2026/01/01 by Li-Ying Huang, Shou-Yu Lin, Ming-Hsun Liu
paper · doi:10.1017/s0266462326103766
Abstract Objective Since 2007, the Taiwan Health Technology Assessment (HTA) system has developed from a review process for new drug reimbursement into a core element of National Health Insurance (NHI) decision-making. This study examines Taiwan’s development of a sustainable, learning-oriented HTA ecosystem. Methods This article synthesizes more than 15 years of HTA development in Taiwan, highlighting recent advancements, including parallel reviews, temporary reimbursement pathways, managed entry agreements (MEAs), real-world evidence (RWE) guidelines, precision medicine frameworks, and structured health technology reassessment. Drawing on national policy sources, administrative datasets, and published evaluations, four interrelated domains were analyzed: institutional development and governance; access pathways for high cost and high clinical impact; infrastructure for evidence generation; and mechanisms to strengthen patient and patient organization involvement (PPI). Results In 2024, 196 rapid HTA assessments were completed, reflecting increased system capacity and methodological sophistication. This evolution builds on earlier HTA-driven policy experiences, including immune checkpoint inhibitors supported by HTA, MEA design, and national RWD collection. These developments formed the groundwork for managing uncertainty, assessing high-cost therapies, and supporting life cycle evidence. Parallel review improved timely access to novel medicines without compromising assessment rigor. The Taiwan Cancer Drugs Fund provided a structured model for temporary reimbursement and RWD collection. Formal PPI processes expanded the integration of patient voices. Conclusions Taiwan’s HTA system is transitioning into a learning health system that supports adaptive coverage, continuous reassessment, and sustainable access to new medical technologies. Developments offer guidance to health systems seeking to balance access, evidence development, and financial sustainability.