Mortality, healthcare resource utilization, and cost among Medicare beneficiaries with Clostridioides difficile infection with and without sepsis

Abstract

Objective: To describe mortality, healthcare resource utilization (HRU), and costs among Medicare beneficiaries with primary Clostridioides difficile infection (pCDI) or recurrent CDI (rCDI), with and without sepsis. Methods: We conducted a retrospective observational study of 100% Medicare Fee-for-Service claims from adults aged ⩾ 65 years with ⩾1 CDI episode between 1 January 2009 and 31 December 2017. Patients were continuously enrolled in Medicare Parts A/B/D 12 months before and up to 12 months after pCDI. ICD-9/10 codes defined CDI using ⩾1 inpatient claim, or ⩾1 outpatient claim plus ⩾1 claim for CDI treatment. The pCDI episode ended after 14 days without a CDI claim. rCDI episodes started within 8 weeks from the end of a previous CDI episode. ICD-9/10 codes identified all-cause sepsis over 12 month follow-up. Results: Of 497,489 CDI patients, 41.0% ( N = 203,888) had sepsis; 57.7% with sepsis died versus 32.4% without sepsis. Among patients with pCDI only ( N = 345,893) or ⩾1 rCDI ( N = 151,596), 39.2% and 45.1% suffered sepsis, respectively. All-cause hospitalizations were frequent for all cohorts (range: 81–99%). Among patients who died, those with sepsis versus without had more-frequent intensive care unit (ICU) use (pCDI: 29% versus 15%; rCDI: 65% versus 34%), longer hospital stays (pCDI: 12 versus 10 days; rCDI: 12 versus 9 days), and higher per-patient-per-month costs (pCDI: $34,841 versus $22,753; rCDI: $42,269 versus $25,047). In both cohorts, sepsis patients who survived had higher total costs and all-cause HRU than those without sepsis. All p < 0.001 above. Conclusions: Sepsis was common among Medicare beneficiaries with CDI. CDI patients with sepsis, especially after an rCDI, experienced higher mortality, HRU, and costs compared with those without sepsis.

Safety of fecal microbiota, live-jslm (REBYOTA™) in individuals with recurrent Clostridioides difficile infection: data from five prospective clinical trials

“…CDI is a serious illness that can lead to complications, including sepsis, colectomy, and death – the risks of which increase with each subsequent CDI recurrence. 18,36 Recent retrospective claims analyses found that approximately 27% of patients aged 18–64 years and 35% of patients aged ⩾65 years with one rCDI event experienced sepsis within 12 months of the initial CDI; these percentages are 20–30 times greater than the less than 1% of participants treated with RBL that experienced sepsis or bacteremia. 18,37 Importantly, there were no reported infections for which the causative pathogen was traced to RBL.…”

Cost-Effectiveness Analysis of REBYOTA™ (Fecal Microbiota, Live-jslm [FMBL]) Versus Standard of Care for the Prevention of Recurrent Clostridioides difficile Infection in the USA

“…Despite current antibiotic treatments, patients with rCDI experience a disproportionately higher economic burden due to elevated use of healthcare resources, including increased hospitalization and post-acute care, and more costly surgeries compared to patients with CDI who have not experienced a recurrence, ICER results are subject to rounding errors. Precise values of costs and effectiveness with more decimals were used in the model calculation FMBL fecal microbiota, live-jslm, ICER incremental costeffectiveness ratio, LY life year, QALY quality-adjusted life year, SOC standard of care, USD United States dollar let alone a higher mortality [23,33,34]. FMBL is the first in class microbiota-based live biotherapeutic which demonstrated efficacy in the prevention of rCDI following antibiotic treatment in clinical trials [6].…”

The burden of CDI in the United States: a multifactorial challenge

“…Significant health complications of CDI include sepsis, colectomy, megacolon, intestinal perforation, and renal failure [ 42 ]. An analysis of three different sources, a commercial younger CDI related population, Medicare and all-cause data from the United Kingdom shows the incidence of complications and surgical intervention increases with rCDI, all of which contribute to longer hospital stays, ICU requirements, and high inpatient admission rates [ 38 , 42 , 55 ].…”

“…2 ) [ 38 ]. Rates are higher for older patients with 39% of Medicare patients with CDI suffering sepsis, increasing to 45% in those with rCDI [ 55 ]. Mortality associated with sepsis is very high with in-hospital, 30-day, and 12-month mortality rates of 24% [ 60 ], 30% [ 61 ], and 58% [ 55 ], respectively.…”

“…The burden of CDI and rCDI on the healthcare system is high CDI and rCDI are associated with a substantial economic burden that is driven by hospitalization costs (e.g., hospital admissions, intensive care use, length of stay) [21,26,28,42,55,60,81]. The number of all CDI-related hospitalizations has increased in recent years with CDI accounting for almost 1% of all admissions [50].…”