Guidance on scoping (G05) published 

❗️G05 defines the essence of the respective HTA
 

🔊 On Dec 9th European Commission finally published 10 guidance documents for EU HTA. Even though publication of Implementing Acts attracted much more  interest, the guidance documents are the fine print that will decide on the details. Today we will take a closer look at how the assessment scope is defined (G05).     Officially it is called "Guidence on the scoping process".  
 

📄 Most of this guidance repeats the EUnetHTA21 deliverable. Tracking changes would have helped to better understand all changes. 
 

🔎Of interest: 

🔹 The scoping process already starts with the submission of the HTD, not with the validation and the official start of the MAA procedure. 

🔹 The PICO survey is based on an assessment scope proposal, prepared by the ASS and Co-ASS 

🔹 The PICO survey is voluntary, but follows an opt-out-format, i.e. Member States have to actively propose a PICO, otherwise they are assumed to accept the assessment scope proposal. 

🔹 Comparators are not limited to approved pharmaceuticals; off label use is also possible as well as non-pharmacological intervention or even "watch and wait". 

🔹 Note that details of the comparator (e.g. dosing) are not be part of the consolidated assessment scope. 

🔹 This guidance also provides details on data presentation in the JCA dossier and the JCA report.