'State-level preparations needed for chronic disease DTx' – KBR

The Covid-19 pandemic led to much attention and the use of digital therapeutics (DTx) worldwide.

Experts said DTx would be used to treat chronic diseases, but Korea needs a national preparation such as a dedicated body to promote DTx.

Korea should prepare for the use of DTx at the national level, a report said.

A research team at the Health Insurance Review and Assessment Service (HIRA), led by Lee Jin-yong, director of the HIRA’s Research Institute, published a paper, “Reimbursement of Digital Therapeutics: Future Perspectives in Korea,” in the Korean Circulation Journal.

The research team said DTx dealing with various diseases such as hypertension is expected to be developed shortly and that the demand for DTx will increase.

“Therefore, it is urgent to define and prepare for DTx, relevant support systems, and health insurance coverage listings,” the research team said. “Several support systems must be considered, including government subsidies, science/technology funds, and health insurance.”

Digital healthcare expands from wellness to disease prevention or management and even treatment. Therefore, as people’s awareness of contactless healthcare improved due to Covid-19, Korea should expand the support and the scope of application for DTx, just like other countries, the research team said.

DTx is mostly developed to treat mental health, but the treatment areas are expanding to chronic diseases such as hypertension and diabetes.

The HIRA’s research team noted that chronic diseases are closely related to lifestyles such as physical activity, smoking, and eating habits. Therefore, DTx can help manage chronic diseases by encouraging lifestyle changes and reducing the socio-economic burden of chronic diseases.

“DTx is expected to meet new medical demands and create value in terms of the economy, and many countries are preparing policies to support DTx,” the research team said.

The FDA has recently eased its regulations on digital technologies to improve access to medical services under the constraints of Covid-19.

Each country has different definitions, regulations, evaluations, and support measures for DTx.

To reduce DTx-related financial burdens, countries are supporting costs for the development and use of DTx, the research team said. Thus, Korea needs to prepare for the introduction and expansion of DTx at the national level.

According to the research team, Germany provides financial support for the development of DTx through the Innovation Fund (Innovationsfonds), which is funded by German Health Insurance (Gestzlicher Krankenversicherung, GKV).

Japan declared Digital Transformation action strategies in healthcare for SaMD (software medical device), called “DASH for SaMD,” to support the foundation for DTx development in 2020.

In Korea, the research team said that rather than setting a different standard to introduce DTx in the Korean health insurance system, it would be more reasonable to set the scope of health insurance coverage according to the existing criteria and procedures.

As DTx are treated similarly to drugs, the remaining challenges are price setting and determining the details of reimbursement.

“When DTx is used to aid in the application of medical services provided by doctors, it may be best to implement a combined reimbursement method that includes service fees and costs of treatment materials,” the research team said.

As the test of the effect of DTx is important, the U.K. considers usability assessment when making DTx coverage determinations. However, in Korea, the research team pointed out that usability assessment is not considered in the New Health Technology Assessment System.

The U.K. and Germany set a one- or two-year period for usability evaluation.

The health insurance coverage for DTx needs a reimbursement system considering the value of DTx, rather than the cost, from a long-term perspective, the research team suggested.

“In this regard, either a council should be organized to lead the coverage determination process, or a dedicated assessment committee should be established.”