Budget law 2025: News for the health sector

1. Innovative medicines

The most notable change is the redefinition of the concept of “innovative“^[2], which will now be assessed according to its “results of efficacy and safety obtained in comparison with therapeutic alternatives available in the National Pharmacopoeia before its introduction in a specific therapeutic indication” and “on the basis of the manufacturing technology of its active substance, its mechanism of action, the way it is administered to the patient, its clinical efficacy and safety, its effects on the quality of life and its implications for the organisation of healthcare”.  The tripartite assessment criteria outlined in AIFA Resolution no. 1535/2017 (i.e. therapeutic need, therapeutic added value and quality of evidence) will thus be replaced by a combination of factors, some of which are new. Indeed, AIFA is expected to adopt a new Resolution by the next 31 March, detailing the new criteria for the assessment of innovation.

Noteworthy provisions include the following: (i) any medicine (more precisely, any therapeutic indication) for which a request for negotiation of reimbursement and price is received by AIFA more than ten years after the first recognition of the innovation will not have access to financing from the dedicated fund; and (ii) therapeutic indications that have lost patent protection or have never had such protection will not be eligible for innovation assessment^[3].

Finally, it is specified that, under certain conditions^[4], even conditionally innovative medicines will have access to the resources allocated to the NHS dedicated fund, amounting at  €1.3 billion for 2025. Any expenditure exceeding the amount allocated by the fund will contribute to the achievement of the ceiling on pharmaceutical expenditure for the purchases of medicines by the NHS, that triggers the obligation of the marketing authorization holders to payback certain amounts to the Regions (i.e. payback mechanism).

2. Essential levels of care (livelli essenziali delle prestazioni)

It is foreseen that part of the NHS resources, equal to 50 million euros per year from 2025, will be earmarked for the updating of the essential levels of care, including the revision of the maximum national tariffs for the relative health services

3. Purchase of health services from accredited providers

The maximum expenditure limit that the NHS may incur for the provision of services to citizens through private healthcare entities accredited with the NHS^[5] will increase by 0.5 percentage points for the year 2025 and by 1 percentage point from the year 2026.

In addition, with a view to reducing the phenomenon of waiting times for hospitalisation in emergency wards, the abovementioned expenditure ceiling will be increased by a further 0.5 percentage from 2026 to reimburse the purchase of hospital services from NHS accredited entities  relating to general medicine, functional recovery and rehabilitation and long-term care hospital wards. Priority will be given to facilities that are immediately available and able to ensure a higher level of capacity in each ward.

4. Governance of the medical devices sector

The Ministry of Health must adopt the national health technology assessment (HTA) programme by 30 June 2025, to be implemented by 1 January 2026, and update it every three years. The main objective is to ensure the efficient and appropriate use of medical device technology within NHS activities. This should also help in limiting the public expenditure for the purchase of medical devices by the NHS, and, accordingly, in reducing the amount of money that Regions can ask companies to pay back, according to the payback mechanism that has been recently extended to the medical devices sector.

5. Adjustment of the allocated quotas (quote di spettanza)

The quotas for pharmaceutical companies and wholesalers on the retail price of class medicines have been revised to 66% (from 66.65%) and 3.65% (from 3%), respectively. On the other hand, the minimum fee for pharmacists remains unchanged.

It is also specified that the 0.65% increase granted to wholesalers is non-negotiable quota and cannot be transferred as a discount to any party in the pharmaceutical chain.

6. Dematerialisation of prescriptions

According to the budget law, from 1 January 2025 all prescriptions, both for medicines reimbursed by the NHS and for medicines paid for out-of-pocket, must be issued electronically. However, considering the ongoing issues with telematics systems, some Italian regions, along with the trade associations of pharmacists, have recommended pharmacies to continue to accept also paper prescriptions, to assure the supply of medicines and other services to the patients.

[1] Referred to as Law no. 207/2024 and published in the Official Gazette on 31 December

[2] The recognition of innovation allows the medicine to be distributed at a cost borne by a dedicated NHS fund.

[3]   Both (i) and (ii) don’t apply to “reserve” and “listed” antibiotics.

[4] Specifically, they can access the fund for an amount not exceeding 300 million euros per year if they are already subject to dispensing monitoring by means of the AIFA Monitoring Register or if the AIFA Scientific and Economic Commission justifies the establishment of the Monitoring Register. For these medicines, the thirty-six-month innovation period starts from the date of recognition of the conditional innovation.

[5] In this respect, article 1, par. 233 of Law no. 213/2023 provides: “In order to contribute to the orderly provision of health services included in the essential levels of care, the expenditure ceiling referred to in the first sentence of paragraph 14 of Article 15 of Legislative Decree no. 95 of 6 July 2012, converted with amendments into law no. 135 of 7 August 2012, shall be redetermined at the value of the expenditure recorded in 2011, increased by 1 percentage point for the year 2024, 3 percentage points for the year 2025 and 4 percentage points for the year 2025, without prejudice to the respect of the economic and financial balance of the regional health service“.