Policy implications of mandatory systemic immunosuppressant trials prior to dupilumab for pediatric atopic dermatitis in Taiwan

The increasing use of dupilumab for moderate-to-severe atopic dermatitis (AD) in Taiwan has drawn attention to the country's reimbursement policy requiring a mandatory three-month trial of systemic immunosuppressants such as methotrexate, azathioprine, or cyclosporine before approval of biologic therapy in children aged 6-12 years. This stepwise approach aims to optimize healthcare resource allocation and ensure that biologics are reserved for refractory cases. However, concerns have been raised regarding potential delays in effective disease control, prolonged disease burden, and exposure to adverse effects associated with traditional immunosuppressants, including hepatotoxicity and infection risk. In contrast, Japan allows direct access to dupilumab without prior systemic therapy, emphasizing early intervention and improved long-term outcomes, though patients must bear 30% of treatment costs. This policy divergence between Taiwan and Japan underscores broader challenges in balancing cost-effectiveness, clinical efficacy, and equity in healthcare delivery. Ongoing evaluation of reimbursement criteria will be essential to align national policies with evolving therapeutic evidence and patient-centered care goals.