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.