Real-World Evidence in Asian Health Technology Assessment: Evolving Roles, Practices, and Future Directions (2015-2024).

OBJECTIVES

To examine the use of real-world evidence (RWE) in health technology assessment (HTA) for postlisting reimbursement decisions across 4 Asian healthcare systems-China, Japan, South Korea, and Taiwan-between 2015 and 2024.

METHODS

We conducted a policy analysis and narrative literature review of HTA submissions, agency guidance documents, and published case examples from 2015 to 2024. Evidence on RWE use by country/region and therapeutic area was extracted from peer-reviewed literature, HTA reports, and official policy sources. Postlaunch evidence-generation mechanisms were summarized and qualitatively compared with practices in Europe (National Institute for Health and Care Excellence, Haute Autorité de Santé) and the United States (Centers for Medicare and Medicaid Services/Medicare).

RESULTS

Use of RWE in Asian HTA increased steadily over the study period. In China, RWE is frequently used to inform epidemiology and economic parameters in National Reimbursement Drug List submissions. Japan applies RWE mainly for postlaunch price reassessment, particularly for oncology and orphan drugs. South Korea incorporates RWE into risk-sharing agreements and reassessment processes. Taiwan's Conditional Reimbursement Listing provides temporary coverage linked to real-world outcome generation. RWE use is most prominent in oncology and rare diseases.

CONCLUSIONS

RWE is increasingly used to address postlisting uncertainty in Asian HTA. Structured, indication-specific RWE requirements following reimbursement are likely to expand, aligning Asian HTA systems more closely with international practice.