US PIE and AMCP Dossiers: Payer Preferences Best Practice and a Comparison With Global Evidence Dossiers
Author(s)
Sophie E. Streeton, PhD.
Petauri, Bicester, United Kingdom.
Petauri, Bicester, United Kingdom.
OBJECTIVES: To explore US payer perspectives on manufacturer-provided information, focusing on pre-approval information exchange (PIE) and Academy of Managed Care Pharmacy (AMCP) dossiers, to support formulary and coverage decision-making. We also aimed to compare key features and requirements of US communication materials with those of global dossiers.
METHODS: In March 2025, we recruited experienced US payers to participate in an online quantitative and qualitative survey on AMCP dossier and PIE use and best practice. Results were aggregated and descriptive statistics were conducted. The findings informed a narrative comparison of US pre- and post-approval materials with early and full global evidence dossiers.
RESULTS: Eighteen participants (4 medical directors, 11 pharmacy directors, and 3 industry/trade relations professionals), representing managed care organisations, pharmacy benefit managers, and integrated delivery networks, completed the survey. Payers reported a preference for early PIE (up to 6 months before product launch, 50%; 6-12 months before launch, 33%), and preferred to receive both a pre-approval AMCP dossier and a PIE deck (56%). Payers considered efficacy data (17/18 respondents), initial pricing estimates (10/18), and safety data (7/18) important to receive prior to launch. First-in class (16/18), large budget impact (16/18), high-cost (15/18), and orphan/cell/gene therapy (14/18) products were considered the priorities for PIE. We found that, while both US and global communication materials serve as tools for manufacturers to consolidate clinical and pharmacoeconomic evidence, key differences emerge for document purpose, audience, timing, and content.
CONCLUSIONS: This study builds on our previous research, providing further insights into best practice for the development of PIE and AMCP dossiers. Our results highlight the importance of early manufacturer engagement with US population health decision-makers, and of clearly communicating available clinical and cost information ahead of market entry. Our study also highlights considerations and potential efficiencies when developing these tools as part of a coordinated global communication strategy.
METHODS: In March 2025, we recruited experienced US payers to participate in an online quantitative and qualitative survey on AMCP dossier and PIE use and best practice. Results were aggregated and descriptive statistics were conducted. The findings informed a narrative comparison of US pre- and post-approval materials with early and full global evidence dossiers.
RESULTS: Eighteen participants (4 medical directors, 11 pharmacy directors, and 3 industry/trade relations professionals), representing managed care organisations, pharmacy benefit managers, and integrated delivery networks, completed the survey. Payers reported a preference for early PIE (up to 6 months before product launch, 50%; 6-12 months before launch, 33%), and preferred to receive both a pre-approval AMCP dossier and a PIE deck (56%). Payers considered efficacy data (17/18 respondents), initial pricing estimates (10/18), and safety data (7/18) important to receive prior to launch. First-in class (16/18), large budget impact (16/18), high-cost (15/18), and orphan/cell/gene therapy (14/18) products were considered the priorities for PIE. We found that, while both US and global communication materials serve as tools for manufacturers to consolidate clinical and pharmacoeconomic evidence, key differences emerge for document purpose, audience, timing, and content.
CONCLUSIONS: This study builds on our previous research, providing further insights into best practice for the development of PIE and AMCP dossiers. Our results highlight the importance of early manufacturer engagement with US population health decision-makers, and of clearly communicating available clinical and cost information ahead of market entry. Our study also highlights considerations and potential efficiencies when developing these tools as part of a coordinated global communication strategy.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
HTA348
Topic
Health Technology Assessment
Topic Subcategory
Value Frameworks & Dossier Format
Disease
No Additional Disease & Conditions/Specialized Treatment Areas