주요 외국의 의약품 위험분담제도에 대한 고찰: 계약현황과 사후관리방안을 중심으로
Review of Risk Sharing Arrangements in Some Developed Countries: Focusing on Type of Contracts and Management System
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This study was carried out to investigate the current situation of risk sharing arrangements (RSA) in other countries, mainly focusing on types of contracts and management system, in order to suggest helpful implications for Korean RSA system. United Kingdom (UK), Australia, Italy, Germany were selected considering their similarity with the Korean system and the availability of data. We searched for existing researches, guidelines, reports, and related webpages using PubMed, Google, and relat- ed websites for each country. UK’s RSA is referred to as patient access scheme (PAS). It is included in NICE’s recommendation and does not have specific criteria for application. It uses simple discount schemes more than complex schemes. PAS is evaluated alongside the NICE’s recommendation. Aus- tralian RSA consists of RSA for financial risk and the managed entry scheme (MES) for clinical uncer- tainty. There are no specific criteria in the application for RSA. But the application for MES requires high clinical needs and subsequent clinical trial. Most of contracts are financial-based schemes. Deci- sion about the renewal of contracts is based on the market situation and the newly introduced man- aged access programme (MAP) requires pharmaceutical companies to provide information about potential cancellation of reimbursement and to obtain patient’s consent. Italian RSA is referred to as managed entry agreements. It also does not include specific criteria in the application but has unique national level web-registry. Unusually, Italy uses outcome-based schemes substantially. Germany has unique mandatory rebate system. Overall, there were considerable differences between those countries we examined and Korea. But Australian MAP shed some light on the management of RSA in Korea.
Abstract
This study was carried out to investigate the current situation of risk sharing arrangements (RSA) in other countries, mainly focusing on types of contracts and management system, in order to suggest helpful implications for Korean RSA system. United Kingdom (UK), Australia, Italy, Germany were selected considering their similarity with the Korean system and the availability of data. We searched for existing researches, guidelines, reports, and related webpages using PubMed, Google, and relat- ed websites for each country. UK’s RSA is referred to as patient access scheme (PAS). It is included in NICE’s recommendation and does not have specific criteria for application. It uses simple discount schemes more than complex schemes. PAS is evaluated alongside the NICE’s recommendation. Aus- tralian RSA consists of RSA for financial risk and the managed entry scheme (MES) for clinical uncer- tainty. There are no specific criteria in the application for RSA. But the application for MES requires high clinical needs and subsequent clinical trial. Most of contracts are financial-based schemes. Deci- sion about the renewal of contracts is based on the market situation and the newly introduced man- aged access programme (MAP) requires pharmaceutical companies to provide information about potential cancellation of reimbursement and to obtain patient’s consent. Italian RSA is referred to as managed entry agreements. It also does not include specific criteria in the application but has unique national level web-registry. Unusually, Italy uses outcome-based schemes substantially. Germany has unique mandatory rebate system. Overall, there were considerable differences between those countries we examined and Korea. But Australian MAP shed some light on the management of RSA in Korea.
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