OBJECTIVES:

To evaluate the impact of added therapeutic value on granting an innovative designation to medicinal products by the Italian Medicines Agency (AIFA).

METHODS:

AIFA reimbursement data from April 2017 to 2022 were included. A descriptive analysis was performed on the results of the assessment process for innovativeness that was based on the AIFA’s innovation criteria (therapeutic need, added therapeutic value, and quality of evidence through GRADE methodology [grading of recommendations, assessment, development, and evaluation]). The impact of added therapeutic value on the results was then evaluated. Observations were made and results were reported.

RESULTS:

A total of 124 reviews from oncological, gastrointestinal, dermatological, and neurological therapeutic areas were included in the analysis of which, 67.74% (n=84) were recommended and gained recognition of innovativeness. AIFA rates the added therapeutic value in the following order: maximum > important > moderate > poor. Of the 84 reviews, 1.19% (n=1) were given a “maximum” rating, 48.8% (n=41) were given an “important” rating, 48.8% (n=41) were given a “moderate” rating, and 1.19% (n=1) were given a “poor” rating, for a total of 98.8% (n=83) of the reviews receiving a maximum, important, or moderate rating.

CONCLUSIONS:

The AIFA reimbursement reviews from different therapeutic areas that were found to have important or moderate added therapeutic value were mostly recognized with innovativeness. During the analysis, it was observed that the quality of evidence was directly correlated with the added therapeutic value rating and, therefore, with the drug’s recognition of innovativeness. The reimbursement reviews determined to have a high, moderate, or low quality of evidence were mostly recognized with innovativeness. However, the reviews with a lower quality of evidence but an important added therapeutic value, and poor added therapeutic value but a high quality of evidence, were recognized as innovative.