Publicly funded healthcare systems in European countries base their decisions on access to medicines on evidences and Health Technology Assessment (HTA) is used to prepare and present this evidence. But HTA means different things in different countries, and HTA processes, methodologies and impact on decisions differ. We will outline market access processes for medicines in BE, FR, DE, IT, NL, PL, SE, England/Wales and also the US, to identify where HTA fits in these systems and what type of HTA is used. We will describe in detail the types of HTA used in FR, DE, England/Wales, PL, and the type of evidence requested from manufacturers across the medicine's life-cycle. We will describe the differences between regulatory requirements and HTA clinical evidence requirements, and economic evaluation requirements. In practical exercises, participants will get a better understanding of the underlying assumptions behind HTA requirements. Based on this review and on participants' knowledge of development, regulatory and market access processes, we will discuss how regulatory assessment and HTA could be streamlined, and which assessment elements could be shared between countries. We will compare these findings with current policy discussions in Europe.
Who Should Attend
- Medical affairs, regulatory and all other industry experts who want to understand why their market access colleagues ask them for additional evidence for 'HTA'; and market access experts who want to hear their colleagues' point of view.
- Representatives from regulatory and HTA authorities who are asked to align their pre- and post-approval evidence requirements.
At the conclusion of this tutorial, attendees will be able to:
- Identify the differences and similarities in objectives, procedures and methodologies of existing HTA systems
- Manage internal company processes to optimally contribute to HTA submissions early in the process
- Influence internal and external policy discussions on regulatory-HTA interactions and on European collaboration on HTA with their specific knowledge and experience