On-Body Injector: An Administration Device for Pegfilgrastim

Abstract

Many chemotherapy regimens used today require the support of a granulocyte-colony-stimulating factor for the prevention of life-threatening neutropenia. In March 2015, a delivery method was introduced for Neulasta® (pegfilgrastim) through an on-body injector (Onpro®), which may eliminate the need for patients to return for injection after chemotherapy, increase workflow, and allow more patients to be seen. The purpose of this study was to monitor the implementation of the Onpro delivery system in an outpatient facility.

Febrile neutropenia hospitalization due to pegfilgrastim on-body injector failure compared to single-injection pegfilgrastim and daily injections with reference and biosimilar filgrastim: US cost simulation for lung cancer and non-Hodgkin lymphoma

“…These costs were compared subsequently to the costs of assured prophylaxis with pegfilgrastim and various published daily regimens of reference filgrastim and biosimilar filgrastim-sndz to estimate the total incremental costs associated with varying rates of PEG-OBI failure. The 1% to 10% device failure rates reflect the published 1.7 to 6.9% failure rates [13][14][15][16] with an additional margin to accommodate any upper-bound imprecision in these point estimates.…”

“…In December 2017, the US FDA label for Neulasta 12 was amended in response to accounts of the device not performing as intended. Studies have reported failure rates between 1.7-6.9% [13][14][15][16] . Being a single-administration formulation, a missed or partial dose puts patients undergoing myelotoxic chemotherapy at risk of levels of FN and FN-related hospitalizations that exceed the rates associated with assured prophylaxis with pegfilgrastim or filgrastim or available G-CSF biosimilars.…”

Cost-efficiency and expanded access of prophylaxis for chemotherapy-induced (febrile) neutropenia: economic simulation analysis for the US of conversion from reference pegfilgrastim to biosimilar pegfilgrastim-cbqv

“…A recent study by IBM Watson Health and Amgen found that, in the period from January 2017 to May 2018, 58.4% of reference pegfilgrastim administrations were "early" or same-day as chemotherapy 39 . While the pegfilgrastim OBI device enables clinicians to administer reference pegfilgrastim per label in the 24-72 h post-chemotherapy time window, failure and malfunction rates between 1.7 and 6.9% [40][41][42][43] have been reported. Extrapolated to a panel of 20,000 patients, this implies that between 340 and 1,380 patients, respectively, would not be prophylacted.…”

Initial testing of pegfilgrastim (Neulasta Onpro) on‐body injector in multiple radiological imaging environments

“…Normal device failure rate should also be accounted for when interpreting these results. Even though no failure was observed in our pilot test, the device's baseline failure rate in patients not exposed to imaging environments has been reported to be up to 7%, including delivery failure or device leakage 25,26 …”

“…Even though no failure was observed in our pilot test, the device's baseline failure rate in patients not exposed to imaging environments has been reported to be up to 7%, including delivery failure or device leakage. 25,26 Many implantable and external devices are considered contraindications for imaging exams by their manufacturers. 27…”