OBJECTIVES

: With more innovative therapies coming to market with limited evidence packages, payers have implemented reimbursement conditions associated with local evidence collection and outcomes tracking. When implemented effectively for broader therapeutic areas, patient registries can significantly improve patient access and improve clinical and financial outcomes at the health system level through the provision of real-world evidence. This analysis aims to explore how EU HTA bodies have currently implemented RWE registries, identify what barriers exist in implementing RWE registry tracking, and highlight potential solutions to increase the use of these registries across the EU.

METHODS

: A comprehensive literature search was conducted to determine the current use of RWE patient registries utilized across EU markets. In addition, several interviews were facilitated to better understand payer perceptions of how the use of RWE patient registries is expected to evolve over the next 3-5 years across market archetypes (e.g., cost-effectiveness, comparative efficacy, budget impact markets).

RESULTS

: Currently the application of RWE registries is restricted to orphan therapies with limited evidence packages (e.g., phase II, single arm data) across EU countries. While some markets (e.g., ITA and FRA) are more experienced with RWE registries and evidence tracking, other countries have only recently implemented new policies to increase registry use (e.g., DEU GSAV law) and capture benefits from a patient access and health systems perspective. Evidence tracking in the form of RWE registries is expected to increase across broader therapeutic areas in the next 3-5 years and could significantly impact health system outcomes across various stakeholders (e.g. more efficient budget impact / allocation for payers, more robust patient data for physicians, etc.)

CONCLUSIONS

: RWE registries and evidence tracking should be implemented more broadly beyond orphan products for therapies with complete evidence packages by leveraging best practices from current RWE registry use.