ORIGINAL RESEARCH article
Front. Pharmacol.
Sec. Drugs Outcomes Research and Policies
Pricing, Price Revision, and Clinical Value of Anticancer Drugs in Japan: A Retrospective Observational Study
Provisionally accepted
- 1Shenyang Pharmaceutical University, Shenyang, China
- 2School of Biomedical Engineering, Hainan University, haikoui, China
- 3Tsinghua University School of Pharmaceutical Sciences, Beijing, China
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Introduction The high cost of anticancer drugs has raised concerns due to the financial burden on patients and pressure on healthcare systems. We examine the relation between pricing premiums, price revision, and clinical value for anticancer drugs approved in Japan. Methods We included anticancer drugs approved in Japan from 2013 to March 2023. Differences in clinical value, as measured by ESMO-MCBS, among drugs receiving different premium proportions, were analyzed using the Mann-Whitney U test. Pearson correlation coefficients were calculated between treatment costs and clinical outcomes and value, including PFS gain, OS gain, objective response rate (ORR) gain and ESMO-MCBS. We also compared the magnitude of price revisions and price reductions with different clinical values. We used regression analysis to explore the association between clinical value, price revision, and influencing factors. Results Our cohort included 94 anticancer drugs and 119 key clinical trials. 39 drugs (41.49%) received premium pricing, while 55 drugs (58.51%) did not. Drugs with pricing premiums had higher ESMO scores than those without (3 vs. 2; P = 0.0013), with ESMO scores showing an increasing trend as the proportion of additional scores rose. Pearson correlation analysis revealed no significant association between daily treatment cost and ESMO score , PFS gain, OS gain or ORR gain . Additionally, no significant differences were observed between high clinical value drugs (ESMO = 4-5) and low-to-medium clinical value drugs (ESMO = 1-3) in median price revision percentage and median price reduction percentage (0.00% vs. −0.02%, P = 0.65; −13.55% vs. −9.86%, P = 0.607). Moreover, multivariate linear regression analysis revealed no association between ESMO score, markup ratio, PFS gain, OS gain, ORR gain, approval year and the magnitude of price revision (P = 0.32; P = 0.06; P = 0.71; P = 0.06; P = 0.70; 0.51). Discussion Our study found that Japan's price premium reflects clinical value and provides incentives for high-clinical-value anticancer drugs. However, during both initial pricing and subsequent revision phases, there is room for improvement in aligning drug prices with clinical value. Policymakers should further refine pricing and revision systems to more effectively promote clinical value-driven drug pricing.
Keywords: anticancer drugs, Pricing, Price revision, Clinical value, japanese
Received: 05 Jun 2025; Accepted: 27 Oct 2025.
Copyright: © 2025 He, Wei and YANG. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence: Yue YANG, yanghappy@tsinghua.edu.cn
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