Billy Amzal, Head of Strategic Consulting at Phastar, examines the evolving EU Health Technology Assessment Regulation (EU-HTAR) landscape and the critical role predictive analytics will play in helping health technology developers navigate its requirements. In this latest article for International Pharmaceutical Industry, he explores how Joint Clinical Assessments (JCAs) are reshaping evidence generation, creating new demands for integrated planning, rapid dossier development, and alignment with both EU-wide and national HTA expectations.
The article highlights the implementation challenges facing both developers and member states, from compressed timelines and limited Joint Scientific Consultation capacity to resource constraints across HTA bodies. Billy outlines how advanced analytics, including predictive modelling, indirect treatment comparisons, Bayesian methods, real-world data integration, and AI-enabled evidence generation, can help organizations demonstrate value, address complex PICO requirements, and prepare for the wider EU-HTAR rollout. As the framework expands to orphan medicines and additional therapies, these capabilities will be essential for achieving timely, robust, and harmonized assessments.