OBJECTIVES : The AMCP Dossier was developed as a method to standardize a consistent process to provide US payers with information for formulary decisions. The FDA issued the final guidance on communication of health care economic information (HCEI) in June 2018. Several communication resources were outlined in the HCEI guidance, including an “evidence dossier” as a medium for communication with payers. This study investigates the current usefulness, benefits, and challenges of AMCP dossiers in health plan decision making and explores unmet needs, gaps and potential alternatives.

METHODS : In-depth phone interviews with 10 senior level US payers were conducted. Interviewees were asked questions on key discussion topics on AMCP dossier value, unmet needs, and a prototype evidence dossier.

RESULTS : Payers indicated a general decline in the utilization of the AMCP Dossier over the past several years citing multiple factors, including: ability to capture data online and internal health plan conducted assessments on products. Clinical trial data was consistently rated the most useful section while the economic section was consistently rated as the least useful section. Payers found sections on off-label use helpful in specific therapeutic areas only. All respondents provided enthusiasm for additional needs to make dossier communications more impactful and valuable, including: comparative effectiveness data, network meta-analyses, biosimilar data, switching studies, best practices by other organizations. Some key features highlighted by respondents of the evidence dossier prototype included: a digital interactive platform, ability to toggle and find information quickly, and hyperlinked supplemental information that can be easier shared.

CONCLUSIONS : This research highlights the unmet needs of current AMCP Dossiers by health plans. Payers have a growing need to receive proactive information in a compelling format facilitating better conversations between manufacturers. An interactive, digital evidence dossier prototype was well received by payers in this study and stated as a solution that can better meet their needs.