Annual Patient and Caregiver Burden of Oncology Clinic Visits for Granulocyte-Colony Stimulating Factor (G-CSF) Therapy in the United States (US)
Authors: Stephens Mark , Li Xiaoyan , Reiner Maureen , Sheldon Wayne , Tzivelekis Spiros 
Published: October 2019

Abstract
Introduction: Cancer patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drug therapy often have suppressed white blood cell counts and are at risk for febrile neutropenia (FN). Treatment with G-CSFs at least 24 hours after administration of myelosuppressive chemotherapy is indicated for patients with a clinically significant incidence of FN. In the US most doses of G-CSFs are administered in the clinic during separate visits after the chemotherapy session, to ensure on label administration. Patients must return to the clinic, usually the next day, for G-CSF administration, often accompanied by a family member or other informal caregiver. Self-administration in the home is sometimes an option, but can be an unattractive option, due to high pharmacy co-pays, patient discomfort with self-treatment, physician concerns, etc. Therefore, the time and economic burden on patients and informal caregivers of clinic visits for G-CSF injections may be significant, and has not previously been estimated from a societal perspective in the US.
Methods: The total national patient and informal caregiver time and cost burden of prophylactic G-CSF clinic (physician office and hospital outpatient) visits was projected for calendar year 2015. Total annual visits for G-CSF injections following myelosuppressive chemotherapy for non-myeloid malignancies were estimated from models using data collected from the oncology literature, cancer patient databases (SEER, Oncology Services Comprehensive Electronic Records (OSCER)), and publically-available G-CSF revenue and pricing data. Average patient and caregiver travel times per visit, plus time in the clinic, were estimated from responses to a questionnaire completed by 598 patients in an ongoing prospective observational study (Prospective Study of the Relationship between Chemotherapy Dose Intensity and Mortality in Early-Stage (I-III) Breast Cancer Patients (CABS)). Total travel time plus time in the clinic for the G-CSF injection were cumulated for both patients and informal caregivers accompanying patients to the clinic. Total travel distance in miles and travel costs were estimated. The opportunity cost of time spent by patients and caregivers in G-CSF visits was monetized using national hourly wage data from the Bureau of Labor Statistics.
Results: The estimated total number of clinic visits for G-CSF injections in the United States following myelosuppressive chemotherapy for non-myeloid malignancies is 1.7 million visits for approximately 400,000 patients in 2015. Two-thirds of patients are expected to be accompanied to the visit by an informal caregiver (1.1 million visits). Mean(SD) travel time (round-trip) per visit is estimated at 62(50) minutes; with mean(SD) time in the clinic of 41(68) minutes. Mean(SD) travel distance round-trip is estimated to be 35(28) miles. The total national patient and informal caregiver time commitment for one year for travel to and from the clinic, plus time at the clinic, is estimated at 4.86 million hours (12.1 hours per patient), with their time valued at approximately $87.2 million ($218 per patient). The cumulative annual travel distance for G-CSF clinic visits is estimated at 59.7 million miles, at a total transportation cost of $28.2 million ($70 per patient). The total economic impact of time plus transportation costs is $115 million.
Table 1. 2015 Estimated Patient and Caregiver Burden of G-CSF Clinic Visits Clinic Visits Cumulative Time (hours) Cumulative Travel Miles Cumulative Time+Travel Costs Patients 1,700,000 2,921,167 59,726,667 $72.4 million Caregivers 1,127,100 1,936,734 39,598,780 $43.0 million Total 1,700,000 4,857,901 59,726,667 $115.4 million
Conclusions: The patient and informal caregiver burden of clinic visits for G-CSF therapy following myelosuppressive chemotherapy is a significant addition to the total disease burden borne by patients and their families. Efforts to reduce this burden for the patient and caregiver should be pursued.

Disclosures
Stephens: Amgen, Inc.: Consultancy; InnoPeritus: Consultancy. Li:Amgen, Inc.: Employment, Equity Ownership. Reiner:Amgen, Inc.: Employment. Sheldon:Amgen, Inc.: Employment. Tzivelekis:Amgen Inc.: Employment, Equity Ownership.