The Cost-Effectiveness of an Advanced Hybrid Closed-Loop System Compared to Standard Management of Type 1 Diabetes in a Singapore Setting.

Background: Despite advances in technology, glycemic outcomes in people with type 1 diabetes (T1D) remain suboptimal. The MiniMed 780G (MM780G) advanced hybrid closed-loop (AHCL) system is the latest technology for T1D management with established safety and efficacy. This study explores the cost-effectiveness of MM780G AHCL compared against multiple daily injections (MDI) plus intermittently scanned continuous glucose monitor (isCGM). Methods: A cost-utility analysis was conducted, simulating lifetime outcomes for 1000 T1D individuals, with baseline hemoglobin A1c of 8.4%, using the IQVIA Core Diabetes Model (CDM) v9.5. A Singapore health care payer perspective was taken with 2023 costs applied. Treatment effects were taken from the ADAPT study and treatment-related events from a combination of sources. T1D complication costs were derived from local literature, and health state utilities and disutilities from published literature. Scenario analyses and probabilistic sensitivity analyses (PSAs) explored uncertainty. Cost-effectiveness was assessed based on willingness-to-pay (WTP) thresholds set to Singapore Dollars (SGD) 45,000 (United States Dollars [USD] 33,087) per quality-adjusted life year (QALY) and Singapore's gross domestic product (GDP) per capita of SGD 114,165 (USD 83,941) per QALY. Results: A switch from MDI plus isCGM to MM780G resulted in expected gains in life-years (+0.78) and QALYs (+1.45). Cost savings through reduction in T1D complications (SGD 25,465; USD 18,723) partially offset the higher treatment costs in the AHCL arm (+SGD 74,538; +USD 54,805), resulting in an estimated incremental cost-effectiveness ratio of SGD 33,797 (USD 24,850) per QALY gained. Findings were robust, with PSA outputs indicating 81% and 99% probabilities of cost-effectiveness at the stated WTP thresholds. Conclusion: MM780G is a cost-effective option for people with T1D managed in a Singapore setting.

Bariatric surgery for patients with type 2 diabetes mellitus requiring insulin: Clinical outcome and cost-effectiveness analyses.

BACKGROUND: Although bariatric surgery is well established as an effective treatment for patients with obesity and type 2 diabetes mellitus (T2DM), there exists reluctance to increase its availability for patients with severe T2DM. The aims of this study were to examine the impact of bariatric surgery on T2DM resolution in patients with obesity and T2DM requiring insulin (T2DM-Ins) using data from a national database and to develop a health economic model to evaluate the cost-effectiveness of surgery in this cohort when compared to best medical treatment (BMT). METHODS AND FINDINGS: Clinical data from the National Bariatric Surgical Registry (NBSR), a comprehensive database of bariatric surgery in the United Kingdom, were extracted to analyse outcomes of patients with obesity and T2DM-Ins who underwent primary bariatric surgery between 2009 and 2017. Outcomes for this group were combined with data sourced from a comprehensive literature review in order to develop a state-transition microsimulation model to evaluate cost-effectiveness of bariatric surgery versus BMT for patients over a 5-year time horizon. The main outcome measure for the clinical study was insulin cessation at 1-year post-surgery: relative risks (RR) summarising predictive factors were determined, unadjusted, and after adjusting for variables including age, initial body mass index (BMI), duration of T2DM, and weight loss. Main outcome measures for the economic evaluation were total costs, total quality-adjusted life years (QALYs), and incremental cost-effectiveness ratio (ICER) at willingness-to-pay threshold of GBP£20,000. A total of 2,484 patients were eligible for inclusion, of which 1,847 had 1-year follow-up data (mean age of 51 years, mean initial BMI 47.2 kg/m2, and 64% female). 67% of patients no longer required insulin at 1-year postoperatively: these rates persisted for 4 years. Roux-en-Y gastric bypass (RYGB) was associated with a higher rate of insulin cessation (71.7%) than sleeve gastrectomy (SG; 64.5%; RR 0.92, confidence interval (CI) 0.86-0.99) and adjustable gastric band (AGB; 33.6%; RR 0.45, CI 0.34-0.60; p < 0.001). When adjusted for percentage total weight loss and demographic variables, insulin cessation following surgery was comparable for RYGB and SG (RR 0.97, CI 0.90-1.04), with AGB having the lowest cessation rates (RR 0.55, CI 0.40-0.74; p < 0.001). Over 5 years, bariatric surgery was cost saving compared to BMT (total cost GBP£22,057 versus GBP£26,286 respectively, incremental difference GBP£4,229). This was due to lower treatment costs as well as reduced diabetes-related complications costs and increased health benefits. Limitations of this study include loss to follow-up of patients within the NBSR dataset and that the time horizon for the economic analysis is limited to 5 years. In addition, the study reflects current medical and surgical treatment regimens for this cohort of patients, which may change. CONCLUSIONS: In this study, we observed that in patients with obesity and T2DM-Ins, bariatric surgery was associated with high rates of postoperative cessation of insulin therapy, which is, in turn, a major driver of overall reductions in direct healthcare cost. Our findings suggest that a strategy utilising bariatric surgery for patients with obesity and T2DM-Ins is cost saving to the national healthcare provider (National Health Service (NHS)) over a 5-year time horizon.

Hyperglycemia requiring insulin during acute lymphoblastic leukemia induction chemotherapy is associated with increased adverse outcomes and healthcare costs.

BACKGROUND: Hyperglycemia is a complication of induction chemotherapy in 10%-50% of pediatric patients with acute lymphoblastic leukemia (ALL). Though hyperglycemia in ALL patients is usually transient, it may be associated with adverse health outcomes. However, the risk factors for and consequences of hyperglycemia are poorly understood. We hypothesized that hyperglycemia significant enough to require insulin therapy during induction chemotherapy would be associated with increased morbidity and mortality in pediatric ALL patients during induction chemotherapy and in subsequent care. METHODS: We abstracted clinical and resource utilization data from the Pediatric Health Information System (PHIS) database utilizing ICD-9 codes and medication charges. We used logistic regression analysis to predict the development of hyperglycemia. The effects of hyperglycemia on binary and count adverse outcomes following induction chemotherapy were modeled using mixed-effect regression models. RESULTS: An increased risk of hyperglycemia requiring insulin was associated with older age, female sex, higher risk group and trisomy 21. Patients on insulin for hyperglycemia had increased mortality following induction chemotherapy. These patients were more likely to have subsequent infectious complications, need for bone marrow transplant, and risk of disease relapse. They also had greater length of inpatient stay, higher cost of care, and were more likely to require intensive care unit admission during induction chemotherapy. CONCLUSIONS: Hyperglycemia requiring insulin during induction chemotherapy in pediatric ALL is associated with an increased risk of short-term and long-term complications. Prospective studies are needed to analyze formal screening, preventive measures, and optimal management practices for hyperglycemia during ALL induction chemotherapy.

Public financing of human insulins in Brazil: 2009-2017 / Financiamento público de insulinas humanas no Brasil: 2009-2017

ABSTRACT: Background: From 2006 to 2017, the Brazilian federal government provided free of charge traditional insulins for diabetes treatment. This involved public tendering by the Department of Health Logistics of the Ministry of Health (DLOG-MOH) and the reimbursement after direct contracting for supply with commercial private retailers (Brazilian Popular Pharmacy Program - PFPB). Objective: We aim to describe the budget of the Brazilian federal government committed to for the acquisition of insulin, as well as corresponding prices and treatment availability from 2009 to 2017. Methods: Insulin volume and expenditure data were obtained in official administrative databases and in the Electronic System of the Information Service to Citizens. Data were analyzed according to the total provision by the federal government, DLOG-MOH and PFPB. Moreover, data were presented according to insulin type. Volumes were calculated in number of defined daily doses (DDD)/1,000 inhabitants/day. Results: Budgetary commitments due to insulin over nine years amounted to U$1,027 billion in 2017, with an approximate average of U$114.1 million per year. DLOG-MOH was the main insulin provider, despite the increase in PFPB provision along period. DLOG-MOH and PFBP together provided an average of 6.08 DDD/1000 inhabitants/day for nine years. Average prices in PFPB were higher than those in the DLOG series, with a downward trend over the years, narrowing to 2.7 times in 2017, when compared to 2009. Conclusions: Brazil evidenced a moderately sustainable and effective, albeit imperfect, policy for public provision of traditional insulins in the period preceding mandatory free supply of insulin analogues. Future studies must address treatment availability and financial sustainability in the new scenario.

RESUMO: Introdução: Entre 2006 e 2017, o governo federal forneceu gratuitamente insulinas tradicionais para o tratamento de diabetes por meio de licitação pública pelo Departamento de Logística em Saúde do Ministério da Saúde (DLOG-MOH) e reembolso a drogarias privadas credenciadas pelo Programa Farmácia Popular do Brasil (PFPB) após contratação direta para fornecimento. Objetivo: Descrever o orçamento federal brasileiro empenhado pela aquisição de insulinas, bem como preços e disponibilidade de tratamento correspondentes entre 2009 e 2017. Métodos: Dados de despesas e volume de insulina foram obtidos em registros administrativos oficiais e mediante solicitação ao Sistema Eletrônico do Serviço de Informações ao Cidadão. Os dados foram analisados de acordo com a provisão total do governo federal e segundo aquisições via DLOG-MOH e PFPB e tipo de insulina. Os volumes de insulina foram calculados em número de doses diárias definidas (DDD)/1.000 habitantes/dia. Resultados: Em nove anos, o orçamento empenhado com a insulina totalizou US$ 1.027 bilhões em 2017, média de US$ 114,1 milhões/ano. O DLOG-MOH foi o principal fornecedor de insulina apesar do crescimento do PFPB durante o período. O DLOG-MOH e o PFPB disponibilizaram em média 6,08 DDD/1.000 habitantes/dia durante o período analisado. Os preços médios no PFPB foram maiores que os do DOG-MOH ao longo do período, com tendência de queda ao longo dos anos, estreitando-se para 2,7 vezes em 2017 em comparação a 2009. Conclusão: O Brasil evidenciou uma política de fornecimento gratuito de insulina moderadamente sustentável e eficaz, ainda que imperfeita, no período que antecedeu o fornecimento obrigatório de análogos. Recomendam-se estudos futuros para avaliar a disponibilidade de tratamento e a sustentabilidade do financiamento nesse novo cenário.

Clinical and economic outcomes among injection-naïve patients with type 2 diabetes initiating dulaglutide compared with basal insulin in a US real-world setting: the DISPEL Study.

Aims: To report 1-year clinical and economic outcomes from the retrospective DISPEL (Dulaglutide vs Basal InSulin in Injection Naïve Patients with Type 2 Diabetes: Effectiveness in ReaL World) Study. Materials and methods: This observational claims study included patients with type 2 diabetes (T2D) and ≥1 claim for dulaglutide or basal insulin between November 2014 and April 2017 (index date=earliest fill date). Propensity score matching was used to address treatment selection bias. Change from baseline in hemoglobin A1c (HbA1c) was compared between the matched cohorts using analysis of covariance; diabetes-related costs were analyzed using generalized linear models. Results: Matched cohorts (903 pairs total; 523 pairs with complete cost data) were balanced in baseline characteristics with mean HbA1c 8.6%, mean age 54 years. At 1 year postindex, dulaglutide patients had significantly greater reduction in HbA1c than basal insulin (-1.12% vs -0.51%, p<0.01), lower medical costs ($3753 vs $7604, p<0.01), higher pharmacy costs ($9809 vs $6175, p<0.01), and similar total costs ($13 562 vs $13 779, p=0.76). Medical and total costs per 1% HbA1c reduction were lower for dulaglutide than basal insulin (medical: $3128 vs $12 673, p<0.01; total: $11 302 vs $22 965, p<0.01), while pharmacy costs per 1% HbA1c reduction were lower without reaching statistical significance ($8174 vs $10 292, p=0.15). Conclusions: In this real-world study, patients with T2D initiating dulaglutide demonstrated greater HbA1c reduction compared with those initiating basal insulin. Although total diabetes-related costs were similar, the total diabetes-related costs per HbA1c reduction were lower for dulaglutide, highlighting the importance of evaluating effectiveness along with the economic impact of medications.

Effect of Roux-en-Y gastric bypass on pharmacologic dependence in obese patients with type 2 diabetes

Background: More than half the diabetes-related health care costs in Canada relate to drug costs. We aimed to determine the effect of Roux-en-Y gastric bypass (RYGB) on the use of insulin and orally administered hypoglycemic medications in patients with diabetes. We also looked to determine overall cost savings with the procedure. Methods: We reviewed the bariatric clinic records of all patients with a confirmed diagnosis of type 2 diabetes mellitus who underwent RYGB between 2010/11 and 2014/15. Percentage estimated weight loss was recorded at 1 year, along with reductions in glycated hemoglobin (HbA1c) level and use of oral hypoglycemic therapy and insulin. We estimated medication costs using Manitoba-specific pricing data. Results: Fifty-two patients with at least 12 months of complete follow-up data were identified. The mean percentage estimated weight loss was 50.2%. The mean HbA1c level decreased from 7.6% to 6.0%, the mean number of orally administered hypoglycemics declined from 1.6 to 0.2, and the number of patients receiving insulin decreased from 18 (35%) to 3 (6%) (all p < 0.001). The rate of resolution of type 2 diabetes was 71%. Estimated mean annual per-patient medication costs decreased from $508.56 to $79.17 (p < 0.001). Potential overall health care savings could total $3769 per patient in the first year, decreasing to $1734 at 10 years. Conclusion: Roux-en-Y gastric bypass resulted in significant improvement in diabetic control, with a reduction in hypoglycemic medication use and associated costs in the early postoperative period. Potentially, large indirect and direct cost savings can be realized in the longer term.

Contexte: Plus de la moitié des coûts des soins de santé liés au diabète au Canada sont générés par les médicaments. Nous avons voulu déterminer l'effet de la dérivation gastrique de Roux-en-Y sur l'utilisation des agents hypoglycémiants oraux et de l'insuline chez les patients diabétiques. Nous avons aussi cherché à déterminer l'ensemble des économies associées à cette intervention. Méthodes: Nous avons passé en revue les dossiers cliniques bariatriques de tous les patients ayant un diagnostic confirmé de diabète de type 2 qui ont subi une dérivation gastrique de Roux-en-Y entre 2010­2011 et 2014­2015. La perte de poids ­ estimée en pourcentage ­ a été notée après un an, ainsi que les réductions des taux d'hémoglobine glyquée (HbA1c) et du recours aux hypoglycémiants oraux et à l'insuline. Nous avons estimé les coûts des médicaments à partir des données de tarification du Manitoba. Résultats: Cinquante-deux patients pour lesquels on disposait d'au moins 12 mois de données de suivi complètes ont été retenus. La perte de poids moyenne estimée en pourcentage était de 50,2 %. Le taux moyen d'HbA1c a diminué de 7,6 % à 6,0 %, le nombre moyen de comprimés d'hypoglycémiants oraux est passé de 1,6 à 0,2, et le nombre de patients sous insuline a diminué de 18 (35 %) à 3 (6 %) (tous p < 0,001). Le taux de résolution du diabète de type 2 était de 71 %. Le coût annuel moyen estimé des médicaments par patient est passé de 508,56 $ à 79,17 $ (p < 0,001). Les économies potentielles globales pour le système de santé pourraient totaliser 3769 $ par patient au cours de la première année, puis passer graduellement à 1734 $ au cours des 10 années suivantes. Conclusion: La dérivation gastrique de Roux-en-Y a permis d'améliorer significativement le contrôle du diabète, ainsi que de réduire le recours aux hypoglycémiants et les coûts associés au début de la période postopératoire. À plus long terme, d'importantes économies sur le plan des coûts indirects et directs pourraient potentiellement être réalisées.

Utilization patterns of insulin for patients with type 2 diabetes from national health insurance claims data in South Korea.

Type 2 diabetes mellitus (T2DM) is a chronic disease that requires long-term therapy and regular check-ups to prevent complications. In this study, insurance claim data from the National Health Insurance Service (NHIS) of Korea were used to investigate insulin use in T2DM patients according to the economic status of patients and their access to primary physicians, operationally defined as the frequently used medical care providers at the time of T2DM diagnosis. A total of 91,810 participants were included from the NHIS claims database for the period between 2002 and 2013. The utilization pattern of insulin was set as the dependent variable and classified as one of the following: non-use of antidiabetic drugs, use of oral antidiabetic drugs only, or use of insulin with or without oral antidiabetic drugs. The main independent variables of interest were level of income and access to a frequently-visited physician. Multivariate Cox proportional hazards analysis was performed. Insulin was used by 9,281 patients during the study period, while use was 2.874 times more frequent in the Medical-aid group than in the highest premium group [hazard ratio (HR): 2.874, 95% confidence interval (CI): 2.588-3.192]. Insulin was also used ~50% more often in the patients managed by a frequently-visited physician than in those managed by other healthcare professionals (HR: 1.549, 95% CI: 1.434-1.624). The lag time to starting insulin was shorter when the patients had a low income and no frequently-visited physicians. Patients with a low level of income were more likely to use insulin and to have a shorter lag time from diagnosis to starting insulin. The likelihood of insulin being used was higher when the patients had a frequently-visited physician, particularly if they also had a low level of income. Therefore, the economic statuses of patients should be considered to ensure effective management of T2DM. Utilizing frequently-visited physicians might improve the management of T2DM, particularly for patients with a low income.

Should the last be first? Questions and dilemmas regarding early short-term insulin treatment in Type 2 Diabetes Mellitus.

INTRODUCTION: Early short-term insulin treatment (STIT), defined as insulin administration shortly after diabetes diagnosis for only a brief period of time, is an alternative concept, aiming to entirely revise the perspective of type 2 diabetes (T2DM) management. AREAS COVERED: The present review intends to summarize what is already known regarding early STIT in T2DM and highlight questions and dilemmas from the clinician's point of view, with a discourse on future research agenda. EXPERT OPINION: STIT has the potential to modify the natural history of T2DM, resulting in improved drug-free remission rates by favorably affecting the underlying pathophysiology of the disease. Existing data in the field manifest significant weaknesses, mainly being the small number of trials and patients included, the lack of control groups in most studies and the wide heterogeneity between study designs and explored outcomes, which limit definitive conclusions. Therefore, before such a therapeutic strategy is incorporated into daily practice, important issues require further clarification by future trials. These issues include the optimal time point for the intervention, the ideal insulin type, the identification of patients being most likely to benefit, the STIT effects on cardiovascular and other clinical outcomes and the cost-effectiveness evaluation of this therapeutic strategy. ABBREVIATIONS: T2DM: Type 2 Diabetes Mellitus; HbA1C: Hemoglobin A1c; OHA: Oral Hypoglycemic Agents; STIT: Short-term Insulin Treatment; CSII: Continuous Subcutaneous Insulin Infusion; MDI: Multiple Daily Injections; PPG: Postprandial Plasma Glucose; FPG: Fasting Plasma Glucose; HOMA-b: Homeostasis Model Assessment of beta-cell function; TDD: Total Daily Insulin Dose; DI: Disposition Index; HOMA-IR: Homeostasis Model Assessment of Insulin Resistance; ROS: Reactive Oxygen Species; TNF: Tumor Necrosis Factor; GLP-1: Glucagon-like peptide-1; GIP: Glucose-dependent Insulinotropic Polypeptide; BMI: Body Mass Index; CV: Cardiovascular; DR: Diabetic Retinopathy; SU: Sulfonylurea; IGI: Insulinogenic Index.

Insulin prices, availability and affordability: a cross-sectional survey of pharmacies in Hubei Province, China.

BACKGROUND: Poor access to affordable insulin results in serious and needless complications and premature deaths for those with diabetes who need this essential medicine. To help address this issue, we assessed insulin availability, prices, affordability and price components in Hubei Province as China has the heaviest burden of diabetes globally. METHODS: In 2016, insulin availability and price data was collected in the capital and five other cities. A total of 30 public sector outlets (hospitals and primary care institutions) and 30 private pharmacies were sampled, using an adaptation of the World Health Organization/Health Action International methodology, Data was collected for all human and analogue insulins in stock, then analyzed by type (prandial, basal or pre-mixed) and duration of action. Prices were expressed as Median Price Ratios (MPRs) to Australian PBS prices. Price components were tracked for five insulin products in two cities.. Affordability was assessed as the number of days' wages of the lowest paid unskilled government worker needed to purchase 10 ml 100 IU/ml (approximately 30 days' supply). RESULTS: Mean availability was highest in public hospitals for prandial (70%), basal (80%) and pre-mixed insulin (90%). In primary care institutions and private pharmacies mean availability ranged from 10% to 33%. Median prices of all insulin types were higher that Australian PBS prices in all three sectors for human and analogue insulins (ranging from1.36-2.59 times). Patients have to pay 4 to 16 days' wages to purchase a month's treatment depending on the insulin type and sector. The largest component of the patient price was the manufacturers' selling price (60%). Taxes in the form of import duties and VAT are applied in some sectors. CONCLUSIONS: The availability of insulin in primary care institutions and private retail pharmacies was very low in Hubei. Only public hospitals had good insulin availability. Insulin prices were high in all sectors making this life-saving medicine unaffordable, especially for those on low incomes. Governments should consider using its bargaining power to reduce prices, abolish taxes on essential medicines such as insulin, and develop strategies for more equitable access to insulin.

Prospective Study of Postoperative Glycemic Control with a Standardized Insulin Infusion Protocol after Infrainguinal Bypass and Open Abdominal Aortic Aneurysm Repair.

BACKGROUND: The aim of this study is to examine the effect of moderate postoperative glycemic control in diabetic and nondiabetic patients undergoing infrainguinal bypass (INFRA) or open abdominal aortic aneurysm (OAAA) repair. METHODS: In a single center prospective study, we investigated postoperative glycemic control using a standardized insulin infusion protocol after elective INFRA bypass (n = 53, 62%) and OAAA repair (n = 33, 38%) between January 2013 and March 2015. The primary end point was optimal glycemic control, defined as having ≥85% of blood glucose values within the 80-150 mg/dL target range. Suboptimal glycemic control was defined as <85% of blood glucose values within the blood glucose target range. Secondary end points included in-hospital and 30-day surgical site infection (SSI) rates, composite adverse events, length of stay (LOS), and hospital cost. RESULTS: Optimal glycemic control was achieved more commonly after OAAA repair than INFRA bypass (85% vs. 64%, P = 0.04). Moderate hypoglycemia (<70 mg/dL) was observed in 32 (37%) patients, while severe hypoglycemia (<50 mg/dL) was observed in 6 (7%) patients. SSI at 30 days was more common after INFRA bypass (n = 15, 29%) than OAAA repair (n = 2, 6%) (P = 0.01). In-hospital (6% vs. 6%, P = 1.0) and 30-day (24% vs. 22%, P = 1.0) SSI rates were similar for optimal versus suboptimal glycemic control patients after INFRA bypass. In-hospital (4% vs. 0%, P = 1.0) and 30-day (4% vs. 0%, P = 1.0) SSI rates were similar for optimal versus suboptimal glycemic control patients after OAAA repair. The percentage of blood glucose > 250 mg/dL was similar for patients with and without SSI (3% vs. 2%, P = 0.36). Adverse cardiac and pulmonary events after INFRA bypass were similar between groups (9% vs. 21%, P = 0.23; 0% vs. 5%, P = 0.36, respectively). Adverse cardiac and pulmonary events after OAAA repair were similar between groups (2% vs. 0%, P = 1.0; 4% vs. 0%, P = 1.0, respectively). Mean LOS was significantly lower in patients with optimal glycemic control after INFRA bypass (4.2 vs. 7.3 days, P = 0.02). Mean LOS was similar after OAAA repair for patients with optimal and suboptimal control (5.8 vs. 6.4 days, P = 0.46). Inpatient hospital costs after INFRA bypass were lower for the group with optimal (median $25,012, interquartile range [IQ] range $21,726-28,331) versus suboptimal glycemic control (median $28,944, IQ range 24,773-41,270, P = 0.02). CONCLUSIONS: Postoperative hyperglycemia is common after INFRA bypass and OAAA repair and can be effectively ameliorated with an insulin infusion protocol. The protocol was low risk with reduced LOS and cost after INFRA bypass. Complications including SSI were not reduced in patients with optimal perioperative glycemic control.

Evaluating drug cost per responder and number needed to treat associated with lixisenatide on top of glargine when compared to rapid-acting insulin intensification regimens on top of glargine, in patients with type 2 diabetes in the UK, Italy, and Spain.

OBJECTIVES: This study investigated the cost per responder and number needed to treat (NNT) in type 2 diabetes mellitus (T2DM) patients for lixisenatide compared to insulin intensification regimens using composite endpoints in the UK, Italy, and Spain. METHODS: Efficacy and safety outcomes were obtained from GetGoal Duo-2, a 26-week phase 3 trial comparing lixisenatide vs insulin glulisine (IG) once daily (QD) and three times daily (TID). Response at week 26 was extrapolated to 52 weeks, assuming a maintained treatment effect, based on long-term evidence in other T2DM populations. Responders were defined using composite end-points, based on an HbA1c threshold and/or no weight gain and/or no hypoglycemia. The HbA1c threshold was varied in sensitivity analyses. Annual treatment costs were estimated in euros (1 GBP = 1.26 EUR), including drug acquisition and resource use costs. Cost per responder was computed by dividing annual treatment costs per patient by the proportion of responders. RESULTS: Lixisenatide was associated with the lowest cost per responder for all composite end-points that included a weight-related component. For the main composite end-point of HbA1c ≤7.5% AND no weight gain AND no symptomatic hypoglycemia, cost per responder results were: UK: 6,867€, 8,746€, and 12,410€; Italy: 7,057€, 9,160€, and 12,844€; Spain: 8,370€, 11,365€, and 17,038€, for lixisenatide, IG QD, and TID, respectively. The NNT analysis showed that, for every 6.85 and 5.86 patients treated with lixisenatide, there was approximately one additional responder compared to IG QD and TID, respectively. LIMITATIONS: A limitation of the clinical inputs is the lack of 52-week trial data from GetGoal Duo-2, which led to the assumption of a maintained treatment effect from week 26 to 52. CONCLUSIONS: This analysis suggests lixisenatide is an efficient economic resource allocation in the UK, Italy, and Spain.

Healthcare resource utilization and related financial costs associated with glucose lowering with either exenatide or basal insulin: A retrospective cohort study.

AIMS: Type 2 diabetes is a major health problem placing increasing demands on healthcare systems. Our objective was to estimate healthcare resource use and related financial costs following treatment with exenatide-based regimens prescribed as once-weekly (EQW) or twice-daily (EBID) formulations, compared with regimens based on basal insulin (BI). MATERIALS AND METHODS: This retrospective cohort study used data from the UK Clinical Practice Research Datalink (CPRD) linked to Hospital Episode Statistics (HES). Patients with type 2 diabetes who received exenatide or BI between 2009 and 2014 as their first recorded exposure to injectable therapy were selected. Costs were attributed to primary care contacts, diabetes-related prescriptions and inpatient admissions using standard UK healthcare costing methods (2014 prices). Frequency and costs were compared between cohorts before and after matching by propensity score using Poisson regression. RESULTS: Groups of 8723, 218 and 2180 patients receiving BI, EQW and EBID, respectively, were identified; 188 and 1486 patients receiving EQW and EBID, respectively, were matched 1:1 to patients receiving BI by propensity score. Among unmatched cohorts, total crude mean costs per patient-year were £2765 for EQW, £2549 for EBID and £4080 for BI. Compared with BI, the adjusted annual cost ratio (aACR) was 0.92 (95% CI, 0.91-0.92) for EQW and 0.82 (95% CI, 0.82-0.82) for EBID. Corresponding costs for the propensity-matched subgroups were £2646 vs £3283 (aACR, 0.80, 0.80-0.81) for EQW vs BI and £2532 vs £3070 (aACR, 0.84, 0.84-0.84) for EBID vs BI. CONCLUSION: Overall, exenatide once-weekly and twice-daily-based regimens were associated with reduced healthcare resource use and costs compared with basal-insulin-based regimens.

Hospitalization costs and clinical outcomes in CABG patients treated with intensive insulin therapy.

BACKGROUND: The financial impact of intensive (blood glucose [BG] 100-140mg/dl [5.5-7.8mM] vs. conservative (141-180mg/dl (7.9-10.0mM) glucose control in the ICU in patients, with and without diabetes, undergoing coronary artery bypass graft (CABG) surgery is not known. METHODS: This post-hoc cost analysis determined differences in hospitalization costs, resource utilization and perioperative complications in 288 CABG patients with diabetes (n=143) and without diabetes (n=145), randomized to intensive (n=143) and conservative (n=145) glucose control. RESULTS: Intensive glucose control resulted in lower BG (131.4±14mg/dl-(7.2±0.8mM) vs. 151.6±17mg/dl (8.4±0.8mM, p<0.001), a nonsignificant reduction in the median length of stay (LOS, 7.9 vs. 8.5days, p=0.17) and in a composite of perioperative complications including wound infection, bacteremia, acute renal and respiratory failure, major cardiovascular events (42% vs 52%, p=0.10) compared to conservative control. Median hospitalization costs were lower in the intensive group ($39,366 vs. $42,141, p=0.040), with a total cost savings of $3654 (95% CI: $1780-$3723), than conservative control. Resource utilization for radiology (p=0.008), laboratory (p=0.014), consultation service (p=0.013), and ICU utilization (p=0.007) were also lower in the intensive group. Compared to patients without perioperative complications, those with complications had longer hospital length of stay (10.7days vs. 6.7days, p<0.001), higher total hospitalization cost ($48,299 vs. $32,675, p<0.001), and higher resource utilization units (2745 vs. 1710, p<0.001). CONCLUSION: Intensive glycemic control [BG 100-140mg/dl (5.5-7.8mM)] in patients undergoing CABG resulted in significant reductions in hospitalization costs and resource utilization compared to patients treated with conservative [BG 141-180mg/dl (7.9-10.0mM)] glucose control.

The Influence of Varying Cost Formats on Preferences.

BACKGROUND: Numerous studies have found that cost strongly influences patients' decision making. The objective of this study was to explore the impact of varying cost formats on patients' preferences. METHODS: Mechanical Turk workers completed a choice-based conjoint (CBC) survey. The CBC survey was designed to examine stated preferences for the use of second-line agents to treat diabetes across 5 attributes: route of administration, efficacy, risk of low blood sugar, frequency of checking blood sugar levels, and cost. We developed 7 versions of the CBC survey that were identical except for the cost attribute. We described cost in terms of: Affordability, Monthly Co-pay, Dollar Sign Rating, How Expensive, or How Cheap compared with other medications, Working Hours Equivalent (per mo) and Percent of Monthly Income. The resulting part-worth utilities were used to calculate the relative importance of cost and to estimate treatment preferences for exenatide, a sulfonylurea, and insulin. RESULTS: The relative impact of cost varied significantly across the 7 formats. Cost had the greatest influence on participants' decisions when framed in terms of Affordability [mean (SD) relative importance, 37.3 (0.9)] and the lowest influence when framed in terms of How Cheap (compared with other drugs) [12.1 (0.9)]. A sulfonylurea was strongly preferred across 4 of the 7 formats. Preference for insulin, the most effective, albeit riskiest, option was low across all cost formats. CONCLUSIONS: The format used to describe cost affects how the attribute impacts patients' preferences. Individuals are most cost-sensitive when cost is framed in terms of affordability and least cost-sensitive when cost is described in terms of how cheap the medication is compared with others.

Incidence, prevalence, costs and quality of care of type 1 diabetes in Italy, age 0-29 years: The population-based CINECA-SID ARNO Observatory, 2002-2012.

BACKGROUND AND AIMS: To assess temporal trend in incidence (2003-12) and prevalence (2002-12) of type 1 diabetes in children and young adults, direct costs and selected indicators of quality of care under the coverage of the universalistic Italian National Health System (NHS). METHODS AND RESULTS: The ARNO Observatory, a healthcare monitoring system based on administrative data, identified a population-based multiregional cohort of subjects aged 0-29 years. Type 1 diabetes was defined by at least two prescriptions of insulin over 12 months and continuous insulin-treatment in the following year. Indicators of quality of care and directs costs were assessed in persons with diabetes and in people without diabetes, individually matched for age, gender and health unit (1:4 ratio). We identified 2357 incident cases of type 1 diabetes aged 0-29 years (completeness of ascertainment, 99%). Incidence rates were similar in ages 0-14 (15.8, 95% CI 14.9-16.8) and 15-29 years (16.3, 15.4-17.2), with no significant trend. Prevalence increased from 137 to 166.9/100,000, particularly in the age 15-29 years. Direct costs accounted for € 2117 in persons with diabetes and € 292 in control individuals. A statistically significant decreasing trend in hospitalization for acute complications was evident (p < 0.001), which was almost completely due to ketoacidosis. People with at least one HbA1c measurement over the year were 48.5%. CONCLUSION: We showed high incidence and increasing prevalence of type 1 diabetes in young adults in Italy, which impact on direct costs under the universalistic coverage of the NHS.

Pharmaceutical cost and multimorbidity with type 2 diabetes mellitus using electronic health record data.

BACKGROUND: The objective of the study is to estimate the frequency of multimorbidity in type 2 diabetes patients classified by health statuses in a European region and to determine the impact on pharmaceutical expenditure. METHODS: Cross-sectional study of the inhabitants of a southeastern European region with a population of 5,150,054, using data extracted from Electronic Health Records for 2012. 491,854 diabetic individuals were identified and selected through clinical codes, Clinical Risk Groups and diabetes treatment and/or blood glucose reagent strips. Patients with type 1 diabetes and gestational diabetes were excluded. All measurements were obtained at individual level. The prevalence of common chronic diseases and co-occurrence of diseases was established using factorial analysis. RESULTS: The estimated prevalence of diabetes was 9.6 %, with nearly 70 % of diabetic patients suffering from more than two comorbidities. The most frequent of these was hypertension, which for the groups of patients in Clinical Risk Groups (CRG) 6 and 7 was 84.3 % and 97.1 % respectively. Regarding age, elderly patients have more probability of suffering complications than younger people. Moreover, women suffer complications more frequently than men, except for retinopathy, which is more common in males. The highest use of insulins, oral antidiabetics (OAD) and combinations was found in diabetic patients who also suffered cardiovascular disease and neoplasms. The average cost for insulin was 153€ and that of OADs 306€. Regarding total pharmaceutical cost, the greatest consumers were patients with comorbidities of respiratory illness and neoplasms, with respective average costs of 2,034.2€ and 1,886.9€. CONCLUSIONS: Diabetes is characterized by the co-occurrence of other diseases, which has implications for disease management and leads to a considerable increase in consumption of medicines for this pathology and, as such, pharmaceutical expenditure.

Cost-effectiveness of once daily GLP-1 receptor agonist lixisenatide compared to bolus insulin both in combination with basal insulin for the treatment of patients with type 2 diabetes in Norway.

BACKGROUND: Lixisenatide is a potent, selective and short-acting once daily prandial glucagon-like peptide-1 receptor agonist which lowers glycohemoglobin and body weight by clinically significant amounts in patients with type 2 diabetes treated with basal insulin, with limited risk of hypoglycemia. OBJECTIVE: To assess the cost-effectiveness of lixisenatide versus bolus insulin, both in combination with basal insulin, in patients with type 2 diabetes in Norway. METHODS: The IMS CORE Diabetes Model, a non-product-specific and validated simulation model, was used to make clinical and cost projections. Transition probabilities, risk adjustments and the progression of complication risk factors were derived from the UK Prospective Diabetes Study, supplemented with Norwegian data. Patients were assumed to receive combination treatment with basal insulin, lixisenatide or bolus insulin therapy for 3 years, followed by intensification of a basal-bolus insulin regimen for their remaining lifetime. Simulated healthcare costs, taken from the public payer perspective, were derived from microcosting and diagnosis related groups, discounted at 4% per annum and reported in Norwegian krone (NOK). Productivity costs were also captured based on extractions from the Norwegian Labor and Welfare Administration. Health state utilities were derived from a systematic literature review. Sensitivity and scenario analyses were performed. RESULTS: Lixisenatide in combination with basal insulin was associated with increased quality-adjusted life years (QALYs) and reduced lifetime healthcare costs compared to bolus insulin in combination with basal insulin in patients with Type 2 diabetes, and can be considered dominant. The net monetary benefit of lixisenatide versus bolus insulin was NOK 39,369 per patient. Results were sensitive to discounting, the application of excess body weight associated disutility and uncertainty surrounding the changes in HbA1c. CONCLUSIONS: Lixisenatide may be considered an economically efficient therapy in combination with basal insulin in the Norwegian setting, due to cost savings, weight loss and associated gains in health-related quality of life.

Prevalence and treatment costs of type 2 diabetes in Germany and the effects of social and demographical differences.

Treatment costs for type 2 diabetes account for a substantial amount of the expenses for statutory health care funds. Within a study sample of the year 2005, 6.8% of the insured were being treated for type 2 diabetes mellitus. Compared to the non-diabetic insured in the sample, patients included more males and older persons. Employed diabetics also showed lower mean gross salary when compared to the non-diabetic employed of the sample. In 2007, their mean costs for in- and outpatient care and drug prescriptions amounted to 2,622 Euros per patient. The impacts of social and demographical patient characteristics on total treatment costs were measured with a multiple linear regression model, controlling for the hypoglycemic therapy of the patient. Here, the impact of age, gender and intensive insulin therapy became evident. A higher annual salary had a negative, yet non-significant, effect.