March 11, 2025

The Health Insurance Review and Assessment Service (HIRA) has announced the results of its research on the 「Development of Guidelines for Generating Economic Evidence」 concerning digital therapeutics (DTx). This research aims to support the generation of economic evidence necessary for determining whether a DTx qualifies for reimbursement and for setting relative value points (or maximum reimbursement price, MRP) during its temporary listing period.

The study examines the economic evaluation guidelines and assessment cases in key markets (UK, US, Germany, Canada and Australia) and proposes guidelines for generating economic evidence for DTx in Korea. For reference, the economic evaluation guidelines for DTx largely follow the structure and content of pharmaceutical economic evaluation guidelines while incorporating the unique characteristics of DTx. Specifically, the research suggests eight key considerations (perspective, analysis period, target population, analysis methods, selection of comparators, data sources, costs, outcomes) for the final economic evaluation of DTx, as outlined below.  

(Perspective) Maintain the healthcare system perspective, consistent with pharmaceutical economic evaluation guidelines. Economic evaluation data generated under the DTx economic evaluation guidelines will serve as a reference for determining health insurance reimbursement (covered/non-covered status) and payment rates while acknowledging the significant uncertainty in measuring social costs (e.g., productivity gains, improved treatment efficiency, cost savings, etc.) associated with digital healthcare technologies.

(Analysis Period) It is recommended that the evaluation period be sufficiently long to verify the primary clinical outcomes, while it is not advisable to assume that the effects observed during the study period will continue beyond that period. If such assumptions are made, they must be based on appropriate supporting evidence.

(Target Population for Analysis) It is additionally noted that DTx may be more cost-effective in age groups familiar with digital technology, and therefore, special attention should be given to ensure that the analysis population aligns with the intended reimbursement population.

(Analysis Methods) Considering the technological characteristics of digital healthcare technologies and the insufficient clinical evidence, budget impact analysis has been added as an evaluation method.
If a manufacturer seeks a higher reimbursement rate than the temporary listing price by demonstrating superior cost-effectiveness compared to existing registered medical technologies with similar purposes, submission of cost-effectiveness (or cost-utility) analysis results should be considered.

(Selection of Comparators) The most commonly used medical technologies (e.g., DTx, pharmaceuticals, etc.) should be selected as comparators. However, considering that DTx can serve as complements to existing treatments, it is also stated that a control group not using DTx for the same disease or condition may be selected as a comparator.

(Data Sources) The economic evaluation guidelines for DTx maintain the fundamental principle of selecting data sources with minimal risk of bias. However, in cases where no published studies are available, it is stated that data prospectively collected and analyzed by the manufacturer during the temporary listing period may also be used. Additionally, it is noted that the effectiveness of DTx may be influenced by sociocultural factors, and thus, a preference is given to studies conducted on domestic populations.

(Costs) Costs related to productivity are not included. As the evaluation of temporarily listed DTx is expected to primarily rely on actual usage data, it is additionally stated that the cost calculation should be based on the actual expenditure during the temporary listing period (either the temporary listing price or the out-of-pocket price for non-reimbursed use).

(Outcomes) The guideline maintains the principle of conducting cost-effectiveness analysis based on final outcomes. Additionally, it is stated that both health benefits and non-health benefits (e.g., improved accessibility, increased efficiency, etc.) should be reported.

Meanwhile, HIRA is reportedly planning to initiate a commissioned research project within the year to “establish criteria for evaluating the reimbursement eligibility of DTx and a pathway for permanent listing”. For reference, this commissioned research is expected to include detailed assessment criteria for evaluating the value of DTx by technology type, reasonable compensation models, a post-listing management framework for permanently listed digital therapeutics, etc.

Please refer to the above information as a reference when
generating economic evaluation data for DTx.
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and global export of medical devices.

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