The "Population, Intervention, Comparator, and Outcome" Puzzle: Navigating Uncertainty in the Joint Clinical Assessment Era

PURPOSE: The European Joint Clinical Assessment (JCA) will provide a single process for the Health Technology Assessment (HTA) for member states (MS). The JCA will be informed by a ‘Population, Intervention, Comparator, Outcome’ (PICO) survey which may result in multiple PICOs within a single submission. Although the JCA is intended to expedite patient access for innovative therapies, the need to collect and present data for multiple MS may create challenges to traditional HEOR. This workshop will explore these challenges using case studies, and possible solutions using online tools for situations where PICOs diverge between MS.

DESCRIPTION: The session will be introduced by Prof. Wim Goettsch who will describe the JCA opportunities and challenges for patients, manufacturers and HTA; and the potential high-stakes of establishing PICOs (7 minutes). Maria Rizzo will review an oncology case study identifying risks of divergent PICOs, driven by varying standards of care, and how an online, all-encompassing comparative effectiveness framework may help prepare evidence generation activities (15 minutes). A case study on reporting considerations using an online systematic literature review tool that generates automated reporting by PICO filtering will be presented by Maria Rizzo (8 minutes). Andrew Satherley will then present a case study on anticipating MS PICOs using an online survey tool to elicit MS HTA and clinical expert PICO requirements, before consolidating PICOs (10 minutes). Finally, leaders will discuss implications for anticipating the JCA scope in the HEOR strategy (5 minutes).

There will be interactive participation; the audience will be asked to make key decisions on their HEOR planning based on the case studies presented. The audience will be asked to consider how tools and other strategies can help navigate any uncertainty in the JCA era (15 minutes).