Short-Term Excess Healthcare Costs Associated with Cardiovascular Events Among Adults with Type 2 Diabetes in Israel: A Retrospective Cohort Study.

OBJECTIVE: The aim was to characterise the short-term (up to 12 months) direct economic burden of new cardiovascular (CV) events among adults with type 2 diabetes (T2D) in Israel. METHODS: In this retrospective cohort study utilising the electronic health records of the Maccabi Healthcare Services, adults aged ≥ 21 years with T2D who experienced their first CV event (2013-2016) were identified via adjudicated enrolment in a CV registry. Wilcoxon rank-sum test estimated excess healthcare resource utilisation in three periods after the CV event: immediate (1 month; for all patients), acute (3 months; for survivors of 1 month of follow-up) and short-term (12 months; for survivors of 3 months of follow-up). Direct healthcare expenditure (2018 United States dollars [USD]) was estimated from unit costs from the State of Israel Ministry of Health price list. RESULTS: In total, 5133 adults experienced a qualifying CV event, with a mean (standard deviation [SD]) age of 67.4 (11.8) years, diabetes duration of 17.7 (11.1) years and glycated haemoglobin of 7.4% (1.6%); 38.0% were female. In USD per patient, mean (SD) immediate costs were $10,741 ($11,707) compared with $2820 ($5661) at baseline (cost ratio [CR] 3.81), acute costs were $14,586 ($15,410) compared with $5202 ($8971) at baseline (CR 2.80) and short-term costs were $23,847 ($25,227) compared with $11,123 ($15,990) at baseline (CR 2.14). A sensitivity analysis of survivors only was consistent with the main analysis. CONCLUSIONS: Our results indicate that CV complications of T2D place a substantial excess economic burden on Israel's healthcare system over the short term (up to 12 months).

Evaluating the Cost-Effectiveness of Once-Weekly Semaglutide 1 mg Versus Empagliflozin 25 mg for Treatment of Patients with Type 2 Diabetes in the UK Setting.

INTRODUCTION: Type 2 diabetes represents a continuing healthcare challenge, and choosing cost-effective treatments is crucial to ensure that healthcare resources are used efficiently. The present analysis assessed the cost-effectiveness of once-weekly semaglutide 1 mg versus empagliflozin 25 mg for the treatment of patients with type 2 diabetes mellitus with inadequate glycaemic control on metformin monotherapy from a healthcare payer perspective in the UK. METHODS: Outcomes were projected over patient lifetimes using the IQVIA CORE Diabetes Model. Baseline cohort characteristics and treatment effects of initiation of once-weekly semaglutide 1 mg and empagliflozin 25 mg were based on an indirect comparison conducted using patient-level data, as there is currently no head-to-head clinical trial comparing these therapies. Modelled patients received treatments until glycated haemoglobin exceeded 7.5% (58 mmol/mol), at which point patients initiated basal insulin. The analysis captured pharmacy costs and costs of diabetes-related complications, expressed in 2019 pounds sterling (GBP). Projected outcomes were discounted at 3.5% annually. Scenario analyses were prepared to assess uncertainty around projected outcomes. RESULTS: Once-weekly semaglutide 1 mg was associated with increases in life expectancy and quality-adjusted life expectancy of 0.12 years and 0.23 quality-adjusted life years (QALYs), respectively, compared with empagliflozin 25 mg. Projected improvements in quality and duration of life resulted from a reduced cumulative incidence and a delayed time to onset of diabetes-related complications. Once-weekly semaglutide was associated with increased pharmacy costs, but this was partially offset by avoided costs of treating complications. Once-weekly semaglutide was associated with an increase in costs of GBP 1017 per patient, leading to an incremental cost-effectiveness ratio of GBP 4439 per QALY gained. CONCLUSION: Once-weekly semaglutide 1 mg was projected to be a cost-effective treatment option from a healthcare payer perspective compared with empagliflozin 25 mg for the treatment of patients with type 2 diabetes in the UK setting.

Costs of diabetes complications: hospital-based care and absence from work for 392,200 people with type 2 diabetes and matched control participants in Sweden.

AIMS/HYPOTHESIS: The risk of complications and medical consequences of type 2 diabetes are well known. Hospital costs have been identified as a key driver of total costs in studies of the economic burden of type 2 diabetes. Less evidence has been generated on the impact of individual diabetic complications on the overall societal burden. The objective of this study was to analyse costs of hospital-based healthcare (inpatient and outpatient care) and work absence related to individual macrovascular and microvascular complications of type 2 diabetes in Sweden in 2016. METHODS: Data for 2016 were retrieved from a Swedish national retrospective observational database cross-linking individual-level data for 1997-2016. The database contained information from population-based health, social insurance and socioeconomic registers for 392,200 people with type 2 diabetes and matched control participants (5:1). Presence of type 2 diabetes and of diabetes complications were derived using all years, 1997-2016. Costs of hospital-based care and of absence from work due to diabetes complications were estimated for the year 2016. Regression analysis was used for comparison with control participants to attribute absence from work to individual complications, and to account for joint presence of complications. RESULTS: Use of hospital care for complications was higher in type 2 diabetes compared with control participants in 2016: 26% vs 12% had ≥1 hospital contact; there were 86,104 vs 24,608 outpatient visits per 100,000 people; and there were 9894 vs 2546 inpatient admissions per 100,000 people (all p < 0.001). The corresponding total costs of hospital-based care for complications were €919 vs €232 per person (p < 0.001), and 74.7% of costs were then directly attributed to diabetes (€687 per person). Regression analyses distributed the costs of days absent from work across diabetes complications per se, basic type 2 diabetes effect and unattributed causes. Diabetes complications amounted to €1317 per person in 2016, accounting for possible complex interactions (25% of total costs of days absent). Key drivers of costs were the macrovascular complications angina pectoris, heart failure and stroke; and the microvascular complications eye diseases, including retinopathy, kidney disease and neuropathy. Early mortality in working ages cost an additional €579 per person and medications used in risk-factor treatment amounted to €418 per person. CONCLUSIONS/INTERPRETATION: The economic burden of complications in type 2 diabetes is substantial. Costs of absence from work in this study were found to be greater than of hospital-based care, highlighting the need for considering treatment consequences in a societal perspective in research and policy. Graphical abstract.

Elevated Costs and Healthcare Resource Utilization in Patients With Type 2 Diabetes and Established Cardiovascular Disease in Israel.

OBJECTIVES: To evaluate excess healthcare resource utilization (HRU) and costs among patients with both type 2 diabetes (T2D) and established cardiovascular disease (CVD) relative to those with T2D only, in Israel. METHODS: A retrospective, observational, cohort study of adult patients with T2D from the Maccabi Healthcare Services in Israel who enrolled in a cardiovascular registry between 2013 and 2016 (pre-index date period). Patients with established CVD between 2013 and 2016 were propensity matched 1:2 to control patients without established CVD. HRU and medical costs (2018 US Dollars [USD]) were extracted for a 2-year observation period (January 1, 2017, to December 31, 2018) and analyzed using generalized linear models. RESULTS: Overall, 4,582 patients with established CVD were matched 1:2 to 9151 controls (including 13 patients matched to a single control). HRU and costs were significantly higher in patients with established CVD versus controls across a wide range of resources. In total, annual costs per patient (USD) were 10 011.8 (95% confidence interval 9,502.2; 10 548) and 7206.8 (95% confidence interval 6631.8; 7831.7) in patients with established CVD and controls, respectively. Hospitalizations, primary care visits, and medications for any condition were the main cost drivers, with greater utilization and higher costs in the established CVD group versus controls (P < .001 for all) in the postevent period. CONCLUSIONS: In a real-world setting, HRU and costs were significantly higher in patients with T2D and established CVD compared with controls across the vast majority of resource types. These up-to-date cost estimates of CVD improve our understanding of the financial implications of established CVD beyond the direct expenses.

Evaluation of the Long-Term Cost-Effectiveness of Once-Weekly Semaglutide Versus Dulaglutide and Sitagliptin in the Spanish Setting.

INTRODUCTION: Healthcare systems aim to maximize the health of the population, but must work within constrained budgets. Therefore, choosing therapies that are both effective and cost-effective is paramount. The present analysis assessed the cost-effectiveness of once-weekly semaglutide 0.5 mg and 1 mg versus once-weekly dulaglutide 1.5 mg and versus once daily sitagliptin 100 mg for the treatment of patients with type 2 diabetes with inadequate glycemic control on oral anti-hyperglycemic medications over patient lifetimes from a healthcare payer perspective in the Spanish setting. METHODS: Cost and clinical outcomes were projected over patient lifetimes using the IQVIA CORE Diabetes Model. Baseline cohort characteristics and treatment effects on initiation of semaglutide 0.5 mg and 1 mg, dulaglutide 1.5 mg and sitagliptin 100 mg were based on the once-weekly semaglutide clinical trial program (SUSTAIN 7 and 2). Captured costs included treatment costs and costs of diabetes-related complications. Projected outcomes were discounted at 3.0% annually. RESULTS: Projections of long-term clinical outcomes indicated that once-weekly semaglutide 0.5 mg and 1 mg were associated with improvements in discounted life expectancy of 0.02 and 0.11 years, respectively, and discounted quality-adjusted life expectancy of 0.03 and 0.11 quality-adjusted life years (QALYs), respectively, versus dulaglutide 1.5 mg. Compared with sitagliptin, once-weekly semaglutide 0.5 mg and 1 mg were associated with improvements in discounted life expectancy of 0.17 and 0.24 years, respectively and discounted quality-adjusted life expectancy of 0.16 and 0.23 QALYs. The increased duration and quality of life with once-weekly semaglutide 0.5 mg and 1 mg resulted from a reduced cumulative incidence and delayed time to onset of diabetes-related complications. Avoided complications resulted in once-weekly semaglutide 0.5 mg and 1 mg being cost-saving versus dulaglutide 1.5 mg and versus sitagliptin 100 mg from a healthcare payer perspective. CONCLUSIONS: Once-weekly semaglutide 0.5 mg and 1 mg were considered dominant (more effective and less costly) versus sitagliptin 100 mg and dulaglutide 1.5 mg for the treatment of patients with type 2 diabetes with inadequate glycemic control on oral anti-hyperglycemic medications and are likely to be a good use of healthcare resources in the Spanish setting.

Since healthcare systems aim to maximize the health of the population but must work within constrained budgets, choosing therapies that are both effective and cost-effective is paramount. We assessed the cost-effectiveness, from a Spanish healthcare payer perspective, of the newly marketed once-weekly semaglutide 0.5 mg and 1 mg versus two established therapies (dulaglutide 1.5 mg and sitagliptin 100 mg) for the treatment of patients with type 2 diabetes with inadequate glycemic control on oral anti-hyperglycemic medications over patient lifetimes.Outcomes were projected using a computer simulation model, based on two trials conducted as part of the once-weekly semaglutide clinical trial program (SUSTAIN 2 and SUSTAIN 7). Captured costs included treatment costs and costs of diabetes-related complications.Projections of long-term clinical outcomes indicated that once-weekly semaglutide 0.5 mg and 1 mg were associated with improvements in quality-adjusted life expectancy of 0.03 and 0.11 quality-adjusted life years (QALYs), respectively, versus dulaglutide 1.5 mg, and 0.16 and 0.23 QALYs, respectively, versus sitagliptin 100 mg. The increased duration and quality of life with once-weekly semaglutide 0.5 mg and 1 mg resulted from a reduced cumulative incidence and delayed time to onset of diabetes-related complications. Avoided complications resulted in once-weekly semaglutide 0.5 mg and 1 mg being cost-saving versus dulaglutide 1.5 mg and versus sitagliptin 100 mg.Once-weekly semaglutide 0.5 mg and 1 mg were more effective and less costly and therefore were considered dominant in both comparisons, and are likely to be a good use of healthcare resources in the Spanish setting.

Cost of macrovascular complications in people with diabetes from a public healthcare perspective: a retrospective database study in Brazil.

Aims: To evaluate costs in patients with diabetes who experienced a macrovascular complication from a Brazilian public healthcare system perspective.Materials and methods: A retrospective, observational study that utilized the database of the Brazilian Unified Health System (DATASUS). Data for direct medical costs (hospitalization and outpatient) were extracted for patients with diabetes and a macrovascular complication (1 January 2012-31 December 2018) and converted to US Dollars (2019 USD). Mixed-effects logistic regression explored associations between demographic and clinical characteristics with the incurrence of high direct medical costs.Results: In total, 1,668 (0.2%) patients with diabetes met study inclusion criteria and experienced a macrovascular complication, either alone (N = 1,193) or together with a microvascular complication (N = 475). Median [95% CI] annual costs (USD/patient) were 130.5 [90.7; 264.2] at baseline, increasing to 334.0 [182.2; 923.5] in the first year after the complication. The odds of incurring high costs were significantly elevated in the first and second year (vs. baseline), and in patients who experienced a macrovascular and microvascular complication (vs. macrovascular alone) (all p < 0.001).Limitations: The DATASUS database does not cover primary care (it covers secondary and tertiary care), adding a selection bias to the sample. Additionally, our findings may not be representative of the entire Brazilian population given that approximately 75% of the population of Brazil depend exclusively on the SUS, while the remaining 25% have some access to private healthcare.Conclusions: This study has demonstrated higher medical costs from the perspective of the Brazilian public healthcare system in patients with diabetes after experiencing a macrovascular complication, either alone or in conjunction with a microvascular complication, in comparison with costs before the complication(s). In addition to providing up-to-date cost estimates, our findings highlight the need to implement strategies to reduce the cardiovascular risk in Brazilian patients with diabetes and drive cost savings.

The Short-Term Cost-Effectiveness of Once-Weekly Semaglutide Versus Once-Daily Sitagliptin and Once-Weekly Dulaglutide for the Treatment of Patients with Type 2 Diabetes: A Cost of Control Analysis in Spain.

INTRODUCTION: Once-weekly semaglutide has been associated with greater reductions in glycated hemoglobin (HbA1c) and body weight than sitagliptin and dulaglutide in the SUSTAIN 2 and 7 clinical trials, respectively. These trials also assessed the proportions of patients achieving treatment targets capturing glycemic control and avoidance of hypoglycemia and weight gain. This study assessed the cost of bringing patients with type 2 diabetes to three clinically relevant endpoints with semaglutide versus sitagliptin and dulaglutide in Spain. METHODS: The proportions of patients achieving endpoints of HbA1c < 7.0%, HbA1c < 7.0% without hypoglycemia and without weight gain, and a ≥ 1.0% HbA1c reduction with ≥ 5.0% weight loss were taken from SUSTAIN 2 and 7. Cost of control was calculated as the annual per patient cost of each medication, expressed in 2019 euros (EUR), divided by the proportion of patients achieving each endpoint. RESULTS: Based on SUSTAIN 2, cost of control was lower for sitagliptin for the HbA1c < 7.0% endpoint, results were comparable for the HbA1c < 7.0% without hypoglycemia and without weight gain endpoint, and both doses of semaglutide were associated with lower costs of control for the ≥ 1.0% HbA1c reduction with ≥ 5.0% weight loss endpoint. Based on SUSTAIN 7, both doses of semaglutide were associated with lower costs of control for all three endpoints. CONCLUSION: Both doses of semaglutide were associated with comparable or lower costs of control versus sitagliptin when considering endpoints incorporating hypoglycemia and weight loss alongside glycemic control, and lower costs of control versus dulaglutide 1.5 mg for all endpoints in Spain. Plain language summary available for this article.

Assessing the cost-effectiveness of a once-weekly GLP-1 analogue versus an SGLT-2 inhibitor in the Spanish setting: Once-weekly semaglutide versus empagliflozin.

Aims: Controlling costs while maximizing healthcare gains is the predominant challenge for healthcare providers, and therefore cost-effectiveness analysis is playing an ever-increasing role in healthcare decision making. The aim of the present analysis was to assess the long-term cost-effectiveness of subcutaneous once-weekly semaglutide (0.5 mg and 1 mg) versus empagliflozin (10 mg and 25 mg) in the Spanish setting for the treatment of patients with type 2 diabetes (T2D) with inadequate glycemic control on oral anti-hyperglycemic medications.Material and methods: The IQVIA CORE Diabetes Model was used to project outcomes over patient lifetimes with once-weekly semaglutide versus empagliflozin, with treatment effects based on a network meta-analysis. The analysis captured treatment costs, costs of diabetes-related complications, and the impact of complications on quality of life, based on published sources. Outcomes were discounted at 3.0% per annum.Results: Once-weekly semaglutide 0.5 mg and 1 mg were associated with improvements in discounted quality-adjusted life expectancy of 0.12 and 0.15 quality-adjusted life years (QALYs), respectively, versus empagliflozin 10 mg and improvements of 0.11 and 0.14 QALYs, respectively, versus empagliflozin 25 mg. Treatment costs were higher with once-weekly semaglutide compared with empagliflozin, but this was partially offset by cost savings due to avoidance of diabetes-related complications. Once-weekly semaglutide 0.5 mg and 1 mg were associated with incremental cost-effectiveness ratios of EUR 2,285 and EUR 161 per QALY gained, respectively, versus empagliflozin 10 mg, and EUR 3,090 and EUR 625 per QALY gained, respectively, versus empagliflozin 25 mg.Conclusions: Based on a willingness-to-pay threshold of EUR 30,000 per QALY gained, once-weekly semaglutide 0.5 mg and 1 mg were projected to be cost-effective versus empagliflozin 10 mg and 25 mg for the treatment of patients with T2D with inadequate glycemic control on oral anti-hyperglycemic medications in the Spanish setting, irrespective of patients' BMI at baseline.

Long-term Cost-effectiveness of Insulin Degludec Versus Insulin Glargine U100 in the UK: Evidence from the Basal-bolus Subgroup of the DEVOTE Trial (DEVOTE 16).

OBJECTIVES: To evaluate the cost-effectiveness of insulin degludec (degludec) versus insulin glargine 100 units/mL (glargine U100) in basal-bolus regimens for patients with type 2 diabetes (T2D) at high cardiovascular (CV) risk based on the DEVOTE CV outcomes trial. METHODS: A microsimulation model, informed by clinical outcomes from the subgroup of patients using basal-bolus insulin therapy in DEVOTE (NCT01959529) and by the UKPDS Outcomes Model 2 risk equations, was used to model direct costs (2018 GBP) and effectiveness outcomes [quality-adjusted life years (QALYs)] with degludec versus glargine U100 over a 40-year time horizon. The model captured the development of eight diabetes-related complications, death, severe hypoglycemia and insulin dosing. This analysis was conducted from the perspective of National Health Service (NHS) England. RESULTS: Treatment with degludec versus glargine U100 in basal-bolus regimens was associated with improved clinical outcomes at a higher cost per patient [incremental cost effectiveness ratio (ICER): £14,956 GBP/QALY]. Degludec remained cost effective versus glargine U100 in all exploratory sensitivity analyses, with ICERs below the widely accepted willingness-to-pay threshold, although the result was most sensitive to assumptions regarding the persistence of treatment effects. CONCLUSIONS: Our long-term modeling analysis suggested that degludec was cost effective (from the perspective of NHS England) versus glargine U100 in basal-bolus regimens for patients with T2D at high CV risk. Our findings raise important questions regarding how to model the health economics of diabetes therapies.

Short-term cost-utility of degludec versus glargine U100 for patients with type 2 diabetes at high risk of hypoglycaemia and cardiovascular events: A Canadian setting (DEVOTE 9).

AIMS: To evaluate the short-term cost-effectiveness of insulin degludec (degludec) vs insulin glargine 100 units/mL (glargine U100) from a Canadian public healthcare payer perspective in patients with type 2 diabetes (T2D) who are at high risk of cardiovascular events and hypoglycaemia. MATERIALS AND METHODS: A decision analytic model was developed to estimate costs (2017 Canadian dollars [CAD]) and clinical outcomes (quality-adjusted life years [QALYs]) with degludec vs glargine U100 over a 2-year time horizon. The model captured first major adverse cardiovascular event, death, severe hypoglycaemia and insulin dosing. Clinical outcomes were informed by a post hoc subgroup analysis of the DEVOTE trial (NCT01959529), which compared the cardiovascular safety of degludec and glargine U100 in patients with T2D who are at high cardiovascular risk. High hypoglycaemia risk was defined as the top quartile of patients (n = 1887) based on an index of baseline hypoglycaemia risk factors. RESULTS: In patients at high hypoglycaemia risk, degludec was associated with mean cost savings (CAD 129 per patient) relative to glargine U100, driven by a lower incidence of non-fatal myocardial infarction, non-fatal stroke and severe hypoglycaemia, which offset the slightly higher cost of treatment with degludec. A reduced risk of cardiovascular death and severe hypoglycaemia resulted in improved effectiveness (+0.0132 QALYs) with degludec relative to glargine U100. In sensitivity analyses, changes to the vast majority of model parameters did not materially affect model outcomes. CONCLUSION: Over a 2-year period, degludec improved clinical outcomes at a lower cost as compared to glargine U100 in patients with T2D at high risk of cardiovascular events and hypoglycaemia.

Screening fathers for postpartum depression can be cost-effective: An example from Sweden.

BACKGROUND: Postpartum depression negatively affects the whole family and its prevalence in Sweden ranges between 6-10% for fathers and 13-16% for mothers. However, only mothers in Sweden are currently routinely screened. AIM: The aim of this study was to determine if a postpartum depression screening for fathers in Stockholm County could be cost-effective. METHODS: National Swedish databases were used to find registry data and a literature review was undertaken to identify the model data inputs associated with postpartum depression in Sweden. The generated evidence was used to build a Markov model in TreeAge. One-way and probabilistic sensitivity analyses were performed to account for parameter uncertainties. Alternative scenario analyses were further undertaken to test the assumptions in the base case analysis. RESULTS: A postpartum screening for depression in fathers is cost-effective in base case and alternative scenarios. The results indicate that the screening program is associated with lower costs and higher health effects. The results were sensitive to variables of quality adjusted life years for the depressed fathers, probabilities of remission in treatment and no treatment groups and start age and productivity losses. The probabilistic sensitivity analysis resulted in a 70% probability of the postnatal depression screening intervention being cost-effective. LIMITATIONS: The current study only uses secondary data; therefore future research should assess the cost-effectiveness of screening fathers for depression. CONCLUSION: The postpartum screening intervention for fathers could be cost-effective compared to no screening. Future research should replicate the potential cost-effectiveness for screening fathers for postpartum depression.

DEVOTE 5: Evaluating the Short-Term Cost-Utility of Insulin Degludec Versus Insulin Glargine U100 in Basal-Bolus Regimens for Type 2 Diabetes in the UK.

INTRODUCTION: The aim of this study was to evaluate the short-term cost-utility of insulin degludec (degludec) versus insulin glargine 100 units/mL (glargine U100) for the treatment of type 2 diabetes in the basal-bolus subgroup of the head-to-head cardiovascular (CV) outcome trial, DEVOTE. METHODS: A cost-utility analysis was conducted over a 2-year time horizon using a decision analytic model to compare costs in patients receiving once daily degludec or glargine U100, both as part of a basal-bolus regimen, in addition to standard care. Clinical outcomes and patient characteristics were taken exclusively from DEVOTE, whilst health-related quality of life utilities and UK-specific costs (expressed in 2016 GBP) were obtained from the literature. The analysis was conducted from the perspective of the National Health Service. RESULTS: Degludec was associated with mean cost savings of GBP 28.78 per patient relative to glargine U100 in patients with type 2 diabetes at high CV risk. Cost savings were driven by the reduction in risk of diabetes-related complications with degludec, which offset the higher treatment costs relative to glargine U100. Degludec was associated with a mean improvement of 0.0064 quality-adjusted life-years (QALYs) compared with glargine U100, with improvements driven predominantly by lower rates of severe hypoglycemia with degludec versus glargine U100. Improvements in quality-adjusted life expectancy combined with cost neutrality resulted in degludec being dominant over glargine U100. Sensitivity analyses demonstrated that the incremental cost-utility ratio was stable to variations in the majority of model inputs. CONCLUSION: The present short-term modeling analysis found that for the basal-bolus subgroup of patients in DEVOTE, with a high risk of CV events, degludec was cost neutral (no additional costs) compared with glargine U100 over a 2-year time horizon in the UK setting. Furthermore, there were QALY gains with degludec, particularly due to the reduction in the risk of severe hypoglycemia. FUNDING: Novo Nordisk A/S. TRIAL REGISTRATION: ClinicalTrials.gov identifier, NCT01959529.