Mapping a Path to Standardized Evidence Quality Tools Across EU HTA Agencies and NICE: Is EU Joint Clinical Assessment Guidance Falling Behind?

OBJECTIVES: The upcoming Joint Clinical Assessment (JCA) aims to coordinate the effort across European Union (EU) members to assess the clinical benefit of new interventions, while allowing other value elements (e.g., costs and societal impact) to be considered at the country level. Data quality is a central consideration in health technology assessment (HTA) submissions, albeit one that is not always consistently assessed across agencies. Assessment of data quality is vital for ensuring transparency in the HTA process. This study aimed to identify data quality guidance across EU HTA agencies, the National Institute for Health and Care Excellence (NICE), and the JCA.

METHODS: We conducted a pragmatic review in June 2023 of guidance documents across several European HTA agencies, NICE and EUnetHTA (responsible for JCA guidance until September 2023). Information on quality criteria and tools across agencies was mapped. Findings were extracted by two reviewers and qualitatively synthesized by study design across agencies.

RESULTS: Guidance documents were retrieved from 12 HTA bodies (all using established processes). The Cochrane risk of bias (RoB) tool was universally recommended to assess the quality of randomized controlled trials. Tools recommended to assess data quality in observational (real-world evidence) studies varied widely; ROBINS-I was referenced by EUnetHTA, NICE, Institute for Quality and Efficiency in Health Care (IQWiG) and Dental and Pharmaceutical Benefits Agency (TLV). NICE provided the most details regarding quality tools by study design. EUnetHTA 2022 guidance specified that RoB assessments are not required for single-arm trials, but it has not updated recommendations for other study designs since 2015.

CONCLUSIONS: Transparent reporting of data quality is essential to the HTA process to ensure greater patient access to novel technologies. Standardized guidance on quality criteria across HTA bodies is lacking, and efforts by the EUnetHTA (JCA) have failed to keep pace with recent methodological advances.