The regulation on European Health Technology Assessment (EU HTA) entered into force on 11 January 2022 and will apply from 12 January 2025. It introduces joint clinical assessments and joint scientific consultations at the European level for new health technologies, including pharmaceuticals and medical devices. While market access, pricing and reimbursement will continue to be the responsibility of EU member states, EU HTA will nevertheless have an immense impact on these national market access activities. This book serves as a practical guide designed to help developers of pharmaceuticals prepare for the upcoming EU HTA process.

Thomas Ecker, CEO of Ecker + Ecker and Accessus Health, possesses over two decades of expertise in HTA and the pricing and reimbursement of pharmaceuticals. With his wealth of experience, including over 100 successful dossier submissions and price negotiations in Germany, he has extended his focus to include EU HTA strategy development and the preparation of EU HTA dossiers.