Schillaci: halt on pharmaceutical spending spree, Aifa puts the brakes on

Pharmaceutical spending continues to gallop, and Health Minister Orazio Schillaci is calling for 'urgent clarification' from Aifa. In a letter sent to the president, Robert Nisticò, and to the technical-scientific director, Pierluigi Russo, the minister calls for "corrective measures" to curb the boom in pharmaceutical spending, which in the first nine months of 2025 reached €18.420 billion, a deviation from the programmed ceiling of €2.85 billion. A brake is needed. "The growing media attention on the trend in pharmaceutical spending calls for in-depth reflection on the management dynamics and monitoring methodologies adopted by this Agency," the minister wrote to the Agency, emphasising how "demographic ageing and the introduction of innovative, high-cost drugs on the market represent known variables and, to a large extent, predictable', but nevertheless 'the data presented in the 'Osmed 2024 Report on the use of medicines' and the subsequent communications of the Aifa Board of Directors (the data communicated in January 2026 on the deviation in the first nine months of 2025) show significant criticalities that have caused alarm in the regional administrations'.

Moreover, underlines Schillaci, 'the interpretative divergence between Aifa and the Regions on the sustainability of pharmaceutical expenditure constitutes an element of particular gravity' and also the internal polemics within the Agency, widely reported in the press, 'have further compromised the overall credibility of the national pharmaceutical governance system'. The Ministry of Health therefore requests: 'complete methodological documentation relating to the criteria for evaluating pharmaceutical expenditure, with particular reference to its analytical composition and the authorisation procedures adopted; Hta (Health Technology Asscssment) evidence in support of the authorisation choices made; detailed information on the existence and functioning of systems for monitoring the performance of innovative drugs in real clinical practice (real-world evidence)'.

It also calls for a 'bi-monthly report containing: analysis of pharmaceutical expenditure trends broken down by therapeutic categories; identification of the critical points that have emerged; concrete and measurable actions for the appreciable reduction of pharmaceutical expenditure; timetable for the implementation of corrective measures; indicators for monitoring the effectiveness of the measures adopted'.

The Aifa president's reply was immediate. 'Minister Schillaci,' said Nisticò, 'in the context of a relationship of loyal collaboration and trust, will receive the requested in-depth studies within the indicated timeframe. To ensure better governance of expenditure, the Aifa president explained, 'the Agency is developing a safeguard clause to manage access to the reimbursability of new high-cost and innovative medicines, as well as working on the implementation of the rule recently introduced with the 2026 budget law, concerning the revision of the national pharmaceutical formulary'.

While for the technical-scientific director, Russo "the growth of expenditure for direct purchases of drugs of all reimbursable classes by public health facilities was +4.9% at present (September 2025) while it was +9.1% in September 2024 and +15% in April 2024. In 2025 we will record a significant reduction in expenditure on innovative drugs following the 36-month expiry of the licence for innovativeness, provided for by law, transferring the burden onto the ceiling of direct purchases, which has been spending more than 10 years above the planned levels". In any case, Russo concludes, 'the new rules introduced on the financing and regulation of pharmaceutical assistance, and the administrative measures to regulate access to medicines implemented by the Agency, are contributing and will further contribute to the results achieved so far'.