Innovative pharmaceutical products are constantly seeking access to developed and emerging markets across the globe, but gaps in clinical evidence and limited real-world data often leave uncertainty around their true value and impact on health and societal benefits.

In a recent article published on Pharmaceutical Executive, Anais Frappe and Mattia Belloni explore the role of non-OS endpoints, and advocate for a more systematic and balanced recognition of these endpoints, alongside OS, in HTAs. 

Despite changes to the IPT process in 2020, Spain continues to have a long and uncertain reimbursement process, where the average time to reimbursement is ~17 months. This article reviews the recent lawsuit against the Spanish MoH, and likely reforms for Spanish HTA processes in 2024.

EU HTA marks the beginning of efforts to streamline and harmonize the Health Technology Assessment (HTA) processes and outcomes across European Union (EU) member states. Despite its imminent rollout (from January 2025*), key uncertainties remain around its implementation and likely success.