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: