Randomised controlled trials (RCTs) have historically been considered the primary source of evidence to support market access and reimbursement. However, real-world data (RWD) are increasingly being considered by industry and payers. The objectives of this research were to review the current perception of RWD across Europe and to assess how RWD can support market access and reimbursement. A review of the literature, guidelines from European health technology assessment (HTA) agencies and governmental authorities, case studies and the latest publications in value-based assessment (VBA) was performed to summarise the current perception of RWD, and to identify the advantages and challenges of using RWD to support market access and reimbursement. Only 10 guidelines were found from 73 European HTA agencies or governmental authorities which cited RWD as a source for evidence. NICE acknowledges the difficulties of generalising RCT results to clinical practice, and supports the capture and analysis of observational data. In addition, recent developments in VBA anticipate a greater scrutiny of attempts to model natural history in economic evaluations, which may be addressed by using longitudinal observational data. Case studies have shown economic evaluations based on RCT data may lack external validity, and may consequently produce inaccurate estimates of economic endpoints. There is a consensus that RWD are valuable in providing clinical practice evidence on treatment pathways, resource use, long-term natural history and true effectiveness. However, there are methodological challenges (such as lack of randomisation) to be addressed before RWD are widely accepted as a complement to RCTs to support decision-making. RWD are increasingly recognised as a valuable source of evidence for market access and reimbursement, and as a complement to clinical trial evidence.  Nevertheless, there are challenges that need to be addressed to ensure real world data provide valid evidence to the decision process.