OBJECTIVES: The contribution of real-world evidence (RWE) to treatment-effect estimates in the assessment of medical technologies (devices, diagnostics, digital health technologies) (MTs) and in health technology assessment (HTA) decision-making is currently unclear. This study aimed to explore whether RWE is considered by HTA bodies across the globe in their MT decisions.
METHODS: An online survey was sent to 55 HTA organisations worldwide. The survey requested information on the types of evidence considered as part of the HTA process and about the inclusion of real-world data. Quantitative and qualitative data were obtained and collated in Excel.
RESULTS: Of the 55 HTA organisations contacted, 17 responded (30.9%). Of these, only 12 confirmed that they assessed MTs, 3 stated they do not assess MTs, and 2 declined to participate. The 12 respondees represented HTA organisations from Tunisia, Germany, the United Kingdom (UK), Canada, Spain, the United States (US), Finland, Denmark, Sweden, Norway, and Japan. All 12 HTA organisations considered clinical evidence from randomised controlled trials. RWE were considered by 83.3% (10/12) of the HTA organisations, while both Germany (G-BA) and the US (AHRQ) did not require RWE. Data from registries were also accepted by 83.3% of HTA organisations: Tunisia, Canada, Spain, Finland, Denmark, Norway, Sweden, Japan, and the UK while the US and Germany did not accept registry data for MT assessment. Other data considered by HTA organisations for MT assessment included comparative and noncomparative study designs in the UK, comparative clinical studies of any design in Canada, nonrandomised studies of interventions in the US, and qualitative data about organisational and patient issues in Denmark.
CONCLUSIONS: While barriers to the use of RWE in decision-making for MTs do still exist, this study provides some evidence that HTA organisations are considering RWE as clinical evidence of treatment effect for MTs.
