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Thibaut Galvain,1 Melek Pinar Bosut,1 Nadine Jamous,1 Nadia Ben Mansour2,3 1Health Economics and Market Access, Johnson & Johnson Medical NV, Diegem, Belgium; 2National Institute of Health, Tunis, Tunisia; 3Faculty of Medicine, Université de Tunis El Manar, Tunis, TunisiaCorrespondence: Thibaut Galvain, Health Economics and Market Access, Johnson & Johnson Medical NV, Leonardo da Vincilaan 15, Diegem, Belgium, Tel +33648649800, Email tgalvain@its.jnj.comPurpose: Obesity is a growing global issue with evidence linking it to an increase in loss of disease-free years, reduced quality of life, increased mortality, and additional economic burden. This study sought to establish the cost-effectiveness of gastric bypass and sleeve gastrectomy, compared to conventional therapy in patients with obesity, from a Tunisian healthcare payor perspective.Patients and Methods: A Markov model compared lifetime costs and outcomes of bariatric surgery with conventional treatment among patients with body mass index (BMI) ≥ 40 kg/m2, BMI ≥ 35 kg/m2 with obesity-related co-morbidities (Group 1), or BMI ≥ 35 kg/m2 with type 2 diabetes mellitus (T2DM) (Group 2). Inputs were sourced from the Tunisian Health Examination Survey, local clinician data and literature sources. Health states were associated with different cost and utility decrements. Changes in body mass index, systolic blood pressure, lipid ratio and diabetes remission rates were modelled on a yearly basis. The incremental cost-effectiveness ratio (ICER), quality-adjusted life years (QALYs) and net monetary benefit (NMB) were key outcomes. Sensitivity and scenario analyses were performed to test the model’s robustness.Results: The model showed that the benefits of bariatric surgery were favorable compared to conventional treatment, with an ICER of 1844 TND/QALY in Group 1 patients and 2413 TND/QALY in Group 2 patients. Bariatric surgery resulted in a QALY gain of 3.26 per patient in Group 1 and a gain of 1.77 per patient in Group 2. At a willingness to pay threshold of 31,379 TND/QALY, the incremental NMB was 96,251 TND and 51,123 TND for Group 1 and Group 2, respectively.Conclusion: From the Tunisian healthcare payor perspective, bariatric surgery is cost-effective for patients with obesity and those with T2DM and obesity-related comorbidities. These findings may have impact on future decision-making on funding and reimbursement of bariatric surgery in Tunisia.Keywords: cost-effectiveness analysis, diabetes, gastric bypass, obesity, sleeve gastrectomy, bariatric surgery

Stephen S Johnston,1 Nadine Jamous,2 Sameer Mistry,3 Simran Jain,4 Gaurav Gangoli,5 Walter Danker,5 Eric Ammann,6 Kingsley Hampton7 1Department of Epidemiology, Medical Devices, Johnson & Johnson, New Brunswick, NJ, USA; 2Department of Health Economics and Market Access, Johnson & Johnson Medical Ltd, Edinburgh, UK; 3Department of Medical Affairs, Johnson & Johnson Medical Ltd, Berkshire, UK; 4Department of Decision Science, Mu Sigma, Bangalore, India; 5Department of Health Economics and Market Access, Ethicon, Inc, Somerville, NJ, USA; 6Department of Epidemiology, Janssen, Titusville, NJ, USA; 7Department of Cardiovascular Science, University of Sheffield, Sheffield, UKCorrespondence: Stephen S JohnstonDepartment of Epidemiology, Medical Devices, Johnson & Johnson, 410 George Street, New Brunswick, NJ 08901, USATel +1-443-254-2222Email sjohn147@its.jnj.comPurpose: To evaluate the association of in-hospital surgical bleeding events with the outcomes of hospital length of stay (LOS), days spent in critical care, complications, and mortality among patients undergoing neoplasm-directed surgeries in English hospitals.Patients and Methods: This is a retrospective cohort study using English hospital discharge data (Hospital Episode Statistics [HES]) linked to electronic health records (Clinical Practice Research Datalink [CPRD]). HES includes information on patient demographics, admission and discharge dates, diagnoses and procedures, days spent in critical care, and discharge status. CPRD includes information on patient demographics, diagnoses and symptoms, drug exposures, vaccination history, and laboratory tests. Patients aged ≥ 18 years who underwent selected neoplasm-directed surgeries between 1-Jan-2010 and 29-February-2016: hysterectomy, low anterior resection (LAR), lung resection, mastectomy, and prostate surgery were included. The primary independent variable was in-hospital surgical bleeding events identified by diagnosis of haemorrhage and haematoma complicating a procedure or reopening/re-exploration and surgical arrest of postoperative bleeding. Outcomes included LOS, days spent in critical care, in-hospital complications (diagnoses of infections, acute renal failure, vascular events), and in-hospital mortality, identified during surgery through discharge. Multivariable regression was used to examine the adjusted association of bleeding events with outcomes.Results: The study included 26,437 neoplasm-directed surgeries (hysterectomy=6092; LAR=2957; lung=1538; mastectomy=12,806; prostate=3044). Incidence proportions of bleeding events were: hysterectomy=1.9% (95% confidence interval=1.1– 2.5%); LAR=3.0% (CI=2.3– 3.6%); lung=1.8% (CI=1.1– 2.5%); mastectomy=1.6% (CI=1.3– 1.8%); prostate=1.0% (CI=0.6– 1.3%). In adjusted analyses, bleeding events were associated with: prolonged LOS: 3.1 (CI=1.1– 6.3) mastectomy to 5.7 (CI=3.6– 8.2) LAR days longer; more days spent in critical care: 0.4 (CI=0.03– 0.27) mastectomy to 6.5 (CI=2.5– 13.6) hysterectomy days more; and higher incidence proportions of all examined complications; all P< 0.05.Conclusion: This study quantifies a substantial clinical and healthcare resource utilization burden associated with surgical bleeding among patients undergoing neoplasm-directed surgery in England hospitals.Keywords: hysterectomy, low anterior resection, lung resection, mastectomy, prostate surgery, hospital episode statistics admitted patient care database, clinical practice research datalink GOLD database

Mitra Corral,1 Nicole Ferko,2 Andrew Hogan,2 Sarah S Hollmann,2 Gaurav Gangoli,1 Nadine Jamous,3 Jonathan Batiller,1 Richard Kocharian1 1Ethicon BioSurgery, Somerville, NJ, USA; 2Cornerstone Research Group, Burlington, ON, Canada; 3Ethicon Biosurgery, Wokingham, Berkshire, UK Background: Despite hemostat use, uncontrolled surgical bleeding is prevalent. Drawbacks of current hemostats include limitations with efficacy on first attempt and suboptimal ease-of-use. Evarrest® is a novel fibrin sealant patch that has demonstrated high hemostatic efficacy compared with standard of care across bleeding severities. The objective of this study was to conduct a hospital cost analysis of the fibrin sealant patch versus standard of care in soft tissue and hepatic surgical bleeding. Methods: The analysis quantified the 30-day costs of each comparator from a hospital perspective. Published US unit costs were applied to resource use (ie, initial treatment, retreatment, operating time, hospitalization, transfusion, and ventilator) reported in four trials. A “surgical” analysis included resources clinically related to the hemostatic benefit of the fibrin sealant patch, whereas a “hospital” analysis included all resources reported in the trials. An exploratory subgroup analysis focused solely on coagulopathic patients defined by abnormal blood test results. Results: The surgical analysis predicted cost savings of $54 per patient with the fibrin sealant patch compared with standard of care (net cost impact: −$54 per patient; sensitivity range: −$1,320 to $1,213). The hospital analysis predicted further cost savings with the fibrin sealant patch (net cost impact of −$2,846 per patient; sensitivity range: −$1,483 to −$5,575). Subgroup analyses suggest that the fibrin sealant patch may provide dramatic cost savings in the coagulopathic subgroup of $3,233 (surgical) and $9,287 (hospital) per patient. Results were most sensitive to operating time and product units. Conclusion: In soft tissue and hepatic problematic surgical bleeding, the fibrin sealant patch may result in important hospital cost savings. Keywords: cost, soft tissue bleeding, hepatic bleeding, surgical bleeding, coagulopathic, fibrin sealant patch, hospital, health economics

Background: In addition to rapid and sustained efficacy, ease of use is also an important characteristic of topical hemostats.Objectives: To evaluate clinician-reported ease of use for the Evarrest fibrin sealant patch across various surgical bleeding situations.Methods: An ease of use questionnaire (EUQ) was validated and administered in four randomized studies comparing the fibrin sealant patch to standard of care (SoC) in soft tissue and hepatic surgical bleeding. Three of these randomized studies have been previously published and all have been registered (NCT00658723; NCT00977925; NCT01166243; NCT01993888). The EUQ is a 19 item instrument evaluating clinician's preferences on five subscales: product ease of use, satisfaction with product properties and efficiency, confidence in product efficacy, global confidence, and global satisfaction. A pair-wise meta-analysis using a random effects model was conducted on EUQ scores for trials that reported data for both treatment arms. Individual scores are presented for each trial.Results: The fibrin sealant patch demonstrated numerically greater scores than SoC in all EUQ subscales. The meta-analysis demonstrated that fibrin sealant patch scores improved for all subscales compared with SoC: satisfaction with product properties (mean difference [MD] = 0.38, 95% CI: 0.04 to 0.73; P = 0.03), confidence in efficacy (MD = 1.10, 95% CI: 0.47 to 1.74; P = 0.0007), global confidence (MD = 0.57, 95% CI: 0.05 to 1.10, P = 0.03), global satisfaction (MD = 0.79, 95% CI: 0.32 to 1.26, P = 0.001), and ease of use (MD = 0.33, 95% CI: -0.29 to 0.94; P = 0.23). Fibrin sealant patch single arm trial results aligned with these findings.Conclusions: Physicians consistently reported high EUQ scores for the fibrin sealant patch across surgical bleeding populations. An important limitation of this study was that the composition of SoC varied across studies and EUQ data were only available for the SoC in two of four trials. Future studies should evaluate ease of use for other hemostats and across other surgical subspecialties, as data are currently limited. [ABSTRACT FROM AUTHOR]