Objective: The paper systematically evaluates the patient accessibility risks posed by advanced therapy medicinal products (ATMPs) throughout their entire lifecycle due to their unique technological characteristics, and explores the key role of diversified financial solutions, centered on commercial health insurance, in mitigating these challenges. Methods: This study analyzes the entire lifecycle of ATMPs from basic research to commercialization, summarizing their core technological characteristics, such as high personalization, complex production supply chains, and potential long-term impacts. Based on this, identifying and evaluating pivotal risks such as R&D success probability, financial commitment, therapeutic performance, and long-term safety. Subsequently, this study systematically reviews the response strategies of government intervention, financial instruments, and commercial health insurance throughout the entire lifecycle, and conducts case studies on domestic and international practices. Results: Based on the technical characteristics of ATMPs, commercial health insurance designs pricing and multi-dimensional risk market transformation strategies. It shares the financial and efficacy uncertainty risks of ATMPs through early intervention in the R&D stage, innovative payment methods, and other strategies. Building a diversified payment system consisting of basic public medical insurance, private commercial health insurance, and innovative payment agreements is a feasible path to promote market transformation. Conclusion: By breaking down fragmented risk management, the paper constructs an integrated risk governance framework that involves collaboration among government, industry, finance, and healthcare institutions throughout the entire life cycle. This framework should be built by applying different levels of payment tools to create an efficient and diversified ATMPs healthcare payment system, thereby effectively translating the value of technological innovation into patient benefits.
Key words
advanced therapy medicinal products /
full lifecycle /
patient accessibility /
commercial health insurance
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