Cost-effectiveness analysis of the new oncological drug durvalumab in Italian patients with stage III non-small cell lung cancer.

BACKGROUND: The monoclonal antibody durvalumab, an immune-checkpoint inhibitor (ICI) antiprogrammed death ligand 1 (PD-L1), is available for unresectable stage III NSCLC patients as consolidation therapy following induction chemoradiotherapy, with very promising overall survival (OS) and progression-free survial (PFS) results in registration trials. The purpose of this study was to provide policymakers with an estimate of the cost-effectiveness of durvalumab in the treatment of non-small cell lung cancer (NSCLC). METHODS: The study developed a Markov model covering a 5-year period to compare costs and outcomes of treating PD-L1 positive patients with or without durvalumab. We conducted a series of sensitivity analyses (Tornado analysis and Monte Carlo simulation) by varying some parameters to assess the robustness of our model and identify the parameters with the greatest impact on cost-effectiveness. RESULTS: Prior to the release of durvalumab, the management of NSCLC over a 5-year period cost €33 317 per patient, with an average life expectancy of 2.01 years. After the introduction of the drug, this increased to €37 317 per patient, with an average life expectancy of 2.13 years. Treatment with durvalumab led to an incremental cost-effectiveness ratio (ICER) of €35 526 per year. OS is the variable that contributes the most to the variability of the ICER. CONCLUSIONS: The study observed that durvalumab is a cost-effective treatment option for patients with unresectable stage III NSCLC.

Estimated direct costs of non-small cell lung cancer by stage at diagnosis and disease management phase: A whole-disease model.

BACKGROUND: Non-small cell lung cancer (NSCLC) is the first cause of cancer-related death among men and the second among women worldwide. It also poses an economic threat to the sustainability of healthcare services. This study estimated the direct costs of care for patients with NSCLC by stage at diagnosis, and management phase of pathway recommended in local and international guidelines. METHODS: Based on the most up-to-date guidelines, we developed a very detailed "whole-disease" model listing the probabilities of all potentially necessary diagnostic and therapeutic actions involved in the management of each stage of NSCLC. We assigned a cost to each procedure, and obtained an estimate of the total and average per-patient costs of each stage of the disease and phase of its management. RESULTS: The mean expected cost of a patient with NSCLC is 21,328 € (95% C.I. -20 897-22 322). This cost is 16 291 € in stage I, 19530 € in stage II, 21938 € in stage III, 22175 € in stage IV, and 28 711 € for a Pancoast tumor. In the early stages of the disease, the main cost is incurred by surgery, whereas in the more advanced stages radiotherapy, medical therapy, treatment for progressions, and supportive care become variously more important. CONCLUSIONS: An estimation of the direct costs of care for NSCLC is fundamental in order to predict the burden of new oncological therapies and treatments on healthcare services, and thus orient the decisions of policy-makers regarding the allocation of resources. KEY POINTS: SIGNIFICANT FINDINGS OF THE STUDY: The high costs of surgery make the early stages of the disease no less expensive than the advanced stages. WHAT THIS STUDY ADDS: An estimation of the direct costs of care is fundamental in order to orient the decisions of policy-makers regarding the allocation of resources.

Differences in direct costs of patients with stage I cutaneous melanoma: A real-world data analysis.

BACKGROUND: Clinical factors, such as tumor thickness, ulceration and growth phase have a role as prognostic factors for stage I melanoma. However, it is still under debate whether these variables influence the related direct costs. We aimed to investigate which clinical factors represent direct health care "cost drivers" for stage I melanoma. MATERIALS AND METHOD: Analyses were conducted on a cohort of patients diagnosed with stage I melanoma. Differences in the costs incurred by different groups of patients were examined using Mann-Whitney or Kruskal-Wallis non-parametric tests. Log linear multivariate analysis was used to identify the clinical drivers of the total direct costs one and two years after diagnosis. The study was conducted from the perspective of Italy's National Health care System. RESULTS: One year after diagnosis, patients whose melanomas had a Breslow thickness ≥0.8 mmin (compared with those with lower thickness) and a vertical growth phase (compared with those with radial growth) incurred higher costs for hospitalization, as well as higher overall costs. One year after their diagnosis, treatment of patients with stage I melanoma in the vertical growth phase costs 50% more (95% CI: 22-85%) than their counterparts with a radial growth pattern, resulting in an estimated absolute increase of € 256.23. Having a tumor thicker than 0.8 mm prompted an increase of 91% (95% CI: 43-155%) in the costs (€955.24 in absolute terms). CONCLUSION: Our data indicate a heterogeneity in the direct costs of stage I melanoma patients during the first year after diagnosis, which can be partly explained by clinical prognostic factors, like tumor thickness and growth pattern.

Multimorbidity and Hospital Admissions in High-Need, High-Cost Elderly Patients.

Objective: The aim was to clarify which pairs or clusters of diseases predict the hospital-related events and death in a population of patients with complex health care needs (PCHCN). Method: Subjects classified in 2012 as PCHCN in a local health unit by ACG® (Adjusted Clinical Groups) System were linked with hospital discharge records in 2013 to identify those who experienced any of a series of hospital admission events and death. Number of comorbidities, comorbidities dyads, and latent classes were used as exposure variable. Regression analyses were applied to examine the associations between dependent and exposure variables. Results: Besides the fact that larger number of chronic conditions is associated with higher odds of hospital admission or death, we showed that certain dyads and classes of diseases have a particularly strong association with these outcomes. Discussion: Unlike morbidity counts, analyzing morbidity clusters and dyads reveals which combinations of morbidities are associated with the highest hospitalization rates or death.

Cost-effectiveness of a melanoma screening programme using whole disease modelling.

OBJECTIVE: To assess the potential impact of a melanoma screening programme, compared with usual care, on direct costs and life expectancy in the era of targeted drugs and cancer immunotherapy. METHODS: Using a Whole Disease Model approach, a Markov simulation model with a time horizon of 25 years was devised to analyse the cost-effectiveness of a one-time, general practitioner-based melanoma screening strategy in the population aged over 20, compared with no screening. The study considered the most up-to-date drug therapy and was conducted from the perspective of the Veneto regional healthcare system within the Italian National Health Service. Only direct costs were considered. Sensitivity analyses, both one-way and probabilistic, were performed to identify the parameters with the greatest impact on cost-effectiveness, and to assess the robustness of our model. RESULTS: Over a 25-year time horizon, the screening intervention dominated usual care. The probabilistic sensitivity analyses confirmed the robustness of these findings. The key drivers of the model were the proportion of melanomas detected by the screening procedure and the adherence of the target population to the screening programme. CONCLUSIONS: The screening programme proved to be a dominant option compared with usual care. These findings should prompt serious consideration of the design and implementation of a regional or national melanoma screening strategy within a National Health Service.

Impactibility Model for Population Health Management in High-Cost Elderly Heart Failure Patients: A Capture Method Using the ACG System.

The aim of the present study is to use the ACG (Adjusted Clinical Groups) System to create an impactibility model by identifying homogeneous clinical subgroups of patients with high risk of an adverse health outcome in a population of heart failure patients with complex health care needs (PCHCN). This method will allow policy makers to target and prioritize services for the highest risk PCHCN in the context of limited health care resources, by identifying relatively homogeneous groups of patients with similar comorbidities. Subjects classified in 2012 as PCHCN in a local health unit by the ACG System were linked with hospital discharge records in 2013. The authors applied the Apriori algorithm to identify the most common sets of the most predictive diseases for the following outcomes of interest: at least 1 admission and at least 1 preventable admission in the year. Predictive performance for the former outcome was compared between the impactability model with the available ACG's individual risk score. The Apriori algorithm also was applied to predict the latter outcome as an example of an event that a policy maker would be able to prevent. Evidence showed no statistically significant difference between the 2 methods. The present model also displayed evidence of good calibration. The Apriori algorithm was applied as an impactibility model, built based on the ACG System, that allowed the authors to obtain an "ACG-based group risk score" and use it to identify clinically homogeneous subgroups of PCHCN. This will help policy makers develop "tool kits" for homogeneous groups of patients that improve health outcomes.

Palliative care quality measures: an exploratory study.

OBJECTIVES: The aim of this study was to investigate how palliative care service structures and processes correlate with their outputs and outcomes, measuring the latter respectively in terms of intensity of care and death at home. METHODS: The Veneto Regional Health Authorities collected a set of 37 quality indicators for the year 2016, covering the following five dimensions: service integration, service structure, accessibility, professional processes and organisational processes. Their validity was assessed by a panel of 29 palliative care experts. A score was assigned to each indicator on the basis of its relevance. Non-parametric correlations between the care quality indicators and the measures of the palliative care outputs and outcomes were investigated, along with the presence of a monotonic trend in the performance of the local health units (LHU) grouped by 'low', 'medium' or 'high' scores and differences between these groups of LHUs. RESULTS: The data showed that palliative care service structure and professional processes were the dimensions correlating significantly with the intensity of care coefficient. An increasingly significant statistical trend was found in both the intensity of care coefficient and the proportion of deaths at home for the three groups of LHUs in terms of the professional processes dimension. CONCLUSIONS: Despite its limitations, this study brought to light some statistically significant findings that are worth investigating in larger samples. To achieve improvements in the quality of palliative care, it is important for healthcare providers to know which variables most affect the output and especially the outcomes of the services offered.

Multimorbidity patterns in high-need, high-cost elderly patients.

INTRODUCTION: Patients with complex health care needs (PCHCN) are individuals who require numerous, costly care services and have been shown to place a heavy burden on health care resources. It has been argued that an important issue in providing value-based primary care concerns how to identify groups of patients with similar needs (who pose similar challenges) so that care teams and care delivery processes can be tailored to each patient subgroup. Our study aims to describe the most common chronic conditions and their combinations in a cohort of elderly PCHCN. METHODS: We focused on a cohort of PCHCN residing in an area served by a local public health unit (the "Azienda ULSS4-Veneto") and belonging to Resource Utilization Bands 4 and 5 according to the ACG System. For each patient we extracted Expanded Diagnosis Clusters, and combined them with information available from Rx-MGs diagnoses. For the present work we focused on 15 diseases/disorders, analyzing their combinations as dyads and triads. Latent class analysis was used to elucidate the patterns of the morbidities considered in the PCHCN. RESULTS: Five disease clusters were identified: one concerned metabolic-ischemic heart diseases; one was labelled as neurological and mental disorders; one mainly comprised cardiac diseases such as congestive heart failure and atrial fibrillation; one was largely associated with respiratory conditions; and one involved neoplasms. CONCLUSIONS: Our study showed specific common associations between certain chronic diseases, shedding light on the patterns of multimorbidity often seen in PCHCN. Studying these patterns in more depth may help to better organize the intervention needed to deal with these patients.

Problematic social networking site usage and substance use by young adolescents.

BACKGROUND: Substance use and abuse by young adolescents has become a serious issue for public health services, and several socio-environmental factors can influence how vulnerable a young adolescent may be to their appeal. The present study was devised to examine whether substance use in early adolescence is associated with problematic social networking site usage (PSNSU). METHODS: In the academic year 2013-2014, secondary schools in Padua (north-eastern Italy) were involved in a survey called "Pinocchio". A sample of 1325 pupils attending years 6 to 8 (i.e. aged from 11 to 13 years) completed self-administered questionnaires, in which PSNSU was measured by applying the DSM-IV criteria of dependence to identify any social network addiction disorder and its fallout on daily life. Multivariate analysis (ordered logistic regression) was performed to assess an adjusted association between young adolescents' substance use and PSNSU. RESULTS: The percentage of pupils classified as problematic social networking site users rose with age (from 14.6% in year 6 to 24.3% in year 7, and 37.2% in year 8), and it was higher in girls (27.1%) than in boys (23.6%). In a fully-adjusted model, PSNSU conferred a higher likelihood of being substance users (OR 2.93 95% CI 1.77-4.85). CONCLUSION: This study identified an association between PSNSU and the likelihood of substance use (smoking, alcohol and energy drink consumption), providing further evidence of the need to pay more attention to PSNSU in early adolescence.