Abstract
BackgroundThe 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.MethodsThe 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.ResultsEighty-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).ConclusionsNHI 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.
Highlights
The relationships between developmental strategies for additional indications and drug price revisions have not been thoroughly studied
We investigated the relationships between National Health Insurance (NHI) price revision and pharmacological and regulatory characteristics and development strategies, represented by additional indication achievement methods, for anticancer drugs approved in Japan
Characteristics of anticancer drugs with NHI price listing Totally, 153 indications of anticancer drugs were approved in Japan between January 2009 and March 2020, including 81 initial approvals and 72 with additional indications
Summary
The relationships between developmental strategies for additional indications and drug price revisions have not been thoroughly studied. We investigated the price revisions for anticancer drugs approved in Japan. There are several special rules, such as market expansion repricing and, price reduction for a long-listed drug to be considered while revising drug price. These are all measures to control medical costs in Japan (Online Resource 1). Japan’s drug pricing system is different from that of other countries. It is characterized by a unique method of calculating the initial NHI price and the NHI price continues to decrease post-marketing [1,2,3]
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