[The Editors' Verdict] A New Opportunity: The Development of Digital Therapeutics

To cure diseases, surgery or procedures are performed and medications are prescribed. Medications are substances made from synthetic compounds or natural ingredients that are applied, ingested, or injected. Until now, all medications have been in hardware form. However, recently, software-based therapeutics have been gaining attention as the future of new drugs. These are digital therapeutics.

In fact, methods using applications (apps) such as games to treat or assist in disease management have been attempted for a long time. Academic studies have shown that computer games significantly reduce the pain of burn patients suffering from severe pain, with patients playing games experiencing up to 50% less pain compared to those who do not play games. It has been found that combining medication with virtual reality technology is more effective than using painkillers alone.

Digital therapeutics were officially recognized as medicine in September 2017. The U.S. Food and Drug Administration (FDA) first approved the sale of this new concept of drug, drawing attention. The first digital therapeutic approved was "reSET," a software-based medicine developed to treat addiction to alcohol or drugs. This product is an app software that provides the psychiatric treatment method called "cognitive behavioral therapy" and can be used via smartphones. reSET treats patients using various content such as text, video, animation, and graphics.

To receive formal FDA approval, digital therapeutics must secure concrete clinical data verifying their effectiveness, just like oral or injectable new drugs. In clinical trials conducted on about 400 patients with addiction, reSET demonstrated outstanding performance. The group treated only with conventional methods such as medication had an abstinence maintenance rate of only 17.6%, whereas the group that used reSET alongside reduced conventional treatments showed a higher abstinence maintenance rate of 40.3%.

So far, a total of three digital therapeutics have received FDA approval for treatment purposes, and several others are under FDA review. In Korea, digital therapeutic development is actively underway, but no cases have yet received approval or review from the Ministry of Food and Drug Safety. There is one case where a clinical trial for digital therapeutic approval was first approved by the Ministry.

In the future, digital therapeutics are expected to be used not only for brain-related diseases such as Alzheimer's disease, autism, attention deficit hyperactivity disorder, schizophrenia, multiple sclerosis, and insomnia?which are known as difficult-to-treat diseases due to challenges in new drug development?but also for lifestyle and behavioral changes leading to treatments for diabetes, hypertension, respiratory diseases, and more.

In the United States, where drug addiction and similar issues have become serious social problems, digital therapeutics that have undergone clinical trials are approved through a fast-track process. On the other hand, in Korea, step-by-step regulations for recognizing digital therapeutics have not yet been established, and a new innovative medical device approval system needs to be promptly prepared. Institutional support is necessary to resolve uncertainties regarding insurance coverage so that doctors can prescribe digital therapeutics in medical settings and patients can use them in daily life.

Digital therapeutics, known as IT new drugs, utilize data. Korea passed the Data 3 Act earlier this year, making the handling of related big data easier. With the world’s leading 5G infrastructure, the environment for fast information use via smartphones is also in place. As an IT powerhouse, Korea has gained a very good opportunity in digital therapeutics. There is no time to hesitate; we must move forward swiftly.

Im Juhwan, Advisor, Korea Information and Communication Industry Association