In this webinar, ICON experts discuss strategies for managing EU Joint Clinical Assessment (JCA) requirements and their impact on local health assessments.
The EU Joint Clinical Assessment (JCA) aims to streamline and improve the process of assessing the clinical benefits of health technologies across European Union (EU) member states. By fostering collaboration, the JCA ensures a more harmonized and efficient approach to Health Technology Assessment (HTA), helping to avoid duplication and increase the speed at which treatments are evaluated and made available to patients.
The PICO simulation (Population, Intervention, Comparator, Outcome) is a key component of this process, providing a structured framework for clinical evidence synthesis and decision-making allowing for more accurate and consistent evaluations of new treatments and medical technologies. The simulated PICOs will serve as an outline of the evidence generation plan and will serve as the outline for the JCA dossier. Including PICO strategy into the clinical trials set up, employing smart strategies like adaptive clinical trial designs and robust real-world evidence can be an effective instrument in addressing different member states' needs and overcoming regional barriers.
When compiling an effective JCA dossier, it is essential to focus on presenting clear, comprehensive, and high-quality evidence, considering the specific HTA requirements in each member state. Due to the large amount of data generated by PICOS, efficient and smart tools are needed to compile the information into the dossier in a time efficient manner. The JCA dossier will need to account for all populations, comparators and outcomes identified following the member state PICO surveys. This means that the dossier will need to include complete, up-to-date information including data, analyses (primary and ad hoc), SLR, ITC, and other relevant evidence aligning with PICOs.
The EU Joint Clinical Assessment (JCA) under the European Health Technology Assessment (HTA) Regulation aims to harmonize clinical assessments across EU member states. However, each country's HTA agencies and healthcare systems will react differently based on their national policies, reimbursement frameworks, and pricing strategies. Countries such as Germany, Italy, Spain, France, Norway, Finland, UK and Switzerland will still have different focus depending on their country's perspective and the question is what impact JCA process will have on the local reimbursement context.
Key Topics Include:
In this webinar our experts will provide you with strategies, guidance and advice on managing JCA requirements in a constructive and efficient way including:
- Evidence generation and planning
- PICO mock-up and impact of PICOs in clinical trials
- JCA dossier information
- Impact of JCA on local HTA and reimbursement
Presenters
Mia Malmenas
Mia Malmenäs is a Senior Principal at ICON and brings 25 years’ experience from the pharmaceutical and CRO sector. She has extensive experienced in evidence generation methodology and planning. Mia has been co-leading the adherence and persistence ISIG at ISPOR for 6 years for which she was awarded ISPOR Distinguished Service Award. Mia has a BSc and MSc in Biostatistics and an EMBA from the Stockholm University.
Xin Zhao
Xin Zhao is a Principal at ICON and she has 15 years of broad experience in academic, consulting and consulting, and pharmaceutical industry. She has extensive market access experiences in early and late-stage asset development strategy including a strong track record of delivering high-quality solutions and insights across various therapeutic areas. Xin holds a Doctor of Pharmacy/Medicine from Cardiff University; an MSc in Applied biomolecular technology from the University of Nottingham; and an Associate’s degree in Business Management from Imperial College.
Liz O'Brien
Liz O’Brien is veteran of life science industry with 25+ years of experience, former regulator at EMA Efficacy Working Party and expert in clinical development.
Andrew Miniuks
Andrew Miniuks is a Divisional Principal at ICON and has 25+ years’ experience in working in market access, pricing, and reimbursement for the UK and the EU markets. Recent work includes leading teams of industry trade association member on national initiatives sponsored by the UK department by the UK Department of Health and Social Care to improve the launch, update, and reimbursement of CARTs in the UK. Andrew holds a BA in Chemistry and a BS in Geology from the University of Massachusetts; an MA in Geochemistry from Boston University; and an MBA from the London Business School.
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