Pre- and Post-Approval Dossiers: Making all evidence count

Webinar Recorded on September 12, 2018 

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Payers are required to provide timely product coverage decisions for formularies that accommodate rising drug costs, strict budgets, and forecasting considerations. Dossiers continue to provide key information to inform this process; however, there is variability among dossiers. This discussion will capture the current state of payer perceptions regarding dossier timing, quality and use as well as future considerations for improving dossier relevancy and optimization of use.

Specifically, this webinar will review: 

  • 2018 US payer survey results – based on responses from the AMCP eDossier System® community (aggregate/benchmarks)
  • Payer perspective using dossiers, citing overall strengths and opportunities for improvement
  • Manufacturer perspective in developing and maintaining dossiers, responding to requests for dossiers, and adhering to the AMCP Format for Formulary Submissions.
  • AMCP Format for Formulary Submissions, v4.0 future considerations (pre- and post FDA-approval)
  • Discussion on perspectives of pre-approval dossiers


  • Elizabeth Sampsel, PharmD, MBA, BCPS, VP, Payer Strategy and Relations, Dymaxium
  • Sina Carlson, PharmD, Senior Director, Drug Intelligence, OptumRx
  • Iris Tam, PharmD, Director and Head, Outcomes Research & Quality of Care, Medical Affairs, Achaogen