Japan is in the midst of a two-year reimbursement cycle which will culminate in the determination of the rules it will use to adjust reimbursement prices in 2014. A key concern is Japan’s plan to adopt some form of health technology assessment (HTA) as a cost containment mechanism. AdvaMed’s goal is to prevent the adoption of an HTA program for reimbursement that is inconsistent with recognized principles, including full transparency, active industry participation in the process; results not derived primarily from clinical evidence.
FAP: Seek elimination of FAP. While FAP remains, secure stability in the rules to minimize the impact on reimbursement prices.
Regulatory: Secure separate provisions for medical devices in revision of Japan’s PAL. Ensure that Japan’s Action Program goals for hiring new medical device reviewers are achieved and regulatory approval times for each of the four product categories are improved. Another concern is Japan’s interest in finding ways to reduce the differential