Overview of the Japanese Rapid Introduction Premium - Premium as a drug pricing framework to enhance patient access to innovative drugs

Sep 30, 2026

Uploaded by awa

The pricing of new drugs shapes patient access by affecting where and when manufacturers choose to launch therapies. The United States uses a largely market-based system set by private insurers, while Japan relies on government-regulated prices under National Health Insurance, resulting in US prices averaging 3.2 times higher. Because Japan’s market entry has often been delayed, Japan introduced the Rapid Introduction Premium in April 2024 to narrow price gaps and promote earlier launches. This review overviews the framework and its drug pricing implications.

LanguageEnglish

CategoryHealthcare

FormatPDF

Pages7

Reading Time18 min

AccessFree to download

Background

International drug approval and pricing role

Differences between US and Japan

Rapid Introduction Premium framework

Policy motivation and pricing gap reduction

Implementation and approved drugs

Takamura etal. Health Economics Review (2026) 16:1 Health Economics Review [https://doi.org/10.1186/s13561-025-00705-9](https://doi.org/10.1186/s13561-025-00705-9) REVIEW Open Access Overview of the Japanese Rapid Introduction Premium as a drug pricing framework to enhance patient access to innovative drugs KentoTakamura 1,2*, Gai Jinnai3, Yuki Niwa 1 and Masuo Kondoh 1,4* Abstract The pricing of new drugs plays a critical role in patient access by influencing where and when pharmaceutical companies choose to launch their products. The United States (US) operates a predominantly market-based pricing system, in which pharmaceutical companies set and manage drug prices under private health insurance. In contrast, Japan has a government-regulated drug pricing system under its National Health Insurance (NHI) . On average, drug prices in the US are 3.2 times higher than those in Japan. The US system facilitates faster patient access to new drugs through rapid market entry, whereas market entry in Japan has often been delayed. To address this issue, the Japanese government introduced the Rapid Introduction Premium in April 2024, aiming to promote earlier launches of new drugs by narrowing the price gap with higher-priced markets such as the US. In this review, we provide an overview of the new drug pricing framework associated with the Rapid Introduction Premium. Keywords Drug pricing, New drug pricing policy, Rapid Introduction Premium, Innovation access, Drug lag Background Drugs have both beneficial and harmful effects on humans; therefore, their quality, effectiveness, and safety must be ensured through a rigorous approval process before a new drug is introduced to the market. This process is coordinated internationally to facilitate the *Correspondence: KentoTakamura [kentot@bu.edu](kentot@bu.edu)[ ](kentot@bu.edu)Masuo Kondoh [masuo@phs.osaka-u.ac.jp](masuo@phs.osaka-u.ac.jp) 1Graduate School of Pharmaceutical Sciences, The University of Osaka, Suita, Osaka 565-0871, Japan 2Pharmaceutical Safety Bureau, Ministry of Health, Labour and Welfare, Tokyo 100-8916, Japan 3Health Policy Bureau, Ministry of Health, Labour and Welfare, Tokyo 100-8916, Japan 4Center for Infectious Disease Education and Research (CiDER), The University of Osaka, Osaka 565-0871, Japan efficient development of new drugs by pharmaceutical manufacturers. The prescription drug pricing framework plays a crucial role in enabling patient access to pharmaceutical therapies, as price strongly influences a manufacturer’s decision to develop a new drug and conduct clinical trials for its launch in a particular country. However, drug pricing systems differ substantially between countries, leading to significant variations in actual drug prices. For instance, drug prices in the United States (US) are 3.6, 3.2, and 4.1 times higher than those in the United Kingdom, Japan, and Canada (Ontario), respectively [1]. The US is often the first country where drug companies sell the drugs [1]. The US has a relatively free-market pricing system, in which pharmaceutical companies determine and manage drug prices, and private health insurance covers most of the population [2]. In contrast, Japan has a government-controlled pricing system, © The Author(s) 2025. Open Access This article is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License, which permits any non-commercial use, sharing, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if you modified the licensed material. You do not have permission under this licence to share adapted material derived from this article or parts of it. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the materi

FAQs

Why does drug pricing influence patient access to new therapies?

Drug prices affect manufacturers’ decisions about where to develop, run trials for, and launch new drugs. As a result, pricing can determine both the timing and availability of innovative treatments to patients.

How do the US and Japan differ in drug pricing systems?

The US largely uses market-based pricing managed by pharmaceutical companies under private health insurance, while Japan uses government-regulated drug pricing under National Health Insurance. These differences contribute to higher average prices in the US compared with Japan.

What is the purpose of Japan’s Rapid Introduction Premium introduced in April 2024?

It aims to promote earlier launches of new drugs by narrowing the price gap with higher-priced markets such as the US. This is intended to reduce drug lag and improve timely patient access to innovative medicines.

Sep 30, 2026

Uploaded by awa