▢ 연구 배경
2016년 세계경제포럼에서 ‘4차 산업혁명의 이해’라는 주제를 다루면서, 4차 산업혁명이 급격히 대두되었다. 4차 산업혁명은 디지털, 바이오, 물리학 등 의 ‘융합 기술혁신’으로 정의된다. 4차 산업혁명은 초연결, 초지능, 대융합에 기반하여 모든 것이 연결되고 더 지능화된 사회로 변화함으로써 산업생태계는 IoT, IoP를 통해 방대한 빅데이터를 생성하고 인공지능이 빅데이터에 대한 해석을 토대로 적절한 판단과 자율제어를 수행함으로써 초지능적인 제품 생산/서비스를 제공하며 산업혁명을 견인한다. 해외 주요국들이 4차 산업혁명을 대비하여 국가전략을 수립·추진하고 있는 시점에 국내에서도 4차 산업혁명 시대를 대비하여 대통령 직속의 ‘4차산업혁명위원회’를 구성하고 대응 체계를 구축하였다. 보건의료분야에 대하여는 비전과 이에 따른 구체적인 실행방안을 논의·마련하기 위하여 4차산업혁명위원회 산하에 ‘헬스케어특별위원회’를 설치하고, 고속으로 성장하고 있는 헬스케어 분야에서 기술·산업 융합으로 국민 건강을 증진하고 새로운 일자리 창출을 도모하고 있다. 헬스케어특별위원회는 헬스케어 분야의 주요 아젠다를 정립하고 6대 프로젝트를 선정하여 4차 산업혁명 대응 계획을 수립 및 추진하고 있다.
신의료기술평가는 새롭게 도입되는 의료기술이 안전하고 유효한 기술인지 여부를 문헌적 근거를 바탕으로 평가한다. 이러한 평가방법론은 기술 발전 속도가 빨라지고 산업의 융복합으로 새로운 개념의 의료기술이 개발되는 상황에서 적절하지 못한 평가방법론이라는 지적이 계속되었다. 한국보건의료연구원은 2017년 첨단의료기술의 별도평가를 위하여 가치기반 의료기술평가 도입하고자 연구를 수행하였다. 선행연구에서 가치기반 의료기술평가의 활용에 대하여 조사하고, 신의료기술평가에서 활용 가능한 가치 항목을 선정하였다.
▢ 연구 목적
본 연구는 문헌적 근거를 바탕으로 의료기술의 안전성과 유효성을 평가하는 기존의 의료기술평가 방법론을 적용하기에 어려움이 있는 의료기술을 평가하기 위한 방안을 마련하고, 평가 수행 시 필수로 검토해야할 사항들을 제시하기 위하여 수행되었다.
▢ 연구 방법
1. 첨단·혁신의료기술 현황 조사
혁신의료기술 도입을 위한 별도 평가 절차 마련을 위하여, 현재 국내·외에서 활발히 논의·회자되고 있는 신규·유망 의료기술 등 분야별 국내 및 해외의 첨단·혁신 의료기술 현황 및 주요 내용 등에 대하여 수집 및 분석을 시행하였다.
2. 해외 주요국 첨단·혁신 의료기술 보험 현황 조사
각국의 건강보험제도의 유형에 따라 첨단·혁신 의료기술의 도입 양상이 달라질 수 있음을 고려하여, 해외 주요국에 대한 보험현황조사를 실시하였다. 영국, 미국, 일본을 대상으로 선정하였으며, 본 조사를 통해 국가별로 혁신의료기술이 품목허가 후 임상에 적용되는 과정을 확인하고, 해당 국가에서 주목받고 있는 몇 개 영역의 기술에서 대표적인 혁신의료기술제품을 선정, 사례 조사를 통해 해외 보험 현황을 파악하고자 하였다.
보험현황조사는 전문조사업체에 의뢰하여 진행하였으며, 혁신의료기술이 임상현장에 진입하는 제도적 장치나 혁신의료기술에 대한 별도 절차 등이 없는 경우, 어떠한 과정을 거쳐 실제 임상현장에 도입이 되는지를 조사하였다.
3. 의료인 대상 설문조사 및 분야별 이해관계자 요구도(NEEDS) 조사
설문조사를 통해 기존의 신의료기술평가 절차에서 혁신의료기술 별도 평가 트랙 도입 시 안전성·유효성 이외의 다양한 잠재적 가치를 평가에 반영하는 방안을 마련하여 평가 결과의 수용성과 신뢰성을 제고하고자 하였다. 설문조사는 전문조사업체에 의뢰하여 2018.10.4.~2018.11.9.(약 4주간) 진행하였으며, 의료인이라 할지라도 신의료기술평가제도에 대한 이해도가 충분하지 않을 경우, 설문 의도에 부합하지 않는 응답을 할 가능성이 높아 비확률 표본추출을 시행하여, 총 80명이 최종 응답하였다. 설문은 전문 조사관이 의료전문가와 접촉한 후 심사설문 조건을 통과할 경우 대면조사를 시행하였으며, 기초 통계분석은 SPSS (Statistical Package for the Social Sciences, ver.21.0)로 분석하였다.
4. 혁신의료기술평가 소위원회 구성 및 운영 방안 마련
선행연구를 통해 혁신의료기술평가 소위원회(선행연구 명칭: ‘신의료기술 가치평가 소위원회’)의 신의료기술평가제도 내의 위치와 역할에 대한 윤곽을 제안한 바 있다. 그 내용은 평가의 전문성과 일관성을 유지하기 위해 총 6인의 ‘고정인원+유동인원’의 형태로 소위원회를 운영하고 구성 인원은 의료전문가, 환자·시민단체 관계자, 보건의료산업계 관계자, 해당 의료기술의 전문가를 포함하며 위원장은 고정인원의 의료전문가로 정하는 것이다.
또한, 당시 제도 상황을 고려하여 문헌적 근거가 부족하여 안전성 및 유효성 평가 소위원회의 검토 결과 연구단계기술로 검토된 기술에 한해서만 별도 평가를 진행하는 것을 제안하였다.
동 연구에서는 선행연구 결과에 기반하여, 각 분야 관계자 및 전문가 자문회의와 연구진 논의를 통해 이해관계자간 갈등을 해소하고 합리적인 평가가 진행될 수 있도록 소위원회를 구성하고, 시뮬레이션 등을 통해 혁신의료기술 별도평가 트랙의 정식 도입을 위한 구체적인 소위원회의 운영 방안을 마련하고자 한다.
5. 평가 항목 및 평가 도구 개발
평가 항목 및 평가 도구 개발의 목적은 신의료기술 평가 시 문헌적 근거 이외에 다양한 사회적 요구를 반영하는 항목을 검토하도록 하는 절차의 도입에 있으며, 제도 도입에 앞서 평가 항목의 적합성과 평가 도구의 의료기술 특성에 따른 활용방안을 모색하고, 시범 평가를 통해 개선사항을 검토하고자 하였다.
평가 항목은 선행연구에서 도출된 8가지 항목(질병의 심각성, 질병의 희귀성, 삶의 질, 환자의 신체적 부담, 환자의 경제적 부담, 대체기술 유무, 기술의 혁신성, 남용 가능성)에 대해 의료법을 포함한 국내외 교과서 및 가이드라인, 문헌 및 연구보고서, 관련 홈페이지(의학용어 홈페이지, 국립국어원 표준국어대사전, 국가주요지표 홈페이지) 등을 다양하게 검토하여 각 항목별 개념 및 정의에 대해 구체화 하였다.
또한, 의료 전문가, 보건의료정책 전문가, 환자-시민단체 관계자, 의료산업계 관계자 등 이해관계자를 대상으로 선정하여 자문회의를 진행하여, 평가 항목 및 정의의 적절성, 평가 도구의 서식 및 결론 제시 방식에 대해 논의하였으며, 취합된 의견을 토대로 평가 항목의 내용 구성 및 평가 도구의 서식을 수정·보완하였다.
6. 시범평가 수행
평가 항목, 평가 도구 서식의 적합성 및 개선사항을 검토하기 위해 실제 의료기술을 대상으로 시범 평가를 수행하였다. 이를 통해 평가 항목 및 각 항목별 개념을 명확히 제시하고, 의료기술의 특성과 성격에 따른 활용방안을 마련하여 평가 도구의 서식을 확정하고자 하였다.
시범평가에 선정된 안건은 ‘콘텍트렌즈형 센서를 이용한 24시간 연속 안압 측정’, ‘환자 맞춤형 3차원 모형을 이용한 심장기형질환 수술 시뮬레이션’, ‘허혈성 심부전 환자를 위한 경피적 좌심실 분리술’, ‘환자 맞춤형 모의 신장암 수술’ 등 총 4건이며, 혁신의료기술평가 소위원회를 임의로 구성하고, 평가 항목과 평가 도구를 활용하여 실제 평가와 동일한 방식으로 진행하였다.
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▢ Background
In 2016, the main theme of the World Economic Forum was ‘Mastering the Fourth Industrial Revolution’ which made a huge wave of the fourth industrial revolution, world widely. Fourth industrial revolution is defined as combination of different fields including ‘Digital’, ‘Bio’, ‘Physics’ and etc.. Advanced countries developed national strategy for the new innovation, at the same time, Korea also established a response system for the new industrial innovation. Korea launched ‘Presidential Committee on the 4th Industrial Revolution’ to deliberate upon and coordinate important policy matters pertaining to the development and acquisition of new science and technology and also new industries and services necessary for Korean society’s adaptation to the 4th industrial revolution. In healthcare field, a special sub-committee to suggest the vision and to discuss action plans for the vision was organized. The special sub-committee decides main agendas and six major projects in healthcare field, and also makes and push forward a response plan for the 4th Industrial Revolution. One of the six major projects is ‘Development and regulatory system improvement regarding smart complex medical devices’. In that project, regulatory system of MFDS (Ministry of Food and Drug Safety), nHTA system and health insurance system of MOHW (Ministry of Health and Welfare) became targets of the system improvement.
The nHTA system uses the evidence-based literature review method in which scientifically and objectively search, analyze and synthesize evidences from the clinical literatures. The main assessment method of nHTA is systematic reviews. Reviewing textbooks or guidelines are also conducted and even expert opinions based on the objective evidence are also reviewed in nHTA. Review system of objective evidences has been pointed out as an inadequate assessment methodology in a situation of rapid and massive development of healthcare technologies with a new concept, such as emerging or complex technologies. NECA conducted a research to develop value-based HTA methodology to the emerging medical technology in 2017. In the study, we investigated the current state of value-based assessment in HTA system and selected value items that could be considered in nHTA system.
▢ Objective
The present study was conducted to develop the new assessment method on innovative or emerging health technology (innovative emerging technology) which has difficulties to applicate evidence-based literature review method. The present study also aimed to present the items to be considered essentially in the nHTA.
▢ Methods
Organizing and operating a subcommittee of nHTA committee for emerging technology
In the previous study, we suggested the state and role of a subcommittee (subcommittee for value assessment) in nHTA system. In the present study, we suggested concrete composition of the subcommittee (subcommittee for emerging technology) to assess innovative emerging technology and also operated the subcommittee to confirm the possibility of introduction of new methodology.
Development of assessment items and tool
We developed items and tool to assess value of innovative emerging technology, to apply various social demands beside evidences. Total 8 assessment items were developed, including rarity of disease, severity of disease, physical burden on the patient, economic burden on the patient, possibility of abuse, affects on the quality of life, state of alternative technology and innovation level of technology. Medical experts, healthcare-policy specialists, patient-civil group member and health industry stakeholders conducted consultation regarding the relevance of item definition, form of assessment tool and method of conclusion suggestion. We collected their opinions and apply to reconfigurate contents and assessment tool.
Pilot assessment for innovative emerging technology
We conducted total 4 pilot assessments in the present study. Suitability of assessment items and tool was examined through the pilot assessment. In the pilot assessment, we tried to find out and correct errors and increase utilization of new assessment system.
‘24 hour continuous IOP monitoring using contact lens sensor’, ‘surgery simulation for repair of congenital heart disease using patient-specific three-dimensional heart model’, ‘Percutaneous left ventricular partitioning in patients with chronic heart failure’ and ‘personalized surgical simulation of renal cancer’ were selected in the pilot assessments. Sub-committee was composed for the pilot assessments and assessments were conducted in the same manner as the real assessment system.
▢ Results
Compsition of sub-committee
The composition of sub-committee for innovative emerging technology result from the consultation of experts and stakeholder are as follows. Members are composed as the chairperson, four medical experts(two fixed and two changeable), a patient-civil group member and a industrial technology expert. The chairman was selected one of the nHTA committee member. Two fixed medical expert members were recommended from the medical society and two changeable members were as members of evidence assessment sub-committee of the technology. The patient-civil group member was recommended from the group on public involvement in NECA.
After the sub-committee composed, researchers make materials by reviewing submitted materials and searching related evidences and submit to the sub-committee. We suggest that members discuss with deliberation about the technology since the assessment is not based on objective evidence. Thus the assessment result should be presented in the recommendation form.
Development of assessment items and tool
In order to construct the contents, the concept and definition, explanation and examination of the assessment items were reviewed by various kinds of experts. We categorized items as clinical value (severity of disease, rarity of disease, affects on the quality of life, physical burden on the patient and state of alternative technology), social value (economic burden on the patient, innovation level of technology and possibility of abuse) and we developed assessment tool draft as followed: 1) quantitative assessment by applying points and weights 2) qualitative assessment by presenting assessment opinions and suggestions 3) mixed form assessment of quantitative and qualitative assessmet.
Assessment tool was revied for 3 times. The first review was carried out by medical experts, health policy expert andmedical industry stakeholder and the second review was by nHTA committee members and patinet-civil group member. For last review, we conducted in-depth interview of medical experts and nHTA committee members.
Results of pilot-assessments
We conducted total four pilot assessments of innovative emerging technologies with sub-committee members.
- 24 hour continuous IOP monitoring using contact lens sensor
This technology was deliberated as a research state technology since lack of effectiveness evidence and the technology does not crucially influence on the treatment of glaucoma. In the pilot assessment, however, experts gave their opinion that the technology can influence on the diagnosis or treatment way decision of glaucoma in a specific patient group such as presenting clinical symptoms of IOP elevation with normal IOP. Although patient’s IOP can be monitored everytime, IOP measurement is one of many methods to diagnose the glaucoma. Thus the sub-committee made a decision that this technology is useful only in a limited condition with the recommendation level is moderately recommendation.
- Surgery simulation for repair of congenital heart disease using patient-specific three-dimensional(3D) heart model
The disease is rare and the influence on the patient is large. Also, it is hard to find the alternative technology and the technology has potential value to increase the safety by assisting to determine the surgery plan and the treatment way decision. On the other hand, because of the possibility of abuse is high on the acquired heart disease, the sub-committee made a decision to limit the patient to congenital heart disease with the recommendation level is moderately recommendation. The sub-committee decided that although the technology can be very helpful for the treatment way decision, it is inappropriate to make a recommendation as ‘strong’ because it is performed outside of the patient’s body. As a minority opinion, a member of sub-committee mentioned that 3D printing technology is useful for student education and not necessary for the medical field.
- Percutaneous left ventricular partitioning in patients with chronic heart failure
The disease is not rare, but the influence on the patient is large and physical burden on the patient is low. Economic burden on the patient is expected high and alternative technology is already exist. The safety risk of the technology on the patient is high. Thus the sub-committee decided that clinical value of the technology is very poor with low recommendation level.
- Personalized surgical simulation of renal cancer
Clinical utility of the technology on the patient with severe partial resection of the kidney is expected high. In sub-committee there was a argue about the application to all kidney surgery including total resection. Recimmendation level was not suggested because the sub-committee failed to agree between members. In such a case, it is recommended that the nHTA committee make the final decisoin.
▢ Conclusions
We confirmed composition of subcommittee members, assessment items and tools used in assessment in the present study. And through four pilot assessments, we try to confirm the feasibility of new assessment system. We selected 8 assessment items, that are rarity of disease, severity of disease, physical burden on the patient, economic burden on the patient, possibility of abuse, affects on the quality of life, state of alternative technology and innovation level of technology. In terms of assessment tool, quantitative assessment tool for the innovative emerging technology was planned in the first place. However during the pilot assessment, we found quantitative assessment is not an appropriate method since the way of making conclusion is gathering consensus opinions of committee members. Instead, using qualitative assessment tool with consensus opinion is more appropriate in the innovative emerging technology assessment. We developed two or three points scale standard of each assessment items to minimize diversity of opinions and make easier to achieve a consensus of committee members.
New health technologies(which are permitted to be implemented in nHTA) through the new assessment method might have less clinical evidences than those using usual assessment method. Thus those technologies should be permitted with condition and adapted to patients under some managements. First, evidence creation should be tried while applying to patients. Thus, protocol submission from hospital and verification by NECA are essential processes. Second, hospitals applying innovative emerging technologies should satisfy some capacity, such as creating clinical evidences and running expensive equipments. Monitoring of evidence creation process for successful evidence acquisition is also needed. We believe that the process of creating evidence should be established and managed and appropriate reassessment of implemented technologies makes it possible the new assessment system established in the health insurance system.
Results from the present study will be used practically when we introduce new assessment methodology of health technology. Although considering values of patients in HTA is tried in some cases as a research, new assessment methodology other than evidence-based HTA is not introduced in any HTA system until the present. It is the first attempt of nHTA in the world to derive value items and establish value-based assessment as a system for the registration of public insurance coverage list.
▢ Acknowledgement
This Research was supported by National Evidence-based Healthcare Collaborating Agency(NECA) funded by the Ministry of Health and welfare(grant number N000-0000).
Key words
new health technology assessment, innovative emerging technology, value assessment
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