OBJECTIVES: AIFA Monitoring Registries were introduced in Italy as an instrument of prescription appropriateness. This study aims to assess the use of registries and the possible impact of their closing on drugs’ sales.

METHODS: Among all registries closed since the introduction of registries platform, registries related to drugs authorized and reimbursed (excluding generics and biosimilars) were selected and descriptive statistics were performed. Subsequently, registries with a duration <8 years and for which it was not possible to attribute the definitive end of monitoring to specific reasons were selected. Descriptive statistics were performed and, for drugs with no new reimbursed indications in the three years after registry closure, turnover values over the 3 Moving Annual Totals preceding and following the closure were analyzed. Data were collected from AIFA reports, Italian Official Journal and IQVIA proprietary databases.

RESULTS: 121 registries were closed since the introduction of registries platform. The median duration of registries was 7.0 years (average 7.2 years); in 28% of cases monitoring proceeded with different tools. 45 registries had a duration <8 years and their definitive end of monitoring was not attributable to specific reasons. Only in 29% of cases the renegotiation of reimbursement conditions could be attributable to registry closing; for these products the renegotiation was accompanied by 5-15% increase of overall discount. Among the 14 drugs whose sales data were analyzed, after the closure of the registry, in 86% of cases turnover showed a decrease or an increase with a slower trend than before closure, in 14% (two orphan drugs) an increase with a faster trend than before the closure.

CONCLUSIONS: Registries closure after a monitoring <8 years does not lead to an increase in turnover trends of non-orphan drugs, even in absence of renegotiation, showing that the registry closure after a period <8 years has no negative impact on prescribing appropriateness.