While still behind the US and EU CDx markets to date, over the next 5 years, more and more CDx’s will be registered and used for precision medicine in Asia. Drug companies doing clinical trials and launching new drugs in Asia will rely on CDx’s from the West. CDx’s are now more prevalent in Japan, China, Korea, Taiwan, and Australia. Despite more CDx registrations in Asia, CDx reimbursement continues to be a challenge in the East. To get reimbursed in Asia, CDx’s must show a reduction of overall treatment costs with positive outcomes. Unfortunately, CDx reimbursement is not well-developed in Asia.
CDx’s in Japan are often classified and registered as SaMD, program medical devices, IVDs, etc. For example, FoundationOne’s CDx Cancer Genome Profile successful test, a class 3 SaMD, received a high reimbursement of about $4,300 including a large part of the reimbursement due to the need for a doctor’s explanation of the test results. However, CDx’s in Japan that result in a yes/no answer to patient eligibility with less doctor’s interpretation may not receive reimbursement so easily. There is no doubt that Foundation’s partner Chugai Pharmaceuticals had many reimbursement consultations with Japan’s MHLW, KOLs, etc.