OBJECTIVES: We compare manufacturers’ and payers’ experiences with proactive sharing of healthcare economic information (HCEI) and preapproval information exchange (PIE) since the passage of Section 3037 of the 21^st Century Cures Act (Section 3037) and the Food and Drug Administration’s (FDA) 2017 guidance.

METHODS: Manufacturer (N = 41) and payer (N = 44) stakeholders completed online surveys (December 2017 - July 2018) regarding communication and approval of HCEI under Section 3037, as well as experiences with proactive HCEI and PIE.

RESULTS: Payers consider the following types of information about investigational products as very important to receive proactively and prior to FDA approval: information about the indication sought (82%), anticipated timeline for FDA approval (80%), and product pricing (86%). Although most manufacturers who already have a process/guidance for approving PIE materials allow proactive sharing of the indication sought (80%) and the FDA timeline (80%), only a minority approve of proactively sharing product pricing (40%). Most manufacturers (61%) say that the frequency of PIE increased during 2017-2018, and although most payers (59%) say that the frequency of PIE stayed the same, a large minority (39%) also say that PIE frequency increased during 2017-2018. Half of payers (47%) prefer PIE to be shared by medical science liaisons (MSLs); however, only a third (34%) of manufacturers who already have a process/guidance for approving PIE materials utilize MSLs to share PIE with payers. Further, while most manufacturers utilize account managers (66%) and health economic outcomes liaisons (63%) to share HCEI with payers, only a third of manufacturers (33%) utilize MSLs to do so.

CONCLUSIONS: After passage of Section 3037, manufactures have become increasingly comfortable sharing HCEI and PIE. However, there are still many improvement opportunities from the payer perspective in terms of sharing data, as well as who should be sharing information/data.