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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.


Percentages of biosimilar users out of the total numbers of erythropoiesis-stimulating agent (ESA) users, stratified by calendar year and center
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Related In: Results  -  Collection


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Fig3: Percentages of biosimilar users out of the total numbers of erythropoiesis-stimulating agent (ESA) users, stratified by calendar year and center

Mentions: The prevalence of total ESA use (Fig. 2) increased from 2.9 per 1000 inhabitants in 2009 to 3.4 per 1000 inhabitants in 2011, with a slight decrease in the following 2 years (3.0 per 1000 in 2013). A similar trend was observed in the age-adjusted analysis. Specifically, the prevalence of ESA use in the Caserta LHU was higher during the first 4 years of the study (1.6–2.1 per 1000 inhabitants in 2009–2012, decreasing thereafter [1.8 per 1000 inhabitants in 2013]) than in the Treviso and Palermo LHUs and in Tuscany (see ESM 4). The patterns of ESA use did not change with stratification by indication for use (see ESM 5), except in Caserta, where an increase in the prevalence of ESA use in cancer patients during the study years was found. Overall, an increase in the proportion of ESA users receiving biosimilars in the four geographic areas over time was observed (Fig. 3), ranging from 1.8 % of total ESA users in 2010 to 33.6 % in 2013, with much larger increases in Treviso (from 0.0 to 45.0 %) and the Tuscany region (from 0.7 to 37.6 %) than in Caserta (from 7.5 to 22.9 %) and Palermo (from 0.0 to 27.7 %). A similar trend was observed when the analysis was stratified by indication for use; biosimilars were most frequently prescribed to treat anemia due to anticancer chemotherapy in the four geographic areas, with a slight decrease in the Caserta LHU during the last study year (19.5 % in 2013 as compared with 27.6 % in 2012) (see ESM 6). Most biosimilar users were naive patients (Fig. 4). Darbepoetin alpha (Aranesp) and epoetin zeta (Retacrit) were the most frequently prescribed ESAs among reference products and biosimilars, respectively. Epoetin zeta (a biosimilar of epoetin alpha) prescriptions increased substantially from 2009 to 2013 (from 0 to 18 % in Palermo, from 0 to 21 % in Caserta, from 0 to 24.0 % in the Tuscany region, and from 0 to 38.0 % in Treviso) (see ESM 7).Fig 2


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)

Percentages of biosimilar users out of the total numbers of erythropoiesis-stimulating agent (ESA) users, stratified by calendar year and center
© Copyright Policy - OpenAccess
Related In: Results  -  Collection

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

Fig3: Percentages of biosimilar users out of the total numbers of erythropoiesis-stimulating agent (ESA) users, stratified by calendar year and center
Mentions: The prevalence of total ESA use (Fig. 2) increased from 2.9 per 1000 inhabitants in 2009 to 3.4 per 1000 inhabitants in 2011, with a slight decrease in the following 2 years (3.0 per 1000 in 2013). A similar trend was observed in the age-adjusted analysis. Specifically, the prevalence of ESA use in the Caserta LHU was higher during the first 4 years of the study (1.6–2.1 per 1000 inhabitants in 2009–2012, decreasing thereafter [1.8 per 1000 inhabitants in 2013]) than in the Treviso and Palermo LHUs and in Tuscany (see ESM 4). The patterns of ESA use did not change with stratification by indication for use (see ESM 5), except in Caserta, where an increase in the prevalence of ESA use in cancer patients during the study years was found. Overall, an increase in the proportion of ESA users receiving biosimilars in the four geographic areas over time was observed (Fig. 3), ranging from 1.8 % of total ESA users in 2010 to 33.6 % in 2013, with much larger increases in Treviso (from 0.0 to 45.0 %) and the Tuscany region (from 0.7 to 37.6 %) than in Caserta (from 7.5 to 22.9 %) and Palermo (from 0.0 to 27.7 %). A similar trend was observed when the analysis was stratified by indication for use; biosimilars were most frequently prescribed to treat anemia due to anticancer chemotherapy in the four geographic areas, with a slight decrease in the Caserta LHU during the last study year (19.5 % in 2013 as compared with 27.6 % in 2012) (see ESM 6). Most biosimilar users were naive patients (Fig. 4). Darbepoetin alpha (Aranesp) and epoetin zeta (Retacrit) were the most frequently prescribed ESAs among reference products and biosimilars, respectively. Epoetin zeta (a biosimilar of epoetin alpha) prescriptions increased substantially from 2009 to 2013 (from 0 to 18 % in Palermo, from 0 to 21 % in Caserta, from 0 to 24.0 % in the Tuscany region, and from 0 to 38.0 % in Treviso) (see ESM 7).Fig 2

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.