Fallacy 2: Global Value Dossier can be used as basis for JCA – really?

♜ Fallacy 2: Global Value Dossier can be used as basis for JCA – really?♜

⚖️ Some people do argue that the Global Value Dossier (GVD) can be used as basis for JCA.

The thinking goes: The GVD is a great information repository. It contains everything with relevance for reimbursement for this product.

🤔But have you ever seen a PICO scoping in a GVP?

🔹 Before answering that question, you should take a look at the information requirements for JCA per PICO. Check yourself: https://health.ec.europa.eu/publications/guidance-filling-joint-clinical-assessment-jca-dossier-template-medical-devices-and-vitro-diagnostic_en

🔹 And be aware of timelines! Preparation for JCA should start latest 12 month prior planned EMA submission.

The list goes on …

🔄 Maybe the other direction will work: Once the JCA is completed, it will be an information repository on comparative evidence with unmatched detail. And an official publication by the European Commission.