Use of Real-World Evidence in HTA Submissions in Emerging Markets

OBJECTIVES: In emerging markets, local populations are often not represented in RCTs, and additional sources of evidence such as real-world evidence (RWE) are required for health technology assessment (HTA) submissions.

This research aimed to provide an overview of RWE used in HTA submissions in emerging markets, focusing on the Asia-Pacific and Middle East and North Africa (MENA) regions, and to discuss challenges associated with the use of RWE in these regions.

METHODS: PubMed and the ISPOR Presentations Database were searched for records published since 2014 that reported on the use of RWE in HTA submissions in Asia-Pacific and MENA.

RESULTS: RWE is accepted as a source of evidence in HTA submissions in several Asia-Pacific countries, either as supplementary data to RCTs or as a standalone source of evidence. In most countries in this region (India, Indonesia, Japan, Singapore, South Korea, Taiwan, and Thailand), HTA bodies require justification for using RWE. Guidance on RWE has been issued by the Pharmaceuticals and Medical Devices Agency in Japan, the National Medical Products Administration in China, and the Taiwan FDA.

In MENA, where implementation of HTA is in the early stages, use of RWE is less common. Key challenges to using RWE in this region include limited availability of local RWE data, disparities in availability of technology required for data collection (e.g., electronic medical records), and a lack of national guidance for best evidence generation practices.

CONCLUSIONS: Acceptance of RWE in HTA submissions is gaining traction in Asia-Pacific, although regional differences exist. In MENA, RWE is not yet widely used, although changes in the healthcare sector and implementation of HTA infrastructure are expected to facilitate the use of RWE in HTA submissions.