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

Ingrasciotta Y, Giorgianni F, Bolcato J, Chinellato A, Pirolo R, Tari DU, Troncone C, Fontana A, Ientile V, Gini R, Santoro D, Santarpia M, Genazzani A, Uomo I, Pastorello M, Addario WS, Scondotto S, Cananzi P, Caputi AP, Trifirò G - BioDrugs (2015)

Bottom Line: 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).Overall, 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.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.

View Article: PubMed Central - PubMed

Affiliation: Department of Clinical and Experimental Medicine, University of Messina, Messina, Italy, ylenia.ingrasciotta@unime.it.

ABSTRACT

Purpose: To 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.

Methods: A 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.

Results: Overall, 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.

Conclusion: Overall, 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.

No MeSH data available.


Identification of erythropoiesis-stimulating agent (ESA) users in the four centers. Asterisk naive ESA users: ESA users without any ESA dispensing in the year prior to the index date, N number
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Related In: Results  -  Collection


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Fig1: Identification of erythropoiesis-stimulating agent (ESA) users in the four centers. Asterisk naive ESA users: ESA users without any ESA dispensing in the year prior to the index date, N number

Mentions: During the study period, from a total population of 6,571,697 persons (more than 10 % of the whole Italian population), 49,491 (0.8 %) received at least one prescription of ESA during the years 2009–2013 (Fig. 1). Of these, 41,286 (83.4 %) were naive users, who mostly started therapy with reference products (N = 32,430; 78.5 %) and much less frequently with biosimilars (N = 8856; 21.5 %) in all four centers. The age and sex distributions of biosimilar and reference product users were comparable (Table 1). Anemia due to CKD was the main reason for prescribing ESAs, mostly to elderly patients, irrespective of the ESA type, except in Tuscany, where 60 % of patients started treatment with a biosimilar ESA to treat anemia induced by anticancer chemotherapy (Table 1).Fig 1


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

Ingrasciotta Y, Giorgianni F, Bolcato J, Chinellato A, Pirolo R, Tari DU, Troncone C, Fontana A, Ientile V, Gini R, Santoro D, Santarpia M, Genazzani A, Uomo I, Pastorello M, Addario WS, Scondotto S, Cananzi P, Caputi AP, Trifirò G - BioDrugs (2015)

Identification of erythropoiesis-stimulating agent (ESA) users in the four centers. Asterisk naive ESA users: ESA users without any ESA dispensing in the year prior to the index date, N number
© Copyright Policy - OpenAccess
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC4561997&req=5

Fig1: Identification of erythropoiesis-stimulating agent (ESA) users in the four centers. Asterisk naive ESA users: ESA users without any ESA dispensing in the year prior to the index date, N number
Mentions: During the study period, from a total population of 6,571,697 persons (more than 10 % of the whole Italian population), 49,491 (0.8 %) received at least one prescription of ESA during the years 2009–2013 (Fig. 1). Of these, 41,286 (83.4 %) were naive users, who mostly started therapy with reference products (N = 32,430; 78.5 %) and much less frequently with biosimilars (N = 8856; 21.5 %) in all four centers. The age and sex distributions of biosimilar and reference product users were comparable (Table 1). Anemia due to CKD was the main reason for prescribing ESAs, mostly to elderly patients, irrespective of the ESA type, except in Tuscany, where 60 % of patients started treatment with a biosimilar ESA to treat anemia induced by anticancer chemotherapy (Table 1).Fig 1

Bottom Line: 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).Overall, 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.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.

View Article: PubMed Central - PubMed

Affiliation: Department of Clinical and Experimental Medicine, University of Messina, Messina, Italy, ylenia.ingrasciotta@unime.it.

ABSTRACT

Purpose: To 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.

Methods: A 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.

Results: Overall, 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.

Conclusion: Overall, 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.

No MeSH data available.