Italy's Pharmaceutical Formulary Revision Threatens Price Cuts of Up to 40% for Off-Patent Medicines
核心洞察
AIFA (搜索)'s proposed formulary revision would set reference prices within broader therapeutic groups rather than by same active ingredient, potentially cutting prices by 30–40%.
The measure targets off-patent medicines including widely used statins (搜索), sartans (搜索), and proton pump inhibitors (搜索), affecting millions of Italian patients.
Companies face unsustainable price alignment demands amid rising raw material and energy costs, while patients risk losing access to preferred medications.
The Italian Medicines Agency (AIFA (搜索)) is advancing a controversial revision of the national pharmaceutical formulary that could slash prices of off-patent medicines by up to 30–40%, triggering alarm across Italy's pharmaceutical industry and raising concerns about patient access to widely prescribed treatments.
The proposed mechanism would fundamentally alter how reference prices are set for reimbursed medicines whose patents have expired. Rather than benchmarking against products with the same active ingredient, AIFA (搜索) intends to establish reference prices within broader therapeutic groups, with the National Health Service (NHS) reimbursing only up to the cost of the cheapest active ingredient in each category.
A Dual Impact on Industry and Patients
The revision's impact would be twofold. For pharmaceutical companies—many of which represent the flagship of Italy's "Made in Italy" manufacturing sector—the price cuts would prove severe. "This would amount to a severe blow, with price cuts of up to 30–40% to bring prices into line with the reference price, a target that is practically impossible to meet, even in the face of soaring costs that have sent expenditure on raw materials and energy skyrocketing in recent years," according to analysis of the proposal.
For patients, the consequences could be equally disruptive. Citizens risk losing access to medications they have used long-term, as prescribing may shift toward fully reimbursed alternatives with different active ingredients. Unless companies can lower prices to unsustainable levels, patients would need to pay the difference out of pocket to continue receiving their established therapy.
Medicines in the Crosshairs
AIFA (搜索) has already begun sending letters to pharmaceutical companies producing several widely prescribed medicine categories, including proton pump inhibitors (搜索), sartans (搜索), and statins (搜索)—medications used by millions of Italians to manage common cardiovascular conditions such as high cholesterol and hypertension (搜索).
These communications are not merely technical notices. They inform companies of the grouping of active ingredients "with similar conditions of use and therapeutic indications," aiming to identify "the active ingredient with the lowest NHS reimbursement price, taking into account the number of dosage units per pack." For statins (搜索) alone, six different active ingredients are being grouped together.
The assessments have been conducted by AIFA (搜索)'s Scientific and Economic Commission (CSE), which "recommends the implementation of this measure, allowing for a reasonable lead time to enable marketing authorisation holders to adjust/align their retail prices with the new reference price." Alternatively, the commission suggests that general practitioners could direct prescriptions toward active ingredients that "minimise any further burden on the public."
A Surplus, Not a Deficit
Notably, the formulary revision targets an area of pharmaceutical expenditure that is not in deficit. According to AIFA (搜索)'s latest monitoring report covering the first 11 months of 2025, territorial pharmaceutical expenditure—medicines dispensed through pharmacies and covered by the NHS—reached €7.732 billion, leaving a surplus of €498 million relative to planned spending limits.
Overall pharmaceutical expenditure for the period stood at €23.131 billion, representing a 7.2% increase compared to 2024, with an overspend of €4.147 billion. However, this overspend is entirely attributable to direct purchases, specifically medicines administered in hospitals, not the territorial spending that the formulary revision would target.
Political Scrutiny Intensifies
The revision, mandated by the latest Budget Law with an effective date of 1 January 2027, is now under scrutiny by Health Minister Orazio Schillaci, who appears unconvinced by the current approach and is expected to seek further clarification in the coming days.
Health Undersecretary Marcello Gemmato has sought to temper concerns, stating: "The Budget Law stipulates that the new pharmaceutical formulary is to come into force on 1 January 2027, so we have plenty of time to carry out thorough investigations." He also noted that pharmaceutical expenditure growth is moderating: "Over the five-year period 2014–2019, there was an average increase of 7% in pharmaceutical expenditure. Between 2019 and 2024, the increase was 7.2%, and in 2025 it was 5.7%, which is more than 20% lower."
Farmindustria (搜索) President Marcello Cattani reinforced this perspective, arguing that "pharmaceutical expenditure is not out of control; it is growing at a natural rate in line with the population's changing needs and with pharmaceutical innovation, which is contributing to increased life expectancy."
The outcome of this policy debate carries significant implications for Italy's pharmaceutical sector, which currently generates production worth €74 billion—a European record—and exports of €69 billion, up 248% over the past decade.