EUnetHTA Multi-HTA Early Dialogues for Pharmaceuticals
As of January 2017, EUnetHTA offers 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 (link to the corresponding page)
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.
Currently, the EDWP is made up of five HTA bodies with a full seat: HAS (France), G-BA (Germany), NICE (UK), AIFA (Italy), NIPN (Hungary) and two HTA bodies, RIZIV-INAMI (Belgium) and ZIN (Netherlands) sharing a seat. In addition, for Italy, a model of having an alternate is being tested, with a regional HTA body (RER) substituting AIFA depending on availability.
Additional HTA bodies may participate in Early Dialogues as needed (on the basis of their availability and area of expertise). The HTA bodies participating in a given ED will constitute the EUnetHTA ED Committee (EDC) for this ED.
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.
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 EUnetHTA ED Secretariat EUnetHTA-HAS@has-sante.fr . Questions about EUnetHTA EDs should be directed to the same address.