(140) Healthcare decision-maker insights on Academy of Managed Care Pharmacy Format Version 5.0 formulary dossiers

Background: : Since its release in 2000, the Academy of Managed Care Pharmacy (AMCP) Format has provided a framework for biopharma manufacturers to communicate clinical and economic evidence to healthcare decision-makers (HCDMs) to inform formulary, coverage, policy, and reimbursement decisions for new and existing medical products. The latest version of the AMCP Format—Version 5.0—was released in April 2024 and included updated guidance on digital therapeutics, health disparities, and pre-approval information exchange (PIE).

Objective: : To assess HCDM insights on the use and value of AMCP Format formulary dossiers.

Methods: : A double-blinded, web-based survey was fielded to FormularyDecisions® users from March 7, 2025, to April 17, 2025. FormularyDecisions is a digital platform that supports the exchange of information between HCDMs and biopharma manufacturers.

Results: : A total of 31 HCDMs responded to the survey, representing national and regional health plans (58%), pharmacy benefit managers (PBMs; 19%), and integrated delivery networks (IDNs; 10%), among other organizations, with roles as pharmacy directors (65%), clinical pharmacists (19%), and medical directors (16%). Most respondents (94%) represented commercial plans. All HCDMs agreed that AMCP Format dossiers contain the information needed for, and improved their ability to make, formulary decisions. Three-quarters (75%) of HCDMs agreed that product review and formulary placement could be delayed if an AMCP Format dossier was not provided by a manufacturer; and nearly half (48%) agreed that patient access to the product could be delayed. Over half (55%) of HCDMs were less likely to request a dossier for a manufacturer’s future products if a previous dossier request went unfulfilled. In regard to PIE, 71% of HCDMs indicated a desire to first receive a product’s AMCP Format dossier before FDA approval. Among respondents who had requested pre-approval dossiers (n=13), 54% noted an increase in the provision of pre-approval dossiers during the past year (vs prior years). HCDMs were also surveyed on health equity and digital therapeutics, topics updated in Format Version 5.0, with variable results.

Conclusions: : The results of this survey indicated that AMCP Format dossiers contain the information needed by HCDMs and improved their ability to make timely formulary decisions. More than two-thirds of HCDMs would prefer to have an AMCP Format dossier ahead of FDA approval timing, representing an opportunity for increased PIE between biopharma manufacturers and HCDMs.

Sponsorship:: Cencora