Objective: To explore the data sources used in economic evaluations performed on new drugs, and to propose an improved data infrastructure in Japan.
Design: A systematic review.
Methods: We systematically reviewed economic evaluation studies of the new drugs which were launched in Japan between April 2006 and March 2011, and have been priced by the cost calculation method. The “Ichushi” and Pubmed databases were used to find the published articles.
Results: 198 drugs were priced under cost calculation methods in the last 5 years in Japan. 14 published articles (9 drugs) were found: 5 CUAs and 10 CEAs (including one that was both CUA and CEA). In all studies, several data from different sources were incorporated. Cost data were estimated by using standard treatment protocols and national price lists for drugs and medical services, or obtained from limited number of claims data. Efficacy data were obtained from RCTs or clinical trial data mostly conducted in Japan. In 4 out of the 5 CUAs, utility data were used from other studies conducted on non-Japanese samples. Other data, such as epidemiological data, were adopted from overseas as well as Japanese studies.
Conclusion: In order to increase quality and efficiency to conduct economic evaluations in Japan, three steps need to be taken in the data environment: increased accessibility to large cost databases such as the national claims database; establish an epidemiological database; and collect and accumulate utility data in Japanese samples.

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One of the target points in the PMDA 2nd midterm plan (FY2009-2013) is reinforcement and enhancement of the system for safety evaluation for pharmaceuticals using expanded data sources beyond spontaneous reports of adverse drug reactions (ADRs). To achieve this goal, PMDA started investigation in FY2009 to develop methodology to utilize electronic medical information for secondary purpose of safety evaluation of pharmaceuticals. (MIHARI project- Medical Information for Risk Assessment Initiative)
Data sources targeted in MIHARI project are claims data, diagnosis procedure combination (DPC) data, hospital information system (HIS) data, etc.
Secondary use of electronic medical information for safety evaluation is expected to enable safety evaluation based on quantitative analysis, which has been difficult so far. It will also provide faster and easier way of evaluation compared to collecting primary data from study planned and conducted just for the purpose.
PMDA intends to establish the system to utilize electronic medical information (eg. claim data, DPC data, HIS data) practically for safety evaluation by the end of FY2013. Aiming for this, PMDA is conducting various pilot studies using currently available data in the MIHARI project. Here we report on recent developments of this project.

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