日本新增适应证的开发策略与抗癌药物价格修订之间的关系。
Relationships between developmental strategies for additional indications and price revisions for anticancer drugs in Japan.
机构信息
Department of Regulatory Science, Meiji Pharmaceutical University, 2-522-1, Noshio, Kiyose, Tokyo, 204-8588, Japan.
Department of Public Health and Epidemiology, Meiji Pharmaceutical University, 2-522-1, Noshio, Kiyose, Tokyo, Japan.
出版信息
BMC Health Serv Res. 2021 Dec 11;21(1):1329. doi: 10.1186/s12913-021-07360-w.
BACKGROUND
The relationships between developmental strategies for additional indications and drug price revisions have not been thoroughly studied. Here, we investigated the price revisions for anticancer drugs approved in Japan.
METHODS
The study was based on published information on anticancer drugs approved between January 2009 and March 2020 in Japan. We investigated the relationships between the pharmacological and regulatory characteristics of anticancer drugs and occurrence/non-occurrence of the Japanese National Health Insurance (NHI) price revisions.
RESULTS
Eighty-one new anticancer drugs were given NHI price listings during the survey. On April 1, 2020, the prices of 23 anticancer drugs had been revised from the initial pricing, the prices were reduced for 21 drugs (91.3%). Several parameters showed the relationships between drug characteristics and NHI price revisions. The achievement of additional indications and compound type were identified as explanatory factors for these relationships. Additional indication profiles were defined to assess the relationships between the methods for additional indication achievement and price revisions. When the type of additional indication was "Expansion", the percentage of drugs received NHI price revisions was the highest (P<0.001).
CONCLUSIONS
NHI price revision was significantly related to the achievement of additional indications and compound type. The strategy for additional indications was found to affect the occurrence/non-occurrence of NHI price revisions.
背景
尚未深入研究将新增适应证的开发策略与药品价格修订之间的关系。本研究旨在调查在日本获批的抗癌药物的价格修订情况。
方法
本研究基于已发表的在日本于 2009 年 1 月至 2020 年 3 月间获批的抗癌药物的信息。我们调查了抗癌药物的药理学和监管特征与日本国民健康保险（NHI）价格修订之间的关系。
结果
在研究期间，81 种新的抗癌药物被列入 NHI 价格清单。2020 年 4 月 1 日，有 23 种抗癌药物的价格已从初始定价进行修订，其中 21 种药物（91.3%）的价格有所降低。几个参数显示了药物特征与 NHI 价格修订之间的关系。额外适应证的获得和化合物类型被确定为这些关系的解释因素。我们定义了新增适应证概况，以评估获得额外适应证的方法与价格修订之间的关系。当新增适应证类型为“扩展”时，接受 NHI 价格修订的药物比例最高（P<0.001）。
结论
NHI 价格修订与新增适应证的获得和化合物类型显著相关。新增适应证策略被发现会影响 NHI 价格修订的发生/未发生。
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