With over a decade of experience delivering HTA submissions, value materials and evidence generation activities fully in-house, our talented team are ready to support our clients with their EU JCA activities.
A year on since the launch of the EU Joint Clinical Assessment, the importance of preparedness when it comes to PICO framework prediction is clearer than ever. But how can you best prepare?
Join us for the first webinar in our new series, where we’ll share practical insights and key takeaways from completed PICO framework simulation projects. Designed for those navigating the EU JCA landscape, this session will explore whether, when and how to conduct a PICO simulation.
The Health Technology Assessment (HTA) community in Europe are continuing to adjust to the introduction of the Joint Clinical Assessment (JCA) for oncology products and advanced medicinal products, and preparing for its further expansion to high-risk medical devices and in vitro diagnostic medical devices (IVDs) in 2026, orphan products in 2028 and all new medicinal products, including vaccines, in 2030.
We have a track record of forming long-term partnerships with our clients, from early-stage strategic planning through to end-stage reimbursement submission support. Our experience in European market access includes Scientific Advice, national and pan-national reimbursement dossiers, including BeNeLuxAIr and EUnetHTA, and global- and European-focussed value dossiers. Drawing on our experience, and in collaboration with our Evidence Development teams, we are proud of our experience supporting our clients to prepare for JCA, including supporting one of the first products selected for EU Joint Scientific Consultation.
Our dedicated EU JCA Taskforce have been rolling out trainings across the company to up-skill teams and ensure we are on top of the latest communications regarding the implementation of the JCA
Our teams across Value and Access and Evidence Development continue to reflect on the key challenges and opportunities the JCA brings. Our recent articles can be found below
We appreciate that, despite it having begun, a lot remains unknown around how EU JCA will work in practice, and how it will develop and change as it continues its roll out. We aim to understand our clients’ questions and concerns around EU JCA, and use these as focus areas for our research
Our EU JCA services span the full range of products eligible to go through EU JCA both now and in the future, including oncology products, ATMPs, orphan products, vaccines and MedTech. If you would like to find out more about our services, please get in touch.
Explore our latest abstracts, blog articles and post-conference reports showcasing our recent thoughts on various aspects of the JCA process, offering practical insights on its implementation and potential implications.
We proposed a structured roadmap for manufacturers to proactively conduct preliminary ITC assessment in conjunction with pivotal trial planning, ensuring comparative effectiveness data is fit-for-purpose for JCA across PICOs. If you wish to discuss this further or learn how our teams can support your JCA evidence-generation planning, please get in touch.
ABSTRACT | ISPOR EUROPE 2025
ABSTRACT | ISPOR EUROPE 2025
ARTICLE | ISPOR EUROPE 2024
REPORT | ISPOR EUROPE 2023
