There is growing interest globally in using real-world data (RWD) and real-world evidence (RWE) for applications including regulatory decisions, health technology assessment (HTA), pharmacovigilance and more. However, Asia currently lacks a framework to effectively collect and utilize a broad range of RWD/RWE[1]. This gap presents Medical Affairs teams with significant opportunity to lead the collection, dissemination and adoption of learnings based on RWE, especially in light of significant market size and burden of diseases such as stroke and ischemic heart disease, which have been the focus on much pharmaceutical development in the West. The objective of this interview-based article is to detail the current state of RWE use in China and Korea and explore what the future evolution will be for its use.

The United States and Europe generate RWE from a patchwork of private and government sources including patient registries, private insurance databases, electronic health records and Medicare/Medicaid databases. In these countries, splitting data ownership across healthcare, industry, academia and government leads to piecemeal data siloed within disparate and often competing databases. In contrast, many APAC countries including Korea, China and Japan collect and concentrate RWE within government-owned databases that encompass records from the vast majority of a county’s population. “In China, 100 percent of the population is handled by the equivalent of Medicare or Medicaid, so the government owns a huge database, a very complete data source,” says Jianwei Xuan, Professor & Director of the Health Economic Research Institute at Sun Yat-sen University, Guangzhou, China. Thus, an overarching theme of RWE collection in Asia versus the U.S. and Europe is government-owned data in Asia leading to much more complete representation of the population, whereas private and government data sources in the U.S. and Europe leading to many siloed repositories of data.

“In Korea, we have a major RWE data set, but these data are strictly controlled by the Korean government and because of that, only a limited number of researchers are allowed access,” says Dong-Churl Suh, RPh, MBA, PhD, Professor and Director of the College of Pharmacy at Chung-Ang University in Seoul, South Korea. Similarly, Xuan points out that whereas the United States and Europe depend on patient privacy laws to regulate what kind of privately collected data can be shared for research purposes, “In China and many other APAC countries, governments own patient data and rules are skewed against sharing, severely limiting access to RWE even through there could be so much benefit,” he says. In many APAC countries, additional data-access challenges exist for studies sponsored by international organizations.

Both Suh and Xuan point out that regulatory approvals in APAC countries remain almost exclusively dependent on clinical trials. However, in these countries, researchers primarily within academia working with funding from industry are starting to define methodology for the use of RWE to inform regulatory decisions. Meanwhile, APAC countries are currently making use of RWE in other ways including pharmacovigilance and pharmacoeconomics. “In Korea, the government uses RWE to see whether medication is appropriately prescribed and used according to indications and also whether there are unexpected adverse effects,” says Suh, “and RWE is commonly used to determine the cost-effectiveness of new medications, and to decide appropriate pricing and formulary reimbursement.” As in the U.S. and Europe, medical societies within APAC countries may also use RWE to define treatment guidelines for certain diseases.

The Future of RWE in APAC Countries