In essence, an AMCP dossier provides a structured format for presenting clinical and economic evidence to healthcare decision-makers in the US. 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. 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. 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. The format of an AMCP dossier for formulary submissions must follow a set template provided by the AMCP. 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. This includes determining what constitutes an unsolicited request for a dossier and how to fulfill such requests within the legal framework. Pharmaceutical and Medtech companies must have clear policies that dictate when and how these dossiers are shared with healthcare decision-makers. Each type of dossier is linked to different points in the development lifecycle and serves different purposes. There are three types of dossiers: unapproved product dossiers, approved product dossiers, and unapproved use dossiers. 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.ĪMCP dossiers can be used across the product lifecycle, from pre-launch to post-launch. Instead, pharmaceutical companies use them to respond to validated and unsolicited requests for information from healthcare decision-makers. Unlike European health technology assessment (HTA) bodies, the AMCP does not assess the dossiers. These dossiers are used to evaluate a product for formulary, coverage, policy, or reimbursement within the US healthcare systems. The AMCP has developed a template that standardizes the presentation of evidence, which is widely accepted by various US stakeholders as the best practice. 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.
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