AIFA issues new criteria for the classification of a drug as “innovative”
As requested by Law No 232/2016, AIFA timely approved the new criteria for the classification of a drug as “innovative”, the assessment procedure and the criteria to maintain the qualification of “innovative”.
The criteria identified by AIFA are: (i) the therapeutic need; (ii) the therapeutic added value; and (iii) the quality of the scientific evidence as well as the reliability of the clinical trials, to be assessed according to the method GRADE (“Grading of Recommendations, Assessment, Development and Evaluation”). On the basis of these criteria, AIFA attributes a score from “absent” to “maximum”.
If both the therapeutic need and therapeutic added value are judged as “maximum” or “significant” and the quality of the scientific evidence is also high, a drug will be classified as “innovative”. Conversely, if the therapeutic need or therapeutic added value or the quality of the scientific evidence are judged as “poor” or “absent”, the drug cannot be classified as “innovative”. Intermediate situations shall be assessed case by case.
As result of this assessment, a drug will be classified as: (i) “innovative”, with the consequence of the granting of certain benefits such as the inclusion in the fund for innovative medicinal products and in the “Prontuario terapeutico regionale”; (ii) “potentially innovative”, with the only benefit of the inclusion in the “Prontuario terapeutico regionale”; or (iii) “not innovative”.
The qualification as “innovative” has a maximum duration of 36 months for the “first in class” drug, while any other follower that should be classified as “innovative” would enjoy the residual duration. Potentially innovative drugs shall be re-assessed after maximum 18 months.
AIFA also approved the form to be used to file the request for the classification of a drug as “innovative”.