In December of last year, we published a news brief explaining that Foreign Reference Pricing is becoming less important in Japan for device reimbursement. Today, Japan’s medical device reimbursement normally closely follows the reimbursement in Europe, not the US and Australia, which are generally significantly higher priced markets.
Recently, we have seen that increased Japanese medical device reimbursement is now leaning heavily toward what the true advantages the clinical data shows. Clinical outcomes are king, and the device must show superiority in diagnosing or treating disease. How does the medical device change inpatient management or patient outcomes? Requirements for a premium price for innovative devices include things such as high efficiency compared to existing devices and superior safety compared to existing devices. To get an increased reimbursement for an innovative device, clinical evidence must be shown. Thus, clinical quantitative and qualitative endpoints must be clear. Thus, it is always a good idea to discuss these endpoints with the PMDA upfront.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.