A systematic review of real-world healthcare resource use and costs of Clostridioides difficile infections.

Objective: To conduct a systematic review of published real-world evidence describing the cost and healthcare resource use for Clostridiodes difficile infection (CDI) in the United States. Methods: A systematic literature review was conducted searching for terms for CDI and healthcare costs. Titles of articles and abstracts were reviewed to identify those that met study criteria. Studies were evaluated to examine overall design and comparison groups in terms of healthcare resource use and cost for CDI. Results: In total, 28 articles met the inclusion criteria. Moreover, 20 studies evaluated primary CDI or did not specify, and 8 studies1-8 evaluated both primary CDI and recurrent (rCDI). Data from Medicare were used in 6 studies. Nearly all studies used a comparison group, either controls without CDI (N = 20) or comparison between primary CDI and rCDI (N = 7). Two studies examined costs of rCDI by the number of recurrences. Overall, the burden of CDI is significant, with higher aggregate costs for patients with rCDI. Compared with non-CDI controls, hospital length of stay increased in patients with both primary and rCDI compared to patients without CDI. Patients with primary CDI cost healthcare systems $24,000 more than patients without CDI. Additionally, 2 studies that evaluated the impact of recurrence among those patients with an index case of CDI demonstrated significantly higher direct all-cause medical costs among those with rCDI compared to those without. Conclusion: CDI, and particularly rCDI, is a costly condition with hospitalizations being the main cost driver.

Assessment of Quality of Life Among Patients With Recurrent Clostridioides difficile Infection Treated with Investigational Oral Microbiome Therapeutic SER-109: Secondary Analysis of a Randomized Clinical Trial.

Importance: Recurrent Clostridioides difficile infection (CDI) is a debilitating disease leading to poor health-related quality of life (HRQOL), loss of productivity, anxiety, and depression. The potential association of treatment with HRQOL has not been well evaluated. Objectives: To explore the association of SER-109 compared with placebo on HRQOL in patients with recurrent CDI up to week 8. Design, Setting, and Participants: This study was a secondary analysis of a randomized, double-blind, placebo-controlled trial that took place at 56 sites in the US and Canada from July 2017 to April 2020 and included 182 patients randomized to SER-109 or placebo groups. Interventions: SER-109 or placebo (4 capsules once daily for 3 days) following antibiotics for CDI. Main Outcomes and Measures: Exploratory analysis of HRQOL using the disease specific Clostridioides difficile Quality of Life Survey (Cdiff32) assessed at baseline, week 1, and week 8. Results: In this study, 182 patients (109 [59.9%] female; mean age, 65.5 [16.5] years) were randomized to SER-109 (89 [48.9%]) or placebo (93 [51.1%]) groups and were included in the primary and exploratory analyses. Baseline Cdiff32 scores were similar between patients in the SER-109 and placebo groups (52.0 [18.3] vs 52.8 [18.7], respectively). The proportion of patients with overall improvement from baseline in the Cdiff32 total score was higher in the SER-109 arm than placebo at week 1 (49.4% vs 26.9%; P = .012) and week 8 (66.3% vs 48.4%; P = .001).Greater improvements in total and physical domain and subdomain scores were observed in patients in the SER-109 group compared with placebo as early as week 1, with continued improvements observed at week 8. Among patients in the placebo group, improvements in HRQOL were primarily observed in patients with nonrecurrent CDI while patients in the SER-109 group reported improvements in HRQOL, regardless of clinical outcome. Conclusions and Relevance: In this secondary analysis of a phase 3 clinical trial, SER-109, an investigational microbiome therapeutic was associated with rapid and steady improvement in HRQOL compared with placebo through 8 weeks, an important patient-reported outcome. Trial Registration: ClinicalTrials.gov Identifier: NCT03183128.

Analysis of the costs and payments of a coordinated stroke center and regional stroke network.

BACKGROUND AND PURPOSE: An earlier study demonstrated significantly improved access, treatment, and outcomes after the implementation of a progressive, comprehensive stroke program at a tertiary care community hospital, Saint Luke's Neuroscience Institute (SLNI). This study evaluated the costs associated with implementing such a program. METHODS: Retrospective analysis of total hospital costs and payments for treating patients with ischemic stroke at SLNI (n=1570) as program enhancement evolved over time (2005, 2007, and 2010) and compared with published national estimates. Analyses were stratified by patient demographic characteristics, patient outcomes, treatments, time, and comorbidities. RESULTS: Controlling for inflation, there was no difference in SLNI total costs between 2005 and either 2007 or 2010, suggesting that while SLNI provided an increased level of services, any additional expenditures were offset by efficiencies. SLNI total costs were slightly lower than published benchmarks. Consistent with previous stroke care cost estimates, the median overall differential between total hospital costs and payments for all ischemic stroke cases was negative. CONCLUSIONS: SLNI total costs remained consistent over time and were slightly lower than previously published estimates, suggesting that a focused, streamlined stroke program can be implemented without a significant economic impact. This finding further demonstrates that providing comprehensive stroke care with improved access and treatment may be financially feasible for other hospitals.

Cost-effectiveness analysis of a new 8% capsaicin patch compared to existing therapies for postherpetic neuralgia.

OBJECTIVE: The purpose of this study was to compare the cost effectiveness of a new 8% capsaicin patch, compared to the current treatments for postherpetic neuralgia (PHN), including tricyclic antidepressants (TCAs), topical lidocaine patches, duloxetine, gabapentin, and pregabalin. METHODS: A 1-year Markov model was constructed for PHN with monthly cycles, including dose titration and management of adverse events. The perspective of the analysis was from a payer perspective, managed-care organization. Clinical trials were used to determine the proportion of patients achieving at least a 30% improvement in PHN pain, the efficacy parameter. The outcome was cost per quality-adjusted life-year (QALY); second-order probabilistic sensitivity analyses were conducted. RESULTS: The effectiveness results indicated that 8% capsaicin patch and topical lidocaine patch were significantly more effective than the oral PHN products. TCAs were least costly and significantly less costly than duloxetine, pregabalin, topical lidocaine patch, 8% capsaicin patch, but not gabapentin. The incremental cost-effectiveness ratio for the 8% capsaicin patch overlapped with the topical lidocaine patch and was within the accepted threshold of cost per QALY gained compared to TCAs, duloxetine, gabapentin, and pregablin. The frequency of the 8% capsaicin patch retreatment assumption significantly impacts its cost-effectiveness results. There are several limitations to this analysis. Since no head-to-head studies were identified, this model used inputs from multiple clinical trials. Also, a last observation carried forward process was assumed to have continued for the duration of the model. Additionally, the trials with duloxetine may have over-predicted its efficacy in PHN. Although a 30% improvement in pain is often an endpoint in clinical trials, some patients may require greater or less improvement in pain to be considered a clinical success. CONCLUSIONS: The effectiveness results demonstrated that 8% capsaicin and topical lidocaine patches had significantly higher effectiveness rates than the oral agents used to treat PHN. In addition, this cost-effectiveness analysis found that the 8% capsaicin patch was similar to topical lidocaine patch and within an accepted cost per QALY gained threshold compared to the oral products.

Impact of postherpetic neuralgia and painful diabetic peripheral neuropathy on health care costs.

UNLABELLED: Knowledge of the health care costs associated with neuropathic pain is limited. Existing studies have not directly compared the health care costs of different neuropathic pain conditions, and patients with neuropathic pain have not been compared with control subjects with the same underlying conditions (for example, diabetes). To determine health care costs associated with postherpetic neuralgia (PHN) and painful diabetic peripheral neuropathy (DPN), patients with these conditions were selected from 2 different administrative databases of health care claims and respectively matched to control subjects who had a diagnosis of herpes zoster without persisting pain or a diagnosis of diabetes without neurological complications using propensity scores for demographic and clinical factors. Total excess health care costs attributable to PHN and painful DPN and excess costs for inpatient care, outpatient/professional services, and pharmacy expenses were calculated. The results indicated that the annual excess health care costs associated with peripheral neuropathic pain in patients of all ages range from approximately $1600 to $7000, depending on the specific pain condition. Total excess health care costs associated with painful DPN were substantially greater than those associated with PHN, which might reflect the great medical comorbidity associated with DPN. PERSPECTIVE: The data demonstrate that the health care costs associated with 1 peripheral neuropathic pain condition cannot be extrapolated to other neuropathic pain conditions. The results also increase understanding of the economic burden of PHN and painful DPN and provide a basis for evaluating the impact on health care costs of new interventions for their treatment and prevention.

The identification of benefit in medical intervention: an overview and suggestions for process.

Benefit and risk assessments are not only important to regulatory authorities but also important to the providers, patients, pharmaceutical industry, and payers. In order for patients and providers to continue to have access to new innovative medicines, which have some level of inherent risk, it is critical to have a systematic and balanced focus on understanding the safety risks and benefits to the patient during drug development, at the time of approval and postmarketing. There has been a significant amount of activity around efforts to improve the ability to assess risks in the postmarketing environment. However, there is no widely accepted, systematic approach or process for the ongoing evaluation of benefit. This article introduces 4 critical components in the process of identifying and assessing benefit with a goal of providing a framework that is transparent, comprehensive, applicable to various perspectives, and simple to communicate and implement. We propose the development of a catalog applied to a particular disease to identify the optimal data sources and methods to address the interests of a given perspective. Two key resources will need to be developed to support the catalog development: (1) a summary of benefit measures and preferences by disease and from various perspectives and (2) an investment in a simple visual communication mechanism with minimal statistical language. As the emphasis is on transparency, relevance, applicability, and communication, this approach to assessing benefit should maximize the impact of these data to all stakeholders and decision makers.