Analysis of Intra-Regional Variability of Drugs’ Time to Access in Italy

OBJECTIVES: Drugs' time to access (TTA) in Italy, from National reimbursement to first regional sales, is highly variable among different regions (inter-regional variability). The aim of this study is to investigate TTA variability within regions (intra-regional variability) and explore its potential determinants.

METHODS: Analysis was based on i-PRIME, an IQVIA proprietary database that integrates clinical and regulatory features on drugs. New molecular entities that received CHMP positive opinion between 2015 and 2021 and were reimbursed in Italy for their first indication were included in the analysis. Drugs marketed through early access programs were excluded. For exploring the determinants of TTA through multivariate regression analysis, the 10 regions with the highest variability in terms of interquartile range were selected. Innovativeness, orphan designation, therapeutic area, monotherapy, AIFA registry and Managed Entry Agreements (MEAs) were assessed as potential determinants of intra-regional variability.

RESULTS: Intra-regional TTA is also highly variable. Regions with the highest variability are Abruzzo, Basilicata, Calabria, Friuli, Lazio, Molise, P.A. Trento, P.A. Bolzano, Sardinia, Umbria. Orphan designation is the only variable consistently increasing TTA across five regions (Abruzzo, Basilicata, Calabria, Lazio, Sardinia), while TTA is positively impacted for monotherapy (Calabria, Molise, P.A. Bolzano), innovative drugs (Sardinia, Umbria), oncology drugs (Lazio) and presence of MEAs (Abruzzo).

CONCLUSIONS: In Italy, inter-regional variability in TTA is accompanied by high intra-regional variability associated with specific drugs’ characteristics in some regions, while still mostly unexplained in other regions. Variability may be also related with distinctive characteristics of the region, such as administrative procedures, hospitals’ organization and size or presence of healthcare regional debt repayment plans. Further analysis is needed to investigate TTA variability in regions with higher impact on Italian pharmaceutical expenditure.