(P-143) Prescribing Patterns of Lipegfilgrastim in EU: A Retrospective Study

Background: In the context of the regulatory approval of lipegfilgrastim in the European Union (EU), the European Medicines Agency requested a drug utilization study as part of the pharmacovigilance risk management plan to examine lipegfilgrastim use patterns. This was a 2-part study: feasibility study and main study. Findings from the preceding feasibility study have been implemented in this main study.

Objectives: The primary objective of this study was to describe lipegfilgrastim use patterns and quantify the extent of lipegfilgrastim use that is consistent with the prescribing information in routine clinical practice in several countries in the EU. The secondary objective was to describe the pattern of lipegfilgrastim use by patients’ clinical characteristics, prescribing physician's specialty and indication.

Methods: Data on lipegfilgrastim use between January 2014 and March 2020 were abstracted from medical records by medical abstractors (health care professionals). Lipegfilgrastim indication was categorized as either consistent or inconsistent with the prescribing information according to pre-defined criteria. The primary endpoint was the extent of lipegfilgrastim use inconsistent with the prescribing information based on the most recent lipegfilgrastim cycle. Lipegfilgrastim use pattern by patients’ and physicians’ characteristics, was described.

Results: A total of 481 patient records from 12 centers in 5 EU countries were obtained. Lipegfilgrastim was most commonly prescribed for the indication of neutropenia by oncologists in the hematology and oncology clinical settings. It was most commonly prescribed for older patients (≥55 years, 65%), and more commonly prescribed in female than in male patients (breast cancer was the most common cancer diagnosis).
For the most recent lipegfilgrastim cycle with no missing data, use consistent with the prescribing information was documented in 452/459 patients (98.5%), while use inconsistent with the prescribing information was documented in 7/459 patients (1.5%). The majority of use inconsistent with the prescribing information was attributed to use with non-cytotoxic drugs (57%). Use inconsistent with the prescribing information of lipegfilgrastim in all treatment cycles with no missing data was 11/1547 cycles (0.7%).

Conclusions: The study data are obtained from a large number of medical records of patients who were administered lipegfilgrastim in both hospital and outpatient clinical settings. The study results confirm the low frequency of use inconsistent with the prescribing information for lipegfilgrastim as reported in a preceding feasibility study and indicate very high adherence to the recommended indication.