The AIFA’s innovativeness appraisal for medicines

A standardized procedure to evaluate the innovativeness of medicines has been implemented by the Italian Medicines Agency since 2017 (AIFA - Determina n. 1535/2017).

Through the national healthcare system, such a procedure seeks to encourage drug innovation in order to improve patient outcomes and offer accessible healthcare services as a whole. Faster regional access, non-application of the mandatory price reductions, and inclusion in dedicated funds are the most important benefits provided for drugs that are granted the innovativeness status.

AIFA has identified unmet medical need, the added therapeutic value, and the quality of the evidence (rated through the GRADE system) as the criteria for the innovativeness appraisal.

To explore the drugs innovativeness within the AIFA’s appraisal, we have analysed 220 appraisal reports available on AIFA’s website (2017-2022) of which 107 (48.6%) innovative and 113 (51.4%) non-innovative. The added therapeutic value has showed statistical significance with the innovative status, although our analysis showed statistical significance for all the evaluation criteria as useful to obtain the innovative designation. Additionally, a subgroup study revealed a substantial distinction between oncology and orphan therapies. In particular:

– for Orphan Drugs, the unmet therapeutic need and the added therapeutic value emerged as significant criteria, while

– for Oncology Drugs, the quality of the evidence significantly correlated with innovation status.

Understanding the AIFA’s determinants of innovativeness appraisals can help define the current prioritization process for innovative medicines, which has significant implications for strategic decision-making. It can also help companies focus their products on the attributes that are most appropriate for the appraisal criteria. More details about the analysis can be found in the report at the following links:



The Italian member of PHAROS Healthcare Consulting, Regulatory Pharma Net, offers end-to-end support, from strategic analysis and advice, including feasibility of the innovativeness request, to the full preparation of the Pricing and Reimbursement application with Health Economic models development or adaptation, up to the negotiation with the Authority.