The pharmaceutical value and access landscape is undergoing once-in-a-lifetime changes, with fundamental innovations happening in both the United States and Europe. With the already implemented Inflation Reduction Act (IRA) in the United States and the incoming Health Technology Assessment (HTA) Regulation in the European Union, manufacturers will encounter new requirements at different stages in the product lifecycle that will affect their strategy.
It is critical that manufacturers are well equipped to deal with the potential obstacles and challenges they will face as they bring new products to the world’s two largest pharmaceutical markets.
In this webinar Lumanity’s Ron Akehurst, Executive Chairman, HEOR, Jonathan Kowalski, Executive Vice President and Head of HEOR US, and Suzette Matthijsse, Senior Director and EU Head of Modelling & Analytics share insights based on first-hand experience of the IRA and intimate knowledge of the EU HTA Regulation through our multi-year involvement in the consultation process and the delivery of a variety of trainings.
We explore the following:
- Experience-based key learnings from the IRA and implications for manufacturers
- Getting ready for Joint Clinical Assessments (JCA) in the EU – insights from our involvement in the consultations
- Comparing and contrasting the IRA and JCA – strategic considerations and best practice sharing
