Ask the Expert

Ames Gross is President and Founder of Pacific Bridge Medical, a Bethesda, Md.-based consulting firm that helps medical companies doing business in the Asia market. A recognized national and international leader in the Asian medical markets, he founded Pacific Bridge Medical in 1988, which has helped hundreds of medical companies with business development and regulatory issues in Asia. For more information, visit www.PacificBridgeMedical.com.

Over the last few years, we have encountered this problem with a number of clients. Once you have received an initial reimbursement price where your sales price in Japan does not yield a profit, what can you do? There are several strategies to try that may work, but nothing is guaranteed.

Increasing reimbursement in Japan after an initial reimbursement has been set is not easy. Generally, only the foreign device company (or their MAH/DMAH in Japan) or the appropriate Japanese academic society/association can reapply to the MHLW for increased reimbursement. When doing so, it is important to show both clinical benefit and cost-effectiveness improvement. In addition, the device manufacturer can apply for a new indication for the same device and then claim that the new indication will warrant a higher reimbursement. This article goes into some of the details of each scenario.

First of all, before submitting additional materials for a higher reimbursement, you need to know and review exactly what was submitted before –  the official product name, the initial reimbursement application, what the MHLW said, and what information the MHLW based their decision on. Also, make sure you understand the initial reimbursement category number as well as other key factors.

Second, you want to see what the Japanese society guidelines are for your device and whether it is helpful to have the guidelines changed. When is your device recommended? When is it not recommended? What competing devices do you compete with, and what is the order of each competing product the society recommends for the medical problem? If the society guidelines are not representative of how you want your device to be used, or the society guidelines put your device as a second or third option for a diagnostic/therapy, can the guidelines be changed? What are the guidelines in the US or EU? Will the Japanese society want to change its guidelines to meet international standards? How will lobbying on your behalf affect the Japanese guidelines?

WEBINAR: Japan Medical Device Reimbursement Strategy

Wednesday, September 17, 2025 | 12 PM ET (US)

Third, the relevant academic society support is very important, as well as KOL support within that academic society. Which academic society covers your device – a specific cardio society, a specific radiology society, etc.? Does your company know the president of the appropriate society or the key reimbursement KOL at that society? If not, you must get to know them and build a trusting relationship. How can you get your new reimbursement application submitted for the upcoming two-year device price readjustment?

To support the appropriate academic society, what can you do? Work on a strategic reimbursement plan with the KOLs in the society. It is important to work with the academic society on the Health Technical Assessment (HTA) with new cost-effectiveness economic data, as well as perform new studies to support your reimbursement claims. Then, the academic society will apply to the Surgical Societies Insurance Committee Union (GAIHOREN). GAIHOREN will confirm the completeness of the application and send it to the Central Social Insurance Medical Council (CSIMC), and a Q&A session will follow. After their analysis, the CSIMC will provide their results to Chuikyo – the government reimbursement agency under the MHLW. When you are working with the academic society, do not write your company name on any of the documents except for the device brochure or device presentation, since this may make the reimbursement members nervous to support a specific company’s products.

Fourth, besides strong support for the academic association, you may want to find a professor/or academic in your field who is willing to do a cost-benefit analysis of your product in the Japanese healthcare system. Things that may be required to do this analysis include staff resources to use your device (doctors, nurses, administrators), number of days in the hospital or outpatient time, x-ray or scan charges if applicable, drugs needed if any, follow-up visits, etc. You will generally need to pay the professor or academic doing this work for you, but their help is crucial. Foreign cost-effectiveness data from the West can supplement your real-world cost-benefit Japanese data. Sometimes primary Japanese data can be run through a Western or global cost-effectiveness model, too.

Fifth, if you are looking to increase reimbursement for the same product, without a change in indication or new indication, you can appeal to the MHLW and say this is the only device for this medical problem or if this is not accurate, focus on the fact that your device has a very high percentage use, for a specific problem. Another strategy may be to appeal directly to the MHLW and say that while the product is very beneficial to Japanese patients, the existing reimbursement price is leading to your unprofitable business in Japan. Thus, at some point in the future, you may not be able to supply your product to the Japanese market, which means patients will suffer, and you may close down your Japan business altogether. Please keep in mind that if you tell the MHLW that you may shut down in the future, it does not mean you will need to actually close your business in Japan. Even if the MHLW does not agree to increase your reimbursement, the MHLW will have no problems if you continue to supply your important device to Japanese patients, even if it is unprofitable for you.

Finally, if you are looking for increased reimbursement for the same product with a different indication, you will most likely need to get a new Japan device approval first before seeking increased reimbursement. Device reimbursement for a new indication in Japan can be expensive, especially if a local clinical trial is needed. Sometimes, an additional indication can be added in Japan if you have good Western clinical data for the additional indication, and the differences between the Western patients and Japanese patients are minimal or non-existent. Then, after the new indication is approved, you can try for a higher reimbursement along the traditional reimbursement paths. While this process will not be quick, it may be successful. Please keep in mind, however, that if your product can now be used for 2 different indications, the number of patients for your device in Japan will increase, and thus the MHLW may decide to lower the reimbursement price for both indications.

Getting more reimbursement in Japan after the original reimbursement price is determined is a long, difficult, and expensive process. Thus, it is always best to get the highest reimbursement on your initial device registration and the initial reimbursement submission.

Read Part 1:

What do you need to know about getting your medical device reimbursed in Japan?

Register for the WEBINAR: Japan Medical Device Reimbursement Strategy

Wednesday, September 17, 2025 | 12 PM ET (US)