Cost-effectiveness of risk stratification for preventing type 2 diabetes using a multi-marker diabetes risk score

Abstract

Background:

Personalized medicine requires diagnostic tests that stratify patients into distinct groups that may differentially benefit from targeted treatment approaches. This study compared the costs and benefits of two approaches for identifying those at high risk of developing type 2 diabetes for entry into a diabetes prevention program. The first approach identified high risk patients using impaired fasting glucose (IFG). The second approach used the PreDx Diabetes Risk Score (DRS) to further stratify IFG patients into high-risk and moderate-risk groups.

Methods:

A Markov model was developed to simulate the incidence and disease progression of diabetes and consequent costs and quality-adjusted life expectancy (QALY), comparing alternative approaches for identifying high-risk patients. We modeled direct medical costs, including the costs of the stratification testing, over a 10-year time horizon from a US payer perspective.

Results:

Stratification of IFG patients by the DRS method leads to improved identification and prevention among those at highest risk. At 5 years, the number needed to treat (NNT) in the IFG-only approach was 39 patients to prevent one case of diabetes compared to an NNT of 15 in the IFG?+?DRS approach. When compared to IFG alone, the IFG?+?DRS approach results in an incremental cost-effectiveness ratio (ICER) of $17,100/QALY gained at 5 years and would become cost saving in 10 years. In contrast and as compared to no stratification, the IFG-only approach would produce an ICER of $235,500/QALY gained at 5 years and $94,600/QALY gained at 10 years. The study findings are limited by the generalizability of the DRS validation study and uncertainty regarding the long-term effectiveness of diabetes prevention.

Conclusions:

The analysis indicates that the cost-effectiveness of diabetes prevention can be improved by better identification of patients at highest risk for diabetes using the DRS.     

The cost of diabetes and obesity in Australia

Aims: To assess and compare the direct healthcare and non-healthcare costs and government subsidies by body weight and diabetes status.

Methods: The Australian Diabetes, Obesity and Lifestyle study collected health service utilization and health-related expenditure data at the 2011–2012 follow-up surveys. Costing data were available for 4,409 participants. Unit costs for 2016–2017 were used where available or were otherwise inflated to 2016–2017 dollars. Age- and sex-adjusted costs per person were estimated using generalized linear models.

Results: The annual total direct cost ranged from $1,998 per person with normal weight to $2,501 per person with obesity in participants without diabetes. For those with diabetes, total direct costs were $2,353 per person with normal weight, $3,263 per person with overweight, and $3,131 per person with obesity. Additional expenditure as government subsidies ranged from $5,649 per person with normal weight and no diabetes to $8,085 per person with overweight and diabetes. In general, direct costs and government subsidies were higher for overweight and obesity compared to normal weight, regardless of diabetes status, but were more noticeable in the diabetes sub-group. The annual total excess cost compared with normal weight people without diabetes was 26% for obesity alone and 46% for those with obesity and diabetes.

Limitations: Participants included in this study represented a healthier cohort than the Australian population. The relatively small sample of people with both obesity and diabetes prevented a more detailed analysis by obesity class.

Conclusion: Overweight and obesity are associated with increased costs, which are further increased in individuals who also have diabetes. Interventions to prevent overweight and obesity or reduce weight in people who are overweight or obese, and prevent diabetes, should reduce the financial burden.     

The impact of non-severe hypoglycemic events on daytime function and diabetes management among adults with type 1 and type 2 diabetes

Abstract

Objectives:

To describe daytime non-severe hypoglycemic events (NSHEs), assess their impact on patient functioning and diabetes self-management, and examine if these impacts differ by diabetes type or country.

Methods:

Internet survey to adults with diabetes in the US, UK, Germany, and France.

Results:

Of 6756 screened respondents, 2439 reported a daytime NSHE in the past month. NSHEs occurred while active (e.g., running errands) (45.1%), 29.6% while not active (e.g., watching TV), and 23.8% at work. On average, it took half a day to respond and recover from NSHE. Respondents monitored their glucose 5.7 extra times on average over the following week. On the day of event, type 1 respondents tested significantly more often than type 2 (p?<?0.05). Type 2 were less likely to confirm NSHE with glucose test (p?<?0.001). Following NSHE, 12.6% of respondents reduced total insulin by an average of 7.6 units (SD?=?8.3). Total units and days with reduced dosing was significantly less, whilst number of additional glucose tests and time to recover was significantly longer if NSHE occurred at work (p?<?0.001). Type 1 decreased insulin doses more often (p?<?0.001); however, type 2 decreased a greater number of units (p?<?0.01). Compared with other countries, US respondents were more likely to eat a light or full meal and respondents in France took significantly longer than all other countries to recognize (p?<?0.05), respond to (p?<?0.001), and recover from (p?<?0.001) NSHE, used significantly more monitoring tests the day of (p?<?0.05) and over the subsequent week (p?<?0.001), and decreased their normal insulin dose more (p?<?0.001). Limitations of the study include potential recall bias and selection bias.

Conclusions:

NSHEs are associated with a significant impact on patient functioning and diabetes management.     

Economic impact of hypoglycemia among insulin-treated patients with diabetes

Objective: The objective of this study was to assess the cost of hypoglycemic events among insulin-treated patients with diabetes and the potential cost savings to a hypothetical US health plan and employer of reducing hypoglycemic events with a device intervention.

Methods: A cost-calculator model was developed to estimate the direct costs of hypoglycemic events, accounting for diabetes type, age, and event severity. Model inputs were derived from published incidence rates of hypoglycemic events and direct medical costs. Assumed intervention efficacy was based on published studies of an emerging technology which yielded 72.2% (LGS Trial; ACTRN12610000024044) and 31.8% (ASPIRE Trial; NCT01497938) reductions in severe and non-severe hypoglycemic events, respectively. Model outcomes—including the number of severe (requiring medical assistance) and non-severe events, and direct/indirect medical costs (excluding intervention costs)—were evaluated over a 1-year period for a hypothetical health plan and employer perspectives.

Results: In a health plan with 10 million enrollees, patients without the intervention would have experienced 0.09 and 14.60 severe and non-severe hypoglycemic events per patient per year (PPPY), respectively (vs 0.02 severe and 9.96 non-severe events with the intervention). This translated into total direct medical cost savings of $45 million ($177 PPPY) for the health plan. For an employer with 100,000 employees, the intervention would have yielded additional savings of $492 PPPY in indirect costs.

Conclusion: Insulin-treated patients experience hypoglycemic events, which are associated with substantial direct and indirect medical costs. The cost savings of reducing hypoglycemic events need to be weighed against the costs of using diabetes device interventions.     

Socio-economic impact of the mHealth adoption in managing diabetes

The increasing prevalence of prediabetes and diabetes has become a serious problem in Korea. This study aims to compare the effects of various policy options for mHealth proliferation for managing and preventing diabetes. To this end, we simulate the plausible possibility of mHealth using system dynamics modelling. There are several important findings of this study that are helpful to policy makers’ decisions. First, innovative healthcare delivery through mHealth has a positive influence on health to significantly reduce prediabetes and diabetes. Moreover, the gap between the healthcare system with and without mHealth increases over time. Second, the effectiveness of mHealth adoption depends on the timing of implementation of institutional reforms. Finally, mHealth adoption can stimulate national economic growth as the demand for a new healthcare system rises.     

Economic burden of comorbid chronic kidney disease and diabetes

Objective: To estimate real-world healthcare utilization and expenditures across the spectrum of chronic kidney disease (CKD), as determined by estimated glomerular filtration rate (eGFR) categories in patients with diabetes.

Methods: This study employed a retrospective cohort study design using the Truven Healthcare and Claims Dataset from 2009–2012. Index date was defined as the first eGFR value during a continuous enrollment period of 24 months. Cohorts of patients were stratified by Kidney Disease: Improving Global Outcomes CKD stage based on eGFR (stages 1: ≥90?mL/min/1.73?m²; 2: 60–89; 3A: 45–59; 3B: 30–44; 4: 15–29; 5: <15). Healthcare expenditures (total patient and payer paid claims) and utilization (number of claims or visits) were estimated 12-months post-index date using generalized linear modeling and negative binomial modeling, respectively, after adjusting for baseline characteristics.

Results: Of 130,098 patients with an index eGFR value and 24-months continuous enrolment, 64,521 (49.59%) were in stage 1 CKD, 47,816 (36.75%) were in stage 2, 13,377 (10.28%) were in stage 3A, 3,217 (2.47%) were in stage 3B, 898 (0.69%) were in stage 4, and 269 (0.21%) were in stage 5. Patients in stages 3A, 3B, and 4 CKD had 1.32 (95% CI?=?1.22–1.43), 1.59 (95% CI?=?1.41–1.80), and 2.65 (95% CI?=?2.23–3.14) times higher rates of diabetes-associated inpatient visits, respectively, compared with stage 1 CKD patients. Patients in stages 3A, 3B, and 4 CKD had increased incremental total annual healthcare expenditures of $1,732 (95% CI?=?$1,109–$2,356), $2,632 (95% CI?=?$1,647–$3,619), and $6,949 (95% CI?=?$5,466–$8,432), respectively, compared with stage 1 CKD patients.

Limitations: The claims data were generated for billing and reimbursement, not for research purposes.

Conclusions: These real-world data suggest an incremental and significant increase in economic burden in diabetes as kidney function declines, starting with moderate (stage 3A) CKD.     

Cardiovascular event costs in patients with Type 2 diabetes mellitus

Abstract

Objective:

To quantify the cost of acute major adverse cardiac events (MACE; myocardial infarction [MI] and stroke) stratified by cardiovascular disease (CVD) risk factors in commercially, Medicare Supplemental-, and Medicaid-insured patients with type 2 diabetes mellitus (T2DM).     

Budget impact analysis for dapagliflozin in type 2 diabetes in Egypt

Abstract

Introduction: Type 2 diabetes mellitus (T2DM) is a major health problem in Egypt with a high impact on morbidity, mortality, and healthcare resources. This study evaluated the budget impact and the long-term consequences of dapagliflozin versus other conventional medications, as monotherapy, from both the societal and health insurance perspectives in Egypt.

Methods: A static budget impact model was developed to estimate the financial consequences of adopting dapagliflozin on the healthcare payer budget. We measured the direct medical costs of dapagliflozin (new scenario) as monotherapy, compared to metformin, insulin, sulphonylurea, dipeptidyl peptidase-4 (DPP-4) inhibitors, thiazolidinedione, and repaglinide (old scenarios) over a time horizon of 3 years. Myocardial infarction (MI), ischemic stroke, hospitalization for heart failure (HHF), and initiation of renal replacement therapy (RRT) rates were captured from DECLARE TIMI 58 trial. One-way sensitivity analyses were conducted.

Results: The budget impact model estimated 2,053,908 patients eligible for treatment with dapagliflozin from a societal perspective and 1,207,698 patients from the health insurance (HI) perspective. The new scenario allows for an initial savings of EGP121 million in the first year, which increased to EGP243 and EGP365 million in the second and third years, respectively. The total cumulative savings from a societal perspective were estimated at EGP731 million. Dapagliflozin allows for savings of EGP71, EGP143, and EGP215 million in the first, second and third years respectively, from the HI perspective, with total cumulative savings of EGP430 million over the 3 years.

Conclusion: Treating T2DM patients using dapagliflozin instead of conventional medications, maximizes patients’ benefits and decreases total costs due to drug cost offsets from fewer cardiovascular and renal events. The adoption of dapagliflozin is a budget-saving treatment option, resulting in substantial population-level health gains due to reduced event rate and cost savings from the perspective of the national healthcare system.     

RT-PCR技术检测VFMRNA在妊娠期糖尿病中的应用

目的探讨晚期妊娠孕妇大网膜组织内脏脂肪素(VF)mRNA表达的变化与妊娠期糖尿病(GDM)的相关性。方法采用半定量RT-PCR技术检测200例晚期妊娠妇女大网膜组织VFmRNA的表达水平,其中包括GDM孕妇90例(GDM组)、糖耐量正常(NGT)孕妇110例(NGT组)。检测各组孕妇空腹血糖、空腹血清胰岛素、总胆固醇(TC)及甘油三酯(TG)水平,采用稳态模型(HOMA)计算胰岛素抵抗(IR)指数(HOMA.IR)并计算孕前体重指数(BMI)。结果 GDM组与NGT组大网膜组织中VFmRNA表达水平分别为0.8±0.4、0.5±0.3,空腹血糖水平分别为(4.12±0.14)、(3.65±0.13)mmol/L,空腹血清胰岛素水平分别为(72±5)、(614-5)pmol/L,TG水平分别为(5.6±0.3)、(3.8±0.3)mmoL/L,TC水平分别为(5.64-0.9)、(3.94-0.3)mmoL/L,孕前BMl分别为(22.6±0.8)、(20.9±0.4)kg/m2,HOMA-IR分别为12.5±5.9、9.5±0.8,两组以上各值分别比较,GDM组各值均高于NGT组,差异均有统计学意义(P<0.05)。VFmRNA表达水平与孕前BMI呈正相关关系(r=0.32,P<0.01),但与HOMA-IR、TC、TG无相关性。结论 VFmRNA表达上调可能与GDM、肥胖的发生密切相关。     

Willingness-to-pay for benefits associated with basal insulin treatment of type 2 diabetes

Abstract

Data from a 20-week trial comparing insulin detemir and neutral protamine Hagedorn (NPH) insulin in insulin-naïve people with type 2 diabetes were analyzed using willingness-to-pay (WTP) data, a proxy for patient preference. The advantages of insulin detemir relative to NPH insulin with respect to a lower hypoglycemia rate and less weight gain were associated with a value of €27.87 per month.     

Mail-order pharmacy use and medication adherence among Medicare Part D beneficiaries with diabetes

Abstract

Objective:

To examine medication adherence among Medicare Part D beneficiaries initiating oral anti-diabetic medications and explore whether there is any association of using mail-order pharmacy (vs. retail pharmacy) with better adherence in this patient population.

Research design and methods:

Using administrative pharmacy claims data, we conducted a retrospective cohort study on Medicare Part D beneficiaries who newly initiated oral anti-diabetic treatment between July 1, 2008 and December 31, 2008. Mail-order pharmacy users were matched to retail pharmacy users via propensity scoring, controlling for patient demographic and clinical characteristics. Adherence with oral anti-diabetic medications during the benefit year of 2009 was assessed using the proportion of days covered (PDC). Comparison of medication adherence between the mail-order pharmacy group and retail pharmacy group was conducted in the propensity matched sample using the paired t-tests and McNemar’s tests.

Results:

A total of 22,546 patients who initiated oral anti-diabetic medications were identified. The average PDC was 0.60 and only 41.6% of the study population attained good adherence (defined as PDC?≥?0.8) with oral anti-diabetic medications during calendar year 2009. The matched sample included 1361 patients in each of the mail-order and retail pharmacy cohorts. Compared with the retail pharmacy group, mail-order pharmacy users demonstrated a significantly higher PDC (0.68 vs. 0.61; P?<?0.001) throughout the benefit year. More patients in the mail-order pharmacy group (49.7%) attained good adherence with their oral anti-diabetic medications compared to 42.8% in the retail pharmacy group (P?<?0.001).

Limitations:

The study was subject to limitations inherent in retrospective claims database analysis.

Conclusions:

Adherence with oral anti-diabetic medications among Medicare Part D beneficiaries is suboptimal. Patients using mail-order pharmacy had better adherence to oral anti-diabetic medications than those who used retail pharmacies. However, the causal relationship between mail-order pharmacy use and adherence should be further examined in a randomized study setting.     

Exenatide BID and liraglutide QD treatment patterns among type 2 diabetes patients in Germany

Abstract

Objectives:

This study evaluated patient and prescriber characteristics, treatment patterns, average daily dose (ADD), and glycemic control of patients initiating glucagon-like peptide 1 (GLP-1) receptor agonists in Germany.

Methods:

The LifeLink? EMR-EU database was searched to identify patients initiating exenatide twice daily (BID) or liraglutide once daily (QD) during the index period (January 1, 2009–April 4, 2010). Eligible patients had ≥180 days pre-index history, ≥90 days post-index follow-up, and a pre-index type 2 diabetes diagnosis. Univariate tests were conducted at α?=?0.05.

Results:

Six hundred and ninety-two patients were included (exenatide BID 292, liraglutide QD 400): mean (SD) age 59 (10) years, 59% male. Diabetologists prescribed liraglutide QD to a larger share of patients (65% vs 35% exenatide BID) than non-diabetologists (51% vs 49%). GLP-1 receptor agonist choice was not associated with age (p?=?0.282), gender (p?=?0.960), number of pre-index glucose-lowering medications (2.0 [0.9], p?=?0.159), pre-index HbA1c (8.2 [1.5%], p?=?0.231) or Charlson Comorbidity Index score (0.45 [0.78], p?=?0.547). Mean (SD) ADD was 16.7?mcg (9.2, label range 10–20?mcg) for exenatide BID and 1.4?mg (0.7, label range 0.6–1.8?mg) for liraglutide QD. Among patients with post-index HbA1c tests, mean unadjusted values did not differ between cohorts. Exenatide BID patients were more likely than liraglutide QD patients to continue pre-index glucose-lowering medications (67.1% vs 60.3%, p?=?0.027) or to start concomitant glucose-lowering medications at index (32.2% vs 25.0%, p?=?0.013); exenatide BID patients were less likely to augment treatment with another drug post-index (15.8% vs 22.5%, p?=?0.027).

Limitations:

Results may not be generalizable. Lab measures for clinical outcomes were available only for a sub-set of patients.

Conclusions:

Results suggested that some differences exist between patients initiating exenatide BID or liraglutide QD, with respect to prescribing physician specialty and pre- and post-index treatment patterns. Both GLP-1 receptor agonists showed comparable post-index HbA1c values in a sub-set of patients.     

Association between provider specialty and healthcare costs and glycemic control for patients with diabetes

Aims: To analyze the association between provider, healthcare costs, and glycemic control for patients with diabetes mellitus (DM).

Materials and methods: This cross-sectional study identified adults with type 1 or 2?DM (T1D, T2D) in the Optum database. The main independent variable was provider (endocrinologist or primary care). Regression analysis compared total medical and pharmacy costs, adjusting for health status and other patient differences, by provider.

Results: For all patients, HbA1C improvement was greater, and medical costs significantly lower with an endocrinologist rather than a primary care provider. The largest HbA1C improvement (4%) occurred for insulin-dependent patients seen by endocrinologists. Significant medical savings with endocrinologist management occurred within the Medicare Advantage population in every sub-group of patients, with 14% lower costs ($4,767) for patients with T1D, 11% lower costs ($3,160) for patients with macro- and microvascular complications, and 10% lower costs ($2,237) for insulin-dependent patients. Within the commercial insurance population, medical costs were reduced by ≥9% in every sub-group of patients, with a 20% reduction ($8,450) for patients with micro- and macrovascular complications. Overall total costs (medical and pharmacy) were 8% ($1,541) higher for patients receiving endocrinologist rather than primary care, although endocrinologist care resulted in a 9% reduction (–$3,710) in costs for Medicare Advantage patients with T1D. Total medical costs (excluding pharmacy costs) may be a more accurate indicator of costs associated with patients in various stages of DM.

Limitations: There was insufficient data to develop risk-adjustment payments for pharmacy costs based on disease severity. The cross-sectional design identifies associations and not cause–effect relationships.

Conclusion: DM management by an endocrinologist was associated with greater HbA1C improvement and significantly lower medical costs. Total costs were higher with an endocrinologist, but for patients with T1D lower costs were seen, ranging from 2–9% regardless of insurance type.