Tuesday, June 18, 2024

Understanding the Role and Use of AMCP Dossiers in US Market Access

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An Academy of Managed Care Pharmacy (AMCP) dossier is a document used by pharmaceutical and medical device manufacturers to provide clinical and economic evidence to healthcare decision-makers in the United States. The AMCP has developed a template that standardizes the presentation of evidence, which is widely accepted by various US stakeholders as the best practice. These dossiers are used to evaluate a product for formulary, coverage, policy, or reimbursement within the US healthcare systems.

Unlike European health technology assessment (HTA) bodies, the AMCP does not assess the dossiers. Instead, pharmaceutical companies use them to respond to validated and unsolicited requests for information from healthcare decision-makers. AMCP dossiers may be read by any US healthcare personnel, committee, or organization that uses an evidence-based process for making healthcare coverage and reimbursement decisions.

AMCP dossiers can be used across the product lifecycle, from pre-launch to post-launch. There are three types of dossiers: unapproved product dossiers, approved product dossiers, and unapproved use dossiers. Each type of dossier is linked to different points in the development lifecycle and serves different purposes.

Pharmaceutical and Medtech companies must have clear policies that dictate when and how these dossiers are shared with healthcare decision-makers. This includes determining what constitutes an unsolicited request for a dossier and how to fulfill such requests within the legal framework. Maintaining an AMCP dossier requires consistent updates throughout the product life cycle, such as changes to the prescribing information, line extensions, new safety information, or new information that affects the overall evidence.

The format of an AMCP dossier for formulary submissions must follow a set template provided by the AMCP. This template includes sections for an executive summary, product information and disease description, clinical evidence, economic value and modeling report, additional supporting evidence, and dossier appendices.

While there are many similarities between an AMCP dossier and a global value dossier (GVD), there are also key differences, particularly around the level of detail and market specifics included. Developing a GVD and AMCP dossier in tandem can lead to efficiencies as sections requiring more detail in one dossier can be developed first and then streamlined for the other.

In essence, an AMCP dossier provides a structured format for presenting clinical and economic evidence to healthcare decision-makers in the US. Despite the significant effort required to develop and maintain these documents, they offer an effective and compliant way to provide payers with timely and trusted information about the latest clinical and economic evidence for a treatment.

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