Despite investment in RWE, many life sciences leaders question how and when RWE influences medical value assessments. Consequently, we find a bifurcation across the industry around how much effort and investment in RWE is warranted. For some organizations, the 21st Century Cures Act signaled that investment in RWE would yield positive ROI—if FDA accepts RWE, non-regulatory decision-makers would follow suit. But other manufacturers are in a wait-and-see period; waiting for clear guidelines and consistent customer commitment to accepting RWE studies. With so much uncertainty about how payers, providers, clinical societies, and HTAs use RWE, we have yet to reach a tipping point on RWE acceptance.