With Resolution No. 1535/2017, AIFA has identified the criteria for the classification of innovative medicinal products and innovative oncological medicinal products pursuant to Article 1, paragraph 402 of Law No. 232 of 11 December 2016.

An updated list of medicines is available which, according to the Scientific-Technical Committee, meet the requirement of full or conditional therapeutic innovation, pursuant to Article 10, paragraph 2 of Law no. 189/2012, as defined by Article 1, paragraph 1, of the State-Regions Agreement of 18 November 2010 (Rep. Atti n.197/CSR).
The list contains the innovative products to be made immediately available to patients, even without formal inclusion in the regional hospital therapeutic schedules.
The reference to the inclusion in the list is published In the Official Gazette for each individual specialty, relating to the indication reimbursed by the National Health Service.
This list also includes the details of the products having access to the Fund for innovative oncological and non-oncological medicines (Article 1, paragraphs 402, 403 and 404, of the Law 11 December 2016, no. 232 and subsequent amendments).
The above list includes the assessment reports for recognition of innovation, by therapeutic indication, in accordance with the provisions of AIFA Resolution no. 1535/2017.
Reports are also published of medicines that have obtained negative results in the innovation assessment. 

At the conclusion of the “Procedure for the revision and validation of the lists of therapeutic indications for innovative medicines by pharmaceutical companies” started on 18/04/2025 and ended on 03/05/2025, the Agency has drawn up a list of medicines which have been recognised as having the requirement of (full) therapeutic innovativeness, for at least one indication.

This list presents all innovative indications and all indications eligible for reimbursement, by specific package, with an impact on the 2024 expenditure.

The information on the list has been shared with the companies holding the MA prior to this publication.

It is important to reiterate that this list, prepared in the context of the activities related to the 2024 Monitoring and Reimbursement of pharmaceutical expenditure procedure, does not include indications with effective date after 31/12/2024 nor indications that are not reimbursed by the SSN (National Health Service).

Finally, the period of innovativeness of the indication was indicated for each medicine, even if a package was marketed after the effective date of innovativeness.

The Agency publishes the lists of innovative medicinal products subject to monitoring in accordance with the 2017 Budget Law. There are different tables for oncological and non-oncological medicinal products and they are constantly updated following the authorisations published in the Official Journal.