신의료기술의 패턴변화에 따른 의사결정제도의 발전방향 : 의약품 허가제도와 약가제도를 중심으로

제목
신의료기술의 패턴변화에 따른 의사결정제도의 발전방향 : 의약품 허가제도와 약가제도를 중심으로
Ways to Improve Decision Making in Line with the Changing Health Technology: With Special Reference to Drug Approval and Pricing Systems
저자

박실비아; 조재국; 유근춘; 박은자채수미

발행연도
2009
발행기관
한국보건사회연구원
초록
⧠ 신의료기술에 의한 신약개발의 패턴 변화의 경향을 조사하고 정책적 함의를 고찰
⧠ 우리나라에서 신약의 도입과 사용에 관한 의사결정제도 현황을 허가제도와 보험급여 및 약가제도를 중심으로 조사하고, 관련되는 신약의 시장 진입 및 보험급여 현황을 파악
⧠ 신약 도입과 관련하여 최근 국제적으로 관찰되는 의사결정제도의 동향을 조사하고 이를 이론적, 정책적 측면에서 비판적으로 고찰
⧠ 우리나라에서 향후 신약개발의 패턴 변화와 관련하여 추구해야 할 의사결정제도 - 허가제도와 보험급여 및 약가제도 - 의 발전방향을 제시

This study investigated new trends in health technology and their policy implications for decision making in health care system. Recent advances in genomics and molecular biotechnology have paved the way for development of new drugs based on 'personalized medicine' and 'targeted therapeutics'.
Personalized medicine enhance the ability to classify patients into sub-populations that differ in their susceptibility to a particular disease or their responses to a specific treatment. Targeted therapeutics, which is guided by the understanding of relevant molecular variations in the expression of diseases, have changed cancer from an acute, remitting disease to a chronic, manageable disease.
There is currently a high level of interest in the new patterns of drug development from a policy perspective not only because of the promise of improved patient care, but also because of the potential to impact decision making in health care system. However, new drugs developed from these new health technologies tend to lack evidence on safety, effectiveness or cost-effectiveness at the time of decision making in health care system.
Faced with challenges from new health technologies with promising effectiveness but with insufficient evidence, decision makers in other countries have tried new evidence-based health care decision making system. Drug regulatory organizations have introduced conditional marketing approval of a new drug or progressive licensing with which to evaluate efficacy and safety of a new drug throughout the whole life cycle. Third-party payers have also been trying new risk sharing system based on the result of drug treatment. Under the result-based risk sharing agreement, drug manufacturers agree to refund the health service if a drug fails to meet agreed performance targets when used under appropriate conditions or drug price is changed to meet the ICER(incremental cost-effectiveness ratio) threshold according to the result of treatment.
In Korea, there has been increasing interest in the result-based risk sharing agreement for new drugs, as many of new drugs with promising effectiveness are not covered by the National Health Insurance because of their high price and insufficient evidence of their cost-effectiveness.
Result-based risk sharing agreement has the potential to reduce risk in health care decisions in times of new health technology and to ensure predictable health gains for a given drug expenditures. However until now it has not gained wide-spread acceptance because of its feasibility issues. Moreover it has not been fully evaluated yet. Result-based risk sharing agreement should thus be considered only for innovative drugs treating life-threatening diseases, for very specific target populations as an option to deal with insufficient evidence and to ensure access to essential medicines.
목차
제1장 서론
제1절 연구의 배경과 필요성
제2절 연구 목적
제3절 연구내용 및 방법

제2장 신약개발의 패턴 변화와 정책적 함의
제1절 신약개발 패턴 변화의 동향과 특징
제2절 신약개발의 패턴 변화에 따른 정책적 함의

제3장 우리나라의 신약도입 관련 의약품 의사결정제도 운영
제1절 신약 허가 분야
제2절 신약 보험등재 및 약가제도 분야

제4장 신약 도입과 관련한 의약품 의사결정제도의 국제적 동향
제1절 신약 도입에 관한 허가제도에서의 국제적 동향
제2절 신약 도입에 관한 허가제도의 국제 동향에 관한 고찰
제3절 신약의 보험 급여와 약가제도에서의 국제적 동향
제4절 신약 급여 및 약가결정제도의 국제 동향에 관한 고찰

제5장 신약의 패턴 변화에 따른 의약품 의사결정제도의 발전방향
제1절 신약 허가제도의 발전방향
제2절 신약 급여 및 약가제도의 발전방향

제6장 결 론

참고문헌
보고서 번호
연구보고서 2009-03
URI
http://repository.kihasa.re.kr:8080/handle/201002/827
ISBN
978-89-8187-578-7
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