As of 7 August 2025, AIFA Notes 2, 4 and 41 are repealed.

Medicines previously included in Note 2 - chenoursodesoxycholic acid, tauroursodesoxycholic acid and ursodesoxycholic acid, indicated for the treatment of primary biliary cirrhosis, primary sclerosing cholangitis, cholestasis associated with cystic fibrosis or familial intrahepatic cholestasis, and cholesterol gallstones - and in Note 4 - duloxetine, gabapentin and pregabalin, indicated for postherpetic neuralgia related to herpes zoster, neuropathy associated with neoplastic disease, post-stroke pain or spinal cord injury polyneuropathies, multineuropathies, painful mononeuropathies and diabetic neuropathy - remain prescribable by the National Health Service (SSN) under the same conditions of reimbursement class and supply regime, without the limitations provided for in the Notes.

For salmon calcitonin-based medicines for the treatment of Paget's disease, included in Note 41, it has been decided to reclassify them in class C/RR.

The update published on 18 July to Note 100, concerning the prescription of medicines for the treatment of type 2 diabetes mellitus, and the repeal of Notes 2, 4 and 41 represent the first measures taken by AIFA to simplify bureaucracy and introduce a new regulatory approach to reimbursement. This continues the review of the AIFA Notes – the regulatory tool aimed at defining the conditions of use of medicines covered by the National Health Service, following prescription in the territory by General Practitioners (GPs) and Paediatricians of Free Choice (PLS) - initiated by the Agency in 2024. The collaboration between the Technical Table for the revision of the Notes and Therapeutic Plans, established on 6 June 2024, and the AIFA Scientific and Economic Committee has made it possible to identify areas in which the current regulations can be simplified, based on new scientific evidence or the use of alternative tools (prescription guidelines). With this in mind, a list of Notes to be repealed, as they are considered obsolete, and a list of Notes to be updated have been drawn up.

For medicines that were subject to Notes 2 and 4, AIFA will monitor expenditure and consumption at 6 and 12 months from the date of entry into force of the decisions published in the Official Journal, in order to verify the impact of these measures, reserving the right to initiate a new renegotiation, if necessary. However, expenditure monitoring is not planned for medicines that were included in Note 41, given that they have been reclassified in class C/RR.

It should be noted that the Regions and Local Health Authorities (ASL) are required to verify the appropriateness of prescriptions for the medicines covered by these measures within their territory.