Nelson Winnie W, Scott Takara A, Boules Mena, Teigland Christie, Parente Alexis, Unni Sudhir, Feuerstadt Paul
Ferring Pharmaceuticals, Parsippany, NJ.
Avalere Health, Washington, DC.
J Manag Care Spec Pharm. 2021 Jul;27(7):828-838. doi: 10.18553/jmcp.2021.20395. Epub 2021 Mar 11.
infection (CDI) affected an estimated 365,000 persons in the United States in 2017. Despite a nationally decreasing trend of CDI cases, the population incidence of recurrent CDI (rCDI) has not improved. Elderly individuals (aged ≥ 65 years) are at higher risk of CDI, rCDI, and complicated CDI compared with younger individuals. To analyze Medicare fee-for-service data for 12 months after an initial CDI episode, in order to obtain real-world data on health care resource utilization (HRU) and costs for elderly patients with CDI and rCDI. A retrospective cohort study of patients who were aged ≥ 65 years and had a first (index) CDI diagnosis from January 1, 2010, to December 31, 2016, and continuous enrollment in Medicare Parts A, B, and D during the 12-month pre-index and 12-month post-index periods was conducted. A CDI episode was identified by either an inpatient stay with CDI diagnosis code or an outpatient medical claim with a CDI diagnosis code plus a CDI treatment. Each CDI episode was followed by a 14-day CDI claim-free period after the last CDI claim or end of CDI treatment. rCDI was a second or subsequent episode of CDI that occurred within an 8-week window after the 14-day CDI claim-free period. The number of CDI and rCDI episodes, HRU, time to recurrence, and total all-cause direct medical costs were calculated over the 12-month pre-index (baseline) and 12-month follow-up periods and stratified by number of rCDI episodes (No rCDI, 1 rCDI, 2 rCDI, 3+ rCDI). A total of 268,762 patients with an index CDI were included. Mean age was 78.3 years, and 69.0% were female. HRU was higher during the 6 months immediately pre-index versus 7-12 months pre-index, including a higher proportion of patients with a hospital admission (55.1% vs. 27.5%) or emergency department visit (41.3% vs. 27.4%), respectively. Moreover, 34.7% of the study population experienced rCDI. Of those who experienced 1 recurrence, 59.1% had a second recurrence, and of those who had 2 recurrences, 58.4% had a third. During the 12-month follow-up, postacute care was used by at least 70% of each rCDI cohort. The proportion of patients with ≥ 4 hospital admissions during follow-up was highest for the 3+ rCDI cohort (24.9% of patients). During the 12-month follow-up, mean total all-cause direct costs were $76,024, $99,348, $96,148, and $96,517 for the No rCDI, 1 rCDI, 2 rCDI, and 3+ rCDI cohorts, respectively, largely driven by inpatient costs. Adjusted all-cause total costs were significantly higher for all 3 rCDI cohorts compared with the No rCDI cohort. Elderly individuals experienced high rates of recurrence after their first CDI episode, and especially after a prior recurrence. The intensity of HRU during follow-up was higher for patients who suffered recurrences. Patients with rCDI had the burden of higher costs of care, including the patient out-of-pocket responsibility, versus patients with a single CDI episode. Funding for this study was provided by Ferring Pharmaceuticals. Nelson is an employee of Ferring Pharmaceuticals, and Scott, Boules, and Unni were employees of Ferring Pharmaceuticals at the time of this study. Teigland and Parente are employees of Avalere Health and provided consulting services to Ferring Pharmaceuticals. Feuerstadt has served as a consultant to and on the speakers bureau for Merck and Co. and has served as a consultant for Ferring Pharmaceuticals and Roche Pharmaceuticals. Portions of the data contained in this study appeared as an abstract/ePoster for the AMCP Annual Meeting 2020, April 2020.
2017年,美国艰难梭菌感染(CDI)影响了约36.5万人。尽管全国范围内CDI病例呈下降趋势,但复发性CDI(rCDI)的人群发病率并未改善。与年轻个体相比,老年个体(年龄≥65岁)发生CDI、rCDI和复杂性CDI的风险更高。为分析初次CDI发作后12个月的医疗保险按服务付费数据,以获取CDI和rCDI老年患者医疗保健资源利用(HRU)及费用的真实世界数据。对年龄≥65岁、在2010年1月1日至2016年12月31日期间首次(索引)诊断为CDI且在索引前12个月和索引后12个月连续参加医疗保险A、B和D部分的患者进行了一项回顾性队列研究。通过带有CDI诊断代码的住院治疗或带有CDI诊断代码加CDI治疗的门诊医疗索赔来确定CDI发作。每次CDI发作后,在最后一次CDI索赔或CDI治疗结束后有14天的无CDI索赔期。rCDI是在14天无CDI索赔期后的8周内发生的第二次或后续CDI发作。在索引前12个月(基线)和12个月随访期内计算CDI和rCDI发作次数、HRU、复发时间和全因直接医疗总费用,并按rCDI发作次数(无rCDI、1次rCDI、2次rCDI、3次及以上rCDI)分层。共纳入268762例索引CDI患者。平均年龄为78.3岁,69.0%为女性。与索引前7 - 12个月相比,索引前立即的6个月内HRU更高,包括住院患者比例更高(55.1%对27.5%)或急诊科就诊患者比例更高(41.3%对27.4%)。此外,34.7%的研究人群经历了rCDI。在经历1次复发的患者中,59.1%有第二次复发,在经历2次复发的患者中,58.4%有第三次复发。在12个月随访期间,每个rCDI队列中至少70%的患者使用了急性后期护理。随访期间住院≥4次的患者比例在3次及以上rCDI队列中最高(占患者的24.9%)。在12个月随访期间,无rCDI、1次rCDI、2次rCDI和3次及以上rCDI队列的全因直接平均总费用分别为76024美元、99348美元、96148美元和96517美元,主要由住院费用驱动。与无rCDI队列相比,所有3个rCDI队列的调整后全因总费用显著更高。老年个体在首次CDI发作后,尤其是在先前复发后,复发率很高。复发患者随访期间HRU强度更高。与单次CDI发作的患者相比,rCDI患者承担着更高的护理费用负担,包括患者自付费用。本研究由辉凌制药公司提供资金。纳尔逊是辉凌制药公司的员工,斯科特、布勒斯和乌尼在本研究期间是辉凌制药公司的员工。泰格兰德和帕伦特是阿瓦雷健康公司的员工,并为辉凌制药公司提供咨询服务。费尔施塔特曾担任默克公司的顾问并在其演讲局任职,还曾担任辉凌制药公司和罗氏制药公司的顾问。本研究中包含的部分数据曾作为2020年4月AMCP年会的摘要/电子海报展示。