OBJECTIVES: Using real-world data and evidence (RWD/RWE) in healthcare decision-making is increasing. However, acceptance of RWE varies among HTA agencies. Some agencies are more willing to consider RWE for evaluating new technologies and making decisions about healthcare resource allocation efficiently. We aim to explore the payer perspective on the barriers and opportunities of incorporating RWE as evidence submission in reimbursement decision-making by HTA bodies.

METHODS: We fielded an online survey with payers from the Ipsos payer panel across multiple EU and non-EU member states. Questions concerning the importance, acceptance, and aspects of RWE studies that are of concern for payers in HTAs were asked in this survey.

RESULTS: Payers indicate that national guidelines guide RWE use in HTAs in country where available (Canada, UK), while international, mainly EMA, guidelines are followed in countries such as Spain and Denmark. Major barriers to RWE adoption include data quality, methodology, and expertise. Transparency and data sources are crucial for payers, with pragmatic trials and registries being the preferred source to support recommendation decisions. RWE is considered valuable for indirect comparisons and treatments needing long-term management, in rapidly evolving landscapes, and with curative benefits after prolonged treatment. Some payers may accept to make HTA recommendations based only on RWE in some situation, such as rare diseases and gene therapies, when conducted according to guidelines.

CONCLUSIONS: The integration of RWE into HTA and access programs is advancing through initiatives aimed at improving data quality, methodology and relevance. Despite these efforts, RWE remains primarily supplementary to RCTs, except in specific cases. The ongoing focus on enhancing RWE’s credibility and use suggests a growing, although cautious, acceptance. Continued multi-stakeholders collaboration and development of standard frameworks to use the appropriate types of RWE and data sources in HTAs is a crucial step for making informed decisions.