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.