Acute Diabetes Complications After Transition to a Value-Based Medication Benefit.

Importance: The association of value-based medication benefits with diabetes health outcomes is uncertain. Objective: To assess the association of a preventive drug list (PDL) value-based medication benefit with acute, preventable diabetes complications. Design, Setting, and Participants: This cohort study used a controlled interrupted time series design and analyzed data from a large, national, commercial health plan from January 1, 2004, through June 30, 2017, for patients with diabetes aged 12 to 64 years enrolled through employers that adopted PDLs (intervention group) and matched and weighted members with diabetes whose employers did not adopt PDLs (control group). All participants were continuously enrolled and analyzed for 1 year before and after the index date. Subgroup analysis assessed patients with diabetes living in lower-income and higher-income neighborhoods. Data analysis was performed between August 19, 2020, and December 1, 2023. Exposure: At the index date, intervention group members experienced employer-mandated enrollment in a PDL benefit that was added to their follow-up year health plan. This benefit reduced out-of-pocket costs for common cardiometabolic drugs, including noninsulin antidiabetic agents and insulin. Matched control group members continued to have cardiometabolic medications subject to deductibles or co-payments at follow-up. Main Outcomes and Measures: The primary outcome was acute, preventable diabetes complications (eg, bacterial infections, neurovascular events, acute coronary disease, and diabetic ketoacidosis) measured as complication days per 1000 members per year. Intermediate measures included the proportion of days covered by and higher use (mean of 1 or more 30-day fills per month) of antidiabetic agents. Results: The study 10 588 patients in the intervention group (55.2% male; mean [SD] age, 51.1 [10.1] years) and 690 075 patients in the control group (55.2% male; mean [SD] age, 51.1 [10.1] years) after matching and weighting. From baseline to follow-up, the proportion of days covered by noninsulin antidiabetic agents increased by 4.7% (95% CI, 3.2%-6.2%) in the PDL group and by 7.3% (95% CI, 5.1%-9.5%) among PDL members from lower-income areas compared with controls. Higher use of noninsulin antidiabetic agents increased by 11.3% (95% CI, 8.2%-14.5%) in the PDL group and by 15.2% (95% CI, 10.6%-19.8%) among members of the PDL group from lower-income areas compared with controls. The PDL group experienced an 8.4% relative reduction in complication days (95% CI, -13.9% to -2.8%; absolute reduction, -20.2 [95% CI, -34.3 to -6.2] per 1000 members per year) compared with controls from baseline to follow-up, while PDL members residing in lower-income areas had a 10.2% relative reduction (95% CI, -17.4% to -3.0%; absolute, -26.1 [95% CI, -45.8 to -6.5] per 1000 members per year). Conclusions and Relevance: In this cohort study, acute, preventable diabetes complication days decreased by 8.4% in the overall PDL group and by 10.2% among PDL members from lower-income areas compared with the control group. The results may support a strategy of incentivizing adoption of targeted cost-sharing reductions among commercially insured patients with diabetes and lower income to enhance health outcomes.

Utilization and cost of drugs for diabetes and its comorbidities and complications in Kuwait.

BACKGROUND: Diabetes imposes a large burden on countries' healthcare expenditures. In Kuwait, diabetes prevalence in adults is estimated at 22.0%%-double the worldwide prevalence (9.3%). There is little current data on pharmaceutical costs in Kuwait of managing diabetes and diabetes-related complications and comorbidities. OBJECTIVES: Estimate the utilization and cost of drugs for diabetes and diabetes-related complications and comorbidities in Kuwait for year 2018, as well determinants of costs. METHODS: This cross-sectional study used a multi-stage stratified sampling method. Patients were Kuwaiti citizens with diabetes, aged 18-80, recruited from all six governorates. Physicians collected demographic data, clinical data, and current drug prescription for each patient which was extrapolated for the full year of 2018. A prevalence-based approach and bottom-up costing were used. Data were described according to facility type (primary care vs. hospital). A generalized linear model with log function and normal distribution compared drug costs for patients with and without comorbidities/complications after adjustments for demographic and health confounders (gender, age group, disease duration, and obesity). RESULTS: Of 1182 diabetes patients, 64.0% had dyslipidemia and 57.7% had hypertension. Additionally, 40.7% had diabetes-related complications, most commonly neuropathy (19.7%). Of all diabetes patients, 85.9% used oral antidiabetics (alone or in combinations), 49.5% used insulin alone or in combinations, and 29.3% used both oral antidiabetics and insulin. The most frequently used oral drug was metformin (75.7%), followed by DPP4 inhibitors (40.2%) and SGLT2 inhibitors (23.8%). The most frequently used injectables were insulin glargine (36.6%), followed by GLP-1 receptor agonists (15.4%). Total annual drug cost for Kuwait's diabetic population for year 2018 was US$201 million (US$1,236.30 per patient for antidiabetics plus drugs for comorbidities/complications). CONCLUSIONS: Drug costs for treating diabetes and comorbidities/complications accounted for an estimated 22.8% of Kuwait's 2018 drug expenditures. Comorbidities and complications add 44.7% to the average drug cost per diabetes patient.

Antidiabetic Therapy and Rate of Severe Hypoglycaemia in Patients with Type 2 Diabetes and Chronic Kidney Disease of Different Stages - A Follow-up Analysis of Health Insurance Data from Germany.

BACKGROUND: The presence of chronic kidney disease (CKD) influences the type of antiglycaemic therapy and the risk for hypoglycaemia. METHODS: In 2006, 2011 and 2016 health insurance data of people with diabetes type 2 were screened for CKD and the presence of severe hypoglycaemia (sHypo). The type of antihyperglycaemic therapy was recorded due to Anatomical Therapeutic Chemical (ATC) codes up to 3 months before suffering sHypo. RESULTS: The prevalence of CKD increased from 5.3% in 2006 to 7.3% in 2011 and 11.2% in 2016. Insulin-based therapies were used in 39.0, 39.1, and 37.9% of patients with, but only in 17.7, 17.4, and 18.8% of patients without CKD. Although the proportion of the CKD stages 1, 2 and 5 decreased, CKD stages 3 and 4 increased. The proportion of sHypo in CKD declined from 2006 (3.5%) to 2011 (3.0%) and 2016 (2.2%) but was still more than 10 times higher as compared to type 2 diabetic patients without CKD (0.3/0.2/0.2%) conferring a significantly higher probability of sHypo (OR 9.30, 95%CI 9.07-9.54) in CKD. The probability of sHypo was significantly lower in 2016 than in 2006 both in patients with (OR 0.58; CI 0.55-0.61) and without CKD (OR 0.70; CI 0.68-0.73). CONCLUSION: The prevalence of CKD increased from 2006 to 2016. Patients with CKD exhibited a 9-fold increased probability of sHypo, especially in patients treated with insulin plus oral anti-diabetic drugs. However, the rate and risk for sHypo decreased over time, probably as a consequence of new antidiabetic treatment options, better awareness of sHypo, and changed therapy goals.

Gold nanoparticles as a promising treatment for diabetes and its complications: Current and future potentials

Diabetes and its complications represent a major cause of morbidity and mortality in diabetes patients. This review is aimed to find the potential of gold nanoparticles (AuNPs) to act as therapeutic agents for diabetes and its complications. Here, we outline the literature related to the self-therapeutic effects of AuNPs. The first goal of this review is to highlight and summarize some of the existing studies (10 years ago) in terms of several parameters such as the size of AuNPs, dose, administration route, experimental model, experimental analysis, and findings. The second goal is to describe the self-therapeutic effects of AuNPs against the pathogenesis determinants of diabetic complications. AuNPs have been found to have inhibitory effects on transforming growth factor-ß, antiglycation, antiangiogenic, anti-hyperglycemic, anti-inflammatory, and antioxidant effects. AuNPs treatment effectively disrupts multiple pathogenesis determinants in an animal model of diabetes and diabetic complications. The present review provides insight into the potential applications of AuNPs, which may help reduce the incidence of diabetes and its complications

Opioid dispensing among adult Medicaid enrollees by diabetes status.

OBJECTIVE: Diabetes disproportionately affects low-income individuals, many of whom are covered by Medicaid. Comorbidities and complications of diabetes can lead to chronic pain; however, little is known about opioid use patterns among Medicaid enrollees with diabetes. This study examined opioid dispensing among Medicaid enrollees by diabetes status. METHODS: Medicaid claims data from 2014 were used to examine opioid dispensing by diabetes status among 622,992 adult enrollees aged 19-64 years. A logistic model adjusting for demographics and comorbidities was used to examine the association between diabetes and opioid dispensing among enrollees. Analyses were completed in 2019. RESULTS: Overall, 61.6% of enrollees with diabetes filled at least one opioid prescription compared to 31.8% of enrollees without diabetes. A higher proportion of enrollees with diabetes had long-term opioid prescriptions (>90 days' supply) (with diabetes: 51.0% vs. without: 32.1%, p < .001). Characteristics of individual prescriptions, including daily morphine milligram equivalents (45.9 vs. 49.4), formulation (percent short-acting: 91.5% vs. 90.7%), and type of opioids (i.e. percent hydrocodone: 46.7 vs. 45.3), were similar for those with and without diabetes. After adjustment, enrollees with diabetes were 1.43 times more likely to receive an opioid prescription compared to those without (95% CI, 1.40-1.46). CONCLUSIONS: Medicaid enrollees with diabetes were prescribed opioids more frequently and were more likely to have longer opioid supply than enrollees without diabetes. For practitioners who care for patients with diabetes, aligning pain management approaches with evidence-based resources, like the CDC Guideline for Prescribing Opioids for Chronic Pain, can encourage safer opioid prescribing practices.

Cost-effectiveness of ranibizumab and aflibercept to treat diabetic macular edema from a US perspective: analysis of 2-year Protocol T data.

Aims: Protocol T (NCT01627249) was a head-to-head study conducted by the Diabetic Retinopathy Clinical Research Network that compared intravitreal aflibercept, bevacizumab, and ranibizumab for the treatment of diabetic macular edema (DME). A cost-effectiveness analysis accompanying the 1-year data of Protocol T revealed that aflibercept was not cost-effective vs ranibizumab for all patients, but could have been cost-effective in certain patient sub-groups if the 1-year results were extrapolated out to 10 years. The present study evaluated the cost-effectiveness of US Food and Drug Administration-approved anti-vascular endothelial growth factor agents (ranibizumab, aflibercept) for treatment of DME using the 2-year data from Protocol T.Methods: Costs of aflibercept 2.0 mg or ranibizumab 0.3 mg, visual acuity (VA)-related medical costs, and quality-adjusted life-years (QALYs) were simulated for eight VA health states. Treatment, adverse event management, and VA-related healthcare resource costs (2016 US dollars) were based on Medicare reimbursement and published literature. VA-related health utilities were determined using a published algorithm. Patients were stratified by baseline VA: 20/40 or better; 20/50 or worse.Results: Total 2-year costs were higher, and QALYs similar, for aflibercept vs ranibizumab in the full cohort ($44,423 vs $34,529; 1.476 vs 1.466), 20/40 or better VA sub-group ($40,854 vs $31,897; 1.517 vs 1.519), and 20/50 or worse VA sub-group ($48,214 vs $37,246; 1.433 vs 1.412), respectively. Incremental cost-effectiveness ratios in the full cohort and 20/50 or worse VA sub-group were $986,159/QALY and $523,377/QALY, respectively. These decreased to $711,301 and $246,978 when analyses were extrapolated to 10 years.Limitations: Key potential limitations include the fact that VA was the only QALY parameter analyzed and the uncertainty surrounding the role of better- and worse-seeing eye VA in overall functional impairment.Conclusions: This analysis suggests that aflibercept is not cost-effective vs ranibizumab for patients with DME, regardless of baseline vision.

The impact of anti-vascular endothelial growth factor agents on visual impairment/blindness prevention in patients with diabetic macular edema and on associated patient and caregiver burden in Japan.

AIMS: To estimate the impact of anti-vascular endothelial growth factor (VEGF) agents on visual impairment and blindness avoided in patients with diabetic macular edema (DME) and on associated patient and caregiver productivity loss in Japan. METHODS: This study compared the impact of current care (estimated at 53.8% utilization of anti-VEGF agents using current data) with that of hypothetical care (characterized by a higher utilization of anti-VEGF agents [80.0%], as estimated by an expert panel) of DME patients. A population-based Markov model (two-eye approach) simulated visual acuity (Early Treatment Diabetic Retinopathy Study [ETDRS] letters) transitions over 5 years with DME treatments (intravitreal aflibercept, ranibizumab, and triamcinolone acetonide, and grid/focal laser) in patients with DME. Patient and caregiver productivity loss was determined using the human capital method. RESULTS: In total, 570,000 DME patients were included in the model over 5 years. Increased utilization of anti-VEGF agents resulted in 6,659 fewer cases of severe visual impairment (SVI; 26-35 ETDRS letters) or blindness (0-25 ETDRS letters) compared with the current care approach (26,023 vs 32,682 cases; 20.38% reduction) over this period. Increased utilization of anti-VEGF agents also contributed to productivity loss savings of ¥12.58 billion (US $115.64 million) (i.e., 17.01%) at the end of year 5. The total overall saving over 5 years was ¥45.83 billion (US $421.27 million) (13.45%). LIMITATIONS: Few Japanese data were available, and assumptions were made for some inputs. Vision changes dependent on the function of both eyes were not studied. Only intravitreal (not sub-Tenon's) injections of triamcinolone were considered in this model. Direct costs were not considered. CONCLUSIONS: Increased utilization of anti-VEGF agents can reduce SVI and legal blindness in patients with DME in Japan. This would also be associated with substantial savings in patient and caregiver productivity loss.

Budget impact analysis of dexamethasone intravitreal implant for the treatment of diabetic macular oedema.

OBJECTIVE: To assess the economic impact following the inclusion of an intravitreal implant of dexamethasone for the treatment of diabetic macular oedema in a healthcare area in Spain. METHOD: A 3-year budget impact model was designed to estimate healthcare  direct costs for adult patients with diabetic macular oedema from the National  Health System perspective. The approved therapies in use  (aflibercept/ranibizumab/dexamethasone) were considered. The target  population was estimated from published diabetic macular oedema prevalence  (6.41%) and incidence (0.82%) for a population of 25,000 adults.  Dexamethasone was assumed to be used annually in 20%, 30% and 40% of  patients, respectively. Annual total costs included: drug acquisition (based on  frequency of injections per every year, considering exfactory prices with  mandatory deduction and split of vials), intravitreal administration, patient  monitoring, management of cardiovascular and ocular adverse events  (cataracts, increased intraocular pressure, endophthalmitis, vitreous  haemorrhage and retinal detachment). Detailed resource consumption reflecting  clinical practice was provided from local experts in retina and vitreous. Unitary  costs (€, 2016) were obtained from national databases and literature. Sensitivity  analyses were performed to assess model robustness. RESULTS: The inclusion of intravitreal dexamethasone implant would lead to  annual cost savings of €35,030 (-4.2%), €10,743 (-1.8%) and €5,051 (-0.9%), years 1-3 respectively. Total costs were reduced mainly by the fewer annual  injections required by dexamethasone. The average annual incremental costs  were -€350, -€96 and -€41 per patient. CONCLUSIONS: The inclusion of an intravitreal dexamethasone implant for the  treatment of diabetic macular oedema would lead to cost-savings for the  considered health area, mainly by reducing the administration costs.

Objetivo: Determinar el impacto económico tras la inclusión del implante intravítreo de dexametasona para el tratamiento del edema macular diabético en un área sanitaria en España.Método: Se diseñó un modelo de impacto presupuestario a tres años para  estimar los costes directos en pacientes adultos con edema macular diabético,  desde la perspectiva del Sistema Nacional de Salud, considerando terapias  intravítreas actualmente utilizadas (aflibercept/ranibizumab/dexametasona). La  población diana se obtuvo a partir de la prevalencia (6,41%) e incidencia  (0,82%) del edema macular diabético publicadas para una población de 25.000  pacientes adultos. Se asumió un 20%, 30% y 40% anual de pacientes tratados  con dexametasona, respectivamente. El coste total incluyó: coste farmacológico  (precio de venta del laboratorio con deducción obligatoria y fraccionamiento de  viales, según frecuencia de inyecciones necesarias cada año de tratamiento),  administración intravítrea, seguimiento de pacientes y manejo de eventos  oculares (cataratas, hipertensión ocular, endoftalmitis, hemorragia intravítrea y  desprendimiento de retina) y cardiovasculares. El consumo de recursos según la  práctica habitual fue estimado por expertos en retina y vítreo. Los costes  unitarios (€, 2016) se obtuvieron de la literatura y de bases de datos nacionales.  Los análisis de sensibilidad evaluaron la robustez del modelo. Resultados: La inclusión del implante intravítreo de dexametasona supondría reducciones de 35.030 € (­4,2%), 10.743 € (­1,8%) y 5.051 € (­ 0,9%) cada año, respectivamente, disminuyendo principalmente por el menor  número anual de inyecciones requeridas con dexametasona. La reducción anual  promedio supondría 350 €, 96 € y 41 € por paciente.Conclusiones: La inclusión del implante intravítreo de dexametasona para el  tratamiento del edema macular diabético supone ahorros para el área sanitaria  considerada, fundamentalmente por la reducción de costes de administración.

Assessment of drug related problems among type 2 diabetes mellitus patients with hypertension in Hiwot Fana Specialized University Hospital, Harar, Eastern Ethiopia.

OBJECTIVE: This study was conducted to assess magnitude and pattern of drug related problems among patients with type 2 diabetes mellitus (T2DM) and hypertension. RESULTS: This study identified 364 drug related problems (DRPs) across the three categories of drug related problems, giving an average of 1.8 DRPs per patient. The effect of drug treatment being not optimal 179 (49.2%), untreated indication and symptoms 77 (21.1%), unnecessary drug-treatment 39 (10.7%) and adverse drug reactions 69 (19%) were the most frequent categories of DRPs identified. In general, high prevalence of drug-related problems was identified among patients with T2DM hypertension. The effect of drug treatment being not optimal, untreated indication and symptoms, unnecessary drug-treatment and adverse drug reactions were the most frequent categories of drug related problems identified. Therefore, the clinicians should work to improve patient care through prevention and resolving drug related problems since it can affect the quality of the care significantly.

Evaluation of the Long-Term Impact of Improving Care for People with Type 2 Diabetes in China.

BACKGROUND: The member states of the United Nations launched 17 sustainable development goals (SDGs) as part of the 2030 Sustainable Development Agenda. SDG target 3.4 focused on reducing premature mortality from noncommunicable diseases by one-third by 2030 through prevention and treatment and promoting mental health and well-being. Diabetes is associated with significant clinical and economic burden in China. OBJECTIVES: To examine the impact of improving care for people with diabetes in China, and how this relates to achieving SDG target 3.4. METHODS: Long-term outcomes were projected for people with type 2 diabetes meeting treatment targets recommended by the Chinese Diabetes Society versus remaining at current care. Baseline characteristics were taken from the China Noncommunicable Disease Surveillance Study. Costs of treating diabetes-related complications were accounted in 2015 Chinese yuan (CNY). Outcomes were discounted at 3% annually when appropriate. RESULTS: Bringing people with diabetes to treatment targets was associated with improved mean undiscounted life expectancy compared with current care (by 0.42 years). Nationally, discounted cost savings of up to CNY540 billion could be generated as a result of reduced onset of diabetes-related complications if all people with diabetes achieved treatment targets. Bringing people to treatment targets reduced premature mortality from diabetes by 6% compared with current care. CONCLUSIONS: Long-term projections suggested that bringing people with diabetes to treatment targets resulted in improved life expectancy and significant cost savings. However, this was not sufficient to meet SDG target 3.4, indicating that diabetes prevention should form a key objective in China.

Comparative Assessment of Tedizolid Pharmacokinetics and Tissue Penetration between Diabetic Patients with Wound Infections and Healthy Volunteers via In Vivo Microdialysis.

Herein, we present pharmacokinetic and tissue penetration data for oral tedizolid in hospitalized patients with diabetic foot infections (DFI) compared with healthy volunteers. Participants received oral tedizolid phosphate 200 mg every 24 h for 3 doses to achieve steady state. A microdialysis catheter was inserted into the subcutaneous tissue near the margin of the wound for patients or into thigh tissue of volunteers. Following the third dose, 12 blood and 14 dialysate fluid samples were collected over 24 h to characterize tedizolid concentrations in plasma and interstitial extracellular fluid of soft tissue. Mean ± standard deviation (SD) tedizolid pharmacokinetic parameters in plasma for patients compared with volunteers, respectively, were as follows: maximum concentration (Cmax), 1.5 ± 0.5 versus 2.7 ± 1.1 mg/liter (P = 0.005); time to Cmax (Tmax) (median [range]), 5.9 (1.2 to 8.0) versus 2.5 (2.0 to 3.0 h) (P = 0.003); half-life (t1/2), 9.1 ± 3.6 versus 8.9 ± 2.2 h (P = 0.932); and plasma area under the concentration-time curve for the dosing interval (AUC p ), 18.5 ± 9.7 versus 28.7 ± 9.6 mg · h/liter (P = 0.004). The tissue area under the concentration-time curve (AUC t ) for the dosing interval was 3.4 ± 1.5 versus 5.2 ± 1.6 mg · h/liter (P = 0.075). Tissue penetration median (range) was 1.1 (0.3 to 1.6) versus 0.8 (0.7 to 1.0) (P = 0.351). Despite lower plasma Cmax and delayed Tmax values for patients with DFI relative to healthy volunteers, the penetration into and exposure to tissue were similar. Based on available pharmacodynamic thresholds for tedizolid, the plasma and tissue exposures using the oral 200 mg once-daily regimen are suitable for further study in treatment of DFI.

Patients lacking glycemic control place more burdens on health services with the use of medications.

INTRODUCTION: DM spending in the world is high, and Brazilian studies of public spending caused by DM are scarce. OBJECTIVE: To estimate the annual direct cost for the municipal health sphere, related to DM2 treatment, in patients with and without glycemic control. METHOD: A cross-sectional study carried out in a city in the interior of Minas Gerais state, with patients with DM2, being municipal PHS users. Data were collected from the computerized system of the municipality and patient records, and analyzed using the IBM SPSS v.19 statistical package. The response variable was categorized into controlled A1c (≤7%) and uncontrolled A1c (>7%). RESULTS: Glycemic control in 56.6% of the patients was unsatisfactory; the mean cost of pharmacotherapy for DM2 was US$ 3.14 per year for patients in the control group and US$ 45.54 per year for uncontrolled patients. CONCLUSION: Patients with unsatisfactory glycemic control are more expensive for the municipal health system.

[Do Turkish reimbursement recommendations cover current European Lipid Guidelines? A retrospective analysis of patients presenting with first acute coronary syndrom]. / Türkiye'de geri ödeme önerileri mevcut Avrupa Lipid Kilavuzlari'ni kapsiyor mu? Ilk akut koroner sendrom ile basvuran hastalarin geriye dönük incelenmesi.

OBJECTIVE: This study was a comparison of the statin therapy protocol issued by the European Society of Cardiology (ESC) and the Ministry of Health's Health Implementation Directive (SUT) in Turkey, performed in order to assess the adequacy of hyperlipidemia treatment indications for primary prevention. METHODS: A total of 582 patients with first acute coronary syndrome were included in the study. Patients with noncritical stenosis observed on coronary angiography or a history of atherosclerotic disease were excluded. The risk calculation was determined using age, sex, smoking status, presence of diabetes mellitus, total cholesterol, and lipoprotein levels. Statin treatment indications were evaluated according to the ESC guidelines (2016) and the SUT (2016). RESULTS: Statin treatment was indicated for 96% of diabetic patients, and according to the ESC, it was appropriate for 13.5% of nondiabetic patients, while the SUT recommendation included 13.3% of nondiabetic patients (p<0.05). For patients younger than 60 years of age, the SUT had more guidelines than the ESC; however, for patients aged 70 to 90, the ESC had more guidelines than the SUT. For patients over 90, the indications were the same. For patients with low-density lipoprotein-cholesterol (LDL-C) >190 mg/dL there was greater discrepancy between the SUT and ESC guidelines. According to the SUT, all patients >190 mg/dL are to receive treatment. The ESC had more guidelines than the SUT for cases of LDLC <160b mg/dL. CONCLUSION: The scope of the SUT guidelines is generally not narrower than the ESC indications. However, the indications for patients >60 years of age and those with LDL-C >160 mg/ dL should be reassessed, as they are more limited than those of the ESC. A new treatment algorithm should be defined.

Long-term Cost-effectiveness of Two GLP-1 Receptor Agonists for the Treatment of Type 2 Diabetes Mellitus in the Italian Setting: Liraglutide Versus Lixisenatide.

PURPOSE: Maintaining glycemic control is the key treatment target for patients with type 2 diabetes mellitus. In addition, the glucagon-like peptide-1 (GLP-1) receptor agonists may be associated with other favorable treatment characteristics, such as reduction in body weight and reduced risk of hypoglycemia compared with traditional diabetes interventions. The aim of the present analysis was to compare the long-term cost-effectiveness of 2 GLP-1 receptor agonists, liraglutide 1.8 mg and lixisenatide 20 µg (both administered once daily), in the treatment of patients with type 2 diabetes failing to achieve glycemic control with metformin monotherapy in the Italian setting. METHODS: The IMS CORE Diabetes Model was used to project long-term clinical outcomes and subsequent costs (in 2015 Euros [€]) associated with liraglutide 1.8 mg versus lixisenatide 20 µg treatment in a cohort with baseline characteristics derived from the open-label LIRA-LIXI trial (Efficacy and Safety of Liraglutide Versus Lixisenatide as Add-on to Metformin in Subjects With Type 2 Diabetes; NCT01973231) over patient lifetimes from the perspective of a health care payer. Efficacy data were taken from the 26-week end points of the same trial, including changes in glycated hemoglobin, body mass index, serum lipid levels, and hypoglycemic event rates. Outcomes projected included life expectancy, quality-adjusted life expectancy, cumulative incidence and time to onset of diabetes-related complications, and direct medical costs. Outcomes were discounted at 3% annually, and sensitivity analyses were performed. FINDINGS: Liraglutide 1.8 mg was associated with improved discounted life expectancy (14.07 vs 13.96 years) and quality-adjusted life expectancy (9.18 vs 9.06 quality-adjusted life years [QALYs]) compared with lixisenatide 20 µg. These improvements were mostly attributable to a greater reduction in glycated hemoglobin level with liraglutide 1.8 mg versus lixisenatide 20 µg, leading to reduced incidence and increased time to onset of diabetes-related complications. Compared with lixisenatide 20 µg, liraglutide 1.8 mg was associated with increased total costs over patient lifetimes (€41,623 vs €41,380), but this was offset by lower costs of treating diabetes-related complications (€26,682 vs €27,476). Liraglutide 1.8 mg was associated with an incremental cost-effectiveness ratio of €2001 per QALY gained versus lixisenatide 20 µg. At a willingness-to-pay threshold of €30,000 per QALY gained, liraglutide 1.8 mg had a probability of 77.2% of being cost-effective. IMPLICATIONS: Based on long-term projections, liraglutide 1.8 mg is likely to be considered cost-effective compared with lixisenatide 20 µg for the treatment of patients with type 2 diabetes in Italy.

Diabetes management and daily functioning burden of non-severe hypoglycemia in Japanese people treated with insulin.

AIMS/INTRODUCTION: The present study investigated the impact of non-severe hypoglycemic events (NSHE) on patients' diabetes management, daily functioning and well-being. MATERIALS AND METHODS: A survey assessing the impact of NSHEs was completed by insulin-treated Japanese people with diabetes, aged ≥20 years with self-reported diabetes, who had experienced at least one NSHE in the past 3 months. Survey questions captured reasons for and the length of the event, and impacts on diabetes management, daily functioning, sleep and well-being. RESULTS: A total of 3,145 people with type 1 diabetes mellitus and type 2 diabetes mellitus were screened, of which 411 respondents were eligible. Increased glucose monitoring was reported by 57 and 54% of respondents after daytime and night-time NSHE, respectively. The average number of additional glucose monitoring tests was 2.4 and 3.0 for daytime and night-time NSHE. Among all respondents, 19% (daytime) and 16% (night-time) changed their insulin dose after an NSHE. After a daytime NSHE, 25% of respondents reported a negative impact on their daily activities or work. After a night-time NSHE, 34 and 23% of respondents reported a negative impact on sleep and next day emotional state, respectively. CONCLUSIONS: NSHEs have a negative impact on the diabetes management, daily functioning, sleep and well-being of Japanese patients.

Cost of Immediate Surgery Versus Non-operative Treatment for Trigger Finger in Diabetic Patients.

PURPOSE: As health care costs continue to rise, providers must increasingly identify and implement cost-effective practice measures without sacrificing quality of care. Corticosteroid injections are an established treatment for trigger finger; however, numerous clinical trials have documented the limited efficacy of these injections in the diabetic population. Furthermore, the most cost-effective treatment strategy for diabetic trigger finger has not been determined. The purpose of this study was to perform a decision analysis to identify the least costly strategy for effective treatment of diabetic trigger finger using existing evidence in the literature. METHODS: Four treatment strategies for diabetic trigger finger were identified: (1) 1 steroid injection followed by surgical release, (2) 2 steroid injections followed by surgical release, (3) immediate surgical release in the operating room, and (4) immediate surgical release in the clinic. A literature review was conducted to determine success rates of the different treatment strategies. Costing analysis was performed using our institutional reimbursement from Medicare. One-way sensitivity and threshold analysis was utilized to determine the least costly treatment strategy. RESULTS: The least costly treatment strategy was immediate surgical release in the clinic. In patients with insulin-dependent diabetes mellitus, this strategy results in a 32% and a 39% cost reduction when compared with treatment with 1 or 2 corticosteroid injections, respectively. For 1 or 2 corticosteroid injections to be the most cost-effective strategy, injection failure rates would need to be less than 36% and 34%, respectively. The overall cost of care for immediate surgical release in the clinic was $642. CONCLUSIONS: Diabetic trigger finger is a common problem faced by hand surgeons, with a variety of acceptable treatment algorithms. Management of diabetic trigger finger with immediate surgical release in the clinic is the most cost-effective treatment strategy, assuming a corticosteroid injection failure rate of at least 34%. TYPE OF STUDY/LEVEL OF EVIDENCE: Economic/decision III.

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.

Reporting on the Strategies Needed to Implement Proven Interventions: An Example From a "Real-World" Cross-Setting Implementation Study.

UNLABELLED: The objective of this study was to empirically demonstrate the use of a new framework for describing the strategies used to implement quality improvement interventions and provide an example that others may follow. Implementation strategies are the specific approaches, methods, structures, and resources used to introduce and encourage uptake of a given intervention's components. Such strategies have not been regularly reported in descriptions of interventions' effectiveness, or in assessments of how proven interventions are implemented in new settings. This lack of reporting may hinder efforts to successfully translate effective interventions into "real-world" practice. A recently published framework was designed to standardize reporting on implementation strategies in the implementation science literature. We applied this framework to describe the strategies used to implement a single intervention in its original commercial care setting, and when implemented in community health centers from September 2010 through May 2015. Per this framework, the target (clinic staff) and outcome (prescribing rates) remained the same across settings; the actor, action, temporality, and dose were adapted to fit local context. The framework proved helpful in articulating which of the implementation strategies were kept constant and which were tailored to fit diverse settings, and simplified our reporting of their effects. Researchers should consider consistently reporting this information, which could be crucial to the success or failure of implementing proven interventions effectively across diverse care settings. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT02299791.

Integrated sensor-augmented pump therapy systems [the MiniMed® Paradigm™ Veo system and the Vibe™ and G4® PLATINUM CGM (continuous glucose monitoring) system] for managing blood glucose levels in type 1 diabetes: a systematic review and economic evaluation.

BACKGROUND: In recent years, meters for continuous monitoring of interstitial fluid glucose have been introduced to help people with type 1 diabetes mellitus (T1DM) to achieve better control of their disease. OBJECTIVE: The objective of this project was to summarise the evidence on the clinical effectiveness and cost-effectiveness of the MiniMed(®) Paradigm™ Veo system (Medtronic Inc., Northridge, CA, USA) and the Vibe™ (Animas(®) Corporation, West Chester, PA, USA) and G4(®) PLATINUM CGM (continuous glucose monitoring) system (Dexcom Inc., San Diego, CA, USA) in comparison with multiple daily insulin injections (MDIs) or continuous subcutaneous insulin infusion (CSII), both with either self-monitoring of blood glucose (SMBG) or CGM, for the management of T1DM in adults and children. DATA SOURCES: A systematic review was conducted in accordance with the principles of the Centre for Reviews and Dissemination guidance and the National Institute for Health and Care Excellence Diagnostic Assessment Programme manual. We searched 14 databases, three trial registries and two conference proceedings from study inception up to September 2014. In addition, reference lists of relevant systematic reviews were checked. In the absence of randomised controlled trials directly comparing Veo or an integrated CSII + CGM system, such as Vibe, with comparator interventions, indirect treatment comparisons were performed if possible. METHODS: A commercially available cost-effectiveness model, the IMS Centre for Outcomes Research and Effectiveness diabetes model version 8.5 (IMS Health, Danbury, CT, USA), was used for this assessment. This model is an internet-based, interactive simulation model that predicts the long-term health outcomes and costs associated with the management of T1DM and type 2 diabetes. The model consists of 15 submodels designed to simulate diabetes-related complications, non-specific mortality and costs over time. As the model simulates individual patients over time, it updates risk factors and complications to account for disease progression. RESULTS: Fifty-four publications resulting from 19 studies were included in the review. Overall, the evidence suggests that the Veo system reduces hypoglycaemic events more than other treatments, without any differences in other outcomes, including glycated haemoglobin (HbA1c) levels. We also found significant results in favour of the integrated CSII + CGM system over MDIs with SMBG with regard to HbA1c levels and quality of life. However, the evidence base was poor. The quality of the included studies was generally low, often with only one study comparing treatments in a specific population at a specific follow-up time. In particular, there was only one study comparing Veo with an integrated CSII + CGM system and only one study comparing Veo with a CSII + SMBG system in a mixed population. Cost-effectiveness analyses indicated that MDI + SMBG is the option most likely to be cost-effective, given the current threshold of £30,000 per quality-adjusted life-year gained, whereas integrated CSII + CGM systems and Veo are dominated and extendedly dominated, respectively, by stand-alone, non-integrated CSII with CGM. Scenario analyses did not alter these conclusions. No cost-effectiveness modelling was conducted for children or pregnant women. CONCLUSIONS: The Veo system does appear to be better than the other systems considered at reducing hypoglycaemic events. However, in adults, it is unlikely to be cost-effective. Integrated systems are also generally unlikely to be cost-effective given that stand-alone systems are cheaper and, possibly, no less effective. However, evidence in this regard is generally lacking, in particular for children. Future trials in specific child, adolescent and adult populations should include longer term follow-up and ratings on the European Quality of Life-5 Dimensions scale at various time points with a view to informing improved cost-effectiveness modelling. STUDY REGISTRATION: PROSPERO Registration Number CRD42014013764. FUNDING: The National Institute for Health Research Health Technology Assessment programme.

Cost-effectiveness of ranibizumab in the treatment of visual impairment due to diabetic macular edema.

Objective Ranibizumab, an anti-vascular endothelial growth factor designed for ocular use, has been deemed cost-effective in multiple indications by several Health Technology Assessment bodies. This study assessed the cost-effectiveness of ranibizumab monotherapy or combination therapy (ranibizumab plus laser photocoagulation) compared with laser monotherapy for the treatment of visual impairment due to diabetic macular edema (DME). Methods A Markov model was developed in which patients moved between health states defined by best-corrected visual acuity (BCVA) intervals and an absorbing 'death' state. The population of interest was patients with DME due to type 1 or type 2 diabetes mellitus. Baseline characteristics were based on those of participants in the RESTORE study. Main outputs were costs (in 2013 CA$) and health outcomes (in quality-adjusted life-years [QALYs]) and the incremental cost-effectiveness ratio (ICER) was calculated. This cost-utility analysis was conducted from healthcare system and societal perspectives in Quebec. Results From a healthcare system perspective, the ICERs for ranibizumab monotherapy and combination therapy vs laser monotherapy were CA$24 494 and CA$36 414 per QALY gained, respectively. The incremental costs per year without legal blindness for ranibizumab monotherapy and combination therapy vs laser monotherapy were CA$15 822 and CA$20 616, respectively. Based on the generally accepted Canadian ICER threshold of CA$50 000 per QALY gained, ranibizumab monotherapy and combination therapy were found to be cost-effective compared with laser monotherapy. From a societal perspective, ranibizumab monotherapy and combination therapy provided greater benefits at lower costs than laser monotherapy (ranibizumab therapy dominated laser therapy). Conclusions Ranibizumab monotherapy and combination therapy resulted in increased quality-adjusted survival and time without legal blindness and lower costs from a societal perspective compared with laser monotherapy.