ISSUE: The pharmacoeconomic evidence provided by the BIA and CEA plays an important role in decision-making within healthcare systems. Despite these two instruments, systems do not always use both analyses or have different interpretations and criteria. To what extent this impacts the access to innovative medicines and how it can support their clinical assessment remains challenging. Efforts have been made to synergize the use of both BIA and CEA, for example, in a “three-dimensional pharmacoeconomic model” or “lock,” while some question the need for CEA. In the Netherlands, drugs or treatments with a high price or financial risk are placed in the lock, meaning the national authorities require both analyses for a decision. Are then BIA and CEA sufficient to address innovative medicines?

As the importance and performance of BIA and CEA increase, the need for consistency in combined use and interpretation becomes more apparent. Therefore, discussing the need to standardize the rules for a logical interplay between BIA and CEA might help industry, academia and health authorities to write and read the same language.

OVERVIEW: This panel will discuss the importance and the need to standardize the rules for a logical interplay between BIA and CEA. The moderator, Cornelis Boersma, will reflect on the situation (5min) and provoke debate based on several questions (15min): Is CEA always the appropriate instrument, and how far that depends on the BIA?; Could the development of a tool linking BIA and CEA support the decision-making of innovative drugs in the phase of their clinical assessment? How can industry, academia, and health authority contribute and benefit from such a tool? The panelists Josephine Mauskopf, Jaime Caro, Thea van Asselt, will address the perspectives mentioned in 10 min presentation per panelist. The audience will actively engage in the debate via online polls and open questions (10min).