This panel discusses several policy aspects regarding the current challenges and implications of the EU Health Technology Assessment (HTA) regulation, covering topics such as the current position of the EU HTA implementation, the major challenges expected from the industry's viewpoint, the stance of member states and various stakeholders, and strategies for the industry to prepare for joint clinical assessments.
On the topic of systematic literature reviews (SLRs) & indirect treatment comparisons (ITCs), the panel presents and discusses the following technical aspects more in detail:
- How will the joint clinical assessment (JCA) process impact the approach needed for SLRs and ITCs, in terms of multiple PICOs for example?
- How will OPEN Health leverage its expertise to meet the timelines of JCA submissions in an efficient manner?
Key Topics:
- To introduce the latest developments and stakeholder positions on the EU HTA regulation
- To discuss the implications of EU HTA regulation for the industry on the JCA dossier preparation process
- To provide insights into possible efficiencies and optimal evidence generation strategies with a focus on scope, timelines, and cost implications
- To ideate on a governance structure at regional and local levels and decision criteria for implementation
Presenters:
- Rosemary Jose, PhD Executive Director & Europe Lead, Strategic Market Access, OPEN Health
- Nick Halfpenny, MSc Director, Strategic Market Access, OPEN Health
- Sonja Kroep, PhD Associate Director, Modeling and Meta-Analysis, OPEN Health
- Ansgar Hebborn, PhD, MBA Head – European Access Policy Affairs, Roche
- James Ryan, MSc Director, Global HTA Policy, Oncology Market Access and Pricing, AstraZeneca
