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. 

After the “Revision and validation procedure of the lists of therapeutic indications for innovative drugs by pharmaceutical companies” started on 22/04/2024 and ended on 03/05/2024, AIFA has drawn up a list of medicines to which the requirement of (full) therapeutic innovation has been recognised, for at least one indication.

This list provides all the innovative indications and all the indications eligible for reimbursement, by specific packaging, with an impact on expenditure in the year 2023.

The information on the list was previously shared with the companies holding the MA before this publication.

It is important to recall that this list was drafted in the context of the 2023 Monitoring and Payback procedure of pharmaceutical expenditure. It contains neither indications with an effective date following 31/12/2023 nor indications not reimbursed by the National Health Service.

Finally, the period of innovation of the indication has always been indicated for each medicine, even if a package was marketed after the starting date of the innovation status.

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.