Aventine specializes in the development of reimbursement dossiers and has years of experience and expertise in developing dossiers that identify the value of products for payers across diverse disease states.
A submission dossier is a compilation of clinical and economic data on a product within the context of a specific disease state or disease states. Its purpose is to share with 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. Dossiers can contain published data, as well as data on file. Importantly, dossiers for FDA-approved products can also contain information on off-label use, as they can only be submitted to health care decision-makers upon receipt of an unsolicited request. 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 health care decision-makers.
Academy of Managed Care Pharmacy (AMCP) Dossiers and US Preapproval Dossiers
The first formulary submission guidelines 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. The latest AMCP guidelines reinforce the existing US formulary submission dossier format standard for approved drugs and provide new recommendations on preapproval dossiers for unapproved agents and unapproved uses of approved drugs, consistent with the June 2018 FDA guidance on preapproval communication with payers.
Aventine has developed more than 200 value dossiers across a wide range of therapeutic areas. Our goal remains consistent throughout our approved product dossiers: to best 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, and ultimately the approved product’s value story.
Global Reimbursement Dossiers
The goal of a global value dossier is to support global reimbursement groups in addressing:
- Reimbursement policy decisions
- Health technology assessments
- Formulary reviews
- Payer educational needs
Aventine has experience developing scientifically-sound core global value dossiers for client-affiliate use for reimbursement submissions outside the US, including Canada, the United Kingdom, France, Germany, Spain, Italy, Australia, and Brazil. In general, global dossiers are more robust 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 and criteria 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.