Integrating Early Economic Evaluation into Target Product Profile development for medical tests: advantages and potential applications.

Cocco, Paola; Messenger, Michael Paul; Smith, Alison Florence; West, Robert Michael; Shinkins, Bethany

Target Product Profiles (TPPs) outline the characteristics that new health technologies require to address an unmet clinical need. To date, published TPPs for medical tests have focused on infectious diseases, mostly in the context of low- and middle-income countries. Recently, there have been calls for a broader use of TPPs as a mechanism to ensure that diagnostic innovation is aligned with clinical needs, yet the methodology underpinning TPP development remains suboptimal. Here, we propose that early economic evaluation (EEE) should be integrated within the TPP methodology to create a more rigorous framework for the development of "fit-for-purpose" tests. We discuss the potential benefits that EEE could bring to the core activities underpinning TPP development-scoping, drafting, consensus building, and updating-and argue that using EEE to help inform TPPs provides a more objective, evidence-based, and transparent approach to defining test specifications.