EUnetHTA Multi-HTA Early Dialogues for Pharmaceuticals
Since January 2017, EUnetHTA has offered multi-HTA Early Dialogues (ED) on evidence generation plans for new pharmaceuticals. These EDs aim to allow medicines developers to obtain simultaneous feedback on their development plans from multiple HTA bodies. The objective is to help generate optimal and strong evidence that satisfies the needs of HTA bodies.
For medicines developers who prefer to engage in a Parallel Consultation providing dialogue with both regulators (the EMA) and HTA bodies, please refer to EUnetHTA/EMA Parallel Consultation.
The Multi-HTA ED procedure involves EUnetHTA’s Early Dialogue Working Party (EDWP). This robust and stable group of HTA bodies is constituted by HTA partners with a substantial experience in ED, high level of commitment and participation in JA3 EDs, and sufficient resources in terms of staff and level of expertise.
Due to limited resources, it is expected that not all the requests for Multi-HTA EDs will be accepted by the EDWP. Selection/prioritization criteria have therefore been adopted.
Patients/Patient representatives and healthcare professionals also participate in the parallel consultation procedure on a routine basis so that their views and experiences are incorporated into discussions.
Some HTA bodies may charge fees for their participation in Multi-HTA ED procedures. The EUnetHTA ED Secretariat can provide information on HTA-associated fees.
Companies willing to apply for a Multi-HTA Early Dialogue complete a Letter of Intent, using the template provided below, and send it to the EUnetHTA ED Secretariat. Questions about EUnetHTA EDs should be directed to the same address.