ABSTRACT
The Japanese healthcare system has offered universal healthcare to its citizens since 1961 through three mandatory insurance programs: the National Health Insurance, the Employees’ Health Insurance and the Government-Managed Health Insurance. New drug applications are reviewed by the Pharmaceutical and Medical Devices Agency, an agency within the Japanese Ministry of Health, Labor and Welfare (MHLW). MHLW also determines coverage policy and pricing for healthcare products that are purchased by hospitals and pharmacies. Japanese prices for drugs are controlled by the MHLW in accordance with a structured system, consisting of internal reference pricing and an adjustment based on international prices. Japan, like many other countries in the world, is facing the challenge of paying for high-cost innovative therapies and a rapidly aging population. In Japan, being listed as a medication or medical device for an orphan or intractable disease comes with certain financial benefits.
