⏲️ Why has publication taken that long?

Three new PICO Exercises for Medicinal Products have been published:

🔹Durvalumab (Imfinzi) in FL HCC

🔹Adagrasib (Krazati) in 2ndL NCSLC and KRAS G12C mutation

🔹Etranacogen Dezaparvovec (Hemgenix) in Hemophilia B

🔍️ 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 wave of exercises should be based as a minimum on Version 1.1.

In addition, the draft Implementing Act on JCA for Medicinal Products was published on March 5th, 2024. This is before the second wave of PICO exercises started. So the use of preliminary versions of the guidance should not distract from interpretation.

💡 Key observations vs. first wave of PICO exercises:

➡️Number of PICOs (7 – 13) has increased

➡️No pressure test (exercise after EMA approval and not in parallel; member state involvement and expert involvement remain unclear)

➡️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?

📖 More on how to prepare for EU HTA in our book: EU HTA 101 (updated in October 2024) https://lnkd.in/eAsxt7NZ