OBJECTIVES: This study compares Japanese HTA guidelines to current HTA guidelines in six countries and identifies similarities and differences between Japanese and other major HTA guidelines.

METHODS: Official HTA guidance was identified via a comprehensive search of the websites of the Canadian Agency for Drugs and Technology in Health (CADTH; Canada), Centre for Outcomes Research and Economic Evaluation for Health (C2H; Japan), Pharmaceutical Benefits Advisory Committee (PBAC; Australia), Federal Joint Committee (G-BA) and Institute for Quality and Efficiency in Health Care (IQWiG; Germany), National Authority for Health (HAS; France), Dental and Pharmaceutical Benefits Agency (TLV; Sweden), and National Institute of Care and Excellence (NICE; England).

Guidelines on methods for conducting health economic evaluation (HEE) from each country were identified and comparisons made between Japan and other countries. All key elements – including population, comparator, analytical technique, perspective, clinical data sources, outcomes, classification of results, utility derivation, discounting, time horizon, sensitivity analysis-methods, equity, and budget impact analysis – were included when comparing guidelines between Japan and other countries.

RESULTS: There are important similarities between HTA guidelines in Japan and other key countries. In most countries, comparators reflect the most common existing treatment, while economic evaluations use QALYs as the preferred outcome over a lifetime horizon. The EQ-5D instrument was recommended as the source of utilities in all countries. However, there are differences in the perspective recommended in Japan and England (public payer) and Sweden (societal), while budget impact analysis is considered less frequently in Japan and Sweden than in other countries.

CONCLUSIONS: Similarities between HTA guidelines in Japan and six key countries were shown in the overall HEE framework, with observed differences in assessing financial impact, and some detailed requirements of HEE. This suggests that differences in HTA outcomes between Japan and other countries results from interpretation of evidence, not differences in methods.