🔦 This briefing book will shape the Joint Scientific Consultation (JSC) 

🔊 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 the JSC Briefing Template (T03). Officially it is called "Briefing document template for HTA Coordination Group (HTACG) Joint Scientific Consultation (JSC) for Medicinal Products (MP)". 
 

This document forms the key element of the briefing package for a JSC. It's use is mandatory. 
 

✅ What's in? 

• Background on disease, product, regulatory status, rationale for seeking advice. 

• Clinical background on existing studies, and studies subject to JSC, including post launch evidence generation (PLEG). 

• All questions must be submitted in the briefing book. Questions can be submitted regarding Population, Intervention, Comparators, Outcomes, overall study design, and PLEG. There is a maximum of 10 questions. 

• For each question, the HTD has to provide a corresponding position, including sufficient justification. 

• Questions around health economic assessment are also possible but optional and subject to voluntary cooperation. 

• Short study synopsis on the planned study which is subject to JSC. 

• Previous advice received (e.g., national HTA authorities within and outside of Europe) have to be annexed. 
 

❌What's missing? 

• There is no section to ask on PICO, i.e. the questions which should be adressed in the JCA. Questions regarding the future appraisals and/or reimbursement/coverage decision will not be answered. 

• There seems to be no room for procedural questions. 

 

🌰In a nutshell:  

• This briefing book will shape the JSC. 

• No relevant changes vs. EUnetHTA21 deliverable D6.2.1 

• It will not help in the JCA, as it does not report on the PICO, but handles each component separately. 

• Previous advice from other HTA bodies can be cross-referenced. So defining an advice sequence as part of the advice strategy can be a valuable option.