Regulation, Reimbursement, and Economic Access: A Health Policy Perspective on Dupilumab in Different Countries' Health Systems

Dupilumab, the first biologic therapy targeting the IL-4 and IL-13 signaling pathways, offers a novel treatment option for patients with moderate-to-severe atopic dermatitis. Despite its demonstrated clinical effectiveness, access to Dupilumab remains uneven across countries, largely due to divergent regulatory approval processes, pricing frameworks, and reimbursement strategies. This study conducts a comparative analysis of the approval timelines, pricing structures, and reimbursement mechanisms in United States, European Union, Japan, and China. In the U.S., expedited pathways such as Breakthrough Therapy Designation facilitate rapid market entry, but the absence of universal healthcare often results in substantial financial barriers for patients. In contract, the EU and Japan implement centralized health technology assessment (HTA) processes and national insurance systems that enable more standardized and equitable access. China's recent inclusion of Dupilumab in the National Reimbursement Drug List (NRDL) has significantly reduced cost and improved access, through provincial disparities persist. Drawing from these international experiences, this paper offers policy insights for emerging markets seeking to enhance timely and affordable access to high-cost innovative therapies.