Ferric carboxymaltose for patients with heart failure and iron deficiency in Italy: cost-effectiveness and budget impact.

Aim: To evaluate the cost–effectiveness of intravenous ferric carboxymaltose (FCM) versus placebo for the management of iron deficiency in patients with chronic heart failure in the Italian healthcare system and to estimate its impact on the national healthcare budget. Materials & methods: A Markov model was developed to project costs and health outcomes over 1 year, based on data from literature. Healthcare resources consumption was derived from an e-survey administered to clinicians. Costs were obtained from official tariffs. Results: Treatment with FCM represents a dominant strategy compared with placebo, leading to national budget annual savings of 20–97 million Euros, according to different increasing utilization rates. Conclusion: FCM is a cost-saving option for the treatment of chronic heart failure patients with iron deficiency in Italy

Endovascular versus surgical creation of arteriovenous fistula in hemodialysis patients: cost-effectiveness and budget impact analyses

Objectives: The aim of the present study was to perform cost-effectiveness and budget impact analyses comparing endovascular arteriovenous fistula creation to surgical arteriovenous fistula creation in hemodialysis patients from the National Healthcare Service (NHS) perspective in Italy. Methods: A systematic literature review has been conducted to retrieve complications’ rates after arteriovenous fistula creation procedures. One study comparing endovascular arteriovenous fistula creation, performed with WavelinQ device, to the surgical approach through propensity score matching was preferred to single-arm investigations to execute the economic evaluations. This study was chosen to populate a Markov model to project, on a time horizon of 1 year, quality adjusted life years and costs associated with endovascular arteriovenous fistula (WavelinQ) and surgical arteriovenous fistula options for both cohorts of incident and prevalent hemodialysis patients. Results: For both incident and prevalent hemodialysis patients, endovascular arteriovenous fistula creation, performed with WavelinQ, was the dominant strategy over surgical arteriovenous fistula approach, showing less cost and better patients’ quality of life. Compared to the current scenario, progressively increasing utilization rates of WavelinQ over surgical arteriovenous fistula creation in the next 5 years in incident hemodialysis patients are expected to save globally 30–36 million euros to the NHS. Conclusion: Endovascular arteriovenous fistula creation performed with WavelinQ could be a cost-saving strategy in comparison with the surgical approach for patients in hemodialysis. Future studies comparing different devices for endovascular arteriovenous fistula creation versus the surgical option would be needed to confirm or reject the validity of this preliminary evaluation. In the meantime, decision-makers can use these results to take decisions on the diffusion of endovascular procedures in Italy

Second-generation antipsychotic drugs for patients with schizophrenia: systematic literature review and meta-analysis of metabolic and cardiovascular side effects

Background and Objectives: Second-Generation Antipsychotics (SGAs) for schizophrenia show different risk profiles, whose evidence has been evaluated through comparative reviews on RCTs and observational studies. Methods: We performed a systematic review and meta-analysis of weight gains, metabolic and cardiovascular side-effects of SGAs, relying on both RCTs and observational studies, by comparing variations between the start of treatment and the end of follow-up. The systematic review refers to papers published from June 2009 to November 2020. PRISMA criteria were followed. No restrictions on heterogeneity level have considered for meta-analysis. A test for the summary effect measure and heterogeneity (I2 metric) was used. Results: Seventy-nine papers were selected from 3,076 studies (61% RCTs, 39% observational studies). Olanzapine and risperidone reported the greatest weight gain and olanzapine the largest BMI increase. Paliperidone showed the highest increase in total cholesterol, but is the only drug reporting an increase in the HDL cholesterol. Quetiapine XR shows the highest decrease in fasting glucose. Lurasidone shows the lowest increase in body weight and a reduction in BMI and was also the only treatment reporting a decrease in total cholesterol and triglycerides. The highest increase in systolic and diastolic blood pressure was reported by quetiapine XR. Conclusions: Despite some limitations (differences in the mean dosages per patient and other side effects not included) this paper provides the first complete meta-analysis on SGAs in variations on metabolic risk profile between start of treatment and end of follow-up, with useful results for clinical practice and possibly for future economic evaluation studies

Investigating patients’ preferences to inform drug development decisions: novel Insights from a discrete choice experiment in migraine

Abstract: There is limited evidence on the scope and overall benefit of patient-centred drug development decisions. The present study assessed patients’ preferences for the characteristics of an ideal migraine treatment through a discrete choice experiment in order to inform decision-making and drug development processes. We investigated the preferences according to five treatment attributes identified from a systematic literature review and two focus group elicitations. The heterogeneity of preferences was also investigated. Overall, the respondents considered the presence of adverse events, duration of treatment effect, reduction of symptom intensity, speed of effect and cost born by the patient as the most relevant treatment features. As expected, the patients preferred treatments with lower levels of adverse events and costs and treatments with greater speed, duration of treatment effect and effectiveness in reducing symptom intensity. There was significant preference heterogeneity only for the presence of adverse events. Compared to men, women had significantly higher preferences for quicker treatment effect and limited adverse events and reported higher preferences for costly treatments. The results of our survey help address research and development strategies in the pharmaceutical industry and public policy regarding treatments that are clinically effective and responsive to the needs expressed by patients

Real-World Data for the Evaluation of Transarterial Radioembolization versus Sorafenib in Hepatocellular Carcinoma: A Cost-Effectiveness Analysis

Abstract Objectives To perform a cost-effectiveness analysis comparing the use of transarterial radioembolization (TARE) with that of sorafenib in the treatment of patients with intermediate or advanced hepatocellular carcinoma (HCC) according to the Barcelona Clinic Liver Cancer staging system. Methods Patient-level data were consecutively recorded and collected at three oncology centers in Italy. A propensity score matching was performed to compare patients with similar clinical characteristics who underwent TARE or sorafenib treatment. Clinical data from the matched cohorts were used to populate a Markov model to project, on a lifetime horizon, life years, quality-adjusted life years, and economic outcomes associated with TARE and sorafenib for both intermediate and advanced HCC stages. Results Starting from data covering 389 and 241 patients who underwent TARE and sorafenib treatment, respectively, the propensity score matching yielded a total of 308 matched patients. For intermediate-stage patients, the model estimated for TARE versus sorafenib an incremental cost-utility ratio of €3,302/QALY (incremental cost-effectiveness ratio of €1,865 per life year gained), whereas for patients in advanced stage TARE dominated (lower costs and greater health improvements) compared with sorafenib. Conclusions From an Italian health care service perspective, TARE could be a cost-effective strategy in comparison with sorafenib for patients with intermediate or advanced HCC. The results from forthcoming randomized controlled trials comparing TARE with sorafenib will be able to confirm or reject the validity of this preliminary evaluation. In the meantime, decision makers can use these results to control and coordinate the diffusion of the technology

Time-driven activity-based costing for capturing the complexity of healthcare processes: the case of deep vein thrombosis and leg ulcers

Time-driven activity-based costing (TDABC) is suggested to assess costs within the value-based healthcare approach, but there is a paucity of applications in chronic diseases such as deep vein thrombosis (DVT) and leg ulcers. In this context, we applied TDABC in a cost-effectiveness analysis comparing venous stenting to compression ± anticoagulation (standard of care—SOC) from both hospital and societal perspectives in Italy. TDABC was applied to both treatments to assess costs that were included in a cost-effectiveness model. Clinical inputs were retrieved from the literature and integrated with real-world data. The Incremental Cost Utility Ratio (ICUR) of stenting compared to SOC was EUR 10,270/QALY and EUR 8962/QALY for hospital and societal perspectives, respectively. The mean cost per patient for venous stenting of EUR 5082 was higher than the Diagnosis-Related Group (DRG) reimbursement (EUR 4742). For SOC, an ulcer healing in 3 months costs EUR 1892, of which EUR 302 (16%) is borne by the patient versus a reimbursement of EUR 1132. TDABC showed that venous stenting may be cost-effective compared with SOC but that reimbursement rates may not completely cover the real costs, which are partially sustained by the patients. A more efficient policy for covering the real costs may be beneficial for both clinical centers and patients

Impella versus VA-ECMO for patients with cardiogenic shock: comprehensive systematic literature review and meta-analyses

Comprehensive systematic review of clinic and economic outcomes of studies on health technologies used in patients suffering from cardiogenic shock. Socio-economic outcomes including quality of life or resource use were not reported in any study. The study highlighted areas where further data collection is needed to clarify the value of complex, new technologies in the treatment of CS, that will enable comparative assessments focusing both on the health impact on patient outcomes, and on the financial burden for government budgets. Future studies need to fill the gap to comply with recent regulatory updates at the European and national levels

Socioeconomic impact of migraine in Italy: Results of a national survey

Background: Literature data indicate that migraine has a stronger impact on both healthcare consumption and quality of life (QoL) in women. Objectives: The objective of this article is to evaluate out-of-pocket (OoP) costs, productivity losses and cost of informal care of migraine in Italy, with a special focus on the detection of potential differences between male and female subjects. Methods: A cross-sectional study was conducted. Data were collected via a web-based survey platform, which included a socioeconomic questionnaire (five sections: clinical history; occupational status; informal assistance; visits, exams and treatments; and loss of productivity) and two questionnaires on QoL (EuroQol 5D 5L and Migraine-Specific Questionnaire, MSQ). Results: Six hundred and seven participants took part in the survey (average age of 42 years; female 70%). The duration of the attack (4-72 hours) was significantly much longer in women than in men (71% vs. 49%; p < 0.001). Seventy per cent of the sample reported to be employed. Lower income was associated with women (p < 0.001). Men received more informal assistance days than women (5.2 vs. 3.9 days; p = 0.007). The quarterly cost including OoP costs, informal assistance and lost productivity averaged €1,088 and was higher for men compared to women (€1,515 vs. €908; p < 0.001). The MSQ reported a significantly worse QoL for women. Conclusion: The results seemed to prove that migraine is a gender disease. Moreover, a potentially unequal access to informal assistance and healthcare resources not covered by the Italian National Health Service is highlighted for women because of their lower average income and purchasing power compared to men

Value-based healthcare: Il nuovo approccio di AIFA alla determinazione multidimensionale del valore

In this viewpoint, we discuss the approach promoted by the Italian Drug Agency (AIFA) to the assessment of the value of new pharmaceuticals in the Italian Healthcare Service. On top of traditionally acknowledged components, such as quality adjusted life years gained and net costs, the overall value framework might include other elements such as productivity and adherence, equity, severity of disease, reduction in uncertainty, spillover effects. There is a residual dimension in the value framework that may capture the option value or reduction in fear of contagion for infectious disease treatments. We debate measurement issues on these elements of value and discuss open issues from a methodological and policy standpoint

Economic evaluation of a bioinductive implant for the repair of rotator cuff tears compared with standard surgery in Italy

Introduction: Rotator cuff tear (RCT) is a painful, progressive condition resulting from damage to the rotator cuff tendons and is the leading cause of shoulder-related disability. Surgical repair of rotator cuff is an established standard of care (SOC); however, failure of the procedure can occur. In this context, the use of collagen-based bioinductive implant REGENETEN showed long-term improvements in clinical scores. The aim of the study was to assess the cost-effectiveness of REGENETEN combined with SOC (SOC + REGENETEN) compared to SOC alone from both National Healthcare Service (NHS) and societal perspectives in Italy. Methods: A decision analytic model was developed to estimate the number of tears healed and costs for the two considered treatment strategies over 1 year. Clinical data were retrieved from the literature, and the clinical pathways for the management of patients with RCTs were retrieved from four key opinion leaders in Italy. Results: Over a 1-year time horizon, healed lesions were 90.70% and 72.90% for surgical repair of RCTs with and without REGENETEN, respectively. Considering the NHS perspective, mean costs per patient were €7828 and €4650 for the two strategies, respectively, leading to an incremental cost-effectiveness ratio (ICER) of €17,857 per healed tear. From the societal perspective, the mean costs per patient were €12,659 for SOC and €11,784 for REGENETEN, thus showing savings of €4918 per healed tear when the bioinductive implant is used. The sensitivity analyses confirmed the robustness of the model results. Conclusion: In the context of paucity of cost-effectiveness studies, our findings provide additional evidence for clinicians and payers regarding the value of a new treatment option that supports a tailored approach for the management of patients with RCTs