming to secure price competitiveness.

The Health Insurance Review and Assessment Service plans to strengthen monitoring to prevent indiscriminate non-reimbursed prescriptions. They will disclose non-reimbursed prices by institution, mandate claims for prescription details such as the number of administrations, and consider restricting non-reimbursed prescriptions if problems arise.

Meanwhile, Welt, the developer of Welt-i, is also preparing for domestic prescriptions. Kang Sung-ji, CEO of Welt, said, "Since Somz was approved first, we are paying close attention to the results it will achieve."