HIRA examines the possibility of insurance benefits for digital therapies


The government has started to prepare reimbursement models to accelerate the commercialization of digital therapies (DTx).

The Medicare Review and Assessment Service (HIRA) recently published a report titled “The Concept of Digital Therapy and Examining the Possibility of Providing Medicare Benefits”.

The government released a report to prepare reimbursement models for digital therapies.

HIRA said that defining the reimbursement rates for the DTx is the most important issue because the DTx cannot be compared to any existing device.

“Unlike existing studies on DTx, this study was conducted with the benefits of health insurance in mind,” HIRA said. “It will be helpful when the nation introduces DTx in the future.”

The HIRA research team analyzed cases abroad and raised the possibility of granting benefits to “low-risk medical devices”, given the definition of DTx by the Ministry of Food Security and pharmaceutical.

Currently, the government does not have separate criteria for granting reimbursement for DTx and applies the same criteria used for existing medical devices.

If a DTx shows verified safety and efficacy in a new health technology assessment, the government assesses its eligibility for insurance benefits taking into account medical benefits, medical significance, therapeutic effect, cost-effectiveness, financial burden on patients and social benefits.

The research team said that if a DTx features equal or better technology with better cost efficiency, it would be better to introduce it to the domestic market.

Five countries – the US, UK, Germany, Japan and Australia – have requested comparative trials to approve DTx products as medical devices.

The United States, Japan and Australia have applied the same criteria for awarding insurance benefits for DTx as for existing medical devices.

The HIRA report also mentioned that if the impact of a DTx on government finances is significant, the government could conduct an economic assessment of the product.

Before determining reimbursement, the government should collect and assess the actual use of data from a DTx to prepare criteria for clinical efficacy, cost-effectiveness and usability testing, according to the report.

Regarding whether to compensate for DTx, the government should review experimental DTx based on clinical trial stages, the report continues.

As DTx products still lack evidence of efficacy and marginal costs are low, the government might consider offsetting the initial cost of an experimental DTx, he said.

The report cites a German case where the effect of offsetting the original costs for a certain period is tested.

The UK Program to Improve Access to Psychological Therapy (IAPT) did not involve financial support for DTx in the testing stages. Still, he identified the impact of DTx on UK healthcare spending, according to the HIRA report.

However, since compensation requires agreement between stakeholders, the Korean government should also consider the value of DTx and the impact of reimbursement on healthcare spending.

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