Summary
Pharmacotherapy in oncology has significantly progressed during the last decade, with innovative advances in the understanding of cancer molecular mechanisms and immunity and new modalities of drugs, including regenerative medicines and gene therapies. Owing to the severity of cancer-related distress, cancer patients and their caregivers live with a huge burden. Thus, innovative anticancer drugs are in high demand worldwide but are unequally available because medical drugs are examined and approved separately in each country. Our study focused on first-in-class (FIC) anticancer drugs and investigated their actual development situation in the United States (US), European Union (EU), and Japan over the last two decades. We identified FIC anticancer drugs using pharmacological classes for the Japanese drug pricing system.
Most FIC anticancer drugs, available in Japan, were first approved in the US. The statistical difference was observed only between US and JP in terms of the accumulation of approved new pharmacological classes.
The linear regression of accumulation rates of new pharmacological classes and ANOVA revealed a significant difference in coefficients in the three regions pre-2010 periods; however, no statistically significant difference was observed in the post-2010 period. It means that the situation in Japan improved after 2010.
|
pre-2010 |
|||
|
Accumulation rate of pharmacological classes |
95% confidence interval |
ANOVA |
|
|
US |
5.52 |
[5.21 - 5.84] |
p<0.001 |
|
EU |
4.29 |
[3.93 - 4.66] |
|
|
JP |
3.11 |
[2.70 - 3.52] |
|
⇓
|
post 2010 |
|||
|
Accumulation rate of pharmacological classes |
95% confidence interval |
ANOVA |
|
|
US |
10.6 |
[9.74 - 11.57] |
p=0.342 |
|
EU |
10.01 |
[9.4 - 10.62] |
|
|
JP |
10.25 |
[9.99 - 10.5] |
|
Submission and approval lag between the US and Japan were more than 2.1 years, and those between the EU and Japan were more than 1.2 years. However, those between the US and the EU were less than 0.8 years. The development rate of FIC anticancer drugs in Japan is slower than in other regions.
This work was a collaboration among Gifu Pharmaceutical University, University of Copenhagen, Utrecht University, and University of Florida. This paper was selected as Editor's choice in Biological and Pharmaceutical Bulletin, an official English journal of the Pharmaceutical Society of Japan.
Summary
- We visualized inequality in how people worldwide obtain the latest innovative cancer pharmacotherapies by utilizing a drug classification system for the unique Japanese drug pricing system.
- The development rate of first-in-class anticancer drugs in Japan is slower than in other regions.
- Considering the high impact of first-in-class anticancer drugs on society worldwide, we should work together to reduce drug lag among regions using an improved international cooperative framework.
Information of our article
Literature name : Biological and Pharmaceutical Bulletin
Title : Regional Disparity in First-in-Class Anticancer Drug Development in the US, EU, and Japan
Authors : Yoshitsugu Hino, Miu Okada, Christine Erikstrup Hallgreen, Marie Louise De Bruin, Randell E Doty, Naoki Matsumaru, Katsura Tsukamoto
URL : https://www.jstage.jst.go.jp/article/bpb/46/5/46_b22-00868/_article/
DOI: https://doi.org/10.1248/bpb.b22-00868