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Acute kidney injury (AKI) is common after cardiac surgery, and expeditious recognition with specific biomarkers may help improve outcome. Because the economic impact of a biomarker-based diagnostic strategy is unknown, we assessed the cost-effectiveness of using urinary neutrophil gelatinase-associated lipocalin (NGAL) for the diagnosis of AKI after cardiac surgery compared with current diagnostic methods. A decision analysis model was developed using the societal perspective to evaluate the cost-effectiveness of NGAL. Cost per quality-adjusted life-year (QALY) was determined for NGAL and standard strategies. The base case was a 67-year-old male patient undergoing coronary artery bypass graft surgery in the United Kingdom. Multiple sensitivity analyses were performed to determine how cost-effectiveness would vary with changes in the underlying clinical and economic variables. The base case yielded expected costs of £4244 and 11.86 QALYs for the NGAL strategy compared with £4672 and 11.79 QALYs for the standard therapy. The cost-effectiveness ratio for the NGAL strategy was £358/QALY compared with £396/QALY for the standard regimen. Cost-effectiveness increased as the treatment effect—defined as the ability to prevent progression of established AKI (kidney injury or failure)—for the therapy triggered by an elevated NGAL level rose. Sensitivity analysis demonstrated that the model was most responsive to the probability of developing AKI and least sensitive to the test cost for NGAL. Probabilistic sensitivity analysis supported the NGAL strategy as the most cost-effective option. Because this study was a decision analysis model incorporating a nonspecific treatment for AKI (as opposed to an observational study or controlled trial), model structural assumptions may therefore have underestimated mortality and the likelihood of developing AKI, although these were tested in multiple sensitivity analyses. Indirect costs were also not explicitly factored. The use of urinary NGAL after cardiac surgery appears to be cost-effective in the early diagnosis of AKI.

A significant portion of patients with Clostridium difficile infections (CDI) experience recurrence, and there is little consensus on its treatment. With the availability of newer agents for CDI and the added burdens of recurrent disease, a cost-effectiveness analysis may provide insight on the most efficient use of resources. A decision-tree analysis was created to compare the cost-effectiveness of 3 possible treatments for patients with first CDI recurrence: oral vancomycin, fidaxomicin, or bezlotoxumab plus vancomycin. The model was performed from a payer's perspective with direct cost inputs and a timeline of 1 year. A systematic review of literature was performed to identify clinical, utility, and cost data. Quality-adjusted life years (QALY) and incremental cost-effectiveness ratios were calculated. The willingness-to-pay (WTP) threshold was set at $100,000 per QALY gained. The robustness of the model was tested using one-way sensitivity analyses and probabilistic sensitivity analysis. Vancomycin had the lowest cost ($15,692) and was associated with a QALY gain of 0.8019 years. Bezlotoxumab plus vancomycin was a dominated strategy. Fidaxomicin led to a higher QALY compared to vancomycin, at an incremental cost of $500,975 per QALY gained. Based on our WTP threshold, vancomycin alone was the most cost-effective regimen for treating the first recurrence of CDI. Sensitivity analyses demonstrated the model's robustness. Vancomycin alone appears to be the most cost-effective regimen for the treatment of first recurrence of CDI. Fidaxomicin alone led to the highest QALY gained, but at a cost beyond what is considered cost-effective.

Abstract Background Global metabolic dysfunction-associated steatotic liver disease (MASLD) prevalence is estimated at 30% and projected to reach 55.7% by 2040. In the Veterans Affairs (VA) healthcare system, an estimated 1.8 million veterans have metabolic dysfunction-associated steatohepatitis (MASH). Methods Adult patients at risk for MASLD in a VA healthcare system underwent Fibrosis-4 (FIB-4) and Enhanced Liver Fibrosis (ELF®) testing. Referral rates and cost savings were compared among 6 noninvasive testing (NIT) strategies using these 2 tests independently or sequentially at various cutoffs. Results Enrolled patients (N = 254) had a mean age of 65.3 ± 9.3 years and mean body mass index (BMI) of 31.7 ± 6, 87.4% male: 78.3% were non-Hispanic/Latino, and 96.5% had type 2 diabetes mellitus (T2DM). Among the 6 evaluated strategies, using FIB-4 followed by ELF at a 9.8 cutoff yielded the highest proportion of patients retained in primary care without need of referral to hepatology clinic (165/227; 72.7%), and was associated with the lowest costs ($407.62). Compared to the FIB-4 only strategy, FIB-4/ELF with a 9.8 cutoff strategy resulted in 26% fewer referrals and 8.47% lower costs. In the subgroup of patients with BMI >32, there were 25.17% fewer referrals and costs were 8.31% lower. Conclusions Our study suggests that sequential use of ELF with a 9.8 cutoff following indeterminate FIB-4 tests results in lower referral rates and lower care costs in a veteran population at risk of MASLD. Adding ELF as a sequential test after indeterminate FIB-4 might help reduce the number of referrals and overall cost of care.

Objective: The authors evaluated the cost-effectiveness of a FISH assay in melanoma diagnosis in the USA. Method: A model was developed simulating the addition of FISH to the diagnosis of suspected melanoma. A decision analytic module simulated diagnosis using microscopic assessment alone versus addition of FISH (sensitivity: 92%; specificity: 94%). The authors simulated a clinical setting in which an initial excisional biopsy microscopic assessment (sensitivity: 73%; specificity: 78%) was followed by dermatopathologist assessment (sensitivity: 89%; specificity: 79%) for inconclusive results. Diagnostic strategies 1 and 2 added FISH to the initial and dermatopathologist assessments, respectively. A Markov outcomes module simulated patients' remaining lifetime, including treatment. Results: In diagnostic strategies 1 and 2, the cost per quality-adjusted life year gained was US$14,930 and 43,925, respectively, versus no FISH. Cost per misdiagnosis avoided was US$3292 and 3759, respectively. Sensitivity and specificity without FISH were both ≥88%; however, addition of FISH exceeded US$100,000/quality-adjusted life year. Conclusion: In specific clinical settings, FISH could be cost effective for melanoma diagnosis.

Monoclonal antibodies directed against the endotoxins produced by gram-negative organisms have been developed for the treatment of patients with sepsis. Phase 3 clinical trials in which two of these agents, E5 and HA-1A, have been evaluated have suggested possible benefit in terms of improved survival and reversal of organ dysfunction for certain subgroups. Since monoclonal antibodies are expected to be expensive, cost-effectiveness analysis is necessary to assess the joint clinical and economic impact. Cost-effectiveness studies based on the clinical data from these phase 3 trials have suggested that monoclonal antibodies may represent a cost-effective approach to the treatment of sepsis. However, an increase in the number of questions concerning the clinical efficacy of these agents and their ultimate impact on survival mandates the need for further clinical and economic investigation.