Heterogeneity in Biomarker Data Collection, Recording, and Availability Across European Sources of Oncology RWD & Potential Impacts on Pan-EU HTA Assessment

OBJECTIVES: The new EU health technology assessment (HTA) regulation aims to streamline access to novel technology across Europe through a unified HTA framework & standardised joint clinical assessment process. A key aspect of this new framework is to harmonise the Population, Intervention, Comparator, and Outcome (PICO) scoping process across Europe. Oncology treatments are increasingly indicated for populations with specific genotypes. Therefore, biomarker data will become a crucial criterion within the PICO scheme for a valid and robust assessment.

METHODS: A structured search on the HMA-EMA, European Health Data Evidence Network and B.R.I.D.G.E TO DATA database catalogues was undertaken to identify sources of oncology data including claims, electronic health records (EHR), and registries across the EU5. Details on the availability, and granularity, of genetic biomarker data recording for each database were assessed, including biomarkers recorded for specific cancers, approaches to data collection, and the availability and quality of relevant data documentation.

RESULTS: In total, 282 databases were retrieved and initially assessed for relevance. Of these 47 relevant databases were included in the feasibility assessment, and >80% were taken forward for viability assessment. Initial results indicate the majority of the data sources do not store or make available biomarker data, including several large, high coverage databases. Biomarkers available data sources storing them ranged from whole genome sequencing to only a few specific markers.

CONCLUSIONS: The heterogeneity of biomarker data in data sources for secondary use presents challenges for defining aligned PICO definitions in multi-country. This is particularly important in the context of a pan-EU regulatory process. The efficiency and alignment of generated evidence would be improved through alignment of biomarker data collection, recording and reporting across EU sources of oncology real-world data.