LAUSR

OBJECTIVES: Rise in national healthcare and pharmaceuticals costs is a concern for Japan. Health economics of medical innovation was listed in social security reforms in 2011. The aim of this study was to describe the history and the current situation of HTA in Japan and the conservative reaction to its progress. METHODS: We reviewed governmental policy reports published by health authorities regarding the HTA. The review was completed with literature search and web browsing. RESULTS: Submission of pharmacoeconomic data has been recommended for price negotiation since 1992. However, HTA dossier was submitted in only less than 5% due to unclear incentives for the industries. In May 2012, a new special committee on costeffectiveness analysis (CEA) was established within Chuikyo (Japanese Central Social Insurance Medical Council). Almost 4 years of discussions led to the HTA pilot in April 2016, with the aim of its full implementation in pricing decisions from 2018. Based on the selection criteria related to premium and sales, seven previously-listed drugs with high drug budget impact were selected for the pilot. However, conservative views were expressed by industrial associations at a council held by Chuikyo in October 2017 suggesting a restricted use of HTA. Discussions throughout 2017 over pricing policies (mainly appraisal and revision methods) had difficulty reaching an agreement among stakeholders. As a result, HTA is only introduced in price revisions of selected technologies in April 2018 and full HTA implementation has been postponed until 2019. CONCLUSIONS: HTA has been gradually penetrating into Japan to inform pricing decisions facing substantial conservatism. While current cost containment policies tend to delay or avoid value discussions, value appreciation is at the core of HTA and it allows innovation to gain recognition. There may be a need for further communication between stakeholders for a seamless introduction of HTA.