Japan IVD Reimbursement Update

IVDs, drugs and medical devices have different reimbursement pathways in Japan. Normally, for all these paths, a reimbursement application is submitted after product approval. Reimbursement is then normally determined within 3-6 months. However,  the MHLW is allowing some companies to have a pre-reimbursement meeting.

For IVD products in Japan, a pre-reimbursement meeting with the MHLW will require putting together some information to be used during the meeting discussion. This information will be submitted in advance. Such information for IVDs will include the following.

• Overview of the target disease and target patients of the referenced product.
• The current testing methods for the target disease and their problems and need for better testing.
• Background that led to the development of the applied product.
• How the applied product contributes to or solves/improves the problems and needs
• Clinical positioning of the applied product and changes in the medical treatment flow.
• Cooperation status with related academic societies (including a request for early introduction or a statement including the target patients)
• Evidence that the applied product is more useful in comparison with currently available products.
• Details of the desired insurance coverage including an explanation of the basis for selecting the applicable technical fee.

Hopefully, the MHLW will provide some feedback at this preliminary meeting for your formal reimbursement application, which will be submitted after the product is approved in Japan.

For the formal application, IVD companies will need to submit  the following information.

Draft of the formal application can be shown at the pre-reimbursement meeting.

• Cost information – raw materials, packaging, general selling and administrative expenses, R&D expenses, distribution expenses, labor and manufacturing expenses, cost of analyzer, etc.
• An outline of the assay including its principle, measurement method, and performance.
• Clinical significance and improved convenience
• Usefulness in medical economics – does the test increase or decrease medical expenditures, what is the final impact?
• Basis for desired reimbursement price
• Patient numbers and market size over a 10-year period
• Forecasted sales of the IVD
• Price of the kit

Of course, this formal reimbursement application needs to be done in Japanese and supporting documents must be provided to confirm the information above. Strong health economics information and support from KOLs and appropriate Japanese Industry are also very important.