How can JSC be rationed sensibly? 
 

🔊 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 selection of MPs for JSC (G12). Officially it is called "Guidance for the selection of Medicinal Products (MP) for Joint Scientific Consultations (JSC)". 

 

✅ Here is how it works: 

There are two formal requirements that every successful request must meet: 

1️⃣ A JSC request needs to refer to a health technology that will be subject to EU HTA 

2️⃣ And the pivotal study subject to #JSC has not yet started. 

 

In case the number of valid requests exceeds the available capacity for JSC, selection criteria will apply: 

🔹unmet medical needs; 

🔹first in class; 

🔹potential impact on patients, public health, or healthcare systems; 

🔹significant cross-border dimension; 

🔹major Union-wide added value; or 

🔹Union clinical research priorities. 

 

The process is structured as follows

🔹Justification to the selection criteria needs to be provided by the HTD in their JSC submission request. 

🔹Each Member State of the JSC Subgroup evaluates the requests according to the selection criteria, using a standardized format. 

🔹Chair and co-chair of the JSC Subgroup prepare a selection of technologies out of the requests, based on this input from Member States. 

🔹JSC Subgroup validates this decision. 

🔹The Coordination Group will inform HTDs on their decision and explain reasons for rejection. 

 

❌What's missing? 

▪️ The format for Member State input on the evaluation is most likely a template. But it is not included in the guideline. 

▪️This guideline does not describe any transparency on the selection process.