Parallel Session 3: Using real-world evidence in the real world: are regulatory and pricing decisions better aligned with health system goals?

Using real-world data to generate real-world evidence, with a view to informing healthcare decisions, has been a topic of growing interest in recent years. In high-income countries, the growing interest has manifested itself as the increasing use of real-world evidence in the decisions for regulatory approval and reimbursement of medicines and health products, including insurance coverage on the condition of further evidence development through a “managed entry” arrangement.

In lower-income countries, a lack of data infrastructure to systematically collect health data continues to pose a challenge in leveraging health data to inform healthcare decisions, including resource allocation. The persistent under-representation in the clinical trials of medicines also means that low- and middle-income countries must rely on real-world data, or at least some set of local knowledge, to adapt the clinical trial and cost-effectiveness evidence generated from high-income countries to their respective contexts.

To what extent have such endeavours to use real-world evidence been useful in achieving health system goals? In this session, the panellists will present initiatives to build data infrastructure and the application of real-world evidence to inform policy recommendations. They will discuss whether and how real-world evidence would contribute to regulatory and pricing decisions that are aligned with health system goals, such as research, universal coverage, affordability, timeliness, efficient resource allocation, and transparency of decisions.


Session Material:

⬇️ PS3_session_slides_combined

⬇️ PS3_questions_answers_and_links