The use of Real World Evidence in the European context: An analysis of key expert opinion

Randomised controlled trials (RCT), traditionally seen as the gold standard in drug approval requirement terms, are becoming more difficult due to, among other reasons, budget constraints, increasing complexities and the shrinking of patient populations. Real world evidence (RWE), data used for decision making that is not derived from traditional RCT, may in future play an increasing role in market access and reimbursement decisions. This paper analyses key pricing and reimbursement stakeholders’ opinions of RWE across five European countries via a focus group-style discussion. Areas probed included regulatory implications and the role of RWE in the study countries, RWE processes and implementation on decision making, meaningful outcomes from RWE and priorities for future focus and industry support. Results showed that RWE was used to some extent in all countries, generally in accelerated access and re-review situations, with accepted endpoints including overall survival, morbidity, avoidable mortality and quality of life among others, but that there were a number of areas where improvement was necessary if RWE use was to become more common place.