🔧 PART 12: PICO scoping processes

Series: monthly news from the EU HTA workshop

 

How predictable are PICO scoping processes of the Coordination Group❓

 

🔎 Across several JCA procedures we are currently supporting, the number of requested PICOs varies substantially depending on the indication. While populations and comparators remain relatively predictable, it becomes increasingly challenging – particularly in complex disease areas – to anticipate how the Coordination Group will ultimately consolidate and structure the final set of PICOs.

 

💡 We have already received the respective assessment scopes and share our early learnings:

 

🔹 Assessments typically include up to four subpopulations, most commonly defined by prior therapies.

🔹 Interventions characteristics are partially specified (e.g., administration), but detailed dosing information is not provided.

🔹 Comparators strongly determine the number of PICOs, with occasional inclusion of unexpected off-label comparators.

🔹 Outcomes partially align with G-BA standards but are at times broadly defined or extend beyond available trial data.

🔹 Subgroup definitions and methodologies vary widely and inconsistently across assessments: with non-systematic inclusion of standard criteria, differing or missing cut-offs, inconsistent application across PICOs, and some country-specific requirements remaining.

 

📌 Overall, our experience highlights that PICO scoping can still introduce considerable methodological variability, particularly around comparators and subgroup definitions.

 

📢 Over the coming weeks, we will take a closer and more detailed look at the individual PICO components and share further practical insights.