동반진단과 표적치료제의 의료기술평가를 위한 고찰
Companion Diagnostics and Targeted Therapy at the Korean Health Technology Assessment Context
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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.
Abstract
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.
참고문헌 (14)
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