Korea approves its first digital medical treatment

Industry

Published: 16 Feb. 2023, 17:56 Updated: 16 Feb. 2023, 19:10

Korea approves its first digital medical treatment

Somzz, a digital treatment device for insomnia, keeps track of the sleeping patterns of the patient. [AIMMED]

A digital medical treatment has been approved for the first time ever by Korea.

The Ministry of Food and Drug Safety licensed “Somzz,” a cognitive behavioral therapy for insomnia (CBT-I) app developed by Aimmed as Korea’s first digital treatment device on Wednesday.

A digital treatment device is a software-based program that prevents, manages and treats a medical disorder or disease. These devices are classified as medical devices and not drugs and are referred to as “next-generation cures” following synthetic drugs and biomedicines because they are used to treat disease.

“This is a software-based medical device that turns CBT-I into a mobile application,” Food and Drug Safety Minister Oh Yu-kyung said in a press briefing held at the ministry in Cheongju, North Chungcheong. “It provides us with a new method of treatment other than drugs.”

CBT-I is a program that helps people who have difficulty falling asleep, staying asleep and feeling refreshed after sleep. Its six-session treatment aims to remove psychological, behavioral and cognitive factors that disturb sleep through sleep evaluation, stimulus control, sleep restriction, sleeping habit training, cognitive treatment and relaxation therapy.

Currently, sleeping disorders are treated with or without medications. Non-medication treatment, like the CBT-I, is considered as the first line of defense against sleeping disorders before medications because sleeping pills have a risk of side effects such as drug resistance.

A total of 684,560 insomnia patients were counted in 2021, according to the Health Insurance Review and Assessment Service.

“Acute insomnia can be treated with a short-term prescription,” Kyung Hee University psychiatry professor Baek Jong-woo said. “But for chronic insomnia, the healthiest method to beat it is to improve sleeping habits.”

Once Somzz is commercialized, patients with a doctor’s prescription can download the app on their smartphones to take the six-session program for six to nine weeks.

“Patients can access the app with the authentication key provided by their doctor,” the ministry’s director for novel products approval Kim Nam-soo said, which meant that patients no longer have to go through a 10-week long therapy involving a face-to-face appointment each week.

Oh said the ministry will cooperate with Aimmed, a Korean company, to make the app more interesting and easy for users who have to take the months-long digital treatment.

Food and Drug Safety Minister Oh Yu-kyung speaks in a press briefing held at the ministry in Cheongju, North Chungcheong, on Wednesday morning. [YONHAP]

Patients who used Somzz showed statistical improvements in their disorder symptoms during the clinical tests held in three local institutions, according to the ministry. Of the tested patients, 46 percent returned to healthy sleeping rhythms.

“There is not much to worry about because the digital medical device is not used directly on the body,” said medical device safety bureau director Chae Gyu-han in regard to the app’s safety.

Next on Somzz’s road to commercialization is setting the fee. According to the Ministry of Health and Welfare, CBT-I costs 50,000 won ($39) per session. Patients pay around 30 percent of that after health insurance.

Doctors can prescribe Somzz to patients as uninsured after the Health Ministry lists the product as an innovative medical technology. It can be insured after a deliberation committee.

“We will closely coordinate with the Health Ministry and involved institutions to have its market value recognized and assist a prompt market entry,” the Food Minister said.

Digital treatment devices are licensed and prescribed in 14 countries, including the U.S., Germany and Britain. The U.S. licensed its first digital treatment device, reSET, in 2017 for drug rehabilitation and Britain licensed Sleepio, also an insomnia treatment app, in May 2022.

The size of the global digital treatement device market is to grow by 20.6 percent each year to reach $23.6 billion, or 30 trillion won, according to the U.S. market research firm Allied Market Research. In Korea, another digital treatment product for insomnia is currently in a clinical test phase.

Digital treatment devices in Korea were mostly developed for treating insomnia and addiction, but in 2022, devices for other disorders and diseases, such as Attention Deficit/Hyperactivity Disorder (ADHD), mild cognitive impairment (MCI) and depression, are being developed.

“The first-ever digital treatment device licensing paves a new road to utilize digital treatment device for improving people’s health, treating disease and disorders digitally,” the Ministry of Food and Drug Safety said in a report.

BY HWANG SOO-YEON,SOHN DONG-JOO [sohn.dongjoo@joongang.co.kr]