Cost-effectiveness of Insulin Degludec Versus Insulin Glargine in Adults with Type 1 and Type 2 Diabetes Mellitus.
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ABSTRACT: Introduction
To estimate the cost-effectiveness of insulin degludec (IDeg) versus insulin glargine U100 (IGlar U100) and new-to-market basal insulin analogues in patients with diabetes in order to aid decision-making in a complex basal insulin market.Methods
A simple, short-term model was used to evaluate the costs and effects of treatment with IDeg versus IGlar U100 over a 12-month period in patients with type 1 (T1DM) and type 2 diabetes (T2DM) from the perspective of the UK National Health Service. New-to-market basal insulin analogues were evaluated in scenario analyses.Results
IDeg is dominant (more effective and less costly) versus IGlar U100 in patients with T1DM and patients with T2DM on a basal-only therapy regimen (T2DMBOT), and is cost-effective versus IGlar U100 in patients with T2DM on a basal-bolus regimen (T2DMB/B). In T1DM, lower costs are primarily driven by lower insulin costs, as a result of a lower daily dose of IDeg. In T2DMBOT, lower overall costs with IDeg are driven by lower costs of severe hypoglycaemic events due to the significant reduction in number of events with IDeg versus IGlar U100. Improvements in clinical outcomes in all three patient groups are a result of the reduced incidence of hypoglycaemic events. Sensitivity analyses demonstrate that the results are robust. Scenario analyses versus two new-to-market basal insulin analogues indicate that in patients with T1DM and T2DMBOT, IDeg is likely to be highly cost-effective versus IGlar biosimilar Abasaglar® and dominant versus IGlar U300 (Toujeo®). In T2DMB/B, IDeg is likely to be cost-effective versus both comparators, with incremental cost-effectiveness ratios (ICERs) below the accepted threshold.Conclusion
IDeg is a cost-effective alternative to IGlar U100 for patients with diabetes in the UK, and it also likely to be cost-effective versus two new-to-market basal insulin analogues.
SUBMITTER: Evans M
PROVIDER: S-EPMC5380498 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:BackgroundThis analysis evaluates the cost-effectiveness of insulin degludec (degludec) versus biosimilar insulin glargine U100 (glargine U100) in patients with type 1 (T1DM) and type 2 diabetes mellitus (T2DM) in Bulgaria.MethodsA simple, short-term model was used to compare the treatment costs and outcomes associated with hypoglycaemic events with degludec versus glargine U100 in patients with T1DM and T2DM from the perspective of the Bulgarian National Health Insurance Fund. Cost-effectiveness was analysed over a 1-year time horizon using data from clinical trials. The incremental cost-effectiveness ratio (ICER) was the main outcome measure.ResultsIn Bulgaria, degludec was highly cost-effective versus glargine U100 in people with T1DM and T2DM. The ICERs were estimated to be 4493.68 BGN/quality-adjusted life year (QALY) in T1DM, 399.11 BGN/QALY in T2DM on basal oral therapy (T2DMBOT) and 7365.22 BGN/QALY in T2DM on basal bolus therapy (T2DMB/B), which are below the cost-effectiveness threshold of 39,619 BGN in Bulgaria. Degludec was associated with higher insulin costs in all three patient groups; however, savings from a reduction in hypoglycaemic events with degludec versus glargine U100 partially offset these costs. Sensitivity analysis demonstrated that the results were robust and largely insensitive to variations in input parameters. At a willingness-to-pay threshold of 39,619 BGN/QALY, the probability of degludec being cost-effective versus glargine U100 was 60.0% in T1DM, 99.4% in T2DMBOT and 91.3% in T2DMB/B.ConclusionDegludec is a cost-effective alternative to biosimilar glargine U100 for patients with T1DM and T2DM in Bulgaria. Degludec could be of particular benefit to those patients suffering recurrent hypoglycaemia and those who require additional flexibility in the dosing of insulin.
| S-EPMC6891960 | biostudies-literature
Project description:IntroductionThis study investigates the cost-effectiveness of insulin degludec versus insulin glargine U100 in patients with type 1 and type 2 diabetes mellitus in Serbia.MethodsA cost-utility analysis, implementing a simple short-term model, was used to compare treatment costs and outcomes with degludec versus glargine U100 in patients with type 1 (T1DM) and type 2 diabetes (T2DM). Cost-effectiveness was analysed in a 1-year setting, based on data from clinical trials. Costs were estimated from the healthcare payer perspective, the Serbian Health Insurance Fund (RFZO). The outcome measure was the incremental cost-effectiveness ratio (ICER) or cost per quality-adjusted life-year (QALY) gained.ResultsDegludec is highly cost-effective compared with glargine U100 for people with T1DM and T2DM in Serbia. The ICERs are estimated at 417,586 RSD/QALY gained in T1DM, 558,811 RSD/QALY gained in T2DM on basal oral therapy (T2DMBOT) and 1,200,141 RSD/QALY gained in T2DM on basal-bolus therapy (T2DMB/B). All ICERs fall below the commonly accepted thresholds for cost-effectiveness in Serbia (1,785,642 RSD/QALY gained). In all three patient groups, insulin costs are higher with degludec than with glargine U100, but these costs are partially offset by savings from a lower daily insulin dose in T1DM and T2DMBOT, a reduction in hypoglycaemic events in all three patient groups and reduced costs of SMBG testing in the T2DM groups with degludec versus glargine U100.ConclusionDegludec is a cost-effective alternative to glargine U100 for patients with T1DM and T2DM in Serbia. Degludec may particularly benefit those suffering from hypoglycaemia or where the patient would benefit from the option of flexible dosing.FundingNovo Nordisk.
| S-EPMC5984929 | biostudies-literature
Project description:BackgroundUnderstanding which therapeutic innovations in diabetes represent the best value requires rigorous economic evaluation. Data from randomised controlled trials and observational studies indicate that insulin degludec has a hypoglycemia advantage versus insulin glargine 100 units/mL (glargine U100), the most widely prescribed basal insulin analogue in the UK. This analysis was done to more rigorously assess cost-effectiveness in a UK setting.MethodsData from two double-blinded, randomised, two-period crossover trials in type 1 (SWITCH 1) and type 2 (SWITCH 2) diabetes mellitus were used to assess the cost-effectiveness of degludec vs. glargine U100 with an economic model. Cost-effectiveness was analysed over a 1-year time horizon based on the different rates of hypoglycaemia and actual doses of insulin used, rather than glycaemic control due to the treat-to-target trial design.ResultsIn type 1 diabetes mellitus, degludec was highly cost-effective compared with glargine U100, with an incremental cost-effectiveness ratio of £984 (increased costs of only £23/year and improvement in participant health of 0.0232 quality-adjusted life-years (QALYs)). In type 2 diabetes mellitus, it was estimated that quality of life was improved (0.0065 QALYs gain) with degludec compared with glargine U100 at an increased annual cost of £117 (incremental cost-effectiveness ratio, £17,939). One-way sensitivity analyses showed that the results were robust to changes in parameters in both type 1 and type 2 diabetes mellitus.ConclusionsThe rigorous design of the SWITCH trials, coupled with a representative patient population and a definition of hypoglycaemia that is relevant for real-world patients, makes the results of these trials highly generalisable. The within-trial analysis has the added value of being able to include doses and event rates directly from the trials. This short-term economic analysis estimated that IDeg would be cost-effective relative to IGlar U100 in both type 1 and type 2 diabetes mellitus in the UK.Trial registrationSWITCH 1 (NCT02034513); SWITCH 2 (NCT02030600).FundingNovo Nordisk, Søborg, Denmark.
| S-EPMC6167291 | biostudies-literature
Project description:INTRODUCTION:To evaluate the efficacy and safety as well as the long-term cost-effectiveness of insulin glargine 100 U/mL (IGlar) versus insulin degludec (IDeg) for the treatment of type 2 diabetes mellitus (T2DM) from the Chinese healthcare system perspective. METHODS:A systematic search of English and Chinese electronic databases for randomized controlled trials (RCTs) comparing IGlar with IDeg for the treatment of T2DM was performed, followed by a meta-analysis to compare the efficacy and safety of IGlar versus IDeg. The CORE Diabetes Model was used to estimate lifetime costs, quality-adjusted life years (QALYs) gained, and cost-effectiveness of IGlar versus IDeg. One-way and probabilistic sensitivity analyses were conducted to assess the underlying parameter uncertainty. RESULTS:Six RCTs were included in the meta-analysis. The IGlar group showed a statistically significant decrease in glycated hemoglobin (HbA1c) from baseline compared to the IDeg group (mean difference [MD] 0.08%, 95% confidence interval [CI] 0.01-0.14%, P = 0.02). Body mass index (BMI) control was numerically better in the IGlar group than in the IDeg group (MD 0.07 kg/m2, 95% CI - 0.01 to 0.14 kg/m2, P = 0.08). In terms of hypoglycemia, the incidence of non-severe overall hypoglycemia was comparable between the IDeg and IGlar patient groups (P > 0.05), while the incidence of non-severe nocturnal hypoglycemia (relative risk [RR 0.79], 95% CI 0.70-0.90, P < 0.01) and the event rates of non-severe overall (RR 0.91, 95% CI 0.85-0.97, P < 0.01) and non-severe nocturnal hypoglycemia (RR 0.91, 95% CI 0.85-0.97, P < 0.01) were lower in the IDeg group. The incidences and event rates of both severe overall and nocturnal hypoglycemia were similar for the two groups (P > 0.05). The cost-effectiveness analysis showed that IGlar is the dominant treatment option compared with IDeg, with a lifetime savings of 1004 Chinese yuan in direct medical costs and a net gain of 0.015 QALYs per patient. Both one-way and probabilistic sensitivity analyses confirmed the robustness of the results. CONCLUSIONS:IGlar is a cost-saving option with incremental effectiveness compared with IDeg for the treatment of T2DM in China. FUNDING:Sanofi China.
| S-EPMC6778565 | biostudies-literature
Project description:BackgroundChronically elevated blood glucose levels are associated with significant morbidity and mortality. Many diabetes patients will eventually require insulin treatment to maintain good glycaemic control. There are still uncertainties about the optimal insulin treatment regimens for type 2 diabetes, but the long-acting insulin analogues seem beneficial. Several reviews have compared either insulin detemir or insulin glargine to NPH insulin, but research directly comparing both insulin analogues is limited.ObjectivesTo assess the effects of insulin detemir and insulin glargine compared with each other in the treatment of type 2 diabetes mellitus.Search strategyWe searched MEDLINE, EMBASE, The Cochrane Library, online registries of ongoing trials and abstract books. Date of last search was January 2011.Selection criteriaAll randomised controlled trials comparing insulin detemir with insulin glargine with a duration of 12 weeks or longer were included.Data collection and analysisTwo authors independently selected the studies and extracted the data. Pooling of studies by means of random-effects meta-analysis was performed.Main resultsThis review examined four trials lasting 24 to 52 weeks involving 2250 people randomised to either insulin detemir or glargine. Overall, risk of bias of the evaluated studies was high. Insulin glargine was dosed once-daily in the evening. Insulin detemir was initiated once-daily in the evening with the option of an additional dose in the morning in three studies and initiated twice-daily in one study. Of randomised patients 13.6% to 57.2% were injecting insulin detemir twice-daily at the end of trial.Glycaemic control, measured by glycosylated haemoglobin A1c (HbA1c) and HbA1c equal to or less than 7% with or without hypoglycaemia, did not differ statistically significantly between treatment groups.The results showed no significant differences in overall, nocturnal and severe hypoglycaemia between treatment groups.Insulin detemir was associated with less weight gain. Treatment with insulin glargine resulted in a lower daily basal insulin dose and a lower number of injection site reactions.There was no significant difference in the variability of FPG or glucose values in 24-hour profiles between treatment groups. It was not possible to draw conclusions on quality of life, costs or mortality. Only one trial reported results on health-related quality of life and showed no significant differences between treatment groups.Authors' conclusionsOur analyses suggest that there is no clinically relevant difference in efficacy or safety between insulin detemir and insulin glargine for targeting hyperglycaemia. However, to achieve the same glycaemic control insulin detemir was often injected twice-daily in a higher dose but with less weight gain, while insulin glargine was injected once-daily, with somewhat fewer injection site reactions.
| S-EPMC6486036 | biostudies-literature
Project description:INTRODUCTION:Insulin degludec (degludec) is a basal insulin with an ultra-long, stable action profile and reduced pharmacodynamic variability. Seven phase 3a trials compared degludec with insulin glargine (glargine). Patient-level meta-analyses were performed to obtain a comprehensive overview of differences between the insulin preparations, possible because consistent outcome definitions were utilized. METHODS:Three categories of trials were analyzed: basal-bolus-treated type 1 diabetes mellitus (T1DMB/B), insulin-naïve type 2 diabetes mellitus (T2DMinsulin-naïve), and basal-bolus-treated T2DM (T2DMB/B). Regression models were adjusted for baseline characteristics. Endpoints analyzed were glycosylated hemoglobin (HbA1c), fasting plasma glucose (FPG), insulin dose and hypoglycemic rates analyzed in mutually exclusive groups: non-severe nocturnal, non-severe daytime, and severe. RESULTS:As with previous treat-to-target trials, reductions in HbA1c were similar between degludec and glargine. Reductions in FPG were significantly greater with degludec in T1DMB/B and T2DMinsulin-naïve. Total daily insulin dose was significantly lower with degludec in T1DMB/B and T2DMinsulin-naïve. Estimated hypoglycemia rate ratios for degludec/glargine were as follows for T1DMB/B, T2DMinsulin-naïve and T2DMB/B, respectively: non-severe nocturnal 0.83, 0.64, 0.75 (all P < 0.05); non-severe daytime 1.14 [not significant (ns)], 0.89 (ns), and 0.83 (P < 0.05). Rate ratios for severe events were 1.12 (ns) (T1DMB/B); 0.14 (P < 0.05) (T2DMinsulin-naïve); and not analyzed (T2DMB/B) due to too few events. CONCLUSIONS:Compared with glargine, degludec is associated with equivalent HbA1c control and significantly lower nocturnal hypoglycemia rates. In T1DMB/B and T2DMinsulin-naïve, degludec is also associated with significantly greater reductions in FPG and lower total doses of insulin versus glargine.
| S-EPMC4269648 | biostudies-literature
Project description:ObjectiveTo evaluate the long-term cost effectiveness of insulin degludec/insulin aspart (IDegAsp) vs. biphasic insulin aspart 30 (BIAsp 30) for the treatment of people with type 2 diabetes mellitus (T2DM) inadequately managed on basal insulin in China.MethodsThe CORE (the Center for Outcomes Research) Diabetes Model, which has been published and verified, was used to simulate disease progression and calculate the total direct medical costs, life years (LYs) and quality-adjusted life years (QALYs) over 30 years, from the perspective of Chinese healthcare system. The patient demographic information and clinical data needed for the model were gathered from a phase III treat-to-target clinical trial (NCT02762578) and other Chinese cohort studies. Medical costs on treating diabetes were calculated based on clinical trial and local sources. The diabetes management and complications costs were derived from published literature. A discounting rate of 5% was applied to both health and cost outcomes. And one-way and probabilistic sensitivity analyses were carried out to test the reliability of the results.ResultsCompared with BIAsp 30, treatment with IDegAsp was associated with an incremental benefit of 0.001 LYs (12.439 vs. 12.438) and 0.280 QALYs (9.522 vs. 9.242) over a 30-year time horizon, and increased CNY (Chinese Yuan) 3,888 (390,152 vs. 386,264) for total costs. IDegAsp was cost-effective vs. BIAsp 30 therapy with an incremental cost-effectiveness ratio of CNY 13,886 per QALY gained. Results were robust across a range of sensitivity analyses.ConclusionCompared with BIAsp 30, IDegAsp was a cost-effective treatment option for people with T2DM with inadequate glycemic management on basal insulin in China.
| S-EPMC9623119 | biostudies-literature
Project description:IntroductionThis study aimed to evaluate the short-term cost-effectiveness of insulin degludec 200 units/mL (degludec) versus insulin glargine 300 units/mL (glargine U300) from a Dutch societal perspective.MethodsA previously published model estimated costs [2018 euros (EUR)] and effectiveness [quality-adjusted life years (QALYs)] with degludec compared with glargine U300 over a 1-year time horizon. The model captured hypoglycaemia rates and insulin dosing. Clinical outcomes were informed by CONCLUDE (NCT03078478), a head-to-head randomised controlled trial in insulin-experienced patients with type 2 diabetes.ResultsTreatment with degludec was associated with mean annual cost savings (EUR 24.71 per patient) relative to glargine U300, driven by a lower basal insulin dose and lower severe hypoglycaemia rate with degludec compared with glargine U300. Lower rates of non-severe nocturnal and severe hypoglycaemia resulted in improved effectiveness (+ 0.0045 QALYs) with degludec relative to glargine U300. In sensitivity analyses, changes to the vast majority of model parameters did not materially affect model outcomes.ConclusionsThis short-term analysis, informed by the latest clinical trial evidence, demonstrated that degludec was a cost-effective treatment option relative to glargine U300. As such, our modelling analysis suggests that degludec would represent an efficient use of Dutch public healthcare resources in this patient population.
| S-EPMC7467476 | biostudies-literature
Project description:In the DEVOTE and SWITCH 2 trials, insulin degludec 100 units/mL (degludec) was superior to insulin glargine 100 units/mL (glargine U100) with respect to the rates of severe (DEVOTE; across trial) and overall symptomatic (SWITCH 2; during the maintenance period of the trial) hypoglycaemia in individuals with type 2 diabetes. In this post hoc analysis, data from 7635 individuals from DEVOTE and 720 individuals from SWITCH 2 were analysed by subgroups of diabetes duration at baseline (<10, ≥10-<15, ≥15-<20 and ≥20 years) using prespecified models from both trials. There was a trend towards lower rates of hypoglycaemia with degludec versus glargine U100 across all diabetes duration subgroups in both trials, with the difference being statistically significant in some subgroups in DEVOTE and SWITCH 2. Overall, however, no significant interaction was observed between diabetes duration and treatment (DEVOTE interaction, P = .496; SWITCH 2 interaction, P = .144). Therefore, in this post hoc analysis of DEVOTE and SWITCH 2, diabetes duration did not appear to affect the reduction in rates of hypoglycaemia observed with degludec compared with glargine U100.
| S-EPMC8286333 | biostudies-literature
Project description:BACKGROUND:Degludec is an ultralong-acting, once-daily basal insulin that is approved for use in adults, adolescents, and children with diabetes. Previous open-label studies have shown lower day-to-day variability in the glucose-lowering effect and lower rates of hypoglycemia among patients who received degludec than among those who received basal insulin glargine. However, data are lacking on the cardiovascular safety of degludec. METHODS:We randomly assigned 7637 patients with type 2 diabetes to receive either insulin degludec (3818 patients) or insulin glargine U100 (3819 patients) once daily between dinner and bedtime in a double-blind, treat-to-target, event-driven cardiovascular outcomes trial. The primary composite outcome in the time-to-event analysis was the first occurrence of an adjudicated major cardiovascular event (death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke) with a prespecified noninferiority margin of 1.3. Adjudicated severe hypoglycemia, as defined by the American Diabetes Association, was the prespecified, multiplicity-adjusted secondary outcome. RESULTS:Of the patients who underwent randomization, 6509 (85.2%) had established cardiovascular disease, chronic kidney disease, or both. At baseline, the mean age was 65.0 years, the mean duration of diabetes was 16.4 years, and the mean (±SD) glycated hemoglobin level was 8.4±1.7%; 83.9% of the patients were receiving insulin. The primary outcome occurred in 325 patients (8.5%) in the degludec group and in 356 (9.3%) in the glargine group (hazard ratio, 0.91; 95% confidence interval, 0.78 to 1.06; P<0.001 for noninferiority). At 24 months, the mean glycated hemoglobin level was 7.5±1.2% in each group, whereas the mean fasting plasma glucose level was significantly lower in the degludec group than in the glargine group (128±56 vs. 136±57 mg per deciliter, P<0.001). Prespecified adjudicated severe hypoglycemia occurred in 187 patients (4.9%) in the degludec group and in 252 (6.6%) in the glargine group, for an absolute difference of 1.7 percentage points (rate ratio, 0.60; P<0.001 for superiority; odds ratio, 0.73; P<0.001 for superiority). Rates of adverse events did not differ between the two groups. CONCLUSIONS:Among patients with type 2 diabetes at high risk for cardiovascular events, degludec was noninferior to glargine with respect to the incidence of major cardiovascular events. (Funded by Novo Nordisk and others; DEVOTE ClinicalTrials.gov number, NCT01959529 .).
| S-EPMC5731244 | biostudies-literature