Examining correlates of treatment satisfaction for injectable insulin in type 2 diabetes: lessons learned from a clinical trial comparing biphasic and basal analogues.

BACKGROUND: Successfully managing diabetes is a complex process that includes addressing issues of drug efficacy, safety and treatment satisfaction. Additionally, the combined impact of patient/disease characteristics and treatment outcomes on treatment satisfaction is not well understood. The purpose of this study was to examine the impact of age, weight, gender, co-morbid conditions, diabetes history, treatment burden, efficacy (HbA1c) and side effects (weight gain, hypoglycemic events) on patients' appraisal of treatment satisfaction using linear regression models. METHODS: Data from a multi-center, randomized clinical trial comparing the efficacy/safety of biphasic insulin aspart 70/30 (BIAsp 70/30) vs. glargine (Glar) among insulin naïve type 2 patients were analyzed. Subjects were between ages 18-75, with baseline HbA1c > 8% and BMI < or = 40 kg/m2 (N = 233). Treatment satisfaction was assessed by the Insulin Treatment Satisfaction Questionnaire (ITSQ). RESULTS: When factors were examined independently, multiple significant relationships (age, co-morbidity, hypoglycemic events, and weight gain) with overall and/or domains of treatment satisfaction were found. However, when all significant relationships were examined together, only neuropathy, treatment efficacy, and number of hypoglycemic events maintained their previous significance. CONCLUSION: By examining predictors independently, significant relationships were identified. However, not all findings remained significant when examined in combination with each other. Thus, to more accurately characterize the impact of factors on treatment satisfaction, a more comprehensive approach may be necessary. By improving patient treatment satisfaction, the efficacy of treatments, as well as critical treatment outcomes such as compliance and cost of care should be improved.

Multivariate models of health-related utility and the fear of hypoglycaemia in people with diabetes.

AIM: The aim was to statistically model the degree of fear of hypoglycaemia experienced by people with diabetes, and then model the resulting change in health-related utility associated with differing severity and frequency of hypoglycaemia. METHODS: The study used pooled data from two previous postal surveys among subjects with confirmed diabetes conducted in Cardiff, UK (n = 1305 responses). The fear of hypoglycaemia was characterised using the Hypoglycaemia Fear Survey (HFS [eight question worry sub-scale only]), and health-related utility using the EQ5D(index). The data were then analysed using univariate and multivariate analysis. RESULTS: Following detailed preliminary analysis, a two-stage approach was used since fear was important when estimating the EQ5D(index). Fear was then modelled as a function of the severity and frequency of hypoglycaemia while controlling for other factors such as diabetes-related complications. Each severe hypoglycaemic event resulted in a change of 5.881 units on the HFS. One or more symptomatic hypoglycaemic events over the same period results in a corresponding change of 1.773 units on the HFS. A 1 unit increase on the HFS results in a 0.008 unit decrease on the EQ5D(index). CONCLUSION: While controlling for other factors, the fear of hypoglycaemia was an important determinant of health-related utility. The magnitude of fear of hypoglycaemia was associated with the severity and frequency of hypoglycaemia. Hypoglycaemia was associated with a considerable decrement in health-related utility as a function of increased fear. Measures should be taken to minimise the severity and frequency of hypoglycaemia.

Overview of costs of stroke from published, incidence-based studies spanning 16 industrialized countries.

OBJECTIVE: The aim of this review is to summarize published data (based on a search of Medline sources, 1993-October 2003) from the last 10 years on the costs of stroke. With the recent encouraging evidence of interventions that reduce the incidence of stroke, the primary focus is on incidence-based cost of stroke studies to identify important factors for future cost-effectiveness analyses on stroke interventions. FINDINGS: Lifetime costs per patient were in the range USD 11 787 for 'unclassified' stroke in Australia to USD 3035671 in stroke patients with untreated non-rheumatic atrial fibrillation in a UK setting (costs inflated to 2003 values). For the lifetime costs of ischemic stroke only, the range narrowed to USD 41257 in Australia and USD 104629 in the UK. These data confirm that stroke management is associated with a vast economic burden. No correlation of lifetime cost of stroke with specific cost components or time horizon was identified. The cost of stroke is influenced by severity (more severe strokes cost more due to extended hospitalization), age (costs were greater in younger stroke patients) and gender (direct costs were greater for women, but indirect costs were greater in men). CONCLUSION: Conducting research according to methodological consensus would markedly improve the quality of data from future studies of stroke and support identification of the main cost drivers in different country-specific settings.

Long-term clinical and cost outcomes of treatment with biphasic insulin aspart 30/70 versus insulin glargine in insulin naïve type 2 diabetes patients: cost-effectiveness analysis in the UK setting.

OBJECTIVES: To evaluate the long-term clinical and cost outcomes associated with biphasic insulin aspart 30/70 (BIAsp 30/70, premixed 30% soluble and 70% protaminated insulin aspart in one injection) compared to insulin glargine treatment in insulin-naïve type 2 diabetes patients failing oral antidiabetic agents in the UK, based on findings recently reported from the INITIATE clinical trial. METHODS: The CORE Diabetes Model, a published, peer-reviewed and validated model of diabetes, was used to evaluate life expectancy, quality-adjusted life expectancy, cumulative incidence of complications and direct medical costs over patient lifetimes. The model simulates the range of diabetic complications and disease progression within a series of sub-models (cardiovascular disease, neuropathy, renal and eye disease) based on published data. Baseline cohort characteristics (54.5% male, mean age 52.45 years, mean diabetes duration 9 years, mean HbA(1c) 9.77%) and treatment effects were based on INITIATE. Costs were derived from published UK sources. The analysis was run over a 35-year time horizon (patient lifetime) from a third party payer perspective. Costs and clinical benefits were discounted at 3.5% per annum. Sensitivity analyses were performed. RESULTS: BIAsp 30/70 was associated with projected improvements in discounted life expectancy (0.19 +/- 0.20 years) and quality-adjusted life expectancy (0.19 +/- 0.14 quality-adjusted life years [QALYs]), as well as a reduced incidence of retinopathy and nephropathy complications, versus glargine. Total lifetime direct costs were 1319 pounds higher with BIAsp 30/70 than with glargine leading to an incremental cost-effectiveness ratio of 6951 pounds per QALY gained. CONCLUSIONS: This study is the first to address the long-term health economic implications of treating type 2 diabetes patients failing oral anti-diabetics with a biphasic insulin mix versus long-acting insulin. Our projections indicate that improved HbA1c levels with BIAsp 30/70 treatment are associated with improvements in life expectancy and quality-adjusted life expectancy, and that BIAsp 30/70 represents excellent value for money compared to insulin glargine in the UK.

The CORE Diabetes Model: Projecting long-term clinical outcomes, costs and cost-effectiveness of interventions in diabetes mellitus (types 1 and 2) to support clinical and reimbursement decision-making.

OBJECTIVES: We have developed an Internet-based, interactive computer model to determine the long-term health outcomes and economic consequences of implementing different treatment policies or interventions in type 1 and type 2 diabetes mellitus. The model projects outcomes for populations, taking into account baseline cohort characteristics and past history of complications, current and future diabetes management and concomitant medications, screening strategies and changes in physiological parameters over time. The development of complications, life expectancy, quality-adjusted life expectancy and total costs within populations can be calculated. METHODS: The model is based on a series of sub-models that simulate important complications of diabetes (cardiovascular disease, eye disease, hypoglycaemia, nephropathy, neuropathy, foot ulcer, amputation, stroke, ketoacidosis, lactic acidosis and mortality). Each sub-model is a Markov model using Monte Carlo simulation incorporating time, state, time-in state, and diabetes type-dependent probabilities derived from published sources. Analyses can be performed on cohorts with type 1 or type 2 diabetes. Cohorts, defined in terms of age, gender, baseline risk factors and pre-existing complications, can be modified or new cohorts defined by the user. Economic and clinical data in the model can be edited, thus ensuring adaptability by allowing the inclusion of new data as they become available; creation of country- or provider-specific versions of the model; and allowing the investigation of new hypotheses. CONCLUSIONS: The CORE Diabetes Model allows the calculation of long-term outcomes, based on the best data currently available. Diabetes management strategies can be compared in different patient populations in a variety of realistic clinical settings, allowing the identification of efficient diabetes management strategies.

Validation of the CORE Diabetes Model against epidemiological and clinical studies.

OBJECTIVES: The aim of this study was to assess the validity of the CORE Diabetes Model by comparing results from model simulations with observed outcomes from published epidemiological and clinical studies in type 1 and type 2 diabetes. METHODS: A total of 66 second- (internal) and third- (external) order validation analyses were performed across a range of complications and outcomes simulated by the CORE Diabetes Model (amputation, cataract, hypoglycaemia, ketoacidosis, macular oedema, myocardial infarction, nephropathy, neuropathy, retinopathy, stroke and mortality). Published studies were reproduced in the model by recreating cohorts in terms of demographics, baseline risk factors and complications, treatment patterns and patient management strategies, and simulating the progress of the cohort to an equivalent time horizon. RESULTS: Correlation analysis on results from 66 validation simulations produced an R2 value of 0.9224 (perfect fit = 1). A correlation plot of published study data versus values simulated by the CORE Diabetes Model had a trend line with a gradient of 1.0187 (perfect fit = 1). Validation analyses in type 1 and type 2 diabetes were associated with R2 values of 0.9778 and 0.8861 respectively. Correlation of second-order validation analyses (model predictions versus observed outcomes in studies used to construct the model) produced an R2 value of 0.9574, and the value for third-order analyses (model predictions versus observed outcomes in studies not used to construct the model) was 0.9023. CONCLUSIONS: The CORE Diabetes Model provides an accurate representation of patient outcomes when compared to 66 studies of diabetes and its complications. Model flexibility ensures it can be used to compare diabetes management strategies in different cohorts across a variety of clinical settings.

Comparing the long-term cost-effectiveness of repaglinide plus metformin versus nateglinide plus metformin in type 2 diabetes patients with inadequate glycaemic control: an application of the CORE Diabetes Model in type 2 diabetes.

OBJECTIVES: As an example application of the CORE Diabetes Model in type 2 diabetes, we simulated the cost-effectiveness of repaglinide/metformin combination therapy versus nateglinide/metformin for treatment of individuals with type 2 diabetes with an inadequate response to sulphonylurea, metformin, or fixed dose glyburide/metformin. METHODS: The CORE Diabetes Model was used to simulate long-term outcomes for a cohort of individuals with type 2 diabetes treated with either repaglinide/metformin or nateglinide/metformin. HbA1c changes for each regimen were taken from a comparative study. At the end of the study, changes in HbA1c from baseline were -1.28% points and -0.67% points for repaglinide/metformin and nateglinide/metformin, respectively. Median final doses were 5.0 mg/day for repaglinide, 360 mg/day for nateglinide and 2000 mg/day metformin in each treatment arm. Costs were calculated as the annual costs for drugs plus costs of complications (US Medicare perspective) over a 30-year period. Life expectancy (LE) and quality-adjusted life expectancy (QALE) were calculated. Outcomes and costs were discounted at 3% annually. RESULTS: With repaglinide/metformin, improved glycaemic control led to projected decreases in complication rates, improvement of LE and QALE by 0.15 and 0.14 years respectively, and total cost savings of 3,662 dollars/person over the 30-year period. Repaglinide/metformin had a 96% probability that the incremental costs per quality-adjusted life year gained would be 20,000 dollars or less, and a 66% probability that repaglinide/metformin would be cost-saving compared to nateglinide/metformin. Sensitivity analyses supported the validity and reliability of the results. CONCLUSIONS: In the health economic context, repaglinide/metformin combination was dominant to nateglinide/metformin. The CORE Diabetes Model is a tool to help third-party reimbursement payers identify treatments for type 2 diabetes that are good value for money.

What impact would pancreatic beta-cell preservation have on life expectancy, quality-adjusted life expectancy and costs of complications in patients with type 2 diabetes? A projection using the CORE Diabetes Model.

OBJECTIVE: Type 2 diabetes is characterised by progressive failure of pancreatic beta-cell function against a background of insulin resistance. Multifactorial interventions, including intensive glycaemic and blood pressure control, reduce the risk of onset and progression of complications. However, current management of type 2 diabetes focuses on treatment of signs and symptoms of disease instead of targeting underlying causes. A number of newer pharmacological interventions, including thiazolidinediones and glucagon-like peptides, have shown early promise in preserving pancreatic beta-cell function. The aim of this study was to investigate the impact of stabilising beta-cell function on long-term outcomes in patients with type 2 diabetes. METHODS: The CORE Diabetes Model was used to project life expectancy (LE), quality-adjusted LE (QALE) and total lifetime complication costs (TC) for a cohort of newly-diagnosed patients with type 2 diabetes, either with a typical increase of HbA1c over time as observed in the UKPDS, or assuming stabilisation of HbA1c after diagnosis with a hypothetical new treatment, representing beta-cell function stabilisation. Costs due to diabetes-related complications (from a US third-party payer perspective), were discounted at 3% annually. Both non-discounted and discounted (at 3% annually) LE and QALE were calculated. Sensitivity analyses were performed to test the robustness of results. RESULTS: Over a time period of 50 years, in a cohort with no increase of HbA1c over time, LE and QALE were improved by mean (SD) 1.02 (0.36) and 0.96 (0.25) years, and total costs of complications were reduced by 6,377 dollars (2,568) per patient compared to the cohort with a typical increase in HbA1c over time. Results were robust under a wide range of plausible assumptions. CONCLUSIONS: New interventions that stabilise pancreatic betacell function may have an important impact on length and quality of life, and lead to reduced costs of complications in patients with type 2 diabetes.

Deleterious effects of increased body weight associated with intensive insulin therapy for type 1 diabetes: increased blood pressure and worsened lipid profile partially negate improvements in life expectancy.

OBJECTIVE: Weight gain is an unwanted side effect of improved glycaemic control in type 1 diabetes, associated with increased blood pressure (BP) and worsening lipid profiles. While improved glycaemic control per se should improve long-term patient outcomes, increases in BP and worsening lipid profiles may counteract these benefits. The aim of this modelling study was to assess whether the increased body weight and associated worsening of lipid profile and blood pressure would negate the improvements in glycaemic control seen with intensive therapy in patients with type 1 diabetes. METHODS: A validated diabetes model projected life expectancy (LE), quality-adjusted LE (QALE) and total lifetime costs of complications in type 1 diabetes cohorts with the characteristics of patients from the Diabetes Control and Complications Trial (DCCT). The following four cohorts (A-D) were created based on increased body weight under either conventional or intensive therapy: A) conventional glycaemic control in the subgroup with lowest weight-gain quartile after 6.5 years (HbA1c increased by 11% from baseline); B) conventional control in the highest weight-gain quartile (no change in HbA1c from baseline); C) intensive control in the lowest quartile of weight gain (with 16.1% decrease in HbA1c, but no increase in weight or associated BP, and improved lipid profile); D) intensive control in the highest quartile of weight gain (with 21% decrease in HbA1c, increased systolic BP of 6 mmHg, and worsened lipid profile). Data were derived from DCCT and other published sources. RESULTS: Intensive control, even with weight gain, led to major improvements in LE and QALE, and reduction in costs of complications versus conventional therapy. Intensive therapy with no weight increase led to a higher LE (increased by 0.57 years) and higher QALE (increased by 0.28 years) and lower costs of complications (reduced by 523 dollars/patient), compared to intensive therapy with the highest quartile of weight gain. CONCLUSIONS: Concerns about weight gain should not deter intensive insulin therapy. However, the value of improving glycaemic control without increasing body weight (and associated increased BP and worsening of lipid profile) has been confirmed.

Evaluating the long-term cost-effectiveness of liraglutide versus exenatide BID in patients with type 2 diabetes who fail to improve with oral antidiabetic agents.

BACKGROUND: The global clinical and economic burden of type 2 diabetes is substantial. Recently, clinical trials with glucagon-like peptide-1 (GLP-1) receptor agonists (liraglutide and exenatide) have shown a multifactorial clinical profile with the potential to address many of the clinical needs of patients and reduce the burden of disease. OBJECTIVE: The goal of this study was to evaluate the long-term cost-effectiveness of once-daily liraglutide versus exenatide BID in patients with type 2 diabetes who failed to improve with metformin and/or sulfonylurea, based on the results of a previous clinical trial in 6 European countries (Switzerland, Denmark, Norway, Finland, the Netherlands, and Austria). METHODS: A validated computer simulation model of diabetes was used to predict life expectancy, quality-adjusted life years (QALYs), and incidence of diabetes-related complications in patients receiving liraglutide (1.8 mg once daily) or exenatide (10 µg BID). Baseline cohort characteristics and treatment effects were derived from the Liraglutide Effect and Action in Diabetes 6 trial. Country-specific complication costs were taken from published sources. Simulations were run over 40 years from third-party payer perspectives. Future costs and clinical benefits were discounted at country-specific discount rates. Sensitivity analyses were performed. RESULTS: Liraglutide was associated with improvements of 0.12 to 0.17 QALY and a reduced incidence of most diabetes-related complications versus exenatide in all settings. Evaluation of total direct medical costs (treatment plus complication costs) suggest that liraglutide was likely to cost between Euro (€) 1023 and €1866 more than exenatide over patients' lifetimes, leading to incremental cost-effectiveness ratios per QALY gained versus exenatide of: Switzerland, CHF (Swiss francs) 10,950 (€6902); Denmark, Danish krone [kr] 88,160 (€11,805); Norway, Norwegian krone [kr], 111,916 (€13,546); Finland, €8459; the Netherlands, €8119; and Austria, €8516. CONCLUSIONS: Long-term projections indicated that liraglutide was associated with benefits in life expectancy, QALYs, and reduced complication rates versus exenatide. Liraglutide was cost-effective from a health care payer perspective in Switzerland, Denmark, Norway, Finland, the Netherlands, and Austria.

Patient preferences for diabetes management among people with type 2 diabetes in Denmark - a discrete choice experiment.

OBJECTIVES: To study patient preferences for diabetes-treatment related attributes among people with type 2 diabetes. RESEARCH DESIGN AND METHODS: Participants were recruited from three diabetes out-patient clinics and two general practitioner surgeries. Data were collected electronically and results were analysed using a standard statistical model designed for choice sets (conditional logit). Six characteristics relating to treatment of diabetes were examined: glycated haemoglobin level (HbA(1c)), weight (gain or loss), hypoglycaemic events, need for injections, transient nausea and need for blood glucose testing. RESULTS: Two hundred and seventy participants with type 2 diabetes (178 males; 92 females) were included. Patients placed the most value on losing weight and were willing to pay the most to lose 6 kg of weight. Loss of 3 kg of weight was the next highly valued, followed by dropping one percentage point in HbA(1c) level. Avoidance of nausea and a reduction in hypoglycaemic events from two per month to none was also highly valued. Patients were willing to accept one injection per day if they, for instance, simultaneously lost 1.4 kg. A limitation of the study is that the survey was web-based and response rates for such surveys can be extremely variable. CONCLUSION: Patients with type 2 diabetes in Denmark were willing to pay for the health benefits associated with improved diabetes treatment, the most important of these being weight loss or avoidance of weight gain, and reduction of HbA(1c) and of hypoglycaemic events.

Willingness to pay for improvements in chronic long-acting insulin therapy in individuals with type 1 or type 2 diabetes mellitus.

BACKGROUND: Long-acting insulin treatments with varying clinical benefits are currently available for patients with type 1 diabetes mellitus (T1DM) and type 2 diabetes mellitus (T2DM). The current evidence base demonstrates the efficacy of treatments, but it is critical also to understand patient preferences regarding treatments and how they are determined. OBJECTIVE: This study aimed to measure the willingness to pay (WTP) of individuals with diabetes in the United Kingdom for different attributes of long-acting insulin therapy. METHODS: A survey based on discrete choice experiment methodology was developed to elicit the preferences and values of adults with T1DM or insulin-dependent T2DM regarding different aspects of their therapy. Participants were presented with a series of 27 paired choices and asked which they preferred. WTP values were calculated for relevant attribute levels. RESULTS: A total of 252 participants completed the questionnaire (52% response rate); 143 had T1DM and 109 had insulin-treated T2DM. The highest WTP values in participants with T1DM were avoiding 2-kg or 4-kg weight gain (£29 and £58, respectively), avoiding major difficulties with the injection device (£49), increasing the number of days per week when blood glucose levels are in the target range from 2 to 6 (£40), reducing the number of daily injections from 3 to 1 (£39), and avoiding nighttime hypoglycemia (£33). In participants with T2DM, similar factors had the highest WTP. CONCLUSIONS: This is the first study to assess WTP for long-acting insulin therapy and could have implications for future guidelines on diabetes management, however some limitations, notably in sample selection, could affect generalizability of the results. In both T1DM and T2DM, the highest WTP values were for avoidance of weight gain, and reduction in the number of injections and hypoglycemia.

Costs of managing severe hypoglycaemia in three European countries.

OBJECTIVES: To assess the costs of severe hypoglycaemic events (SHEs) in diabetes patients in Germany, Spain and the UK. METHODS: Healthcare resource use was measured by surveying 639 patients aged ≥ 16 years, receiving insulin for type 1 (n=319) or type 2 diabetes (n=320), who experienced ≥ 1 SHE in the preceding year. Patients were grouped by location of SHE treatment: group 1, community (family/domestic); group 2, community (healthcare professional); group 3, hospital. Costs were calculated from published unit costs applied to estimated resource use. Costs per SHE were derived from patient numbers per subgroup. Weighted average costs were derived using a prevalence database. RESULTS: Hospital treatment was a major cost in all countries. In Germany and Spain, costs per SHE for type 1 patients differed from those for type 2 patients in each group. Average SHE treatment costs were higher for patients with type 2 diabetes (Germany, €533; Spain, €691; UK, €537) than type 1 diabetes patients (€441, €577 and €236, respectively). Telephone calls, visits to doctors, blood glucose monitoring and patient education contributed substantially to costs for non-hospitalised patients. CONCLUSIONS: Treatment of SHEs adds significantly to healthcare costs. Average costs were lower for type 1 than for insulin-treated type 2 diabetes, in all three countries.

[Health economic consequences of insulin analogues in the treatment of type 1 diabetes in Denmark]. / Sundhedsøkonomiske konsekvenser af insulinanaloger til behandling af type 1-diabetes i Danmark.

INTRODUCTION: Diabetes is a major challenge to the Danish health care system, and complications account for the majority of total treatment costs. MATERIALS AND METHODS: The majority of type 1 diabetes patients in Denmark are treated with the flexible basal-bolus insulin regimen. Use of insulin analogues provides superior metabolic control, lower blood glucose viability, flexible life style, reduced frequency of hypoglycaemia and no undesired weight gain. The long term health economic consequences were projected in a published and validated Markov model. Treatment effects of insulin analogues and a similar human insulin regimen were based on results from a clinical RCT study and Danish health care costs were applied in the model. RESULTS: In the model, the improved glycaemic control and the reduction in hypoglycaemia episodes obtained with insulin analogues resulted in a reduction in late stage diabetes complications, improved quality of life and increased life expectancy compared to human insulin. The incremental costs-effectiveness ratio was estimated to DKK 55,867 per quality-adjusted life year gained, which is considered beneficial to society. CONCLUSION: Modelling predicts insulin analogues to be a cost-effective alternative to human insulin in Denmark.

Cost-effectiveness of intensified versus conventional multifactorial intervention in type 2 diabetes: results and projections from the Steno-2 study.

OBJECTIVE: To assess the cost-effectiveness of intensive versus conventional therapy for 8 years as applied in the Steno-2 study in patients with type 2 diabetes and microalbuminuria. RESEARCH DESIGN AND METHODS: A Markov model was developed to incorporate event and risk data from Steno-2 and account Danish-specific costs to project life expectancy, quality-adjusted life expectancy (QALE), and lifetime direct medical costs expressed in year 2005 Euros. Clinical and cost outcomes were projected over patient lifetimes and discounted at 3% annually. Sensitivity analyses were performed. RESULTS: Intensive treatment was associated with increased life expectancy, QALE, and lifetime costs compared with conventional treatment. Mean +/- SD undiscounted life expectancy was 18.1 +/- 7.9 years with intensive treatment and 16.2 +/- 7.3 years with conventional treatment (difference 1.9 years). Discounted life expectancy was 13.4 +/- 4.8 years with intensive treatment and 12.4 +/- 4.5 years with conventional treatment. Lifetime costs (discounted) for intensive and conventional treatment were euro45,521 +/- 19,697 and euro41,319 +/- 27,500, respectively (difference euro4,202). Increased costs with intensive treatment were due to increased pharmacy and consultation costs. Discounted QALE was 1.66 quality-adjusted life-years (QALYs) higher for intensive (10.2 +/- 3.6 QALYs) versus conventional (8.6 +/- 2.7 QALYs) treatment, resulting in an incremental cost-effectiveness ratio of euro2,538 per QALY gained. This is considered a conservative estimate because accounting prescription of generic drugs and capturing indirect costs would further favor intensified therapy. CONCLUSIONS: From a health care payer perspective in Denmark, intensive therapy was more cost-effective than conventional treatment. Assuming that patients in both arms were treated in a primary care setting, intensive therapy became dominant (cost- and lifesaving).

An economic assessment of analogue basal-bolus insulin versus human basal-bolus insulin in subjects with type 1 diabetes in the UK.

BACKGROUND: A recent study demonstrated that treatment of type 1 diabetes with an analogue basal-bolus insulin regimen was associated with improved glycaemic control (HbA(1c) -0.22% points, p < 0.001), reduced risk of hypoglycaemic events (-21%, p = 0.036) and reduction in body mass index (-0.30 kg/m(2), p < 0.001) compared to a human basal-bolus regimen after 18 weeks. METHODS: A published and validated computer simulation model was used to project long-term economic and clinical outcomes in a simulated cohort of type 1 diabetes patients treated with either insulin detemir plus insulin aspart (analogue) or Neutral Protamine Hagedorn plus human soluble insulin (human), in a UK setting. Probabilities of complications and HbA(1c)-dependent adjustments were derived from major clinical and epidemiological studies. Complication and treatment costs were projected over patient lifetimes from a National Health Service perspective. Costs and clinical benefits were discounted at 3.5% annually. RESULTS: Quality-adjusted life expectancy (QALE) was 0.66 quality-adjusted life years (QALY) higher in the analogue insulin versus the human insulin group (mean +/- SD) (7.65 +/- 0.09 versus 6.99 +/- 0.08). Direct lifetime costs were 1654 pounds greater with analogue versus human insulin treatment (40,876 pounds +/- 1119 versus 39,222 pounds+/- 1141), producing an incremental cost effectiveness ratio (ICER) of 2500 pounds per QALY gained. Sensitivity analyses showed the results were robust under a range of plausible scenarios. CONCLUSIONS: Treatment with analogue insulin was associated with a decreased incidence of long-term complications and improved QALE, but slightly higher treatment costs compared to human insulin therapy. Analogue insulin treatment had an ICER within the range generally considered to represent good value for money in the UK.