Aventine specializes in the development of dossiers and has years of experience and expertise in developing dossiers that identify the value of products for payers across diverse disease states.
A US value dossier, also known as a formulary submission dossier, is a compilation of clinical and economic data on a product, within the context of a specific disease state(s), that presents the evidence-based value story for the product. In the US, dossiers are commonly referred to as AMCP dossiers, which implies compliance with the latest Academy of Managed Care Pharmacy format for formulary submissions.
The first formulary submission guidelines for dossiers were adopted by AMCP in 2000. Since that time, AMCP has updated their guidelines five times with the most recent being AMCP version 4.1 released in late December of 2019. Within the latest guidelines, AMCP and FDA have provided guidance for the communication of specific information about an investigational drug in advance of FDA approval via preapproval information exchange (PIE) and preapproval dossiers.
Academy of Managed Care Pharmacy (AMCP) Dossiers
Approved Product Dossiers (Postapproval Dossiers)
Following FDA approval of a product, the primary objectives of an Approved Product Dossier are to share with US payers the value of a product to allow for an informed coverage decision and to streamline the data acquisition and review process by the payer.
Approved Product Dossiers contain published data and evidence-based value messaging, and often provide unpublished data on file as well, at the discretion of the product manufacturer. Importantly, dossiers for FDA-approved products can contain information about off-label use. As such, dossiers can only be submitted to healthcare decision-makers upon receipt of an unsolicited request for the product’s dossier. Dossiers are not marketing materials, but instead are scientific documents designed to allow a manufacturer to share the entire evidence-based value story for a product to healthcare decision-makers.
Aventine has developed more than 250 value dossiers across a wide range of therapeutic areas. Our goal has remained consistent over the years for Approved Product Dossiers: succinctly show the evidence-based value of a product to the payer audience in order to optimize reimbursement. While we follow the latest submission guidelines closely, each dossier is unique based on the type of product, the data available, its US marketplace, and ultimately the approved product’s value story.
Unapproved Product/Unapproved Use Dossiers (Preapproval Dossiers)
The latest AMCP guidelines now offer new guidance on dossier format for unapproved agents and unapproved uses of approved drugs that is consistent with the June 2018 FDA guidance on preapproval communication with payers. The driving force behind such preapproval information exchange (PIE) between manufacturers and US payers has been the critical need for payers to gain key information to aid in planning for budget cycles a year or more in advance of a product’s anticipated US approval.
Since 2018, Aventine has been developing preapproval information exchange (PIE) materials for our clients, such as slide decks and infographics. Starting in 2020, Aventine began supporting our clients’ rapid expansion into the new preapproval dossier arena by developing Unapproved Product/Use dossiers, often in parallel or in sequence with the preparation of the Approved Product Dossier content.
Global Value Dossiers
The goal of a global value dossier (GVD) is to support our clients’ global affiliates’ needs for addressing:
- Reimbursement policy decisions
- Health technology assessments
- Formulary reviews
- Payer educational needs
Aventine has experience developing scientifically-sound core GVDs for client-affiliate use for reimbursement submissions outside the US, including Canada, the United Kingdom, parts of the EU (Germany, France, Spain, Italy), Australia, and Latin America. In general, GVDs are more expansive than US-based dossiers, as one document is often developed to meet the needs of several countries and is later customized by client-affiliates to address requirements that are specific for each country.
The Aventine writing style is based on the American Medical Association (AMA) Manual of Style; however, we are frequently asked to adopt more client-specific style guides for individual projects tailored to the stylistic needs of our clients’ internal departments and/or publication editors. In addition to following AMA style, our team develops documents written in scientific American-English, using US-native technical writing tone, sentence structure, spelling, and grammatical idioms.