The Japanese government appears to be planning annual National Health Insurance (NHI) drug price revisions from fiscal years 2016-2018 — and perhaps beyond. Pharmaceutical prices in Japan are set by the government, based on standardized formulas and negotiations with the manufacturer. For the past 25 years, revisions have generally been conducted every two years in order to control the country’s health care expenditures. The move to annual price revisions — even if only temporary — could have a negative impact on the willingness of Japanese and Western pharmaceutical companies to introduce innovative drugs in Japan.
Furthermore, Japan’s Central Social Insurance Medical Council recently approved a change to the pricing formula for new drugs. The change will go into effect with the next group of drugs added to the NHI price list. The new point-based method rewards drug innovation and improvement in treatment. The government is further considering including cost-effectiveness in NHI pricing rules.
Japan is also working on a project to develop a patient registry at select national medical centers. This registry could be used by drug manufacturers to recruit and enroll clinical trial patients as well as to select trial sites. Liaison offices would also be available to advise pharmaceutical companies on clinical trial considerations. The government hopes that this initiative will make drug clinical trials in Japan faster and cheaper.
Japan has also announced that, starting in October 2016, all drug manufacturers must use Clinical Data Interchange Standards Consortium (CDISC) electronic submissions for clinical trial data on safety, dosage, efficacy, and trial administration. CDISC electronic submissions will also be required for post-marketing data.