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KMID : 1142220160110010085
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Regulatory Research on Food, Drug & Cosmetic
2016 Volume.11 No. 1 p.85 ~ p.91
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Conditional Coverage with Evidence Development for Evoltra in Korea
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Kim Min-Young
Do Weon
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Abstract
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ALL (Acute Lymphoblastic Leukemia) is a cancer disease that often occurs in children and adolescents. When refractory to the treatment(s) or relapsed, it becomes a serious life threatening disease. Evoltra was developed for such refractory or relapsed ALL patients and approved by MFDS (Ministry of Food and Drug Safety) in 2011. Evoltra was then granted NHI (National Health Insurance) reimbursement through an RSA (Risk Sharing Agreement) pilot program of CED (Coverage with Evidence Development). RSA system was introduced by MOHW (Ministry of Health and Welfare) in January 2014 for the purpose of improving the patient access to treatments for cancer diseases or rare diseases. As of June 2016, 10 drugs have been granted NHI reimbursement through the RSA system. Evoltra CED program includes both a prospective study and a retrospective study. The prospective study aims to prove the clinical effectiveness of Evoltra in consideration that the clinical evidence for survival data, etc. is limited and the retrospective study is an observational study aiming to draw a comparative understanding on the result of the prospective study vs. that of the retrospective study, knowing that the prospective study is designed as a single arm trial. As the purpose of CED program, Evoltra NHI reimbursement including pricing will be subject to a re-evaluation based on the result of the prospective study result. For example, whether to
maintain NHI reimbursement or whether to refund the NHI reimbursement expense during CED study and how
much to refund if any, etc. will be determined afterwards. It is very obvious that patient access to new innovative treatments, e.g. Evoltra, for life threatening diseases has been improved by implementing RSA system. However, it is still early stage of the new system and there are areas for further attention to develop operational guideline, post management guideline and process establishment, which will help the RSA system settle down as a customized policy measure to South Korea.
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KEYWORD
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Evoltra, Risk Sharing Agreement, Coverage with Evidence Development
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