The Impact of Preapproval Information Exchange on Formulary Decision-Making

Preapproval information exchange (PIE) involves drug manufacturers supplying proactive clinical and economic information to healthcare decision makers before FDA approval. While previous studies have shown an increase in the quantity and quality of PIE to support formulary review, there is limited evidence on how PIE impacts the formulary decision-making process in the preparation of budget impact analyses and policy development. This study aimed to assess trends in utilization of PIE among manufacturers and healthcare decision makers to identify proactive content that may support more timely formulary decisions in relation to FDA approval.

A double-blinded, web-based survey was deployed in May 2022 to FormularyDecisions healthcare decision maker users to gather insights on their experience with PIE in the last year and their perceptions across preapproval content.

Of 17 survey respondents, 94% indicated that their organizations were at least somewhat experienced with using preapproval information, with the most crucial benefit of PIE being provided timely access to economic and clinical information for analyzing budget impacts. Levels of use of preapproval information varied, with 30% of respondents reporting utilization of preapproval information for more than 40% of their formulary reviews. Of the healthcare decision makers surveyed, their most utilized resources were found to be Academy of Managed Care Pharmacy (AMCP) preapproval dossiers (88%) and PIE webinars (76%), with the availability of preapproval information shortening formulary decision time for 47% of respondents. All respondents rated information on anticipated place in therapy as helpful, with 88% rating product pricing as very impactful to decreasing their organizations’ formulary decision-making timeline.

These findings suggest that PIE is beneficial in various aspects of the formulary review process, with preapproval content regarding anticipated place in therapy and drug pricing providing the greatest likelihood of shortening formulary decision-making timelines. Drug manufacturers should consider the value of deploying preapproval information—particularly in relation to drug pricing (ie, rationale for pricing; pricing estimates relative to other treatments)—to help address the needs of healthcare decision makers.


Bannister B, Hydery T, Gorey C, et al. The utilization of pre-approval information and impact on formulary decision-making timelines. Presented at: 2022 Academy of Managed Care Pharmacy Nexus Annual Meeting; October 11-14, 2022; National Harbor, MD. Poster U12.

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