Factors That Affect the Acquisition of Reward Premiums for Promotion of Innovative Drug Discovery in Japan
Factors That Affect the Acquisition of Reward Premiums for Promotion of Innovative Drug Discovery in Japan
复制标题
影响日本创新药研发推广奖励溢价获取的因素
DOI：
10.1177/2168479015596007
复制
发表时间：
2016
影响因子：
1.5
通讯作者：
Takeshi Suzuki
中科院分区：
文献类型：
--
作者：
Shoyo Shibata;Ryotaro Uemura;Takeshi Suzuki
背景 日本特有的新奖励溢价制度“促进创新药物发现和解决超说明书使用问题等的奖励溢价”于2010年推出，并于2010年、2012年和2014年开始使用。如果新的奖励制度应用于药物，公司可以尽早收回成本，并重新投资于未经批准或创新药物的研发。然而，尚未对应用该新系统的药物进行详细分析。在这项研究中，进行了数据分析以确定哪些因素与获得奖励密切相关。方法选取2009年9月、2011年、2013年销售额前500名的国产药品进行研究。进行多变量或单变量逻辑回归。结果 以下因素与获得奖励显着相关：最近的上市、全球推广公司和孤儿药指定。心血管药物获得奖励的可能性较小，而作用于中枢神经系统的药物、抗癌药物和免疫调节药物则明显更有可能获得奖励。结论 这些发现表明孤儿药和具有特定解剖治疗化学 (ATC) 分类（例如 N 和 L）的药物可能会获得奖励。我们可以验证这一激励计划在日本运作良好，推出了满足高医疗需求的真正创新药物。
Background A new reward premium system, “Reward Premiums for the Promotion of Innovative Drug Discovery and Resolution of Off-label Use Issue, etc,” unique to Japan, was introduced in 2010 and was used in 2010, 2012, and 2014. If the new rewards system is applied to a drug, the company can recover costs early and reinvest in research and development of unapproved or innovative drugs. However, a detailed analysis of the drugs to which this new system was applied has not been conducted. In this study, a data analysis was performed to determine what factors were strongly associated with receiving a reward. Methods Domestic pharmaceuticals in the top 500 sales in September 2009, 2011, and 2013 were selected for this study. Multivariable or univariate logistic regression was performed. Results The following factors were significantly related to receiving a reward: a more recent launch, a global promotional company, and orphan drug designation. Cardiovascular drugs were less likely to receive rewards, whereas drugs acting on the central nervous system, anticancer agents, and immunomodulatory agents were significantly more likely to receive rewards. Conclusions These findings suggest that orphan drugs and drugs with specific Anatomical Therapeutic Chemical (ATC) classifications such as N and L are likely to receive rewards. We can verify that this incentive program works well in Japan, launching truly innovative drugs that meet high medical needs.