Pharmaceutical Pricing and Reimbursement in Japan: For Faster, More Complete Access to New Drugs.

Abstract

In Japan, National Health Insurance (NHI) has ensured that all Japanese citizens can use the health services they need for more than 50 years. This paper gives an overview of the Japanese NHI drug price listing scheme and practice, and it also discusses the issue of drug price setting and health insurance system from the viewpoint of better patient access to new drugs as well as the environment for innovative new drug development. For each New Molecular Entity (NME) approved between October 2004 and December 2014, we checked its presence in the list of NHI drug prices as of January 31, 2015, to calculate the NHI coverage rate and the average time between marketing approval and the date of NHI listing. A total of 304 NMEs were listed in the NHI price list during the study period, and the NHI coverage rate (excepting preventive vaccines) was 97.4%. The average time between marketing authorization and the initiation of reimbursement was 66 days. There were 88 drugs that gained premiums for innovativeness/usefulness. From the view of NHI coverage scope and speed, the hurdle to access new drugs in Japan is shown to be lower than in other countries that also set public prices for reimbursement. Although the difficulty of controlling health expenditures increases, drug pricing that properly reflects the drug's clinical value is important in that it also furthers the development of medical technology. Better price setting can also facilitate patient access to innovative drugs.