PART 18: Assessment Scope Explanation Meeting – helpful milestone or limited dialogue?

🔧 PART 18: Assessment Scope Explanation Meeting – helpful milestone or limited dialogue?
Series: monthly news from the EU HTA workshop

How valuable is the Assessment Scope Explanation Meeting within the JCA framework❓

🔎 Based on several ongoing JCA procedures we are supporting, the Assessment Scope Explanation Meeting has now become a recurring and important procedural milestone. Where requested by the HTD, it must take place no later than 20 days after finalization of the assessment scope, in line with the EU HTA Regulation.

💡 We have now supported multiple procedures through this step and share our early learnings:
🔹 Already with the first request, HTDs are invited to indicate whether they would like to make use of such a meeting.
🔹 If this was missed initially, the meeting can usually still be requested retrospectively – however, timing is critical given the procedural timeline set out in the EU HTA Regulation.
🔹 The format is typically large and highly structured, often involving about 30 participants in total, including assessor, co-assessor, members of the JCA subgroup, and representatives of the HTD team.
🔹 It is essential to submit questions in advance, as ad hoc questions are generally not addressed during the meeting; the deadline for submission is five days prior to the meeting.
🔹 At present, the format is not yet a true dialogue between the assessors/JCA subgroup and the HTD. Rather, it tends to be a formal communication of the finalized scope and procedural workflows.
🔹 Detailed rationale on the derivation of specific PICOs or the reasoning behind selected requirements has, at least so far, remained limited.

👉 From a strategic perspective, the Assessment Scope Explanation Meeting is a welcome procedural element, as it creates an official touchpoint shortly after scope finalization and supports alignment on the overall process. At the same time, its practical value for dossier preparation and for deepening the understanding of specific PICO expectations currently remains limited. Greater transparency around the rationale for selected PICOs and a more interactive dialogue format would significantly increase its usefulness for HTDs.

👉 In the final part of this series, we will share our recommendations on how to effectively navigate PICO requirements within the JCA framework.

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