Understanding the Gap Between Efficacy in Randomized Controlled Trials and Effectiveness in Real-World Use of GLP-1 RA and DPP-4 Therapies in Patients With Type 2 Diabetes.

OBJECTIVE: The objective of this study was to estimate and explain the gap between clinical efficacy and real-world (RW) effectiveness of type 2 diabetes medications. RESEARCH DESIGN AND METHODS: This mixed-methods quasi-experimental study used retrospective claims (Optum/Humedica) to compare the change in HbA1c of RW patients with type 2 diabetes 12 months after starting a glucagon-like peptide 1 receptor agonist (GLP-1 RA) or dipeptidyl peptidase 4 (DPP-4) inhibitor with published findings from randomized controlled trials (RCTs) evaluating these drugs. Selected RW patients were similar to RCT patients, and regression analysis was used in the RW data to adjust for differences between poorly adherent and adherent patients to explain why RCT and RW findings may differ. RESULTS: RW patients initiating a GLP-1 RA (n = 221) or a DPP-4 (n = 652) experienced smaller reductions in HbA1c (GLP-1 RA: -0.52% [-6 mmol/mol], DPP-4: -0.51% [-6 mmol/mol])than reported in RCTs (-1.30% [-14 mmol/mol] from seven GLP-1 RA RCTs, n = 2,600; -0.68% [-8 mmol/mol] from four DPP-4 RCTs, n = 1,889). Baseline HbA1c, additional medications, and adherence were significant explanatory factors in the RW HbA1c change. Modeled estimates of RCT efficacy (-1.04% GLP-1 RA [-12 mmol/mol], -0.69% DPP-4 [-8 mmol/mol]) were within the RCTs' reported range (GLP-1 RA: -0.84% to -1.60% [-9 to -18 mmol/mol], DPP-4: -0.47% to -0.90% [-5 to -10 mmol/mol]). Poor medication adherence accounted for approximately three-fourths of the gap between RW and expected RCT results (gap = 0.51% [6 mmol/mol] GLP-1 RA; 0.18% [3 mmol/mol] DPP-4). CONCLUSIONS: Poor medication adherence is primarily why RW effectiveness is significantly less than RCT efficacy, suggesting an urgent need to effectively address adherence among patients with type 2 diabetes.

Engagement in health and wellness: An online incentive-based program.

Increasingly, corporate health promotion programs are implementing wellness programs integrating principles of behavioral economics. Employees of a large firm were provided a customized online incentive program to design their own commitments to meet health goals. This study examines patterns of program participation and engagement in health promotion activities. Subjects were US-based employees of a large, nondurable goods manufacturing firm who were enrolled in corporate health benefits in 2010 and 2011. We assessed measures of engagement with the workplace health promotion program (e.g., incentive points earned, weight loss). To further examine behaviors indicating engagement in health promotion activities, we constructed an aggregate, employee-level engagement index. Regression models were employed to assess the association between employee characteristics and the engagement index, and the engagement index and spending. 4220 employees utilized the online program and made 25,716 commitments. Male employees age 18-34 had the highest level of engagement, and male employees age 55-64 had the lowest level of engagement overall. Prior year health status and prior year spending did not show a significant association with the level of engagement with the program (p > 0.05). Flexible, incentive-based behavioral health and lifestyle programs may reach the broader workforce including those with chronic conditions and higher levels of health spending.

Cost comparison between uterine-sparing fibroid treatments one year following treatment.

BACKGROUND: To compare one-year all-cause and uterine fibroid (UF)-related direct costs in patients treated with one of the following three uterine-sparing procedures: magnetic resonance-guided focused ultrasound (MRgFUS), uterine artery embolization (UAE) and myomectomy. METHODS: This retrospective observational cohort study used healthcare claims for several million individuals with healthcare coverage from employers in the MarketScan Database for the period 2003-2010. UF patients aged 25-54 on their first UF procedure (index) date with 366-day baseline experience, 366-day follow-up period, continuous health plan enrollment during baseline and follow-up, and absence of any baseline UF procedures were included in the final sample. Cost outcomes were measured by allowed charges (sum of insurer-paid and patient-paid amounts). UF-related cost was defined as difference in mean cost between study cohorts and propensity-score-matched control cohorts without UF. Multivariate adjustment of cost outcomes was conducted using generalized linear models. RESULTS: The study sample comprised 14,426 patients (MRgFUS = 14; UAE = 4,092; myomectomy = 10,320) with a higher percent of older patients in MRgFUS cohort (71% vs. 50% vs. 12% in age-group 45-54, P < 0.001). Adjusted all-cause mean cost was lowest for MRgFUS ($19,763; 95% CI: $10,425-$38,694) followed by myomectomy ($20,407; 95% CI: $19,483-$21,381) and UAE ($25,019; 95% CI: $23,738-$26,376) but without statistical significance. Adjusted UF-related costs were also not significantly different between the three procedures. CONCLUSIONS: Adjusted all-cause and UF-related costs at one year were not significantly different between patients undergoing MRgFUS, myomectomy and UAE.

Podiatrist care and outcomes for patients with diabetes and foot ulcer.

We examined whether outcomes of care (amputation and hospitalisation) among patients with diabetes and foot ulcer differ between those who received pre-ulcer care from podiatrists and those who did not. Adult patients with diabetes and a diagnosis of a diabetic foot ulcer were found in the MarketScan Databases, 2005-2008. Multivariate Cox proportional hazard models estimated the hazard of amputation and hospitalisation. Logistic regression estimated the likelihood of these events. Propensity score weighting and regression adjustment were used to adjust for potentially different characteristics of patients who did and did not receive podiatric care. The sample included 27 545 patients aged greater than 65+ years (Medicare-eligible patients with employer-sponsored supplemental insurance) and 20 208 patients aged lesser than 65 years (non Medicare-eligible commercially insured patients). Care by podiatrists in the year prior to a diabetic foot ulcer was associated with a lower hazard of lower extremity amputation, major amputation and hospitalisations in both non Medicare-eligible commercially insured and Medicare-eligible patient populations. Systematic differences between patients with diabetes and foot ulcer, receiving and not receiving care from podiatrists were also observed; specifically, patients with diabetes receiving care from podiatrists tend to be older and sicker.

Impact of medication adherence on absenteeism and short-term disability for five chronic diseases.

OBJECTIVE: To estimate the impact of medication adherence on absenteeism and short-term disability among employees with chronic disease. METHODS: Cross-sectional analysis of administrative health care claims, absenteeism, and short-term disability data using multivariate regression and instrumental variable models for five cohorts of employees: diabetes, hypertension, congestive heart failure, dyslipidemia, and asthma/chronic obstructive pulmonary disease. Adherence was defined as possessing medication on at least 80% of days during follow-up. RESULTS: Adherent employees with diabetes, hypertension, dyslipidemia, and asthma/chronic obstructive pulmonary disease realized between 1.7 and 7.1 fewer days absent from work and between 1.1 and 5.0 fewer days on short-term disability. Absenteeism and short-term disability days by adherent employees with congestive heart failure were not significantly different from nonadherent employees with the condition in most specifications. CONCLUSIONS: Appropriate management of chronic conditions can help employers minimize losses due to missed work.

The cost burden of oral, oral pharyngeal, and salivary gland cancers in three groups: commercial insurance, Medicare, and Medicaid.

BACKGROUND: Head and neck cancers are of particular interest to health care providers, their patients, and those paying for health care services, because they have a high morbidity, they are extremely expensive to treat, and of the survivors only 48% return to work. Consequently the economic burden of oral cavity, oral pharyngeal, and salivary gland cancer (OC/OP/SG) must be understood. The cost of these cancers in the U.S. has not been investigated. METHODS: A retrospective analysis of administrative claims data for 6,812 OC/OP/SG cancer patients was undertaken. Total annual health care spending for OC/OP/SG cancer patients was compared to similar patients without OC/OP/SG cancer using propensity score matching for enrollees in commercial insurance, Medicare, and Medicaid. Indirect costs, as measured by short term disability days were compared for employed patients. RESULTS: Total annual health care spending for OC/OP/SG patients during the year after the index diagnosis was $79,151 for the Commercial population. Health care costs were higher for OC/OP/SG cancer patients with Commercial Insurance ($71,732, n = 3,918), Medicare ($35,890, n = 2,303) and Medicaid ($44,541, n = 585) than the comparison group (all p < 0.01). Commercially-insured employees with cancer (n = 281) had 44.9 more short-term disability days than comparison employees (p < 0.01). Multimodality treatment was twice the cost of single modality therapy. Those patients receiving all three treatments (surgery, radiation, and chemotherapy) had the highest costs of cost of care, from $96,520 in the Medicare population to $153,892 in the Commercial population. CONCLUSIONS: In the U.S., the cost of OC/OP/SG cancer is significant and may be the most costly cancer to treat in the U.S. The results of this analysis provide useful information to health care providers and decision makers in understanding the economic burden of head and neck cancer. Additionally, this cost information will greatly assist in determining the cost-effectiveness of new technologies and early detection systems. Earlier identification of cancers by patients and providers may potentially decrease health care costs, morbidity and mortality.

Intent-to-treat analysis of health care expenditures of patients treated with atypical antipsychotics as adjunctive therapy in depression.

OBJECTIVE: To compare health care utilization and expenditures in patients with depression whose initial antidepressant (AD) treatment was augmented with a second-generation antipsychotic. METHODS: Claims data from January 1, 2001, through June 30, 2009, were used to select patients aged 18 to 64 years with depression treated with ADs augmented with aripiprazole, olanzapine, or quetiapine. Patients were required to have 6 months of continuous eligibility before the first AD prescription and 6 months after the second-generation antipsychotic augmentation (index) date. Utilization and expenditures were assessed for 6 months after the index date. Multivariate regression was used to estimate adjusted expenditures and risks for hospitalizations and emergency department visits. RESULTS: A total of 483 patients treated with aripiprazole, 978 with olanzapine, and 2471 with quetiapine were selected. Mean adjusted expenditures for aripiprazole were significantly lower than those for olanzapine for each service category (all-cause, all-cause medical care, mental health-related, and mental health-related medical care) and were significantly lower than those for quetiapine for each category with the exception of mental health-related. The adjusted risks for hospitalization and emergency department visits were significantly higher for quetiapine than for aripiprazole. CONCLUSIONS: Compared with patients treated with ADs and aripiprazole, those treated with ADs and olanzapine or quetiapine had greater utilization and higher expenditures.

The economic value of specialized lower-extremity medical care by podiatric physicians in the treatment of diabetic foot ulcers.

BACKGROUND: We sought to examine the economic value of specialized lower-extremity medical care by podiatric physicians in the treatment of diabetic foot ulcers by evaluating cost outcomes for patients with diabetic foot ulcer who did and did not receive care from a podiatric physician in the year before the onset of a foot ulcer. METHODS: We analyzed the economic value among commercially insured patients and Medicare-eligible patients with employer-sponsored supplemental medical benefits using the MarketScan Databases. The analysis consisted of two parts. In part I, we examined cost or savings per patient associated with care by podiatric physicians using propensity score matching and regression techniques; in part II, we extrapolated cost or savings to populations. RESULTS: Matched and regression-adjusted results indicated that patients who visited a podiatric physician had $13,474 lower costs in commercial plans and $3,624 lower costs in Medicare plans during 2-year follow-up (P < .01 for both). A positive net present value of increasing the share of patients at risk for diabetic foot ulcer by 1% was found, with a range of $1.2 to $17.7 million for employer-sponsored plans and $1.0 to $12.7 million for Medicare plans. CONCLUSIONS: These findings suggest that podiatric medical care can reduce the disease and economic burdens of diabetes.

The relationship between health risks and health and productivity costs among employees at Pepsi Bottling Group.

OBJECTIVE: To evaluate relationships between modifiable health risks and costs and measure potential cost savings from risk reduction programs. METHODS: Health risk information from active Pepsi Bottling Group employees who completed health risk assessments between 2004 and 2006 (N = 11,217) were linked to medical care, workers' compensation, and short-term disability cost data. Ten health risks were examined. Multivariate analyses were performed to estimate costs associated with having high risk, holding demographics, and other risks constant. Potential savings from risk reduction were estimated. RESULTS: High risk for weight, blood pressure, glucose, and cholesterol had the greatest impact on total costs. A one-percentage point annual reduction in the health risks assessed would yield annual per capita savings of $83.02 to $103.39. CONCLUSIONS: Targeted programs that address modifiable health risks are expected to produce substantial cost reductions in multiple benefit categories.

The Novartis health index: a method for valuing the economic impact of risk reduction in a workforce.

OBJECTIVES: To develop a calculator that measures the potential cost impact of changes in health risks and presents results graphically. METHODS: Demographic and health risk data for Novartis employees were input into a calculator that estimated employer medical care, short-term disability, absenteeism, and presenteeism costs associated with risk prevalence, based on a previous cross-sectional analysis of the association between risks and costs. Estimated costs were presented as a relative score, the Novartis Health Index, which is a measure of the overall costs associated with the risk profile of a population of interest. RESULTS: The population of Novartis employees had an index score of 81.5 (out of 100), indicating a relatively healthy risk profile, and baseline annual costs of $9619 per employee. Risk reduction of 1% and 10% for tobacco, alcohol use, and emotional health risks had the potential to generate annual savings of $91,500 and $915,000, respectively. CONCLUSIONS: The Novartis Health Index framework allows employers to track performance relative to health risk management using a single, accessible, user-friendly measure.

Uterine fibroid treatment patterns in a population of insured women.

OBJECTIVE: To profile women treated for uterine leiomyomas who are covered by commercial insurance from large, self-insured employers in the United States. DESIGN: Retrospective, observational study. SETTING: Inpatient, outpatient, and prescription drug experience of women with employer-sponsored insurance in the United States. PATIENT(S): Data were obtained from the MarketScan insurance databases for 1999 through 2004 and weighted to represent the population of women with employer-sponsored health insurance in the United States. INTERVENTION(S): None. MAIN OUTCOME MEASURE(S): The proportion of women with clinically significant leiomyomas was determined in each year, based on inpatient and outpatient medical claims with diagnostic codes indicating leiomyoma. Patient characteristics, comorbidities, prescription drug treatments, and surgical interventions were profiled in 2004. RESULT(S): Approximately 1% of women had clinically significant leiomyomas. Comorbid genital or menstrual conditions were common and much more prevalent for women with leiomyomas. Of women with leiomyomas, 18.4% received no surgical or prescription drug treatment, whereas 16.8% received only surgical treatment, 22.4% received only prescription drug treatment, and 42.4% received both. Hysterectomy was the most common surgical treatment. CONCLUSION(S): Generalizing from this sample, we estimate that 443,445 women with employer-sponsored insurance in the United States had clinically significant leiomyomas in 2004.