利拉鲁肽与罗格列酮、格列美脲、艾塞那肽和甘精胰岛素治疗2型糖尿病患者的短期成本-效果比较

目的以第26周末达到HbA1c<7%、无体重增加和无低血糖事件作为糖尿病综合管理的有效复合终点,分析在中国2型糖尿病患者治疗中每日一次1.2mg利拉鲁肽相比罗格列酮、格列美脲、艾塞那肽和甘精胰岛素的经济性。方法利用利拉鲁肽全球Ⅲ期临床试验(LEADTM)的临床数据计算每日一次1.2mg利拉鲁肽相比罗格列酮、格列美脲、艾塞那肽和甘精胰岛素的成功治疗1例患者的成本。成本包括药物、针头、自我血糖监测,以及处置严重不良事件(SAE)、低血糖事件和体重干预的成本,效果指标为复合终点达标率,并进行单因素敏感度分析。结果在使用研究药物治疗26周后,相对罗格列酮、格列美脲、艾塞那肽和甘精胰岛素,每日一次1.2mg利拉鲁肽治疗每100例患者分别使额外26例、24例、7例和17例患者达到复合终点,利拉鲁肽成功治疗1例患者所需成本小于对应比较治疗方案。敏感度分析支持了结果的稳健性。结论相比罗格列酮、格列美脲、艾塞那肽和甘精胰岛素,利拉鲁肽是具有成本-效果的治疗方案。     

Cost-effectiveness of saxagliptin vs glimepiride as a second-line therapy added to metformin in Type 2 diabetes in China

Abstract

Objective:

This study aims to estimate the long-term cost-effectiveness of saxagliptin?+?metformin (SAXA?+?MET) vs glimepiride?+?metformin (GLI?+?MET) in patients with Type 2 diabetes mellitus (T2DM) inadequately controlled with MET in China.     

Economic impact of severe and non-severe hypoglycemia in patients with Type 1 and Type 2 diabetes in the United States

Abstract

Objective:

To identify the direct and indirect costs of hypoglycemia in patients with Type 1 or Type 2 diabetes mellitus (DM) in the US setting.     

Comparison of treatment costs in inadequately controlled type 2 diabetes in Germany based on the APOLLO trial with insulin glargine

Abstract

Objective: A cost analysis of once-daily insulin glargine versus three-times daily insulin lispro in combination with oral antidiabetic drugs (OADs) for insulin-naive type 2 diabetes patients in Germany based on the APOLLO trial (A Parallel design comparing an Oral antidiabetic drug combination therapy with either Lantus once daily or Lispro at mealtime in type 2 diabetes patients failing Oral treatment).

Methods: Annual direct treatment costs were estimated from the perspective of the German statutory health insurance (SHI). Costs accounted for included insulin medication, disposable pens and consumable items (needles, blood glucose test strips and lancets). Sensitivity analyses (on resource use and unit costs) were performed to reflect current German practice.

Results: Average treatment costs per patient per year in the base case were €1,073 for glargine and €1,794 for lispro. Insulin costs represented 65% vs. 37% of total costs respectively. Acquisition costs of glargine were offset by the lower costs of consumable items (€380 vs. €1,139). Sensitivity analyses confirmed the robustness of the results in favour of glargine. All scenarios yielded cost savings in total treatment costs ranging from €84 to €727.

Conclusions: Combination therapy of once-daily insulin glargine versus three-times daily insulin lispro both with OADs, in the management of insulin-dependent type 2 diabetes offers the potential for substantial cost savings from the German SHI perspective.     

An economic evaluation of ramipril in the treatment of patients at high risk for cardiovascular events due to diabetes mellitus

SUMMARY

Cardiovascular disease (CVD) is a major cause of death and morbidity in the United Kingdom (UK) and carries with it a significant financial cost through health care resource use. More than one in three people die from CVD events, and the cost to the UK National Health Service (NHS) was £1.6 billion in 1996¹. The recently published MICRO-HOPE study evaluated the treatment of 3,577 patients at high risk for cardiovascular events from diabetes mellitus and demonstrated significant survival and morbidity benefits associated with ramipril.

The purpose of this paper is to assess whether the significant clinical benefits offered by ramipril can be translated into economic benefits, and to what extent it can reduce the economic burden of CVD to the UK NHS.

Applying the same analytical framework used in a previous economic analysis of the HOPE study, our base case estimate of cost-effectiveness for ramipril in the MICRO HOPE study is £2,396 per life-year saved (undiscounted) and £2,971 per life-year saved (discounted). A sensitivity analysis was performed which ranged from a best case of £1,954 per life-year saved (undiscounted) to a worst case of £2,964 per life-year saved (undiscounted). Our base case estimate of cost-effectiveness suggests that treating patients at high risk for CVD events with ramipril is likely to be a good investment of NHS resources.     

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

Abstract

Aims: The clinical and economic impact of diabetes is growing in the US. Choosing therapies that are both effective and cost-effective is becoming increasingly important. The aim of the present analysis was to assess the long-term cost-effectiveness of IDegLira for treatment of patients with type 2 diabetes mellitus not meeting glycemic targets on basal insulin, vs insulin glargine U100 plus insulin aspart, in the US setting.

Materials and methods: Long-term projections of cost-effectiveness outcomes were made using the IQVIA CORE Diabetes Model. Clinical inputs were based on the DUAL VII trial, with costs (accounted from a healthcare payer perspective) and utilities based on published sources. Future costs and clinical benefits were discounted at 3% annually.

Results: IDegLira was associated with increased discounted life expectancy by 0.02 years and increased discounted quality-adjusted life expectancy by 0.22 quality-adjusted life years compared with insulin glargine U100 plus insulin aspart. Evaluation of direct medical costs suggested that the mean cost per patient with IDegLira was $3,571 lower than with insulin glargine U100 plus insulin aspart. The cost saving was driven predominantly by the lower acquisition cost of IDegLira compared with insulin glargine U100 plus insulin aspart, with further cost savings identified as a result of avoided treatment of diabetes-related complications. IDegLira was associated with improved clinical outcomes at a reduced cost compared with insulin glargine U100 plus insulin aspart.

Conclusions: Based on clinical trial data, the present analysis suggests that IDegLira is associated with improved clinical outcomes and cost savings compared with treatment with insulin glargine U100 plus insulin aspart for patients with type 2 diabetes not achieving glycemic control on basal insulin in the US. Therefore, IDegLira is likely to be considered dominant (cost saving and more effective) and, consequently, highly cost-effective in the US setting.     

Clinical and economic outcomes in patients with type 2 diabetes initiating insulin glargine disposable pen versus exenatide BID

Abstract

Objective:

To evaluate clinical and economic outcomes in patients with type 2 diabetes mellitus (T2DM) who failed oral anti-diabetic drug (OAD) therapy and initiated either insulin glargine with disposable pen (GLA-P) or exenatide BID (EXE).

Research design and methods:

This retrospective study used data from a large US-managed care claims database and included adult T2DM patients initiating treatment with GLA-P or EXE in 2007 or 2008. Propensity score matching was used to control observed baseline differences between treatment groups. Primary study end-points included treatment persistence, A1C, healthcare utilization, and healthcare costs during the 1-year follow-up period.

Results:

Two thousand three hundred and thirty nine patients were included in the study (GLA-P: 381; EXE: 1958); 626 patients were in the 1:1 matched cohort (54% male; mean age: 54 years; mean A1C: 9.2%). At follow-up, patients in the GLA-P group were significantly more persistent in treatment than EXE patients (48% vs 15% in persistence rate and 252 vs 144 days in persistence days; both p?<?0.001). GLA-P patients also had significantly lower A1C at follow-up (8.02% vs 8.32%; p?=?0.042) and greater A1C reduction from baseline (?1.23% vs ?0.92%; p?=?0.038). There were no significant differences in claims-based hypoglycemia rates and overall diabetes-related healthcare utilization and cost.

Limitations:

Since this was a retrospective analysis, causality of treatment benefits cannot be established. The study was specific to two treatments and may not generalize to other models of insulin administration. Some of the results, although statistically significant, may not be found clinically important.

Conclusions:

In a real-world setting among T2DM patients who failed to achieve or sustain glycemic goal with OADs, initiation of GLA-P instead of EXE may be a more effective option because it was associated with greater treatment persistence, greater A1C reduction without a significantly higher rate of hypoglycemia, and similar healthcare costs.     

Outcomes associated with concordance of oral antidiabetic drug treatments to prescribing information in patients with type 2 diabetes mellitus and chronic kidney disease

Abstract

Objectives:

This retrospective study aims to examine the association between prescribing information (PI)-concordant oral antidiabetic drug (OAD) treatment and clinical and economic outcomes in patients with type 2 diabetes mellitus and stages 3–5 chronic kidney disease (CKD).

Methods:

The study used a large, national administrative claims database with laboratory findings to identify patients with a diagnosis of diabetes and indication of stages 3–5 CKD (first observed indication as the index date) between 1/1/2005 and 30/06/2009. OADs prescribed during 6 months following the index date (baseline period) were evaluated and patients were considered non-PI-concordant if any did not meet the recommendations regarding patients with renal impairment. Glycemic control and measures of healthcare costs (standardized to 2010 US dollars using the Consumer Price Index) and resource utilization were assessed during the 12 months following the baseline period. Severe hypoglycemic events were assessed after the baseline period until lost to follow-up. Regression analyses were performed after adjusting for demographic and clinical characteristics.

Results:

Among the 3300 patients included in the study, 2454 (74.4%) were non-PI-concordant. The non-PI-concordant patients had higher risk of severe hypoglycemic events identified in all settings (HR?=?1.35, 95% CI: 1.10–1.67) and events identified in inpatient hospital setting (HR?=?2.51, 95% CI: 1.49–4.22), were more likely to have inpatient hospital admissions (OR?=?1.27, 95% CI: 1.02–1.57), and were less likely to have glycemic control (OR?=?0.56, 95% CI: 0.44–0.71). Annual diabetes-related cost was $1638 higher in the non-PI-concordant cohort (p?=?0.0048).

Limitations:

The retrospective cohort design does not allow for conclusions to be drawn on the causal effect of PI-concordant use based on the associations observed.

Conclusion:

Our findings suggest PI-concordant treatment to be associated with better clinical and diabetes-associated economic outcomes. Future research is warranted to confirm the associations found in this study.     

Hypoglycemia in patients with type 2 diabetes using concomitant exenatide BID and long-acting insulin therapy

Abstract

Objective:

The objective of this study was to examine the frequency of hypoglycemia among patients with type 2 diabetes who had concomitantly used exenatide BID (exenatide) and long-acting insulin and continued this combination vs those who continued long-acting insulin alone.

Methods:

Retrospective analyses, using a large managed care database, were used to estimate the frequency of hypoglycemia (episodes/patient/6 months) for patients who concomitantly used exenatide and long-acting insulin during a 6-month follow-up period.

Results:

From among 2082 patients on concomitant exenatide and long-acting insulin, those who continued this combination (n?=?472) had a lower frequency of hypoglycemia compared to those who remained on long-acting insulin alone (n?=?312) (0.03?±?1.9 vs 0.10?±?1.01 [episodes/patient/6 months]; p?<?0.0001).

Limitations:

Only hypoglycemia that required medical intervention (coded for hypoglycemia) was captured. The study could not evaluate any association between insulin dose titration and hypoglycemia or examine other outcomes such as HbA1c, weight, and body mass index, due to lack of data availability.

Conclusions:

Patients who concomitantly used exenatide BID and long-acting insulin experienced a lower rate of hypoglycemia.     

A short-term cost-utility analysis of insulin degludec versus insulin glargine U100 in patients with type 1 or type 2 diabetes in Denmark

Background and aims: Insulin degludec is an insulin analog with an ultra-long duration of action that exhibits less intra-patient variability in its glucose-lowering activity, and reduces nocturnal, overall, and severe hypoglycemia relative to insulin glargine. The aim of the present study was to evaluate the cost-effectiveness of insulin degludec relative to insulin glargine in patients with: type 1 diabetes (T1D), type 2 diabetes receiving basal-only therapy (T2DBOT), and type 2 diabetes receiving basal-bolus therapy (T2DBB) in Denmark.

Methods: A short-term (1 year) cost-utility model was developed to model insulin use, non-severe and severe hypoglycemia, and self-monitoring of blood glucose in patients using insulin degludec and insulin glargine from the perspective of a Danish healthcare payer. Where possible, data were derived from Danish patients with diabetes and meta-analyses of clinical trials comparing insulin degludec with insulin glargine. Using these characteristics, the model estimated costs and quality-adjusted life years (QALYs) gained for the two insulin regimens in each of the three diabetes populations.

Results: Insulin degludec dominated insulin glargine (i.e. reduced costs while improving quality-adjusted life expectancy) in patients with T1D and patients with type 2 diabetes using a basal-only insulin regimen. In the T2DBB cohort, insulin degludec was associated with an incremental cost-effectiveness ratio of DKK 221,063 per QALY gained, which would be considered cost-effective at a willingness-to-pay threshold of EUR 30,000 (～DKK 224,000) per QALY gained. Sensitivity analysis showed that results were most affected by changes in hypoglycemia rate ratio assumptions, but were broadly insensitive to changes in individual input parameters.

Conclusions: Insulin degludec reduces incidence of hypoglycemia and improves quality-of-life in patients with diabetes. Over a 1-year time horizon, insulin degludec resulted in cost savings relative to insulin glargine in T1D and T2DBOT cohorts, while being cost-effective in T2DBB.