Cookbooks Versus Blenders: Paradigms for Integrating Factors Relevant to the CMS Drug Price Negotiation Process

ISSUE: The first phase of Medicare drug price negotiation is under way, but how the Centers for Medicare and Medicaid Services (CMS) will put all the pieces of information together in its initial offer prices and subsequent negotiation remains a critical unknown for stakeholders and the academic community. Since CMS has suggested that they will evolve this process as they learn more and their capabilities grow, this panel will present key options for how the disparate types of information, including qualitative and quantitative elements, can be integrated and translated into the negotiation process, highlighting key pros and cons of different approaches, and exploring the role that external input can best support CMS in this effort.

OVERVIEW: Steve Pearson (Moderator) (10 minutes) will set the stage by outlining the elements that the inflation reduction act (IRA) sets out as relevant for determining initial price offers by CMS. Marina Richardson (12 minutes) will share elements of ICER’s submission to CMS, which included a comparative clinical and cost-effectiveness assessment of apixaban and rivaroxaban, both of which are on the initial negotiation list. Brett McQueen (12 minutes) will discuss how a structured deliberation could be used by CMS to aggregate and prioritize evidence in a way that acknowledges the relative importance of factors being considered in the determination of an initial offer price. Kyle Hvidsten (12 minutes) will react to both presentations and share the views and concerns of industry on how information should be integrated to guide CMS actions. The floor will then be open to interactive polling and Q&A with the audience, and discussions about how the research and policy community should focus their efforts to inform CMS processes.