Sigal Kaplan1, Dana Ilic Bogojevic2, Carolyn Rainville3, Nicholas Gross4. 1. Teva Pharmaceutical Industries Ltd, 12 Hatrufa St, 4250483, Netanya, Israel. Sigal.Kaplan@teva.co.il. 2. Teva Pharmaceutical Industries Ltd, 400 Interpace Pkwy, Parsippany, NJ, 07054, USA. 3. Teva Pharmaceutical Industries Ltd, 41 Moores Road, Malvern, PA, 19355, USA. 4. Teva Pharmaceutical Industries Ltd, 145 Brandywine Pkwy, West Chester, PA, 19380, USA.
Abstract
PURPOSE: Lipegfilgrastim (Lonquex, Teva Pharma B.V.) is approved for reduction in neutropenia duration and febrile neutropenia incidence. In the framework of lipegfilgrastim regulatory approval in the EU, the Health Authorities requested a drug utilization study. This study was conducted to characterize prescribing patterns of lipegfilgrastim and quantify the extent of on- and off-label use of lipegfilgrastim in real-world setting in Europe. METHODS: Information on lipegfilgrastim use between January 2014 and March 2020 was abstracted from medical records in hospital and outpatient clinical settings. Indication for lipegfilgrastim was classified either as on-label or off-label use according to pre-determined criteria. The primary endpoint was the extent of lipegfilgrastim off-label use based on the most recent lipegfilgrastim cycle. RESULTS: Records of 481 patients were obtained from five European countries. Lipegfilgrastim was most commonly prescribed for prevention of neutropenia by oncologists and hematologists. Patients who were administered lipegfilgrastim were primarily ≥ 55 years old (65.1%) and female (65.7%). The most frequent underlying diagnosis was breast cancer (38.3%). For the most recent lipegfilgrastim cycle, on-label use was recorded in 452/459 patients with no missing data (98.5%), while off-label use was recorded in 7/459 patients (1.5%). The majority of off-label use was attributed to use with non-cytotoxic chemotherapy (57.1%). Off-label use of lipegfilgrastim across all treatment cycles with no missing data was 11/1547 cycles (0.7%). CONCLUSION: Using real-world data, these findings confirm the low rate of lipegfilgrastim off-label use as reported in a preceding feasibility study, indicating very high adherence to the approved indication.
PURPOSE: Lipegfilgrastim (Lonquex, Teva Pharma B.V.) is approved for reduction in neutropenia duration and febrile neutropenia incidence. In the framework of lipegfilgrastim regulatory approval in the EU, the Health Authorities requested a drug utilization study. This study was conducted to characterize prescribing patterns of lipegfilgrastim and quantify the extent of on- and off-label use of lipegfilgrastim in real-world setting in Europe. METHODS: Information on lipegfilgrastim use between January 2014 and March 2020 was abstracted from medical records in hospital and outpatient clinical settings. Indication for lipegfilgrastim was classified either as on-label or off-label use according to pre-determined criteria. The primary endpoint was the extent of lipegfilgrastim off-label use based on the most recent lipegfilgrastim cycle. RESULTS: Records of 481 patients were obtained from five European countries. Lipegfilgrastim was most commonly prescribed for prevention of neutropenia by oncologists and hematologists. Patients who were administered lipegfilgrastim were primarily ≥ 55 years old (65.1%) and female (65.7%). The most frequent underlying diagnosis was breast cancer (38.3%). For the most recent lipegfilgrastim cycle, on-label use was recorded in 452/459 patients with no missing data (98.5%), while off-label use was recorded in 7/459 patients (1.5%). The majority of off-label use was attributed to use with non-cytotoxic chemotherapy (57.1%). Off-label use of lipegfilgrastim across all treatment cycles with no missing data was 11/1547 cycles (0.7%). CONCLUSION: Using real-world data, these findings confirm the low rate of lipegfilgrastim off-label use as reported in a preceding feasibility study, indicating very high adherence to the approved indication.
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Authors: S Fruehauf; J Klaus; J Huesing; M R Veldwijk; E C Buss; J Topaly; T Seeger; L W J Zeller; T Moehler; A D Ho; H Goldschmidt Journal: Bone Marrow Transplant Date: 2007-04-23 Impact factor: 5.483