Drug treatment of type 2 diabetes: Its cost is significantly associated with HbA1c levels.

AIMS: To examine the relationship between costs of hyperglycaemia drug treatment and glycemic control amongst people with type 2 diabetes (T2D). METHODS: This observational study utilised data from the QUALIDIAB database on 3,452 T2D patients seen in Diabetes Centers in Argentina. Patients were classified according to their HbA1c value into two groups: on target (OT; HbA1c ≤ 7%), and not on target (NOT; HbA1c > 7%); within each category we considered clinical and metabolic indicators, as well as type of hyperglycaemia treatment. Monthly expenditure on drugs was estimated by micro-costing. Multivariable regression analysis was used to evaluate the association between cost of hyperglycaemia treatment and HbA1c values. RESULTS: In total, 48.9% of the participants have HbA1c OT values. Overall monthly per capita costs of this treatment increased significantly (134%) in the NOT group. Multivariable regression analysis showed that expenditure for hyperglycaemia drugs treatment was significant associated with glycemic control (OR: 0.705), diabetes duration (OR: 1.017), systolic blood pressure (OR: 1.006) and treatment of T2D (OR: 2.622). CONCLUSIONS: HbA1c NOT significantly increases drugs monthly cost of hyperglycaemia treatment in people with T2D in a country with an emerging market economy.

Cost-effectiveness of a New Opportunistic Screening Strategy for Walk-in Fingertip HbA1c Testing at Community Pharmacies in Japan.

OBJECTIVE: A new opportunistic community-based strategy was launched in Japan in April 2014 to detect lifestyle-related diseases, including diabetes, by creating Specimen Measurement Offices (SMOs). SMOs offer walk-in fingertip HbA1c testing. This article aimed to assess the value-for-money of HbA1c testing services at SMOs by conducting a cost-effectiveness analysis. RESEARCH DESIGN AND METHODS: We compared two scenarios: 1) status quo, defined as HbA1c testing that is available only through conventional screening, and 2) HbA1c testing available at SMOs as a complement to the status quo scenario. The model consisted of a screening module with a decision tree and a disease progression module with a Markov model. We calculated incremental cost-effectiveness ratios (i.e., cost per quality-adjusted life-years [QALYs]) over the lifetime analytic horizon as the primary end point of the cost-effectiveness analysis. In this model, we assumed the participant cohort to be people 40-74 years of age who sought walk-in fingertip HbA1c testing at SMOs on the premises of community pharmacies. Costs and outcomes were discounted at a rate of 3%. The cost-effectiveness was analyzed from a societal perspective. RESULTS: The incremental cost per individual for those 40-74 years of age was estimated to be -527 U.S. dollars (USD) (-52,722 Japanese yen [JPY]) for HbA1c testing at SMOs compared with the status quo. Incremental effectiveness was estimated to be 0.0203 QALYs for HbA1c testing at SMOs compared with the status quo. Therefore, this cost-effectiveness analysis showed that compared with the status quo, HbA1c testing at SMOs was more effective and had lower cost for the population studied. CONCLUSIONS: We consider our results to be robust because most simulations were under the threshold of USD 50,000 (JPY 5,000,000) per QALYs gained, by sensitivity analysis. These results will be useful to managers of pharmacies or other health institutions and/or policy makers in local government.

Estimating Cost-Effectiveness in Type 2 Diabetes: The Impact of Treatment Guidelines and Therapy Duration.

OBJECTIVES: Type 2 diabetes mellitus (T2DM) clinical guidelines focus on optimizing glucose control, with therapy escalation classically initiated within a "failure-based" regimen. Within many diabetes models, HbA1c therapy escalation thresholds play a pivotal role, controlling duration of therapy and, consequently, incremental costs and benefits. The objective of this study was to assess the relationship between therapy escalation threshold and time to therapy escalation on predicted cost-effectiveness of T2DM treatments. METHODS: This study used the Cardiff Diabetes Model to illustrate the relationship between costs and health outcomes associated with first-, second-, and third-line therapy as a function of time on each. Data from routine clinical practice were used to contrast predicted costs and health outcomes associated with guideline therapy escalation thresholds compared with clinical practice. The impact of baseline HbA1c and therapy escalation thresholds on cost-effectiveness was investigated, comparing a sodium/glucose cotransporter 2 inhibitor v. sulfonylurea added to metformin monotherapy. RESULTS: Lower thresholds are associated with a shorter time spent on monotherapy, ranging from 1.1 years (escalation at 6.5%) to 13 years (escalation at 9.0%) and an increase in total lifetime cost of therapy. Treatment-related disutility is minimized with higher thresholds because progression to insulin is delayed. Using metformin combined with either dapagliflozin or a sulfonylurea to illustrate lower baseline HbA1c and/or higher therapy escalation thresholds was associated with increased cost-effectiveness ratios, driven by a longer duration of therapy. DISCUSSION: A marked difference in treatment cost-effectiveness was demonstrated when comparing routine clinical practice with guideline-advocated therapy escalation. This is important to both health care professionals and the wider health economic community with respect to understanding the true cost-effectiveness profile of any particular T2DM therapy option.

Screening practices for identifying type 2 diabetes in adolescents.

OBJECTIVE: To characterize pediatrician and family physician (FP) screening practices for type 2 diabetes among adolescents and to examine the impact of the 2010 American Diabetes Association (ADA) guidelines, recommending use of Hemoglobin A1c (HbA1c). METHODS: We conducted a cross-sectional mail survey of a random sample of 1,400 U.S. pediatricians and FPs and we received 604 eligible responses. Our main outcome measure was the types of tests ordered by physicians, particularly HbA1c, when presented with a hypothetical scenario. RESULTS: The overall response rate was 52% (57% for pediatricians and 48% for FPs). Fasting glucose and HbA1c were the most commonly ordered tests. Overall, at least 58% of physicians ordered HbA1c; 35% ordered HbA1c in conjunction with fasting tests; and 22% ordered HbA1c alone or with nonfasting tests. Only 38% of providers were aware of the new ADA recommended HbA1c screening guidelines. However, a majority (67%) said they would change their screening practices. In the context of the guidelines, 84% of physicians would now order HbA1c. Furthermore, there was a large increase in the proportion of physicians who would shift to using HbA1c only or with other nonfasting tests. CONCLUSIONS: When screening adolescents for type 2 diabetes, providers are more likely to order HbA1c and order fewer fasting tests in response to the new ADA guidelines. HbA1c has lower sensitivity and higher costs than other testing modalities in children, therefore increasing uptake of this test (HbA1c) in children may have implications for both detection rates and healthcare costs.

Screening for type 2 diabetes: a short report for the National Screening Committee.

BACKGROUND: The prevalence of type 2 diabetes mellitus (T2DM) has been increasing, owing to increases in overweight and obesity, decreasing physical activity and the changing demographic structure of the population. People can develop T2DM without symptoms and up to 20% may be undiagnosed. They may have diabetic complications, such as retinopathy, by the time they are diagnosed, or may suffer a heart attack, without warning. Undiagnosed diabetes can be detected by raised blood glucose levels. AIM: The aim of this review was to provide an update for the UK National Screening Committee (NSC) on screening for T2DM. METHODS: As this review was undertaken to update a previous Health Technology Assessment review published in 2007, and a more recent Scottish Public Health Network review, searches for evidence were restricted from 2009 to end of January 2012, with selected later studies added. The databases searched were MEDLINE, EMBASE, MEDLINE-in-Process & Other Non-Indexed Citations, Science Citation Index and Conference Proceedings Citation Index. The case for screening was considered against the criteria used by the NSC to assess proposed population screening programmes. RESULTS: Population screening for T2DM does not meet all of the NSC criteria. Criterion 12, on optimisation of existing management, has not been met. A report by the National Audit Office (NAO) gives details of shortcomings. Criterion 13 requires evidence from high-quality randomised controlled trials that screening is beneficial. This has not been met. The Ely trial of screening showed no benefit. The ADDITION trial was not a trial of screening, but showed no benefit in cardiovascular outcomes from intensive management in people with screen-detected T2DM. Criterion 18 on staffing and facilities does not appear to have been met, according to the NAO report. Criterion 19 requires that all other options, including prevention, should have been considered. A large proportion of cases of T2DM could be prevented if people avoided becoming overweight or obese. The first stage of selection would use risk factors, using data held on general practitioner computer systems, using the QDiabetes Risk Score, or by sending out questionnaires, using the Finnish Diabetes Risk Score (FINDRISC). Those at high risk would have a measure of blood glucose. There is no perfect screening test. Glycated haemoglobin (HbA1c) testing has advantages in not requiring a fasting sample, and because it is a predictor of vascular disease across a wider range than just the diabetic one. However, it lacks sensitivity and would miss some people with diabetes. Absolute values of HbA1c may be more useful as part of overall risk assessment than a dichotomous 'diabetes or not diabetes' diagnosis. The oral glucose tolerance test is more sensitive, but inconvenient, more costly, has imperfect reproducibility and is less popular, meaning that uptake would be lower. CONCLUSIONS: When considered against the NSC criteria, the case for screening is less strong than it was in the 2007 review. The main reason is the absence of cardiovascular benefit in the two trials published since the previous review. There is a case for selective screening as part of overall vascular risk assessment. Population screening for T2DM does not meet all of the NSC criteria. FUNDING: The National Institute for Health Research Health Technology Assessment programme.

Economic effect of following HbA1c testing practice guidelines in the elderly Medicare population: an instrumental variable analysis.

This retrospective follow-up study aimed to evaluate the effect of following glycated hemoglobin (HbA1c) testing practice guidelines on Medicare expenditures. The authors identified 12 635 incident diabetes patients from 1998 and 1999 Medicare 5% claims data and calculated Medicare payments from 2000 to 2003. They applied a 2-stage least-squares model with instrumental variable (IV) methodology to estimate the effect of receiving > or = 2 HbA1c tests annually on Medicare expenditures. Only 27.7% (3503/12 635) of the sample received > or = 2 HbA1c tests annually. IV estimation results showed that receiving the tests was associated with a $953 decrease in Medicare payments per patient-year. Improved HbA1c test rates could save Medicare costs. For each year, 2000 to 2003, the authors estimate that approximately $174 million in Medicare expenditures could have been saved through Medicare patients aged > or = 67 years who developed diabetes in 1998 and 1999, had no diabetes complications at baseline, and subsequently did not receive > or = 2 HbA1c tests annually.

Cost-effectiveness of Roux-en-Y gastric bypass in type 2 diabetes patients.

OBJECTIVE: To assess the cost-effectiveness of Roux-en-Y gastric bypass for treating type 2 diabetes mellitus (T2DM) in the United States compared with standard medical management, using clinical data from a prospective observational study conducted at an academic medical center. STUDY DESIGN: Our study used a predictive health economic model (the CORE Diabetes Model) to project the long-term costs and clinical effectiveness of Roux-en-Y gastric bypass as a treatment for T2DM using the prospective observational study as the basis for our clinical effectiveness assumptions. METHODS: The CORE Diabetes Model used Monte Carlo simulation with tracker variables to estimate the lifetime costs and clinical outcomes of Roux-en-Y gastric bypass compared with standard medical management of obese T2DM patients. Sensitivity analyses were performed on key clinical assumptions, discount rates, and shorter time horizons. RESULTS: The base-case scenario yielded an incremental cost-effectiveness ratio (ICER) of $21,973 per quality-adjusted life-year (QALY) gained. In sensitivity analyses, shortening the time horizon to 5 and 10 years and excluding the negative impact of increased body mass index on the patient's quality of life had the greatest adverse impact on the ICERs (ie, higher cost per QALY). CONCLUSIONS: Under base-case assumptions, Roux-en-Y gastric bypass is cost-effective in the treatment of T2DM in the United States with an ICER below $50,000 per QALY gained. Sensitivity analyses indicated that bariatric surgery is not cost-effective over shorter time horizons, or if the negative quality-of-life impact of increased body mass index is ignored.

The cost to health plans of poor glycemic control.

OBJECTIVE: We tested the hypothesis that level of glycemic control is related to medical care costs in adults with diabetes. RESEARCH DESIGN AND METHODS: Regression analysis was used to estimate the relationship between glycemic control and medical care charges for 3,017 adults with diabetes who were continuously enrolled in a large health maintenance organization (HMO) over a 4-year period. Diagnosis of diabetes was ascertained from diagnostic and pharmaceutical databases using a method with an estimated sensitivity of 0.91 and an estimated specificity of 0.99. Charges for care included defined outpatient and inpatient services. Patients who disenrolled or who died during the 4-year period were excluded from the main analysis. RESULTS: Charges for medical care for patients with diabetes from 1993 to 1995 were closely related to HbA1c level in 1992 before and after adjustment for age, sex, coronary heart disease, and hypertension. Standardized 3-year estimates of charges ranged from $10,439 for patients without comorbid conditions to $44,417 for those with heart disease and hypertension. Medical care charges increased significantly for every 1% increase above HbA1c of 7%. For a person with an HbA1c value of 6%, successive 1% increases in HbA1c resulted in cumulative increases in charges of approximately 4, 10, 20, and 30%. The increase in charges accelerated as the HbA1c value increased. For patients with diabetes only, or with diabetes plus other chronic conditions, the rate of increase in charges with HbA1c was consistent. CONCLUSIONS: HbA1c provides useful information to providers and patients regarding both health status and future medical care charges. Economic data suggest that clinicians should assign high importance to low HbA1c results and aggressively maintain the HbA1c status of patients who have low HbA1c values. For economic as well as clinical reasons, it may be beneficial to lower HbA1c when it is > 8% and to reduce cardiovascular risk factors. The medical charge data suggest that investment in clinical systems to improve diabetes care may benefit both payers and patients.