DIA 2019 Global Annual Meeting

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.