National pharmaceutical expenditure is set to close 2025 exceeding the record threshold of 25 billion euros, with an estimated annual growth rate between 6% and 7%.
The latest data from the Italian Medicines Agency (Aifa) highlight an overall overspending of expenditure ceilings by more than 3.7 billion euros in the first ten months of the year, a situation that severely tests the stability of the National Health Service (NHS).
While the territorial pharmacy sector remains within limits, the financial gap generated by direct hospital purchases has triggered a very harsh institutional clash between the Ministry of Health and the Agency’s leadership.
THE CONVENTIONAL MODEL AND THE EFFECT OF NEW RECLASSIFICATIONS
Between January and October 2025, conventional pharmaceutical expenditure showed overall resilience, amounting to 7,208.8 million euros with an incidence of 6.39% on the National Health Fund. Compared to the programmed ceiling of 6.80%, territorial management recorded a positive trend “generating a surplus of 461.3 million euros.”
However, the sector’s balance is influenced by the adoption of the reclassification of certain drug categories, such as gliflozins, whose transfer from the hospital category to pharmacies is expected to increase territorial expenditure while reducing direct purchase costs.
Despite a net expenditure increase of 252.6 million euros compared to the previous year, the number of prescriptions dispensed remained substantially stable at 478.8 million.
THE FINANCIAL ABYSS OF DIRECT PURCHASES AND THE PAYBACK ISSUE
The direct purchase sector, which includes medicines distributed by public healthcare facilities, represents the main criticality of the pharmaceutical budget with an expenditure of 13,605.9 million euros. The programmed ceiling of 8.30% was widely exceeded, reaching a real incidence of 12.06% and causing “a deficit compared to programmed expenditure of +4,243.9 million euros.”
This billion-euro overspending activates the payback mechanism, which requires pharmaceutical companies to cover half of the hospital deficit, a burden that in 2025 could reach record figures putting the industrial sector in difficulty. Experts warn that this instrument is however limited by continuous legal appeals that make the actual availability of these resources for the State coffers uncertain.
STRUCTURAL CAUSES: INNOVATION AND POPULATION AGING
The expenditure growth is not considered an accidental phenomenon, but the result of a structural criticality fueled by the arrival of new advanced and high-cost biotechnological therapies, especially in oncology and rare diseases.
Added to this is the aging population, which entails an increased demand for health for multiple chronic diseases treated with drugs dispensed “for life.” Overall, total pharmaceutical expenditure absorbed 18.64% of resources, “highlighting an absolute deviation from total resources of 15.30% (17,257.7 million euros) equal to +3,769.7 million euros.”
At the same time, investments for innovative medicines and “reserve” antibiotics amounted to 654.9 million euros, a figure that “is fully covered by the respective” national fund specifically allocated.
INSTITUTIONAL TENSIONS AND HYPOTHESES OF FORMULARY REVISION
As reported by both LaPresse and Il Sole 24 Ore, the current cost dynamics have generated strong political tensions, leading the Ministry of Health to send a formal request for clarifications to Aifa’s leadership for growth deemed insufficiently controlled. To respond to the emergency, the Agency has begun evaluating drastic countermeasures, including renegotiation of reimbursement prices and an annual revision of the pharmaceutical formulary.
The intervention would aim to identify medicines to exclude or reclassify, eliminating so-called therapeutic “duplicates” and introducing reference prices for therapeutic areas with off-patent drugs.
The issue remains open, however, with pharmaceutical companies inclined to resist linear cuts that could translate into new burdens on citizens for the purchase of medicines.
