The main objective of Work Package 5 is to help generate, all along the technology lifecycle, optimal and robust evidence for health technologies (pharmaceuticals or others), bringing benefits for patient access and public health.
This Work Package consists of two strands:
- Strand A: Early dialogues (initial evidence generation)
- Strand B: Post-Launch Evidence Generation and Registries.
Work Package 5A
AEMPS, AETS-ISCIII, AETSA, Agenas, AIFA, AOTMiT, AQuAS, AVALIA-T, GBA, HAS, Hdir, HVB, INFARMED, IQWIG, JAZMP, KCE, MoH Cyprus, MPA, NCPHA, NICE, NIPN, NOMA, NSPHMPDB, Osteba, RER, RIZIV-INAMI, SNHTA, TLV, Veneto/CRUF, ZIN
Composition of the Early Dialogues Working Party (EDWP): France (HAS), Germany (GBA), United Kingdom (NICE), Italy (Italian Medicines Agency: AIFA with alternate Regione Emilia-Romagna: RER), Hungary (National Institute of Pharmacy and Nutrition: NIPN), and a shared seat for The Netherlands/ Belgium (Zorginstituut Nederland: ZIN/ Rijksinstituut voor Ziekte- en Invaliditeitsverzekering/ Institut national d’assurance maladie-invalidité: RIZIV-INAMI)
Work Package 5B
Deliverables from Strand A – Early Dialogues (ED):
- Develop and establish an organizational structure for EDs
- Evaluate how the collection of fees from industry and the redistribution among partners could best be implemented.
- Deliver 33-35 Early Dialogues
Develop and implement a financially sustainable system for delivering EDs.
Deliverables for Strand B – Post-Launch Evidence Generation (PLEG) and Registries:
- Conduct eight PLEG pilots on technologies (drugs, devices, procedures) or diseases of common interest. Such pilots consist of:
- defining a common research question for additional (post-launch) evidence generation;
- defining a minimum data set for registries or a core common protocol;
- whenever possible, sharing the produced additional data.
- Produce a practical tool to assess the quality of registry data to be used in HTA (“Quality standards for Registries tool”), mainly building upon the work of the PARENT Joint action.
- Produce a document summarizing key learning from JA3 and providing recommendations for a permanent HTA cooperation on PLEG.