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.