The Pharma Value team participated in ISPOR Europe 2024held in Barcelona from 17 to 20 November. Under the theme "Generating Evidence Toward Health and Well-Being," the conference explored how scientific evidence drives global health improvements, focusing on Health Economics and Outcomes Research (HEOR).
ISPOR Europe 2024
Key topics included:
- Joint Clinical Assessments
- Real-World Data
- Digital Health Transformation
- Regulatory and Policy Developments
The team contributed two posters that explore some of the most interesting themes of Health Technology Assessment and Market Access:
HTA Regulation: procedure and impact on regulatory processes in Spain, France, Germany and Italy
This study explores the challenges and potential of the HTA regulation and JCA in the BIG4 countries.
Italy needs a revision of its drug evaluation procedures and national regulations, particularly for pricing and reimbursement processes. In Spain, the fragmentation of the regional healthcare system presents a risk of increased workloads, as the standards of care across the 17 autonomous regions must be considered. Germany and France, with methodologies similar to the JCA, must decide whether to fully integrate the JCA into their internal assessments to avoid duplication or participate in the JCA while maintaining separate national assessments.
FDA vs EMA a comparison of new chemical entity approvals: the role of start-ups
This analysis aims to identify the variables influencing approvals of new chemical entities, with particular attention to company size and the role of start-ups.
Between 2020 and 2023, the FDA approved 196 new chemical entities, while the EMA approved 189. In the U.S., 161 approved molecules are owned by large companies, with around 50% being American. Additionally, among the 35 start-ups that received approval, 85% are American-owned. In the EU, U.S. companies have received 79 approvals. Of the 21 start-ups that obtained approval, 50% are American-owned.
The analysis showed that large companies dominate approvals in both markets. U.S. start-ups face challenges accessing the European market, likely due to their smaller structure and the complexity of the European market, fragmented across different member states, especially from a regulatory perspective.
Last year we also participated in Ispor Europe 2023 and exhibited two posters:
– Evolution of the utilisation of the AIFA 5% Fund for orphan drugs and rare diseases
– Regional Access Timelines in Italy: Factors Affecting Speed and Equity.
