Long-term cost-effectiveness of Dexcom G6 real-time continuous glucose monitoring system in people with type 1 diabetes in Australia.

INTRODUCTION: Real-time continuous glucose monitoring (rt-CGM) allows patients with diabetes to adjust insulin dosing, potentially improving glucose control. This study aimed to compare the long-term cost-effectiveness of the Dexcom G6 rt-CGM device versus self-monitoring of blood glucose (SMBG) and flash glucose monitoring (FGM) in Australia in people with type 1 diabetes (T1D). METHODS: Long-term costs and clinical outcomes were estimated using the CORE Diabetes Model. Clinical input data for the analysis of rt-CGM versus SMBG and FGM were sourced from the DIAMOND study and a network meta-analysis, respectively. Rt-CGM and FGM were associated with quality of life (QoL) benefits due to reduced fear of hypoglycaemia (FoH) and fingerstick testing. Analyses were performed over a lifetime time horizon from an Australian healthcare payer perspective, including direct costs from published data. Future costs and clinical outcomes were discounted at 5% per annum. RESULTS: Rt-CGM was associated with an increased quality-adjusted life expectancy of 1.199 quality-adjusted life years (QALYs), increased mean total lifetime costs of AUD 21,596 and an incremental cost-effectiveness ratio (ICER) of AUD 18,020 per QALY gained compared with SMBG. Compared with FGM, rt-CGM was associated with an increased quality-adjusted life expectancy of 0.569 QALYs, increased mean total lifetime costs of AUD 11,064 and an ICER of AUD 19,455 per QALY gained. Key drivers of outcomes included HbA1c benefits and QoL benefits associated with reduced FoH and fingerstick testing. CONCLUSIONS: Due to improved clinical outcomes and QoL gains rt-CGM is highly cost-effective compared with SMBG and FGM in people with T1D in Australia.

Cost-effectiveness of sensor-augmented pump therapy in two different patient populations with type 1 diabetes in Italy.

BACKGROUND AND AIMS: Sensor-augmented pump therapy (SAP) combines real time continuous glucose monitoring (CGM) with Continuous Subcutaneous Insulin Infusion (CSII) and provides additional benefits beyond those provided by CSII alone. SAP with automated insulin suspension provides early warning of the onset of hyperglycemia and hypoglycemia and has the functionality to suspend insulin delivery if sensor glucose levels are predicted to fall below a predefined threshold. Aim of this study was to assess the cost-effectiveness of SAP with automated insulin suspension versus CSII alone in type 1 diabetes. METHODS AND RESULTS: Cost-effectiveness analysis was performed using the CORE Diabetes Model. The analysis was performed in two different cohorts: one with high baseline HbA1c and one at elevated risk for hypoglycemic events. Clinical input data were sourced from published data. The analysis was conducted from a societal perspective over a lifetime time horizon; costs and clinical outcomes were discounted at 3% per year. In patients with poor glycemic control, SAP with automated insulin suspension resulted in improved discounted quality-adjusted life expectancy (QALY) versus CSII (12.44 QALYs vs. 10.99 QALYs) but higher mean total lifetime costs (€324,991 vs. €259,852), resulting in an incremental cost effectiveness ratio (ICER) of €44,982 per QALY gained. In patients at elevated risk for hypoglycemia, the ICER was €33,692 per QALY gained for SAP versus CSII. CONCLUSION: In Italy, the use of SAP with automated insulin suspension is associated with projected improvements in outcomes as compared to CSII. These benefits translate into an ICER usually considered as good value for money, particularly in patients at elevated risk of hypoglycemia.

Cost-effectiveness of continuous subcutaneous insulin infusion versus multiple daily injections of insulin in Type 1 diabetes: a systematic review.

AIM: Continuous subcutaneous insulin infusion (CSII) is increasingly used in clinical practice for the management of selected patients with Type 1 diabetes. Several cost-effectiveness studies comparing CSII vs. multiple insulin injections (MDI) have been reported. The aim was systematically to review these analyses and test the hypothesis that CSII is a cost-effective use of healthcare resources across settings. METHODS: A literature review was performed using MEDLINE, Cochrane Library and other databases. No time limit or language restrictions were applied. After two rounds of screening, 11 cost-effectiveness analyses were included in the final review, of which nine used the CORE Diabetes Model. A narrative synthesis was conducted and mean cost effectiveness calculated. RESULTS: CSII was considered cost-effective vs. MDI in Type 1 diabetes in all 11 studies in 8 countries, with a mean (95% CI) incremental cost effectiveness ratio of €30 862 (17 997-43 727), US$40 143 (23 409-56 876) per quality-adjusted life year (QALY) gained. CSII was associated with improved life expectancy and quality-adjusted life expectancy (0.4-1.1 QALYs in adults), driven by lower HbA(1c) and lower frequency of hypoglycaemic events vs. MDI. CSII was associated with higher lifetime direct costs due to higher treatment costs but this was partially offset by cost-savings from reduced diabetes-related complications. CONCLUSIONS: Published cost-effectiveness analyses show that in Type 1 diabetes CSII is cost-effective vs. MDI across a number of settings for patients who have poor glycaemic control and/or problematic hypoglycaemia on MDI, with cost-effectiveness highly sensitive to the reduction in HbA1c and hypoglycaemia frequency associated with CSII.

Health-economic analysis of real-time continuous glucose monitoring in people with Type 1 diabetes.

AIM: To evaluate the clinical benefits and cost-effectiveness of the sensor-augmented pump compared with self-monitoring of plasma glucose plus continuous subcutaneous insulin infusion in people with Type 1 diabetes. METHODS: The CORE Diabetes Model was used to simulate disease progression in a cohort of people with baseline characteristics taken from a published meta-analysis. Direct and indirect costs for 2010-2011 were calculated from a societal payer perspective, with cost-effectiveness calculated over the patient's lifetime. Discount rates of 3% per annum were applied to the costs and the clinical outcomes. RESULTS: Use of the sensor-augmented pump was associated with an increase in mean discounted, quality-adjusted life expectancy of 0.76 quality-adjusted life years compared with continuous subcutaneous insulin infusion (13.05 ± 0.12 quality-adjusted life years vs 12.29 ± 0.12 quality-adjusted life years, respectively). Undiscounted life expectancy increased by 1.03 years for the sensor-augmented pump compared with continuous subcutaneous insulin infusion. In addition, the onset of complications was delayed (by a mean of 1.15 years) with use of the sensor-augmented pump. This analysis resulted in an incremental cost-effectiveness ratio of 367,571 SEK per quality-adjusted life year gained with the sensor-augmented pump. The additional treatment costs related to the use of the sensor-augmented pump were partially offset by the savings attributable to the reduction in diabetes-related complications and the lower frequency of self-monitoring of plasma glucose. CONCLUSIONS: Analysis using the CORE Diabetes Model showed that improvements in glycaemic control associated with sensor-augmented pump use led to a reduced incidence of diabetes-related complications and a longer life expectancy. Use of the sensor-augmented pump was associated with an incremental cost-effectiveness ratio of 367,571 SEK per quality-adjusted life year gained, which is likely to represent good value for money in the treatment of Type 1 diabetes in Sweden.

Biphasic insulin aspart 70/30 vs. insulin glargine in insulin naïve type 2 diabetes patients: modelling the long-term health economic implications in a Swedish setting.

OBJECTIVES: To evaluate the long-term clinical and economic outcomes of biphasic insulin aspart 70/30 (BIAsp 70/30) treatment vs. insulin glargine in insulin naïve, type 2 diabetes patients failing oral antidiabetic drugs in a Swedish setting. METHODS: A published and validated computer simulation model (the CORE Diabetes Model) was used to project life expectancy, quality-adjusted life expectancy (QALE) and costs over patient lifetimes. Cohort characteristics [54.5% male, mean age 52.4 years, 9 years mean diabetes duration, mean glycosylated haemoglobin (HbA1c) 9.77%] and treatment effects were based on results from the Initiate Insulin by Aggressive Titration and Education (INITIATE) clinical trial. Direct medical costs were accounted in 2006 Swedish Kronor (SEK) and economic and clinical benefits were discounted at 3% per annum. RESULTS: Biphasic insulin aspart 70/30 treatment when compared with insulin glargine treatment was associated with improvements in discounted life expectancy of 0.21 years (13.10 vs. 12.89 years) and QALE of 0.21 quality-adjusted life years (QALYs) (9.16 vs. 8.96 QALYs). Reductions in the incidence of diabetes-related complications in the BIAsp 70/30 treatment arm led to reduced total costs of SEK 10,367 when compared with insulin glargine (SEK 396,475 vs. SEK 406,842) over patient lifetimes. BIAsp 70/30 treatment was projected to be dominant (cost and lifesaving) when compared with insulin glargine in the base case analysis. CONCLUSIONS: Biphasic insulin aspart 70/30 treatment was associated with improved clinical outcomes and reduced costs compared with insulin glargine treatment over patient lifetimes. These results were driven by improved HbA1c levels associated with BIAsp 70/30 compared with insulin glargine and the accompanying reduction in diabetes-related complications despite increases in body mass index.

Therapy conversion to insulin detemir among patients with type 2 diabetes treated with oral agents: a modeling study of cost-effectiveness in the United States.

The aim of this study was to gain a preliminary indication of the long-term clinical and economic implications of converting treatment for patients with type 2 diabetes to insulin detemir+/-oral hypoglycemic agents (OHAs) in a routine clinical practice setting in the United States. With the use of outcome data and patient characteristics reported from an ongoing prospective observational trial, a validated computer simulation model of diabetes was used to project the clinical and cost outcomes associated with therapy conversion to insulin detemir over a 35-y period from (1) OHA only, (2) neutral protamine Hagedorn insulin (NPH)+/-OHA, and (3) insulin glargine+/-OHA. Cost-effectiveness was assessed from a third-party healthcare payer perspective for the year 2005. Costs and clinical outcomes were discounted at a rate of 3%. Treatment with insulin detemir+/-OHA was associated with increases in quality-adjusted life expectancy of 0.309, 0.350, and 0.333 quality-adjusted life-years (QALYs) versus treatment with OHA alone, NPH+/-OHA, and insulin glargine+/-OHA, respectively. Increases in pharmacy costs were partially offset by reduced complications, rticularly renal complications and neuropathy. Projected incremental cost-effectiveness ratios were well within the range considered to represent good value in the United States, at $7412, $6269, and $3951 per QALY gained for treatment with Idet+/-OHA versus OHA alone, NPH+/-OHA, and Iglarg+/-OHA, respectively. On the basis of preliminary evidence of short-term improvements in glycemic control and reduced hypoglycemia, therapy conversion to insulin detemir+/-OHA from OHA alone, NPH+/-OHA, or insulin glargine+/-OHA was projected to increase quality-adjusted life expectancy and to represent a cost-effective treatment option in the United States.

Cost-effectiveness of sensor-augmented pump therapy versus standard insulin pump therapy in patients with type 1 diabetes in Denmark.

AIMS: The use of continuous subcutaneous insulin infusion (CSII) in type 1 diabetes (T1D) has increased in recent years. Sensor-augmented pump therapy (SAP) with low glucose suspend (LGS) (allowing temporary suspension of insulin delivery if blood glucose level falls below a pre-defined threshold level) provides additional benefits over CSII alone, but is associated with higher acquisition costs. Therefore, a cost-effectiveness analysis of SAP+LGS versus CSII in patients with T1D was performed. METHODS: Analyses were performed using the CORE Diabetes Model in two different patient cohorts in Denmark, one with hyperglycemia at baseline and one with increased risk for hypoglycemic events. Clinical input data were sourced from published literature. The analysis was performed over a lifetime time horizon from a societal perspective. Future costs and clinical outcomes were discounted at 3% per annum. RESULTS: In patients who were hyperglycemic at baseline the use of SAP+LGS versus CSII resulted in improved quality-adjusted life expectancy (12.44 versus 10.99 quality-adjusted life years [QALYs]) but higher mean lifetime costs (DKK 2,027,316 versus DKK 1,801,293) leading to an incremental cost-effectiveness ratio (ICER) of DKK 156,082 per QALY gained. For patients at increased risk for hypoglycemic events the ICER for SAP+LGS versus CSII was DKK 89,868 per QALY gained. CONCLUSIONS: The ICER for SAP+LGS versus CSII falls below commonly cited willingness-to-pay thresholds. Therefore, in Denmark, the use of SAP+LGS is likely to be considered cost-effective relative to CSII for patients with T1D who are either hyperglycemic, despite CSII use, or who experience frequent severe hypoglycemic events.

Cost-consequence analysis in a French setting of screening and optimal treatment of nephropathy in hypertensive patients with type 2 diabetes.

AIM: Forty percent of hypertensive type 2 diabetes patients develop nephropathy (microalbuminuria/overt nephropathy), indicating end organ damage, increased risk of cardiovascular disease (CVD), and death. In France, screening rates and nephropathy treatment are suboptimal. We assessed the health economic impact of nephropathy screening in hypertensive patients with type 2 diabetes followed by optimal antihypertensive/nephroprotective therapy in those who have nephropathy in France. METHODS: A Markov/Monte Carlo model simulated lifetime impacts of screening for albuminuria (microalbuminuria/overt nephropathy) using semi-quantitative urine dipsticks in a primary care setting, and subsequent addition of irbesartan 300 mg to conventional therapy in hypertensive type 2 diabetes patients identified as having nephropathy. Progression from no renal disease to end-stage renal disease (ESRD) was simulated. Probabilities, utilities and costs of CVD events, medications and ESRD treatment came from published sources. Cumulative incidence of ESRD, life expectancy, quality-adjusted life years (QALYs) and direct costs were projected. Second-order Monte Carlo simulation accounted for uncertainty in multiple parameters. Costs and QALYs were discounted at 3% annually. RESULTS: Screening and optimized treatment led to a 42% reduction in the cumulative incidence of ESRD from 10.1 +/- 9.9% without screening to 5.8 +/- 5.7%, improvements in life expectancy of 0.38 +/- 0.59 years, improvements of 0.29 +/- 0.32 QALYs, and decreased costs of Euro 4,812 +/- 7,882/patient over 25 years. Sensitivity analysis showed that the results were robust. Screening was most beneficial when performed in younger patients. CONCLUSION: In hypertensive patients with type 2 diabetes, screening for albuminuria followed by optimal antihypertensive/nephroprotective treatment improves patient outcomes and leads to cost savings in France.

Cost-effectiveness of continuous subcutaneous insulin infusion in people with type 2 diabetes in the Netherlands.

AIMS: Up to 30% of insulin-treated type 2 diabetes patients are unable to achieve HbA1c targets despite optimization of insulin multiple daily injections (MDI). For these patients the use of continuous subcutaneous insulin infusion (CSII) represents a useful but under-utilized alternative. The aim of the present analysis was to examine the cost-effectiveness of initiating CSII in type 2 diabetes patients failing to achieve good glycemic control on MDI in the Netherlands. METHODS: Long-term projections were made using the IMS CORE Diabetes Model. Clinical input data were sourced from the OpT2mise trial. The analysis was performed over a lifetime time horizon. The discount rates applied to future costs and clinical outcomes were 4% and 1.5% per annum, respectively. RESULTS: CSII was associated with improved quality-adjusted life expectancy compared with MDI (9.38 quality-adjusted life years [QALYs] vs 8.95 QALYs, respectively). The breakdown of costs indicated that ∼50% of costs were attributable to diabetes-related complications. Higher acquisition costs of CSII vs MDI were partially offset by the reduction in complications. The ICER was estimated at EUR 62,895 per QALY gained and EUR 60,474 per QALY gained when indirect costs were included. CONCLUSIONS: In the Netherlands, CSII represents a cost-effective option in patients with type 2 diabetes who continue to have poorly-controlled HbA1c despite optimization of MDI. Since the ICER falls below the willingness-to-pay threshold of EUR 80,000 per QALY gained, CSII is likely to represent good-value for money in the treatment of poorly-controlled T2D patients compared with MDI.

An economic evaluation of the Irbesartan in Diabetic Nephropathy Trial (IDNT) in a UK setting.

There are substantial healthcare costs associated with the provision of renal replacement therapy. Patients with diabetes mellitus are the largest and fastest growing group developing end-stage renal disease (ESRD) in the United Kingdom (UK). Treatment leading to a slowing of progression to ESRD in diabetic patients could lead to considerable cost savings. Using treatment-specific probabilities derived from the Irbesartan in Diabetic Nephropathy Trial (IDNT), the cost effectiveness of treating patients with hypertension, type II diabetes and nephropathy with irbesartan, amlodipine or control was calculated using a Markov model. UK-specific ESRD-related data were retrieved from published sources to reflect local management practices, ESRD outcomes and costs. Mean 10-year costs and changes in life expectancy due to ESRD delayed or avoided were calculated. Future costs and clinical benefits were discounted at 6.0 and 1.5% per annum and extensive sensitivity analyses were performed. Delay in the onset of ESRD with irbesartan led to cost savings of pound sterling 5125 and pound sterling 2919/patient and improvements in projected discounted life expectancy of 0.07 and 0.21 years over 10 years vs amlodipine and control, respectively. The costs of treatment of ESRD were the main contributor to the total costs. The cost of trial medications had only a minor impact. These results were robust in a wide range of plausible assumptions. Given that the IDNT efficacy results could be translated to a UK setting, treating patients with hypertension, type II diabetes and overt nephropathy with irbesartan was cost saving over a 10-year period compared to amlodipine and control.

[Cost-efectiveness of Ibersartan in type II diabetic nephropathy with hypertension. A Spanish perspective]. / Coste-efectividad de irbesartan en pacientes hipertensos con nefropatía diabética tipo II: una perspectiva española.

BACKGROUND: In the Irbesartan Diabetic Nephropathy Trial (IDNT), treatment with irbesartan demonstrated 23% and 20% reductions in the combined endpoint of doubling of serum creatinine (DSC), end-stage renal disease (ESRD) or death in patients with hypertension, type 2 diabetes and overt nephropathy compared to amlodipine and control respectively. A simulation model was developed to project long-term cost consequences of the IDNT in the Spanish setting. METHODS: A Markov model simulated progression from nephropathy to DSC, ESRD and death in patients with hypertension, type 2 diabetes and overt nephropathy. Treatment-specific probabilities were derived from IDNT. Country-specific ESRD-related data were retrieved from published sources. Delay in onset of ESRD, life expectancy and mean lifetime costs were calculated for patients with baseline age 59 years. Future costs were discounted at 6% per annum, and clinical benefits were discounted at 0% and 6% per annum. Extensive sensitivity analyses were performed. RESULTS: Onset of ESRD was delayed with irbesartan by 1.41 and 1.35 years versus amlodipine and control respectively. When a 25-year (lifetime) horizon was considered, delay in ESRD onset led to anticipated improvements in life expectancy (discounted at 6% shown in brackets) of 0.46 (0.21) years versus amlodipine and 0.75 (0.37) years versus control. Irbesartan was associated with cost savings of 13,673 Euro and 7,632 Euro patient versus amlodipine and control respectively. The results were robust under a wide range of plausible assumptions. CONCLUSIONS: Treating patients with hypertension, type 2 diabetes and overt nephropathy using irbesartan was both cost- and life-saving compared to amlodipine and control in the Spanish setting.

Cost-effectiveness of raising HDL cholesterol by adding prolonged-release nicotinic acid to statin therapy in the secondary prevention setting: a French perspective.

AIM: To evaluate the cost-effectiveness of raising high-density lipoprotein cholesterol (HDL-C) with add-on nicotinic acid in statin-treated patients with coronary heart disease (CHD) and low HDL-C, from the French healthcare system perspective. METHODS AND RESULTS: Computer simulation economic modelling incorporating two decision analytic submodels was used. The first submodel generated a cohort of 2000 patients and simulated lipid changes using baseline characteristics and treatment effects from the ARterial Biology for the Investigation of the Treatment Effects of Reducing cholesterol (ARBITER 2) study. Prolonged-release (PR) nicotinic acid (1 g/day) was added in patients with HDL-C < 40 mg/dl (1.03 mmol/l) on statin alone. The second submodel used standard Markov techniques to evaluate long-term clinical and economic outcomes based on Framingham risk estimates. Direct medical costs were accounted from a third party payer perspective [2004 Euros (euro)] and discounted by 3%. Addition of PR nicotinic acid to statin therapy resulted in substantial health gain and increased life expectancy, at a cost well within the threshold (< 50,000 euros per life year gained) considered good value for money in Western Europe. CONCLUSIONS: Raising HDL-C by adding PR nicotinic acid to statin therapy in CHD patients was cost-effective in France at a level considered to represent good value for money by reimbursement authorities in Europe. This strategy was highly cost-effective in CHD patients with type 2 diabetes.