ABSTRACT

The Japanese healthcare system has offered universal healthcare to its citizens since 1961 through three mandatory insurance programs: the National Health Insurance (NHI), the Employees' Health Insurance and the Government-Managed Health Insurance. A network of largely private hospitals and clinics is reimbursed on a fee-for-service basis, although a Diagnosis Related Group (DRG) based system is gradually being implemented over time. New drug applications are reviewed by the Pharmaceutical and Medical Devices Agency (PMDA), an agency within the Japanese Ministry of Health, Labor, and Welfare (Korosho). Japanese prices for drugs are controlled by the Korosho in accordance with a very structured system, consisting of internal reference pricing and an adjustment based on international prices. In Comparative method, pricing is determined on the basis of a selected comparator and an improvement related premium over the price of that comparator. Selected drugs, for which an appropriate comparator cannot be assigned, can qualify for cost-plus-based pricing.