AIFA new era: What we’ve learned so far – and what’s next?

A year after AIFA’s reform, how have the changes impacted market access and pricing negotiations in Italy? Our experts analyze the new regulatory framework’s initial impact, focusing on the CSE’s role and efficiency, examining shifts in negotiation timelines, and looking at how interactions with manufacturers may have changed.

Over the past year, Italy has introduced significant changes to streamline drug evaluation and accelerate patient access to medicines. On the one hand, AIFA's reorganization, centered around a unified committee, aims to simplify negotiations and enhance overall efficiency. On the other hand, the 2025 Budget Law broadens access to the innovation fund for high-value medicines, with updates to innovation criteria expected in the coming months. Together, these initiatives seek to optimize decision-making, reduce negotiation timelines, and ensure faster access to innovative therapies.

AIFA's reorganization

A…