New PICO Exercises Released: What Can We Learn?

Why has publication taken that long?⏱️

Three new PICO exercises for Medical Devices have been published:
🧠 EASEE SYSTEM for patients with epilepsy
🫁 Edwards EVOQUE for patients with severe tricuspid regurgitation
🫀 Bioabsorbable stent for patients with cyanotic congenital heart defects

For background:
📑 Final scoping guidance is based on updated EUnetHTA21 scoping deliverable (Version 1.1) which was published October 2023. Scoping methodology for this second series of exercises should be based as a minimum on Version 1.1.
📝 In addition, the draft Implementing Act on JCA for Medical Devices is still in preparation as of today. So, no published draft was available for these exercises.

Key observations:
⁉️ Prior to any relevant implementing act or guidance documents ➔ what was the conceptual base for this exercise?
🔄 Exercise was “used to improve the guidance.” So far, no guidance does exist.
🚫 Lack of documentation – even less than in the first wave

Motivation for this second wave is not stated by the Coordination Group and therefore remains unclear. The same goes for any conclusions, learnings, etc.

Finally: Why wait with publication for more than six months, especially as this is for transparency purposes only?

Given the importance of PICOs for EU HTA, we see a lot that can be learned out of the PICO Exercises.

Follow our thoughts in this new series Reflections On Second Wave Of PICO Exercises to Get Ready For EUHTA.  

📖 More on how to prepare for EU HTA in our book: EU HTA 101 (updated in October 2024) https://shop.tredition.com/booktitle/EU_HTA_101/W-587-633-024