Reimbursement and Market Access for Medical Devices in Japan
Obtaining a high device reimbursement price from Japan’s Chuikyo.
To learn more about Japan medical device reimbursement, please contact us.
To succeed in Japan’s medical device market, Japanese medical device reimbursement is crucial. The reason for this is Japanese have full healthcare coverage from the Japanese government and they will normally only use devices that are reimbursed. In fact, it is illegal to use medical devices in Japan that are not reimbursed, except for cosmetic procedures where there is no reimbursement. When a device company is entering Japan, besides registering their device or finding a marketing partner, device reimbursement must be closely examined upfront, to make sure the pricing in Japan will yield the foreign device company profit.
Under the Japanese MHLW, Chuikyo is the main reimbursement agency. Japanese reimbursement is generally determined by two strategies – 1. Functional reimbursement or Foreign Reference Pricing. While reimbursement is normally dealt with after product approval, in some cases you can discuss your product’s reimbursement during the registration process. Key factors for reimbursement include – 1. Strong KOL and Japanese Association support, 2. Health economic data showing better outcomes, and 3. Ways to reduce the burden on the Japanese government’s budget.
Functional reimbursement pricing is often a good benchmark in Japan. There are a number of Functional reimbursement categories including – A1, A2, A3, B1, B2, B3, C1 and C2. Category A products are reimbursed as part of the technical fee. Category B products are determined by other one-time use devices. And Category C devices are for new devices that have a new function or new technology or both.
Foreign Reference Pricing (FRP) evaluates the average prices in five reference countries – the US, England, France, Germany and Australia. If the prices in the US or another country are too high the reimbursement price may be determined by only averaging the 3 or 4 lowest prices. There are also a number of other formulas that can reduce FRP. Generally, Japan sees the US price as too high and today looks to European prices as more realistic.
Recently, the MHLW has stated that Japan device reimbursement should be lower than in the US.
To learn more about Japan medical device reimbursement, please contact us.
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