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首页> 外文期刊>Orphanet journal of rare diseases >A proposed definition of rare diseases for China: from the perspective of return on investment in new orphan drugs
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A proposed definition of rare diseases for China: from the perspective of return on investment in new orphan drugs

机译：中国罕见病的拟议定义：从新孤儿药的投资回报率角度

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A prevalence threshold to define rare diseases is needed for orphan drug designation. Here, we propose a bottom-up approach to defining rare diseases for China, based on the minimum number of patients needed for the industry to make a reasonable profit on a new drug. To obtain this patient population size, we considered three factors: (1) the industry research and development cost per new drug; (2) the sales per new drug to recoup its research and development costs and generate profit; (3) the highest affordable cost for one patient’s treatment in a given healthcare system. Using this model, we estimate that, with the current level of innovation in the pharmaceutical industry in China, between 300,000 and 500,000 patients could be a reference threshold to define rare diseases. Compared with other proposals, this evidence-based definition is more useful for designing rare diseases and orphan drug policies for China.
机译：需要指定罕见病的流行阈值来指定孤儿药。在此，我们提出了一种自下而上的方法来确定中国的罕见病，这是基于该行业从新药中获得合理利润所需的最少患者数。为了获得该患者的人数，我们考虑了三个因素：（1）每一种新药的行业研发成本; （二）新药的销售收入，以弥补其研发成本并产生利润; （3）在给定的医疗系统中，一位患者的治疗费用最高。使用该模型，我们估计，在中国医药行业当前的创新水平下，300,000至500,000的患者可以作为定义罕见病的参考门槛。与其他提议相比，这种基于证据的定义对于设计针对中国的罕见病和孤儿药政策更为有用。

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