JA3 Work Package 5 – Lifecycle Approach to improve Evidence Generation

Objectives

The main objective of Work Package 5 is to help generate, all along the technology life cycle, 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.

Partners

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

AETSA, Agenas, AIFA, AQuAS, AVALIA-T, CIPH/HZJZ, DGFDM IT, EKAPTY SA, FIMEA, HAS, Hdir, INFARMED, IPH, JAZMP, MPA, NICE, NIJZ, NOMA, Osteba, RER, SNHTA, UCSC GEMELLI, UniBA FOF, UTA, Veneto/CRUF, ZIN

Deliverables

Deliverables from Strand A – Early Dialogues (ED):

• Develop and establish an organisational 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 8 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 summarising key learnings from JA3 and providing recommendations for a permanent HTA cooperation on PLEG.

Partners

Lead Partner

HAS

French National Authority for Health (Haute Autorité de Santé)

5, avenue du Stade de France

F-93218 Saint-Denis La Plaine Cedex

France

Email: eunethta-has@has-sante.fr

Co-Lead Partner

GBA

Associated Partners

AEMPS, AETS-ISCIII, AETSA, Agenas, AIFA, AOTMiT, AQuAS, AVALIA FNS, AVALIA-T, CIPH, DGFDM IT, EKAPTY SA, FIMEA, Hdir, HVB, INFARMED, IPH, IQWIG, JAZMP, KCE, MoH Cyprus, MPA, NCPHA, NICE, NIJZ, NIPN, NOMA, NSPHMPDB, Osteba, RER, RIZIV-INAMI, THL, TLV, UCSC GEMELLI, UniBA FOF, UTA, Veneto/CRUF, ZIN