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European benefit assessment

The EU plans to harmonize the multitude of national benefit assessments and HTAs. Initial approaches have already been implemented in the form of the »Early Dialogues for Pharmaceutical Products« and »Early Dialogues for Medical Devices«, which can be applied for at the »European Network for Health Technology Assessment« (EUnetHTA). The »Early Dialogues« are legally non-binding consultations for pharmaceutical companies and medical device manufacturers with the aim of improving the data basis of benefit assessments and HTAs in the EU member states. They are carried out either as »Parallel Consultations« or as »Multi-HTA Early Dialogues«.

In addition, a »Rapid Relative Effectiveness Assessment« (REA) or »Joint Assessment« can already be carried out on a voluntary basis, which is applied for with a »Letter of Intent«. These assessments are based on a dossier prepared by the company in which the domains health problem, current use of the technology, clinical effectiveness and safety have to be addressed.

The experiences gained by companies that are already involved in the »Early Dialogues« and are subject to a REA or »Joint Assessment« will give them an important advantage over their competitors if the European benefit assessment becomes mandatory.

How you can benefit from our services:

  • Comprehensive advice on European benefit assessment
  • Support with »Early Dialogues«, »Rapid Relative Effectiveness Assessments« and »Joint Assessments«
  • Writing the required documents: »Letters of Intent«, »Briefing Book«, etc.
  • Preparation of the dossier for REA/»Joint Assessment«
  • Support for and attendance of face-to-face meetings