주요국 디지털 치료기기의 보건의료기술평가 현황과 시사점: 독일, 영국, 미국 발전과정을 중심으로
Health Technology Assessment of Digital Therapeutics; Developments in Germany, the United Kingdom, and the United States, and Implications for Korea
1
조회
0
다운로드
0
인용
0
참고문헌
키워드
초록
As evidence-based software programs to prevent, manage, and treat diseases and disorders, digital therapeutics (DTx) have emerged as a new type of interventions abroad and in Korea. Establishment of regulatory frameworks for DTx has been recognized as a key step to promote use. European countries like Germany and the U.K. apply health technology assessment (HTA) for DTx. Germany is the first country to create the fast-track process and assessment criteria for the reimbursement of prescription DTx by passing the Digitale-Versorgung-Gesetz (translated as Digital Healthcare Act) in 2019. The U.K.’s National Health Service (NHS) first created the evidence standard framework (ESF) for digital technology in 2018 and updated it in 2021. Compliance with the ESF is not a requirement and the framework can be used only as guidelines when NHS evaluates digital health technology to make a purchasing decision. Unlike Germany and the U.K., the U.S. have not yet established a framework for assessment and reimbursement of DTx. In 2023, Korea issued the draft guidelines for the reimbursement of DTx. According to the guidelines, a new DTx is to be listed provisionally for reimbursement from the National Health Insurance for three years. The rationale for the provisional listing is that the manufacturer collects data on the efficacy of DTx, which will later be used for the formal assessment of DTx. This paper will provide a detailed review of the developments in pioneering countries like Germany and the U.K. to inform policies regarding HTA and reimbursement of DTx in Korea.
Abstract
As evidence-based software programs to prevent, manage, and treat diseases and disorders, digital therapeutics (DTx) have emerged as a new type of interventions abroad and in Korea. Establishment of regulatory frameworks for DTx has been recognized as a key step to promote use. European countries like Germany and the U.K. apply health technology assessment (HTA) for DTx. Germany is the first country to create the fast-track process and assessment criteria for the reimbursement of prescription DTx by passing the Digitale-Versorgung-Gesetz (translated as Digital Healthcare Act) in 2019. The U.K.’s National Health Service (NHS) first created the evidence standard framework (ESF) for digital technology in 2018 and updated it in 2021. Compliance with the ESF is not a requirement and the framework can be used only as guidelines when NHS evaluates digital health technology to make a purchasing decision. Unlike Germany and the U.K., the U.S. have not yet established a framework for assessment and reimbursement of DTx. In 2023, Korea issued the draft guidelines for the reimbursement of DTx. According to the guidelines, a new DTx is to be listed provisionally for reimbursement from the National Health Insurance for three years. The rationale for the provisional listing is that the manufacturer collects data on the efficacy of DTx, which will later be used for the formal assessment of DTx. This paper will provide a detailed review of the developments in pioneering countries like Germany and the U.K. to inform policies regarding HTA and reimbursement of DTx in Korea.
참고문헌 (32)
- "Pear Therapeutics obtains FDA clearance of the first prescription digital therapeutic to treat disease"[URL]
- "The fast-track process for digital health applications (DiGA) according to section 139e SGB V. A guide for manufacturers, service providers and users"[URL]
- "Digital Health Global Market report 2023:ease of access, shorter development timelines and decreased cost of treatment bolster demand - ResearchAndMarkets.com"[URL]
- Korea Health Industry Development Institute, "Regulatory cases and issues responding to technological innovation Ⅱ: reimbursement for newly emerging medical technologies in digital health" (2023), Korea Health Industry Development Institute
- "Digital therapeutics (DTx)"[URL]
- "Understanding DTx"[URL]
- Phan P, "Digital therapeutics in the clinic", Bioeng Transl Med, 8, pp.e10536~ (2023)
- Wang W, "Economic modeling of reSET-O, a prescription digital therapeutic for patients with opioid use disorder", J Med Econ, 24, pp.61~68 (2021)
- Velez FF, "Real-world reduction in healthcare resource utilization following treatment of opioid use disorder with reSET-O, a novel prescription digital therapeutic", Expert Rev Pharmacoecon Outcomes Res, 21, pp.69~76 (2021)
- Sapanel Y, "Economic evaluation associated with clinical-grade mobile app-based digital therapeutic interventions : systematic review", J Med Internet Res, 25, pp.e47094~ (2023)
- van Kessel R, "Mapping factors that affect the uptake of digital therapeutics within health systems : scoping review", J Med Internet Res, 25, pp.e48000~ (2023)
- Prodan A, "Success factors for scaling up the adoption of digital therapeutics towards the realization of P5 medicine", Front Med(Lausanne), 9, pp.854665~ (2022)
- "Driving the digital transformation of Germany’s healthcare system for the good of patients"[URL]
- Fürstenau D, "Digital therapeutics(DTx)", Bus Inf Syst Eng, 65, pp.349~360 (2023)
- Brönneke JB, "Dynamic HTA for digital health solutions : opportunities and challenges for patient-centered evaluation", Int J Technol Assess Health Care, 39, pp.e72~ (2023)
- Lauer W, "Digital health applications (DiGA):assessment of reimbursability by means of the “DiGA Fast Track”procedure at the Federal Institute for Drugs and Medical Devices (BfArM)", Bundesgesundheitsbl, 64, pp.1232~1240 (2021)
- Gerke S, "Germany’s digital health reforms in the COVID-19 era : lessons and opportunities for other countries", NPJ Digit Med, 3, pp.94~ (2020)
- Dittrich F, "Digital health applications from a government-regulated directory of reimbursable health apps in Germany-a systematic review for evidence and bias", Mhealth, 9, pp.35~ (2023)
- "Digital therapeutics in the United Kingdom"[URL]
- Unsworth H, "The NICE evidence standards framework for digital health and care technologies – Developing and maintaining an innovative evidence framework with global impact", Digit Health, 7, pp.20552076211018617~ (2021)
- Yan K, "The impact of digital therapeutics on current health technology assessment frameworks", Front Digit Health, 3, pp.667016~ (2021)
- "Evidence standards framework for digital health technologies"[URL]
- "Evidence standards framework for digital health technologies. Section C: evidence standards tables"[URL]
- "NICE recommends offering app-based treatment for people with insomnia instead of sleeping pills | News | News" (2022)[URL]
- "117th Congress (2021-2022): H.R.7051 - access to prescription digital therapeutics act of 2022"[URL]
- Patel NA, "Characteristics and challenges of the clinical pipeline of digital therapeutics", NPJ Digit Med, 3, pp.159~ (2020)
- 보건복지부, "의료기기산업 육성 및 혁신의료기기 지원법(시행 2020. 5. 1.) (법률 제16405호, 2019. 4. 30., 제정)", ~ (2020)
- 식품의약품안전처, "디지털치료기기 허가·심사 가이드라인", 식품의약품안전처, ~ (2020)
- 식품의약품안전처, "디지털의료제품법(시행 2025. 1. 24.) (법률 제20139호, 2024. 1. 23., 제정)", ~ (2024)
- 보건복지부, "디지털치료기기 건강보험 등재가이드라인", 보건복지부, 건강보험심사평가원, ~ (2023)
- 보건복지부, "2023년 제13차 건강보험정책심의위원회: 디지털치료기기·인공지능 임시등재 방안", 보건복지부, ~ (2023)
- Huh KY, "Clinical evaluation of digital therapeutics : present and future", Healthc Inform Res, 28, pp.188~197 (2022)