Factors That Affect the Acquisition of Reward Premiums for Promotion of Innovative Drug Discovery in Japan

Abstract

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.