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. 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

Ilaria Marcianò  1 , Ylenia Ingrasciotta  2 , Francesco Giorgianni  1 , Valentina Ientile  1 , Alessandro Chinellato  3 , Daniele Ugo Tari  4 , Rosa Gini  5 , Salvatore Cannavò  6 , Maurizio Pastorello  7 , Salvatore Scondotto  8 , Pasquale Cananzi  9 , Giuseppe Traversa  10 , Francesco Trotta  11 , Valeria Belleudi  11 , Antonio Addis  11 , Gianluca Trifirò  1   2   12
Affiliations

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

Ilaria Marcianò et al. Front Endocrinol (Lausanne). .

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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Figures

Figure 1
Figure 1
Identification of rGH users in the six participating centers. Legend: rGH, recombinant growth hormone (i.e., somatropin). *Naïve rGH users: rGH users without any rGH dispensing within 1 year prior to Index Date (date of first rGH dispensing during the study period).
Figure 2
Figure 2
Prevalence of recombinant growth hormone users per 1,000 inhabitants, stratified by calendar year and center. (A) Crude prevalence of use, (B) age-adjusted prevalence of use.
Figure 3
Figure 3
Prevalence of recombinant growth hormone users per 1,000 inhabitants in 2014, stratified by age classes and center.
Figure 4
Figure 4
Proportions (%) of users of biosimilars recombinant growth hormone on the total of recombinant growth hormone users, stratified by calendar years and center.
Figure 5
Figure 5
Time to discontinuation of recombinant growth hormone (rGH) therapy among naïve rGH users, stratified by sex.
Figure 6
Figure 6
Time to discontinuation of recombinant growth hormone (rGH) therapy among naïve rGH users, stratified by sex and age classes. (A) Sex: female, (B) sex: male.
Figure 7
Figure 7
Time to discontinuation of recombinant growth hormone (rGH) therapy among naïve rGH users, stratified by medicinal product.
Figure 8
Figure 8
Time to discontinuation of recombinant growth hormone (rGH) therapy among naïve rGH users affected by growth hormone deficiency, stratified by age classes.
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