신의료기술평가의 주요 이슈와 개선 방안

장승경,안형식,이상일 한국보건의료기술평가학회 2020 보건의료기술평가 Vol.8 No.2

Objectives: This study reviewed the current major issues of New Health Technology Assessment Program (nHTA) in Korea and suggested ways to promote evidence-based approaches to nHTA. Methods: Data covered the list of all applications to nHTA from 2007 when nHTA was introduced to September 30, 2019. A total of 2539 application cases were analyzed. In addition 11 experts who had experience in the nHTA were surveyed and conducted 1:1 non-face-to-face interviews from June 18th to July 5th, 2020. The questionnaire for the expert survey was developed based on the 15 principles of the best HTA practice. Results: Of the 2539 applications, 891 were classified as new technologies, 440 existing technologies, 568 early stage technologies, 243 research stage technologies, and 397 others. Among the 891 new technologies, there were 320 in vitro diagnostic tests, 259 genetic tests, 194 treatments and procedures, and 128 others including one oriental medicine. The average time required for nHTA was 226 days (±96.8), and it took an average of 43.3 days (±22.7) from notification to the applicant to official release of the Ministry of Health and Welfare. Of the 243 cases classified as the research stage technologies, 124 cases were Grade I, which means that the potential benefit of clinical introduction was not significant. About 76% (435/568) of early stage technologies were Grade I. Among 567 cases of new technologies with Scottish Intercollegiate Guidelines Network recommendation grading Grade C was the most common with 236 cases, followed by Grade D 218, Grade B 87, and Grade A 47 in that order. Based on the result of the expert survey, we propose recommendations for improving nHTA. Conclusion: This study based on the analysis of nHTA database and expert survey results can help policy makers and health care professional societies to make better nHTA in Korea.

디지털헬스 정책환경의 국제 동향과 의료기술평가에 대한 시사점

최솔지,박종연,차선미,유근주,홍석원 한국보건의료기술평가학회 2018 보건의료기술평가 Vol.6 No.2

As technologies develop, the digital health sector is gradually expanding. Internationally, the global summit for Digital Health named Global Digital Health Partnership (GDHP) was launched in 2018. Many countries are participating in GDHP and share their policy experiences on digital health and find the ways to cooperate with participating countries (13 countries, including South Korea, and Hong Kong). This article reviewed the international trends in digital health policy environment and evidence assessment focusing on GDHP activities, and derived implications for health technology assessment of digital health. Consequently, to assess the intervention effects of digital health is very complex and the assessment should be considered multidimensional aspects (social, clinical, and technical). In addition the patient experience should be assessed qualitatively. Health technology assessment (HTA) should assess the effect of digital health policies to changes in health care systems resulting from the application of advanced technologies related to the 4th Industrial Revolution. Digital health is also related to new HTA, HTA of existing technologies, and R&D on the promising health technology. Therefore, it is necessary to review the trends of the technology’s management policy consistently through the HTA of digital health.

동반진단과 표적치료제의 의료기술평가를 위한 고찰

최상은,임은아 한국보건의료기술평가학회 2016 보건의료기술평가 Vol.4 No.2

Companion diagnostics (CDx) and it’s sequential targeted therapy are becoming a unique pattern of personalized medicine. Recently the new combination of CDx and therapeutic agent has been more available in the global pharmaceutical market. The expected effect of CDx is to reduce the pharmaceutical costs through identifying patients who are more proper to use the new drug and to achieve better patient’s health outcomes in aspect of effectiveness and safety. This study tried to ex- plain the current state of CDx, such as it’s market authorization and health technology assessment (HTA). It found that clinical evidence of CDx and targeted therapy needs to be improved. Korean reg- ulator has developed the guidelines for review of CDx, but HTA agency and public payer has insuf- ficient experiences and consideration of CDx assessment.

의료기술평가의 국민참여 동향과 시사점

김희선,박종연 한국보건의료기술평가학회 2020 보건의료기술평가 Vol.8 No.2

Evidence-based medicine (EBM) has contributed to recent advancements in healthcare; the concept of EBM includes Patient and Public Involvement (PPI), along with the best research evidence and clinical expertise. That is, to provide the best healthcare services, it is necessary to consider patients’ experiences and emotion as a consumer of healthcare services, together with clinicians’ competency. Therefore, PPI is required for EBM. This paper aims to examine the international trends and the implication of public involvement in healthcare technology assessment (HTA) that is considered the system based on EBM. In the process of various research and analysis related to technology assessment in healthcare, patients and public can provide part of evidence as participants in interviews, questionnaires, other forms of consultation and qualitative research. In detail, it is possible to provide a perspective on social implications for specific health conditions, diseases, and treatments, along with knowledge by experiences and burden of disease, diagnosis and treatment, treatment route, cost-effectiveness analysis, etc. In the UK’s National Institute for Health Research, it is recommended that patients and public engage in the entire cycle of conducting the research, and deriving and utilizing the research results, starting from a planning stage such as identifying research topics. PPI in the specialized area such as healthcare can provide unique and valuable insights, as they are users of healthcare services and payers of healthcare costs. Additionally, they contribute to cost saving by providing effective and reliable advices when designing, implementing, and evaluating the research. With an open awareness of embracing various perspectives on decision-making in the process of HTA, PPI has great implications on establishing roles and functions of HTA for developing the national healthcare system by ensuring appropriate medical coverage and medical services.

의료기술평가 기반으로서의 데이터 연계

박종연 한국보건의료기술평가학회 2018 보건의료기술평가 Vol.6 No.2

With the recent change of healthcare environment including rapid technological development, evidences are more and more important and necessary to support relevant policies in health technology assessment to provide safe and effective health services, utilizing medical resources efficiently. Despite of the emphasis on the importance of real world data and real world evidence in health care research, current infrastructure supporting clinical research is considerably weak due to absence of legal and institutional basis. However, in accordance with the Article 26 of the Health and Medical Technology Promotion Act, there is a limited legal apparatus that can be used only in public data with other dataset for the purpose of healthcare technology assessment at the National Evidencebased Collaborating Agency. Although the use of linked data from various sources was often required in the field of clinical research, it was not yet working well due to insufficient environmental conditions. In order to support the decision-making of medical practice and health care policies, data-linking platform for clinical research is needed. If the legal system that can link up to the data of the private institutions without violating the significant value such as the protection of private informations is established, it will be a decisive foundation reinforcing the researches and policy making processes for the improvement of the national health care system.

미국과 영국의 의료기술평가 연구주제 도출 과정

김민정,강신희,박종연 한국보건의료기술평가학회 2014 보건의료기술평가 Vol.2 No.1

Objectives: This study is to review international research trends in Health Technology Assessment (HTA) through USA and UK HTA institutions’ research agenda setting processes. This will be useful for people’s health protection and efficient utilization of health care resources. Methods: For this study, we selected subject institutions, AHRQ, PCORI, NETSCC, and NICE as the major HTA institutions in the US and UK. To investigate these institutions’ research agenda setting process, we collected relevant materials from their internet site and consultation from experts meeting or email communications, and reviewed literatures. Results: In the USA and UK HTA institutions, research agenda were extracted from various sources including general peoples, experts, policy makers and other stakeholders. Research topics were selected at the various settings as priority committee, expert panel, consultation committee, and policy makers. And the standards were considered the elements of importance of the theme, disease burden (e.g., prevalence, severity), the impact of the technology, feasibility, and the agenda or priority groups. Although the research agenda setting processes were various with the institutions’ role in the national health care systems, there was consistency in the processes with their institutions’ establishing background, mission, and objective and transparent priority standards and processes with stakeholders’ active participation. Conclusion: Research agenda setting processes in the USA and UK could be prior examples and give valuable implications for establishment of the research agenda setting mechanism and Korean HTA system development.

보건의료정책결정에서 보건의료기술평가의 역할

오인환 한국보건의료기술평가학회 2017 보건의료기술평가 Vol.5 No.2

The importance of evidence needs to be emphasized in the era of a changing society. JoHTA has been publishing evidence which could be relevant to evidence-based health policy. We published eight papers in this issue and hope they can be used as evidence in the future.

NICE의 설립과 변화를 통해 살펴본 영국 보건의료기술평가의 발전 배경과 과제

배은영 한국보건의료기술평가학회 2020 보건의료기술평가 Vol.8 No.2

NICE is the most influential health technology assessment (HTA) organization in the world. This study reviews the brief history of NICE and explores how an institution like NICE has been created and expanded its role, interacting with the institutional and socioeconomic environment. Factors that contributed to the UK’s health technology assessment system include its long-standing empirical academic tradition, effective mobilization of human resources through changes in research and development strategies, the influence of medical publications such as BMJ and Lancet and their support for HTA, and the centralized health care system. NICE, which was created to solve the “postcode lottery” issues, has faced several challenges since its launch, but its achievement are recognized both domestically and internationally and has continued to expand the scope of its activities. Political circles have been able to avoid responsibility for uncomfortable decisions by taking technocratic approaches, and NICE has gained some recognition from stakeholders by emphasizing transparency and communication with stakeholders from the beginning of its establishment. However, because rationing itself is a political decision, the controversy surrounding the NICE appraisal has continued, and NICE has several challenges at hand.

환자안전과 보건의료기술평가

이상일 한국보건의료기술평가학회 2016 보건의료기술평가 Vol.4 No.1

Patient safety becomes a major health policy issue since the Institute of Medicine report, To Err is Hu- man. Patient Safety Act shall come into operation on the 29th of July 2016 in Korea. This law empha- sizes the importance of shared learning based on voluntary, confidential, and non-punitive reporting of patient safety incidents at the national level. In addition patient safety indicators and standards will be introduced after enforcing this law. Recently several policies around patient safety issues (for exam- ple, limiting resident duty hour and expanding the coverage of telemedicine) are under debate. With this change in healthcare policy environment, more technology assessment activities in the field of pa- tient safety will be needed. In this context producing and synthesizing evidence for patient safety prac- tices will be one of very important areas for health technology assessment (HTA) in Korea. Patient safety issues come not only from traditional clinical areas (e.g., adverse drug events, surgical complica- tions) and emerging clinical areas (e.g., provider fatigue, information transfer), but also from non- medical approach (e.g., information technology, human factors research). But little is known about many patient safety technologies. This may be attributed to several factors; the relatively weak infra- structure for patient safety HTA; the rapid introduction of patient safety technologies; differences in HTA methodology between typical biomedical technologies and patient safety technologies. Increased government funding for supporting patient safety research in Korea will contribute to more patient safety HTA, leading to evidence-based policy making for patient safety.

시장진입을 위한 치료재료 신의료기술평가 제도: 의료법, 의료기기법, 국민건강보험법 중심으로

천새임 한국보건의료기술평가학회 2016 보건의료기술평가 Vol.4 No.2

The “New Health Technology Assessment” system for new health technology was first introduced in 2007 in Korea and there have been some gradual changes and improvements. The Health Tech- nology Assessment (HTA) is a process that is being implemented in major countries across Europe as well as Korea through which the safety and effectiveness of new health technology is evaluated using a systematic review methodology. Despite the fact that HTA is focused on assessment of tech- nology, rather than on individual medical devices, treatments are mostly caused by those newly-de- veloped medical devices. Accordingly, even if it’s an assessment on health technology, clinical evi- dence is for medical devices used in this technology. HTA is different from the point of view product approval that verifies safety and effectiveness of the product itself, since it assesses safety and effectiveness on health outcomes when the treatment with a medical device is operated for the patient. However, considering the opinion that the reimbursement application process of medical service for the right of access to health insurance circle needs a long period and has to take compli- cated procedures compared to the product approval by the Ministry of Food and Drug Safety (MFDS), there have been various adjustments to improve the process since 2013. Including the most recently implemented “MFDS product approval-HTA parallel review” system, there are five tracks for HTA as of present. It is essential that the applicant applying for nHTA should review the relevant provisions on the Medical Law, Medical Device Law and National Health Insurance Law for accurate understanding of the system and needs to make an effort to prepare materials suitable for the objective. The purpose of this review is to discuss the purpose and objective of current nHTA in Korea, to review similar process of other countries and to introduce relevant administrative pro- cess according to relevant laws to suggest further necessary improvements of the system.