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
Presenters
Rosemary Jose
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.
Rosemary has >16 years of experience across the pharmaceutical industry, including >14 years in market access and health economics, both in global and consulting roles – leading strategic projects, managing international clients and mentoring multi-cultural teams. She has also provided on-site support to pharmaceutical clients in Europe, driving the market access strategy through cross-functional collaboration, to facilitate launch and reimbursement. Her experience covers multiple therapeutic areas including oncology, neurosciences, ophthalmology, infections and immunology, gastroenterology and cardiovascular medicine. Rosemary holds a PhD in Pharmacogenetics, and certifications in HTA and Market Access.
James Ryan
James Ryan is a health economist with over 25 years’ experience across different disease areas, as well as diagnostic technologies, medicines, and devices. He is Director, Global Health Technology Assessment for AstraZeneca representing the company on a regional and international level. He is leading the company’s external engagement and internal work on the upcoming EU HTA, working closely with colleagues across rare diseases, oncology, respiratory and cardiovascular. He is also been supporting EFPIA with their industry response to the EU HTA Regulation, as well as representing AstraZeneca at the HTAi Global Policy Forum.
James has a passion for evidence development across the life cycle and the use of HTA science to demonstrate the comparative benefit and economic value of new health technologies. James has an MSc in Health Economics from the University of York, UK, and has worked in academia, consultancy, and industry over his career.
Ansgar Hebborn
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. 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.
Sonja Kroep
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. Sonja holds an M.Sc. degree in Econometrics and Management Science, and a PhD in Public Health (Erasmus University Rotterdam, the Netherlands). She is currently leading the ITC service area within OPEN Health.
Nick Halfpenny
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.
Sponsor
