“State-level preparations required for chronic disease DTx”


The Covid-19 pandemic has drawn much attention and use of digital therapeutics (DTx) worldwide.


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


Korea should prepare to use DTx nationally, a report said.


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


The research team said that DTx to treat various diseases such as high blood pressure is expected to be developed soon and demand for DTx will increase.


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


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


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


The HIRA research team found that chronic diseases are closely related to lifestyles such as physical activity, smoking and eating habits. Therefore, DTx can help manage chronic disease by promoting lifestyle changes and reducing the socioeconomic burden of chronic disease.


“DTx is expected to meet new medical needs and create economic value, and many countries are preparing strategies to support DTx,” said the research team.


The FDA recently relaxed its regulations on digital technologies to improve access to medical services under Covid-19 restrictions.


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


To ease the financial burdens associated with DTx, countries are supporting the cost of developing and using DTx, the research team said. Therefore, Korea must prepare for the introduction and expansion of DTx at the national level.


According to the research team, Germany financially supports the development of DTx through the Innovation Fund, which is financed by the German Health Insurance (GKV).


Japan declared action strategies for healthcare digital transformation for SaMD (Software Medical Device), dubbed “DASH for SaMD” to support the foundation for DTx development in 2020.


In Korea, the research team said that it would make more sense to set the scope of health insurance coverage according to the existing criteria and procedures than to set a different standard for introducing DTx in the Korean health insurance system.


Since DTx are treated similarly to pharmaceuticals, the remaining challenges are pricing and determining the details of reimbursement.


“If DTx is used to support the application of medical services by physicians, it may be best to implement a combined reimbursement method that includes service fees and treatment material costs,” the research team said.


As testing the impact of DTx is important, the UK considers a usability assessment when determining DTx coverage. However, in Korea, the research team pointed out that the usability assessment is not considered in the New Health Technology Assessment System.


The UK and Germany specify a one or two year period for usability evaluation.


Health insurance coverage for DTx needs a reimbursement system that takes into account the value of DTx and not the cost from a long-term perspective, the research team suggested.


“In that regard, either a council should be organized to guide the process of determining coverage, or a dedicated evaluation committee should be set up.”

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