Overview
The EU JCA aims to harmonize and streamline the evaluation of health technologies across EU member states, enhancing the efficiency and speed of Health Technology Assessment (HTA). Central to this process is the PICO simulation (Population, Intervention, Comparator, Outcome), which provides a structured framework for clinical evidence synthesis and decision-making. This approach ensures accurate and consistent evaluations, addressing the diverse needs of member states and overcoming regional barriers.
An effective JCA dossier must present clear, comprehensive, and high-quality evidence, tailored to the specific HTA requirements of each member state. Given the extensive data generated by PICOs, efficient tools are essential for compiling this information. The dossier should include up-to-date data, analyses, systematic literature reviews (SLR), indirect treatment comparisons (ITC), and other relevant evidence.
While the goal of the JCA process is harmonization across member states, 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, Poland, Ireland, Finland, UK and Switzerland, will still have different focus depending on their country’s perspective. The question is: what impact will the JCA process have on the local reimbursement context?
Key topics
Our speakers will provide strategies, guidance and advice on managing JCA requirements in a constructive and efficient way to include:
- 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
Speakers
Mia Malmenäs
Mia Malmenäs is a Senior Principal at ICON and brings 25 years’ experience from the pharmaceutical and CRO sector. She has extensive experience 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.
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.
Xin Zhao
Xin Zao is a Principal at ICON, and she has 15 years of broad experience in academic, consulting, and the 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.
Liz O’Brien
Liz O’Brien is therapeutic expert at ICON Drug Development Solutions for Oncology and Women's Health. She is veteran of the Life Sciences industry with 25+ years of experience in executive medical affairs, clinical development, commercialisation and market access. Liz Is former member of CHMPs Efficacy Working Party and former clinical assessor at national competent authority, Ireland. Most recently Liz served as CMO in a global pharma company leading a breast cancer development program and large portfolio of commercialized products with LCM and global expansion activities.