Real-World Data and Real-World Evidence in Australia: Opportunities and Next Steps Following Review of the Health Technology Assessment System
Author(s)
Nathaniel D. Fox, BEc, MPH1, Gary L. O'Brien, PharmD, PhD2.
1BIOINTELECT, Melbourne, Australia, 2BIOINTELECT, Sydney, Australia.
1BIOINTELECT, Melbourne, Australia, 2BIOINTELECT, Sydney, Australia.
OBJECTIVES: Real-world data (RWD) and real-world evidence (RWE) are invaluable for emerging therapy, rare diseases, and small population health technology assessments (HTA). The Australian Government’s 2024 HTA Policy & Methods Review (‘HTA Review’) made Australian HTA system reform recommendations for RWD and RWE. This abstract examines priority issues and opportunities to enhance their use in Australian HTA.
METHODS: A recently conducted literature review, including two key publications of the HTA Review, systematically examined key RWD/RWE-related issues, including industry stakeholder perspectives and recommendations.
RESULTS: Key identified challenges included: encouraging their increased use, the absence of a coordinated national infrastructure for data collection and sharing; legal, privacy, and consent barriers; data collection and curation resource constraints; uncertainty about their use in HTA; and current limited RWE investment. Recommendations included an Australia-specific framework; identifying suitable data; building RWD infrastructure; key stakeholder collaboration for developing infrastructure and governance arrangements; data harmonisation and collaboration; development of best-practice data quality, analytics, and reporting approaches; participation in global methods and data-sharing standardisation; and updating HTA guidelines to clarify their use.
CONCLUSIONS: With broad support for RWD and RWE to improve HTA, clear frameworks, robust infrastructure, and secure dating sharing are required to progress their use. Australia’s government department infrastructure, which collectively oversees policy, regulation, and reimbursement, provides the opportunity to efficiently and effectively enhance the role of RWD/RWE in HTA decision-making. Doing so would greatly support emerging technology access, ensuring Australia maintains its status as a first-launch nation for new therapies.
METHODS: A recently conducted literature review, including two key publications of the HTA Review, systematically examined key RWD/RWE-related issues, including industry stakeholder perspectives and recommendations.
RESULTS: Key identified challenges included: encouraging their increased use, the absence of a coordinated national infrastructure for data collection and sharing; legal, privacy, and consent barriers; data collection and curation resource constraints; uncertainty about their use in HTA; and current limited RWE investment. Recommendations included an Australia-specific framework; identifying suitable data; building RWD infrastructure; key stakeholder collaboration for developing infrastructure and governance arrangements; data harmonisation and collaboration; development of best-practice data quality, analytics, and reporting approaches; participation in global methods and data-sharing standardisation; and updating HTA guidelines to clarify their use.
CONCLUSIONS: With broad support for RWD and RWE to improve HTA, clear frameworks, robust infrastructure, and secure dating sharing are required to progress their use. Australia’s government department infrastructure, which collectively oversees policy, regulation, and reimbursement, provides the opportunity to efficiently and effectively enhance the role of RWD/RWE in HTA decision-making. Doing so would greatly support emerging technology access, ensuring Australia maintains its status as a first-launch nation for new therapies.
Conference/Value in Health Info
2025-09, ISPOR Real-World Evidence Summit 2025, Tokyo, Japan
Value in Health Regional, Volume 49S (September 2025)
Code
RWD173
Topic Subcategory
Data Protection, Integrity, & Quality Assurance
Disease
SDC: Rare & Orphan Diseases