Performance of the pegfilgrastim on-body injector as studied with placebo buffer in healthy volunteers

Abstract

The pegfilgrastim OBI was well tolerated, and deliveries of placebo buffer were successful 98.3% of the time. The generalizability of these results may be limited by the conduct of this study in healthy subjects in a controlled environment.

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.…”

How to prevent medication errors: a multidimensional scaling study to investigate the distinguishability between self-injection platform device variants

“…Recently, the customization of device platforms into commercial device derivatives has emerged as a new dominant logic of device innovation for wearable on-body patch injectors [e.g. 10,11,12], dial-and-dose pens [e.g. 13,14,15,16,17,18], and syringe-based autoinjectors [e.g.…”