Improved efficiency of daratumumab treatment of multiple myeloma adopting the subcutaneous route: A micro-costing analysis in three Italian hematology centers.

BACKGROUND: Daratumumab is a humanized monoclonal antibody approved for the treatment of adult patients with newly diagnosed or relapsed/refractory multiple myeloma (RRMM). Subcutaneous (SC) formulation proved to be non-inferior in comparison with intravenous (IV) administration route. This study aimed at assessing the economic and time impact associated with the use of SC versus IV daratumumab in patients with RRMM from the perspective of the hematology center. METHODS: This was a 5-month multicenter time-and-motion cross-sectional micro-costing study conducted in three Italian hematology centers among adult patients diagnosed with RRMM with ongoing treatment with IV or SC daratumumab. Measurements were performed by an ad hoc App. RESULTS: Nineteen (20%) IV and 76 (80%) SC administration procedures were measured. Patients spent a mean of 4.85 ± 0.91 or 1.08 ± 0.56 h in the hematology center to receive IV or SC daratumumab, respectively. Healthcare professionals (HCPs) spent a mean of 49.38 ± 16.13 and 20.37 ± 7.88 min of active working time to manage IV and SC administrations, respectively. The infusion chair was occupied for a mean of 4.85 ± 0.91 and 0.99 ± 0.55 h during IV or SC administration, respectively. On average, considering the costs due to HCP and chair time, materials, and overhead costs, every IV and SC administration costed €80.33 and 34.90, respectively. CONCLUSIONS: In conclusion, as compared with IV administration, SC daratumumab was associated with 78%, 59%, 80% savings in terms of patient time, HCP active working time, and infusion chair, respectively, and 56.6% budget savings.

Cost-utility analysis of real-time artificial intelligence-assisted colonoscopy in Italy.

Background and study aims Artificial intelligence (AI)-assisted colonoscopy has proven to be effective compared with colonoscopy alone in an average-risk population. We aimed to evaluate the cost-utility of GI GENIUS, the first marketed real-time AI system in an Italian high-risk population. Methods A 1-year cycle cohort Markov model was developed to simulate the disease evolution of a cohort of Italian individuals positive on fecal immunochemical test (FIT), aged 50 years, undergoing colonoscopy with or without the AI system. Adenoma or colorectal cancer (CRC) were identified according to detection rates specific for each technique. Costs were estimated from the Italian National Health Service perspective. Results Colonoscopy+AI system was dominant with respect to standard colonoscopy. The GI GENIUS system prevented 155 CRC cases (-2.7%), 77 CRC-related deaths (-2.8%), and improved quality of life (+0.027 QALY) with respect to colonoscopy alone. The increase in screening cost (+€10.50) and care for adenoma (+€3.53) was offset by the savings in cost of care for CRC (-€28.37), leading to a total savings of €14.34 per patient. Probabilistic sensitivity analysis confirmed the cost-efficacy of the AI system (almost 80% probability). Conclusions The implementation of AI detection tools in colonoscopy after patients test FIT-positive seems to be a cost-saving strategy for preventing CRC incidence and mortality.

Economic Analysis of a Ketoanalogue-supplemented Very Low-protein Diet in Patients With Chronic Kidney Disease in Vietnam.

PURPOSE: The aim of this study was to estimate the cost-effectiveness of a very low-protein diet (VLPD) supplemented with ketoanalogues of essential amino acids compared with a conventional low-protein diet (LPD) in Vietnam. METHODS: The study was conducted from payer (base case), patient, and societal perspectives. A Markov model simulated costs and quality-adjusted life-years (QALYs) for patients with chronic kidney disease stage 4 or 5 (CKD4+) who were followed up during their lifetimes. Patients received a VLPD (0.3- to 0.4-g/kg/d diet) supplemented with ketoanalogues (5 kg/d [1 tablet]) versus LPD (0.6 g/kg/d, mixed proteins). In each model cycle, patient transitions among the health states-CKD4+ (nondialysis), dialysis, and death-were based on transition probabilities taken from the published literature. The time horizon covered the cohort's lifetime. Utilities and costs were estimated from literature review and projected for the lifespan considered in the model. Probabilistic and deterministic sensitivity analyses were performed. FINDINGS: The ketoanalogue-supplemented VLPD increased survival and QALYs compared with the LPD. From a payer's perspective, total cost of care in Vietnam was ₫216,854,268 (€8684/$9242) per patient with LPD versus ₫200,928,819 (€8046/$8563) per patient with a supplemented VLPD (sVLPD) (difference, -₫15,925,449 [-€638/-$679]). From a patient's perspective, total cost of care in Vietnam was ₫217,872,043 (€8724/$9285) per patient with LPD versus ₫116,015,672 (€4646/$4944) per patient with sVLPD (difference, -₫101,856,371 [-€4,079/ -$4341]). From a societal perspective, total cost of care in Vietnam was ₫434,726,312 (€17,408/-$18,527) per patient with LPD versus ₫316,944,491 (€12,692/ $13,508) per patient with sVLPD (difference, -₫117,781,820 [-€4716 €/$5020). IMPLICATIONS: Ketoanalogue-supplemented VLPD lowered costs compared with LPD in all 3 perspectives considered.

Benefits of MR-proADM-guided decision-making in the emergency department: clinical and economic evaluation in Italy, Germany, Spain, and the UK.

AIM: In a randomized control trial mid-regional proadrenomedullin (MR-proADM)-guided decision-making has been proven to safely reduce hospital admissions based on an accurate assessment of disease severity in the Emergency Department (ED). This study aimed to assess the impact of a MR-proADM-Guided Triage (MR-GT) versus standard Hospital Triage (HT) on clinical and economic outcomes in ED patients with suspected infection in Spain, Italy, Germany, and the UK, using Patient-Level Data (PLD) from two observational studies. METHODS: PLD was collected from patients enrolled at a Spanish hospital during two observational studies. Logistic regression was used to identify predictors of hospitalization. A patient-level simulation model was subsequently developed to evaluate the clinical and economic impact of MR-GT versus HT using results from the statistical analysis and country-specific cost data from the published literature. Probabilistic and deterministic sensitivity analyses were carried out. RESULTS: Four hundred seventy-three patients were enrolled in this study. MR-proADM had the strongest association with hospital admission, followed by age and National Early Warning Score (NEWS). In the simulation model, MR-GT was associated with an overall reduction in hospitalization relative to HT, equal to 22.6 percentage points (40.9 vs. 63.5%). In addition, the use of MR-GT would reduce the total hospital cost per patient presenting to the ED with suspected infection by roughly 30%, with a mean cost saving per patient of €626, €1,484, €1,154, and £1,113 in Spain, Italy, Germany, and the UK, respectively. The robustness of these findings was confirmed by sensitivity analyses. LIMITATIONS: The statistical analyses were not performed on the same population simulated in the model. Clinical input parameters were assumed to be the same for all countries. CONCLUSIONS: MR-proADM showed to be the main predictor of hospitalization. An MR-proADM decision algorithm provides cost savings in Spain, Italy, Germany, and the UK.

Cost-Impact Analysis of a Novel Diagnostic Test to Assess Community-Acquired Pneumonia Etiology in the Emergency Department Setting: A Multi-Country European Study.

BACKGROUND: We aimed to estimate the economic and clinical impacts of a novel diagnostic test called LIAISON® MeMed BV® (LMMBV), which can differentiate bacterial from viral infections, in patients with community-acquired pneumonia (CAP) in emergency departments. METHODS: A cost-impact simulation model was developed to investigate the financial consequences of the introduction of LMMBV into the standard of care (SOC) diagnostic process in Italy, Germany, and Spain. Clinical outcomes were expressed as antibiotic patients and days saved, reduced hospital admissions, and shortened hospital length of stay (LOS). Cost savings were evaluated from the perspectives of third-party payers and hospitals. A deterministic sensitivity analysis (DSA) was carried out. RESULTS: LMMBV was associated with a reduction in antibiotic prescriptions, treatment duration, and LOS. Furthermore, the adoption of LMMBV would allow savings per patient up to EUR 364 and EUR 328 for hospitals and EUR 91 and EUR 59 for payers in Italy and Germany, respectively. In Spain, average savings per patient could reach up to EUR 165 for both payers and hospitals. Savings were most sensitive to test accuracy, with DSA confirming the robustness of the results. CONCLUSIONS: Combining LMMBV with the current SOC diagnostic process is expected to provide clinical and economic benefits in Italy, Germany, and Spain.

CELESTIA: Cost-Effectiveness Analysis of Empagliflozin Versus Sitagliptin in Patients with Type 2 Diabetes in Greece.

Purpose: Globally, the prevalence of diabetes is on the rise, with the number of affected individuals predicted to cross 700 million by 2045. In Greece, in 2015, almost 700,000 people received prescribed medication for type 2 diabetes. The CELESTIA study aims to assess the cost-effectiveness of empagliflozin compared to branded sitagliptin in type 2 diabetes patients both with and without established cardiovascular disease in Greece from a third payer perspective. Methods: The IQVIA Core Diabetes Model was used and analyses were conducted from the Greek healthcare payer perspective. Patients received either empagliflozin or sitagliptin until HbA1c threshold of 8.5% (69 mmol/mol) was exceeded. Subsequently, patients were assumed to intensify to insulin therapy. Baseline cohort characteristics and treatment effects were derived from clinical trial data. Literature data were used for input (utilities, treatment costs and costs of diabetes-related complications costs). A lifetime time horizon (50 years) was applied, and costs and benefits were discounted at an annual rate of 3.5%. Results: Over a lifetime horizon, for empagliflozin, the estimated ICER was of €6,587 and €966 per quality-adjusted life years gained versus sitagliptin, in patients without established cardiovascular disease and in patients with established cardiovascular disease, respectively. Probabilistic sensitivity analysis confirmed the robustness of the analysis. Conclusion: The analysis demonstrated that for type 2 diabetes patients, empagliflozin is a cost-effective treatment option versus branded sitagliptin in Greece.

Prevalence and economic cost of malnutrition in Italy: A systematic review and metanalysis from the Italian Society of Artificial Nutrition and Metabolism (SINPE).

OBJECTIVES: Disease-related malnutrition (DRM) is a major public health issue with dramatic consequences on outcomes. However, in Italy a comprehensive and updated overview on national prevalence, in both the adult and pediatric populations, and its burden on the health care environment, is missing. The aim of this systematic literature review and meta-analysis was to identify and summarize the available evidence regarding the prevalence of DRM in Italy from pediatric to adult and older ages, and to project its global costs on the health care system. METHODS: We performed a systematic literature search for articles on epidemiology of DRM in Italy published up to June 2021. Studies reporting data on the prevalence of DRM in community-dwelling individuals with chronic diseases, nursing home patients, and hospitalized patients (medical, surgery, and oncology patients), were selected for inclusion. Methodological quality of the studies was assessed by two independent reviewers using published criteria. An epidemiologic meta-analysis to obtain an aggregate estimate of prevalence of DRM was performed and a model for estimating the cost of illness, based on the application of epidemiologic results to official national hospitalization data, and attribution of relevant unit costs in the national context was constructed. RESULTS: Sixty-seven studies reporting on the prevalence of DRM in Italian populations were included in the final selection; meta-analytical pooling yields mean prevalence estimates of about 50% and 30% in adult and pediatric hospitalized populations, respectively, with even higher findings for residents of long-term care facilities. Modeled projections of DRM-attributable yearly economic effects on the Italian health care system exceed 10 billion € in base case analysis, with the most optimistic estimate still exceeding 2.5 billion €. CONCLUSION: Although comparable in magnitude to data from previous studies in analogous international settings, the diffusion and effects of DRM in the Italian setting is impressive. Increased awareness of these data and proactive fostering of clinical nutrition services are warranted, as prompt identification and treatment of malnutrition have been shown to effectively improve clinical and economic results.

State-of-the-art review on AL amyloidosis in Western Countries: Epidemiology, health economics, risk assessment and therapeutic management of a rare disease.

Amyloidosis is the term to define a broad array of rare protein misfolding syndromes. Among them, light chain (AL) amyloidosis is the most common, affecting roughly 10 people per million/year. The core purpose of the present literature review is to shed light on the academic and clinical knowledge on the condition, encompassing its i) epidemiology, ii) economic burden, and iii) quality of life consequences. The areas of interest are Europe and North America. Literature search was primarily performed on Embase® and finally integrated with additional, deemed eligible, sources. Pre-defined PICOS criteria were employed for the inclusion and exclusion processes. A total of 64 studies were comprehensively included in the current literature review as compliant with the inclusion criteria. The results were presented according to the outcomes of interest and eventually triangulated and compared to available literature studies. A broad picture on the main aspects of AL amyloidosis is delivered.

Economic Analysis of a Ketoanalogue-Supplemented Very Low-Protein Diet in Patients With Chronic Kidney Disease in Taiwan and Thailand.

OBJECTIVE: A vegetarian very low-protein diet (VLPD) supplemented with ketoanalogues of essential amino acids Ketoanalogue-supplemented very low-protein diet (sVLPD) delays dialysis initiation in patients with chronic kidney disease (CKD). In this cost-effectiveness analysis, we compare an sVLPD with a conventional low-protein diet (LPD) in patients with CKD stage 4-5 using data from Taiwan and Thailand. DESIGN AND METHODS: A Markov model simulated health outcomes and care costs in patients receiving an sVLPD (0.3-0.4 g/kg-day, vegetarian diet) supplemented with ketoanalogues (1 tablet/5 kg-day) or an LPD (0.6 g/kg-day, mixed proteins). Health state transition probability and resource cost inputs were based on published literature and local sources, respectively. RESULTS: An sVLPD increased survival and quality-adjusted life years (QALYs) at a lower cost than an LPD. Total cost of care in Taiwan was 2,262,592.30 New Taiwan dollars (NTD) (68,059.35 EUR) with an LPD and 1,096,938.20 NTD (32,996.18 EUR) with an sVLPD (difference -1,165,654.10 NTD; -35,063.17 EUR). Total cost of care in Thailand was 500,731.09 Thai baht (THB) (14,584.12 EUR) with an LPD and 421,019.22 THB (12,262.46 EUR) with an sVLPD (difference -79,711.86 THB; -2,321.66 EUR). CONCLUSION: A ketoanalogue-supplemented vegetarian sVLPD increased QALYs and lowered lifetime care costs versus an LPD in patients with predialysis CKD in Taiwan and Thailand. These data, together with the new KDOQI Guidelines for nutrition in CKD, support dietary intervention using ketoanalogue-supplemented vegetarian sVLPDs to prevent CKD progression and postpone dialysis as a cost-effective approach, with beneficial effects for patients and health care providers.

Economic burden of hospital malnutrition: A cost-of-illness model.

BACKGROUND & AIMS: Hospital malnutrition is a highly prevalent condition that leads to an increased risk of clinical complications and a corresponding increase in healthcare resource utilisation. Despite the high prevalence and adverse clinical consequences, limited data are available on the magnitude of the economic burden associated with hospital malnutrition in Asian countries. The aim of the present analysis was to calculate country-specific estimates of the economic burden of hospital malnutrition in Asia. METHODS: Country-specific cost and prevalence data were used to calculate the incremental healthcare costs attributable to hospital malnutrition in 11 countries in Asia. The cost-of-illness was evaluated from the public perspective. Sources of increased cost included increased length of stay (LOS) and increased antibiotic use in malnourished patients who develop a healthcare-associated infection. Costs were calculated separately for the ward and intensive care unit (ICU) and currencies were converted to US$ to facilitate comparison. RESULTS: The estimated annual economic burden attributable to hospital malnutrition in Asia is $30.1 billion. Increased LOS accounts for the largest portion of the incremental cost, totalling $23.2 billion (77.2%) in the ward and $3.5 billion (11.5%) in the ICU. Medication costs related to the treatment of infectious complications account for an additional $3.4 billion (11.3%). Countries with the highest incremental costs include Japan ($19 billion), South Korea ($2.5 billion), and Taiwan ($2.2 billion). CONCLUSIONS: Hospital malnutrition imposes a substantial economic burden on Asian countries, resulting in an estimated $30 billion per year in additional healthcare costs. This finding underscores the need for rigorous screening and assessment as well as continuous monitoring of nutrition status in hospitalised patients to facilitate early identification and proactive management of hospital malnutrition.

Cost-Utility Analysis of Fixed-Dose Combination of Indacaterol Acetate Glycopyrronium Bromide and Mometasone Furoate as a Maintenance Treatment in Adult Patients with Asthma Not Adequately Controlled with a Maintenance Combination of a Long-Acting Beta-Agonist and a High Dose of an Inhaled Corticosteroid Who Experienced One or More Asthma Exacerbations in the Previous Year.

BACKGROUND AND OBJECTIVE: In asthma, symptom control is a primary goal that is not consistently met with available treatment options. The first commercially available fixed-dose combination in a single inhaler of a long-acting beta-agonist (indacaterol, IND), an inhaled corticosteroid (mometasone furoate, MF) and a long-acting muscarinic antagonist (glycopyrronium, GLY) has shown promising clinical results in phase III trials. The aim of the present study is to evaluate the cost-utility of IND/GLY/MF fixed-dose combination relative to a combination of salmeterol/fluticasone and tiotropium or salmeterol/fluticasone or IND/MF in adult patients with asthma, from the Italian Health Service (NHS) perspective. METHODS: A two-state and 4-week cycle Markov model was used to estimate lifetime clinical outcomes and costs. Patients entered the model in stable disease and could experience a non-fatal exacerbation event. The exacerbation rate is dependent upon the therapy a patient is receiving, as per the IND/GLY/MF clinical trials. The impact of each type of exacerbation is accounted by applying a utility decrement, obtained from the literature, and a treatment cost. Utility values were obtained from the EQ-5D questionnaires in the IND/GLY/MF clinical trials. Lifetime costs considered in the analysis were drugs and exacerbation management. Probabilistic sensitivity analyses were carried out, with the aim of evaluating the impact of uncertainty on input parameters. RESULTS: IND/GLY/MF is associated with a higher quality of life [+ 0.25 quality-adjusted life-year (QALY)] than salmeterol/fluticasone plus tiotropium, with an incremental cost of -€3213.90. The incremental cost-utility ratio indicates dominance. At a threshold of €5000 per QALY, IND/GLY/MF has nearly a 100% probability of being cost effective. IND/GLY/MF is associated with a higher quality of life (+ 0.21 QALY) than salmeterol/fluticasone, with an incremental cost of €2547.76. Incremental cost-utility ratio results in €11,897 per QALY. At a threshold of €20,000 per QALY, IND/GLY/MF has nearly a 100% probability of being cost effective. IND/GLY/MF is associated with a higher quality of life (+ 0.34 QALY) than IND/MF, with an incremental cost of €4745.91. Incremental cost-utility ratio results in €14,088 per QALY. At a threshold of €20,000 per QALY, IND/GLY/MF has nearly a 100% probability of being cost effective. CONCLUSION: The results indicate that IND/GLY/MF is cost effective against the considered comparators in a cohort representative of adult patients with asthma in Italy.

Obinutuzumab Plus Chemotherapy Compared with Rituximab Plus Chemotherapy in Previously Untreated Italian Patients with Advanced Follicular Lymphoma at Intermediate-High Risk: A Cost-Effectiveness Analysis.

OBJECTIVE: To assess the cost-effectiveness of obinutuzumab (O-chemo) in comparison to rituximab (R-chemo) in patients with untreated advanced follicular lymphoma (FL) at intermediate or high risk from an Italian National Health Service (NHS) perspective. METHODS: A previously developed four-state Markov model was adapted to estimate lifetime clinical outcomes and costs of Italian patients with advanced FL and an FL international predictive index score ≥2 in treatment with O-chemo and R-chemo. Life expectancy was derived from the GALLIUM and PRIMA clinical trials. Progression-free survival (PFS), early progressive disease (PD), and treatment duration were extrapolated by fitting parametric distributions to empirical data in GALLIUM and late PD to data in PRIMA. Expected survival was weighed by published utilities. Costs updated to 2020 Euros and health gains occurring after the first year were discounted at an annual 3% rate. Probabilistic sensitivity analysis (PSA) was carried out. RESULTS: O-chemo was associated with an incremental survival increase (0.97 life-years [LYs]), even when weighted for quality (0.88 quality-adjusted LYs [QALYs]), and incremental costs (around €15,000), driven by longer treatment during PFS state relative to R-chemo. The incremental cost-effectiveness ratio and incremental cost-utility ratio are both widely accepted by the Italian NHS (around €15,500/LY and €17,000/QALY gained, respectively). PSA simulations confirmed the robustness of results given sensible variations in assumptions. CONCLUSION: O-chemo has superior clinical efficacy compared to rituximab, and should be considered a cost-effective option in first-line treatment of patients with advanced FL at intermediate or high risk in Italy. Incremental cost-effectiveness ratios are below the threshold considered affordable by developed countries.

Comparative Cost and Effectiveness of a New Algorithm for Early Lyme Disease Diagnosis: Evaluation in US, Germany, and Italy.

PURPOSE: This Lyme disease early detection economic model, for patients with suspected Lyme disease without erythema migrans (EM), compares outcomes of standard two-tier testing (sTTT), modified two-tier testing (mTTT) and the DiaSorin Lyme Detection Algorithm (LDA), a combination of both serology tests and Interferon-ɤ Release Assay. PATIENTS AND METHODS: A patient-level simulation model was built to incorporate effectiveness estimation from a structured focused literature review, and health-care cost inputs for the United States, Germany, and Italy. Simulated clinical outcomes were 1) percent of patients with timely and correct diagnosis, 2) patients appropriately treated and exposed to antibiotics therapy, and 3) patients with late Lyme disease manifestations. Expected health outcomes were expressed in terms of differences in quality-adjusted life years (QALYs) due to disseminated Lyme disease and persisting symptoms, and economic outcomes were analyzed from a third-party payer perspective. RESULTS: The DiaSorin LDA resulted in a better sensitivity compared to sTTT and mTTT, 84% vs 49% and 45%, respectively, in the base case (13% of infected patients in the tested population). Due to the improved diagnostic performance, the LDA-based strategy is expected to be more effective, providing mean incremental 0.024 QALYs per tested patient, or 0.19 per infected patient. Furthermore, from a third-party payer perspective, the adoption of the LDA-based strategy would reduce the expected health-care cost for suspected and confirmed Lyme disease by roughly 40%, ie about $410, €130, and €170 per tested patient in the United States, Germany, and Italy, respectively, compared to sTTT. The results are most sensitive to the infection rate in the tested population, with LDA maintaining a cost advantage for Lyme disease active infection rates ≥0.8-2.5%. CONCLUSION: LDA early diagnostic testing and subsequent treatment of subjects with early Lyme disease without EM are expected to outperform traditional management strategies both clinically and economically in the US, Germany, and Italy.

Preliminary Cost-Effectiveness and Cost-Utility Analysis of Cemiplimab in Patients with Advanced Cutaneous Squamous Cell Carcinoma in Italy.

PURPOSE: Cutaneous squamous cell carcinoma (CSCC) is a common cancer that in most cases is curable with surgery. About 3-5% of patients develop advanced CSCC (aCSCC) and are no longer responsive to surgery or radiation therapy. The aim of this study was to assess the cost-effectiveness and cost-utility of cemiplimab, the first systemic therapy approved in Italy for patients with aCSCC, vs platinum-based chemotherapy from the Italian National Health Service (SSN) perspective. METHODS: A partitioned survival model, which included three mutually exclusive health states, was developed to estimate costs and outcomes for patients with aCSCC, over a 30-year time horizon (lifetime). No direct evidence of the comparative efficacy and safety of cemiplimab versus other therapies currently exists. Therefore, a simulated treatment comparison (STC) was conducted to estimate the comparative efficacy of cemiplimab versus chemotherapy. Individual patient data for cemiplimab were collected from the EMPOWER-CSCC 1 trial whereas chemotherapy data were derived from a retrospective study. In the STC a regression model was used to predict outcomes for cemiplimab in the population observed in the comparator study. Costs of drug acquisition/administration and management of adverse events were included. Costs and outcomes were discounted at 3% per year. Incremental cost-effectiveness ratio (ICER) and incremental cost-utility ratio (ICUR) were calculated; sensitivity and scenario analyses were performed to assess the robustness of results. RESULTS: In the base-case, treatment with cemiplimab was associated with a gain of 4.89 LYs and 3.99 QALYs, compared with a platinum-based chemotherapy regimen, resulting in an estimated ICER of 27,821 €/LY gained and an ICUR of 34,110 €/QALY gained. Both ICER and ICUR were below the commonly used Italian SSN willingness to pay thresholds. CONCLUSION: The use of cemiplimab, compared with a platinum-based chemotherapy regimen, can be considered a cost-effective option for the treatment of aCSCC patients in Italy.

Economic impact of mepolizumab in uncontrolled severe eosinophilic asthma, in real life.

BACKGROUND AND AIMS: Severe asthma is burdened by frequent exacerbations and use of oral corticosteroids (OCS) which worsen patients' health and increase healthcare spending. Aim of this study was to assess the clinical and economic effect of adding mepolizumab (MEP) for the treatment of these patients. METHODS: Patients >18 years old, referred to 8 asthma clinics, starting MEP between May 2017 and December 2018, were enrolled and followed-up for 12 months. Information in the 12 months before mepolizumab were collected retrospectively. The evaluation parameters included: OCS use, number of exacerbations/hospitalizations, concomitant therapies, comorbidity, and annual number of working days lost due to the disease. The primary objective was to compare the annual total cost per patient pre- and post-MEP. Secondary outcomes included rates of exacerbations and number of OCS-dependent patients. RESULTS: 106 patients were enrolled in the study: 46 male, median age 58 years. Mean annual cost pre- and post-MEP (cost of biologic excluded) was €3996 and €1,527, respectively. Total savings due to MEP resulted in €2469 (95%CI 1945-2993), 62% due to exacerbations reduction and 33% due to productivity increase. Such savings could fund about 22% of the total cost of MEP for one year. The introduction of MEP induced a clinical benefit by reducing both OCS-dependent patients (OR = 0.12, 95%CI 0.06-0.23) and exacerbation rate (RR = 0.19, 95%CI 0.15-0.24). CONCLUSIONS: Patients with severe eosinophilic asthma experienced a clinical benefit in asthma control adding MEP to standard therapy. Biologic therapy can be, partially, funded by the savings produced by patients' improvement.

Cost-Effectiveness of Parenteral Nutrition Containing ω-3 Fatty Acids in Hospitalized Adult Patients From 5 European Countries and the US.

BACKGROUND: ω-3 Fatty acid (FA)-containing parenteral nutrition (PN) is associated with improvements in patient outcomes and with reductions in hospital length of stay (HLOS) vs standard PN regimens (containing non-ω-3 FA lipid emulsions). We present a cost-effectiveness analysis of ω-3 FA-containing PN vs standard PN in 5 European countries (France, Germany, Italy, Spain, UK) and the US. METHODS: This pharmacoeconomic model was based on estimates of ω-3 efficacy reported in a recent meta-analysis and data from country-specific sources. It utilized a probabilistic discrete event simulation model to compare ω-3 FA-containing PN with standard PN in a population of critically ill and general ward patients. The influence of model parameters was evaluated using probabilistic and deterministic sensitivity analyses. RESULTS: Overall costs were reduced with ω-3 FA-containing PN in all 6 countries compared with standard PN, ranging from €1741 (±€1284) in Italy to €5576 (±€4193) in the US. Expenses for infections and HLOS were lower in all countries for ω-3 FA-containing PN vs standard PN, with the largest cost differences for both in the US (infection: €825 ± €4001; HLOS: €4879 ± €1208) and the smallest savings in the UK for infections and in Spain for HLOS (€63 ± €426 and €1636 ± €372, respectively). CONCLUSION: This cost-effectiveness analysis in 6 countries demonstrates that the superior clinical efficacy of ω-3 FA-containing PN translates into significant decreases in mean treatment cost, rendering it an attractive cost-saving alternative to standard PN across different healthcare systems.

Omega-3 fatty acid-containing parenteral nutrition in ICU patients: systematic review with meta-analysis and cost-effectiveness analysis.

BACKGROUND: Omega-3 (ω-3) fatty acid (FA)-containing parenteral nutrition (PN) is associated with significant improvements in patient outcomes compared with standard PN regimens without ω-3 FA lipid emulsions. Here, we evaluate the impact of ω-3 FA-containing PN versus standard PN on clinical outcomes and costs in adult intensive care unit (ICU) patients using a meta-analysis and subsequent cost-effectiveness analysis from the perspective of a hospital operating in five European countries (France, Germany, Italy, Spain, UK) and the US. METHODS: We present a pharmacoeconomic simulation based on a systematic literature review with meta-analysis. Clinical outcomes and costs comparing ω-3 FA-containing PN with standard PN were evaluated in adult ICU patients eligible to receive PN covering at least 70% of their total energy requirements and in the subgroup of critically ill ICU patients (mean ICU stay > 48 h). The meta-analysis with the co-primary outcomes of infection rate and mortality rate was based on randomized controlled trial data retrieved via a systematic literature review; resulting efficacy data were subsequently employed in country-specific cost-effectiveness analyses. RESULTS: In adult ICU patients, ω-3 FA-containing PN versus standard PN was associated with significant reductions in the relative risk (RR) of infection (RR 0.62; 95% CI 0.45, 0.86; p = 0.004), hospital length of stay (HLOS) (- 3.05 days; 95% CI - 5.03, - 1.07; p = 0.003) and ICU length of stay (LOS) (- 1.89 days; 95% CI - 3.33, - 0.45; p = 0.01). In critically ill ICU patients, ω-3 FA-containing PN was associated with similar reductions in infection rates (RR 0.65; 95% CI 0.46, 0.94; p = 0.02), HLOS (- 3.98 days; 95% CI - 6.90, - 1.06; p = 0.008) and ICU LOS (- 2.14 days; 95% CI - 3.89, - 0.40; p = 0.02). Overall hospital episode costs were reduced in all six countries using ω-3 FA-containing PN compared to standard PN, ranging from €-3156 ± 1404 in Spain to €-9586 ± 4157 in the US. CONCLUSION: These analyses demonstrate that ω-3 FA-containing PN is associated with statistically and clinically significant improvement in patient outcomes. Its use is also predicted to yield cost savings compared to standard PN, rendering ω-3 FA-containing PN an attractive cost-saving alternative across different health care systems. STUDY REGISTRATION: PROSPERO CRD42019129311.

Pharmacoeconomics of Parenteral Nutrition with ω-3 Fatty Acids in Hospitalized Adults.

The inclusion of ω-3 fatty acids as part of parenteral nutrition is associated with clinical benefits such as a reduced likelihood of infectious complications and shorter hospital and intensive care unit (ICU) stays. As healthcare resources are limited, pharmacoeconomic analyses have been performed, typically modeling studies, using cost and outcomes data to investigate the cost-effectiveness of parenteral nutrition regimens including ω-3 fatty acids from fish oil compared with standard parenteral nutrition without such ω-3 fatty acids. This review covers pharmacoeconomic studies encompassing Italian, French, German, and UK hospitals for ICU and non-ICU hospitalized patients, and for ICU patients in China. The results show that the use of parenteral nutrition including ω-3 fatty acids more than offsets any additional acquisition costs in all national scenarios investigated to date, indicating that parenteral nutrition including ω-3 fatty acids is a clinically and economically beneficial strategy compared with standard parenteral nutrition.

Cost-utility of surgical sutureless bioprostheses vs TAVI in aortic valve replacement for patients at intermediate and high surgical risk.

BACKGROUND: Meta-analyses of studies comparing transcatheter aortic valve implants (TAVIs) and sutureless aortic valve replacement (SU-AVR) show differing effectiveness and safety profiles. The approaches also differ in their surgical cost (including operating room and device). OBJECTIVE: The objective of this study was to assess the incremental cost-utility of SU-AVR vs TAVIs for the treatment of intermediate- to high-risk patients in the US, Germany, France, Italy, UK, and Australia. METHODS: A patient-level simulation compares in-hospital pathways of patients undergoing SU-AVR or TAVIs; later, patient history is modeled at the cohort level. Hospital outcomes for TAVIs reproduce data from recent series; in SU-AVR patients, outcomes are obtained by applying relative efficacy estimates in a recent meta-analysis on 1,462 patients. After discharge, survival depends on the development of paravalvular leak and the need for dialysis. A comprehensive third-party payer perspective encompassing both in-hospital and long-term costs was adopted. RESULTS: Due to lower in-hospital (4.1% vs 7.0%) and overall mortality, patients treated with SU-AVR are expected to live an average of 1.25 years more compared with those undergoing TAVIs, with a mean gain of 1.14 quality-adjusted life-years. Both in-hospital and long-term costs were lower for SU-AVR than for TAVIs with total savings ranging from $4,158 (France) to $20,930 (US). CONCLUSION: SU-AVR results dominant when compared to TAVIs in intermediate- to high-risk patients. Both in-hospital and long-term costs are lower for SU-AVR than for TAVI patients, with concomitant significant gains in life expectancy, both raw and adjusted for the quality of life.

Economic burden of hospital malnutrition and the cost-benefit of supplemental parenteral nutrition in critically ill patients in Latin America.

AIM: Disease-related malnutrition (DRM) is a prevalent condition that significantly increases the risk of adverse outcomes in hospitalized patients, particularly those with critical illness. Limited data is available on the economic burden of DRM and the cost-benefit of nutrition therapy in high-risk populations in Latin America. The aims of the present study were to estimate the economic burden of DRM and evaluate the cost-benefit of supplemental parenteral nutrition (SPN) in critically ill patients who fail to receive adequate nutrient intake from enteral nutrition (EN) in Latin America. METHODS: Country-specific cost and prevalence data from eight Latin American countries and clinical data from studies evaluating outcomes in patients with DRM were used to estimate the costs associated with DRM in public hospitals. A deterministic decision model based on clinical outcomes from a randomized controlled study and country-specific cost data were developed to examine the cost-benefit of administering SPN to critically ill adults who fail to reach ≥60% of the calculated energy target with EN. RESULTS: The estimated annual economic burden of DRM in public hospitals in Latin America is $10.19 billion (range, $8.44 billion-$11.72 billion). Critically ill patients account for a disproportionate share of the costs, with a 6.5-fold higher average cost per patient compared with those in the ward ($5488.35 vs. $839.76). Model-derived estimates for clinical outcomes and resource utilization showed that administration of SPN to critically ill patients who fail to receive the targeted energy delivery with EN would result in an annual cost reduction of $10.2 million compared with continued administration of EN alone. LIMITATIONS: The cost calculation was limited to the average daily cost of stay and antibiotic use. The costs associated with other common complications of DRM, such as prolonged duration of mechanical ventilation or more frequent readmission, are unknown. CONCLUSIONS: DRM imposes a substantial economic burden on Latin American countries, with critically ill patients accounting for a disproportionate share of costs. Cost-benefit analysis suggests that both improved clinical outcomes and significant cost savings can be achieved through the adoption of SPN as a therapeutic strategy in critically ill patients who fail to receive adequate nutrient intake from EN.