Navigating Italy’s new regulatory landscape

Under this new organization, regulatory submissions are assessed by the CSE and eventually cleared by the board. The CSE has dual responsibility for both the scientific and economic evaluation of a new drug product. This is a departure from practices in other major European markets, such as France and Germany, which continue to handle clinical and economic assessments separately. The theory behind giving the CSE dual responsibility is to streamline both processes with a single meeting, and thus allow patients to access medicines sooner.

“We are working to reduce the time of access procedures with a reduction of bureaucracy and with administrative simplification, ensuring that citizens may quickly use truly innovative medicines,” AIFA’s President Robert Nisticò said.²

However, many questions remain as to how the reform will impact regulatory review and market access.

During the workshop, members of the CSE, and other presenters shared their thoughts on the reform and its impact on product innovation and access. They also answered questions from members of the audience. 

At the start of the workshop, Fulvio Luccini, Managing Director of Market Access, PharmaLex Italy, presented a report3 based on internal, but publicly available data on time to access under the previous commission. According to the analysis, the median time to access was 464 days. While the theory behind the reforms is that this time could be halved, the reality is that only 27 percent of that time was actually spent in the commissions.³

Based on this finding, we believe that while streamlining the scientific and economic evaluation has the potential to reduce timelines, this will only partially address the issue since the time allocated for administrative activities remains unchanged. As such, there is a need to also look at ways to address other aspects of the procedure including administrative and pre-assessment steps. Bolder decisions could also be considered, such as limiting the type of procedures that require full CSE assessment. 

Furthermore, questions remain as to how the European HTA reforms – including the Joint Clinical Assessment which applies to some products from January 2025 – will impact the AIFA reforms, and whether the CSE structure will align with the EU-wide changes. The potential benefits of a unified clinical assessment at the European level include the potential to reduce duplication of the clinical evaluation and expedite transitions to economic assessments, though what this means in practice remains to be seen. 

Attendees at the workshop posed questions about how the reforms at AIFA combined with the EU’s HTA would impact regulatory and pricing reviews. For example, some doubts were expressed about potentially sacrificing accuracy for speed by choosing to have clinical and economic processes handled by one body. Companies are eager to ensure the right balance between speed and accuracy as they navigate this period of change.

Connect with our experts in Italy to learn more about how the reform is impacting the evaluation process and get answers to your market access challenges.