Multi-Center Quantification Study of Time, Effort and Resource Utilization Associated with Autologous Peripheral Blood Stem Cell Mobilization: A European Perspective
Authors: Hübel Kai , Azar Nabih , Dunning David , Reitan John , Gallagher Meghan E. , Mohty Mohamad 
Published: October 2019

Abstract
Autologous peripheral blood stem cell mobilization has demonstrated clinical benefit for improving stem cell collection prior to autologous or allogenic transplantation. With intense competition for hospital resources required to evaluate and manage patients preparing for stem cell mobilization and transplantation, resource requirements associated with varying therapeutic interventions is warranted. Plerixafor is indicated in combination with G-CSF to enhance mobilization of hematopoietic stem cells to peripheral blood (PBSC) for collection and subsequent autologous transplantation inpatients with lymphoma (Non-Hodgkin's Lymphoma (NHL)) and multiple myeloma (MM) whose cells mobilize poorly. A non-interventional two-part study using aggregated, de-identified data was initiated across three European countries to assess resource utilization associated with PBSC mobilization and apheresis in NHL patients in the era prior to and following approval of plerixafor (to the "Pre-P" era through June 1, 2009, and "P" era from July 1, 2010 onwards; "P", respectively).
Adult patients aged ≥18 years, with a primary diagnosis of NHL, who underwent PBSC mobilization at 9 European centers in France, Germany and Italy were included in the study. Part I is a retrospective medical record review of 200 NHL patients. Outcomes measured in Part I included # of visits for administration of mobilizing agents and # days administered; assessment of adverse events (AEs) associated with administered mobilizing agents; # of apheresis sessions; hours of apheresis sessions; attainment of CD34+ target; and days until CD 34+ target level met. For Pre-P era patients, the peripheral CD-34+ count recorded immediately prior to the first apheresis; for P era patients, it was that recorded immediately prior to plerixafor administration. Part II is a prospective time and motion evaluation of apheresis performed at each center (5 events recorded per center; patient consent was obtained). Apheresis events were measured in consecutive patients scheduled to be candidates for PBSC mobilization. Time-motion assessments, obtained retrospectively (Part I) and prospectively (Part II), included total time to prepare the patient, perform apheresis and manage AEs. A micro-costing exercise was carried out by obtaining costs per unit of resource utilization from interviews with hospital administration staff. The study end points are the difference in mean time/effort to perform apheresis (including apheresis related AEs, if any) and total costs associated with mobilization to the hospital between patients in the Pre-P versus P eras.
Evaluation of patient demographics revealed no significant differences between pre-P and P era cohorts. Analysis of the number of apheresis sessions demonstrated a statistically significant reduction (P<0.001) for the P era group, including # of sessions, total blood volume collected and total apheresis time required to reach the targeted PBSC compared with Pre-P era group. Total cost differences between cohorts was estimated based on observed clinical and resource utilization differences. In addition, more than twice as many patients who had a CD 34+ <10 were mobilized in the P era compared with patients in the Pre-P era.
This study demonstrates that use of plexiafor is associated with statistically significant reductions in the # of apheresis sessions, driving both resource utilization efficiencies and cost savings for NHL patients undergoing autologous PBSC mobilization vs patients in the pre-P era. Further research to quantify the time and motion and cost-consequences of treatment approaches for stem cell mobilization in routine clinical care is warranted to optimize treatment for NHL patients.

Disclosures
Azar: Sanofi: Honoraria, Research Funding. Reitan:Amgen: Research Funding; Sanofi: Research Funding; Spectrum: Research Funding. Gallagher:Sanofi: Employment, Equity Ownership.