의약품 및 의료기기 생애주기별 국내외 급여 관리제도 비교

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HIRAHealth Insurance Review & Assessment Servicemedicinemedical technologymedical deviceapprovalreimbursementpost managementNational Health Insurancelife cycle
Korean society is aging rapidly and such trend is expected to result in high supply and demand of medicine and medical technology. The phenomenon is likely to lead to increased health expense of the National Health Insurance (NHI) fund, calling for management measures to secure appropriate reimbursement. Against this backdrop, ‘The First Comprehensive Plan of NHI’ has introduced diverse management systems for medicine and medical device, without much success due to conflicts between different programs and purposes. As such, rational and effective adjustment measures are required.

This study aimed to systematically and comprehensively review medicine and medical technology management systems on approval, reimbursement, and post management by life cycle. Based on the country comparison and analysis, the results of this study will serve as the baseline data for preemptive system improvement in response to changing health environment.

This study was largely based on literature review from Korea and abroad as well as consultation of experts in the field. In order to understand current status of reimbursement management systems on medicine and medical technology in Korea and abroad, we analyzed reports of international organizations, papers published in journals, and health-related governmental websites. In addition, interviews took place with professors with expertise and relevant enterprises.

In this study, the life cycle of a medicine and medical technology consisted of 5 stages: 1) research and development along with regulation and procedure check, 2) approval, 3) manufacture and distribution, 4) NHI coverage listing/reimbursement, and 5) post management. This study consolidated management systems of 7 reference countries (the
U.S., the U.K, France, Germany, Italy, Switzerland, Japan) as well as Australia and Canada for full cycle of medicine and medical technology of each country in an organized manner.

Conclusion and proposal
Korean medicine management system was found to be similar to those of comparison countries with the exceptions of Global Budget and Reference Pricing. There were some confusions coming from use of terminology, as Korea uses differentiated terms such as ‘medical technology’, ‘medical equipment’, and ‘medical device’ depending upon the function, objective, and lifespan of a medicine. Like other reference nations, Korea had systems of phased review, value assessment, and preliminary benefits in place, but it lacked Unique Device Identification (UDI) system for tracking. In regards to medical technology and post management, the level was lower than that of medicine, and reassessment cycle was sparser. The following is suggestions of this study based on such results.
First, systematic policy road map and reinforced consumption volume control measures are required. Korea has established and operated medicine management system on par with those of advanced countries, yet systematic inefficiency is an issue as there are hundreds of generic drugs for one medicine.
Second, current approval and reimbursement linkage in generic drug pricing system is limited to quality assurance feedback (bioequivalence test, use of registered drug master file), which requires further connection of patient health data of clinical trial. The mechanism should be prepared so that the effective use of approval – reimbursement linkage can be realized.
Third, terminology clarification and clean-up is necessary to improve consistency and reduce confusions in the area of approval, reimbursement, and post management. For example in medical technology system, the term ‘medical device’ used for medical supplies covered by NHI could be specified to ‘separately reimbursed medical device’, ‘not separately reimbursed medical device’, and ‘non-benefit medical technology’.
Forth, more proactive tracking system is required through revising and reinforcing medical technology and UDI.
Fifth, post management of medical device should consider introducing price-volume agreement. Such adoption would require evidence data from suppliers and data transfer system with the review authority, in consideration of both the new products and existing listed products. The objective of reassessment should be clarified as well, whether it should be about management efficiency or cost saving. France’s case could serve as a reference where after a certain period of time from listing, price is adjusted down as the item is categorized as existing group.
Sixth, active post management measures should be implemented for high risk medical device, such as adverse drug event reporting system. When the quality is not guaranteed, the item should be subject to elimination from the price list and benefit quality assessment for additional action.
Alternative Title
A comparison study on reimbursement management systems by life cycle of medicine and medical technology in Korea and abroad
Table Of Contents
요 약 ⅰ

제1장 서 론 ---------------------------------- 1
1. 연구 배경 ---------------------------------- 1
2. 연구 목적 ---------------------------------- 3
3. 연구 내용 및 방법 ---------------------------------- 3

제2장 국가별 의약품 생애주기별 관리제도 ---------------------------------- 5
1. 한국 ---------------------------------- 5
2. 일본 ---------------------------------- 93
3. 미국 ---------------------------------- 135
4. 캐나다 ---------------------------------- 171
5. 독일 ---------------------------------- 223
6. 프랑스 ---------------------------------- 265
7. 영국 ---------------------------------- 291
8. 스위스 ---------------------------------- 325
9. 호주 ---------------------------------- 393
10. 이탈리아 ---------------------------------- 475

제3장 국가별 의료기기 생애주기별 관리제도 ---------------------------------- 495
1. 한국 ---------------------------------- 495
2. 일본 ---------------------------------- 577
3. 미국 ---------------------------------- 607
4. 캐나다 ---------------------------------- 629
5. 독일 ---------------------------------- 659
6. 프랑스 ---------------------------------- 675
7. 영국 ---------------------------------- 691
8. 스위스 ---------------------------------- 701
9. 호주 ---------------------------------- 743

제4장 국가별 의약품 및 의료기기 생애주기별 관리제도 비교 및 결론 ---------------------------------- 811
1. 의약품 생애주기별 관리제도 비교 및 결론 ---------------------------------- 811
2. 의료기기 생애주기별 관리제도 비교 및 결론 ---------------------------------- 813

참고문헌 ---------------------------------- 815
ABSTRACT ----------------------------------843
부록 ---------------------------------- 849
윤상헌 et al. (202201). 의약품 및 의료기기 생애주기별 국내외 급여 관리제도 비교.
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