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Front Endocrinol (Lausanne). 2018 Mar 13;9:95. doi: 10.3389/fendo.2018.00095. eCollection 2018.

Pattern of Use of Biosimilar and Originator Somatropin in Italy: A Population-Based Multiple Databases Study During the Years 2009-2014.

Author information

1
Unit of Clinical Pharmacology, A.O.U. Policlinico "G. Martino", Messina, Italy.
2
Department of Biomedical and Dental Sciences and Morphofunctional Imaging, University of Messina, Messina, Italy.
3
Pharmaceutical Service, Local Health Authority (ULSS9), Treviso, Italy.
4
Caserta-1 Local Health Service, Caserta, Italy.
5
Agenzia regionale di sanità della Toscana, Florence, Italy.
6
Endocrinology, Department of Adult and Childhood Human Pathology G. Barresi, University of Messina, Messina, Italy.
7
Department of Pharmacy, Palermo Local Health Unit, Palermo, Italy.
8
Department of Epidemiologic Observatory, Health Department of Sicily, Palermo, Italy.
9
Sicilian Regional Centre of Pharmacovigilance, Servizio 7-Farmaceutica, Health Department of Sicily, Palermo, Italy.
10
Pharmacoepidemiology Unit, National Centre for Epidemiology, Italian National Institute of Health, Rome, Italy.
11
Department of Epidemiology, Lazio Regional Health Service, Rome, Italy.
12
Department of Medical Informatics, Erasmus Medical Centre, Rotterdam, Netherlands.

Abstract

Purpose:

Somatropin [recombinant growth hormone (rGH)] is approved in children and adults for several conditions involving growth disturbances and the corresponding biosimilar is available in Italy since 2006. No population-based data are available on the pattern of rGH use in Italian clinical practice. This study aimed at exploring the pattern of biosimilar and originator rGH use in six Italian centers, where different policy interventions promoted biosimilar use.

Methods:

This population-based, drug-utilization study was conducted in the years 2009-2014, using administrative databases of Umbria, Tuscany, and Lazio Regions and Local Health Units of Caserta, Treviso, and Palermo. Naïve rGH users were characterized, and prevalence of use and discontinuation were assessed over time.

Results:

Among 6,785 patients treated with rGH during the study years, 4,493 (66.2%) were naïve users (males/females = 1.3), mostly affected by GH deficiency. The prevalence of rGH use increased from 2009 to 2010, remaining stable thereafter, but it was heterogeneous across centers (twofold higher prevalence of use in center n.2 than centers n.4 and 1 in 2014). Biosimilar rGH uptake increased over time but was low (7.8% in 2014) and heterogeneous as well. Discontinuation of rGH therapy occurred in 54.0% of naïve users, more frequently in females than males (58.1 vs. 50.9%). During the first year of treatment, discontinuation was frequent (39.9%), but no statistically significant differences were observed in treatment persistence for biosimilar vs. originator rGH (p > 0.05).

Conclusion:

Geographical heterogeneity in the prevalence of rGH use was observed. Similarly, the biosimilar rGH uptake was low and variable across centers. Post-marketing monitoring is required to continuously monitor the benefit-risk profile of rGH, thus guaranteeing greater savings than only promoting lowest cost rGH.

KEYWORDS:

biosimilar; drug-utilization study; health-care administrative databases; pattern of use; somatropin

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