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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 sector.

Under the AMCP format, the pharmaceutical industry has the opportunity to justify the price of a new agent in terms of its health value to the health plan. The format does not specify methods for economic evaluation but rather requests the use of appropriate techniques and data sources in order to demonstrate:

  • Disease description and agent's role in therapy
  • Clinical efficacy, safety, and effectiveness
  • Economic evaluations
  • Cost modeling
  • Value justification

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.


Pharma and Biotech