OBJECTIVES: Evidence from randomized clinical trials (RCTs) continues to be the standard reference point for treatment efficacy across the world. However, Real-World Data (RWD) and Real-World evidence (RWE) can complement evidence from RCTs, not always adequate to guide healthcare decisions. This research explores variation from RWD collection and RWE uses in the health technology assessment (HTA) of Australia, EU4 and UK.

METHODS: Information regarding RWD collection and RWE uses for Australia, France, Germany, Italy, Spain, and the UK were obtained from published HTA documents, HTA websites and relevant literature.

RESULTS: The HTA Authorities of the Countries analyzed have not a transparent and well-organized form to collect data: France and UK can have the support of a national database recording medical information of the population, while Italy, Spain and Germany collect data for highly specialized drugs from registries (312 drugs monitored by Italy, 83 by Spain and only 7 by Germany). Australia can have the support of both databases and registries. In European countries, RWE is not very used in regulatory decision-making as the EMA decision is based on a risk-benefit ratio, however it does serve to support post-marketing evaluations, except for Germany, where evidence from RCTs remains the gold standard. In Australia RWD and RWE have played an increasingly significant role in supporting decision-making also during approval and in May 2024 a new report of reccomendations will be finalized. Also UK is optimizing RWD collection, launching a RWE framework in June 2022.

CONCLUSIONS: European countries don’t currently use extensively RWD and RWE, even if an increase valorization of these tools has been recorded. Australia gives more value to them, but in all Countries analyzed is lacking central and well-established organization that could support the HTA with guidelines shared by all Countries.