Effective tools to manage biosimilars prescription: The Italian experience

Abstract

Introduction: Biosimilars represent both a clinical and a financial opportunity. However, low biosimilar penetration has been observed across Europe. Italy has registered a high and increasing biosimilars uptake, but not uniform across regions. Objectives:The paper aims to describe different managerial tools that can be leveraged to exploit the biosimilars' potential. A focus on Italy and the Tuscany region will be specifically carried out. Furthermore, this research is intended to propose some preliminary considerations about the most effective measures to support biosimilars' uptake.Methods: This article is based on both desk research and on action research. A desk research was carried out to explore the existing international and national literature on the measures implemented to promote biosimilars' penetration. The action research concerned a longitudinal cooperation project between the Management and Health Laboratory of Scuola Superiore Sant'Anna of Pisa and the Drugs and Appropriateness Policy Sector of Tuscany Region. The activity saw the direct involvement of the Management and Health Laboratory in supporting the regional pharmaceutical governance in managing biosimilars' penetration.Results: Several demand and supply side policies to foster biosimilar penetration have been implemented both at national and regional levels. In Italy, most regions have adopted specific biosimilar policies at different moments and with heterogeneous contents. The Tuscan Regional Health System implemented three main measures: formal top-down, bottom-up and "mixed" measures. The strategy was effective in increasing biosimilar uptake. The success is probably associated with its comprehensive approach and to the coherence of the different measures it was composed of.

An exploration of biosimilar TNF-alpha inhibitors uptake determinants in hospital environments in Italy, Portugal, and Spain

“…Regions such as Friuli-Venezia-Giulia and Veneto followed this initiative and established biosimilar prescription quotas for newly diagnosed patients. The regions Basilicata, Calabria, Puglia and Sicilia legislated as well on the importance of preferring biosimilars over originator products, provided that the biosimilars were the most economically advantageous alternatives ( 27 , 28 ).…”

“…Most regions now require prescribers to justify the choice of an originator if a patient is eligible for a switch to a more cost-effective biosimilar (e.g., Toscana and Piemonte). In Piemonte for example, current biosimilar adoption guidelines incorporate prescribing objectives for BVB higher than the 95% ( 28 ). Compliance with these guidelines has been reflected in the achievement of 99.5 and 98.2% market shares for infliximab and adalimumab biosimilars, respectively.…”

Budget Saving Potential of Pegfilgrastim Biosimilar for the Treatment of Chemotherapy-Induced Febrile Neutropenia, in Italy

“…The recent patent expiration of several biological drugs led to the commercialisation of biosimilar products, nowadays representing an important segment of the global pharmaceutical market. Biosimilar penetration has been observed across the five major European Union (EU) markets and Italy has registered a high and increasing biosimilars up-take, albeit not uniform across the Italian regions [36,37].…”

“…The opportunity to switch more patients to LA G-CSF may have the potential to improve patient outcomes [37,40,41]. No requirement for daily self-administration, hospital visits, or regular tests to evaluate absolute neutrophil count levels, may also provide improved compliance with LA over SA G-CSF [42,43], thus reducing indirect costs, such as patients' and caregivers' time and costs, as well as productivity losses or reductions.…”

Evaluating the benefits of TNF-alfa inhibitor biosimilar competition on off-patent and on-patent drug markets: A Southern European analysis

“…After more than 6 years since TNF-alfa inhibitor biosimilars market availability, up to 87.3% and 91.1% regional variation in biosimilars uptake has been observed for Italy and Spain, respectively. This variability may be associated to the decentralized nature of healthcare competences, and to the design of biosimilar policies at the regional and local level (Caputi et al, 2016;ACSS, 2017;Brogonzoli et al, 2018;AIReF, 2020;Guidotti E et al, 2020). In Portugal, although certain competences of the health administration are delegated to the regional level, biosimilar policies have been broadly implemented at the central level.…”