고비용의약품 국내외 급여관리제도 비교 연구

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고비용의약품재정효율화신약의 환자접근성환자 참여high-cost medicinesfinancial sustainabilityaccessibility to new medicinespatients involvementHIRAHealth Insurance Review & Assessment
Recently, ultra high-cost medicines that are completely different from existing
concepts, such as Advanced Therapy Medicinal Products(ATMP) and one-time gene therapy, are being developed. Along with the increase in applications for health insurance reimbursement, an increase in health insurance finances is expected, raising concerns about the financial sustainability of health insurance. In addition, the government continues to pursue policies to strengthen coverage for anticancer drugs and rare disease treatments, and social demand for expensive drugs is also increasing. In addition, high-cost drugs are characterized by high prices and financial impact, but there is clinical uncertainty in the actual clinical settings after marketing. In addition, it is necessary to prepare a comprehensive high-cost medicines reimbursement management plan from the insurer's perspective. Accordingly, this study investigates domestic and foreign high-cost drug reimbursement management systems, and through trend consideration and status analysis, we aim to derive implications related to the domestic high-cost drug reimbursement management system and suggest improvement measures. Through a review of domestic and international literature, we reorganized the WHO drug innovation and accessibility improvement policy framework for Korea and 7 major countries (United Kingdom, France, Germany, Italy, Canada, Australia, Taiwan) to suit the domestic situation, and provided high-cost drug coverage in line with the analysis framework. We reviewed literature related to the current status, including the management system and patient opinion collection procedures. In addition, stakeholder opinions on the introduction of a separate fund were collected through analysis of cases of domestically registered high-cost drugs and performance of FGI and IDI. The appropriate definition of high-cost drugs is an annual medication cost of approximately KRW 100 million (KRW 94 million) per person based on the amount, based on the analysis of domestic and international literature and regulations, including the maximum payment level by health insurance, and analysis of claims data and collection of stakeholder opinions through FGI & IDI. Appear. The characteristics of high-cost drugs are mostly biological drugs, anticancer drugs, and rare disease treatments, and although they have a large financial impact, they appear to have a large clinical uncertainty when making decisions. Issues related to high-cost drugs include the affordability of insurers due to high drug prices and financial burden, financial sustainability issues, the need for follow-up management to resolve clinical uncertainty when making new drug decisions, and the need for social consensus on issues of equity in resource expenditure. Domestic high-cost drug-related systems include economic evaluation, essential drugs for medical treatment, risk sharing system, economic evaluation exemption system, prior approval system, and expansion of reimbursement standards. As a result of reviewing the current status of high-cost drug-related systems in seven major countries, the UK is operating an advanced system of various high-cost drug-related systems, including horizon scanning, early access system, ICER threshold increase, managed benefit contract, separate fund, and patient participation system. There is. France seeks to improve accessibility to rare disease treatments through horizon scanning, a managed benefit contract centered on a financial-based system, and the early access system (ATU) , and also has a patient participation system. Germany is seeking to improve accessibility to new drugs by operating the Early Benefit Assessment (EBA) system for new drugs and drugs with expanded reimbursement standards. In addition, there are managed benefit contracts, legal reimbursement, and patient participation systems. Italy is a country that widely implements managed benefit contracts and is also operating an early access system and separate funds. Canada is a country that implements various systems related to high-cost drugs, including horizon scanning, early access system, managed benefit contract, separate fund, prescription drug price and cost management, and patient participation system. Australia is a country that implements a prior approval system, and in addition, there are managed benefit contracts , separate funds, and patient participation systems. In Taiwan, a prior authorization system, managed benefit contract , and patient participation system are being implemented. As an analysis of cases of high-cost drugs registered domestically, the registration methods of each country were compared for Spinraza , Zolgensma , and Hemlibra , three representative high-cost drugs, and the registration methods of each country differed depending on the national institutional environment. Most of them were applying prior approval systems, early access systems, and performance-based risk sharing/benefit management systems. As a result of in-depth interviews about the separate fund, most of them said that a separate fund was needed because expensive rare disease treatments and anticancer drugs were being developed. The direction of system improvement was to prioritize maintenance and improvement within the current system, while activating a patient-level performance-based risk sharing system, and a separate fund was proposed as a mid- to long-term improvement plan. Through domestic and international literature review, claims data analysis, registration case analysis, in-depth interview results, etc. As a result of reviewing the current status and implications of high-cost drug-related systems in Korea and seven major countries, measures to improve the domestic system are as follows. Priority is given to strengthening the existing system and maximizing its efficiency. In the short term, it is necessary to strengthen the approval-evaluation linkage system, improve the prior approval system, improve the competitiveness exemption system, and
establish and strengthen the expensive drug follow-up management system. From a mid- to long-term perspective, it is necessary to review the possibility of introducing foreign innovative systems through the process of social public discussion on innovative payment models, such as the early access system.
Alternative Title
Comparative study of domestic and foreign countries’ pricing and reimbursement schemes for high-cost medicines
Table Of Contents
제1장 서론 ······································································· 1
1. 연구 배경 및 필요성 ··············································································· 1
2. 연구 목적 ······························································································ 2
3. 연구 내용 및 방법 ·················································································· 3

제2장 고비용의약품의 정의와 특성, 현황 ······································································· 7
1. 고비용의약품의 개념 및 정의 ··································································· 9
2. 고비용의약품의 특성 및 현황 ································································· 25
3. 고비용의약품 관련 쟁점 ········································································ 30
4. 소결 ···································································································· 33

제3장 국내 고비용의약품 관련 제도 개요와 현황 ······································································· 35
1. 고비용의약품 관련 제도 개요와 현황, 성과 ············································ 37
2. 환자단체 관련 이슈 및 현황 ·································································· 49
3. 소결 ···································································································· 57

제4장 주요 7개국의 고비용의약품 관련 제도 현황 ······································································· 61
1. 영국 ···································································································· 63
2. 프랑스 ································································································· 82
3. 독일 ·································································································· 109
4. 이탈리아 ···························································································· 126
5. 캐나다 ······························································································· 132
6. 호주 ·································································································· 145
7. 대만 ·································································································· 163
8. 소결 ·································································································· 173

제5장 국내 등재 고비용의약품 사례 분석 ······································································· 179
1. 대상 선정 및 분석 내용 ······································································ 181
2. 대상 약제 사례 분석 ·········································································· 182
3. 소결 ································································································· 244

제6장 심층면접(FGI와 IDI) ······································································· 249
1. 개요 ·································································································· 251
2. 설문지 ······························································································· 255
3. 심층면접 결과 ···················································································· 256
4. 소결 ·································································································· 287

제7장 결론 및 제언 ······································································· 291
1. 결론 ·································································································· 293
2. 국내외 고비용의약품 급여관리제도 비교 분석 및 평가 ···························· 309
3. 정책 제언 ·························································································· 311
4. 연구의 의의 및 한계점 ········································································ 315

◾ 참고 문헌 ····················································································· 316
◾ 부록 ····························································································· 335
◾ ABSTRACT ················································································· 337
김유정. (2024-03). 고비용의약품 국내외 급여관리제도 비교 연구.
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