Department of Pharmaceutical Outcomes and Policy, College of Pharmacy, University of Florida, Gainesville.
Center for Drug Evaluation and Safety, University of Florida, Gainesville.
JAMA Netw Open. 2021 Nov 1;4(11):e2133474. doi: 10.1001/jamanetworkopen.2021.33474.
The introduction of biosimilars and novel delivery devices between 2014 and 2019 may have changed the utilization of granulocyte colony-stimulating factors (G-CSF).
To assess utilization trends of G-CSFs for primary prophylaxis of febrile neutropenia (FN) among patients with cancer receiving myelosuppressive chemotherapy with commercial or Medicare insurance.
DESIGN, SETTING, AND PARTICIPANTS: This cross-sectional study assessed G-CSF utilization trends overall and stratified by regimen febrile neutropenia risk level. Associations between patient characteristics and G-CSF use were evaluated. Patients with cancer, including breast, lung, colorectal, esophageal and gastric, pancreatic, prostate, ovarian, and non-Hodgkin lymphomas, initiating myelosuppressive chemotherapy courses were included from the 2014 to 2019 commercial insurance and 2014 to 2018 Medicare fee-for-service claims databases. Data were analyzed from March to June 2021.
Year of chemotherapy initiation.
The main outcomes were use and trends of G-CSFs for primary prophylaxis, from completion to 3 days after in the first chemotherapy cycle.
In total, 86 731 chemotherapy courses (mean [SD] age, 57.7 [11.5] years; 57 838 [66.7%] women and 28 893 [33.3%] men) were identified from 82 410 patients in the commercial insurance database and 32 398 chemotherapy courses (mean [SD] age, 71.8 [8.3] years; 18 468 [57.0%] women and 13 930 [43.0%] men) were identified from 30 279 patients in the Medicare database. Among the commercially insured population, 39 639 patients (45.7%) received G-CSFs, and 12 562 patients (38.8%) received G-CSFs among Medicare insured patients. Overall G-CSF use increased significantly throughout the study period in both populations, from 45.1% (95% CI, 44.4%-45.7%) of patients in 2014 to 47.5% (95% CI, 46.5%-48.5%) of patients in 2019 (P = .001) in the commercially insured population and from 36.0% (95% CI, 34.2%-38.0%) of patients in 2014 to 39.1% (95% CI, 38.1%-40.1%) of patients in 2018 (P < .001) in the Medicare population. The greatest increases in G-CSF use were observed among patients with high FN risk, from 75.0% (95% CI, 74.1%-76.0%) of patients to 83.2% (95% CI, 82.0%-84.2%) of patients (P < .001) among the commercially insured population and 75.3% (95% CI, 71.8%-78.6%) of patients to 86.2% (95% CI, 84.7%-87.6%) of patients (P < .001) among the Medicare population. Use of G-CSFs decreased in the commercially insured population among patients with intermediate FN risk (from 27.5% [95% CI, 26.4%-28.5%] of patients to 20.4% [95% CI, 19.1%-21.7%] of patients; P < .001) or low FN risk (from 19.3% [95% CI, 18.3%-20.4%] of patients to 16.3% [95% CI, 14.7%-18.0%] of patients; P < .001) and remained stable in the Medicare population (intermediate risk: from 26.4% [95% CI, 23.8%-29.2%] of patients to 28.4% [95% CI, 27.0%-29.8%] of patients; P = .35; low risk: from 19.6% [95% CI, 17.0%-22.4%] of patients to 20.9% [95% CI, 19.6%-22.3%] of patients; P = .58). Factors associated with increased odds of G-CSF use included older age (commercial insurance: adjusted odds ratio [aOR], 1.50 [95% CI, 1.41-1.59]; Medicare: aOR, 1.36 [95% CI, 1.08-1.71]), receiving a regimen with high FN risk (commercial insurance: aOR, 16.01 [95% CI, 15.17-16.90]; Medicare: aOR, 17.17 [95% CI, 15.76-18.71]), and history of neutropenia (commercial insurance: 3.90 (3.67-4.15); Medicare: 3.82 (3.50-4.18).
This cross-sectional study found that utilization of G-CSFs increased among patients with cancer with high FN risk in both a commercially and Medicare-insured population, but 14% to 17% of patients still did not receive preventive treatment.
重要性:在 2014 年至 2019 年间,生物仿制药和新型给药装置的引入可能改变了粒细胞集落刺激因子(G-CSF)的利用情况。
目的:评估在有商业保险或医疗保险的癌症患者中,接受骨髓抑制化疗的患者中 G-CSF 用于预防发热性中性粒细胞减少症(FN)的使用趋势。
设计、地点和参与者:本横断面研究评估了整体 G-CSF 利用趋势,并按方案发热性中性粒细胞减少症风险水平进行了分层。评估了患者特征与 G-CSF 使用之间的关联。纳入了接受骨髓抑制化疗的癌症患者,包括乳腺癌、肺癌、结直肠癌、食管癌和胃癌、胰腺癌、前列腺癌、卵巢癌和非霍奇金淋巴瘤,来自 2014 年至 2019 年商业保险和 2014 年至 2018 年医疗保险费用报销数据库。数据于 2021 年 3 月至 6 月进行分析。
暴露:化疗开始的年份。
主要结果和措施:主要结果是在第一个化疗周期完成后 3 天内,预防使用 G-CSF 的情况和趋势。
结果:在商业保险数据库中,从 82410 名患者中确定了 86731 个化疗疗程(平均[标准差]年龄为 57.7[11.5]岁;57838[66.7%]名女性和 28893[33.3%]名男性),从 30279 名患者中确定了 32398 个化疗疗程(平均[标准差]年龄为 71.8[8.3]岁;18468[57.0%]名女性和 13930[43.0%]名男性)在医疗保险数据库中。在商业保险人群中,有 39639 名患者(45.7%)接受了 G-CSF,12562 名患者(38.8%)接受了 G-CSF。在两个人群中,总体 G-CSF 使用率在整个研究期间均显著增加,从 2014 年的 45.1%(95%置信区间,44.4%-45.7%)到 2019 年的 47.5%(95%置信区间,46.5%-48.5%)(P<.001)在商业保险人群中,从 2014 年的 36.0%(95%置信区间,34.2%-38.0%)到 2018 年的 39.1%(95%置信区间,38.1%-40.1%)(P<.001)在医疗保险人群中。高 FN 风险患者中 G-CSF 使用率的增加最为显著,从 75.0%(95%置信区间,74.1%-76.0%)的患者增加到 83.2%(95%置信区间,82.0%-84.2%)的患者(P<.001)在商业保险人群中,从 75.3%(95%置信区间,71.8%-78.6%)的患者增加到 86.2%(95%置信区间,84.7%-87.6%)的患者(P<.001)在医疗保险人群中。商业保险人群中,中度 FN 风险(从 27.5%(95%置信区间,26.4%-28.5%)的患者降至 20.4%(95%置信区间,19.1%-21.7%)的患者;P<.001)或低 FN 风险(从 19.3%(95%置信区间,18.3%-20.4%)的患者降至 16.3%(95%置信区间,14.7%-18.0%)的患者;P<.001)的 G-CSF 使用率下降,而医疗保险人群的使用率保持稳定(中度风险:从 26.4%(95%置信区间,23.8%-29.2%)的患者降至 28.4%(95%置信区间,27.0%-29.8%)的患者;P=.35;低风险:从 19.6%(95%置信区间,17.0%-22.4%)的患者降至 20.9%(95%置信区间,19.6%-22.3%)的患者;P=.58)。与 G-CSF 使用增加相关的因素包括年龄较大(商业保险:调整后优势比[OR],1.50[95%置信区间,1.41-1.59];医疗保险:OR,1.36[95%置信区间,1.08-1.71])、接受高 FN 风险方案(商业保险:OR,16.01[95%置信区间,15.17-16.90];医疗保险:OR,17.17[95%置信区间,15.76-18.71])和中性粒细胞减少症史(商业保险:3.90[3.67-4.15];医疗保险:3.82[3.50-4.18])。
结论:本横断面研究发现,在有商业保险和医疗保险的癌症患者中,高 FN 风险患者的 G-CSF 使用率均有所增加,但仍有 14%至 17%的患者未接受预防治疗。