How do payers utilize the AMCP eDossier System for pre-approval information and could it qualify as a safe harbor?
Webinar Recorded on January 18, 2017
Currently there is no accepted FDA sanctioned safe harbor mechanism for the exchange of truthful and non-misleading information between payers and manufacturers and the FDA is currently reviewing options. Payers are reviewing products in many cases 18-24 months in advance of FDA approval to meet budget and formulary approval timelines. The AMCP eDossier System (System) has been supporting the exchange of manufacturer-provided approved dossier information since 2009. The need for pre-approval information is apparent, as indicated during the recent FDA hearings. This webinar will review research and evidence that can support the opportunity to use the AMCP eDossier System as a potential safe harbor mechanism.
Specifically this webinar will review:
- Recent research on how US payers are utilizing the AMCP eDossier System for pre-approval information
- eDossier insights regarding the information exchange, tracking and usage
- Discuss how this System could be a potential safe harbor mechanism for pre-approval information and support the decision making process
- Payer perspective on the need for pre-approval information for HDCM budget and formulary planning
- Jackie Gladman, Vice President, Sales and Marketing, Dymaxium
- Elizabeth Sampsel, PharmD, MBA, Senior Payer Consultant, Dymaxium
- Alan Pannier, PharmD, MBA, Director of Clinical Services, Veridicus Health