The Role of Multimodal Imaging in Pathological Response Prediction of Locally Advanced Cervical Cancer Patients Treated by Chemoradiation Therapy Followed by Radical Surgery.

PURPOSE: This study aimed to develop predictive models for pathological residual disease after neoadjuvant chemoradiation (CRT) in locally advanced cervical cancer (LACC) by integrating parameters derived from transvaginal ultrasound, MRI and PET/CT imaging at different time points and time intervals. METHODS: Patients with histologically proven LACC, stage IB2-IVA, were prospectively enrolled. For each patient, the three examinations were performed before, 2 and 5 weeks after treatment ("baseline", "early" and "final", respectively). Multivariable logistic regression models to predict complete vs. partial pathological response (pR) were developed and a cost analysis was performed. RESULTS: Between October 2010 and June 2014, 88 patients were included. Complete or partial pR was found in 45.5% and 54.5% of patients, respectively. The two most clinically useful models in pR prediction were (1) using percentage variation of SUVmax retrieved at PET/CT "baseline" and "final" examination, and (2) including high DWI signal intensity (SI) plus, ADC, and SUVmax collected at "final" evaluation (area under the curve (95% Confidence Interval): 0.80 (0.71-0.90) and 0.81 (0.72-0.90), respectively). CONCLUSION: The percentage variation in SUVmax in the time interval before and after completing neoadjuvant CRT, as well as DWI SI plus ADC and SUVmax obtained after completing neoadjuvant CRT, could be used to predict residual cervical cancer in LACC patients. From a cost point of view, the use of MRI and PET/CT is preferable.

Real-world data on patients with metastatic non-small-cell lung cancer treated with checkpoint inhibitors in an Italian Teaching Hospital in 2015-2018.

BACKGROUND: Non-small-cell lung carcinoma (NSCLC) accounts for 85-90% of all forms of lung cancer. Immuno-oncology represents a valid new approach but the high cost requires a specific evaluation of the health outcomes. This study describes the real-world efficacy, safety and cost profiles of the new anti-PD-1 immune-checkpoint inhibitors nivolumab and pembrolizumab on a cohort of 56 selected patients with advanced NSCLC. METHODS: A retrospective, observational analysis was conducted on patients treated with immune checkpoint inhibitors from September 2015 to September 2018 at Azienda Ospedaliera Universitaria "Mater Domini" in Catanzaro, Italy. Data sources were medical records, internal prescription cards and reports of adverse reactions. RESULTS: Fifty-six patients were diagnosed with advanced NSCLC, 64.3% characterized by a non-squamous histology, 30.3% squamous and 5.4% not specified. First-line treatment with pembrolizumab was administered to 11 patients for an average of 4.4 months, while 45 patients were treated with nivolumab for an average of 8.6 months. Data showed a survival rate of 95% after 6 months and 88% after 12 months. Most patients received immunotherapy as a second-line or subsequent treatment. In terms of prior therapy among all the patients, 43 had received platinum-based treatments. Indirect comparison with other real-world data studies showed variability in methodologies and an alignment in terms of results. CONCLUSION: This study, based on real-world data, was a first step in the assessment of the impact of the introduction of a significant new class of treatments, i.e. immunotherapy, and covers patients, treatments and outcomes, as well as organizational and economic variables.

Risk factors for mortality and cost implications of complicated intra-abdominal infections in critically ill patients.

PURPOSE: To assess risk factors for 28-day mortality and cost implications in intensive care unit (ICU) patients with complicated intra-abdominal infections (cIAIs). METHODS: Single-center retrospective cohort study of prospectively collected data analysing ICU patients with a microbiologically confirmed complicated intra-abdominal infections. RESULTS: 137 complicated intra-abdominal infections were included and stratified according to the adequacy of antimicrobial therapy (initial inadequate antimicrobial therapy [IIAT], n = 44; initial adequate antimicrobial therapy [IAAT], n = 93). The empirical use of enterococci/methicillin-resistant Staphylococcus aureus active agents and of carbapenems was associated with a higher rate of therapeutic adequacy (p = 0.016 and p = 0.01, respectively) while empirical double gram-negative and antifungal therapy did not. IAAT showed significantly lower mortality at 28 and 90 days and increased clinical cure and microbiological eradication (p < 0.01). In the logistic and Cox-regression models, IIAT and inadequate source control were the unique predictors of 28-day mortality. No costs differences were related to the adequacy of empirical therapy and source control. The empirical double gram-negative and antifungal therapy (p = 0.03, p = 0.04) as well as the isolation of multidrug-resistant (MDR) bacteria and the microbiological failure after targeted therapy were drivers of increased costs (p = 0.004, p = 0.04). CONCLUSIONS: IIAT and inadequate source control are confirmed predictors of mortality in ICU patients with complicated intra-abdominal infections. Empirical antimicrobial strategies and MDR may drive hospital costs.

Use of robot-specific resources and operating room times: the case of Telelap Alf-X robotic hysterectomy.

INTRODUCTION: The aim of this study was to identify, quantify and evaluate the use of robotic materials and operating theatre times in Telelap ALF-X robotic hysterectomy. MATERIALS AND METHODS: Cost analysis was performed on 81 patients who underwent a Telelap ALF-X robotic hysterectomy. Data were collected during a phase II study trial conducted at the University Hospital A. Gemelli, Catholic University, Rome. According to micro-costing technique, surgical team costs, materials and operating theatre usage were recorded during each surgical intervention. Cost data were provided by the hospital's accounting office. Probabilistic sensitivity analysis was carried out in order to test the robustness of the results by assuming an Inv-norm random variable. RESULTS: The base case analysis showed a cost/patient of €3391.82. The new robotic device requires a low consumption of robotic materials. Sensitivity analysis showed that the most sensitive cost driver was use of the operating theatre. CONCLUSION: This study shows that Telelap ALF-X robotic hysterectomy is feasible and safe and could offer specific advantages in terms of cost. Copyright © 2016 John Wiley & Sons, Ltd.

Cost-effectiveness analysis of transnasal fentanyl citrate for the treatment of breakthrough cancer pain.

INTRODUCTION: Pain is a symptom of cancer and is categorized in two forms: background pain to be treated with analgesics, and breakthrough cancer pain (BTcP), which needs drug treatment on demand. We present a cost-effectiveness analysis of transnasal fentanyl citrate as an alternative to morphine. METHODS: A Markov model considers a cohort of 100 patients on a daily basis. Effectiveness was included by selecting three clinical studies. Side effects, hospitalizations and visits were valued by referring to national formularies. Utility data were used to differentiate the health status inherent to BTcP. RESULTS: The incremental cost-effectiveness ratio of transnasal fentanyl citrate is 10,140 euros/QALY. Sensitivity analysis shows that with a threshold of 30,000 euros/QALY, the treatment of BTcP with transnasal fentanyl citrate would have an 86% probability of being cost-effective. CONCLUSION: Transnasal Fentanyl citrate is cost-effective, therefore represents a good investment in health.

Economic evaluation of 5-grass pollen tablets versus placebo in the treatment of allergic rhinitis in adults.

BACKGROUND: Allergen immunotherapy (AIT) is aimed at modifying the immune response to a causative allergen, thereby reducing clinical symptoms and symptomatic medication intake and improving quality of life. Long-term AIT research has led to the development of 5-grass pollen tablets, currently indicated for the treatment of grass pollen-induced allergic rhinitis (AR). METHODS: A post-hoc analysis was conducted using the Average Adjusted Symptom Score (AAdSS) to compare the effect of treatment of AR with 5-grass pollen tablets versus placebo treatment. Using the results of the VO34.04 and VO53.06 trials and economic data, cost-effectiveness analysis of 5-grass pollen tablet treatment was performed from the Italian third-party payer perspective with cost data derived from a study of 2008 updated to 2011. Also a societal perspective was considered by using the costs related to the losses of productivity by following the human capital approach. Using the results of the analysis, the estimated receiver-operating characteristic curve was plotted to evaluate medication effectiveness in terms of quality-adjusted life years (QALYs) and a decision tree constructed to model the possible outcomes and costs for adults and paediatric patients with a low, medium, and high AAdSS. Finally, probabilistic sensitivity analysis was conducted to test the robustness of the results as well as their consistency at an assumed cost-effectiveness threshold of € 30,000/QALY. RESULTS: The results indicate that compared to the placebo, the 5-grass pollen tablet treatment provides a benefit of 0.127 QALYs in medium AAdSS patients and of 0.143 QALYs in high AAdSS patients. The 5-grass pollen tablet treatment was found to cost € 1,024/QALY for patients with a medium AAdSS and € 1,035/QALY for patients with a high AAdSS. Of all the simulations performed in the probabilistic sensitivity analysis, 99 % indicated that the incremental cost-effectiveness ratio of the 5-grass pollen tablet treatment was below the threshold of € 30,000/QALY in patients with medium and high AAdSS, whereas it was found to be dominated in 67 % of simulations related to patients with low AAdSS. CONCLUSION: The 5-grass pollen tablet is a cost-effective treatment for adult AR patients with a medium or high AAdSS. This finding should be carefully considered when deciding the management strategy for these patients.

Impact of technology overlapping: a case study on colorectal cancer screening.

OBJECTIVES: Technology overlapping is a phenomenon based on the availability of different technologies to treat the same morbidity in the same patient group. The aim of this study was to explore the cost-effectiveness of technology overlapping in a case study on colorectal cancer (CRC), and describe an approach to investigate the phenomena and to propose adequate interventions. METHODS: A Semi-Markov model, based on a cohort of 10,000 people undergoing a CRC diagnostic test, was developed to simulate the overlapping phenomena and compare it with hypothetical scenarios where only one diagnostic tool is available. Deterministic sensitivity analyses were conducted on parameters with the greatest uncertainty. RESULTS: The results of the Semi-Markov model indicated that technology overlapping is not cost-effective. CONCLUSIONS: This study is a first attempt to address the significance of technology overlapping. The Semi-Markov model demonstrated that technology overlapping is the least cost-effective arm, so alternate health care policies must be investigated.

Impact of drug policy on the use of parenteral cephalosporins in Italy.

OBJECTIVE: To evaluate the effects of the 1998 revision of CUF Note 55 on doctors' prescribing behaviour and drug costs with regard to intramuscularly administered cephalosporins. METHOD: National data on drug use between January 1998 and June 2000 were provided by the Drug Utilisation Monitoring Centre of the Ministry of Health. The Anatomic Therapeutic Chemical classification and the Defined Daily Dose methodology, as well as population estimates obtained from the Italian National Statistics Institute were used to define consumption as the number of defined daily doses per 1000 inhabitants per day. The cost of these antibiotic medications was determined using the wholesale price reported in Informatore Farmaceutico. Italian inflation rates were used to annuitize the expenditure. "STATA 6.0" software was used for all statistical analyses. RESULTS: The use of cefonicid rose dramatically after the revision (+ 136.3%), whereas the utilisation of the other active ingredients decreased. A decrease of 5.6% in the expenditure for all parenteral cephalosporins was observed in this period while the same figure increased by 2.3% after one year. CONCLUSION: The exclusion of cefonicid from a restricted list appears to have significantly affected doctors' prescribing practices, while the effect on drug expenditure was contradictory.