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Haute Autorité de Santé (HAS) strengthens its European and international commitment in its two core areas of activity: health technology assessment (HTA) and improvement in the quality of care and patient safety.

 

HAS's European and international commitment results in:

  • HAS's participation in multi-year international projects
  • HAS's participation in networks and partnerships
  • The reception of foreign delegations who want to learn about and share in HAS's areas of activity: HTA or quality of and patient safety.

 

EUROPEAN EARLY DIALOGUES, HAS INITIATIVE IN THE FIELD OF HTA: TOWARDS A SUSTAINABLE MODEL

Background

As part of its reflection on the methods and data needed for health technology assessment for reimbursement purposes, HAS has taken the initiative to organise the first ever European early dialogues (EDs).

Objectives and characteristics of the EDs

These early meetings between companies developing healthcare products and a group of national and regional HTA agencies aim to improve the quality of data produced during the development of the health technologies involved (medicines, medical devices, in vitro diagnostics). The early dialogues enable healthcare manufacturers to present a detailed plan for development of their product to HTA institutions and ask them specific questions about this plan. The goal is to reduce the risk of the data produced being poorly suited to assessment for reimbursement purposes (e.g., if the comparator chosen is not suitable, or if the endpoint chosen is not the most relevant).

 

The original aspect of these early dialogues is that they allow exchanges between participating HTA agencies in order to compare viewpoints on national requirements and to change them when consensus is possible.

 
HAS’s activities in the field of EDs

In recent years, HAS has been particularly active in the field of early dialogues, as part of EUnetHTA Joint Action 2 and the SEED (Shaping European Early Dialogues for health technologies) project.

 

The continuation of early dialogues activity was confirmed by the permanent network of European HTA agencies or the HTA network (HTAN) which was established in October 2013 and whose 2016-2019 work program is being developed.

 

HAS has also participated in pilot experiences of HTA agency participation in the scientific opinions of the European Medicines Agency (EMA). This involves opening an EMA scientific opinion meeting to some HTA agencies, chosen by the manufacturer. The latter adds questions for HTA agencies to the questions for the EMA. Each HTA agency gives its opinion. All of the opinions given (EMA, national HTA agencies) are then considered by the manufacturer in its development work.

 

HTA Network

The HTA network, created in 2013, is the governing body of collaborations in the field of HTA (Art. 15 of Directive 2011/24 on the application of patients’ rights in cross-border healthcare).

 

Posted on Oct 27 2015