Clinical registries have primarily been leveraged to fulfil post-marketing safety and regulatory commitments; however, stakeholders are realizing the potential and value of registry data to support payer and health technology assessment (HTA) evidence needs. Changes in regulatory dynamics across both the EU and US are being seen through new regulations, such as the European HTA Regulation and the US Inflation Reduction Act. These new regulations are causing companies to re-evaluate their evidence of product value and consider additional data to strengthen their payer/HTA submissions.

This session will discuss these changing dynamics and greater opportunities to use robust clinical registry data to supplement and enrich traditional data sources, including the ability to link registry data with EMR and claims data. Case studies will be highlighted to show successful data linkages and their ability to strengthen payer and HTA submissions.