Italian expenditure data confirm direct-purchase overshoot
Italy’s final 2025 pharmaceutical-expenditure monitoring has confirmed that the main pressure in public medicines spending sits in direct purchases, while community pharmacy expenditure remains below its programmed ceiling.
The Italian Medicines Agency (Agenzia italiana del farmaco, AIFA) published Monitoraggio AIFA della spesa farmaceutica gennaio-dicembre 2025 (AIFA monitoring of pharmaceutical expenditure January-December 2025) on 17 June 2026. The report closes the 2025 monitoring cycle and updates the partial picture previously available from the January-September data.
Earlier articles had already identified the main direction of Italian medicines policy: rising public pharmaceutical expenditure, recurring overshoot in direct purchases, the 2026 Budget Law’s permanent 5% price measure, regional variation in medicines use and the use of biosimilar policy as part of spending control. The final 2025 monitoring adds a more precise basis for the next stage of the debate. It fixes the full-year statutory position against the expenditure ceilings and shows how far the imbalance has become concentrated in one channel.
Specialist press reporting on the AIFA data puts total public pharmaceutical expenditure in 2025 at almost €25 billion, up 5.4% on 2024. Direct purchases exceeded the programmed ceiling by more than €4.7 billion. Community pharmacy expenditure was still below its ceiling, by about €460 million.
The figures make the policy challenge more specific. The community channel remains broadly contained within the formal ceiling. The pressure sits instead in the hospital and regional purchasing channel, where high-cost medicines, specialist therapies and products managed outside ordinary pharmacy reimbursement are concentrated.
Quotidiano Sanità has reported that AIFA is examining possible measures including revision of the national formulary, identification of therapeutically homogeneous groups, wider reference-price concepts and a safeguard clause in company negotiations. The same report states that the Ministry of Health has asked for stronger technical, scientific and economic documentation before those ideas are treated as a complete proposal.
The final 2025 monitoring does not suggest a single policy response. It does, however, strengthen the evidence base for a more detailed discussion of direct-purchase expenditure. The policy question is whether Italy continues to rely mainly on price cuts and payback, or moves towards a more structured review of therapeutic groups, reimbursement prices and the formulary position of established medicines.
Source: Italian Medicines Agency; Quotidiano Sanità
Link: Monitoraggio AIFA della spesa farmaceutica gennaio-dicembre 2025 (AIFA monitoring of pharmaceutical expenditure January-December 2025); Farmaci. Aifa studia revisione del Prontuario e clausola di salvaguardia. Aziende contrarie e timori per l’impatto sui cittadini. Ministero frena e chiede documentazioni tecnico-scientifiche più solide (Medicines. AIFA studies formulary review and safeguard clause. Companies opposed and concerns over the impact on citizens. Ministry slows the process and asks for stronger technical and scientific documentation)
Date: 17 June 2026 and 19 June 2026
