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 include:
- AMCP Format for Formulary Submissions, version 4.0
- 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)
- WellPoint Health Technology Assessment Guidelines, drug submission guidelines for new products, new indications, and new formulations
- WellPoint Health Technology Assessment Guidelines, drug submission guidelines for re-evaluation of products, indications, and formulations
- RegenceRx Medication Value Appraisal Principles
- 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
- Pan-Canadian Oncology Drug Review (pCODR) Submission Guidelines
- Canadian Agency for Drugs and Technologies in Health (CADTH) Common Drug Review (CDR) Submission Guidelines for Manufacturers
When developing a formulary submission dossier for the US, one document may be elected by the client that meets the needs of all US-based guidelines. This one-document principle has been reiterated by AMCP, WellPoint, and Regence at multiple professional conference sessions over the past several years.
When developing a global value dossier, the affiliates for individual countries generally adapt the core value dossier for the specific reimbursement needs of their country. The ISPOR website provides a reference tool for country-specific submission guidelines and pharmacoeconomic recommendations around the world.