Establishing an Ecosystem for Regenerative Medical Products

This white paper discusses the establishment of an ecosystem for regenerative medical products, focusing on CAR-T cell therapy. It outlines the purpose of the project, which is to advance discussions among experts in medical economics, technology development, and clinical practice regarding the barriers to implementing regenerative medical products in Japan. The document details the clinical and societal value of CAR-T cell therapy, emphasizing its potential to revolutionize treatment approaches for various diseases, including cancers. It also addresses the challenges faced in the development, manufacturing, and supply of CAR-T cell therapy, including issues related to pricing, reimbursement, and patient access. The paper highlights the necessity of reforming the current medical fee system and pricing structures to support the dissemination and sustainability of regenerative medical products. Recommendations are provided to enhance stakeholder collaboration and develop infrastructure to promote innovation in this field. The overall aim is to create a sustainable ecosystem that benefits patients and the healthcare system.