The Italian Medicines Agency's latest expenditure report reveals a significant overspend on medicines for the first third of the year, driven primarily by costs for new cancer drugs and cardiovascular therapies.
The Italian Medicines Agency (AIFA) has published its routine monitoring report, AIFA Monitoring of Pharmaceutical Expenditure January-April 2025, on 22 September 2025. The data reveals that national pharmaceutical expenditure reached €7.9 billion in the first four months of 2025, representing a 3.2% overspend against the allocated national budget for the period. This equates to a budget deficit of approximately €245 million.
The report, issued by AIFA as part of its financial governance function, provides a detailed breakdown of spending drivers. Expenditure on innovative oncology drugs was a primary factor, accounting for €1.2 billion of the total. Spending on new-generation anticoagulants and therapies for heart failure also exceeded forecasts, contributing significantly to the overspend. In contrast, spending on biosimilars and generics remained within budget, reflecting successful uptake policies.
This regular analysis allows national and regional health authorities to identify areas of financial pressure. The findings will now be scrutinised by government bodies to inform budget planning for the remainder of the year and for 2026. The consistent overspend in specific high-cost therapeutic areas is likely to trigger renewed discussions on cost-containment measures and may lead to tougher price negotiations for products in these classes.
Original Title: Monitoraggio AIFA spesa farmaceutica gennaio-aprile 2025
English: AIFA Monitoring of Pharmaceutical Expenditure January-April 2025
Date: 22 September 2025
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