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 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-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.

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.

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.

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.

Insulin therapy in type 2 diabetes patients failing oral agents: cost-effectiveness of biphasic insulin aspart 70/30 vs. insulin glargine in the US.

OBJECTIVES: To project the long-term clinical and economic outcomes of treatment with biphasic insulin aspart 30 (BIAsp 70/30, 30% soluble and 70% protaminated insulin aspart) vs. insulin glargine in insulin-naïve type 2 diabetes patients failing to achieve glycemic control with oral antidiabetic agents alone (OADs). METHODS: Baseline patient characteristics and treatment effect data from the recent 'INITIATE' clinical trial served as input to a peer-reviewed, validated Markov/Monte-Carlo simulation model. INITIATE demonstrated improvements in HbA1c favouring BIAsp 70/30 vs. glargine (-0.43%; p < 0.005) and greater efficacy in reaching glycaemic targets among patients poorly controlled on OAD therapy. Effects on life expectancy (LE), quality-adjusted life expectancy (QALE), cumulative incidence of diabetes-related complications and direct medical costs (2004 USD) were projected over 35 years. Clinical outcomes and costs were discounted at a rate of 3.0% per annum. Sensitivity analyses were performed. RESULTS: Improvements in glycaemic control were projected to lead to gains in LE (0.19 +/- 0.24 years) and QALE (0.19 +/- 0.17 years) favouring BIAsp 70/30 vs. glargine. Treatment with BIAsp 70/30 was also associated with reductions in the cumulative incidences of diabetes-related complications, notably in renal and retinal conditions. The incremental cost-effectiveness ratio was $46 533 per quality-adjusted life year gained with BIAsp 70/30 vs. glargine (for patients with baseline HbA1c >/= 8.5%, it was $34 916). Total lifetime costs were compared to efficacy rates in both arms as a ratio, which revealed that the lifetime cost per patient treated successfully to target HbA1c levels of <7.0% and

A health economic model to determine the long-term costs and clinical outcomes of raising low HDL-cholesterol in the prevention of coronary heart disease.

OBJECTIVES: The aim of this study was to describe a health economic model developed to project lifetime clinical and cost outcomes of lipid-modifying interventions in patients not reaching target lipid levels and to assess the validity of the model. METHODS: The internet-based, computer simulation model is made up of two decision analytic sub-models, the first utilizing Monte Carlo simulation, and the second applying Markov modeling techniques. Monte Carlo simulation generates a baseline cohort for long-term simulation by assigning an individual lipid profile to each patient, and applying the treatment effects of interventions under investigation. The Markov model then estimates the long-term clinical (coronary heart disease events, life expectancy, and quality-adjusted life expectancy) and cost outcomes up to a lifetime horizon, based on risk equations from the Framingham study. Internal and external validation analyses were performed. RESULTS: The results of the model validation analyses, plotted against corresponding real-life values from Framingham, 4S, AFCAPS/TexCAPS, and a meta-analysis by Gordon et al., showed that the majority of values were close to the y = x line, which indicates a perfect fit. The R2 value was 0.9575 and the gradient of the regression line was 0.9329, both very close to the perfect fit (= 1). CONCLUSIONS: Validation analyses of the computer simulation model suggest the model is able to recreate the outcomes from published clinical studies and would be a valuable tool for the evaluation of new and existing therapy options for patients with persistent dyslipidemia.

Improving life expectancy and decreasing the incidence of complications associated with type 2 diabetes: a modelling study of HbA1c targets.

To project the long-term clinical and cost outcomes that accompany predefined improvements in glycaemic control in patients with type 2 diabetes. A peer-reviewed, validated, non-product-specific Markov model of type 2 diabetes was used to project the long-term clinical and cost outcomes associated with three HbA1c reduction scenarios (vs. no reduction): (i) decreasing mean HbA1c from 9.5% to 8.0%; (ii) from 8.0% to 7.0%; and (iii) from 7.0% to 6.5%. A typical baseline US type 2 diabetes cohort derived from National Health and Nutrition Examination Survey data was simulated over a lifetime horizon (35 years). Incidence of diabetes-related complications and costs (2005 USD) were accounted based on published data. Discount rates (3% per annum) were applied to clinical benefits and costs. Sensitivity analyses were performed. Stepwise reductions in HbA1c as an independent variable correlated with delayed time to diabetes-related complications and a reduced cumulative incidence of complications, including cardiovascular, renal and neurologic comorbidities. Related costs also decreased. Reductions in both poorly- (9.5-8.0%) and better-controlled (7.0-6.5%) patients produced incremental gains in undiscounted life expectancy (LE) [1.06 (0.31) and 0.32 (0.34) years [mean (SD)], respectively]. Similar improvement patterns were observed in quality-adjusted life expectancy (QALE). Benefits from sequential reduction scenarios, when aggregated, exhibited the most dramatic effect. Improved glycaemic control was associated with reductions in complication rates and costs, as well as increased LE and QALE among type 2 patients. These data illustrate the long-term importance of reaching normoglycaemia and support intensified HbA1c control as a cornerstone of effective long-term type 2 diabetes management.

[Clinical and health economic implications of early treatment with irbesartan of patients with type 2 diabetes mellitus, hypertension and nephropathy]. / Klinische und gesundheitsökonomische Auswirkungen einer frühen Irbesartan-Therapie bei Typ-2-Diabetes, Hypertonie und Nierenerkrankung.

BACKGROUND AND OBJECTIVE: It was the aim of this study to project the long-term clinical and cost outcomes of irbesartan treatment, based on data from the irbesartan in Reduction of Microalbuminuria-2 (IRMA-2) study and the irbesartan in Diabetic Nephropathy Trial (IDNT), in hypertensive patients with type 2 diabetes and renal disease in Germany. PATIENTS AND METHODS: A Markov model adapted to the German setting simulated progression of renal disease and associated changes in mortality in patients with hypertension, type 2 diabetes and microalbuminuria. Early irbesartan 300 mg daily (initiated at microalbuminuria) and late irbesartan (initiated at overt nephropathy) were compared to a control scheme of antihypertensive standard medications with comparable blood pressure control, initiated at microalbuminuria. Cumulative incidence of ESRD, time to onset of ESRD, life expectancy (LE), quality-adjusted life years (QALY) and costs were projected over 25 years for 1,000 simulated patients, from a third party payer perspective. Clinical and cost outcomes were discounted at 5% per annum. RESULTS: When compared to standard blood pressure control, both early and late treatment with irbesartan were projected to reduce the cumulative incidence of ESRD fromm23.80.3% to 9.10.6% and 19.83%, increase discounted LE by 0.670.04 and 0.030.00 years, and improve QALY by 0.750.04 and 0.070.01 years per treated patient, respectively. Early irbesartan treatment was associated with a cost savings of i 12,658825 per patient while late irbesartan treatment was associated with a cost savings of i 4,116575 per patient compared to control over the 25-year time horizon. CONCLUSIONS: Early irbesartan treatment was projected to improve LE and QALY, and reduce the onset of ESRD, with cost savings, in hypertensive patients with type 2 diabetes and microalbuminuria in Germany. Later use of irbesartan in overt nephropathy is also superior to standard care. These findings suggest that irbesartan should be started earlier and continued long-term.