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

Rosemary Jose, PhD
Executive Director & Europe Lead, Strategic Market Access, OPEN Health
Rosemary Jose, PhD is Executive Director, Strategic Market Access, and is based out of the Netherlands. Her main areas of focus are payer value communication, payer/HTA landscape assessments, EU HTA and policy, market access insights into clinical trials and observational studies, cross-functional evidence generation plans, and trainings/workshops.
Nick Halfpenny, MSc
Director, Strategic Market Access, OPEN Health
Nick Halfpenny, MSc 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.
Sonja Kroep, PhD
Associate Director, Modeling and Meta-Analysis, OPEN Health
Sonja Kroep, PhD 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. Sonja is co-leading the Indirect Treatment Comparison Service Area within OPEN Health.
Ansgar Hebborn, PhD, MBA
Head – European Access Policy Affairs, Roche
Ansgar Hebborn is Roche Pharma’s Head of Access Policy Affairs Europe and chair of EFPIA’s European HTA Working Group. During the past few years, he has taken an active role as advisor and stakeholder representative in various HTA collaboration networks e.g. EU HTA Network, EUnetHTA and the HTAi Policy Forum Committee, and also has been involved in the foundation of other initiatives in this field e.g. the Green Park Collaborative, the HTAi Asia Policy Forum, and SwissHTA. In an earlier role as health economist and outcomes research specialist for Roche in the US, he has gathered extensive experience with real world data research.
James Ryan, MSc
Director, 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.
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