Session (CTI)

PURPOSE: The objectives of this session are to introduce the audience to how health technology assessment (HTA) bodies in incorporate real-world evidence (RWE) into their evaluation of medical devices and discuss lessons learned in leveraging RWE in HTA and market access in Australia and Japan. DESCRIPTION: RWE is becoming increasingly important for reimbursement and market access. However, globally, HTA bodies vary in their required levels of evidence and their willingness to consider and standards they use to evaluate RWE in their decision-making process. This session will discuss lessons learned from the Australian and Japanese approaches and highlight the case study of the Micra leadless pacemaker, a medical device technology that was recently evaluated by both country HTA bodies and was the first medical device technology to be evaluated through Japan’s new cost-effectiveness evaluation schema. Dr. Strachan will begin with a global overview of RWE use and acceptance in HTA (10 min). Dr. Igarashi will introduce the Japanese HTA process and approach to RWE (10 min) and then Mr. Tilden will provide a similar introduction for Australia (10 min). Mr. Tilden and Dr. Igarashi will then introduce the Micra leadless pacemaker case study, how RWE was leveraged in these evaluations, and compare and contrast across the two countries (15 min). Dr. Strachan will then lead the panelists in a discussion of best practices for leveraging RWE for medical device HTA in future before concluding with audience questions (15 min).