The Impact of Unrelated Future Medical Costs on Economic Evaluation Outcomes for Different Models of Diabetes.

Objective: This study leveraged data from 11 independent international diabetes models to evaluate the impact of unrelated future medical costs on the outcomes of health economic evaluations in diabetes mellitus.

Methods: Eleven models simulated the progression of diabetes and occurrence of its complications in hypothetical cohorts of individuals with type 1 (T1D) or type 2 (T2D) diabetes over the remaining lifetime of the patients to evaluate the cost effectiveness of three hypothetical glucose improvement interventions versus a hypothetical control intervention. All models used the same set of costs associated with diabetes complications and interventions, using a United Kingdom healthcare system perspective.

Cost-Effectiveness of Oral Nirmatrelvir/Ritonavir in Patients at High Risk for Progression to Severe COVID-19 in the United States.

Objectives: Nirmatrelvir/ritonavir (NMV/r) is an orally administered antiviral indicated for the outpatient treatment of patients with mild-to-moderate COVID-19 at high risk for disease progression to severe illness. We estimated the cost-effectiveness of NMV/r versus best supportive care for patients with mild-to-moderate COVID-19 at high risk for progression to severe illness from a US health sector perspective.

Methods: A cost-effectiveness model was developed using a short-term decision-tree (1 year) followed by a lifetime 2-state Markov model (alive and dead).

Estimating the value of sodium-glucose cotransporter-2 inhibitors within the context of contemporary guidelines and the totality of evidence.

Aims: To comprehensively estimate the cost-effectiveness of sodium glucose cotransporter-2 (SGLT2) inhibitor usage in the management of type 2 diabetes mellitus (T2DM) at established clinical review points, incorporating the totality of proven health benefits.

Materials And Methods: This study considered the cardio- and reno-protective effects of SGLT2 inhibitors using the Cardiff type 2 diabetes model. Conventional cost-effectiveness evaluations were undertaken for eligible populations at relevant intensification points reflecting the 2022 guidelines versus the 2015 National Institute of Health and Care Excellence (NICE) guidelines; incremental cost-effectiveness ratio lifetime trajectories and timepoints for complete cost-offset were estimated for each pathway.

External Validation of the Core Obesity Model to Assess the Cost-Effectiveness of Weight Management Interventions.

Background: For economic models to be considered fit for purpose, it is vital that their outputs can be interpreted with confidence by clinicians, budget holders and other stakeholders. Consequently, thorough validation of models should be carried out to enhance confidence in their predictions. Here, we present results of external dependent and independent validations of the Core Obesity Model (COM), which was developed to assess the cost-effectiveness of weight management interventions.

Cost-Effectiveness Analysis of Empagliflozin in Comparison to Sitagliptin and Saxagliptin Based on Cardiovascular Outcome Trials in Patients with Type 2 Diabetes and Established Cardiovascular Disease.

Introduction: In the cardiovascular outcome trials (CVOT) EMPA-REG OUTCOME, TECOS and SAVOR-TIMI 53, empagliflozin [sodium/glucose cotransporter 2 (SGLT2) inhibitor], sitagliptin and saxagliptin [both dipeptidyl peptidase 4 (DPP4) inhibitors] + standard of care (SoC) were compared to SoC in patients with type 2 diabetes and established cardiovascular disease (CVD). This study assessed the cost-effectiveness (CE) of empagliflozin + SoC in comparison to sitagliptin + SoC and saxagliptin + SoC based on the respective CVOT.

Methods: The IQVIA Core Diabetes Model (CDM) was calibrated to reproduce the CVOT outcomes.

Assessing the Burden of Type 2 Diabetes in China Considering the Current Status-Quo Management and Implications of Improved Management Using a Modeling Approach.

Background: Recent estimates from the International Diabetes Federation Diabetes Atlas have quantified the total annual expenditure for diabetes in China to be between 354 and 611 billion Chinese yuan (¥) (2015).

Objectives: To use a modeling approach to assess the current and possible future diabetes burden in China on the basis of the current standard of type 2 diabetes (T2D) management (status quo [SQ]) and a series of hypothetical improved management strategies.

Methods: The IQVIA CORE Diabetes Model was used to evaluate the economic burden of T2D in China on the basis of assumptions reflecting the current SQ of T2D management and a number of stepwise improvements.

Computer Modeling of Diabetes and Its Transparency: A Report on the Eighth Mount Hood Challenge.

Objectives: The Eighth Mount Hood Challenge (held in St. Gallen, Switzerland, in September 2016) evaluated the transparency of model input documentation from two published health economics studies and developed guidelines for improving transparency in the reporting of input data underlying model-based economic analyses in diabetes.

Methods: Participating modeling groups were asked to reproduce the results of two published studies using the input data described in those articles.

Economic impact of severe and non-severe hypoglycemia in patients with Type 1 and Type 2 diabetes in the United States.

Objective: To identify the direct and indirect costs of hypoglycemia in patients with Type 1 or Type 2 diabetes mellitus (DM) in the US setting.

Methods: A literature review was conducted to identify and review studies that reported data on the economic burden of hypoglycemia and the related medical resource consumption or productivity loss related to hypoglycemia in patients with Type 1 or Type 2 DM. Relevant information was collated in an economic model to assess the direct and indirect costs following severe and non-severe hypoglycemic events in Type 1 and Type 2 DM.

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

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.

Validation of the IMS CORE Diabetes Model.

Background: The IMS CORE Diabetes Model (CDM) is a widely published and validated simulation model applied in both type 1 diabetes mellitus (T1DM) and type 2 diabetes mellitus (T2DM) analyses. Validation to external studies is an important part of demonstrating model credibility.

Objective: Because the CDM is widely used to estimate long-term clinical outcomes in diabetes patients, the objective of this analysis was to validate the CDM to contemporary outcomes studies, including those with long-term follow-up periods.

Computer modeling of diabetes and its complications: a report on the Fifth Mount Hood challenge meeting.

Objectives: The Mount Hood Challenge meetings provide a forum for computer modelers of diabetes to discuss and compare models, to assess predictions against data from clinical trials and other studies, and to identify key future developments in the field. This article reports the proceedings of the Fifth Mount Hood Challenge in 2010.

Methods: Eight modeling groups participated.

Self-monitoring of blood glucose (SMBG) in patients with type 2 diabetes on oral anti-diabetes drugs: cost-effectiveness in France, Germany, Italy, and Spain.

Objective: Stakeholders in Europe remain interested in assessments of country-specific value of self-monitoring of blood glucose (SMBG) for patients with type 2 diabetes treated with oral anti-diabetes drugs (OADs). This study used the IMS-CORE Diabetes Model to project the long-term (40-year) cost-effectiveness of SMBG at once, twice, or three times per day (vs. no SMBG) for this population from national reimbursement system perspectives in France, Germany, Italy, and Spain.

Long-term cost-effectiveness of pioglitazone versus placebo in addition to existing diabetes treatment: a US analysis based on PROactive.

Objective: To estimate the long-term cost-effectiveness of adding pioglitazone versus placebo to standard treatment in high-risk patients with type 2 diabetes.

Methods: The validated CORE Diabetes Model was modified to project long-term clinical and cost outcomes associated with pioglitazone versus placebo, based on results from PROactive. The model retained basic structure and functionality, with interdependent Markov submodels, Monte Carlo simulation and user interface.

An economic assessment of analogue basal-bolus insulin versus human basal-bolus insulin in subjects with type 1 diabetes in the UK.

Background: A recent study demonstrated that treatment of type 1 diabetes with an analogue basal-bolus insulin regimen was associated with improved glycaemic control (HbA(1c) -0.22% points, p < 0.001), reduced risk of hypoglycaemic events (-21%, p = 0.

Exenatide versus insulin glargine in patients with type 2 diabetes in the UK: a model of long-term clinical and cost outcomes.

Objectives: The aim of this study was to evaluate the long-term clinical and economic outcomes associated with exenatide or insulin glargine, added to oral therapy in individuals with type 2 diabetes inadequately controlled with combination oral agents in the UK setting.

Methods: A published and validated computer simulation model of diabetes was used to project long-term complications, life expectancy, quality-adjusted life expectancy and direct medical costs. Probabilities of diabetes-related complications were derived from published sources.

CorrXpression--identification of significant groups of genes and experiments by means of correspondence analysis and ratio analysis.

CorrXpression is a stand-alone desktop application for the identification of significant genes within collections of microarrays. The software combines three methods in two steps of analysis: correspondence analysis (CA), ratio analysis and correlation analysis. The graphical interface of CorrXpression visualizes the result of the CA with a biplot and the expression of selected genes in dependency of the experiments as bar diagrams.

Cost-effectiveness of basal insulin from a US health system perspective: comparative analyses of detemir, glargine, and NPH.

The purpose of this study was to compare in clinical and economic terms the long-acting insulin analogue detemir with intermediate-acting Neutral Protamine Hagedorn (NPH) insulin and with long-acting insulin glargine. Investigators used the validated Center for Outcomes Research (CORE) Diabetes Model to project clinical and cost outcomes over a 35-year base case time horizon; outcome data were extracted directly from randomized, controlled trials designed to compare detemir with NPH and with insulin glargine. Modeled patient characteristics were derived from corresponding trials, and simulations incorporated published quality-of-life utilities with cost data obtained from a Medicare perspective.

Long-term clinical and cost outcomes of treatment with biphasic insulin aspart 30/70 versus insulin glargine in insulin naïve type 2 diabetes patients: cost-effectiveness analysis in the UK setting.

Objectives: To evaluate the long-term clinical and cost outcomes associated with biphasic insulin aspart 30/70 (BIAsp 30/70, premixed 30% soluble and 70% protaminated insulin aspart in one injection) compared to insulin glargine treatment in insulin-naïve type 2 diabetes patients failing oral antidiabetic agents in the UK, based on findings recently reported from the INITIATE clinical trial.

Methods: The CORE Diabetes Model, a published, peer-reviewed and validated model of diabetes, was used to evaluate life expectancy, quality-adjusted life expectancy, cumulative incidence of complications and direct medical costs over patient lifetimes. The model simulates the range of diabetic complications and disease progression within a series of sub-models (cardiovascular disease, neuropathy, renal and eye disease) based on published data.

Treating diabetes to accepted standards of care: a 10-year projection of the estimated economic and health impact in patients with type 1 and type 2 diabetes mellitus in the United States.

Objective: The aim of this study was to investigate the health-economic impact of maintaining glycosylated hemoglobin (HbA(1c)) values in all US patients with currently uncontrolled type 1 or type 2 diabetes mellitus at the American Diabetes Association (ADA) standard of 7.0% and the American Association of Clinical Endocrinologists (AACE) target of 6.5% compared with maintenance at current population-based values.

Validation of the CORE Diabetes Model against epidemiological and clinical studies.

Objectives: The aim of this study was to assess the validity of the CORE Diabetes Model by comparing results from model simulations with observed outcomes from published epidemiological and clinical studies in type 1 and type 2 diabetes.

Methods: A total of 66 second- (internal) and third- (external) order validation analyses were performed across a range of complications and outcomes simulated by the CORE Diabetes Model (amputation, cataract, hypoglycaemia, ketoacidosis, macular oedema, myocardial infarction, nephropathy, neuropathy, retinopathy, stroke and mortality). Published studies were reproduced in the model by recreating cohorts in terms of demographics, baseline risk factors and complications, treatment patterns and patient management strategies, and simulating the progress of the cohort to an equivalent time horizon.

The CORE Diabetes Model: Projecting long-term clinical outcomes, costs and cost-effectiveness of interventions in diabetes mellitus (types 1 and 2) to support clinical and reimbursement decision-making.

Objectives: We have developed an Internet-based, interactive computer model to determine the long-term health outcomes and economic consequences of implementing different treatment policies or interventions in type 1 and type 2 diabetes mellitus. The model projects outcomes for populations, taking into account baseline cohort characteristics and past history of complications, current and future diabetes management and concomitant medications, screening strategies and changes in physiological parameters over time. The development of complications, life expectancy, quality-adjusted life expectancy and total costs within populations can be calculated.