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Purpose: Clinical guidelines recommend radiofrequency ablation (RFA) for eradication of Barrett esophagus in patients with low-grade dysplasia (LGD) and high-grade dysplasia (HGD), but evidence on whether RFA provides good value for money is still sparse. This study evaluates the cost-effectiveness of RFA in Italy., Methods: A Markov model was used to estimate lifelong costs and consequences of disease progression with different treatments. RFA was compared with esophagectomy in the HGD group or endoscopic surveillance in the LGD group. Clinical and quality-of-life parameters were derived from a review of the literature and expert opinions, whereas Italian national tariffs were used as a proxy for costs., Findings: RFA dominated esophagectomy in patients with HGD with a probability of 83%. For patients with LGD, RFA was more effective and more costly than active surveillance (incremental cost-effectiveness ratio, €6276 per quality-adjusted life-year). At a cost-effectiveness threshold of €15,272, the probability of RFA being the optimal strategy in this population was close to 100%. Model results were sensitive to the cost of the interventions and utility weights used in the different disease states., Implications: RFA is likely to be the optimal choice for patients with LGD and HGD in Italy. Italy is discussing the implementation of a national program for the health technology assessment of medical devices, requiring more studies to prove value for money of emerging technologies., Competing Interests: Declaration of Interest Mr Federici and Dr Callea reported that in past years CERGAS SDA Bocconi has received unconditional grants for projects related to the products of Medtronic Italy. In all these research projects, the company did not play a role in any of the phases of the work. Dr Testoni, Dr Costamagna, Dr Trentino, and Dr Repici have in the past received honoraria for lectures, presentations, speaker's bureaus, manuscript writing, and/or educational events. The authors have indicated that they have no other conflicts of interest regarding the content of this article., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Purpose: Resource modeling aims to explicitly quantify the effects of adopting new health care technologies in settings with capacity-related constraints. The aim of this analysis was to use resource modeling to explore the effects of the uptake of first-line treatment with daratumumab on wait lists and wait times in patients with untreated multiple myeloma. Two formulations were compared: the standard IV formulation (DARA-IV) and a recently approved SC formulation (DARA-SC)., Methods: First, semi-structured interviews at six oncologic centers were used to retrieve data on the management of patients given a DARA-IV regimen. Second, a discrete event simulation (DES) model was built to estimate the effects on resource consumption, wait lists, and wait times in scenarios with different incident numbers of patients treated with either DARA-IV or DARA-SC., Findings: In all of the simulated scenarios with more incident patients initiated on first-line treatment with DARA-IV, the actual capacity of infusion chairs was not enough to meet the demand, leading to increases in wait times and wait lists. In the highest-demand scenario, 17 more infusion chairs per center would be required to avoid such increases. Treatment with DARA-SC would allow centers to meet the demand with their actual capacity., Implications: DES modeling can effectively be used to formally explore the effects of different formulations on the use of limited resources, wait lists, and wait times at the facility level. Based on the findings from this analysis, DARA-SC may free up resources and prevent short- and long-term costs to infusion centers., (Copyright © 2022. Published by Elsevier Inc.)

Purpose: Electrochemotherapy is increasingly entering into national and international guidelines, requiring formal evaluation of treatment costs and cost-effectiveness to ensure that its uptake provides value to budget-constrained health care systems. This study analyzed the early cost-effectiveness of electrochemotherapy in patients with Stage IIIc/IV skin melanoma in clinical practice in Slovenia. The costs of electrochemotherapy were compared to those of the standard of care, consisting of palliative treatment and therapy for symptoms., Methods: wThe study enrolled 23 patients treated with electrochemotherapy at the Institute of Oncology (Ljubljana, Slovenia). The mean cost of electrochemotherapy was estimated using patient-specific cost data on electrochemotherapy procedures and subsequent follow-up. Quality-adjusted life-years (QALYs) were estimated by collecting EQ-5D-3L questionnaires at baseline, after complete or partial response following the treatment, and after a relapse of skin lesions. A discrete-time Markov model was built to estimate the lifetime costs and consequences of using electrochemotherapy compared to standard of care, from the perspective of the Slovenian health care system. The analysis was conducted separately in the whole patient sample and in the subset of patients with bleeding lesions. Deterministic and probabilistic sensitivity analyses were conducted to test model assumptions and to characterize the uncertainty around model parameters., Findings: In the whole patient population, electrochemotherapy for skin melanoma Stage IIIc/IV was expected to increase QALYs by 0.29 (95% credible interval [CrI], 0.10-0.50), at the higher cost of 6568 EUR (95% CrI, 4593-8928) in comparison to the standard of care. At the cost-effectiveness threshold of 20,000 EUR/QALY, the estimated probabilities of electrochemotherapy being cost-effective compared to standard of care were 0.30 and 0.91 in the whole patient sample and in patients with bleeding lesions, respectively. In the whole sample population, a 50% reduction in the price of the electrodes was expected to increase the probability of electrochemotherapy being cost-effective from 0.30 to ~0.64., Implications: The findings from this cost-effectiveness analysis of data from clinical practice were based on a small sample size (ie, 23 patents), which made the subgroup of patients with bleeding lesions very small. Therefore, the findings in this patient population should be carefully interpreted., (Copyright © 2020 The Authors. Published by Elsevier Inc. All rights reserved.)

Somatic deoxyribonucleic acid (DNA) damage has been associated with early-phase and/or acute complications of atherosclerosis. However, it remains unclear whether circulating levels of DNA damage have prognostic value in patients with coronary artery disease (CAD). The aim of this study was to assess the prognostic significance of chromosomal DNA damage in human lymphocytes on the rate of major adverse cardiovascular events in patients with CAD. A follow-up prospective cohort study was carried out of 178 patients (153 men, mean age 61.9 +/- 9.7 years) with angiographically proved CAD who underwent micronucleus assay, a sensitive biomarker of chromosomal damage and genetic instability, from March 1999 and June 2001. During a mean follow-up period of 51.4 +/- 23.8 months, 58 patients had major adverse cardiovascular events (cardiac death, myocardial infarction, stroke, congestive heart failure, unstable angina, or coronary and peripheral revascularization). The overall event-free survival rates were 77.5%, 70.4%, and 49.0% in patients in the lower, middle, and upper tertiles of micronucleus level, respectively (log rank = 11.5, p = 0.003). In a multivariate Cox regression model, only the upper tertiles were significantly associated with a higher risk for major adverse cardiovascular events (hazard ratio 2.2, 95% confidence interval 1.1 to 4.7, p = 0.03). In conclusion, levels of peripheral chromosomal DNA damage may be a new sensitive biomarker of prognostic stratification in patients with known CAD.