Overview

Planning for a global product launch means a coherent evidence plan and value dossier must address the needs of multiple geographies. This session will review the evolving perspectives of US payers on evidence for medical devices, and contrast these trends with major EU markets and Japan. Specific topics to be addressed will include:

• US Medicare and private payer bundled payment models.
• New bundling of In Vitro Diagnostics under Medicare outpatient rules.
• British requirements for Specialised Services.
• French programs to generate real world evidence.
• Germany’s trial regulation.
• Japan’s new HTA requirements.