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Pre-Approval Information Exchange Could Positively Impact Formulary Decision Making


October 30, 2019

Results from recent survey show that pre-approval information exchange (PIE), the communication of information regarding prescription drugs and medical devices with US health care decision makers (HDCMs), is positively received and could become more prevalent in formulary decision making.

Guidance on the appropriate levels of communication that has become known as PIE was approved by the US Food and Drug Administration in June 2018. A bill that could potentially clarify PIE is currently awaiting committee review in congress.

Researchers from Xcenda at AMCP Nexus 2019 in National Harbor, MD, sought to survey HDCMs to gauge their experiences, attitudes and perceptions of PIE over time in an effort to better understand its usefulness.

Two online surveys conducted in 2018 and 2019 surveyed HDCMs representing managed care organizations, pharmacy benefit managers, and integrated delivery networks.

According to the survey results, “From 2018 to 2019 HCDM respondents reported a slight increase in the average number of months that they would like to receive preapproval information from a manufacturer prior to approval, although the difference was not statistically significant (5.4 vs. 6.0, respectively; P>0.05).”

Results from the 2019 survey showed that HCDMs prefer to have Medical Science Liaisons and Health Economics Liaisons share preapproval information, and fewer HCDMs preferred Account Managers (P < 0.05).

The results also showed that the perceived quality or usefulness of PIE doubled. As for a timeline, HCDMs responded that receiving PIE approximately 6 months prior to approval is preferred.

“Given pending HR 2026 legislation, PIE is likely to become increasingly more prevalent and essential for timely HCDM formulary decision making,” concluded researchers.

—Edan Stanley

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