Session (CTI)

PURPOSE: Increasing demand for timely, evidence-based access to innovative intervention has led to the growing adoption of conditional listing mechanisms for costly health technology with great uncertainty. Health technology reassessment (HTR) is urgent to ensure long-term effectiveness/safety and economic outcomes in real-world settings. Real-world evidence (RWE) becomes essential in supporting these adaptive reimbursement strategies. Across Asia and other regions, insurance payers and policy regulators are engaged in developing mechanisms to generate, evaluate, and apply RWE throughout the life cycle of health technology. This workshop will explore how RWE supports conditional coverage and HTR, with a focus on adaptation and application within specific country contexts. Participants will gain insights into methodological considerations, implementation challenges, and case studies illustrating how RWE supports decision-making under uncertainty. Challenges and considerations from multiple stakeholders will also be discussed.

DESCRIPTION: Attendees will gain a practical view of the strengths/limitations and key considerations of current RWE guidance applied in specific country contexts. We will begin with an overview of recent policy reforms in Taiwan and highlight the need for RWE (10 min). International guidance will be discussed, emphasizing methodological transferability and local adaptation. Taiwan’s RWE framework will be introduced as a regional case, illustrating how infrastructure, data governance, and stakeholder collaboration support evidence generation (15 min). Case examples will demonstrate practical approaches to study design, outcome selection, and flexible data strategies for conditional listing and HTR (20 min). The workshop will conclude with a multi-stakeholder panel featuring government, academia, and industry perspectives on implementation barriers and future directions (20 min). This workshop aims to strengthen the role of RWE in dynamic coverage models.