Aventine develops value dossiers and economic analyses consistent with relevant submission and best-practice guidelines.
Dossier submission guidelines as well as best-practice guidelines for economic modeling are updated every few years and Aventine maintains an up-to-date knowledge base of these submission requirements.
Relevant guidelines for US post-approval and preapproval dossiers as well as economic models include:
- AMCP Format for Formulary Submissions, version 4.1
- 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)
- ISPOR’s Principles of Good Practice for Budget Impact Analysis
- ISPOR’s Budget Impact Analysis-Principles of Good Practice II Task Force
- ISPOR’s Good Research Practices for Measuring Drug Costs in Cost-Effectiveness Analyses
Additional influential and evolving health technology evaluation frameworks: