Regional Policies Impact on Biosimilar Adoption For Autoimmune Diseases In Italy

Abstract

The Italian Medicines Agency (AIFA) developed specific guidelines to promote the use of biosimilar drugs. AIFA recommended preferring biosimilar drugs for naïve patients, when they represent an economic advantage. However, Regions are free to establish their own policies within a fragmented driven market. This research evaluates the Regional behavior in terms of regulation and adoption of biosimilar drugs, focusing on naïve patients with autoimmune diseases. The analysis focused on 15 biologic drugs indicated to treat autoimmune diseases, in 3 therapeutic areas (i.e. rheumatology, dermatology, gastroenterology). A desk research was conducted on regional policies on biologic and biosimilar drugs, focusing on the promotion of biosimilars in naïve patients and the definition of specific prescriptive patterns. The research was integrated with patient data (source: around 3,000 patient records, last quarter 2016), for 15 Italian macro-regions to highlight potential differences across the National territory. The majority of Italian regions encouraged biosimilar drugs usage in naïve patients balancing the attention to the prescriptions appropriateness and the pharmaceutical spending. Lombardy, Puglia and Sicily developed specific regulations for naïve patient but without a focus on autoimmune biosimilars. On the contrary, Campania, Emilia, Piedmont and Tuscany defined specific prescription targets for these drugs. The analysis of the patient share adoption showed variability across the territory: Emilia (33.0%), Trentino (23.0%), Veneto (21.6%) and Piedmont (21.0%) were Regions with the highest biosimilar usage in naïve patients, especially for gastroenterological indications. Some regions show a high biosimilars consumption in specific indications, but not in the remaining, demonstrating that the influence of clinicians can be relevant in the biosimilar adoption. Although there are significant differences among Regions, all of them encourage biosimilar uptake by setting prescribing guidelines and targets. The presence of regional policies can play an influence on biosimilar adoption: a national North-South gradient is observed.