Long-term Cost-effectiveness Analysis Research Articles

Cost-effectiveness of Lutetium [177Lu] oxodotreotide versus best supportive care with octreotide in patients with midgut neuroendocrine tumors in France

Background and aims In France, there are approximately 2,400 new cases of neuroendocrine tumors (NETs) annually. Peptide receptor radionuclide therapy with 177Lu-Dotatate plus long-acting repeatable [LAR] octreotide 30 mg has been shown to significantly improve progression-free survival and overall survival relative to high-dose octreotide LAR 60 mg in patients with unresectable or metastatic progressive midgut NETs. A long-term cost-effectiveness analysis was performed to assess whether 177Lu-Dotatate is a cost-effective option versus octreotide 60 mg for patients with unresectable/metastatic progressive midgut NETs from the perspective of French healthcare payer. Methods The analysis was performed using a three-state partitioned survival model. In the base case analysis 177Lu-Dotatate plus octreotide LAR 30 mg was compared with high-dose octreotide LAR 60 mg in patients with midgut NETs. Survival data were obtained from the phase III NETTER-1 trial in patients with metastatic midgut NETs. Future costs and clinical outcomes were discounted at 4% per annum. One-way deterministic and probabilistic sensitivity analyses were performed. Results In the base case analysis, for patients with midgut NETs, 177Lu-Dotatate treatment improved quality-adjusted life expectancy by 1.21 quality-adjusted life years (QALYs) relative to octreotide LAR 60 mg and the lifetime treatment costs were EUR 50,784 higher with 177Lu-Dotatate resulting in an incremental cost-effectiveness ratio (ICER) of EUR 42,106 per QALY gained versus octreotide LAR 60 mg. When compared with everolimus, 177Lu-Dotatate was associated with an ICER of EUR 59,769 per QALY gained. Sensitivity analyses showed that the results were sensitive to methods used to extrapolate survival data. Conclusions For patients with advanced progressive midgut NETs 177Lu-Dotatate is likely to be considered a cost-effective option versus octreotide 60 mg from the perspective of the French healthcare payer.

Lower Drug Cost of Successfully Treating Patients with Type 2 Diabetes to Targets with Once-Weekly Semaglutide versus Once-weeklyDulaglutide in Japan: A Short-Term Cost-Effectiveness Analysis.

In the head-to-head trial (SUSTAIN 7), the novel, injectable, once-weekly GLP-1 analogue semaglutide showed superiority in both glycemic outcomes and body weight reduction, compared with once-weeklydulaglutide in the treatment of type 2 diabetes (T2D). However, no economic evaluation using these data has yet been conducted in the Japanese setting. The objective of this analysis was to assess the short-term cost-effectiveness in Japan of once-weekly semaglutide 0.5mg (the approved maintenance dose in Japan) compared withonce-weekly dulaglutide 0.75mg (the only licensed dose in Japan) over a 1-year period using Japanese cost data. Responder endpoints were obtained from the SUSTAIN 7 trial to assess the cost of successfully treating patients to these targets ("cost of control"). Responder endpoint definitions consisted of single, dual, and triple composite endpoints related to glycemic control, body weight, and hypoglycemia outcomes. The cost of treatment was accounted from a healthcare payer perspective, capturing drug costs only. Treatment with once-weekly semaglutide 0.5mg was associated with a lower cost and a lower cost per patient treated to target for all endpoints, compared with once-weeklydulaglutide 0.75mg. For each JPY1 spent on bringing patients to target with once-weekly semaglutide 0.5mg, JPY1.58, JPY1.44, JPY1.60, JPY2.10, and JPY2.33 would need to be spent on once-weeklydulaglutide 0.75mg to achieve an equivalent outcome for endpoints of HbA1c ≤ 6.5%, HbA1c < 7.0%, HbA1c < 7.0% without hypoglycemia, and no weight gain, weight loss ≥ 5%, and ≥ 1.0% HbA1c reduction and ≥ 3.0% weight loss, respectively. These findings suggest that once-weekly semaglutide is a cost-effective treatment option compared withonce-weekly dulaglutide for patients with T2D in Japan. In the future, this finding should be extrapolated to traditional long-term cost-effectiveness analysis, using common outcomes such as quality-adjusted life years.

Long-Term Cost-Effectiveness Analyses of Empagliflozin Versus Oral Semaglutide, in Addition to Metformin, for the Treatment of Type 2 Diabetes in the UK

IntroductionInternational guidelines recommend treatment with a sodium-glucose cotransporter-2 (SGLT-2) inhibitor or glucagon-like peptide-1 (GLP-1) receptor agonist for treatment intensification in type 2 diabetes mellitus (T2DM) patients with progression on metformin. In the randomised, controlled, Peptide Innovation for Early Diabetes Treatment (PIONEER) 2 trial, the SGLT-2 inhibitor empagliflozin was compared with the GLP-1 receptor agonist oral semaglutide, in addition to metformin. The aim of the current study was to assess the long-term cost-effectiveness of empagliflozin 25 mg versus oral semaglutide 14 mg, in addition to metformin, for T2DM patients in the UK.MethodsAnalyses were conducted from the UK healthcare payer perspective, using the IQVIA Core Diabetes model, with a time horizon of 50 years. Patients received either empagliflozin or oral semaglutide, in addition to metformin, until Hba1c threshold of 7.5% (58 mmol/mol) was exceeded, following which treatment intensification with insulin glargine in addition to empagliflozin or oral semaglutide plus metformin was assumed. Baseline cohort characteristics and 52-week treatment effects were derived from the PIONEER 2 trial. Treatment effects of empagliflozin and GLP-1 receptor agonists on hospitalisation for heart failure (hHF) were based on the Empagliflozin Comparative Effectiveness and Safety (EMPRISE) real-world study. Utilities, treatment costs and costs of diabetes-related complications were obtained from published sources.ResultsDirect costs for empagliflozin plus metformin were considerably lower than those for oral semaglutide plus metformin (by more than GBP 6000). Compared with oral semaglutide plus metformin, empagliflozin plus metformin was a cost-effective treatment for T2DM patients in all scenarios tested. Probabilistic sensitivity analysis showed cost-effectiveness in > 95% of the iterations using a threshold of 20,000 GBP/QALY.ConclusionEmpagliflozin 25 mg is a cost-effective treatment option versus oral semaglutide 14 mg, when used in addition to metformin, for the treatment of T2DM patients in the UK.Electronic supplementary materialThe online version of this article (10.1007/s13300-020-00883-1) contains supplementary material, which is available to authorized users.

Changing costs of type 1 diabetes care among US children and adolescents.

Modern therapy for type 1 diabetes (T1D) increasingly utilizes technology such as insulin pumps and continuous glucose monitors (CGMs). Prior analyses suggest that T1D costs are driven by preventable hospitalizations, but recent escalations in insulin prices and use of technology may have changed the cost landscape. We conducted a retrospective analysis of T1D medical costs from 2012 to 2016 using the OptumLabs Data Warehouse, a comprehensive database of deidentified administrative claims for commercial insurance enrollees. Our study population included 9445 individuals aged ≤18 years with T1D and ≥13 months of continuous enrollment. Costs were categorized into ambulatory care, hospital care, insulin, diabetes technology, and diabetes supplies. Mean costs for each category in each year were adjusted for inflation, as well as patient-level covariates including age, sex, race, census region, and mental health comorbidity. Mean annual cost of T1D care increased from $11 178 in 2012 to $17 060 in 2016, driven primarily by growth in the cost of insulin ($3285 to $6255) and cost of diabetes technology ($1747 to $4581). Our findings suggest that the cost of T1D care is now driven by mounting insulin prices and growing utilization and cost of diabetes technology. Given the positive effects of pumps and CGMs on T1D health outcomes, it is possible that short-term costs are offset by future savings. Long-term cost-effectiveness analyses should be undertaken to inform providers, payers, and policy-makers about how to support optimal T1D care in an era of increasing reliance on therapeutic technology.

Cost-Effectiveness Analysis Applied to the Treatment of Unruptured Anterior Circulation Aneurysms in a Middle-Income Country

Object. Controversy exists regarding the best treatment option for unruptured anterior circulation aneurysms (UA); we performed a long-term cost-effectiveness analysis comparing different treatment options from an economic standpoint.&#x0D; Methods. A decision-tree model was built based on a hypothetical cohort of 1,000 patients undergoing treatment for UA. Health outcomes and cost analysis were modeled over the projected lifetime. All treatment outcome probabilities and likelihood ratios were obtained from natural history and outcome studies. Costs were assessed from the societal perspective of the general healthcare system in Colombia. A univariate sensitivity analysis was conducted to evaluate the impact and significance of results.&#x0D; Results. Significant differences were shown in treatment cost and total effectiveness. SC had a mean treatment cost of US$2,322 and a cost-effectiveness ratio of US$2,735 (EC: US$4,650 and US$5,798). A univariate sensitivity analysis showed that the total cost-effectiveness of SC remained dominantly superior to EC. Conclusions. From an economic standpoint, results show that SC is the most cost-effective treatment alternative in a middle-income country. These results must be taken into account during the decision-making process for the treatment of UA, especially in those countries where cost-effective measures are of vital importance. Nevertheless, further studies are warranted in different healthcare-system settings.

Oral Semaglutide Versus Empagliflozin, Sitagliptin and Liraglutide in the UK: Long-Term Cost-Effectiveness Analyses Based on the PIONEER Clinical Trial Programme.

IntroductionThe PIONEER trial programme showed that, after 52 weeks, the novel oral glucagon-like peptide-1 (GLP-1) analogue semaglutide 14 mg was associated with significantly greater reductions in glycated haemoglobin (HbA1c) versus a sodium-glucose cotransporter-2 inhibitor (empagliflozin 25 mg), a dipeptidyl peptidase-4 inhibitor (sitagliptin 100 mg) and an injectable GLP-1 analogue (liraglutide 1.8 mg). The aim of the present analysis was to assess the long-term cost-effectiveness of oral semaglutide 14 mg versus each of these comparators in the UK setting.MethodsAnalyses were performed from a healthcare payer perspective using the IQVIA CORE Diabetes Model, in which outcomes were projected over patient lifetimes (50 years). Baseline cohort characteristics and treatment effects were based on 52-week data from the PIONEER 2, 3 and 4 randomised controlled trials, comparing oral semaglutide with empagliflozin, sitagliptin and liraglutide, respectively. Treatment switching occurred when HbA1c exceeded 7.5% (58 mmol/mol). Utilities, treatment costs and costs of diabetes-related complications (in pounds sterling [GBP]) were taken from published sources. The acquisition cost of oral semaglutide was assumed to match that of once-weekly semaglutide.ResultsOral semaglutide was associated with improvements in quality-adjusted life expectancy of 0.09 quality-adjusted life years (QALYs) versus empagliflozin, 0.20 QALYs versus sitagliptin and 0.07 QALYs versus liraglutide. Direct costs over a patient’s lifetime were GBP 971 and GBP 963 higher with oral semaglutide than with empagliflozin and sitagliptin, respectively, but GBP 1551 lower versus liraglutide. Oral semaglutide was associated with a reduced incidence of diabetes-related complications versus all comparators. Therefore, oral semaglutide 14 mg was associated with incremental cost-effectiveness ratios of GBP 11,006 and 4930 per QALY gained versus empagliflozin 25 mg and sitagliptin 100 mg, respectively, and was more effective and less costly (dominant) versus liraglutide 1.8 mg.ConclusionOral semaglutide was cost-effective versus empagliflozin and sitagliptin, and dominant versus liraglutide, for the treatment of type 2 diabetes in the UK.Electronic Supplementary MaterialThe online version of this article (10.1007/s13300-019-00736-6) contains supplementary material, which is available to authorized users.

Three-Dimensional Printing in Minimally Invasive Spine Surgery.

To summarize the recent advances in 3D printing technology as it relates to spine surgery and how it can be applied to minimally invasive spine surgery. Most early literature about 3D printing in spine surgery was focused on reconstructing biomodels based on patient imaging. These biomodels were used to simulate complex pathology preoperatively. The focus has shifted to guides, templates, and implants that can be used during surgery and are specific to patient anatomy. However, there continues to be a lack of long-term outcomes or cost-effectiveness analyses. 3D printing also has the potential to revolutionize tissue engineering applications in the search for the optimal scaffold material and structure to improve bone regeneration without the use of other grafting materials. 3D printing has many potential applications to minimally invasive spine surgery requiring more data for widespread adoption.

Cost-Effectiveness of Sensor-Augmented Insulin Pump Therapy Versus Continuous Insulin Infusion in Patients with Type 1 Diabetes in Turkey.

Background and Aims: Sensor-augmented pump therapy (SAP) combines continuous glucose monitoring with continuous subcutaneous insulin infusion (CSII). SAP is costlier than CSII but provides additional clinical benefits relative to CSII alone. A long-term cost-effectiveness analysis was performed to determine whether SAP is cost-effective relative to CSII in patients with type 1 diabetes (T1D) in Turkey. Methods: Analyses were performed in two different patient cohorts, one with poor glycemic control at baseline (mean glycated hemoglobin 9.0% [75 mmol/mol]) and a second cohort considered to be at increased risk of hypoglycemic events. Clinical input data and direct medical costs were sourced from published literature. The analysis was performed from a third-party payer perspective over patient lifetimes and future costs and clinical outcomes were discounted at 3.5% per annum. Results: In both patient cohorts, SAP was associated with a gain in quality-adjusted life expectancy but higher costs relative to CSII (incremental gain of 1.40 quality-adjusted life years [QALYs] in patients with poor baseline glycemic control and 1.73 QALYs in patients at increased risk of hypoglycemic events). Incremental cost-effectiveness ratios for SAP versus CSII were TRY 76,971 (EUR 11,612) per QALY gained for patients with poor baseline glycemic control and TRY 69,534 (EUR 10,490) per QALY gained for patients at increased risk for hypoglycemia. Conclusions: SAP is associated with improved long-term clinical outcomes versus CSII, and in Turkey, SAP is likely to represent good value for money compared with CSII in T1D patients with poor glycemic control and/or with frequent severe hypoglycemic events.

A Long-Term Cost-Effectiveness Analysis Comparing Radiofrequency Catheter Ablation with Antiarrhythmic Drugs in Treatment of Chinese Patients with Atrial Fibrillation.

Radiofrequency catheter ablation (RFCA) is widely used to treat atrial fibrillation (AF) in China. We aimed to determine the long-term cost effectiveness of RFCA versus antiarrhythmic drugs (AADs) in treating AF from the perspective of third-party payers. The model was structured as a 12-month decision tree leading to a Markov model that simulated the follow-up treatment outcomes and costs with time horizons of 8, 15, and 20years. Comparators were standard-of-care AADs. Clinical parameters captured normal sinus rhythm, AF, stroke, post-stroke, intracranial hemorrhage (ICH), gastrointestinal bleeding, post-ICH, and death. The risk of operative death, procedural complications, and adverse drug toxicity were also considered. The model output was quality-adjusted life-years (QALYs) and incremental cost per QALY gained. RFCA incurred more costs than the AADs but resulted in more QALYs gained than did AADs. The incremental cost per QALY gained with RFCA versus AADs was ¥66,764, ¥36,280, and ¥29,359 at 8, 15, and 20years, respectively. The sensitivity analyses showed that the results were most sensitive to the changes in RFCA cost and CHADS2 score (clinical prediction rule for assessing the risk of stroke in patients with non-rheumatic AF). Compared with AADs, RFCA significantly improves clinical outcomes and QALYs among patients with paroxysmal or persistent AF. From the Chinese payer's perspective, RFCA is a cost-effective therapy over long-term horizons.

Short-term and long-term cost-effectiveness of a pedometer-based exercise intervention in primary care: a within-trial analysis and beyond-trial modelling

ObjectivesA short-term and long-term cost-effectiveness analysis (CEA) of two pedometer-based walking interventions compared with usual care.Design(A) Short-term CEA: parallel three-arm cluster randomised trial randomised by household. (B) Long-term CEA: Markov...

Long-term cost-effectiveness analysis shows that IDegLira is associated with improved outcomes and lower costs compared with insulin glargine U100 plus insulin aspart in the US

Aims: The clinical and economic impact of diabetes is growing in the US. Choosing therapies that are both effective and cost-effective is becoming increasingly important. The aim of the present analysis was to assess the long-term cost-effectiveness of IDegLira for treatment of patients with type 2 diabetes mellitus not meeting glycemic targets on basal insulin, vs insulin glargine U100 plus insulin aspart, in the US setting.Materials and methods: Long-term projections of cost-effectiveness outcomes were made using the IQVIA CORE Diabetes Model. Clinical inputs were based on the DUAL VII trial, with costs (accounted from a healthcare payer perspective) and utilities based on published sources. Future costs and clinical benefits were discounted at 3% annually.Results: IDegLira was associated with increased discounted life expectancy by 0.02 years and increased discounted quality-adjusted life expectancy by 0.22 quality-adjusted life years compared with insulin glargine U100 plus insulin aspart. Evaluation of direct medical costs suggested that the mean cost per patient with IDegLira was $3,571 lower than with insulin glargine U100 plus insulin aspart. The cost saving was driven predominantly by the lower acquisition cost of IDegLira compared with insulin glargine U100 plus insulin aspart, with further cost savings identified as a result of avoided treatment of diabetes-related complications. IDegLira was associated with improved clinical outcomes at a reduced cost compared with insulin glargine U100 plus insulin aspart.Conclusions: Based on clinical trial data, the present analysis suggests that IDegLira is associated with improved clinical outcomes and cost savings compared with treatment with insulin glargine U100 plus insulin aspart for patients with type 2 diabetes not achieving glycemic control on basal insulin in the US. Therefore, IDegLira is likely to be considered dominant (cost saving and more effective) and, consequently, highly cost-effective in the US setting.

PMU33 - Economic Evaluation of A Randomised Controlled Trial of An Intervention to Reduce Desk-Based Workers' Sitting Time: The Stand-Up Victoria Trial

Interventions to reduce workplace sitting time have been shown to be effective, but little is known about their cost-effectiveness. This study assessed the economic credentials of a workplace-delivered intervention to reduce sitting time in desk-based workers. Within-trial cost-efficacy analysis and long-term cost-effectiveness analysis (CEA) modelled for the Australian population were performed. In total, 231 desk-based workers aged 24-65 years of one organisation were recruited in a clustered randomized controlled trial. A multicomponent workplace-delivered intervention (including organizational, environmental [sit-stand workstations], and individual [health coaching] intervention elements) was compared to usual practice. Total device-measured workplace sitting time (primary), Body Mass Index (BMI: kg/m2), self-reported health-related quality of life (measured by Assessment of Quality of Life-8D), and absenteeism were measured at 12 months. Compared to usual practice, the intervention was associated with greater cost (AUD431/person) and benefits in terms of reduced workplace sitting time (-46.8 mins/8-h workday, 95% confidence interval: -69.9 to -23.7) and increased workplace standing time (42.2 mins/8-h workday, 23.8 to 60.6). However, there were no significant benefits for BMI (0.148 kg/m2 [-1.407 to 1.703]), AQoL-8D (-0.006 [-0.074 to 0.063]) or absenteeism (2.12 days [-2.01 to 6.26]). The incremental cost-efficacy ratios ranged from AUD9.94 cost/minute reduction in workplace sitting time to AUD13.37/minute reduction in overall sitting time. The intervention contributed to higher life year gains (LY) (0.01 [0.009 to 0.011]), higher health-adjusted life year gains (HALY) (0.012 [0.0105 to 0.0135]), and higher net costs (AUD344 [$331 to $358]), with corresponding incremental cost effectiveness ratios of AUD34,443/LY and $28,703/HALY. CEA results were sensitive to assumptions surrounding intervention-effect decay rate and discount rate. The intervention was cost-effective over the lifetime of the cohort when scaled up to the national workforce. It provides important evidence for policy makers and workplaces regarding allocation of resources to reduce workplace sitting.

Economic evaluation of a randomized controlled trial of an intervention to reduce office workers' sitting time: the "Stand Up Victoria" trial.

Objectives This study aimed to assess the economic credentials of a workplace-delivered intervention to reduce sitting time among desk-based workers. Methods We performed within-trial cost-efficacy analysis and long-term cost-effectiveness analysis (CEA) and recruited 231 desk-based workers, aged 24-65 years, across 14 worksites of one organization. Multicomponent workplace-delivered intervention was compared to usual practice. Main outcome measures including total device-measured workplace sitting time, body mass index (BMI), self-reported health-related quality of life (Assessment of Quality of Life-8D, AQoL-8D), and absenteeism measured at 12 months. Results Compared to usual practice, the intervention was associated with greater cost (AU$431/person), benefits in terms of reduced workplace sitting time [-46.8 minutes/8-hour workday, 95% confidence interval (CI): -69.9- -23.7] and increased workplace standing time (42.2 minutes/8-hour workday, 95% CI 23.8-60.6). However, there were no significant benefits for BMI [0.148 kg/m 2(95% CI-1.407-1.703)], QoL-8D [-0.006 (95% CI -0.074-0.063)] and absenteeism [2.12 days (95% CI -2.01-6.26)]. The incremental cost-efficacy ratios (ICER) ranged from AU$9.94 cost/minute reduction in workplace sitting time to AU$13.37/minute reduction in overall sitting time. CEA showed the intervention contributed to higher life year (LY) gains [0.01 (95% CI 0.009-0.011)], higher health-adjusted life year (HALY) gains [0.012 (95% CI 0.0105 - 0.0135)], and higher net costs [AU$344 (95% CI $331-358)], with corresponding ICER of AU$34 443/LY and AU$28 703/HALY if the intervention effects were to be sustained for five-years. CEA results were sensitive to assumptions surrounding intervention-effect decay rate and discount rate. Conclusions The intervention was cost-effective over the lifetime of the cohort when scaled up to the national workforce and provides important.

Addition of docetaxel to first-line long-term hormone therapy in prostate cancer (STAMPEDE): Long-term survival, quality-adjusted survival, and cost-effectiveness analysis.

162 Background: Results from large randomised controlled trials have shown that adding docetaxel to standard of care (SOC) in men initiating hormone therapy for prostate cancer prolongs survival for those with metastatic disease and prolongs time to treatment failure for those without metastatic disease. We report on the impact of docetaxel on health related quality of life (HRQoL), resource use and cost-effectiveness for men treated in the STAMPEDE trial. Methods: Health outcomes and costs in the UK NHS were modelled using EuroQol (EQ-5D)and resource use data collected within the STAMPEDE trial (STAMPEDE enrolled men advanced prostate cancer starting first line hormone therapy. SOC was hormone therapy for ≥2 years and radiotherapy in some patients. Docetaxel (75 mg/m2) was administered alongside SOC for six 3-weekly cycles with prednisolone 10 mg daily. Lifetime predictions of costs, changes in predicted survival duration, quality adjusted life years (QALYs), and incremental cost effectiveness ratios (ICERs) were calculated. Results: Compared to patients allocated SOC, docetaxel was estimated to extend predicted survival by an average of 0.89 years for M1 patients and 0.78 years for M0 patients. Docetaxel was estimated to extend discounted QALYs by 0.51 years in M1 patients and 0.39 years in M0 patients. QALY gains in M0 patients were driven by the beneficial effect of delayed and reduced relapse. Docetaxel was cost-effective both in M1 patients (ICER = £5,514/QALY vs. SOC) and M0 patients (higher QALYs, lower costs vs. SOC). The probabilistic sensitivity analysis indicated a very high probability ( &gt; 99%) that docetaxel is cost-effective in both M0 and M1 patients. Docetaxel remained cost effective in M0 patients even when no survival advantage was assumed due to reductions and delays in relapse. Conclusions: Docetaxel improves overall HRQoL, delays time to, and reduces the need for, subsequent therapy, and is cost-effective, amongst patients with both non-metastatic and metastatic disease. Clinicians should consider whether the evidence is now sufficiently compelling to support docetaxel use in non-metastatic patients. Clinical trial information: ISRCTN78818544.

The UK EndoVascular Aneurysm Repair (EVAR) randomised controlled trials: long-term follow-up and cost-effectiveness analysis.

Short-term survival benefits of endovascular aneurysm repair (EVAR) compared with open repair (OR) of intact abdominal aortic aneurysms have been shown in randomised trials, but this early survival benefit is soon lost. Survival benefit of EVAR was unclear at follow-up to 10 years. To assess the long-term efficacy of EVAR against OR in patients deemed fit and suitable for both procedures (EVAR trial 1; EVAR-1); and against no intervention in patients unfit for OR (EVAR trial 2; EVAR-2). To appraise the long-term significance of type II endoleak and define criteria for intervention. Two national, multicentre randomised controlled trials: EVAR-1 and EVAR-2. Patients were recruited from 37 hospitals in the UK between 1 September 1999 and 31 August 2004. Men and women aged ≥ 60 years with an aneurysm of ≥ 5.5 cm (as identified by computed tomography scanning), anatomically suitable and fit for OR were randomly assigned 1 : 1 to either EVAR (n = 626) or OR (n = 626) in EVAR-1 using computer-generated sequences at the trial hub. Patients considered unfit were randomly assigned to EVAR (n = 197) or no intervention (n = 207) in EVAR-2. There was no blinding. EVAR, OR or no intervention. The primary end points were total and aneurysm-related mortality until mid-2015 for both trials. Secondary outcomes for EVAR-1 were reinterventions, costs and cost-effectiveness. In EVAR-1, over a mean of 12.7 years (standard deviation 1.5 years; maximum 15.8 years), we recorded 9.3 deaths per 100 person-years in the EVAR group and 8.9 deaths per 100 person-years in the OR group [adjusted hazard ratio (HR) 1.11, 95% confidence interval (CI) 0.97 to 1.27; p = 0.14]. At 0-6 months after randomisation, patients in the EVAR group had a lower mortality (adjusted HR 0.61, 95% CI 0.37 to 1.02 for total mortality; HR 0.47, 95% CI 0.23 to 0.93 for aneurysm-related mortality; p = 0.031), but beyond 8 years of follow-up patients in the OR group had a significantly lower mortality (adjusted HR 1.25, 95% CI 1.00 to 1.56, p = 0.048 for total mortality; HR 5.82, 95% CI 1.64 to 20.65, p = 0.0064 for aneurysm-related mortality). The increased aneurysm-related mortality in the EVAR group after 8 years was mainly attributable to secondary aneurysm sac rupture, with increased cancer mortality also observed in the EVAR group. Overall, aneurysm reintervention rates were higher in the EVAR group than in the OR group, 4.1 and 1.7 per 100 person-years, respectively (p < 0.001), with reinterventions occurring throughout follow-up. The mean difference in costs over 14 years was £3798 (95% CI £2338 to £5258). Economic modelling based on the outcomes of the EVAR-1 trial showed that the cost per quality-adjusted life-year gained over the patient's lifetime exceeds conventional thresholds used in the UK. In EVAR-2, patients died at the same rate in both groups, but there was suggestion of lower aneurysm mortality in those who actually underwent EVAR. Type II endoleak itself is not associated with a higher rate of mortality. Devices used were implanted between 1999 and 2004. Newer devices might have better results. Later follow-up imaging declined, particularly for OR patients. Methodology to capture reinterventions changed mainly to record linkage through the Hospital Episode Statistics administrative data set from 2009. EVAR has an early survival benefit but an inferior late survival benefit compared with OR, which needs to be addressed by lifelong surveillance of EVAR and reintervention if necessary. EVAR does not prolong life in patients unfit for OR. Type II endoleak alone is relatively benign. To find easier ways to monitor sac expansion to trigger timely reintervention. Current Controlled Trials ISRCTN55703451. This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and the results will be published in full in Health Technology Assessment; Vol. 22, No. 5. See the NIHR Journals Library website for further project information.

Incremental Costs and Cost Effectiveness of Intensive Treatment in Individuals with Type 2 Diabetes Detected by Screening in the ADDITION-UK Trial: An Update with Empirical Trial–Based Cost Data

BackgroundThere is uncertainty about the cost effectiveness of early intensive treatment versus routine care in individuals with type 2 diabetes detected by screening. ObjectivesTo derive a trial-informed estimate of the incremental costs of intensive treatment as delivered in the Anglo-Danish-Dutch Study of Intensive Treatment in People with Screen-Detected Diabetes in Primary Care-Europe (ADDITION) trial and to revisit the long-term cost-effectiveness analysis from the perspective of the UK National Health Service. MethodsWe analyzed the electronic primary care records of a subsample of the ADDITION-Cambridge trial cohort (n = 173). Unit costs of used primary care services were taken from the published literature. Incremental annual costs of intensive treatment versus routine care in years 1 to 5 after diagnosis were calculated using multilevel generalized linear models. We revisited the long-term cost-utility analyses for the ADDITION-UK trial cohort and reported results for ADDITION-Cambridge using the UK Prospective Diabetes Study Outcomes Model and the trial-informed cost estimates according to a previously developed evaluation framework. ResultsIncremental annual costs of intensive treatment over years 1 to 5 averaged £29.10 (standard error = £33.00) for consultations with general practitioners and nurses and £54.60 (standard error = £28.50) for metabolic and cardioprotective medication. For ADDITION-UK, over the 10-, 20-, and 30-year time horizon, adjusted incremental quality-adjusted life-years (QALYs) were 0.014, 0.043, and 0.048, and adjusted incremental costs were £1,021, £1,217, and £1,311, resulting in incremental cost-effectiveness ratios of £71,232/QALY, £28,444/QALY, and £27,549/QALY, respectively. Respective incremental cost-effectiveness ratios for ADDITION-Cambridge were slightly higher. ConclusionsThe incremental costs of intensive treatment as delivered in the ADDITION-Cambridge trial were lower than expected. Given UK willingness-to-pay thresholds in patients with screen-detected diabetes, intensive treatment is of borderline cost effectiveness over a time horizon of 20 years and more.

IDegLira Versus Insulin Glargine U100: A Long-term Cost-effectiveness Analysis in the US Setting.

IntroductionTreatment with IDegLira has the potential to improve glycemic control in patients with type 2 diabetes mellitus (T2DM) without the weight gain and with a lower risk of hypoglycemia than with other therapies. The aim of the present analysis was to evaluate the long-term cost-effectiveness of IDegLira versus insulin glargine U100 with re-education and up-titration of the dose for treatment of patients with T2DM failing to achieve glycemic control on basal insulin in the US setting.MethodsData were obtained from the DUAL V randomized controlled trial in which adults with T2DM failing to achieve glycemic targets with insulin glargine U100 were randomly allocated to receive either IDegLira or insulin glargine U100. Long-term projections of clinical outcomes and direct costs were made using the IMS CORE Diabetes Model. Costs were accounted from a healthcare payer perspective. Future costs and clinical benefits were discounted at 3% annually.ResultsIDegLira was associated with improved discounted life expectancy (13.99 [standard deviation 0.19] versus 13.82 [standard deviation 0.20] years) and quality-adjusted life expectancy (9.14 [standard deviation 0.12] versus 8.87 [standard deviation 0.13] quality-adjusted life years [QALYs]) compared to insulin glargine U100. IDegLira was associated with increased direct costs of $16,970, yielding an incremental cost-effectiveness ratio (ICER) of $63,678 per QALY gained versus insulin glargine U100. Sensitivity analyses identified that the key driver of cost-effectiveness was the greater reduction in glycated hemoglobin with IDegLira compared with insulin glargine U100.ConclusionsBased on head-to-head clinical trial data, the present analysis suggests that IDegLira is likely to improve long-term clinical outcomes for patients with T2DM not achieving glycemic control on basal insulin compared to re-education and up-titration of the dose of insulin glargine U100, with these improvements coming at an increased cost from a healthcare payer perspective. An ICER within the range described as high care value was calculated, suggesting IDegLira is a cost-effective treatment option in the US. Funding: Novo Nordisk A/S and Novo Nordisk Inc.Electronic supplementary materialThe online version of this article (doi:10.1007/s13300-017-0251-x) contains supplementary material, which is available to authorized users.

Endoscopic Stenting as Bridge to Surgery versus Emergency Resection for Left-Sided Malignant Colorectal Obstruction: An Updated Meta-Analysis.

Introduction Emergency resection represents the traditional treatment for left-sided malignant obstruction. However, the placement of self-expanding metallic stents and delayed surgery has been proposed as an alternative approach. The aim of the current meta-analysis was to review the available evidence, with particular interest for the short-term outcomes, including a recent multicentre RCT. MethodsWe considered randomized controlled trials comparing stenting as a bridge to surgery and emergency surgery for the management of left-sided malignant large bowel obstruction, performing a systematic review in MEDLINE, PubMed database, and the Cochrane libraries. ResultsWe initially identified a total of 2543 studies. After the elimination of duplicates and the screening of titles and abstracts, seven studies, for a total of 448 patients, were considered. The current meta-analysis revealed no difference in the mortality rate between the stent group and the emergency surgery group; the postoperative complication rate (37.84% versus 54.87%, P = 0.02), the stoma rate (28.8% versus 46.02%, P < 0.0001), and the incidence of wound infection (8.11% versus 15.49%, P = 0.01) were reduced after stent as a bridge to surgery. Conclusion Colonic stenting as a bridge to surgery appears to be a safe approach to malignant large bowel obstruction. Possible advantages of this treatment can be identified in a reduced incidence of postoperative complications and a lower stoma rate. Further RCTs considering long-term outcomes and cost-effectiveness analysis are needed.

PP025 Thrombopoietin Receptor Agonist For Treatment Of Adults With Chronic Immune Thrombocytopenic Purpura

INTRODUCTION:This study aims to report the clinical effectiveness and cost-effectiveness of Thrombopoietin (TPO) receptor agonist for the treatment of adults with spontaneous Immune Thrombocytopenic Purpura (ITP) in Taiwan.METHODS:In the clinical effectiveness evaluation section, particularly for the TPO receptor agonist, we searched PubMed, EMBASE, and the Cochrane Central Register of Controlled Trials to identify all randomized trials in chronic ITP. In the economic evaluation section, we performed a long-term cost-effectiveness analysis using a Markov model to evaluate the value of TPO receptor agonist to achieve durable platelet response for chronic ITP patients.RESULTS:Our findings revealed that the National Health Insurance (NHI) in Taiwan covers TPO receptor agonists romiplostim and eltrombopag, which have also been recommended by the Pharmaceutical Benefits Advisory Committee (PBAC) of Australia and the National Institute for Health and Care Excellence (NICE) in the United Kingdom. In addition, a systematic review and meta-analysis combining six trials were included to assess the current evidence on the role of TPO receptor agonist in chronic ITP. The primary outcome of randomized controlled trials (RCTs) showed an improving trend in significant bleeding events; however there was not any significant difference between the TPO receptor agonists group and the control group (placebo). The gain in life years and quality-adjusted life-years (QALYs) from introducing long-term use of TPO receptor agonists over current clinical practice were 1.52 years and 1.44 QALYs, respectively. Most of the sensitivity analysis results show that the ICER values were greater than 3GDP per capita in Taiwan.CONCLUSIONS:Compared to placebo, and despite a significantly increased platelet response, there was no evidence to demonstrate that TPO receptor agonists did improve significant bleeding events in chronic ITP. The effect on overall survival awaits further analysis. Although long-term studies are lacking, current data demonstrated that adverse effects of TPO receptor agonists were similar to that of placebo.

Robotic Pancreaticoduodenectomy: Single-Surgeon Initial Experience

Minimally invasive surgery has gained increasing acceptance over the last few years, which has expanded to pancreaticoduodenectomy. Laparoscopic pancreaticoduodenectomy has been determined to be a feasible, safe, and effective procedure in an experienced surgeon's hands, but the adaptations to the clumsy instruments are needed. The improved dexterity of the Da Vinci robotic system provides a good opportunity to perform this challenging procedure in the minimally invasive context. The aim of this study was to share our preliminary experience of totally robotic pancreaticoduodenectomy. From April 2015 to August 2015, four patients were selected to undergo totally robotic pancreaticoduodenectomy in the Department of Pancreatic Surgery, West China Hospital, Sichuan University, China. The demographic characteristics, perioperative details, and pathological results were retrospectively reviewed. One female and two male patients underwent totally robotic pancreaticoduodenectomy, while another male patient underwent robotic total pancreatectomy due to the severe atrophy of pancreatic body and tail. The mean age of the four patients was 56.8years. The average operation time and intraoperative blood loss were 563min and 228mL, respectively. No one needed blood transfusion, conversion to open pancreaticoduodenectomy, or postoperative analgesia. The postoperative courses of these patients were uneventful. The mean postoperative hospital stay was 10days. No one required to be readmitted, and there was no death within 30days following the surgery. Final pathologic examinations revealed one malignant pancreatic ductal adenocarcinoma, and three benign lesions. Based on this initial study, robotic pancreaticoduodenectomy is safe and feasible, with acceptable oncological outcomes for highly selected patients in experienced surgeons' hands. However, concerns such as long-term outcomes, cost-effectiveness analysis, and learning curve analysis should be fully demonstrated before the popularization of this challenging procedure.