How Much Are Biosimilars Used in Clinical Practice? A Retrospective Italian Population-Based Study of Erythropoiesis-Stimulating Agents in the Years 2009–2013

Abstract

PurposeTo explore the prescription patterns of erythropoiesis-stimulating agents (ESAs) in four large Italian geographic areas, where different health policy interventions to promote biosimilar use in routine care are undertaken.MethodsA retrospective drug utilization study was conducted during the years 2009–2013. The data sources were the administrative databases of the Tuscany region and of the Caserta, Palermo, and Treviso Local Health Units (LHUs). The characteristics, prevalence, and switching patterns of different ESAs (biosimilars and reference products), stratified by indication for use, were calculated over time and across centers.ResultsOverall, 49,491 patients were treated with ESAs during the years 2009–2013 in the four centers. Of these, 41,286 patients (83.4 %) were naive users. The prevalence of ESA use increased from 2.9 to 3.4 per 1000 inhabitants in the years 2009–2011 but decreased thereafter (3.0 per 1000 in 2013). Moreover, the proportion of biosimilar users increased overall from 1.8 % in 2010 to 33.6 % in 2013, with larger increase in Treviso (from 0.0 to 45.0 %) and Tuscany (from 0.7 to 37.6 %) than in Caserta (from 7.5 to 22.9 %) and Palermo (from 0.0 to 27.7 %). Switching between different ESAs during the first year of therapy was frequent (17.0 %), much more toward reference products than toward biosimilars.ConclusionOverall, the prevalence of ESA use decreased slightly, while use of biosimilar ESAs, especially in naive patients, increased significantly but to different extents in these four large Italian geographic areas. Switching between different ESAs during the first year of treatment was very frequent, which may affect pharmacovigilance monitoring. New strategies are necessary to further improve market penetration of low-cost medicines, such as biosimilars, and also to harmonize effective health policy interventions that aim to reduce pharmaceutical expenses and optimize patient benefit across all regions.Electronic supplementary materialThe online version of this article (doi:10.1007/s40259-015-0132-7) contains supplementary material, which is available to authorized users.

key Drivers for Market Penetration of Biosimilars in Europe

“…Incentive policies applied to biosimilars are heterogeneous across countries. At the time of the review, pharmaceutical prescription budgets or prescription quotas were reported in place for half of the countries [14,19,[39][40][41][42][43] Financial incentives or penalties measures were found in countries applying pharmaceutical prescription budgets and/or prescription quotas, but were reported as not frequently enforced (Belgium, Germany) or enforcement was not documented in the literature (Greece, Italy, Sweden, the UK) [14,39,41,42,44] Except for Poland, where switching by the physician is generally encouraged [45][46][47], some countries (Belgium, France, and Italy) do not recommend switching even if they do not prohibit it [14,39], while some other countries might recommend it in some specific cases (e.g., products with same producer (Germany, Sweden) [14], sufficient elapse time between two treatments, or in case of treatment failure (Hungary) [46,47]. In Spain, patients who started biologic therapy usually continue to receive the same medicine, and all decisions should be taken by physicians [13].…”

Supply-Side and Demand-Side Policies for Biosimilars: An Overview in 10 European Member States

“…In Italy, several regional provisions related to biosimilars regulate biologic prescription and expenditure targets. For example, (1) in the Campania and Umbria regions, the main objective is to achieve a biosimilar utilization rate at least equal to the number of naïve patients, whereas in the Veneto region, the dispensed packages of biosimilars must constitute at least 60% of all dispensed packages of G-CSF, EPO, or hGH; (2) in Sicily, Veneto, Campania, and Tuscany, drug-naïve patients must be treated with cheaper biosimilars, and when patients are switched, the lower cost medicine should be chosen; any deviations from these rules should be justified by the prescriber [57][58][59][60]. In Sweden, county councils set quotas and target budgets for hospitals, applicable to various therapeutic classes, including biosimilars.…”

“…Germany, Italy [58,59], and Belgium) or potential financial rewards for physicians who meet their targets (e.g. Italy [6], Sweden, some Spanish regions, and the UK [63,64]).…”

“…Various guidelines on biosimilars have been published by national regulatory authorities, regional authorities, or HTA bodies [e.g. the Federal Joint Committee (G-BA) in Germany; French Drug Agency (ANSM); AIFA, and the regional governments of Tuscany, Veneto, Campania, Umbria, and Sicily in Italy [58,59,67]; as well as NICE; and some county councils and the Drug Therapeutic Committee in the Stockholm region, Sweden [68,69]] and various scientific associations (e.g. the Belgian IBD Research & Development Group [70], French National Society of Gastroenterology [71], Spanish Society of Rheumatology [72], and British Society for Rheumatology [73]).…”

“…In Poland, treatment-naïve patients with IBD should be treated with a biosimilar [74]. In Italy, several regions recommended that physicians should use biosimilars as a first line treatment for new patients; in the case of EPOs, a treatment plan (the Piano Terapeutico) must be completed [59,67,75]. In a position paper published in September 2016, AIFA stated that biosimilars have the same risk-benefit ratio as the reference medicine, and thus constitute a valid therapeutic option not only for treatment-naïve but also for experienced patients [76].…”