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 Include:
- 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
Resources
Presenters
Moderator
Executive Director & Europe Lead, Strategic Market Access
OPEN Health
Rosemary Jose is Executive Director, Strategic Market Access at OPEN Health. With an experience of over 17 years across the pharma industry in both global and consulting roles, her main areas of focus are payer value communication, EU HTA joint clinical assessments, market access strategy, cross-functional evidence generation plans and regional trainings/workshops.
Associate Director
Modeling and Meta-analysis
OPEN Health
Sonja Kroep is an Associate Director in the Modeling & Meta-Analysis Center of Excellence at OPEN Health. Her expertise lies in quantitative evidence synthesis and endpoint surrogacy analysis. Additionally, she is specialized in data analysis, with a particular emphasis on statistical models and survival analysis.
Director
Strategic Market Access
OPEN Health
Nick Halfpenny is a Director working in the Strategic Market Access Center of Excellence based in OPEN Health’s Rotterdam office. Nick has 10 years of HEOR and Market Access consultancy experience and is the lead for the systematic and targeted literature review service area for Europe within OPEN Health.
Head
European Access Policy Affairs
Roche
Ansgar Hebborn is Roche Pharma's Head of Access Policy Affairs Europe. He represents Roche in relevant industry associations e.g. in Brussels as the chair of EFPIA’s European HTA Working Group.
Director of Global HTA Policy
Oncology Market Access and Pricing
AstraZeneca
James Ryan, a health economist with over 25 years’ experience across different disease areas, diagnostic technologies, medicines and devices, is the Director for Global HTA Policy at AstraZeneca, leading the company’s external engagement and internal work on the upcoming EU HTA, and supporting EFPIA in their industry response to the Regulation.
Production Partner
OPEN Health
Uniquely equipped to deliver patient-centered, world-class solutions. The ethos of many experts coming together in order to create solutions with impact is what makes OPEN Health different from the rest. OPEN Health continues to flourish as a fluid team of over 875 skilled individuals in 16 offices across 6 countries.
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