Health technology assessment (HTA) is widely used throughout Europe and elsewhere to make decisions about the reimbursement and/or pricing of healthcare technologies including new medicines. Several countries require evidence on cost-effectiveness and budget impact and so estimates of healthcare use and costs are important. This poses challenges to companies generating such evidence in support of their products from multiple countries and datasets. EHDEN is a federated network of data sources

more »

... pping to the OMOP common data model (OMOP-CDM). This has the potential to facilitate companies in generating high quality real word evidence by improving the interoperability of data and support the application of common analytical code across databases from different countries. Such evidence may be valuable to the HTA community when making reimbursement decisions. We organised a virtual, half-day workshop titled 'Federated data networks and health technology assessment' to introduce EHDEN and the OMOP-CDM and its use to generate real world evidence (RWE) to HTA bodies. This involved the presentation of regulatory and early HTA use cases. We also asked attendees for feedback on where they saw the potential for the use of OMOP-CDM and EHDEN in HTA settings and which areas and applications they felt EHDEN should prioritise in the next year. In general, HTA bodies see RWE as complementary to clinical trial evidence and were particularly interested in areas where clinical trial evidence may be unavailable or limited, such as rare diseases and medical devices. They also would value RWE which supports challenging areas in HTA, such as assessment of advanced therapy medicinal products (ATMPs) and providing evidence to support outcome-based managed entry arrangements. The need for transparently reported, high quality RWE studies was also emphasised.