The role of real-world evidence (RWE) in value-based healthcare has been a prominent topic in healthcare forums for the past few years. Payers, providers and regulators are all demanding more real-world data to demonstrate the safety, efficacy, and value of treatments as a key component of their decision-making. Yet there is still little consensus about exactly what RWE is, how should be gathered, and how to use that data to develop better products, and demonstrate their value to industry stakeholders.

Though some of these questions may be answered at the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) annual meeting in Boston later this month. The theme is Evidence and Value in a Time of Social and Policy Change, and the schedule features dozens of workshops, presentations and networking opportunities to discuss the role of RWE and how we can establish best practices for generating the most value from these efforts.

QuintilesIMS will host several of these events, focusing on the scalable, seamless integration of RWE into daily decisions and actions across the organization, including a panel discussion entitled “Is there a way to agree on evidence requirements before evidence is generated?” I will be chairing the panel, which will host a multi-disciplinary group experts representing academia, pharma, and the payer and provider communities, who each bring unique insights into the challenges surrounding the heterogeneity of RWE. The panelists include:

We need to agree on RWE

Different stakeholders have various expectations for evidence used in decision-making. This heterogeneity poses challenges for health economics and outcomes research (HEOR), medical affairs and market access strategists to efficiently develop robust evidence. We believe that guidance is needed earlier in the development lifecycle on what evidence is required for payers and other decision makers to assess the value of new treatments, and to clarify what data decision makers need to make evidence more compelling.

The goal of the panel is to come to consensus around guidelines for evidence generation earlier in the development process, including when and where pharma should engage with regulators to review the nature of their evidence collection, their study methodologies, and the expected size, scope and detail of the data gathered in these studies. Our panel of experts, who represent those generating evidence as well as those evaluating it, will discuss novel approaches to early engagement and potential triggers to break out of the status quo. They will also share their perspective on best practices for evidence generation in different countries, and review the role RWE plays in health technology assessments (HTA) and value frameworks — today and in the future.

Value optimization and risk mitigation surrounding RWE are becoming increasingly important considerations for pharma, yet most companies today do not engage early enough with regulators and payers to ensure the evidence they collect will have the desired impact. This amazing group of panelists promise to provide some clarity around how these issues impact development decisions today, and what pharma companies can do to evolve their thinking about RWE to ensure they generate the most value from these efforts going forward. 

Topics in this blog post: Evidence, Market Access, HTA, Population Health