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Supply-side and demand-side policies for biosimilars: an overview in 10 European member states

机译:生物仿制药的供需方政策:欧洲10个成员国的概述

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Objective: This study aimed to provide an overview of biosimilar?policies in 10 EU MSs.Methods: Ten EU MS pharmaceutical markets (Belgium, France, Germany, Greece, Hungary, Italy, Poland, Spain, Sweden, and the UK) were selected. A comprehensive literature review?was performed to identify supply-side and demand-side policies in place in the selected countries.Results: Supply-side policies for biosimilars commonly include price linkage, price re-evaluation, and tendering; the use of internal or external reference pricing varies between countries; health technology assessment is conducted in six countries. Regarding demand-side policies, pharmaceutical prescription budgets or quotas and monitoring of prescriptions (with potential financial incentives or penalties) are in place in eight and in seven countries respectively. Switching is generally allowed, but is solely the physician’s responsibility. Automatic substitution is not recommended, or even forbidden, in most EU MSs. Prescription conditions ...
机译:目的:本研究旨在概述10个欧盟成员国的生物仿制药政策。方法:选择了10个欧盟成员国的药品市场(比利时,法国,德国,希腊,匈牙利,意大利,波兰,西班牙,瑞典和英国) 。进行了全面的文献综述,以查明所选国家/地区已制定的供应方和需求方政策。结果:生物仿制药的供应方政策通常包括价格链接,价格重新评估和招标;内部或外部参考定价的使用因国家而异;卫生技术评估在六个国家进行。关于需求方政策,分别在八个和七个国家建立了药品处方预算或配额以及对处方进行监控(可能有经济激励或罚款的措施)。通常允许进行切换,但这完全是医生的责任。在大多数EU MS中,不建议甚至禁止使用自动替换。处方条件...

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