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How Much are Biosimilars Used in Southern Italy?

A Retrospective Analysis of Epoetin Utilization in the Local Health Unit of Messina in the Years 2010–2011

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Abstract

Background

Epoetins are one of the three biologics for which biosimilars are available in Italy. So far, there is a lack of Italian national/regional longitudinal data about epoetin use.

Objective

The aim of this study was to evaluate the prescribing pattern of epoetins (reference products and biosimilars) in a Local Health Unit (LHU) of Southern Italy in recent years.

Methods

A retrospective drug utilization study was conducted during the period 1 January 2010–31 May 2011. The data source was the dispensing database of the Messina LHU, which contains anonymized data about dispensed drugs (including epoetins) that are prescribed by specialists to the residents in the catchment area. Indication of use and prescribed dosage of epoetins were derived by the therapeutic plans filled in by specialists and linked to drug dispensing records. Prevalence of epoetin use in the province of Messina (653 810 inhabitants) in 2010 was calculated. Furthermore, frequency analyses by sex, age, indication of use of epoetin users, as well as measurement of volume of use (defined daily dose [DDD]/1000/day) and expenditure of epoetins in 2010 were also performed. Analysis of the switching pattern between different reference products and biosimilar epoetins was performed.

Results

Overall, 4288 patients were treated with epoetins during the study period (mean age +1 SD: 74.2±13.7; females: 52%). Darbepoetin alpha and reference product epoetin alpha accounted overall for 79.8% of epoetin users, while biosimilars of epoetin alpha accounted for 0.9%. Among 1247 epoetin users for whom the therapeutic plan was revised, 1065 (85.4%) were treated because of anemia due to chronic kidney disease and 158 (12.6%) because of chemotherapy-induced anemia. In 2010, prevalence of epoetin use was 5.5 (95% CI 5.3, 5.7) per 1000 inhabitants in the province of Messina. The volume of use and related expenditure for epoetins was 3.58 DDD/1000 inhabitants/day and €5 572 457 (about €8.50 per capita/day) in 2010. Switching between different epoetins was very frequent (21.8% of users) but switching from reference products to biosimilars was very rare.

Conclusions

Epoetins are frequently dispensed to residents in the province of Messina, mainly for the treatment of chronic kidney disease-related anemia, with a relevant impact on the pharmaceutical expenditure covered by the National Health System. Use of biosimilar products is very low in both naïve patients and in those who switch from other reference product epoetins.

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Acknowledgments

G. Trifirò had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. G. Trifirò and A. Caputi played a major role in the study concept and design. Analysis and interpretation of data as well as drafting of the manuscript was mainly performed by G. Trifirò, C. Loiacono, A. Cannata, V. Arcoraci, R. Ferrara, and M. Schuemie; all the authors carried out a critical revision of the manuscript for important intellectual content and approved the final version of the manuscript.

No sources of funding were used to conduct this study. The authors have no conflicts of interest that are directly relevant to the content of this article.

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Authors and Affiliations

  1. Department of Clinical and Experimental Medicine and Pharmacology, Unit of Pharmacology, University of Messina, Via Consolare Valeria Gazzi, 98125, Messina, Italy

    Chiara Loiacono, Angelo Cannata, Rosarita Ferrara, Vincenzo Arcoraci, Achille P. Caputi &  Gianluca Trifirò

  2. Pharmaceutical Department of Local Health Unit of Messina, Messina, Italy

    Carmela Sgroi

  3. Unit of Pharmacy — P.O. “Barone I. Romeo” Patti, Messina, Italy

    Salvatore Coppolino

  4. Regional Center of Pharmacovigilance, Health Assessorate of Sicilian Region, Palermo, Italy

    Pasquale Cananzi

  5. Department of Clinical and Experimental Medicine and Pharmacology — Unit of Nephrology and Dialysis, University of Messina, Messina, Italy

    Vincenzo Savica

  6. Department of Medical Informatics, Erasmus University Medical Center, Rotterdam, the Netherlands

    Martijn Schuemie &  Gianluca Trifirò

Authors
  1. Chiara Loiacono
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  2. Carmela Sgroi
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  3. Salvatore Coppolino
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  4. Angelo Cannata
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  5. Rosarita Ferrara
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  6. Vincenzo Arcoraci
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  7. Pasquale Cananzi
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  8. Vincenzo Savica
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  9. Martijn Schuemie
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  10. Achille P. Caputi
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  11. Gianluca Trifirò
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Corresponding author

Correspondence to Gianluca Trifirò.

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Loiacono, C., Sgroi, C., Coppolino, S. et al. How Much are Biosimilars Used in Southern Italy?. BioDrugs 26, 113–120 (2012). https://doi.org/10.2165/11630770-000000000-00000

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  • DOI: https://doi.org/10.2165/11630770-000000000-00000

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