The Italian Medicines Agency (Aifa) plays a crucial role in facilitating early access to innovative therapies, particularly in oncology, by utilizing a multidimensional assessment model focused on therapeutic need, added therapeutic value, and quality of evidence. Since 2017, Aifa has evaluated over 160 oncohaematological indications, awarding full innovativeness in 36% of cases, with added therapeutic value being the primary determinant of these evaluations. Recent changes, including the establishment of a unified Scientific and Economic Commission and updated criteria for assessing innovativeness, have prompted a multidisciplinary working group to explore new parameters for defining added therapeutic advantage, especially regarding treatment outcomes in early-stage malignancies.
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Link to original article source: https://en.ilsole24ore.com/art/drug-innovativeness-value-to-be-measured-by-patient-clinical-outcomes-AIlrCTXD
