The Academy of Managed Care Pharmacy (AMCP) formulary dossier is a comprehensive collection of US clinical and economic evidence for new and existing medical drugs, tests, or devices. This framework, created in 2000, has been widely adopted as the industry standard for the synthesis and organization of clinical, safety, and economic data. Managed care organizations or health care decision-makers (HCDMs) use dossiers for formulary and medical policy considerations regarding coverage or reimbursement. Dossiers must contain the most recent, relevant, scientifically accurate and balanced information regarding medicinal products, without any promotional material. Communication between HCDMs and manufacturers is strictly regulated by the FDA and stakeholder requests for dossiers must be unsolicited. Key sections of a dossier generally include:

  • Executive Summary
  • Product Information/Disease Background
  • Clinical Evidence
  • Economic Value and Model Report
  • Additional Supporting Evidence
  • Supporting Information

Prior to FDA approval of a product (new product or unapproved use), pharmaceutical manufacturers may provide product information to HCDMs via a pre-approval dossier to allow for planning, coverage decision making, and budgeting for future reimbursement. The information presented in the pre-approval dossier is provided at the discretion of the company and based on internal policies and procedures. AMCP provides guidelines regarding the format used for the inclusion of clinical, safety, and economic data. The key sections of a pre-approval dossier include:

  • Product Information/Disease Background
  • Indications being researched
  • Anticipated timeline for possible FDA approval or development deadlines
  • Factual and non-promotional presentations of in-progress clinical study reports (no conclusions regarding the safety or efficacy of the unapproved product or use)
  • Anticipated estimated product pricing ranges (not required and can be brief)
  • Estimated eligible populations
  • Patient utilization projections
  • Patient support programs

The pre-approval dossier can serve as a foundation for creating a post-approval dossier once the product has been approved by the FDA. It is updated as new evidence and information becomes available throughout the product’s life cycle. The information should be current, objective, relevant, and developed by medical experts with appropriate clinical and scientific expertise.

A Global Value dossier is a broader representation of the evidence available to support clinical and economic value of a pharmaceutical product’s use outside the US. It is often used to present the value of the product to stakeholders and how it can be distinguished from competitor products. While AMCP and Global Value dossiers contain similar key sections, other items such as extensive evidence tables, statistical significance of outcomes, and clinical study limitations are requirements for AMCP dossiers.

How can Med Communications help?

Med Communications’ scientific content team has extensive experience developing content for dossiers and updating them as new information becomes available. Dossiers may be reviewed and updated when there are significant changes regarding a pharmaceutical product, such as:

  • changes to the prescribing information (e.g., indication, dosing, etc.)
  • new clinical or economic evidence
  • new safety information
  • identification of patients or subpopulations who should or should not receive the product
  • demonstration of real-world or long-term effectiveness.

Our team of highly experienced and knowledgeable scientific writers and reviewers can present the value of your product relative to existing alternatives by improving the span, quality, and relevance of information in the dossier to meet your needs. At Med Communications, we understand the importance of communicating your product’s value effectively in order to facilitate formulary additions and optimize reimbursement. For more than 25 years, we have partnered with several clients and successfully developed valuable and strategic product dossiers across various therapeutic areas. By leveraging the clinical expertise of our Scientific Content team, we can effectively convey the evidence-based value of your product to HCDMs and other stakeholders across local and global markets.