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      • KCI등재

        암환자에서 암발생부위와 생존기간에 따른 사망전 1년간의 의료비용

        이지전,유원곤,김소윤,김광기,이상욱,Yi, Jee-Jeon,Yoo, Won-Kon,Kim, So-Yoon,Kim, Kwang-Ki,Yi, Sang-Wook 대한예방의학회 2005 예방의학회지 Vol.38 No.1

        Objectives : To analyze medical expenses by cancer site and survival time among cancer patients in their last year of life. Method : The study subjects were 45,394 people that had died of cancers in 2002, were registered by the Korea Central Cancer Registry and received National Health Insurance benefit in the last year (360 days) of life. Personal identification data, general characteristics, dates of death and cancer incidence, and site of cancer were collected from the National Statistical Office and the Korea Central Cancer Registry, and merged with the data of the individual medical expenses of the Health Insurance Review Agency. Results : Average monthly cost curves were U-shaped with high costs near the time of diagnosis and death, and lower costs in between. Medical expenses in the last year of life were around 30.3, 16.7, 13.0, and 12.1 million won among leukemia, lymphoma, ovarian cancer, and breast cancer patients, respectively. Digestive organ cancers including stomach, esophagus, liver, pancreas, and colorectal cancers had relatively low medical expenses. Medical expenses in the last year of life were inverse U-shaped with high expenses near one year of survival. Average monthly cost in the 12 months before death among the patients who had survived $10{\sim}15$ years were more than two-fold greater than the cost before diagnosis among those who had survived for less than one year. Conclusions : Leukemia was the most expensive cancer. It is possible that once diagnosed as cancer, medical expenses do not return to the level before diagnosis. Further research will be needed to understand the magnitude and change of the medical expenses among cancer patients with long term follow up data.

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        희귀의약품 제도의 국가별 비교 연구

        박실비아 ( Park Sylvia ),채수미 ( Chae Su-mi ),박은자 ( Park Eun-ja ),주민희 ( Ju Min Hui ),구현민 ( Gu Hyun Min ),유원곤 ( Yoo Won Kon ) 한국보건사회연구원 2013 保健社會硏究 Vol.33 No.2

        희귀의약품은 소수의 환자들이 앓는 희귀질환 치료제로서 시장의 크기가 작아 제약기업의 개발 동기가 낮다. 이에 미국, EU, 일본 등 국가는 제도적 개입을 통하여 희귀의약 품의 개발을 촉진해왔다. 우리나라는 희귀의약품의 수입을 통한 공급 위주의 정책을 시행해왔으나, 연구개발 역량이 향상됨에 따라 희귀의약품 개발이 증가하고 있으며 이에 따라 희귀의약품의 정책의 전환이 필요하다. 이 연구는 희귀의약품의 연구개발 국가인 미국, EU, 일본과 우리나라의 희귀의약품 제도를 비교분석하였다. 미국과 EU, 일본은 연구개발 단계에서부터 희귀의약품을 지정하여 연구개발을 직간접적으로 지원하고 있다. 우리나라에서는 희귀의약품의 허가 및 시판후 관리에서 안전성, 유효성에 대한 평가를 일부 완화하고 있으나, 다른 국가들에서는 희귀의약품이라는 이유로 절차를 완화하고 있지는 않았다. 향후 국내에서 개발되는 희귀의약품이 증가할수록 우리나라에서도 희귀의약품의 연구개발 단계에서의 지원프로그램이 필요하며, 안전성, 유효성에 관한 시판전후 평가를 강화할 필요가 있다. This study investigated orphan drug policies of Korea, US, EU, and Japan and compared them. We focused on orphan drug designation, R&D support program, marketing authorization, and market exclusivity. The US, EU, and Japanese governments have provided various incentives for orphan drug development including research grants, tax credits for development costs, protocol assistances, and market exclusivity. Those countries designate products as orphan drugs eligible for the supporting programs during the R&D phase. In Korea, the primary purpose of orphan drug policy has been accelerating the provision of orphan drugs most of which are imported drugs developed in other countries. Therefore, designation of orphan drug has been only possible at the marketing approval phase and there have been few R&D support programs. In addition, the regulatory authority has partly skipped evaluation of efficacy and safety. These days, however, there has been much progress in new drug research capacity and increasing number of ongoing projects for orphan drug development in Korea. Considering these changes, orphan drug policy of Korea needs to shift to accelerating drug development and ensuring safety and efficacy through the regulatory process.

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