OBJECTIVES: On 15/01/2024, the Italian Decree of the Minister of Health of 8 January 2024 on “Changes to the the regulation on the organization and functioning of Italian Medicines Agency (AIFA)” came into force. The new Regulation replaced the former Technical Scientific Commission (CTS) and Pricing and Reimbursement Committee (CPR) with a new “Scientific and Economic Committee for Medicines” (CSE). The purpose of this work is to analyze the activity of the new CSE, so far.

METHODS: Outcomes of CSE meetings (HTA evaluations for medicinal products, MPs) was extracted from the AIFA website, from the first session (22-24/04/24) to the last available at the time of abstract submission (14-17/05/24). For each MPs’ procedure, type of negotiation and outcome have been tracked.

RESULTS:

To date, in 3 CSE session 292 procedures were planned (127; 43% evaluated and 165; 57% postponed). Among the TN-1 planned procedures (42,8%; New drugs, orphan drugs, and/or new indications), 53% (n=66/125) were evaluated, prioritizing “Extension of indication” (32/52; 61,5%) and “Orphan drugs” (12/21; 57,1%), while only 40% (20/50) of the “New active substance” procedures have been treated. 68% (19/28) of the TN-2 planned procedures (9,6%; Medicines and/or indications already marketed) were evaluated, prioritizing “New packaging” (15/17; 88,2%). Among the TN-4 planned procedures (43,2%; “Revisions to the conditions of eligibility for reimbursement”) only 28% (n=35/126) were evaluated. Quicker procedure (generic drugs, new packing) have almost all been treated.

CONCLUSIONS: One of the key goals of the new AIFA framework is to simplify and accelerate the drug approval processes. Our data clearly show that since its inception, the new CSE has been working in this direction, prioritizing new drugs and more strategic procedures. In the next few months, having more mature data, we will also be able to observe the impact in terms of time to patients.