Guidelines
Aventine develops value dossiers and economic analyses consistent with relevant submission and best-practice guidelines.
Dossier submission guidelines are updated every few years and Aventine maintains an up-to-date knowledge base of these submission requirements.
Relevant guidelines for US preapproval dossiers, including more broadly preapproval information exchange (PIE), and postapproval dossiers as well as economic models include:
- AMCP Format for Formulary Submissions, version 5.0
- Final FDA guidance on Manufacturer’s communication with Payors on healthcare economic information (HCEI) and preapproval information for investigational agents and uses (released 6/12/2018)
Additional influential and evolving health technology evaluation frameworks: