Abstract
In Japan, the drug price calculation criteria is applied to determine the price of drugs based on the National Health Insurance (NHI) Drug Price List (NHI Price List) proposed by the Central Social Insurance Medical Council (Chuikyo). NHI Price List affects the research and development strategy of a pharmaceutical company. We surveyed the Chuikyo-documents from October 27, 2006 to August 26, 2015. The number of approved new drugs was 792 and that of new compounds was 483. The number of new drugs whose prices were calculated based on “drugs of similar efficacy comparison-based price setting (Ⅰ),” “cost-based price setting,” and “drugs of similar efficacy comparison-based price setting (Ⅱ) ” was 473 (59.7%), 192 (24.2%), and 67 (8.5%), respectively. The number of new compounds belonging to therapeutic categories such as “other agents affecting metabolism,” “agents affecting central nervous system,” “antineoplastic agents,” and “cardiovascular agents” was 82 (17.0%), 57 (11.8%), 58 (12.0%), and 36 (7.5%), respectively. In the antineoplastic agent category, the prices of more than half the drugs were calculated based on “cost-based price setting.” The number of patients expected to take antineoplastic agents was low, whereas the expected drug price was high. In particular, very few patients were expected to take drugs marketed by a foreign pharmaceutical company whereas the expected drug price was high compared with that observed for drugs marketed by a domestic pharmaceutical company. These results provide a basis for the development and application of new drugs in Japan.
