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Due to the epidemic of the new coronavirus infection, there has been a lot of interest in "online medical treatment", which allows medical treatment without face-to-face, but digital treatment apps that enhance treatment effects by causing changes in behavior other than when going to the hospital are also becoming popular in the new normal era. It may be a new treatment option. Digital therapy is a treatment method that works to change the behavior of patients who have not been targeted by conventional treatments. Similar to pharmaceuticals and medical devices, the effects have been proven through the process of approval and insurance reimbursement through the creation of evidence through clinical trials. It refers to a medical device that has been It is said to be the third treatment after pharmaceuticals and medical devices. It is expected to contribute to individual optimization of therapeutic effects for patients, prevention of aggravation, and reduction of the workload of doctors. As a mechanism, the application is installed (downloaded) on the patient's smartphone or tablet according to the doctor's prescription and used. When a patient enters information such as their physical condition, the algorithm built into the app analyzes it and provides personalized medical advice to the patient at the optimum timing, while providing detailed support and treatment until the next visit. Sustain the desire to continue.

The earliest developed digital therapeutic app is BlueStar, an app for diabetes patients developed by Welldoc in the United States. It was approved as a medical device by the US Food and Drug Administration (FDA) in 2010 and is sold in the US and Canada. BlueStar's development cost is about one-tenth that of pharmaceuticals, and the HbA1c lowering effect in clinical trials was 1.2% (combined use with existing drugs), exceeding the effect of new drugs. When diabetic patients enter their daily blood sugar levels into the app, they can receive information from the app such as personalized dietary guidance, messages encouraging exercise, and the appropriate dosage of insulin. In Japan, Astellas Pharma has partnered with the company to proceed with development.

In addition, the digital therapeutic application "AKL-T01", which is indicated for improving inattention symptoms in children with attention-deficit hyperactivity disorder (ADHD), has received approval from the US Food and Drug Administration (FDA), and has also received the CE mark in Europe. I'm here. Developed by Akill Interactive Labs, it uses an app to improve inattention symptoms for ADHD in children aged 8-12. It is designed to activate the prefrontal cortex of the brain, which plays an important role in cognitive function. is improved. In clinical trials, we used the attention function score, an objective evaluation method for attention and inhibitory control, and examined the amount of change in the Attention Performance Index. Noticed an improvement. In Japan, Shionogi & Co. has obtained the marketing rights for "AKL-T01" from Akill Interactive Labs and is proceeding with clinical trials.

Japan's first treatment app for nicotine addiction, "CureApp SC nicotine addiction treatment app" was launched by Cure App in December 2020 after undergoing clinical trials, regulatory approval, and insurance coverage. Patients measure the carbon monoxide concentration in their exhaled breath, which increases when they smoke, with a dedicated device every day, record it in the app, and enter their medication status and side effects. The doctor will check the information entered by the patient on the doctor's app and use it for subsequent examinations. In the clinical trial, the smoking cessation rate from 9 to 52 weeks in the standard smoking cessation treatment group was 41.5%, but in the group using the app it was as high as 52.3%. The app is said to have already been introduced by more than 100 medical institutions. The company has also developed an app for treating hypertension, and submitted a regulatory application in May of this year. Based on the patient's daily blood pressure and lifestyle records at home, treatment guidance tailored to the individual patient's situation is displayed to encourage changes in awareness and behavior. In the clinical trial, 390 patients with untreated hypertension were tested. In the group that underwent standard lifestyle changes (control group), 24-hour systolic function by ambulatory blood pressure measurement (ABPM) after 12 weeks The change from baseline in blood pressure was -2.5 mmHg, but in the app group it was -4.9 mmHg, indicating a significant antihypertensive effect. A blood pressure reduction of 2.4 mmHg, which is the difference between the two groups, is thought to reduce the risk of developing cerebrovascular disease by 10.7%.

Susmed is developing an app to treat insomnia with cognitive-behavioral therapy (CBT) and has conducted clinical trials with more than 100 people. Patients receive regular CBT sleep programs through a smartphone app. Face-to-face CBT is conducted for 30 to 60 minutes at a time, but it is said that it is spread out every day.

Regarding digital therapeutic applications, the Pharmaceuticals and Medical Devices Law was amended in 2014, making it possible to treat software as a "medical device program." As a result, the development of digital therapeutic apps to support patients in each disease area is accelerating. In the post-corona era, digital therapeutic apps that enhance therapeutic effects by encouraging behavioral changes outside of hospital visits are expected to become a new treatment option.