OBJECTIVES: From April 2016, a pilot program to utilize economic evaluation of pharmaceuticals and medical devices for price adjustment is implemented in Japan.  In order to make evaluation results comparable, standardized method of evaluation is required.  We created the economic evaluation guideline for the pilot program. METHODS: We organized a research team for developing guideline.  Based on the previously proposed guidelines in Japan and in other countries, the research group discussed and created economic evaluation guideline suitable for Japan. RESULTS: The guideline consists of 15 items, 1)Objective, 2)Perspective of analysis, 3)Target population, 4)Comparators, 5)Additional efficacy and safety, 6)Method of analysis, 7)Time horizon, 8)Choice of outcome measures, 9)Data sources, 10)Costing, 11)Costs of long-term care and productivity loss, 12)Discounting, 13)Modeling, 14)Uncertainty, 15)Reporting.  The guideline was approved by the cost effectiveness evaluation subcommittee under the central social insurance medical council, where reimbursement prices are determined. CONCLUSIONS: In Japan a new pilot program is implemented with a new economic evaluation guideline. This research was funded by a grant from Ministry of Health, Labour and Welfare, Japan.