🗝️ This outcome document will play a key role in shaping the design of the pivotal study.

🔊 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 Outcome Template (T05). Officially it is called "Outcome document for Joint Scientific Consultations (JSC) on Medicinal Products (MP)". 
 

This document is a template for outcomes of JSC. So all documents submitted by the Coordination Group subsequently will follow this format. 
 

✅ What's in? 

• Document history: Course of events of this specific JSC (omitting selection procedure). 

• Summary of the clinical development programm, as of relevance for this JSC. 

• Feedback is devided into clinical development and post-launch evidence generation. 

• Each section thereof is split into questions on Population (2.1.1), Intervention (2.1.2), Comparators (2.1.3), Outcomes (2.1.4), and overall study design (2.1.5). 

• For each question, the HTD position is mentioned as well as the (consolidated) recommendation by the HTACG. If available, input from patients, clinical experts, and other relevant experts are also summarized.  

• Additional recommendations by individual member states can be found in the appendix.  

• Feedback on questions around health economic assessment can also be included in the appendix. 

• Contributions by experts are reported in detail by their written statements or minutes provided by assessor / co-assessor. 
 

❌ What's missing? 

• The selection procedure of the JSC request is not reported. 

• There is no section to report on PICO, i.e. the questions which should be adressed in the JCA.  

• Advice is strictly based on current knowledge as per Recital 39 HTAR, so it does not anticipate potential modifications as per JCA. 

• CHMP Scientific Advice (in case of parallel HTACG/EMA JSC) is provided in a seperate document, indicating the strict seperation between both advice bodies. 
 

🌰 In a nutshell:  

• This outcome document will inform the design of the pivotal study. 

• The corresponding EUnetHTA21 deliverable D6.3 was not published, but no surprises. 

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