디지털 치료기기의 건강보험 적용방안

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디지털 치료기기디지털 치료제소프트웨어 의료기기디지털 헬스건강보험 등재수가Digital TherapeuticsSoftware as a Medical DeviceDigital HealthHealth Technology AssessmentReimbursement
This study was performed to prepare for the coverage of Digital Therapeutics (DTx) as a benefit under National Health Insurance (NHI) of the Republic of Korea. To this end, the study first examines the characteristics of DTx and then discusses how to incorporate DTx into the existing benefit listing procedure and pricing method. As part of this study, the researchers reviewed DTx-related benefit policies in countries such as the US, UK, and Germany, which have prior experience of introducing insurance coverage of DTx, and gathered the opinions of stakeholders in the DTx field in Korea by conducting one-on-one in-depth interviews (IDI). The key results of this study are presented below.
○ First, this study defined DTx that is eligible for coverageunder NHI as "prescribed DTx," which is used according to a physician's prescription. In addition, since DTx is managed by the Ministry of Food and Drug Safety (MFDS) as a medical device, it would likewise be appropriate for DTx to be classified as a non-pharmaceutical benefit (a medical procedure or medical supply) under NHI. Moreover, given that there is minimal intervention by a physician during the use of DTx and continued management of each device is necessary, reimbursement for DTx should be provided separately as a medical supply rather than indirectly as part of a medical procedure.
○ Second, considering the fast pace of technological advances for DTx, it would be appropriate for DTx to be subject to the "Innovative Health Technology Assessment" track in the New Health Technology Assessment (nHTA) stage. Furthermore, the level of clinical evidence required for approval of DTx by the MFDS is higher than that required for other health technologies and DTx is expected to improve the efficiency of the healthcare system in the long-term. Accordingly, this study proposes a way of supporting the use of DTx by temporarily listing DTx that has been selected for Innovative Health Technology Assessment as an NHI benefit.
○ Third, since the permanent listing of DTx as an NHI benefit could affect the health of the entire Korean population, it is
crucial that the safety and efficacy of DTx is evaluated against stringent criteria. In particular, the importance of demonstrating the clinical value of DTx through comparisons with existing benefits has been emphasized.
○ Fourth, the reimbursement for DTx is proposed to be based on the price of the DTx product and the medical fee for the prescribing physician’s service. This study suggests setting a price ceiling for DTx by applying a costing method based on the function points of software. Since this method arrives at a price based on the size and complexity of software functions, it essentially has similar aims as the existing value-based pricing in NHS. In addition, while a physician's efforts related to DTx were considered to be included in the scope of basic consultation fees, the cost of initial consultation and training on DTx use, which would be provided by non-physician staff, should be compensated separately.
The results of this study are presented in consideration of the early stages of incorporating DTx into the NHI system, without any DTx listed as NHI benefits. Therefore, it is crucial to improve the system in a flexible manner in the future by building on the policy experience gained through the process of coverage decision-making and the outcome of using DTx in real-world clinical contexts. In particular, although this study proposed including DTx in the existing benefit category of medical supplies for the time being, it may become more appropriate in the future to create a separate listing system for the digital health field, including DTx, considering its potential for growth and sustainability. Keeping this in mind, all relevant stakeholders, including the medical community, patients, industry, and government, should come together and continue to seek the most appropriate option for the Korean context.
Alternative Title
Approaches for National Health Insurance Coverage of Digital Therapeutics
Table Of Contents
제1장 서론 --------------------------- 1
1. 연구 배경 및 필요성 --------------------------- 1
2. 연구 목적 --------------------------- 2
3. 연구내용 및 방법 --------------------------- 3

제2장 디지털 치료기기의 개념 및 특성 --------------------------- 5
1. 디지털 치료기기의 개념 --------------------------- 5
2. 디지털 치료기기의 잠재적 가치 --------------------------- 11
3. 건강보험 적용 시 고려사항 --------------------------- 14

제3장 해외 사례 --------------------------- 19
1. 미국 --------------------------- 19
2. 독일 --------------------------- 31
3. 영국 --------------------------- 45
4. 소결 --------------------------- 60

제4장 이해관계자 의견 조사 --------------------------- 65
1. 조사 개요 --------------------------- 65
2. 조사 결과 --------------------------- 67

제5장 디지털 치료기기 건강보험 등재 방안 --------------------------- 77
1. 요양급여 결정신청의 대상 --------------------------- 77
2. 요양급여 등재절차 --------------------------- 84
3. 요양급여 전달체계 --------------------------- 93
4. 디지털 치료기기 보상 체계 --------------------------- 101

제6장 디지털 치료기기의 원가기반 가격 산정(안) --------------------------- 109
1. 검토 개요 ---------------------------109
2. 원가 산출기준 검토 --------------------------- 110
3. 사용량-가격 연동 --------------------------- 120
4. 디지털 치료기기 가격 산정(안) --------------------------- 127

제7장 결론 --------------------------- 129

참고문헌 --------------------------- 132

ABSTRACT --------------------------- 141

부 록 --------------------------- 145
심보람 et al. (202206). 디지털 치료기기의 건강보험 적용방안.
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