Comparison of New Drug Accessibility and Price Between Japan and Major European Countries.

BACKGROUND: A common concern about universal health insurance coverage is how to control health expenditure. The escalation of health care costs raises public awareness of the optimization of drug price and increased demand for cost-effectiveness assessment. In this paper, we show the differences in patient access to new drugs and drug price among countries, in which the situation of introduction of cost-effectiveness assessment scheme is different. METHODS: We investigated the health insurance coverage proportion of newly approved drugs in Japan, France, Germany, and the United Kingdom (UK). Then, we calculated the ratios of the European to the Japanese price for products that were reimbursed in both countries. RESULTS: Japan had the highest health insurance coverage proportion (98.6%) in the 4 countries. In Japan, all the drugs that were approved in 2015 had been already listed in the latest formulary of February 2016. As for drug price, there wasn't much difference between Japan and the European countries in many cases. CONCLUSION: From the viewpoint of the health insurance coverage proportion and the speed of reimbursement decision, the hurdle to access new drugs in Japan is lower than that in major European countries. While extensive coverage of health insurance and prompt reimbursement decision lower the hurdles to access new drugs and expand treatment options, they could lead to the increased medical expenditure. We should continue to discuss sustainable health insurance systems and drug price calculation schemes that properly reflect the drug's clinical value while keeping the availability of new drugs to patients.

Quantitative Assessment of Premium Rates for Clinical Usefulness in New Drug Price Calculation in Japan.

BACKGROUND: In Japan, the reimbursement price of a newly approved drug is calculated according to the rule established by the government. As an incentive to innovative Research & Development, a new drug that meets certain criteria obtains premiums on its price. To quantify the clinical value of new drugs in pricing, a point-based system was proposed by an academic study group. This paper gives the background to and overview of the system, and reviews the drugs that gained the premiums after its introduction. METHODS: For drugs to which premiums for innovativeness/usefulness were applied between April 2008 and August 2013, detailed information including the grounds for the premiums was identified. Then, subdivided factors for the requirement of the premium were set and points were allocated to them inductively depending on the degree of clinical impact. Finally, consistency between the rate actually applied and that calculated based on the system were reviewed for new drugs that gained the premiums after its introduction. RESULTS: Forty-seven drugs gained the premium for usefulness between April 2008 and August 2013. Based on the grounds for the premium, a point-based system was established. After its introduction, 11 drugs gained premium for innovativeness/usefulness. The applied rates of premium were consistent with the calculated rate by the system in most cases. CONCLUSIONS: Predictability of future drug price is expected to be enhanced by the point-based system. As the control of health expenditure becomes strict, the importance of considering drug pricing policy that properly reflects the drug's clinical value increases.

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

BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.