Abstract

Italian regional policy tends to foster off patent drug prescriptions, within specific therapeutic areas, in order to reduce pharmaceutical expenditure. The aim of this research is to compare regional legislative measures, while evaluating the real consumption of off-patent branded drugs and generic medicines, for every Italian region. A desk-based research was conducted to gather regional guidelines and policies, related to the adoption and prescription of off-patent molecules. Off-patent drugs include brands that lost their patent protection and generic medicines launched after the patent had expired. IMS Health data, based on retail pharmacy distribution, were used to provide information on 2014 and 2015 pharmaceutical spending and volume drug consumption. The majority of Italian regions established legal regulations with the aim of increasing penetration of off-patent molecules and reducing territorial pharmaceutical spending. These measures include specific consumption and prescription objectives, frequently addressing selected therapeutic areas. An overall analysis shows that off-patent drug (both off-patent branded and generic medicines) diffusion is currently growing in the Italian territory; however data underline different market penetration levels of off-patent molecules among regions (ranging as a percentage of the total drug consumption from the 79,1% of Umbria to the 71,5% of Veneto). When focusing on generic medicine penetration, even more net differences emerge among territorial areas (from the 36,0% of Provincia Autonoma di Trento to the 14,7% of Calabria). Although prescriber’s decision to use an off-patent medicine is influenced by many factors, adoption of these drugs plays a significant role in controlling national and regional pharmaceutical spending. To this purpose, regional measures aimed to increase the prescription of these drugs, can markedly drive the change in off-patent volume share.

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