ABSTRACT
The interest has been officially growing in introducing health economics approach to the issues of pricing and reimbursement for new drugs and medical devices. In the Social Security Reform Plan of the Cabinet Office, the Ministry of Health, Labor, and Welfare proposed an idea for further investigating a role of socio-economic evaluation to assess the innovation of medical technology. To address this new circumstance, the government must develop and implement an official guideline for economic evaluation of medical technology. Responding to the emerging need for a socio-economic evaluation guideline, we illuminate an outline of the socio-economic evaluation guideline drafted by experts' consensus and proposed to Ministry of Health, Labor, and Welfare in March 2007. Also the potentials and the issues to substantiate the guideline by government were identified for future discussions between government, academics and industry.