Cost-effectiveness of switching to biphasic insulin aspart from human premix insulin in a US setting

Objectives: To evaluate the cost-effectiveness of switching to biphasic insulin aspart (BIAsp 30) from human premix insulin for type 2 diabetes patients in the United States (US) setting.

Methods: The previously published and validated IMS Core Diabetes Model was used to project life expectancy, quality-adjusted life expectancy (QALE) and costs over 30 years. Patient characteristics and treatment effects were based on Canadian patients included the IMPROVE observational study (n = 311). Mean glycohaemoglobin (HbA_1c) was 8.4%, duration of diabetes 16 years and prevalence of complications high at baseline. Simulations were conducted from the perspective of a third-party payer, with costs accounted in 2008 US dollars ($).

Results: BIAsp 30 was projected to improve life expectancy by 0.202 years and QALE by 0.301 quality-adjusted life-years (QALYs), due to a reduced incidence of most diabetes-related complications. BIAsp 30 was associated with increased lifetime direct medical costs ($76,517 vs. 67,518) and an incremental cost-effectiveness ratio of $29,870 per QALY gained. Long-term outcomes were sensitive to the impact of BIAsp 30 on hypoglycaemia and changes in HbA_1c.

Conclusions: BIAsp 30 may represent a cost-effective treatment option in the US setting for advanced type 2 diabetes patients experiencing poor glycaemic control or hypoglycaemia on human premix insulin.

Limitations: The application of treatment effect data derived from a Canadian cohort to the US setting was a limitation of the cost-effectiveness analysis. The findings of this cost-effectiveness analysis are not applicable to insulin-naïve diabetes patients.     

Healthcare utilization changes in relation to treatment intensification with insulin aspart in patients with type 2 diabetes. Data from a large US managed-care organization

ABSTRACT

Objective: Most patients with type 2 diabetes eventually require exogenous insulin therapy to achieve good glycemic control due to the progressive nature of the disease. Insulin aspart is a rapid-acting insulin analog developed for prandial use. This study aimed to illustrate the implications on healthcare costs of adding insulin aspart to basal therapy in a real-world setting.

Methods: Patients with type 2 diabetes who intensified previous basal therapy with insulin aspart were identified from a large commercial US healthcare data source between April 2007 and September 2008. Patients were required to have received basal insulin treatment with or without concomitant oral antidiabetic (OAD) therapy for at least 90 days pre- and post-initiation of insulin aspart. Wilcoxon signed-rank test and McNemar's test were used for continuous and categorical variables, respectively, to analyze the difference of self-comparison between pre- and post insulin aspart add-on.

Results: In total, 1,739 patients with an average age of 56 years were identified, of whom 55% were male. After initiation of insulin aspart, a significant improvement in glycemic control was observed (change in HbA_1c: –0.5%, p=0.0013). Similarly, a reduction of 0.4% in HbA_1c was observed for the subpopulation of 151 patients, who had both pre-and post-index HbA_1c data (p=0.0085). Also, significantly fewer patients used OADs after insulin aspart initiation (56 vs. 64%, p< 0.0001). Overall and diabetes-related healthcare costs also significantly decreased by $2,283 and $2,028, respectively (p≤0.0001). Diabetes-related inpatient visits appear to be the main contributor to total cost (46%); however, after initiation of insulin aspart the number of inpatient visits decreased by 0.50 visits/patient/year (p< 0.05). This decrease was reflected in a large reduction in cost related to inpatient visits ($3,019/patient).

Limitations: A regression to the mean effect may be associated with this pre-post comparison. The ability to make conclusions regarding cause and effect may be limited due to the retrospective design of this study.

Conclusions: Patients with type 2 diabetes achieved better glycemic control and needed less OAD treatment after adding insulin aspart to previous basal therapy. Furthermore, patients experienced on average reduced healthcare utilization after initiation of insulin aspart, which resulted in significant cost savings.     

Modeling the lifetime costs of insulin glargine and insulin detemir in type 1 and type 2 diabetes patients in Canada: a meta-analysis and a cost-minimization analysis

Abstract

Background:

Two basal insulin analogues, insulin glargine once daily and insulin detemir once or twice daily, are marketed in Canada.

Objective:

To estimate the long-term costs of insulin glargine once daily (QD) versus insulin detemir once or twice daily (QD or BID) for type 1 (T1DM) and type 2 (T2DM) diabetes mellitus from a Canadian provincial government’s perspective.

Methods:

A cost-minimization analysis comparing insulin glargine (IGlarg) to insulin detemir (IDet) was conducted using a validated computer simulation model, the CORE Diabetes Model. Lifetime direct medical costs including costs of insulin treatment and diabetes complications were projected. T1DM and T2DM patients’ daily insulin dose (T1DM: IGlarg QD 26.2?IU; IDet BID 33.6?IU; T2DM: IGlarg QD 47.2?IU; IDet QD 65.7?IU or IDet BID 80.4?IU) was derived from a meta-analysis of randomized trials. All patients were assumed to stay on the same treatment for life. Costs were discounted at 5% per annum and reported in 2010 Canadian Dollars.

Results:

The meta-analysis showed T1DM and T2DM patients had similar HbA_1c change from baseline when receiving IGlarg compared to IDet (T1DM: 0.002%-points; p?=?0.97; T2DM: ?0.05%-points; p?=?0.28). Treatment of T1DM patients with IGlarg versus IDet BID resulted in lifetime cost savings of $4231 per patient. Treatment of T2DM patients with IGlarg resulted in lifetime cost savings of $4659 per patient versus IDet QD and cost savings of $8709 per patient versus IDet BID.

Conclusions:

Similar HbA_1c change from baseline can be achieved with a lower IGlarg than IDet dose. From the perspective of a Canadian provincial government, treatment of T1DM and T2DM patients with IGlarg instead of IDet can generate long-term cost savings. Main limitations include trial data were derived from multi-country studies rather than the Canadian population and self-monitoring blood glucose costs were not included.     

Distribution and drivers of costs in type 2 diabetes mellitus treated with oral hypoglycemic agents: a retrospective claims data analysis

Objective:

To describe the distribution of costs and to identify the drivers of high costs among adult patients with type 2 diabetes mellitus (T2DM) receiving oral hypoglycemic agents.

Methods:

T2DM patients using oral hypoglycemic agents and having HbA1c test data were identified from the Truven MarketScan databases of Commercial and Medicare Supplemental insurance claims (2004–2010). All-cause and diabetes-related annual direct healthcare costs were measured and reported by cost components. The 25% most costly patients in the study sample were defined as high-cost patients. Drivers of high costs were identified in multivariate logistic regressions.

Results:

Total 1-year all-cause costs for the 4104 study patients were $55,599,311 (mean cost per patient?=?$13,548). Diabetes-related costs accounted for 33.8% of all-cause costs (mean cost per patient?=?$4583). Medical service costs accounted for the majority of all-cause and diabetes-related total costs (63.7% and 59.5%, respectively), with a minority of patients incurring >80% of these costs (23.5% and 14.7%, respectively). Within the medical claims, inpatient admission for diabetes-complications was the strongest cost driver for both all-cause (OR?=?13.5, 95% CI?=?8.1–23.6) and diabetes-related costs (OR?=?9.7, 95% CI?=?6.3–15.1), with macrovascular complications accounting for most inpatient admissions. Other cost drivers included heavier hypoglycemic agent use, diabetes complications, and chronic diseases.

Limitations:

The study reports a conservative estimate for the relative share of diabetes-related costs relative to total cost. The findings of this study apply mainly to T2DM patients under 65 years of age.

Conclusions:

Among the T2DM patients receiving oral hypoglycemic agents, 23.5% of patients incurred 80% of the all-cause healthcare costs, with these costs being driven by inpatient admissions, complications of diabetes, and chronic diseases. Interventions targeting inpatient admissions and/or complications of diabetes may contribute to the decrease of the diabetes economic burden.     

Association between glycemic control and short-term healthcare costs among commercially insured diabetes patients in the United States

Abstract Objectives: Glycemic control, measured by HbA(1c), is well known to be a risk marker for long-term costly diabetes-related complications. The relationship between HbA(1c) and short-term costs is unclear. This study investigates how HbA(1c) is correlated to short-term diabetes-related medical expenses. Methods: Patients with diabetes with an HbA(1c) reading ≥6% between April and September 2007 were identified from a large US managed-care organization. Healthcare utilization data was obtained during the subsequent 12-month period. Multivariate analyses were performed to estimate the correlation between HbA(1c) and diabetes-related healthcare costs. Results: In all, 34,469 and 1,837 patients with type 2 and type 1 diabetes, respectively, were identified with an HbA(1c) reading ≥6% (mean HbA(1c): 7.4% and 7.9%). The majority of patients with type 1 diabetes were treated with insulin, while most patients with type 2 diabetes were treated with metformin. The multivariate analysis showed that several characteristics, including HbA(1c), significantly correlate with diabetes-related medical costs for both patients with type 1 and type 2 diabetes. A 1-percentage-point increase in HbA(1c) will, on average, lead to a 6.0% and 4.4% increase in diabetes-related medical costs for type 1 and type 2 diabetes, respectively. This corresponds to an annual cost increase of $445 and $250 for patients with type 1 and type 2 diabetes, respectively. Limitations: Retrospective data analyses inherently associated with selection bias which can only partly be adjusted by statistical techniques. Furthermore, the study population is not necessarily representative of the general population and there can be isolated coding or data errors in the dataset. Conclusions: These results suggest that tighter glycemic control is associated with short-term cost benefits for patients with diabetes. This supplements conventional wisdom that HbA(1c) affects risk of long-term complications and long-term costs.     

Cost-effectiveness of switching to insulin degludec from other basal insulins in real-world clinical practice in Italy

Abstract

Aims: The costs associated with insulin therapy and diabetes-related complications represent a significant and growing economic burden for healthcare systems. The aim of this study was to evaluate the cost-effectiveness of switching to insulin degludec (degludec) vs continuing previous basal insulin, in Italian patients with type 1 (T1D) or type 2 (T2D) diabetes, using a long-term economic model.

Materials and methods: Data were retrieved from a real-world population of patients from clinical practice in Italy. Clinical parameters included in the base-case model were change from baseline in HbA_1c, rates of hypoglycemia, and basal and bolus insulin dose, at 6?months following switch to degludec. Costs of treatments were taken from official Italian pharmaceutical list prices and costs of hypoglycemia were based on the literature. The data were used to populate a long-term (lifetime) IQVIA CORE Diabetes Model to evaluate the incremental cost-effectiveness ratio (ICER) – cost per quality-adjusted life-year (QALY). The robustness of these results was tested with extensive sensitivity analyses by varying the time horizons and abolishing each of the treatment differences and previous basal insulins.

Results: The total incremental cost for degludec vs previous basal insulin was €–6,310 and €–2,682 for patients with T1D and T2D, respectively; the switch to degludec resulted in a QALY gain of 0.781 and 0.628. The long-term ICER for degludec vs continuing the previous basal insulin regimen showed that degludec was dominant for both T1D and T2D, meaning that patient health was improved in terms of QALYs with lower healthcare costs. Sensitivity analyses showed that degludec remained dominant in most scenarios including after elimination of any benefit in non-severe hypoglycemia and insulin dose, in both T1D and T2D.

Conclusions: Under routine care, switching to degludec is dominant, compared with continuing previous basal insulin, in Italian patients with T1D or T2D.     

Cost-effectiveness of insulin detemir compared with NPH insulin in people with type 2 diabetes in Denmark,Finland, Norway,and Sweden

Abstract

Objective:

To assess the cost-effectiveness of insulin detemir compared with Neutral Protamine Hagedorn (NPH) insulin when initiating insulin treatment in people with type 2 diabetes mellitus (T2DM) in Denmark, Finland, Norway, and Sweden.

Methods:

Efficacy and safety data were derived from a 20-week multi-centre randomized controlled head-to-head clinical trial comparing insulin detemir and NPH insulin in insulin naïve people with T2DM, and short-term (1-year) cost effectiveness analyses were performed. As no significant differences in HbA_1c were observed between the two treatment arms, the model was based on significant differences in favour of insulin detemir in frequency of hypoglycaemia (Rate-Ratio?=?0.52; CI?=?0.44–0.61) and weight gain (Δ?=?0.9?kg). Model outcomes were measured in Quality Adjusted Life Years (QALYs) using published utility estimates. Acquisition costs for insulin and direct healthcare costs associated with non-severe hypoglycaemic events were obtained from National Health Service public sources. One-way and probabilistic sensitivity analyses were performed.

Results:

Based on lower incidence of non-severe hypoglycaemic events and less weight gain, the QALY gain from initiating treatment with insulin detemir compared with NPH insulin was 0.01 per patient per year. Incremental cost-effectiveness ratios for the individual countries were: Denmark, Danish Kroner 170,852 (€22,933); Finland, €28,349; Norway, Norwegian Kroner 169,789 (€21,768); and Sweden, Swedish Krona 226,622 (€25,097) per QALY gained. Possible limitations of the study are that data on hypoglycaemia and relative weight benefits from a clinical trial were combined with hypoglycaemia incidence data from observational studies. These populations may have slightly different patient characteristics.

Conclusions:

The lower risk of non-severe hypoglycaemia and less weight gain associated with using insulin detemir compared with NPH insulin when initiating insulin treatment in insulin naïve patients with type 2 diabetes provide economic benefits in the short-term. Based on cost/QALY threshold values, this represents good value for money in the Nordic countries. Using a short-term modelling approach may be conservative, as reduced frequency of hypoglycaemia and less weight gain may also have positive long-term health-related implications.     

The association between the severity of chronic kidney disease and medical costs among patients with type 2 diabetes

Aims: Examine healthcare costs across chronic kidney disease (CKD) stages for US patients with type 2 diabetes (T2D).

Materials and methods: IQVIA Real World Data Adjudicated Claims linked electronic medical records and insurance claims from January 1, 2012 through March 31, 2017 were used for this retrospective study. Adults diagnosed with T2D and comorbid CKD were included. General linear models incorporating splines were constructed, and information from these regressions were used to inform the relationship between medical costs and CKD. Multivariable analyses controlled for patient characteristics, vital signs, general health, prior medication use, prior visit to specialists, index A1c, and year of index date.

Results: There were 6,645 individuals who met the study criteria. Results generally indicate sharp increases in annual total medical costs and non-drug medical costs in the 1?year post-period for patients with Stage 4 or 5 CKD (estimated glomerular filtration rate [eGFR]?≤?30?mL/min/1.73 m²) with each 1 point reduction in eGFR from 30 associated with an increase of $1,870 in all-cause total medical costs (p?<?0.0001) and $1,805 of all-cause non-drug medical costs (p?<?0.0001). Similarly, each point decline below 30?mL/min was associated annual cost increases of $1,701 for CKD-related total medical costs, $1,695 for CKD-related non-drug medical costs, $173 for diabetes-related medical costs, and $187 for diabetes-related non-drug medical costs (all p?<?0.0001).

Limitations: The investigation included only patients with medical insurance and laboratory test results, and results may not be generalizable to all T2D patients with CKD. The methodology allowed us to determine associations, not causation, and potential confounders, such as duration of diabetes, diet, exercise, or social support, could not be assessed.

Conclusions: Results indicate there are sharp and significant increases in medical costs among T2D patients with Stage 4 and 5 CKD compared to those with earlier stages of CKD.     

Long-term cost-consequence analysis of exenatide once weekly vs sitagliptin or pioglitazone for the treatment of type 2 diabetes patients in the United States

Abstract

Objective:

Exenatide once-weekly (ExQW) is a GLP-1 receptor agonist shown to lower glucose and cardiovascular risk factors in patients with type 2 diabetes mellitus (T2DM). The objective of this study was to estimate the clinical benefits and associated economic benefits of treatment with ExQW compared with sitagliptin or pioglitazone in the US.

Methods:

The IMS CORE Diabetes Model, a validated computer simulation model, was used to project lifetime clinical outcomes and complication costs. The costs of glucose-lowering drugs were excluded as not all prices were available. Baseline patient characteristics (mean values: age, 52.5 years; diabetes duration, 6 years; HbA1_c, 8.51%; body mass index, 32.12?kg/m²) and clinical data were derived from a phase 3 clinical trial that compared ExQW with sitagliptin or pioglitazone in T2DM patients. At 6 months, patients treated with ExQW had greater improvements in HbA1_c and body weight than those treated with sitagliptin or pioglitazone. Complication costs were extracted from published sources. Health outcomes and costs were discounted at 3% per year. Sensitivity analyses were performed.

Results:

Over 35 years, and compared with sitagliptin or pioglitazone, ExQW increased life expectancy by, respectively, 0.28 (13.76?±?0.17 vs 13.48?±?0.18) and 0.17 years (13.76?±?0.17 vs 13.59?±?0.17), and quality-adjusted life years by, respectively, 0.28 (9.56?±?0.12 vs 9.28?±?0.12) and 0.24 years (9.56?±?0.12 vs 9.32?±?0.12). ExQW was associated with lower lifetime complication costs: compared with sitagliptin or pioglitazone, ExQW saved, respectively US$2215 (US$55,647?±?2039 vs US$57,862?±?2159) and US$933 (US$55,647?±?2039 vs US$56,580?±?2007) direct cost per patient. Cost-savings resulted mainly from a lower projected cumulative incidence of cardiovascular diseases and neuropathic complications.

Limitations:

Short-term changes in surrogate end-points were used to project lifetime effects on clinical outcomes. Pharmacy costs were excluded from the analyses.

Conclusions:

Over a patient’s lifetime, ExQW was projected to improve health and decrease diabetes-related complication costs compared with sitagliptin or pioglitazone.     

Predictors of glycemic control and diabetes-related costs among type 2 diabetes patients initiating therapy with liraglutide in the United States

Objective:

Liraglutide has been shown to significantly improve glycemic control and reduce body weight while minimizing the risk of hypoglycemia in adult patients with type 2 diabetes (T2D). This study aimed to identify characteristics that predict clinical and economic outcomes associated with liraglutide therapy in clinical practice in the US.

Methods:

Using the Truven Health MarketScan Laboratory Database, glycemic control (A1C <7%) and diabetes-related costs were evaluated in T2D patients initiating liraglutide between January 1, 2010 and June 30, 2012. Patients were required to have ≥1 post-index claim for liraglutide and A1C values at baseline and 6 months follow-up. All valid values of baseline A1C were included. Patients previously treated with GLP-1 receptor agonist(s) or insulin, or with evidence of type 1 diabetes, pregnancy, or gestational diabetes during the study period were excluded. Multivariable regression models were used to identify predictors of glycemic control and diabetes-related costs.

Results:

Of 417 patients newly treated with liraglutide, 54.0% achieved glycemic control (A1C <7%) during follow-up. Factors associated with increased odds of glycemic control during follow-up were: being female, POS/EPO health plan type, baseline A1C, early liraglutide initiation (0–1 prior oral anti diabetics [OADs] vs ≥2), adherence to liraglutide (defined as the proportion of days covered [PDC]), and diabetic retinopathy. Being female, earlier liraglutide initiation (0–1 prior OADs), and higher patient share of liraglutide costs were associated with significantly lower diabetes-related costs during follow-up. Factors associated with significantly higher post-index diabetes-related costs were: higher baseline A1C, baseline use of sulfonylureas, and diabetic retinopathy.

Conclusions:

Within this commercially-insured population of T2D patients treated with liraglutide, gender, baseline A1C, early liraglutide initiation (0–1 prior OADs), diabetic retinopathy, better adherence, and patient share of liraglutide costs were associated with increased odds of achieving glycemic control and the odds of having higher or lower diabetes-related costs.     

Long-term health economic benefits of sensor-augmented pump therapy vs continuous subcutaneous insulin infusion alone in type 1 diabetes: a UK perspective

Aims/hypothesis:

Continuous subcutaneous insulin infusion (CSII) is an important treatment option for type 1 diabetes patients unable to achieve adequate glycemic control with multiple daily injections (MDI). Combining CSII with continuous glucose monitoring (CGM) in sensor-augmented pump therapy (SAP) with a low glucose-suspend (LGS) feature may further improve glycemic control and reduce the frequency of hypoglycemia. A cost-effectiveness analysis of SAP?+?LGS vs CSII plus self-monitoring of blood glucose (SMBG) was performed to determine the health economic benefits of SAP?+?LGS in type 1 diabetes patients using CSII in the UK.

Methods:

Cost-effectiveness analysis was performed using the CORE diabetes model. Treatment effects were sourced from the literature, where SAP?+?LGS was associated with a projected HbA_1c reduction of ?1.49% vs ?0.62% for CSII, and a reduced frequency of severe hypoglycemia. The time horizon was that of patient lifetimes; future costs and clinical outcomes were discounted at 3.5% and 1.5% per annum, respectively.

Results:

Projected outcomes showed that SAP?+?LGS was associated with higher mean quality-adjusted life expectancy (17.9 vs 14.9 quality-adjusted life years [QALYs], SAP?+?LGS vs CSII), and higher life expectancy (23.8 vs 21.9 years), but higher mean lifetime direct costs (GBP 125,559 vs GBP 88,991), leading to an incremental cost-effectiveness ratio (ICER) of GBP 12,233 per QALY gained for SAP?+?LGS vs CSII. Findings of the base-case analysis remained robust in sensitivity analyses.

Conclusions/interpretation:

For UK-based type 1 diabetes patients with poor glycemic control, the use of SAP?+?LGS is likely to be cost-effective compared with CSII plus SMBG.     

Cost-utility of exenatide once weekly compared with insulin glargine in patients with type 2 diabetes in the UK

Abstract

Objective:

To compare the cost-utility of exenatide once weekly (EQW) and insulin glargine in patients with type 2 diabetes in the United Kingdom (UK).

Research design and methods:

The IMS CORE Diabetes Model was used to project clinical and economic outcomes for patients with type 2 diabetes treated with EQW or insulin glargine. Treatment effects and patient baseline characteristics (mean age: 58 years, mean glycohaemoglobin: 8.3%) were taken from the DURATION-3 study. Unit costs and health state utility values were derived from published sources. As the price of EQW is not yet known, the prices of two currently available glucagon-like peptide-1 products were used as benchmarks. To reflect diabetes progression, patients started on EQW switched to insulin glargine after 5 years. The analysis was conducted from the perspective of the UK National Health Service over a time horizon of 50 years with costs and outcomes discounted at 3.5%. Sensitivity analyses explored the impact of changes in input data and assumptions and investigated the cost utility of EQW in specific body mass index (BMI) subgroups.

Main outcome measures:

Incremental cost-effectiveness ratio (ICER) for EQW compared with insulin glargine.

Results:

At a price equivalent to liraglutide 1.2?mg, EQW was more effective and more costly than insulin glargine, with a base case ICER of £10,597 per quality-adjusted life-year (QALY) gained. EQW was associated with an increased time to development of any diabetes-related complication of 0.21 years, compared with insulin glargine. Three BMI subgroups investigated (<30, 30–35 and >35?kg/m²) reported ICERs for EQW compared with insulin glargine ranging from £9425 to £12,956 per QALY gained.

Conclusions:

At the prices investigated, the cost per QALY gained for EQW when compared with insulin glargine in type 2 diabetes in the UK setting, was within the range normally considered cost effective by NICE. Cost effectiveness in practice will depend on the final price of EQW and the extent to which benefits observed in short-term randomised trials are replicated in long-term use.     

An indirect treatment comparison of the efficacy of insulin degludec/liraglutide (IDegLira) and insulin glargine/lixisenatide (iGlarLixi) in patients with type 2 diabetes uncontrolled on basal insulin

Aims: To obtain estimates of the relative treatment effects between insulin degludec/liraglutide (IDegLira) and insulin glargine U100/lixisenatide (iGlarLixi) in patients with type 2 diabetes mellitus (T2DM) uncontrolled on basal insulin therapy.

Materials and methods: Data from phase 3 trials providing evidence for estimating the relative efficacy and safety of IDegLira vs iGlarLixi in patients uncontrolled on basal insulin-only regimens were used in this analysis. Outcomes of interest were changes in HbA_1c, body weight and insulin dose, and rate ratio of hypoglycemia. The indirect comparison of the reported trial findings followed the principles of Bucher et al.

Results: IDegLira was estimated to provide a 0.44 [95% CI?=?0.17–0.71] %-point reduction in HbA_1c compared with iGlarLixi. Body weight was reduced by 1.42 [95% CI?=?0.35–2.50] kg with IDegLira compared with iGlarLixi. Insulin dose was comparable between the two interventions. The rate of severe or blood glucose-confirmed (self-measured plasma glucose [SMPG]?≤?3.1?mmol/L) hypoglycemia with IDegLira was approximately half that of iGlarLixi (rate ratio?=?0.51 [95% CI?=?0.29–0.90]). However, using the American Diabetes Association definition of documented symptomatic hypoglycemia (SMPG ≤3.9?mmol/L) the rate was comparable between the two treatments (rate ratio?=?1.07 [95% CI?=?0.90–1.28]).

Limitations: The assumptions made in the indirect comparison and differences between the included trials in baseline HbA_1c levels, previous use of sulfonylureas, definitions of hypoglycemia, presence or absence of run-in period, the different duration of the trials, and the cross-over design of one of the trials.

Conclusions: The results of this indirect treatment comparison demonstrate that, among patients with T2DM uncontrolled on basal insulin, treatment with IDegLira results in a greater reduction of HbA_1c and a greater reduction in body weight compared with iGlarLixi at similar insulin doses.     

Insulin degludec early clinical experience: does the promise from the clinical trials translate into clinical practice—a case-based evaluation

Abstract

Background:

Clinical experience of patients is an additional source of information that can inform prescribing decisions for new therapies in practice. In diabetes, for example, patients with recurrent hypoglycemia may be excluded from trials conducted for regulatory purposes. Using insulin degludec (IDeg), a new basal insulin with an ultra-long duration of action as an example, an interim analysis is presented describing whether the decision to prescribe IDeg to patients experiencing treatment-limiting problems on their existing insulin regimes represented good clinical and economic value.

Methods:

Records from the first 51 consecutive patients with diabetes (35 type 1 [T1D] and 16 type 2 [T2D]) switching to insulin degludec from either insulin glargine (IGlar) or insulin detemir (IDet), mostly due to problems with hypoglycemia (39/51, 76.5%), were reviewed at up to 37 weeks. Patients indicated frequency of hypoglycemia and completed a disease-specific questionnaire reporting six measures of confidence and treatment satisfaction. For the largest group of exposed patents, the T1D module of the IMS Core Diabetes Model (CDM) was used to evaluate the cost-effectiveness of the treatment decision.

Findings:

HbA_1c decreased by 0.5?±?0.3% points and 0.7?±?0.3% points for T1D and T2D, respectively. Hypoglycemic events decreased by >90%. Combined mean scores were ≥3.7 (1?=?much worse, 3?=?no change, 5?=?much improved) for all six satisfaction and confidence items. In T1D, the treatment decision was highly cost-effective in the CDM lifetime analysis. Even when excluding benefits beyond hypoglycemia reduction, predicted cost per quality-adjusted life-year for IDeg vs IGlar/IDet was £10,754.

Interpretation:

These data illustrate the complementary nature of clinical trial and practice data when evaluating the value of therapeutic innovations in diabetes care. There were reductions in patient-reported hypoglycemia, reduced HbA_1c, and improved treatment satisfaction in relation to the decision to prescribe IDeg. Initial health economic evaluation suggested that the decision to prescribe IDeg in this phenotypic group of T1D patients represented good value for money.     

Examining and interpreting responsiveness of the Diabetes Medication Satisfaction measure

Abstract

Objective: Treatment satisfaction (TS) is an important patient reported outcome (PRO) in diabetes as it is correlated with outcomes necessary for optimal treatment (e.g., compliance, self-management behaviour). The objective of this study was to examine the responsiveness of the DiabMedSat, a disease-specific PRO measure, assessing Overall, Burden, Efficacy and Symptom TS.

Methods: The DiabMedSat was included in an open label, observational study of the safety and efficacy of biphasic insulin aspart 30 (NovoMix 30) in routine practice with type 2 diabetes. Responsiveness analyses, examining both internal and external responsiveness, were conducted and minimally important differences (MID) assessed.

Results: In 18,817 patients, all TS scores significantly improved after 26 weeks of treatment (p<0.001). The effect sizes for these changes were above 0.5 indicating that the ability to detect change was moderate-to-large in size. Significant differences were found for all TS scores comparing patients who met their HbA_1c goal, who improved but did not meet goal and who did not improve (p<0.01), and for patients who experienced a minor hypoglycaemic event and those who did not (p<0.001). DiabMedSat scores were able to detect changes in patients’ own global rating of satisfaction (MID ranging from 5.3 to 11.7) and in physician-rated satisfaction with patients’ HbA_1c improvement (MID ranging from 5.3 to 10.2).

Conclusions: In the context of an observational study, the DiabMedSat has been shown to be highly responsive to change and can be considered as an acceptable PRO measure for TS in diabetes.     

Comparison of utilization,cost, adherence,and hypoglycemia in patients with type 2 diabetes initiating rapid-acting insulin analog with prefilled pen versus vial/syringe

Abstract

Background:

Studies examining outcomes of different insulin delivery systems are limited. The objective of this study was to compare healthcare utilization, costs, adherence, and hypoglycemia rates in patients with type 2 diabetes mellitus (T2DM) initiating rapid-acting insulin analog (RAIA) using prefilled pen versus vial/syringe.

Methods:

A retrospective analysis was conducted using a US claims database (1/1/2007 to 12/31/2008). Inclusion criteria were: ≥18 years old, with T2DM, ≥12 months of continuous eligibility, and new to RAIA. Difference-in-difference analyses after propensity score matching were conducted to compare changes in outcomes from 6 months prior to and 6 months after initiating RAIA with a prefilled pen versus vial/syringe (Wilcoxon rank-sum test for costs and t-test for other outcomes). Categories of utilization and costs (2009 USD) included total and diabetes-related inpatient, outpatient, and emergency room. Adherence was measured by proportion of days covered (PDC). Hypoglycemia was identified using ICD-9-CM codes.

Results:

Baseline characteristics were similar between the prefilled pen (n?=?239) and vial/syringe (n?=?590) cohorts after matching. Adherence to RAIA was greater in the prefilled pen cohort than the vial/syringe cohort (PDC: 54.6 vs. 45.2%, p?<?0.001). While the increase in diabetes-related pharmacy costs from before to after initiating RAIA was greater in the prefilled pen cohort than the vial/syringe cohort (+$900 vs. +$607, p?<?0.001), the prefilled pen cohort was associated with greater reductions in the total diabetes-related costs (–$235 vs. +$61, p?=?0.006) and the utilization of oral anti-hyperglycemic agents (–1.3 vs. –0.7, p?=?0.016). There were no significant differences in other outcomes.

Limitations:

Claims databases do not provide optimal measures for adherence or T2DM severity, and only capture hypoglycemia events requiring clinical intervention.

Conclusion:

Initiating RAIA with a prefilled pen was associated with better adherence and greater reduction in total diabetes-related costs than a vial/syringe. There was no significant difference in total healthcare costs.     

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.