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Challenges to Access: Bringing Payers to the Table
Session Chair(s)
Ruslan Horblyuk, PHD, MA
Chief Strategic Consulting Officer, AESARA, United States
While the FDA and EMA avail themselves for early engagement with pharmaceutical manufacturers, non-binding joint consultations with regulators and payers have been to-date available to manufacturers primarily in Europe. With the moving target of paradigm shift from volume-based to value-based healthcare delivery in the US, the question remains if viable avenues for engagement with payers exist in the fragmented market place. Traditional engagement opportunities through payer advisory boards and standing panels have proven moderately effective and with the growing focus on health technology assessment in the US that spans comparative effectiveness, short-term affordability and long-term value for money assessments, a dialogue may be warranted to explore more formal ways to engage manufacturers, regulators and payers. A panel composed of the relevant stakeholders will have an open dialogue on the topic offering a forum for generating potential concepts for testing to enable formal early payer engagement in the medicine development process in the US.
Learning Objective : Identify potential innovative ways of early engagement with payers in the US to enhance medicine development programs and produce a “reimbursable file” at the time of regulatory approval.
Speaker(s)
Panelist
Founder and Strategic Advisor, CTMP; Founder, Rubix Health LLC, United States
EMA Perspective
EMA Official at the FDA, European Medicines Agency, United States
Industry Perspective
Vice President, Patient and Health Impact, Vaccines, Pfizer Inc, United States
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