학술논문

A retrospective review of the real-world experience of the Pegfilgrastim biosimilar (Lapelga®) to the reference biologic (Neulasta®).
Document Type
Article
Source
Journal of Oncology Pharmacy Practice. Jan2022, Vol. 28 Issue 1, p5-16. 12p.
Subject
*BIOLOGICAL products
*FEBRILE neutropenia
*GRANULOCYTE-colony stimulating factor
*ACQUISITION of data methodology
*CONFIDENCE intervals
*BIOSIMILARS
*RETROSPECTIVE studies
*DISEASE incidence
*EXPERIENCE
*TREATMENT effectiveness
*CANCER patients
*COST analysis
*MEDICAL records
*DESCRIPTIVE statistics
*COMBINED modality therapy
Language
ISSN
1078-1552
Abstract
Introduction: Cancer patients receiving myelosuppressive chemotherapy are vulnerable to febrile neutropenia (FN) which contributes to poor treatment outcomes. The use of granulocyte colony-stimulating factors is administered to prevent chemotherapy-induced neutropenia. The introduction of biosimilars has allowed for greater cost-savings while maintaining safety and efficacy. This retrospective study assessed the incidence of FN and related treatment outcomes and the cost minimization of a pegfilgrastim biosimilar and its reference. Methods: A retrospective chart review of breast cancer patients receiving (neo) adjuvant chemotherapy from February 2017 to May 2020 was conducted. The endpoints included the incidence of FN, the occurrence of dose reduction (DR), dose delay (DD) and pain. A cost minimization analysis was performed from a third-party payer perspective. Results: One hundred Neulasta® and 74 Lapelga® patients were included in the first-cycle analysis. The rate of FN in cycle 1 for Neulasta® and Lapelga® was 2/100 and 4/74, respectively; risk difference (RD) = 3.4%; 95% CI: –2.4 to 9.2%. Eighty-three Neulasta® and 59 Lapelga® patients were included in the all-cycle analyses, where DR was reported in 76 (15%) Neulasta® cycles vs 33 (10%) Lapelga® cycles (RD = –3.6, 95% CI: –10.2 to 2.9). DD was reported in 20 (4%) Neulasta® cycles vs. 11 (3.5%) Lapelga® cycles (RD = –0.3; 95% CI: –2.7 to 2.0). Adverse events were similar between groups. Cost minimization using a cohort of 20,000 patients translated into an incremental savings of $21,606,800 CAD for each cycle. Conclusion: The biosimilar pegfilgrastim was non-inferior to the reference biologic based on FN incidence in addition to related outcomes including DR and DD. [ABSTRACT FROM AUTHOR]