♜ Fallacy 7 ♜

JCA is the first HTA submission in Europe. Really?

 

⏳ Most national HTA assessment start once a product is approved. But some begin earlier!

 

Think of submissions for compassionate use programs (CUP). These often require an overview over the clinical evidence and further information, and are often initiated prior to EMA submission.

 

Not relevant for JCA❓ Let‘s think about it❗

 

These national CUP-submissions shape the country-level narrative, particularly with regard to relevant evidence, unmet need, and epidemiology. Although they remain confidential, they establish the benchmark against which the JCA dossier and subsequent JCA report will be assessed.

 

💡 Key takeaway:

Early alignment across functions and markets helps to avoid pitfalls.