Validation of a Model Estimating the Budget Impact of Video Capsule Endoscopy for Surveillance of Crohn's Disease in an Italian Center.

Background: Crohn's disease is a chronic ailment affecting the gastrointestinal tract. Mucosal healing, a marker of reduced disease activity, is currently assessed in the colonic sections using ileocolonoscopy and magnetic resonance enteroscopy. Video capsule endoscopy (VCE) offers visualization of the entire GI mucosae. Objective: To validate a Crohn's disease model estimating the budget impact of VCE compared with the standard of care (SOC) in Italy. Methods: A patient-level, discrete-event simulation was developed to estimate the budget impact of VCE compared with SOC for Crohn's disease surveillance over 5 years in the Italian setting. Input data were sourced from a physician-initiated study from Sant'Orsola-Malpighi Hospital in Bologna, Italy, and the literature. The care pathway followed hospital clinical practice. Comparators were the current SOC (ileocolonoscopy, with or without magnetic resonance enteroscopy) and VCE. Sensitivity analysis was performed using 500-patient bootstraps. A comparative analysis regarding clinical outcomes (biologics use, surgical interventions, symptom remission) was performed to explore the validity of the model compared with real-world data. Cumulative event incidences were compared annually and semi-annually. Bayesian statistical analysis further validated the model. Results: Implementing VCE yielded an estimated €67 savings per patient per year, with savings in over 55% of patients, compared with SOC. While annual costs are higher up to the second year, VCE becomes cost saving from the third year onward. The real-world validation analysis proved a good agreement between the model and real-world patient records. The highest agreement was found for biologics, where Bayesian analysis estimated an 80.4% probability (95% CI: 72.2%-87.5%) that a decision maker would accept the result as an actual reflection of real-world data. Even where trend data diverged (eg, for surgery [43.1% likelihood of acceptance, 95% CI: 33.7%-52.8%]), the cumulative surgery count over 5 years was within the margin of error of the real-world data. Conclusions: Implementing VCE in the surveillance of patients with Crohn's disease and small bowel involvement may be cost saving in Italy. The congruence between model predictions and real-world patient records supports using this discrete-event simulation to inform healthcare decisions.

Comparative Life Cycle Assessment Between Single-Use and Reprocessed IPC Sleeves.

Purpose: Healthcare has a large environmental footprint, not least due to the wide use of single-use supplies. Reprocessing of medical devices is a well-established, regulated process, and can reduce its environmental impact. This life cycle assessment (LCA) compares the environmental footprint of a single-use and a reprocessed version of otherwise identical intermittent pneumatic compression (IPC) sleeves. Materials and Methods: The LCA was performed in accordance with the international standard ISO 14044 using the Environmental Footprint 3.0 (EF) method for the assessment. Data were obtained in cooperation with IPC sleeve manufacturers. Where no primary data were available, ecoinvent database records were used. The functional unit is five hospital treatments applying IPC. The robustness of the results was interrogated in sensitivity analyses of the energy mix, the ethylene oxide emissions during reprocessing, and the transport distances. The impact of waste reduction on hospital disposal costs was calculated. Results: The environmental footprint of reprocessed IPC sleeves was found to be reduced in all categories compared to single-use devices, leading to a weighted normalized reduction of 43% across all categories. In a breakdown of the LCA results, reprocessed IPC sleeves were found to reduce the carbon footprint by 40%, with the treatment of five patients with single-use IPC sleeves creating 7 kg CO2eq, compared to 4.2 kg CO2eq from reprocessed sleeves. Waste disposal costs were also reduced by 90%. Conclusion: Reprocessing of IPC sleeves provides an environmental and economic benefit in comparison to single-use devices.

A Health Economic Analysis Exploring the Cost Consequence of Using a Surgical Site Infection Prevention Bundle for Hip and Knee Arthroplasty in Germany.

Background: According to the European Centre for Disease Prevention and Control, surgical site infections (SSIs) constitute over 50% of all hospital-acquired infections. Reducing SSIs can enhance healthcare efficiency. Objective: This study explores the cost consequences of implementing an SSI prevention bundle (SPB) in total hip and knee arthroplasty (THKA). Methods: A health-economic model followed a cohort of THKA patients from admission to 90 days postdischarge. The perioperative process was modeled using a decision tree, and postoperative recovery and potential SSI evaluated using a Markov model. The model reflects the hospital payers' perspective in Germany. The SPB includes antimicrobial incision drapes, patient warming, and negative pressure wound therapy in high-risk patients. SSI reduction associated with these interventions was sourced from published meta-analyses. An effectiveness factor of 70% was introduced to account for potential overlap of effectiveness when interventions are used in combination. Sensitivity analyses were performed to assess the robustness of model outcomes. Results: The cost with the SPB was €4274.32 per patient, €98.27, or 2.25%, lower than that of the standard of care (€4372.59). Sensitivity analyses confirmed these findings, indicating a median saving of 2.22% (95% credible interval: 1.00%-3.79%]). The SPB also reduced inpatient SSI incidence from 2.96% to 0.91%. The break-even point for the SPB was found when the standard of care had an SSI incidence of 0.938%. Major cost drivers were the cost of inpatient SSI care, general ward, and operating room, and the increased risk of an SSI associated with unintended, intraoperative hypothermia. Varying the effectiveness factor from 10% to 130% did not substantially impact model outcomes. Conclusions: Introducing the SPB is expected to reduce care costs if the inpatient SSI rate (superficial and deep combined) in THKA procedures exceeds 1%. Research into how bundles of measures perform together is required to further inform the results of this computational analysis.

Fast In-House Next-Generation Sequencing in the Diagnosis of Metastatic Non-small Cell Lung Cancer: A Hospital Budget Impact Analysis.

Background: Targeted therapy for cancer is becoming more frequent as the understanding of the molecular pathogenesis increases. Molecular testing must be done to use targeted therapy. Unfortunately, the testing turnaround time can delay the initiation of targeted therapy. Objective: To investigate the impact of a next-generation sequencing (NGS) machine in the hospital that would allow for in-house NGS testing of metastatic non-small cell lung cancer (mNSCLC) in a US setting. Methods: The differences between 2 hospital pathways were established with a cohort-level decision tree that feeds into a Markov model. A pathway that used in-house NGS (75%) and the use of external laboratories (so-called send-out NGS) (25%), was compared with the standard of exclusively send-out NGS. The model was from the perspective of a US hospital over a 5-year time horizon. All cost input data were in or inflated to 2021 USD. Scenario analysis was done on key variables. Results: In a hospital with 500 mNSCLC patients, the implementation of in-house NGS was estimated to increase the testing costs and the revenue of the hospital. The model predicted a $710 060 increase in testing costs, a $1 732 506 increase in revenue, and a $1 022 446 return on investment over 5 years. The payback period was 15 months with in-house NGS. The number of patients on targeted therapy increased by 3.38%, and the average turnaround time decreased by 10 days when in-house NGS was used. Discussion: Reducing testing turnaround time is a benefit of in-house NGS. It could contribute to fewer mNSCLC patients lost to second opinion and an increased number of patients on targeted therapy. The model outcomes predicted that, over a 5-year period, there would be a positive return on investment for a US hospital. The model reflects a proposed scenario. The heterogeneity of hospital inputs and the cost of send-out NGS means context-specific inputs are needed. Conclusion: Using in-house NGS testing could reduce the testing turnaround time and increase the number of patients on targeted therapy. Additional benefits for the hospital are that fewer patients will be lost to second opinion and that in-house NGS could generate additional revenue.

Cost-effectiveness of mechanical thromboprophylaxis for cesarean deliveries in Brazil.

OBJECTIVE: To evaluate the cost-effectiveness of using mechanical thromboprophylaxis for patients undergoing a cesarean delivery in Brazil. METHODS: A decision-analytic model built in TreeAge software was used to compare the cost and effectiveness of intermittent pneumatic compression to prophylaxis with low-molecular-weight heparin or no prophylaxis from the perspective of the hospital. Related adverse events were venous thromboembolism, minor bleeding, and major bleeding. Model data were sourced from peer-reviewed studies through a structured literature search. A willingness-to-pay threshold of R$15,000 per avoided adverse event was adopted. Scenario, one-way, and probabilistic sensitivity analyses were performed to evaluate the impact of uncertainties on the results. RESULTS: The costs of care related to venous thromboembolism prophylaxis and associated adverse events ranged from R$914 for no prophylaxis to R$1,301 for low-molecular-weight heparin. With an incremental cost-effectiveness ratio of R$7,843 per adverse event avoided. Intermittent pneumatic compression was cost-effective compared to no prophylaxis. With lower costs and improved effectiveness, intermittent pneumatic compression dominated low-molecular-weight heparin. The probabilistic sensitivity analyses showed that the probability of being cost-effective was comparable for intermittent pneumatic compression and no prophylaxis, with low-molecular-weight heparin unlikely to be considered cost-effective (0.07). CONCLUSIONS: Intermittent pneumatic compression could be a cost-effective option and is likely to be more appropriate than low-molecular-weight heparin when used for venous thromboembolism prophylaxis for cesarean delivery in Brazil. Use of thromboprophylaxis should be a risk-stratified, individualized approach.

A single-patient-use ECG system for cardiothoracic surgery admissions in the UK: A cost-consequence analysis.

Background: Deep sternal wound infections (DSWI) are severe complications in up to 1.36% of coronary artery bypass grafting (CABG) procedures in the United Kingdom. Each event adds between £4,000 and £11,000 in healthcare costs, owing primarily to prolonged hospitalisations. ECG devices have been shown to convey infection throughout perioperative CABG. On the other hand, single-patient ECG devices (spECG) can effectively reduce the incidence of surgical site infections (SSI), including DSWI, but no assessment of spECG impact in NHS cardiac units has been conducted. Methods: To estimate the impact of spECG on NHS cardiac units, we conducted a cost-consequence analysis modeling the CABG care pathway in the United Kingdom using Simul8 software for a probabilistic, individual-patient simulation. The simulation time was 1 year, with each patient followed from admission through 30 days post-discharge. The base case simulation mirrors the cardiac unit of Bart Health NHS Trust, London. A total of 2,183 patients are generated with demographic and clinical attributes from probabilistic distributions informed by hospital-specific inputs from NHS Digital Data. The Brompton Harefield Infection Score (BHIS) is allocated to gauge the risk of SSI. Results are averaged across 50 independent and randomly seeded iterations. Results: Simulation results indicate a base-case savings of £388 per patient, determined by the incidence of infections rather than the number of CABG procedures. In the base-case simulation, the mean cost of care with rECG was £13,096, whereas the mean cost with spECG was £12,708, resulting in a cost saving of £388 (2021 GBP). The simulation yielded an overall 8.6% SSI incidence rECG, whereas the incidence of SSIs with spECG was 6.9%. The model was most sensitive to changes in general ward and ICU costs, and infection incidence was a stronger predictor of potential per-patient savings than annual CABG volume. Conclusion: Single-patient ECG is a sustainable and effective alternative to reusable ECG cables and lead wires in terms of patient safety and resource allocation.

Cancer patient management: Current use of next-generation sequencing in the EU TOP4.

BACKGROUND: Next-generation sequencing (NGS) is recognised by a growing audience of medical professionals as a functional diagnostic tool in oncology. However, adoption in clinical routine proceeds haphazardly in Europe. METHODS: A semi-structured interview survey was administered to 68 cancer care professionals in four EU countries between June-August and November-December 2021. Pre-screening questionnaires assessed sufficient NGS expertise, diverse geographical distribution, and professional roles. RESULTS: Our findings provide a better understanding of current clinical, regulatory, and reimbursement practices for NGS in four EU countries. CONCLUSIONS: Despite the impending European In-vitro Diagnostic Medical Devices Regulation (IVDR), tortuous national guidelines implementations and limping reimbursement policies are common traits across surveyed countries and produce disparity in access to advanced healthcare services amid regional distinctions. POLICY SUMMARY: The evident information gap between involved parties and demand for consistent national guidelines could be filled by health economics analyses tailored to local specifics to provide factual leverage for a structured adoption of NGS testing.

Moving preinduction cervical ripening to a lower acuity inpatient setting using the synthetic hygroscopic cervical dilator: a cost-consequence analysis for the United States.

BACKGROUND: Leveraging the safety profile of the synthetic hygroscopic cervical dilator (SHCD), one potential way to reduce the burden-of-care provision in the labor-and-delivery unit without compromising safety is to introduce a low-acuity care room (ripening room) for patients undergoing cervical ripening as a part of labor induction at term. METHODS: Implementing a ripening room using SHCDs was compared to scenarios using prostaglandins including a dinoprostone insert (PGE2 insert) or gel (PGE2 gel) and misoprostol given orally (oral PGE1) or vaginally (vaginal PGE1). A theoretical, cost-consequence model was developed to assess costs, staff time, and selected clinical outcomes related to cervical ripening. The model assessed a hypothetical cohort where patients remained in hospital from admission for induction of labor (IOL) to delivery, taking the US labor-and-delivery unit perspective. Model inputs were taken from structured searches of PubMed and ClinicalTrials.gov, published US guidance, and clinical practice. Results are presented as mean (95% credible interval [CrI]). RESULTS: The ripening room using SHCDs cost US$3,210 and required 10.22 hours (h) of nurse time on average per patient. The cost difference to prostaglandins ranged from -$894 (-$2,269 to $398) for PGE2 gel to +$460 (-$1,467 to $1,539) for vaginal PGE1. Mean nurse time was shorter than all prostaglandins, with time savings ranging from -7.05 (-24.55 to 5.73) h for PGE2 insert to -0.97 (-14.69 to 9.59) h for vaginal PGE1. When outcomes of the probabilistic sensitivity analysis were ranked from 1 (best) to 5 (worst), the ripening room using SHCDs ranked 1.94 for costs and 1.97 for nurse time. In a nulliparous population, results improved for the ripening room using SHCDs relative to all prostaglandins. CONCLUSION: In this theoretical study, implementing a ripening room using SHCDs resulted in the lowest time burden and the second lowest costs. The cheapest option for preinduction cervical ripening was vaginal misoprostol.

It is estimated that approximately 20% of deliveries in the USA are submitted to cervical ripening prior to induction of labor to facilitate a vaginal delivery. Cervical ripening can be achieved either by administering a synthetic hormone, called a prostaglandin (e.g. misoprostol or dinoprostone), or by using mechanical means of stretching the cervix (e.g. using the synthetic hygroscopic cervical dilator ­ SHCD). Prostaglandins have been associated with an increased risk of overstimulating uterus contractions such that the person undergoing cervical ripening with prostaglandins requires close monitoring. Each method for cervical ripening has advantages and disadvantages and there is no high-quality evidence to recommend one from the others based on clinical outcomes. In this theoretical study, we estimated the hospital costs and staff time for induction of labor care when using the SHCD in a lower acuity setting within the hospital, without monitoring facilities, in comparison to the patient remaining in the labor-and-delivery room using misoprotol or dinoprostone preparations. Our results suggest that misoprostol resulted in the least expensive option closely followed by the SHCD in a lower acuity setting, both with the potential for notable cost savings when compared to using dinoprostone preparations for cervical ripening. In addition, we associated up to several hours less staff time with the use of the SHCD in a lower acuity setting in comparison to misoprostol and dinoprostone. Patients that were delivering for the first time benefitted more from using the SHCD in a lower acuity setting in comparison to those who had delivered previously.

Synthetic osmotic dilators (Dilapan-S) or dinoprostone vaginal inserts (Propess) for inpatient induction of labour: A UK cost-consequence model.

OBJECTIVE: To estimate the costs of synthetic osmotic dilators (Dilapan-S) compared to dinoprostone vaginal inserts (Propess) for inpatient induction of labour (IOL). STUDY DESIGN: A population-level, Markov model-based cost-consequence analysis was developed to compare the impact of using Dilapan-S versus Propess. The time horizon was modelled from admission to birth. The target population was women requiring inpatient IOL from 37 weeks with an unfavourable cervix in the UK. Mean population characteristics reflected those of the SOLVE (NCT03001661) trial. No patient data were included in this analysis. The care pathways and staff workload were modelled using data from the SOLVE trial and clinical experience. Cost and clinical inputs were sourced from the SOLVE trial and peer-reviewed literature. Costs were inflated to 2020 British pounds (GBP, £). Outcomes were reported as an average per woman for total costs and required staff time (minutes) from admission for IOL until birth. The model robustness was assessed using a probabilistic, multivariate sensitivity analysis of 2,000 simulations with results presented as the median (interquartile range, IQR). RESULTS: Dilapan-S was cost neutral compared to Propess. Midwife and obstetrician times were decreased by 146 min (-11%) and 11 min (-54%), respectively. Sensitivity analysis showed that in 78% of simulations, use of Dilapan-S reduced midwife time with a median of -160 min (IQR -277 to -24 min). Costs were reduced in 54% of simulations (median -£33, IQR -£319 to £282). CONCLUSIONS: The model indicates that adoption of Dilapan-S is likely to be cost-neutral and reduce staff workload in comparison to Propess. Results require support from real-world data and further exploration of Dilapan-S is to be encouraged.

Economic and clinical impact of a novel, light-based, at-home antiviral treatment on mild-to-moderate COVID-19.

OBJECTIVES: Antiviral treatments for early intervention in patients with mild-to-moderate COVID-19 are needed as a complement to vaccination. We sought to estimate the impact on COVID-19 cases, deaths, and direct healthcare costs over 12 months following introduction of a novel, antiviral treatment, RD-X19, a light-based, at-home intervention designed for the treatment of mild-to-moderate COVID-19 infection. METHODS: A time-dependent, state transition (semi-Markov) cohort model was developed to simulate infection progression in individuals with COVID-19 in 3 US states with varying levels of vaccine uptake (Alabama, North Carolina, and Massachusetts) and at the national level between 1 June 2020 and 31 May 2021. The hypothetical cohort of patients entering the model progressed through subsequent health states after infection. Costs were assigned to each health state. Number of infections/vaccinations per day were incorporated into the model. Simulations were run to estimate outcomes (cases by severity, deaths, and direct healthcare costs) at various levels of adoption of RD-X19 (5%, 10%, 25%) in eligible infected individuals at the state and national levels and across three levels of clinical benefit based on the results from an early feasibility study of RD-X19. The clinical benefit reflects a decline in the duration of symptomatic disease by 1.2, 2.4 (base case), and 3.6 days. RESULTS: In the base case analysis with 10% adoption, simulated infections/deaths/direct healthcare costs were reduced by 10,059/275/$69 million in Alabama, 21,092/545/$135 million in North Carolina, and 16,670/415/$102 million in Massachusetts over 12 months. At the national level, 10% adoption reduced total infections/deaths/direct healthcare costs by 686,722/17,748/$4.41 billion. CONCLUSION: At-home, antiviral treatment with RD-X19 or other interventions with similar efficacy that decrease both symptomatic days and transmission probabilities can be used in concert with vaccines to reduce COVID-19 cases, deaths, and direct healthcare costs.

Proportional-assist ventilation with load-adjustable gain factors for mechanical ventilation: a cost-utility analysis.

BACKGROUND: Mechanical ventilation is an important component of patient critical care, but it adds expense to an already high-cost setting. This study evaluates the cost-utility of 2 modes of ventilation: proportional-assist ventilation with load-adjustable gain factors (PAV+ mode) versus pressure-support ventilation (PSV). METHODS: We adapted a published Markov model to the Canadian hospital-payer perspective with a 1-year time horizon. The patient population modelled includes all patients receiving invasive mechanical ventilation who have completed the acute phase of ventilatory support and have entered the recovery phase. Clinical and cost inputs were informed by a structured literature review, with the comparative effectiveness of PAV+ mode estimated via pragmatic meta-analysis. Primary outcomes of interest were costs, quality-adjusted life years (QALYs) and the (incremental) cost per QALY for patients receiving mechanical ventilation. Results were reported in 2017 Canadian dollars. We conducted probabilistic and scenario analyses to assess model uncertainty. RESULTS: Over 1 year, PSV had costs of $50 951 and accrued 0.25 QALYs. Use of PAV+ mode was associated with care costs of $43 309 and 0.29 QALYs. Compared to PSV, PAV+ mode was considered likely to be cost-effective, having lower costs (-$7642) and increased QALYs (+0.04) after 1 year. In cost-effectiveness acceptability analysis, 100% of simulations would be cost-effective at a willingness-to-pay threshold of $50 000 per QALY gained. INTERPRETATION: Use of PAV+ mode is expected to benefit patient care in the intensive care unit (ICU) and be a cost-effective alternative to PSV in the Canadian setting. Canadian hospital payers may therefore consider how best to optimally deliver mechanical ventilation in the ICU as they expand ICU capacity.

The Economic Implications of Introducing Single-Patient ECG Systems for Cardiac Surgery in Australia.

INTRODUCTION: Sternal wound infections (SWIs) are severe adverse events of cardiac surgery. This study aimed to estimate the economic burden of SWIs following coronary artery bypass grafts (CABG) in Australia. It also aimed to estimate the national and hospital cost-benefit of adopting single-patient electrocardiograph (spECG) systems for CABG monitoring, a measure that reduces the rate of surgical site infections (SSIs). MATERIAL AND METHODS: A literature review, which focused on CABG-related SSIs, was conducted to identify data which were then used to adapt a published Markov cost-effectiveness model. The model adopted an Australian hospital perspective. RESULTS: The average SWI-related cost of care increase per patient was estimated at 1022 Australian dollars (AUD), and the annual burden to the Australian health care system at AUD 9.2 million. SWI burden comprised 360 additional intensive care unit (ICU) days; 1979 additional general ward (GW) days; and 186 readmissions. Implementing spECG resulted in 103 fewer ICU days, 565 fewer GW days, 48 avoided readmissions, and a total national cost saving of AUD 2.5 million, annually. A hospital performing 200 yearly CABGs was estimated to save AUD 54,830. CONCLUSION: SWIs cause substantial costs to the Australian health care system. Implementing new technologies shown to reduce the SWI rate is likely to benefit patients and reduce costs.

Out-of-Hospital Cervical Ripening With a Synthetic Hygroscopic Cervical Dilator May Reduce Hospital Costs and Cesarean Sections in the United States-A Cost-Consequence Analysis.

Objective: Out-of-hospital (outpatient) cervical ripening prior to induction of labor (IOL) is discussed for its potential to decrease the burden on hospital resources. We assessed the cost and clinical outcomes of adopting an outpatient strategy with a synthetic hygroscopic cervical dilator, which is indicated for use in preinduction cervical ripening. Methods: We developed a cost-consequence model from the hospital perspective with a time period from IOL to post-delivery discharge. A hypothetical cohort of women to undergo IOL at term with an unfavorable cervix (all risk levels) were assessed. As the standard of care (referred to as IP-only) all women were ripened as inpatients using the vaginal PGE2 insert or the single-balloon catheter. In the comparison (OP-select), 50.9% of low-risk women (41.4% of the study population) received outpatient cervical ripening using a synthetic hygroscopic cervical dilator and the remaining women were ripened as inpatients as in the standard of care. Model inputs were sourced from a structured literature review of peer-reviewed articles in PubMed. Testing of 2,000 feasible scenarios (probabilistic multivariate sensitivity analysis) ascertained the robustness of results. Outcomes are reported as the average over all women assessed, comparing OP-select to IP-only. Results: Implementing OP-select resulted in hospital savings of US$689 per delivery, with women spending 1.48 h less time in the labor and delivery unit and 0.91 h less in the postpartum recovery unit. The cesarean-section rate was decreased by 3.78 percentage points (23.28% decreased to 19.50%). In sensitivity testing, hospital costs and cesarean-section rate were reduced in 91% of all instances. Conclusion: Our model analysis projects that outpatient cervical ripening has the potential to reduce hospital costs, hospital stay, and the cesarean section rate. It may potentially allow for better infection-prevention control during the ongoing COVID-19 pandemic and to free up resources such that more women might be offered elective IOL at 39 weeks.

Economic Analysis of the European Healthcare Burden of Sternal-Wound Infections Following Coronary Artery Bypass Graft.

Background: Sternal wound infections (SWIs) can be some of the most complex surgical-site infections (SSIs) and pose a considerable risk following coronary artery bypass graft surgery (CABG). Objective: To capture the cost burden of SWIs following CABG across European countries. Methods: We modeled a standardized care pathway for CABG, starting at the point of surgery and extending to 1-year post surgery. The Markov model captures the incidence and cost of an SWI (deep or superficial SWIs). The cost burden is calculated from a hospital perspective such that the main inputs relating to costs were intensive-care-unit (ICU) and general-ward (GW) days. Outpatient care, not in the hospital setting, has no cost in this analysis. Model input parameters were taken from Eurostat and a review of published, peer-reviewed literature. European countries were included in this analysis when values for 50% of the required input parameters per country were identified. Missing data points were interpolated from available data. The robustness of results was assessed via probabilistic sensitivity analysis. Results: Full required input data were available for 8 European countries; a further 18 countries had sufficient data for analysis. The median (interquartile range) for SWI incidence across the 26 countries was 3.9% (2.9-5.6%). The total burden for all 26 countries of SWIs after CABG was €170.8 million. These costs were made up of 25,751 additional ICU days, 137,588 additional GW days, and 7,704 readmissions. The mean cost of an SWI ranged from €8,924 in Poland to €21,321 in Denmark. Relative to the costs of post-CABG care without an SWI complication, the incremental cost of an SWI was highest in Greece (24.9% increase) and lowest in the UK (3.8% increase) with a median (interquartile range) of 12% (10-16%) across all 26 countries. Conclusions: SWIs following CABG present a considerable burden to healthcare budgets.

Earlier Provision of Gastric Bypass Surgery in Canada Enhances Surgical Benefit and Leads to Cost and Comorbidity Reduction.

Background: Effective provision of bariatric surgery for patients with obesity may be impeded by concerns of payers regarding costs or perceptions of patients who drop out of surgical programs after referral. Estimates of the cost and comorbidity impact of these inefficiencies in gastric bypass surgery in Canada are lacking but would aid in informing healthcare investment and resource allocation. Objectives: To estimate total and relative public payer costs for surgery and comorbidities (diabetes, hypertension, and dyslipidemia) in a bariatric surgery population. Methods: A decision analytic model for a 100-patient cohort in Canada (91% female, mean body mass index 49.2 kg/m2, 50% diabetes, 66% hypertension, 59% dyslipidemia). Costs include surgery, surgical complications, and comorbidities over the 10-year post-referral period. Results are calculated as medians and 95% credibility intervals (CrIs) for a pathway with surgery at 1 year ("improved") compared with surgery at 3.5 years ("standard"). Sensitivity analyses were performed to test independent contributions to results of shorter wait time, better post-surgical weight loss, and randomly sampled cohort demographics. Results: Compared to standard care, the improved path was associated with reduction in patient-years of treatment for each of the three comorbidities, corresponding to a reduction of $1.1 (0.68-1.6) million, or 34% (26-41%) of total costs. Comorbidity treatment costs were 9.0- and 4.7-fold greater than surgical costs for the standard and improved pathways, respectively. Relative to non-surgical bariatric care, earlier surgery was associated with earlier return on surgical investment and 2-fold reduction in risk of prevalence of each comorbidity compared to delayed surgery. Conclusions: Comorbidity costs represent a greater burden to payers than the costs of gastric bypass surgery. Investments may be worthwhile to reduce wait times and dropout rates and improve post-surgical weight loss outcomes to save overall costs and reduce patient comorbidity prevalence.

Economic analysis of the adoption of capsule endoscopy within the British NHS.

OBJECTIVE: Identification of a cost-effective treatment strategy is an unmet need in Crohn's disease (CD). Here we consider the patient outcomes and cost impact of pan-intestinal video capsule endoscopy (PVCE) in the English National Health Service (NHS). DESIGN: An analysis of a protocolized CD care pathway, informed by guidelines and expert consensus, was performed in Microsoft Excel. Population, efficacy and safety data of treatments and monitoring modalities were identified using a structured PubMed review with English data prioritized. Costs were taken from the NHS and Payer Provided Services (PSS) 2016-17 tariffs for England and otherwise literature. Analysis was via a discrete-individual simulation with discounting at 3.5% per annum. SETTING: NHS provider and PSS perspective. PARTICIPANTS: 4000 simulated CD patients. INTERVENTIONS: PVCE versus colonoscopy ± magnetic resonance enterography (MRE). MAIN OUTCOME MEASURES: Costs in 2017 GBP and quality-adjusted life years (QALY). RESULTS: The mean, total 20-year cost per patient was £42 266 with colonoscopy ± MRE and £38 043 with PVCE. PVCE incurred higher costs during the first 2 years due to higher treatment uptake. From year 3 onwards, costs were reduced due to fewer surgeries. Patients accrued 10.67 QALY with colonoscopy ± MRE and 10.96 with PVCE. PVCE dominated (less cost and higher QALY) colonoscopy ± MRE and was likely (>74%) to be considered cost-effective by the NHS. Results were similar if a lifetime time horizon was used. CONCLUSIONS: PVCE is likely to be a cost-effective alternative to colonoscopy ± MRE for CD surveillance. Switching to PVCE resulted in lower treatment costs and gave patients better quality of life.

Comparison of Comorbidity Treatment and Costs Associated With Bariatric Surgery Among Adults With Obesity in Canada.

Importance: Information on the associations between barriers to delivery of bariatric surgery and poor weight trajectory afterward is lacking. Estimates are needed to inform decisions by administrators and clinicians to improve care. Objective: To estimate the difference in patient-years of treatment for diabetes, hypertension, and dyslipidemia and public-payer cost between the Canadian standard and an improved bariatric surgery care pathway. Design, Setting, and Participants: Economic evaluation of a decision analytic model comparing the outcomes of the standard care in Canada with an improved bariatric care pathway with earlier sleeve gastrectomy delivery and better postsurgical weight trajectory. The model was informed by published clinical data (101 studies) and meta-analyses (11 studies) between January and May 2019. Participants were a hypothetical 100-patient cohort with demographic characteristics derived from a Canadian study. Interventions: Reduction of Canadian mean bariatric surgery wait time by 2.5 years following referral and improvement of patient postsurgery weight trajectory to levels observed in other countries. Main Outcomes and Measures: Modeling weight trajectory after sleeve gastrectomy and resolution rates for comorbidities in Canada in comparison with an improved care pathway to estimate differences in patient-years of comorbidity treatment over 10 years following referral and the associated costs. Results: For the 100-patient cohort (mean [SD] 88.2% [1.4%] female; mean [SD] age, 43.6 [9.2] years; mean [SD] body mass index, 49.4 [8.2]; and mean [SD] comorbidity prevalence of 50.0% [4.1%], 66.0% [3.9%], and 59.3% [4.0%] for diabetes, hypertension, and dyslipidemia, respectively) over 10 years following referral, the improved vs standard care pathway was associated with median reduction in patient-years of treatment of 324 (95% credibility interval [CrI], 249-396) for diabetes, 245 (95% CrI, 163-356) for hypertension, and 255 (95% CrI, 169-352) for dyslipidemia, corresponding to total savings of $900 000 (95% CrI, $630 000 to $1.2 million) for public payers in the base case. Relative to standard of care, the associated reduction in costs was approximately 29% (95% CrI, 20%-42%) in the improved pathway. Sensitivity analyses demonstrated independent associations of earlier surgical delivery and various levels of postsurgical weight trajectory improvements with overall savings. Conclusions and Relevance: This study suggests that health care burden may be decreased through improvements to delivery and management of patients undergoing sleeve gastrectomy. More data are needed on long-term patient experience with bariatric surgery in Canada to inform better estimates.

Critical Review of European Health-Economic Guidelines for the Health Technology Assessment of Medical Devices.

Background: Health-technology assessment (HTA) is a recognized mechanism to determine the relative benefits of innovative medical technologies. One aspect is their health-economic impact. While the process and methodology for pharmaceuticals is well-established, guidance for medical devices is sparse. Aim: To provide an overview of the health-economic aspect in current European HTA guidelines concerning medical devices and identifying issues raised and potential improvements proposed in recent literature. Methodology: Available guidelines by European agencies were each reviewed and summarized. To complement this, a full systematic review of current literature concerning potential improvements to existing HTA practices for medical devices, from PubMed and EMBASE, was conducted; the focus was on health economics. Authors could only review documents in English, French, or German. The systematic review yielded 518 unique articles concerning HTA for medical devices, 32 of which were considered for full-text review after screening of all abstracts. Results: There is very limited consensus in-and mostly a complete lack of-guidance specific to medical devices in official HTA guidelines, for both clinical and economic analyses. Twenty two of 41 European countries had published official HTA guidance in English, French, or German. Among these only 4 (England, France, the Netherlands, and Sweden) dedicated a chapter or separate document to medical devices. In the literature, there is sufficient evidence to suggest medical devices need to be addressed separately from pharmaceuticals. However, mostly challenges are discussed rather than implementable solutions offered. We present the following set of frequently discussed issues and summarize any solutions that pertain to them: a weak evidence base, learning-curve effects, organizational impact, incremental innovation, diversity of devices, dynamic pricing, and transferability. We further combine reviewed information to suggest a set of possible best practices for health-economic assessment of medical devices. Conclusion: For greater efficiency in medical-device innovation, European agencies should look to (re-)address the specific requirements of medical devices in their HTA guidelines. When both the health-economic and data requirements for the HTA of medical devices are defined, the development of practical solutions will likely follow.

Evaluating the clinical and economic consequences of using video capsule endoscopy to monitor Crohn's disease.

BACKGROUND: To assess the cost and patient impact of using small bowel and colon video capsule endoscopy (SBC) for scheduled monitoring of Crohn's disease (CD). METHODS: An individual-patient, decision-analytic model of the CD care pathway was developed given current practice and expert input. A literature review informed clinical endpoints with data from peer-reviewed literature. Four thousand simulated CD patients were extrapolated from summary patient data from the Project Sonar Database. Two monitoring scenarios were assessed in this population. The first scenario represented common monitoring practice (CMP) for CD (ileocolonoscopy plus imaging), while in the second scenario patients were converted to disease monitoring using SBC. The cost-effectiveness of using SBC was assessed over 20 years. The cost of switching 50% of patients to SBC was assessed over 5 years for a health-plan including 12,000 patients with CD. Uncertainty of results was assessed using probabilistic sensitivity analysis. RESULTS: All patient groups showed increased quality of life with SBC versus CMP, with the highest gain in active symptomatic patients. Over 20 years, SBC reduced costs ($313,367 versus $320,015), increased life expectancy (18.15 versus 17.9 years) and increased quality of life (8.7 versus 8.0 QALY), making it a cost-effective option. SBC was cost-effective in 71% of individuals and 78% of populations including 50 patients. A payer implementing SBC in 50% of patients over 5 years could expect a decreased cost of monitoring (-$469 mean per patient) and surgery (-$698), but increased costs for active treatments (+$717). The discounted mean annual cost of care using CMP was $22,681 per patient over 5 years. The annual savings were $1135 per SBC-patient. The total savings for the payer over 5 years were $36.5 million. CONCLUSION: SBC is likely to be a cost-effective and cost-saving strategy for monitoring CD in the US.

The Cost Effectiveness of Single-Patient-Use Electrocardiograph Cable and Lead Systems in Monitoring for Coronary Artery Bypass Graft Surgery.

Background: During admission for coronary artery bypass graft (CABG) surgery patients receive electrocardiograph (ECG) monitoring; for which reusable ECG cable and leads (rECG) are standard. Objective: Evaluate the cost effectiveness of a single-patient-use ECG cable and lead system (spECG). Methods: Review of the Medicare 2011-2014 database followed by a cost-effectiveness model considering a Medicare facility transitioning from rECG ($9 per patient) to spECG ($15). In-hospital ECG monitoring was for ≤8 days. In the model, patients underwent CABG and recovered in the intensive care unit, before transfer to the general ward and discharge. Surgical site infection (SSI) resulted in increased length of stay, readmission, or outpatient care. Health outcomes impacted EQ-5D-measured quality adjusted life years (QALYs). Health and cost outcomes were discounted at 3.5% annually. All costs in 2016 USD. Significance (95% level) was assessed via 2,000 simulations. Results: In 2014, 5.49% of patients had an SSI by 90-days post-surgery, with spECG reducing the odds of an SSI (odds ratio: 0.74, 0.62-0.89). Mean 40-year, per-patient costs to Medicare were $65,497 with rECG and $65,048 with spECG. The $450 saving was significant, with a median (95% credible interval) reduction of $466 ($174 to $989). Cost drivers were days required to treat inpatient SSIs. QALYs increases with spECG were significant but minor (median increase 0.008). Medicare savings may total $40 million per year with use of spECG. Conclusions: Post-operative SSI is a concern for Medicare patients undergoing CABG, and use of spECG is likely to provide cost and patient benefits.