• Gracy Crane, John C W Lim, Churn-Shiouh Gau, Jipan Xie, and Laura Chu.
• F. Hoffmann-La Roche Ltd, Welwyn Garden City, UK.
• Curr Med Res Opin. 2022 Sep 1; 38 (9): 154315511543-1551.

ObjectiveTo provide recommendations for overcoming the challenges associated with the generation and use of real-world evidence (RWE) in regulatory approvals, health technology assessments (HTAs), and reimbursement decision-making in East Asia.MethodsA panel of experts convened at the International Society for Pharmacoeconomics and Outcomes Research Asia Pacific 2020 congress to discuss the challenges limiting the use of RWE in healthcare decision-making and to provide insights into the perspectives of regulators, HTA agencies, the pharmaceutical industry, and physicians in China, Japan, and Taiwan. A nonsystematic literature review was conducted to expand on the themes addressed.ResultsThe use of RWE in regulatory approvals, HTAs, and reimbursement decision-making remains limited by legal/regulatory, technical, and attitudinal challenges in East Asia.ConclusionsWe recommend approaches and initiatives that aim to drive improvements in the utilization of RWE in healthcare decision-making in East Asia and other regions. We encourage large-scale collaborations that leverage the full range of skills offered by different stakeholders. Government agencies, hospitals, research organizations, patient groups, and the pharmaceutical industry must collaborate to ensure appropriate access to robust and reliable real-world data and seek alignment on how to address prioritized evidence needs. Increasingly, we believe that this work will be conducted by multidisciplinary teams with expertise in healthcare research and delivery, data science, and information technology. We hope this work will encourage further discussion among all stakeholders seeking to shape the RWE landscape in East Asia and other regions and drive next-generation healthcare.

11 keywords...

hide…