The challenges and pitfalls of incorporating evidence from cardiovascular outcomes trials in health economic modelling of type 2 diabetes.

The clinical evidence base for evaluating modern type 2 diabetes interventions has expanded greatly in recent years, with numerous efficacious treatment options available (including dipeptidyl peptidase-4 inhibitors, glucagon-like peptide-1 receptor agonists and sodium-glucose cotransporter-2 inhibitors). The cardiovascular safety of these interventions has been assessed individually versus placebo in numerous cardiovascular outcomes trials (CVOTs), statistically powered to detect differences in a composite endpoint of major adverse cardiovascular events. There have been growing calls to incorporate these data in the long-term modelling of type 2 diabetes interventions because current diabetes models were developed prior to the conduct of the CVOTs and therefore rely on risk equations developed in the absence of these data. However, there are numerous challenges and pitfalls to avoid when using data from CVOTs. The primary concerns are around the heterogeneity of the trials, which have different study durations, inclusion criteria, rescue medication protocols and endpoint definitions; this results in significant uncertainty when comparing two or more interventions evaluated in separate CVOTs, as robust adjustment for these differences is difficult. Analyses using CVOT data inappropriately can dilute clear evidence from head-to-head clinical trials, and blur healthcare decision making. Calibration of existing models may represent an approach to incorporating CVOT data into diabetes modelling, but this can only offer a valid comparison of one intervention versus placebo based on a single CVOT. Ideally, model development should utilize patient-level data from CVOTs to prepare novel risk equations that can better model modern therapies for type 2 diabetes.

The value of fast-acting insulin aspart compared with insulin aspart for patients with diabetes mellitus treated with bolus insulin from a UK health care system perspective.

BACKGROUND: Fast-acting insulin aspart is a new formulation of the rapid-acting insulin analogue insulin aspart and represents an advancement over current rapid-acting insulin analogues in terms of onset of action and postprandial glucose control. The objective of the current analysis was to demonstrate the cost impact of prescribing fast-acting insulin aspart instead of insulin aspart, to highlight the value of fast-acting insulin aspart for the treatment of people with diabetes requiring mealtime insulin. METHODS: A cost-impact analysis was conducted from the perspective of the UK National Health Service (NHS). The analysis excluded patients' out-of-pocket expenses, carers' costs and lost productivity. The time horizon of the analysis was 1 year, and no discounting was therefore applied. RESULTS: The displacement of insulin aspart with fast-acting insulin aspart is cost neutral for the UK NHS. Fast-acting insulin aspart is at price parity to insulin aspart in terms of the vial and Penfill® cartridge and is available in the FlexTouch® pen at the same price as the insulin aspart FlexPen® (and thus cheaper than the insulin aspart FlexTouch® pen). Patients using the insulin aspart FlexPen® will be upgraded to the FlexTouch® pen device, which is preferred by patients and healthcare professionals, on switching to fast-acting insulin aspart, at no additional cost. CONCLUSIONS: Fast-acting insulin aspart offers additional clinical benefit but at no additional cost when compared with insulin aspart, and thus provides value to the UK NHS.

Evaluating the Long-Term Cost-Effectiveness of Daily Administered GLP-1 Receptor Agonists for the Treatment of Type 2 Diabetes in the United Kingdom.

INTRODUCTION: The glucagon-like peptide-1 (GLP-1) receptor agonist class has grown in the last decade, with several agents available in the UK. However there is currently a paucity of evidence regarding the relative cost-effectiveness of liraglutide 1.2 mg versus other daily administered GLP-1 receptor agonists, due to a lack of head-to-head trial data. Therefore the present analysis was performed, using results from a network meta-analysis (NMA), to compare the cost-effectiveness of three currently available daily administered GLP-1 receptor agonists for treatment of diabetes in the UK setting. METHODS: A validated and published diabetes model was used to make long-term projections of clinical outcomes and direct costs (2015 GBP) for patients receiving liraglutide 1.2 mg once-daily, exenatide 10 µg twice daily and lixisenatide 20 µg once-daily. Treatment effects were taken from an NMA evaluating the efficacy of GLP-1 receptor agonists and were applied in a cohort based on the Liraglutide Effect and Action in Diabetes 6 (LEAD-6) trial. Costs and utilities were based on published sources. RESULTS: Liraglutide 1.2 mg was associated with improved quality-adjusted life expectancy versus exenatide [9.19 versus 9.17 quality-adjusted life years (QALYs)] and lixisenatide (9.19 versus 9.12 QALYs). Improvements were driven by benefits in glycemic control, leading to a reduced incidence of diabetes-related complications. Liraglutide 1.2 mg was associated with reduced costs versus exenatide (GBP 36,394 versus GBP 36,547) and lixisenatide (GBP 36,394 versus GBP 36,496), with cost savings as a result of complications avoided entirely offsetting increased acquisition costs. Based on the projected outcomes, liraglutide was found to be dominant over both exenatide and lixisenatide. CONCLUSION: Liraglutide 1.2 mg is likely to be considered cost-effective versus alternative daily administered GLP-1 receptor agonists for treatment of type 2 diabetes in the UK.

Resource use and outcomes associated with initiation of injectable therapies for patients with type 2 diabetes mellitus.

INTRODUCTION: Management of type 2 diabetes mellitus (T2DM) often requires intervention with oral and injectable therapies. Across National Health Service (NHS) England, injectable therapies may be initiated in secondary, intermediate or primary care. We wished to understand resource utilization, pathways of care, clinical outcomes, and experience of patients with T2DM initiated on injectable therapies. METHOD: We conducted three service evaluations of initiation of injectable therapies (glucagon-like peptide-1 receptor agonists (GLP-1 RAs) or basal insulin) for T2DM in primary, secondary and intermediate care. Evaluations included retrospective review of medical records and service administration; prospective evaluation of NHS staff time on each episode of patient contact during a 3-month initiation period; patient-experience survey for those attending for initiation. Data from each evaluation were analysed separately and results stratified by therapy type. RESULTS: A total of 133 patients were included across all settings; 54 were basal-insulin initiations. After initiation, the mean HbA1c level fell for both types of therapies, and weight increased for patients on basal insulin yet fell for patients on GLP-1 RA. The mean cost of staff time per patient per initiation was: £43.81 for GLP-1 RA in primary care; £243.49 for GLP-1 RA and £473.63 for basal insulin in intermediate care; £518.99 for GLP-1 RA and £571.11 for basal insulin in secondary care. Patient-reported questionnaires were completed by 20 patients, suggesting that patients found it easy to speak to the diabetes team, had opportunities to discuss concerns, and felt that these concerns were addressed adequately. CONCLUSION: All three services achieved a reduction in HbA1c level after initiation. Patterns of weight gain with basal insulin and weight loss with GLP-1 RA were as expected. Primary care was less resource-intensive and costly, and was driven by lower staff costs and fewer clinic visits.

Use of the Omaha System data to validate Medicare required outcomes in home care.

Millions of dollars have been spent developing standardized terminologies for nursing. However, many nurses are unaware of them, because vendors have not incorporated them into electronic health records (EHRs), and quality assurance staff and researchers have not benefited from reuse of the data to examine practice. Government regulations require the use of particular data sets, such as OASIS in home care. Most staff and agencies are focused on government-mandated data without realizing how the nationally recognized terminologies for nursing can benefit an agency. This article seeks to demonstrate the value of using the Omaha System in an EHR for documenting care and conducting Medicare's required Outcome-Based Quality Improvement process in one home care agency.