Abstract
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. 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. 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). 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.
Highlights
Discontinuation of somatropin therapy was frequent, but no statistically significant differences were observed for biosimilar vs. originator recombinant growth hormone (rGH)
Somatropin is a biological product containing recombinant growth hormone that is approved in adults with pronounced GH deficiency as replacement therapy and for a wide range of conditions associated to growth disturbances and short stature in children, such as Turner or Prader–Willi syndrome, GH deficiency, chronic kidney disease (CKD) or in short children/adolescents born small for gestational age (SGA)
Thanks to unique patient identifiers, different claims data [diagnosis at hospital discharge, reasons for health-care service payment exemptions, emergency department (ED) visits diagnosis, and other dispensed drugs reimbursed by the National Health Service (NHS)] from the six centers can be linked together. rGH prescription is associated to a therapeutic plan that is filled by specialists, who report the exact indication for use, brand name, dosing regimen, and dispensed number of packages
Summary
Somatropin is a biological product containing recombinant growth hormone (rGH) that is approved in adults with pronounced GH deficiency as replacement therapy and for a wide range of conditions associated to growth disturbances and short stature in children, such as Turner or Prader–Willi syndrome, GH deficiency, chronic kidney disease (CKD) or in short children/adolescents born small for gestational age (SGA). On the Italian market, rGH is available in different devices, which differ for technical aspects, quantity of rGH, and costs. Since 2006, biosimilar rGH is available on the European and Italian market, while no biosimilars rGH are marketed in the United States (US). The national report on medicines use in Italy reported a decreasing overall consumption of rGH in 2015, but showed an increasing trend in biosimilar rGH use, compared to the previous year (+21.5% for biosimilar rGH). Among the hormones-based systemic preparations, dispensed by public hospitals (excluding sex hormones), rGH ranks first for cost, with expenditure at €1.5/per capita [3] a relevant difference in overall rGH consumption across Italian regions has been reported [4], showing a patchy pattern throughout the country
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