Presentation (CTI)

OBJECTIVES: Systematic literature reviews (SLRs) for health technology assessment (HTA) submissions are required to provide a comprehensive summary of existing evidence for an intervention and its comparators. To understand the certainty of the effectiveness results in an SLR, the internal validity of included studies must be evaluated; therefore, HTA bodies generally require a risk of bias assessment of included studies. In January 2025, the European Union (EU) Joint Clinical Assessment (JCA) was introduced, with several guidance documents and implementing acts published in the lead up to its adoption. Following publication of these guidance documents, this study sought to compare the risk of bias assessment requirements between individual European HTA agencies and the EU JCA.
METHODS: A structured review of publicly available guidance documents from several European HTA agencies, National Institute for Health and Care Excellence (NICE), Scottish Medicines Consortium (SMC), and the HTA Co-ordination group (HTACG, responsible for coordinating and implementing JCA guidance based on Regulation (EU) 2021/2282 on HTA [HTAR] by the European Commission) was conducted. Key documents were sourced from official websites and screened for relevance.
RESULTS: Across the European HTAs, NICE and SMC, Cochrane Risk of Bias (RoB) 2.0 was recommended the most for RCTs although flexibility to choose alternative appropriate tools was noted. Contrastingly, updated HTAR guidance for the EU JCA states RCTs should be evaluated using Cochrane RoB 1.0. This differs from previous HTAR recommendations of Cochrane RoB 2.0. The most recommended tool for observational studies across the European HTA bodies was Risk Of Bias In Non-randomised Studies - of Interventions (ROBINS-I). This was also the recommended tool by current (and prior) HTAR guidance.
CONCLUSIONS: Risk of bias assessment requirements for reimbursement submissions vary across Europe. Consequently, despite JCA implementation, this misalignment may result in additional or re-assessment of bias at the country-specific level.