OBJECTIVES: Health Technology Assessment (HTA) was introduced to the Japanese National Health Insurance (NHI) system in 2019. It was implemented not for coverage decision-making but for price revision in order to maintain the pre-existing rule of the Japanese NHI, covering almost all medications and avoiding delays to the initial pricing phase. We clarified issues with HTA in Japan from a procedural perspective.

METHODS: Reviewed the Japanese HTA guideline and HTA system-related documents in order to evaluate issues in the HTA system.

RESULTS: Two issues in the system have been spotted. Firstly, only one conventional strategy was allowed according to the HTA guideline. Under this guideline, the cheapest but rarely used “very old” drug would be chosen as a single comparator, representing all other drugs. This criteria could pick up a comparator that was approved long ago, is inexpensive, and has a small market share could be chosen just because its efficacy is not statistically inferior to other drugs. The type of comparator makes it difficult to interpret the results, as the drug is not in standard use. Secondly, in the official HTA discussion procedure, the expert organization, which determines the analytical framework, must be held three months after HTA target selection. However, in the pre-analysis consultation between the HTA body and the manufacturer, the accumulated time for all the procedures before the expert organization exceeds three months. As the timeline is operated inflexibly, processes must be omitted or make their preparation time shorter, which results in premature discussions.

CONCLUSIONS: Japanese HTA was just introduced. Therefore, this is the time to identify more appropriate HTA practices. The Japanese HTA system is expected to improve with further discussion, including the points in this presentation. Interactive dialogue between the government, academia, and industry will be necessary for better HTA practices in Japan.