A comparison of preferences for two GLP-1 products – liraglutide and exenatide – for the treatment of type 2 diabetes

Abstract

Objective:

To use time trade-off (TTO) to compare patient preferences for profiles of two glucagon-like peptide (GLP-1) products for the treatment of type 2 diabetes (liraglutide and exenatide) that vary on four key attributes – efficacy (as measured by hemoglobin A_1C), incidence of nausea, incidence of hypoglycemia, and dosing frequency (QD vs. BID) – and measure the contribution of those attributes to preferences.

Methods:

A total of 382 people with T2DM were recruited to participate in an internet-based survey consisting of a series of health-related questions, a conjoint exercise and a set of time trade-off items. In the conjoint exercise, respondents were presented with eight pairs of hypothetical GLP-1 profiles, and completed a time-tradeoff exercise for each pair.

Results:

The product profile representing liraglutide was preferred by 96% of respondents and resulted in significantly higher health utilities (0.038) than the product profile representing exenatide (0.978 vs. 0.94, p?<?0.05). Estimated preference scores from the conjoint analysis revealed that efficacy measured by hemoglobin A_1C is the most important attribute, followed by nausea, hypoglycemia, and dosing schedule.

Limitations:

On-line participants may not represent ‘typical’ type 2 diabetes patients, and brief product profiles represented results from clinical trials, not clinical practice

Conclusion:

Based on the four attributes presented, patients prefer liraglutide over exenatide. Preference is based on superior efficacy and less nausea more than less hypoglycemia and once-daily dosing.     

Economic outcomes of exenatide vs liraglutide in type 2 diabetes patients in the United States: results from a retrospective claims database analysis

Abstract

Objective:

The safety and efficacy of the GLP-1 receptor agonists exenatide BID (exenatide) and liraglutide for treating type 2 diabetes mellitus (T2DM) have been established in clinical trials. Effective treatments may lower overall treatment costs. This study examined cost offsets and medication adherence for exenatide vs liraglutide in a large, managed care population in the US.

Methods:

This was a retrospective cohort analysis comprising adult patients with T2DM who initiated exenatide or liraglutide between 1/1/2010 and 6/30/2010 and had 6 months pre-index and post-index continuous eligibility. Patients were propensity score-matched to controls for baseline differences. Medication adherence was measured by proportion of days covered (PDC). Paired t-test and McNemar’s test were used to compare outcomes.

Results:

Matched exenatide and liraglutide cohorts (n?=?1347 pairs) had similar average total 6-month follow-up costs ($6688 vs $7346). However, exenatide patients had significantly lower mean pharmacy costs ($2925 vs $3272, p?<?0.001). Among liraglutide patients, patients receiving the 1.8?mg dose had significantly higher average total costs compared to those receiving the 1.2?mg dose ($8031 vs $6536, p?=?0.026), with higher mean pharmacy costs in the 1.8?mg cohort ($3935 vs $3146, p?<?0.001). There were no significant differences in inpatient or outpatient costs or medication adherence between groups (mean PDC: exenatide 56% vs liraglutide 57%, p?=?0.088).

Limitations:

The study assumed that all information needed for case classification and matching of cohorts was present and not differential across cohorts. The study did not control for covariates that were unavailable, such as HbA1c and duration of diabetes.

Conclusions:

Patients initiating exenatide vs liraglutide for T2DM had similar medication adherence and total healthcare costs; however, exenatide patients had significantly lower total pharmacy costs. Patients prescribed 1.8?mg liraglutide had significantly higher costs compared to those on 1.2?mg.     

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.     

The cost-effectiveness of exenatide twice daily (BID) vs insulin lispro three times daily (TID) as add-on therapy to titrated insulin glargine in patients with type 2 diabetes

Objective: To evaluate the cost-effectiveness of exenatide twice daily (BID) vs bolus insulin lispro three times daily (TID) as add-on therapy when glycemic control is sub-optimal with titrated basal insulin glargine and metformin.

Methods: The analysis was based on the recent 4B Study, which compared exenatide BID and lispro TID as add-on therapies in subjects with type 2 diabetes insufficiently controlled, despite titrated insulin glargine. The Cardiff Diabetes Model was used to simulate patient costs and health benefits beyond the 4B Study. The Swedish healthcare perspective was adopted for this analysis; costs are reported in €EUR to aid interpretation. The main outcome measure was the cost per quality-adjusted life-year (QALY) gained with exenatide BID compared to lispro TID.

Results: Exenatide BID was associated with an incremental cost of €1,270 and a QALY increase of +0.64 compared with lispro TID over 40 years. The cost per QALY gained with exenatide BID compared with lispro TID was €1,971, which is within conventional limits of cost-effectiveness. Cost-effectiveness results were generally robust to alternative assumptions and values for key model parameters.

Limitations: Extrapolation of trial data over the longer term can be influenced by modeling and parameter uncertainty. Cost-effectiveness results were generally insensitive to alternative values of key model input parameters and across scenarios.

Conclusions: The addition of exenatide BID rather than insulin lispro to basal insulin is associated with similar or better clinical outcomes. Illustrated from the Swedish healthcare perspective, analysis with the Cardiff Diabetes Model demonstrated that exenatide BID represents a cost-effective treatment alternative to lispro TID as add-on therapy in type 2 diabetes patients insufficiently controlled on basal insulin.     

Exenatide BID and liraglutide QD treatment patterns among type 2 diabetes patients in Germany

Abstract

Objectives:

This study evaluated patient and prescriber characteristics, treatment patterns, average daily dose (ADD), and glycemic control of patients initiating glucagon-like peptide 1 (GLP-1) receptor agonists in Germany.

Methods:

The LifeLink? EMR-EU database was searched to identify patients initiating exenatide twice daily (BID) or liraglutide once daily (QD) during the index period (January 1, 2009–April 4, 2010). Eligible patients had ≥180 days pre-index history, ≥90 days post-index follow-up, and a pre-index type 2 diabetes diagnosis. Univariate tests were conducted at α?=?0.05.

Results:

Six hundred and ninety-two patients were included (exenatide BID 292, liraglutide QD 400): mean (SD) age 59 (10) years, 59% male. Diabetologists prescribed liraglutide QD to a larger share of patients (65% vs 35% exenatide BID) than non-diabetologists (51% vs 49%). GLP-1 receptor agonist choice was not associated with age (p?=?0.282), gender (p?=?0.960), number of pre-index glucose-lowering medications (2.0 [0.9], p?=?0.159), pre-index HbA1c (8.2 [1.5%], p?=?0.231) or Charlson Comorbidity Index score (0.45 [0.78], p?=?0.547). Mean (SD) ADD was 16.7?mcg (9.2, label range 10–20?mcg) for exenatide BID and 1.4?mg (0.7, label range 0.6–1.8?mg) for liraglutide QD. Among patients with post-index HbA1c tests, mean unadjusted values did not differ between cohorts. Exenatide BID patients were more likely than liraglutide QD patients to continue pre-index glucose-lowering medications (67.1% vs 60.3%, p?=?0.027) or to start concomitant glucose-lowering medications at index (32.2% vs 25.0%, p?=?0.013); exenatide BID patients were less likely to augment treatment with another drug post-index (15.8% vs 22.5%, p?=?0.027).

Limitations:

Results may not be generalizable. Lab measures for clinical outcomes were available only for a sub-set of patients.

Conclusions:

Results suggested that some differences exist between patients initiating exenatide BID or liraglutide QD, with respect to prescribing physician specialty and pre- and post-index treatment patterns. Both GLP-1 receptor agonists showed comparable post-index HbA1c values in a sub-set of patients.     

Real-world rates,predictors, and associated costs of hypoglycemia among patients with type 2 diabetes mellitus treated with insulin glargine: results of a pooled analysis of six retrospective observational studies

Abstract

Objective:

To evaluate the real-world rates of hypoglycemia and related costs among patients with type 2 diabetes mellitus (T2DM) who initiated insulin glargine with either a disposable pen or vial-and-syringe.

Methods:

Pooled data were evaluated from six previously published, retrospective, observational studies using US health plan insurance claims databases to investigate adults with T2DM who initiated insulin glargine. The current study evaluated baseline characteristics, hypoglycemic events, and costs during the 6 months prior to and 12 months following insulin glargine initiation. Comparisons were made between patients initiating treatment with a disposable pen (GLA-P) and vial-and-syringe (GLA-V). Multivariate analyses using baseline characteristics as covariates determined predictors of hypoglycemia after initiating insulin glargine.

Results:

This study included 23,098 patients (GLA-P: 14,911; GLA-V: 8187). Overall annual prevalence of hypoglycemia was low (6.3% overall, 2.2% related to hospital admission or emergency department visit). Prevalence was significantly lower with GLA-P (5.5% vs 7.7%; p?<?0.0001). Furthermore, average glycated hemoglobin HbA1c reduction was higher with GLA-P (?1.22% vs ?0.86%; p?=?0.0012). The average annual hypoglycemia-related cost associated with initiating insulin glargine was $293, with GLA-P being 46% lower than GLA-V ($225 vs $417; p?=?0.001). Patients who had already developed microvascular complications at the time of initiating insulin therapy were at higher risk for developing hypoglycemia.

Limitations:

This study is limited by the use of retrospective data and ICD-9-CM codes, which are subject to coding error. In addition, this pooled analysis used unmatched cohorts, with multivariate regression analyses employed to adjust for between-group differences. Finally, results describe a managed care sample and cannot be generalized to all patients with T2DM.

Conclusions:

Patients with T2DM initiating insulin glargine treatment showed low rates of hypoglycemia, especially when using a disposable pen device. Hypoglycemia-related costs were low, contributing a very small proportion to overall diabetes-related healthcare costs.     

A long-term analysis evaluating the cost-effectiveness of biphasic insulin lispro mix 75/25 and mix 50/50 versus long-acting basal insulin analogs in the United States

Abstract

Objective:

To evaluate the cost-effectiveness of biphasic insulin lispro mix 75/25 (LM75/25) and mix 50/50 (LM50/50) compared with a long-acting analog insulin (LAAI) regimen from the perspective of a US healthcare payer.

Methods:

A published computer simulation model of diabetes was used to evaluate the cost-effectiveness of LM75/25 and LM50/50 vs a LAAI (insulin glargine) from the perspective of a US healthcare payer. Treatment effects in terms of HbA1c benefits were taken from a recent meta-analysis. Direct medical costs including pharmacy, complication, and patient management costs were obtained from published sources. All costs were expressed in 2010 US dollars and future costs and clinical benefits were discounted at 3% per annum. Sensitivity analyses were performed.

Results:

LM75/25 and LM50/50 were associated with improvements in life expectancy of 0.08 and 0.09 years, improvements in quality-adjusted life expectancy of 0.07 quality-adjusted life years (QALYs) and 0.08 QALYs and increases in cost of US$ 1724 and US$ 1720, respectively, when compared with LAAI.

Limitations:

The base case analysis did not capture mild or serious hypoglycemia on the grounds that the hypoglycemia rate odds ratios failed to reach statistical significance in the meta-analysis. In addition, the baseline cohort characteristics were based on an insulin-naïve population, as opposed to the cohorts in the meta-analysis, which were heterogeneous with regard to insulin treatment history.

Conclusions:

Based on a recently published meta-analysis, biphasic analog insulins are likely to improve clinical outcomes and reduce costs vs LAAIs in the long-term treatment of type 2 diabetes patients in the US.     

Cost-effectiveness analysis of exenatide twice daily (BID) vs insulin glargine once daily (QD) as add-on therapy in Chinese patients with Type 2 diabetes mellitus inadequately controlled by oral therapies

Abstract

Objective:

To estimate cost-effectiveness of exenatide twice daily (BID) vs insulin glargine once daily (QD) as add-on therapy in Chinese type 2 diabetes patients not well controlled by oral anti-diabetic (OAD) agents.     

Comparative persistence and adherence with newer anti-hyperglycemic agents to treat patients with type 2 diabetes in the United States

Objectives: Non-adherence and non-persistence to anti-hyperglycemic agents are associated with worse clinical and economic outcomes in patients with type 2 diabetes. This study evaluated treatment persistence and adherence across newer anti-hyperglycemic agents (canagliflozin, dapagliflozin, sitagliptin, saxagliptin, linagliptin, liraglutide, or exenatide).

Methods: This retrospective cohort study of Truven Health Analytics Marketscan databases included adult patients with type 2 diabetes whose first pharmacy claim for a newer anti-hyperglycemic agent was between February 1, 2014 and July 31, 2014. Treatment persistence and adherence were assessed for 12 months after the first claim (post-index). Persistence was defined as no gap ≥90 days between the end of one pharmacy claim and the start of the next pharmacy claim post-index. Adherence used two definitions: proportion of days covered (PDC) and medication possession ratio (MPR). Multivariable analyses of non-persistence (hazard ratios) and adherence (odds ratios) were adjusted for baseline demographics, drug cost, clinical characteristics, and other anti-hyperglycemic agents.

Results: A total of 11,961 patients met all study selection criteria. Persistence rates at 12 months were significantly greater (p?p?=?0.83; PDC?=?0.79) and canagliflozin 300?mg (MPR?=?0.92; PDC?=?0.81) were greater than for the other index anti-hyperglycemic agents (MPR?=?0.33–0.75; PDC?=?0.33–0.72). Consistent results for treatment persistence and adherence were observed in multivariable analyses that were adjusted baseline characteristics.

Conclusions: Canagliflozin was associated with better treatment persistence and treatment adherence compared with other anti-hyperglycemic agents in real-world settings.     

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.     

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.     

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.     

Treatment persistence in attention deficit/hyperactivity disorder: a retrospective analysis of patients initiated on lisdexamfetamine vs other medications

Abstract

Objective:

To compare treatment persistence in attention-deficit/hyperactivity disorder (ADHD) of patients initiated on lisdexamfetamine (LDX) vs other ADHD medications.

Methods:

A large US administrative claims database was used to select ADHD patients who initiated an ADHD medication (index treatment) during/after 2007. Patients were classified, based on age and previous treatment status, as treatment-naïve or previously treated children and adolescents (6–17 years) and treatment-naïve or previously treated adults (18 years and older). Furthermore, patients were classified into seven mutually exclusive treatment groups, based on their index treatment: LDX, atomoxetine (ATX), osmotic-release methylphenidate hydrochloride long-acting (OROS MPH), other methylphenidate/dexmethylphenidate short-acting (MPH SA) and long-acting (MPH LA), and amphetamine/dextroamphetamine short acting (AMPH SA) and long-acting (AMPH LA). Treatment persistence, analyzed through discontinuation (interruption of the index treatment for ≥30 consecutive days), was compared between treatment groups using multivariate Cox proportional hazards. Patients were followed until first treatment discontinuation or up to 12 months after the initiation of the index treatment, whichever occurred first.

Results:

Among children and adolescents, LDX patients had a significantly lower discontinuation rate compared to other treatment groups (range hazard ratios [HRs]; 1.04–2.26; all p?<?0.05), except when compared to treatment-naïve patients on ATX and OROS MPH, where no statistically significant differences were found and where LDX had a higher risk of discontinuation, respectively. Among adults, LDX patients had a significantly lower discontinuation rate compared to patients in other treatment groups (range HR; 1.14–1.86; all p?<?0.05), except for the comparison with AMPH LA patients, where differences were not statistically significant.

Limitations:

This study did not control for ADHD severity.

Conclusion:

LDX-treated patients were associated with higher persistence compared to patients initiated on other ADHD medications, except for the comparisons with OROS MPH and ATX treated patients in treatment-naïve children and adolescents and AMPH LA-treated patients in adults.     

Psychiatric inpatient cost of care before and after admission at a residential subacute step-up/step-down mental health facility

Background: Residential step-up/step-down services provide transitional care and reintegration into the community for individuals experiencing episodes of subacute mental illness. This study aims to examine psychiatric inpatient admissions, length of stay, and per capita cost of care following the establishment of a step-up/step-down Prevention And Recovery Care (PARC) facility in regional Australia.

Methods: This was a pragmatic before and after study set within a participatory action research methodology. The target sample comprised patients at a PARC facility over 15?months. Six-month individual level data prior to study entry, during, and over 6-months from study exit were examined using patient activity records. Costs were expressed in 2015–2016AU$.

Results: An audit included 192 people experiencing 243 episodes of care represented by males (58%), mean age?=?39.3 years (SD?=?12.7), primarily diagnosed with schizophrenia (48%) or mood disorders (30%). The cost of 1?day in a psychiatric inpatient unit was found to be comparable to an average of 5 treatment days in PARC; the mean cost difference per-bed day (AU$1,167) was associated with fewer and shorter inpatient stays. Reduced use of inpatient facility translated into an opportunity cost of improved patient flow equivalent to AU$12,555 per resident (bootstrapped 95% CI?=?$5,680–$19,280). More noticeable outcomes were observed among those who stayed in PARC for longer during index admission (r_s = 0.16, p?=?0.024), who have had more and lengthy inpatient stays (r_s = 0.52, p?r_s = 0.69, p?p?Conclusion: Efforts should be directed toward the adoption of cost-effective alternatives to psychiatric inpatient facilities that provide comparable or improved patient outcomes.     

Cost-effectiveness of insulin degludec compared with insulin glargine in a basal-bolus regimen in patients with type 1 diabetes mellitus in the UK

Abstract

Objective:

The aim of this study was to evaluate the cost-effectiveness of insulin degludec (IDeg) vs insulin glargine (IGlar) as part of a basal-bolus treatment regimen in adults with T1DM, using a short-term economic model.

Methods:

Data from two phase III clinical studies were used to populate a simple and transparent short-term model. The costs and effects of treatment with IDeg vs IGlar were calculated over a 12-month period. The analysis was conducted from the perspective of the UK National Health Service. Sensitivity analyses were conducted to assess the degree of uncertainty surrounding the results. The main outcome measure, the incremental cost-effectiveness ratio (ICER), was the cost per quality-adjusted life-year (QALY).

Results:

IDeg is a cost-effective treatment option vs IGlar in patients with T1DM on a basal-bolus regimen. The base case ICER was estimated at £16,895/QALY, which is below commonly accepted thresholds for cost-effectiveness in the UK. Sensitivity analyses demonstrated that the ICER was stable to variations in the majority of input parameters. The parameters that exerted the most influence on the ICER were hypoglycemia event rates, daily insulin dose, and disutility associated with non-severe nocturnal hypoglycemic events. However, even under extreme assumptions in the majority of analyses the ICERs remained below the commonly accepted threshold of £20,000–£30,000 per QALY gained.

Conclusions:

This short-term modeling approach accommodates the treat-to-target trial design required by regulatory bodies, and focuses on the impact of important aspects of insulin therapy such as hypoglycemia and dosing. For patients with T1DM who are treated with a basal-bolus insulin regimen, IDeg is a cost-effective treatment option compared with IGlar. IDeg may be particularly cost-effective for sub-groups of patients, such as those suffering from recurrent nocturnal hypoglycemia and those with impaired awareness of hypoglycemia.     

The economic impact of insulin-related hypoglycemia in Denmark: an analysis using the Local Impact of Hypoglycemia Tool

Aims: To estimate the direct cost of hypoglycemia in insulin-treated adults with type 1 diabetes (T1DM) and type 2 diabetes (T2DM) in Denmark.

Materials and methods: The Local Impact of Hypoglycemia Tool (LIHT) was used to estimate the costs associated with insulin-related hypoglycemia. Average utilization of healthcare resources, including the costs of pre-hospitalization, hospital admission, healthcare professional contact and follow-up, glucose/glucagon, and extra SMBG tests to monitor blood glucose following an episode, was used to calculate an average cost per severe and per non-severe hypoglycemic episode. The cost per episode was then applied to the rates of severe and non-severe hypoglycemia in people with T1DM and T2DM in Denmark.

Results: The direct cost of insulin-related hypoglycemia in Denmark is DKK 96.2 million per year, which equates to EUR 12.9 million. For people with T1DM prone to severe hypoglycemia (defined as having ≥2 severe episodes in the past year), the cost per person per year increases by DKK 4,155 compared with the T1DM population average, and for people with T2DM prone to non-severe hypoglycemia (defined as having ≥1 non-severe episode in the last 4 weeks), the cost increases by DKK 647 per person per year compared with the T2DM population average.

Conclusions: The LIHT highlights the substantial economic burden of insulin-related hypoglycemia in Denmark, and provides a means to estimate the savings that could be made by lowering hypoglycemia rates. For example, the costs associated with using a new insulin or introducing a patient education program could be offset with the cost saving from reducing hypoglycemia.     

Hospitalization rates in patients switched from oral anti-psychotics to aripiprazole once-monthly: final efficacy analysis

Abstract

Objective:

To compare hospitalization rates in patients with schizophrenia treated prospectively with aripiprazole once-monthly 400?mg (AOM 400; an extended-release injectable suspension) vs the same patients’ retrospective rates with their prior oral anti-psychotic therapy.

Research design and methods:

Multi-center, open-label, mirror-image, naturalistic study in a community setting in North America. Patients who required a change in treatment and/or would benefit from long-acting injectable anti-psychotic therapy were treated prospectively for 6 months with AOM 400. Retrospective data on hospitalization rates were obtained.

Clinical trial registration:

ClinicalTrials.gov: NCT01432444.

Main outcome measures:

The proportion of patients with ≥1 psychiatric inpatient hospitalization with oral anti-psychotic therapy examined retrospectively (months –4 to –1 before oral conversion) and after switching to AOM 400 (months 4–6 after initiating AOM 400).

Results:

Psychiatric hospitalization rates were significantly lower when patients were treated with AOM 400 compared with oral anti-psychotic therapy both in the 3-month primary efficacy sample (2.7% [n?=?9/336] vs 27.1% [n?=?91/336], respectively; p?<?0.0001) and in the total sample (6-month prospective rate: 8.8% [n?=?38/433] vs 6-month retrospective rate: 38.1% [n?=?165/433]; p?<?0.0001). Discontinuations due to adverse events (AEs) during cross-titration were lower in patients cross-titrated on oral aripiprazole for >1 and <4 weeks (2.9% [n?=?7/239]) compared with patients cross-titrated for ≤1 week (10.4% [n?=?5/48]). The most common treatment-emergent AEs during the prospective treatment phase were insomnia (6.7% [n?=?29/431]) and akathisia (6.5% [n?=?28/431]). Patient-rated injection-site pain decreased from the first injection to the last visit.

Conclusions:

In a community setting, patients with schizophrenia demonstrated significantly lower psychiatric hospitalization rates after switching from their prior oral anti-psychotic therapy to AOM 400. Patients served as their own control, and thus an active control group was not included in this study. Confounding factors, such as insurance coverage and availability of hospital beds, were not examined here and deserve further consideration.     

Hypoglycemia: An overview of fear of hypoglycemia,quality-of-life,and impact on costs

Abstract

Background:

The clinical goal in the treatment of diabetes is to achieve good glycemic control. Tight glycemic control achieved with intensive glucose lowering treatment reduces the risk of long-term micro- and macro-vascular complications of diabetes, resulting in an improvement in quality-of-life for the patient and decreased healthcare costs. The positive impact of good glycemic control is, however, counterbalanced by the negative impact of an increased incidence of hypoglycemia.

Methods:

A search of PubMed was conducted to identify published literature on the impact of hypoglycemia, both on patient quality-of-life and associated costs to the healthcare system and society.

Results:

In people with type 1 or type 2 diabetes, hypoglycemia is associated with a reduction in quality-of-life, increased fear and anxiety, reduced productivity, and increased healthcare costs. Fear of hypoglycemia may promote compensatory behaviors in order to avoid hypoglycemia, such as decreased insulin doses, resulting in poor glycemic control and an increased risk of serious health consequences. Every non-severe event may be associated with a utility loss in the range of 0.0033–0.0052 over 1 year, further contributing to the negative impact.

Limitations:

This review is intended to provide an overview of hypoglycemia in diabetes and its impact on patients and society, and consequently it is not a comprehensive evaluation of all studies reporting hypoglycemic episodes.

Conclusion:

To provide the best possible care for patients and a cost-effective treatment strategy for healthcare decision-makers, a treatment that provides good glycemic control with a limited risk of hypoglycemia would be a welcome addition to diabetes management options.