As a conclusion of the “Revision and validation procedure of the lists of therapeutic indications for innovative drugs by pharmaceutical companies”, started on 10/02/2023 and ended on 14/03/2023, AIFA has drawn up a list of medicines (reported below) to which the requirement of (full) therapeutic innovation has been recognized, for at least one indication.

The list provides all the innovative indications and the indications eligible for reimbursement, by specific packaging, with an impact on expenditure in the year 2022.

The information in the list was previously shared with the companies holding the marketing authorization prior to this publication.

The list was drafted in the context of the 2022 Monitoring and Payback procedure of pharmaceutical expenditure, and contains neither indications with an effective date following 31/12/2022 nor indications not reimbursed by the NHS (National Health Service).

Finally, the period of innovation of the indication has always been indicated for each medicine, even in the event that a package has been marketed after the starting date of the innovation effectiveness.