🔧 PART 17: JCA scoping process, predictability and transparency
Series: monthly news from the EU HTA workshop

 

How predictable is the PICO scoping process within the JCA framework❓

 

🔎 Based on several ongoing JCA procedures we are currently supporting, the scoping phase remains a critical, yet only partially predictable step within the overall process.

 

💡 We have received the respective assessment scopes and share our early learnings focusing on the scoping process and PICO development:
🔹 Across assessments, the number of requested PICOs varies substantially depending on the indication.
🔹 While populations and comparators are often directionally predictable, it remains challenging, particularly in complex disease areas, to anticipate how the Coordination Group consolidates and structures the final set of PICOs.
🔹 Off-label comparators are included in several cases, especially in indications with limited or no approved treatment options or where standard of care varies significantly across Member States.
🔹 The consolidation step conducted by the Coordination Group lacks transparency, limiting predictability for manufacturers.

🔹The scoping guideline provides a general framework for how PICOs are developed, however, for PICOs requested by individual Member States, it remains difficult to anticipate whether they will be included in the final assessment scope.
🔹 It is not transparent whether all Member States have contributed to the PICO scoping, which clinical guidelines have informed the PICO proposal, and to what extent clinical experts and patients have been involved.

 

👉 From a strategic perspective, early scenario planning across multiple potential PICO configurations is essential. This includes proactively anticipating alternative comparators, including off-label options, and preparing flexible evidence generation strategies to ensure readiness despite limited predictability.

 

👉 In the next part of this series, we will share our experiences from the Assessment Scope Explanation Meeting.

 

We are providing you with insights from our current work on EU HTA.