Purpose: Somatropin [recombinant growth hormone (rGH)] is approved in children\nand adults for several conditions involving growth disturbances and the corresponding\nbiosimilar is available in Italy since 2006. No population-based data are available on the\npattern of rGH use in Italian clinical practice. This study aimed at exploring the pattern of\nbiosimilar and originator rGH use in six Italian centers, where different policy interventions\npromoted biosimilar use.\nMethods: This population-based, drug-utilization study was conducted in the years\n2009ââ?¬â??2014, using administrative databases of Umbria, Tuscany, and Lazio Regions and\nLocal Health Units of Caserta, Treviso, and Palermo. NaÃ?¯ve rGH users were characterized,\nand prevalence of use and discontinuation were assessed over time.\nResults: Among 6,785 patients treated with rGH during the study years, 4,493 (66.2%)\nwere naÃ?¯ve users (males/females = 1.3), mostly affected by GH deficiency. The prevalence\nof rGH use increased from 2009 to 2010, remaining stable thereafter, but it was\nheterogeneous across centers (twofold higher prevalence of use in center n.2 than\ncenters n.4 and 1 in 2014). Biosimilar rGH uptake increased over time but was low (7.8%\nin 2014) and heterogeneous as well. Discontinuation of rGH therapy occurred in 54.0%\nof naÃ?¯ve users, more frequently in females than males (58.1 vs. 50.9%). During the first\nyear of treatment, discontinuation was frequent (39.9%), but no statistically significant\ndifferences were observed in treatment persistence for biosimilar vs. originator rGH\n(p > 0.05). Conclusion: Geographical heterogeneity in the prevalence of rGH use was observed.\nSimilarly, the biosimilar rGH uptake was low and variable across centers. Post-marketing\nmonitoring is required to continuously monitor the benefit-risk profile of rGH, thus guaranteeing\ngreater savings than only promoting lowest cost rGH.
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