Event Outline
This multi-stakeholder workshop will explore the dynamic Health Technology Assessment (HTA) environment in Europe and its critical impact on cancer care. The event will bring together experts from regulatory agencies, HTA bodies, pharmaceutical industry, academia, healthcare providers, and patient advocacy groups to examine how scientific innovation, healthcare sustainability, patient access, transparency, equity, and societal expectations are reshaping HTA decision-making.
Participants will delve into the practical implications of Regulation (EU) 2021/2282 and Joint Clinical Assessments, while analyzing the methodological foundations that underpin HTA processes. The workshop will provide actionable insights on integrating HTA considerations earlier in drug development and assess how HTA systems can adapt to future innovations in precision medicine, advanced therapies, AI, and digital health.
The 1.5-day meeting consists of 4 plenary sessions, interactive panel discussions, and dedicated time for multi-stakeholder dialogue and networking. Each session is designed to foster cross-disciplinary understanding and practical application of HTA principles in oncology.
Learning Objectives
By the end of the meeting, participants will be able to:
- Describe the evolving Health Technology Assessment (HTA) landscape in Europe and explain how scientific innovation, healthcare system sustainability, patient access, transparency, equity, and societal expectations are shaping HTA decision-making in cancer care.
- Explain the practical implications of Regulation (EU) 2021/2282 and Joint Clinical Assessments for oncology medicines, including emerging implementation challenges, opportunities to reduce duplication, and the need for methodological consistency and alignment with national decision-making processes.
- Analyse the methodological foundations of HTA, including assessment scope, comparator selection, outcomes, patient subgroups, evidence maturity, indirect comparisons, uncertainty, added value, and the appropriate use of real-world evidence.
- Apply HTA considerations earlier in cancer drug development by identifying how trial design, endpoint selection, evidence generation strategies, regulatory interactions, and access planning can better address the needs of clinicians, patients, HTA bodies, payers, and national decision-makers.
- Assess how HTA systems can adapt to future innovation in oncology, including precision medicine, advanced therapy medicinal products, artificial intelligence, digital health tools, real-world data infrastructures, and adaptive evidence-generation models, while supporting timely, equitable, and sustainable patient access.
Target audience
The target is a multidisciplinary audience of academia representatives, EU and US regulatory bodies (EMA, FDA, National Agencies), the pharmaceutical industry, HTAs, and patient advocates.
Language
The main language of the workshop is English.