Data generated from randomized controlled trials (RCTs) is recognized to have some limitations in its application to real-life clinical experience due to patient selection criteria and the controlled environment. Utilizing real world evidence (RWE) of how medicines are used and perform in clinical practice offers an opportunity to bridge evidence gaps and validate RCT outcomes. Payers often want real world data to be local to their patient population to ensure its relevance. However, this presents a ‘catch-22:’ at the point of reimbursement decision-making the medicine is not on the market but you can only collect local RWE once a therapy is on the market. Nevertheless, Early Access Programs (EAPs), national programs that allow patients with severe diseases and no therapeutic alternatives to access therapies prior to their marketing authorisation, offer the potential to utilize local RWE to inform reimbursement decision-making. This is especially in some countries which have well-established cohort based programs under which many patients can be treated (ATU [France], law 648 [Italy], EAMS [UK], and FDA expanded access scheme [USA]). However, access to EAPs is typically only for patients with no treatment alternatives, who may be expected to have a poor performance status with worse treatment outcomes. EAPs may only operate for a limited duration of time pre-authorization, limiting the data that can be collected. Further, EAPS are often designed to only be an option for those who cannot access RCTs and not interfere with the clinical trial development program, with restrictions on what data can be collected accordingly. Nevertheless, in certain settings EAPs may provide an opportunity to generate local real world evidence to help support product value at the point of initial reimbursement submissions. These include providing data on sub-populations not represented in the RCTs and informing the design and predicting outcome of pay-for-performance reimbursement schemes.