At the end of 2017, as required by Italian Law No. 232/2016, AIFA approved new criteria for the classification of a drug as innovative, the assessment procedures and the criteria to maintain the qualification of “innovative”.
The criteria identified by AIFA are:
1) Therapeutic need: to be considered “innovative”, the therapeutic need can be classified into five levels:
| Maximum | Important | Moderate | Poor | Absent |
| absence of therapeutic options for the specific indication; | presence of therapeutic alternatives for the specific indication, but no impact on clinically relevant outcomes or validated for the pathology in question; | presence of therapeutic alternatives for the specific indication with impact defined as limited on outcomes recognized as clinically relevant; | presence of one or more therapeutic alternatives for the specific indication with impact assessed as high on outcomes recognized as clinically relevant and with a favorable security profile; | presence of therapeutic alternatives for the specific indication; ability to modify the natural history of the disease and with a favorable safety profile. |
2) Therapeutic added value: to be considered “innovative”, the added therapeutic value can be broken down into five levels:
| Maximum | Important | Moderate | Poor | Absent |
| greater efficacy demonstrated on clinically relevant outcomes compared to therapeutic alternatives (if available) | greater efficacy demonstrated on clinically relevant outcomes or ability to reduce the risk of disabling or potentially fatal complications or better relationship risk/benefit (R / B) compared to alternatives, or ability to avoid resorting to procedures high-risk clinics | greater efficacy than moderate or demonstrated entity in some subpopulations of patients or on surrogate outcomes, and with limited effects on quality of life | greater efficacy which, however, has been demonstrated on outcomes not clinically relevant or is not very large | absence of additional clinical benefit compared to therapeutic alternatives available |
3) Quality of the scientific evidence: for the evaluation of this parameter, AIFA implements the GRADE method (Grading of Recommendations Assessment, Development and Evaluation). Based on this assessment, quality may result in one of the following classifications:
- High
- Moderate
- Low
- Very low
The request for recognition of innovation must be submitted using the specific form prepared by AIFA which contains a guide on the type of information required and how to present it.
The benefits associated with recognition of innovation have a maximum duration of 36 months for the first in-class drug, while any subsequent drugs which are recognized as innovative will benefit from it for the remaining period.
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