Price Comparison Of New Drugs In Japan, Eu And Us

Abstract

Japan has the following pricing guidance: a premium is possible to be applied for an Orphan Designated drug if the premium has not been applied to its comparator. The objective of this study is to compare National Healthcare Insurance (NHI) prices of Orphan Designated drugs with Reference Countries' prices (listed in US: Red Book; UK: MIMS; Germany: Rote Liste; France: Vidal) at the time of NHI price listing. NHI price information was obtained from official websites of the Ministry of Health, Labor and Welfare (MHLW). We investigated if new drugs listed from April 2014 to December 2016 had reference countries' prices and Orphan Designation, and selected NHI prices of new drugs which have at least one or more reference countries' prices, in addition to Orphan Designation. We compared the selected NHI prices with "Foreign Average Price (FAP)", the average of all existing reference countries' prices the "EU Average Price (EUP)", the average of all existing prices of UK, Germany and France and the "US Price (USP)." A total of 181 new drugs were listed on the NHI price list from April 2014 to December 2016. Out of 181 drugs, 120 drugs (66%) had at least one or more reference countries' prices, of which 48 drugs (40%) received Orphan Designation. In addition, among the Orphan Designated drugs, 83%, 65% and 91% were priced lower than FAP, EUP and USP, respectively. For other drugs, 88%, 71% and 94% were priced lower than FAP, EUP and USP, respectively. In the past three years, NHI pricings for new drugs in Japan tended to be lower than Reference Countries' prices, even of new drugs for unmet medical needs. Further guidance to value new drugs, especially Orphan Designated drugs, would be necessary for the pricing system in Japan.