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Methods for Assessing Therapeutic Innovation of Drugs: Changes at the Italian Medicine Agency
Domenico Motola1, Nicola Montanaro2, Massimiliano Broccoli3
1Unit of Pharmacology, Department of Medical and Surgical Sciences, Alma Mater Studiorum University of Bologna, Bologna, Italy. domenico.motola@unibo.it.
Introduction:
Therapeutic drug innovation is a fundamental point for patients, healthcare professionals, and national health services. In Europe, the assessment of the therapeutic innovation of drug is establish to the individual national health agencies. In Italy, the Italian Medicines Agency (AIFA) was the first to adopt an algorithm for assessing the degree of therapeutic innovation of drugs in 2007. Afterwards, the AIFA has been issuing various versions of a method of assessment of therapeutic innovations, the most recent one being that issued in September 2025.
Aim:
To compare the results of the assessment of therapeutic innovation of drugs recently authorized by the European Medicines Agency (EMA), by using the former method (here called AIFA2007) vs the present one (here called AIFA2025), in order to determine which of the two was more selective.
Results:
38 new medicines authorized by the EMA between June 2023 and 2025 were evaluated. Among those analyzed with AIFA2007, only 3 achieved a degree of "important" therapeutic innovation (8%). Based on AIFA2025 criteria, as many as 12 drugs were classified as innovative (32%).
Conclusion:
The 2007 algorithm appeared to be much more selective in comparison to the recent one AIFA2025.
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