Real-world data for health technology assessment for reimbursement decisions in Asia: current landscape and a way forward

TLDR

Real‑world data and evidence are increasingly used for health technology assessment worldwide, yet Asia lacks a standardized framework, limiting trial representation and delaying reimbursement decisions, so aligning RWD/RWE policies could improve evidence relevance and patient access. This study reviews the current RWD/RWE landscape across eleven Asian health systems and proposes a strategy to harmonize regional policies. The authors analyzed data from eleven Asian health systems to assess RWD/RWE use and identify gaps for policy alignment. They recommend forming the REALISE working group to produce non‑binding guidance on applying RWD/RWE in Asian HTA and reimbursement decisions.

Abstract

There is growing interest globally in using real-world data (RWD) and real-world evidence (RWE) for health technology assessment (HTA). Optimal collection, analysis, and use of RWD/RWE to inform HTA requires a conceptual framework to standardize processes and ensure consistency. However, such framework is currently lacking in Asia, a region that is likely to benefit from RWD/RWE for at least two reasons. First, there is often limited Asian representation in clinical trials unless specifically conducted in Asian populations, and RWD may help to fill the evidence gap. Second, in a few Asian health systems, reimbursement decisions are not made at market entry; thus, allowing RWD/RWE to be collected to give more certainty about the effectiveness of technologies in the local setting and inform their appropriate use. Furthermore, an alignment of RWD/RWE policies across Asia would equip decision makers with context-relevant evidence, and improve timely patient access to new technologies. Using data collected from eleven health systems in Asia, this paper provides a review of the current landscape of RWD/RWE in Asia to inform HTA and explores a way forward to align policies within the region. This paper concludes with a proposal to establish an international collaboration among academics and HTA agencies in the region: the REAL World Data I n A S ia for H E alth Technology Assessment in Reimbursement (REALISE) working group, which seeks to develop a non-binding guidance document on the use of RWD/RWE to inform HTA for decision making in Asia.