ASOURCE Times

From 2020 in Japan,
Medical App Approved by Pharmaceutical Affairs and Covered by Insurance

Currently, there are various applications used in the medical field. There are health management apps for health maintenance and disease prevention, and disease management apps for patients. There are prescribed therapeutic apps (table below).

These distinctions depend on the policies of the companies publishing the apps. Treatment apps are prescribed by doctors following the same process of pharmaceutical approval and insurance coverage as pharmaceuticals and medical devices. On the other hand, symptom recording apps are freely used by patients as a support tool for medical care, regardless of whether they are covered by public health insurance or advised by a doctor. Symptom recording apps include apps that record side effects of cancer drug therapy and are used to communicate with medical professionals.

Currently, the therapeutic apps that have been approved by the Japanese regulatory affairs are “CureApp SC Nicotine Dependence Treatment App and CO Checker” (approved in 2020, covered by insurance) and “CureApp HT”, a hypertension treatment assistance app (approved in 2022, covered by insurance). , “Susmed Med CBT-i App for Insomnia Disorder” (approved in 2023). "Treatment AppⓇ" is registered as a trademark by CureApp. In this article, we will use the term “therapeutic app” to distinguish it.

Whether the patient feels value
Key to popularization of therapeutic apps

The good thing about therapeutic apps is that they connect “medical care” and “lifestyle”. Physicians cannot accurately confirm whether patients are taking prescribed medicines properly, and patients cannot consult with them outside of consultation hours. Therapeutic apps are useful in the daily lives of patients, where medical care is not available.

For example, "CureApp SC Nicotine Dependence Treatment App and CO Checker" is prescribed in combination with varenicline, a smoking cessation aid, so patients always visit a smoking cessation clinic. And if you feel like quitting in front of a doctor, but want to smoke when you're alone at home, the app will help you with chat. You can also know when you want to smoke while looking at the record that you entered the smoking cessation status. The doctor will also look at the patient's records and advise. It's like having a doctor or tutor at home, so to speak.

CureApp's therapeutic app clinical trials were double-blind with a control app that didn't contain the core of the treatment. The number of current prescriptions and usage is unclear. Some official data on app prescribing should be available by early next year, including when the just-approved Susmed app is covered by insurance.

In Japan, smartphone apps have received pharmaceutical approval and insurance coverage. It is possible to treat people with social phobia, such as immersive training, which cannot be done with smartphones.

In this way, therapeutic apps are expected to be effective in areas where behavior modification and training are necessary for chronic diseases and symptoms. Another advantage is that there are no direct side effects on the body.

On the other hand, therapeutic apps are not without concerns.

One is whether the patient feels worth paying for the app. "CureApp SC nicotine addiction treatment app and CO checker" costs 7620 yen per month at 30% copayment, excluding smoking cessation aids. "CureApp HT" costs about 15,000 yen in half a year with a 30% burden. Since treatment apps are medical devices, they cannot advertise directly to patients, and it is difficult to convey value to patients.
　
The other is that it is necessary to teach patients how to use the app at the medical institution that prescribed it. Whether the medical institution has the capacity to teach users how to download apps, enter prescription codes, etc.

That said, compared to pharmaceuticals, therapeutic apps are characterized by lower R&D and clinical trial costs. If the two therapeutic apps, which are covered by health insurance in Japan, become popular and show their effectiveness, the hurdles to approval will be lower than before. Currently, not only pharmaceutical and medical device companies but also companies from other industries are starting to enter the market. Susmed's new therapeutic app is expected to be covered by insurance around the end of 2023.

As with pharmaceuticals and medical devices, there will likely be competing apps. The time may come when we will be able to use them according to age, gender, and preferences. In addition, it is possible that there will be entertainment added that cannot be achieved with pharmaceuticals and medical devices, such as characters growing up and earning points when used. This may encourage patients to actively participate in treatment.

Digital medical information is now essential for management and clinical decisions about what to include and what not to include. Regardless of whether or not they actually prescribe therapeutic apps, I hope medical professionals are aware of these developments.