Dossier Development: Global Value Dossier (GVD) and Academy of Managed Care Pharmacy (AMCP) Dossier
Critical to ensuring market access success for your product or technology, global value dossiers and AMCP dossiers are utilized to communicate product value with an eye to the unique access and reimbursement influencers within the market. Your product’s GVD or AMCP dossier should be started early in development and updated frequently with new clinical evidence and economic information, as well as incorporating feedback from stakeholders.
What Is a GVD?
A GVD is a strategic and comprehensive evidence-based document that consolidates important information about a pharmaceutical or medical device product.
In addition to providing a repository of clinical and economic data, a GVD details your product’s value story for payers, healthcare professionals, and other key stakeholders. Incorporating a strong payer value proposition within the GVD can strengthen its impact by clearly aligning product benefits with payer priorities. A GVD should also compare your product to competitors, highlighting key advantages as well as potential challenges. Internally, a GVD can be used to chronicle market access difficulties and provide a strategic roadmap for overcoming those obstacles.
What Is an AMCP Dossier?
Similarly, an AMCP dossier is a document that helps manufacturers to communicate clinical and economic evidence and other information to healthcare decision-makers (HCDMs).
The AMCP dossier is a standardized format or template developed as manufacturer guidance by AMCP in 2000. There are 3 different formats available, depending on the life cycle of the product: Unapproved product dossier, unapproved use dossier, and approved product dossier. An AMCP dossier is important as it provides payers with the comprehensive and objective information they need to review and assess products for formulary, coverage, policy, and reimbursement decisions.
How Are GVD and AMCP Dossiers Different?
A GVD and AMCP dossier are similar in that they both contain information on the condition or disease, the clinical efficacy and safety data, and economic information. AMCP dossiers follow a standardized format while GVDs can be customized or tailored to the product. AMCP dossiers are typically developed for use with US payers and generally include US-specific condition, cost, and treatment guideline information. GVDs are typically more comprehensive and include global data to potentially meet the needs of other countries. Manufacturers should consider developing both a GVD and AMCP dossier as they convey information for different audiences.
GVD and AMCP Dossier Development at Magnolia Market Access
We have extensive expertise in access and reimbursement decision-making within the US and across major global markets, with a deep understanding of the unique drivers and influencers. Partnering with Magnolia Market Access, you’ll develop a GVD or an AMCP dossier that effectively communicates your product or technology’s story, empowering local markets to tailor their own dossier submissions.
Magnolia Market Access Authors: Rebecca Roman, Ajay Keshava, Amanda O’Hora
