As a conclusion of the “Revision and validation procedure of the lists of therapeutic indications for innovative drugs by pharmaceutical companies”, started on 11/03/2022 and ended on 25/03/2022, 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 2021.

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 2021 Monitoring and Payback procedure of pharmaceutical expenditure, and contains neither indications with an effective date following 31/12/2021 nor indications not reimbursed by the NHS (National Health Service).

In cases where the AIFA Scientific-Technical Commission has recognized the requirement of therapeutic innovation for part of the authorized indication, it has been necessary to separate the innovative part of the indication from the non-innovative one, only for the purpose of monitoring expenditure.

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.