Objective : To identify the issues in conducting pharmacoeconomics (PE) studies at pharmaceutical companies in Japan.
Methods : A questionnaire survey on the conditions of PE studies was conducted for the pharmaceutical companies that are members in the Pharmaceutical Manufacturers Association of Tokyo. Seventy-seven of 94 member companies participated, an 82% response rate. The survey covered the following topics with regard to the companies : the number of applications of PE data for the new drug pricing process, the timing and phases to conduct a PE analysis, a recognition of the necessity for PE analysis, and issues for conducting optimum PE analysis.
Results : Out of 77 responding companies, 36 companies (47%) answered that they conduct PE analysis at their regulatory affair department in order to submit supplemental applications for the drug pricing process to the Ministry of Health, Labor and Welfare. However, only 42% companies of approved drugs since April 1997 were actually submitted with PE data for the drug pricing review. Seventy-seven percent of companies recognized the necessity for PE analysis for the drugs. On the other hand, they did not perceive PE as a useful tool for negotiating drug prices with the Japanese government. Major issues for PE analysis to be conducted are ; lack of Japanese guidelines and epidemiological databases, lack of transparency in the method which reflects the data for the policy making, and lack of companies'initiative.
Conclusion : Establishment of a Japanese guideline for PE studies will be important for companies to conduct accurate and reliable PE studies. The Japanese government should disclose the process of using the PE data for policy making. At the same time, it is necessary for the companies to be more spontaneous in their PE studies.

Objectives : Pharmaceutical companies in Japan can attach pharmacoeconomic (PE) data to their application for new drug prices covered by the National Health Insurance (NHI) system since 1992. To examine the present state of PE studies in Japan by investigating the situation of PE data attachments and their details and also to identify problems concerning how to reflect the PE information in new drug pricing, a questionnaire-based survey of pharmaceutical companies was conducted.
Method : The survey covered 115 drugs filed by the members of the Japanese Pharmaceutical Manufacturers Association (JPMA), which are among the 137 drugs listed between June 20, 1997, when the NHI drug price formula was published, and November 17, 2000. Questionnaires were returned on 114 of the 115 drugs studied and the response rate was 99%.
Results : PE data was attached to 37 of the 114 drugs (32%) at the time of application. The ratio of applications accompanied by PE data tended to be decreased from 1998. No significant relation was observed between a premium for a drug and the attachment of PE data. The most common method used in the attached PE data was cost-effective analysis (14 of 37 drugs ; 38%), followed by cost-benefit analysis (7 drugs) and cost-minimization analysis (6 drugs). Cost-utility analysis was not applied to any of the 37 drugs.
Discussion : Compared with overseas PE studies, Japanese studies were found to be less comparable with one another due to the lack of a uniform system of research and reporting results. Other problems observed included insufficient epidemiological data for analysis and difficulty in the cost data collection. The questionnaire-based survey revealed that Japan needs to set guidelines for PE studies and to establish epidemiological and cost databases for these research activities. It also suggested the necessity of reviewing the present method of clinical tests so that economic parameters for PE analysis and QOL may be obtained from these tests.