OBJECTIVES : In 2000, the Academy of Managed Care Pharmacy (AMCP) released a Format for Formulary Submissions. This format provided a framework for manufacturers to submit evidence required by healthcare decision makers in their consideration of products for formulary placement. In April 2016, a new format iteration (version 4.0) was released; one key change was the ability to submit separate product dossiers for each indication. This research investigates the frequency of drugs being approved by the Food and Drug Administration (FDA) with multiple indications to which this new recommendation would apply.

METHODS : FDA New Drug Application and Biologic License Application Efficacy Supplement and New Molecular Entity (NME) approvals were analyzed (01/01/2016-11/31/2017) and the number of previous FDA-approved indications for each drug approved was extracted. Statistical tests were completed using SAS^® version 9.4.

RESULTS : CONCLUSIONS : FDA approvals are increasingly associated with a greater frequency and number of prior approvals. Utilization of the option within the new AMCP dossier format to submit separate AMCP dossiers for each indication can enable more concise and compelling value propositions to be communicated in line with each individual FDA approval and best support formulary decision-making.