OBJECTIVES: AIFA Registries may represent a valuable source of information on drugs’ safety, effectiveness and real-life utilization. Monitoring registries are decided at the National level, being designed both to enforce Managed Entry Agreements (MEAs) as well as to collect Real World Data (RWD) including patients’ demographics, treatment duration, safety profile for a given drug, in a real world setting. The aim of this analysis was to demonstrate to what extent AIFA registries can represent an important source of RWD, highlighting the potential outcomes that can be achieved from registry analyses of drugs under AIFA monitoring.

METHODS: From the AIFA Registries Platform, all patients who initiated treatment in 2016 with one oncology drug, were extracted in order to analyse: patient characteristics (distribution by age and gender); epidemiology and real-life utilisation (number of patients treated; mean treatment duration); reasons for treatment discontinuation (e.g. toxicity, death, progression).

RESULTS: A pool of 265 patients, who started treatment during 2016, were identified as candidates for the analysis. Mean patients age was 64 with a 60/40 male/female ratio. Patients received on average 7.2 treatment cycles and the main reason for treatment discontinuation was disease progression (55%), treatment completion (8%), death (6%), patient’s decision (3%), toxicity (2%) and reasons not related to the registry drug (26%). Comparing the results from AIFA registry to Phase III clinical trials endpoints, this drug showed better safety profile in the real world compared to clinical trial results (incidence of AEs 2% vs 5%) and similar treatment duration (7.2 in registry vs 7.9 in RCTs).

CONCLUSIONS: This study shows that RWD from AIFA registries may represent a significant source of knowledge on drug use, patient characteristics and safety and thus can contribute to the evidence base needed for healthcare decision-making.