In just under a year, the times for submitting and approving pharmaceutical dossiers have been significantly shortened. “The reduction in times is a first sign that the AIFA reform is working,” says President Robert Nisticò, “and this means speeding up citizens’ access to innovative medicines. This important result,” he adds, “must be credited to the work carried out by the entire Scientific and Economic Committee of the Agency.”

According to the monitoring published on the AIFA portal, there has been a significant reduction in the length of the procedures for admission to reimbursement by the NHS submitted to the evaluation of the Scientific and Economic Committee (CSE) of the Agency. The time from the opening of the case to the examination in the CSE has almost halved, going from approximately 262 days in the first three sessions of the Committee (April-May 2024) to 136 in the last three sessions (November 2024-January 2025). A decrease of 48% is recorded, which reaches -60% considering the last session of the CSE. The monitoring has analysed a variable range of 140-190 procedures in each session of the Commission since it was established, relating to different types of negotiations: new chemical and biological entities, orphan drugs, extensions of therapeutic indications, generics, new packaging, price renegotiations.

“The data” comments the technical scientific director of AIFA, Pierluigi Russo “highlight a constantly improving trend, which gives hope for a further reduction in procedure times and faster access for citizens to medicines reimbursed by the National Health Service”.

This trend is also confirmed when considering the procedures with a long duration and which, also due to the suspension period during the first months of 2024, were inherited from the previous organisation of the Agency, based on two separate commissions that in the past dealt on the one hand with prices and reimbursements and on the other with the placing on the market of new medicines.