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Dossiers

If you’re working in pharmaceutical market access, you’ve likely encountered AMCP formulary dossiers. These comprehensive documents compile US clinical and economic evidence for medical drugs, tests, or devices, serving as a critical bridge between manufacturers and healthcare decision-makers. Since its introduction in 2000, this framework has become the go-to standard across our industry for organizing clinical, safety, and economic data in a way that healthcare decision-makers can easily digest. AMCP’s Format 5.0, released in April 2024, expands that framework with guidance on digital therapeutics, health disparities, pre-approval information exchange (PIE) decks, and an emphasis on concise dossiers. Managed care organizations or health care decision-makers (HCDMs) use dossiers for formulary and medical policy considerations regarding coverage or reimbursement. The AMCP Format is advisory rather than mandatory, but most payers expect manufacturers to follow it when submitting clinical and economic evidence. Dossiers must contain the most recent, relevant, scientifically accurate and balanced information regarding medicinal products, without any promotional material. It’s important to understand that the FDA strictly regulates how manufacturers and healthcare decision-makers can communicate about these dossiers. This means that any requests for dossier information must come unsolicited from the healthcare organizations themselves. 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
  • Digital therapeutics and health disparities considerations

Before FDA approval of a new product or unapproved use, manufacturers can share a pre-approval dossier with HCDMs. This early information helps payers plan budgets, evaluate coverage options, and prepare for reimbursement decisions. Companies have flexibility in what they include in pre-approval dossiers, typically following their own internal guidelines and policies for sharing this type of information. 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

AMCP describes the dossier as a “living document” that evolves from pre-approval through post-approval updates.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.

Dossier Development Services from Med Communications

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., indications, dosing, contraindications)
  • 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 scientific writing team brings deep expertise to help you effectively communicate your product’s value compared to existing alternatives. We focus on enhancing the comprehensiveness, quality, and relevance of your dossier content to address the specific needs of healthcare decision-makers. Effective value communication is crucial for successful formulary inclusion and reimbursement outcomes. Our approach focuses on presenting evidence in ways that resonate with healthcare decision-makers’ evaluation processes. 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.

How Can Med Communications Help?

Our scientific writers plan, create, and update AMCP, pre-approval, and global value dossiers. We:

  • review new label changes, safety data, and clinical or economic evidence,
  • refresh your dossier so payers always see the most current, balanced information,
  • highlight your product’s value next to competing therapies, and
  • support global and U.S. teams across many therapeutic areas.

With more than 25 years of experience, we make sure your dossier speaks clearly to health care decision-makers. Contact Med Communications today to get started.

Frequently Asked Questions

What Is an AMCP Formulary Dossier?

An AMCP dossier is a structured document that pulls together a drug’s clinical, safety, and economic evidence. U.S. payers use it to decide formulary placement, coverage, and reimbursement.

How Is a Global Value Dossier Different From an AMCP Dossier?

An AMCP dossier follows the U.S. AMCP Format and is built for American payers. A global value dossier is a master document for markets outside the United States and offers more flexibility to present one value story that local teams adapt to their own payer needs.

What Does AMCP Stand For?

AMCP stands for the Academy of Managed Care Pharmacy, the U.S. professional society that created the formulary dossier format.

When Should You Update a Dossier?

Refresh your dossier whenever the product label, clinical or economic data, safety profile, or price changes in a way that matters to payers. Most teams review and update at least annually or right after an FDA approval of a new use.