ISSUE

: 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 paradigm shift from volume-based to value-based healthcare delivery in the US, the question remains if viable avenues for engagement with payers exist or should these avenues be put in place in the fragmented US healthcare market. Traditional engagement opportunities through payer advisory boards and standing panels have proven to be moderately effective and often offer questionable benefits. With the growing focus on health technology assessment in the US that spans comparative effectiveness, short-term affordability and long-term value for money evaluations, a dialogue is warranted to explore more formal ways to engage manufacturers, regulators and payers early on in the medicine development process to improve outcomes of technology assessment and ultimately address increasing patient access hurdles in the US.

OVERVIEW

: A panel composed of the relevant stakeholders, including pharmaceutical manufacturers, payers and regulators, will have a debate with audience participation on the topic of feasibility of and potential ways for formal manufacturer engagement with regulators and payers in the medicine development process in the US. Specifically, learnings to-date from EU and US experiences will be reviewed and discussed from panelists’ perspectives engaging with the audience with periodic (or interactive) participant questions, focusing on tangible benefits and insufficiencies. Additionally, current US practices with respect to payer engagement will be reviewed and the needs for and potential ways to operationalize joint consultations will be debated, offering a forum for generating potential concepts for testing to enable formal early payer engagement in the medicine development process in the US. Time will be allotted throughout the panel discussion for audience viewpoints and questions.