Impact of Real-World Data on Market Authorization, Reimbursement Decision & Price Negotiation.

Real-world data (RWD) and real-world evidence (RWE) appear now as complementary to traditional randomized controlled trials (RCT), that remain the gold standard of the evidence. This review aims to illustrate how health authorities in France, United States (USA) and United Kingdom (UK) can integrate RWD and RWE in market authorization discussions and in new pathways of price and reimbursement negotiations. We conducted a review from the literature, online investigations and interviews.