Product Dossiers and Formulary Kits
Rxperts consultants have extensive experience in developing product dossiers for Pharmaceutical and Biotechnology companies that comply with the Academy of Managed Care Pharmacy’s (AMCP) Format for Formulary Submission Guidelines version 2.1 (available at www.amcp.org).
The Guidelines serve as a tool for managed care organizations to use in obtaining and arraying useful clinical and pharmacoeconomic data that will enable a P&T Committee to draw evidence-based decisions that will guide the treatment options available to the covered population. It is intended as a template for pharmaceutical and medical device manufacturers to use to construct a formulary submission dossier designed to make the product evaluation process in formulary development more rational.
The growing need for combining clinical
safety, efficacy and effectiveness information with the economic
evaluation of pharmaceuticals in a standardized manner for the
submission process has been widely recognized within the health care
Rxperts will create or revise a product dossier for a new or existing agent that meets the current AMCP format for formulary submission guidelines by working with your company's brand team, medical affairs and health economics departments.
ExamplesPharma and Biotech