Real-world impact of continuous positive airway pressure on sleepiness in patients with obstructive sleep apnea in a national registry.

OBJECTIVE: Excessive daytime sleepiness (EDS) persists in some patients with obstructive sleep apnea (OSA) despite continuous positive airway pressure (CPAP) treatment. This study characterized response to CPAP and factors associated with residual EDS. METHODS: Danish National Patient Registry data were analyzed. Patients with OSA diagnosis (1994-2016), Epworth Sleepiness Scale (ESS) scores and apnea-hypopnea index recorded before beginning CPAP (baseline) and after 1-13 months of CPAP use, and CPAP adherence were included. Odds ratios (OR) for residual EDS after CPAP treatment were estimated using multivariate logistic regression. RESULTS: Of 1174 patients (mean age, 57 years; 75.5% male), 41.1% had baseline EDS (mild, 13.2%; moderate, 14.0%; severe, 13.9%); 58.9% did not. After CPAP treatment, follow-up mean ESS scores were normal (≤10) for all baseline EDS subgroups; however, 15.6% (n = 183) of patients had residual EDS (mild, 6.7%; moderate, 5.5%; severe, 3.4%). Odds of residual EDS were higher for patients with mild (OR, 5.2; 95% confidence interval [CI], 3.2-8.6), moderate (OR, 4.5; 95% CI, 2.7-7.4), and severe (OR, 13.0; 95% CI, 8.0-21.2) EDS at baseline compared with those with normal daytime sleepiness at baseline. Patients adherent with CPAP use were 38.2% less likely to have residual EDS compared with nonadherent patients (OR, 0.62; 95% CI, 0.43-0.88). CONCLUSIONS: EDS was common in this cohort of Danish patients with OSA. Baseline EDS severity predicted higher odds of residual EDS. After CPAP treatment, adherence was associated with reduced odds of residual EDS, but EDS persisted in a subgroup of patients.

Obstructive sleep apnea and risk of motor vehicle accident.

OBJECTIVE: To evaluate the association between obstructive sleep apnea (OSA) and risk of motor vehicle accident (MVA). METHODS: We conducted a cohort study at Kaiser Permanente Washington using electronic health plan data and linked Washington State Department of Transportation MVA records. We included persons 18-79 years of age during 2005-2014. OSA was ascertained via diagnosis codes. The primary outcome, first MVA during cohort follow-up, was ascertained from state MVA records. Risk factors for MVAs, including medical conditions and medication use, were ascertained from health plan data. Multivariable Cox proportional hazards models were used to estimate the adjusted hazard ratio (HR) and 95% confidence interval (CI) for the association between OSA and study outcomes. RESULTS: Among the 879,547 eligible persons, the unadjusted rate of MVA in those with and without OSA was 238 and 229 per 10,000 person-years, respectively. A diagnosis of OSA was associated with a 17% increased risk of MVA (adjusted HR = 1.17; 95% CI: 1.13 to 1.20). CONCLUSION: In this large population-based study, a diagnosis of OSA was associated with a modestly increased risk of MVA.

Assessing the impact of sodium oxybate treatment on functioning, productivity, and health-related quality of life in patients with narcolepsy: findings from the Nexus Narcolepsy Registry (waves 1-4).

BACKGROUND: The aim of this study was to evaluate the impact of different therapy regimens, including sodium oxybate (SXB)-containing regimens, on patient-reported outcomes (PROs) in people with narcolepsy. METHODS: Online surveys were used to collect information from persons with narcolepsy in the Nexus Narcolepsy Registry. Surveys contained questionnaires assessing self-reported sleep quality (SQ; via single question), daytime sleepiness and function (Epworth Sleepiness Scale and Functional Outcomes of Sleep Questionnaire), health-related quality of life (HRQoL; 36-Item Short Form Health Survey [SF-36]), work productivity and impairment (Work Productivity and Activity Impairment: Specific Health Problem), and history of injuries or motor vehicle accidents. Treatment with SXB (including monotherapy or combination therapy; SXB group) was compared with non-SXB therapy (No SXB group). The P values presented are nominal, as there are no adjustments for multiplicity. RESULTS: From June 2015 through December 2017, 983 participants completed 1760 surveys. SQ and daytime functioning scores were better in the SXB group compared with the No SXB group (all P < 0.001). HRQoL scores were better for the SXB group compared with the No SXB group for the SF-36 Physical Component (P = 0.016), Mental Component (P < 0.001), and all 8 subscales. Additionally, PROs were better for the SXB group for presenteeism, overall work and activity impairment, and risk of motor vehicle accidents (all P ≤ 0.001). CONCLUSION: Based on participants' self-assessments, treatment regimens with SXB were associated with better outcomes than regimens not containing SXB across many PROs, including SQ, HRQoL, work and activities, and risk of traffic accidents. CLINICALTRIALS. GOV IDENTIFIER: NCT02769780.

The Nexus Narcolepsy Registry: methodology, study population characteristics, and patterns and predictors of narcolepsy diagnosis.

OBJECTIVE/BACKGROUND: The real-world experience of people with narcolepsy is not well understood. PATIENTS/METHODS: The Nexus Narcolepsy Registry (NCT02769780) is a longitudinal, web-based patient registry of self-reported data from adults with physician-diagnosed narcolepsy. Surveys were electronically distributed every 6 months; the current analysis reports registry population demographics, narcolepsy diagnosis journey, and predictors of diagnostic delays. RESULTS: The registry population included in this analysis (N = 1024) was predominantly female (85%) and White (92%), with a mean age of 37.7 years. Most participants had education/training beyond high school (93%). Mean (median) reported ages at narcolepsy symptom onset, first consultation for symptoms, and narcolepsy diagnosis were 18.1 (16), 26.4 (24), and 30.1 (28) years, respectively. A majority (59%) of participants reported ≥1 misdiagnosis, and 29% reported consulting ≥5 physicians before narcolepsy diagnosis. More than half (56%) of participants' first consultations for narcolepsy symptoms were with a general practitioner, whereas the diagnosing clinician was usually a sleep specialist (64%) or neurologist (27%). Pediatric symptom onset was associated with a longer mean interval to first consultation than adult symptom onset (10.7 and 4.6 years, respectively; P < 0.001) and a longer mean interval between first consultation and diagnosis (4.5 and 2.2 years, respectively; P < 0.001). Overall, mean (95% CI) time from symptom onset to diagnosis was 11.8 (11.1-12.5) years. CONCLUSIONS: The Nexus Narcolepsy Registry data indicate that onset of narcolepsy symptoms frequently occurs in childhood or adolescence. In many individuals, the diagnostic process is long and involves multiple physicians and frequent misdiagnosis.

Burden of disease in pediatric narcolepsy: a claims-based analysis of health care utilization, costs, and comorbidities.

BACKGROUND: This study analyzed a privately insured pediatric population with and without narcolepsy to determine the impact of pediatric narcolepsy on comorbidities, health care utilization, and cost. Additional analyses compared narcolepsy type 1 and type 2. METHODS: This retrospective cross-sectional study identified US patients with narcolepsy <18 years of age with ≥2 claims with a diagnosis code of narcolepsy using Truven MarketScan® data 2011 to 2015. Patients were matched to controls without narcolepsy. Comorbid conditions, health care utilization, and costs were measured by calendar year. P values are nominal, and no adjustments for multiplicity or multiple comparisons were made. RESULTS: A total of 1427 pediatric patients with narcolepsy were identified and matched with 4281 controls from 2011 to 2015. Patients with narcolepsy had more comorbid conditions (mean 5.8 vs 2.4, nominal P < 0.001). Respiratory diseases and mood disorders were more common in patients with narcolepsy than controls (57% vs 32% and 56% vs 14%, respectively; both nominal P < 0.001). Compared to controls, patients with narcolepsy underwent more diagnostic tests (electroencephalogram, EEG [0.13 vs 0.0053]) and brain computed tomography, CT/magnetic resonance imaging, MRI (0.26 vs 0.022; both nominal P < 0.001). Mean annual inpatient days (0.71 vs 0.15), emergency department visits (0.51 vs 0.15), and outpatient office visits (8.6 vs 2.3) were higher for patients with narcolepsy than controls (all nominal P < 0.001). Annual mean health care costs were higher for patients with narcolepsy versus controls ($15,797 vs $2449, nominal P < 0.001). CONCLUSION: Pediatric patients with narcolepsy had greater comorbidity, higher health care utilization, and higher costs than patients without narcolepsy.

Treatment satisfaction with ITCA 650, a novel drug-device delivering continuous exenatide, versus twice-daily injections of exenatide in type 2 diabetics using metformin.

AIMS: To evaluate treatment satisfaction in patients with type 2 diabetes (T2D) not adequately controlled by metformin, randomized to ITCA 650 (continuous exenatide in osmotic mini-pump) vs twice-daily exenatide injections (Ex-BID). MATERIALS AND METHODS: The Diabetes Medication Satisfaction Tool (DM-SAT) was administered and assessments were made at baseline, Week 8 and Week 20 during a 24-week open-label phase 2 trial. In Stage I (Weeks 1-12), 155 patients, comprising the ITT population, were randomized to 3 groups: ITCA 650 20 µg/day, ITCA 650 40 µg/day and Ex-BID 10 µg BID. In Stage II (Weeks 13-24), ITCA 650 groups were re-randomized to either remain on the Stage I dose or receive a higher dose. Patients treated with Ex-BID were randomized to 40 or 60 µg/day ITCA 650. RESULTS: Patients using ITCA 650 reported significant increases in overall treatment satisfaction by Week 8 vs those using Ex-BID (P < .01), despite similar clinical efficacy and overall rates of nausea. During Stage II, further improvement in HbA1c and weight were seen after 3-fold dose escalation of ITCA 650 and treatment satisfaction was maintained. When patients using Ex-BID were switched to ITCA 650, treatment satisfaction increased and reached levels similar to those initially treated with ITCA 650. Neither GI side effects of nausea and/or vomiting, nor the procedure to sub-dermally place ITCA 650, significantly impacted treatment satisfaction scores. CONCLUSION: ITCA 650 added to metformin for patients with T2D, and for those who switched to ITCA 650 from Ex-BID, meaningfully improved glucose control and significantly increased overall treatment satisfaction.

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.

Achievement of Glycated Hemoglobin Goals in the US Remains Unchanged Through 2014.

INTRODUCTION: Previous research has found that the percentage of US adults with diabetes achieving a glycated hemoglobin (HbA1c) target of <7.0% with currently available treatments has been fairly constant from 2003 to 2010, remaining at just over 50% [1]. The objective of this study was to compare the most recent data (2011-2014) with earlier data to track progress on HbA1c target achievement, for both the general target of <7.0% and inferred individualized targets based on age and the presence of complications. METHODS: Data from 2677 adults with self-reported diabetes from the National Health and Nutrition Examination Survey (NHANES) from 2007 to 2014 were examined to determine the percentage of adults who achieved HbA1c targets of <7% and an individualized target based on age and comorbidities. National estimates are reported by using weights that account for the complex sampling design of the NHANES. RESULTS: The percentage of people with diabetes and HbA1c <7.0% slightly declined from 52.2% (95% CI 48.7-55.7%) to 50.9% (95% CI 47.2-54.7%) between the two most recent waves of data. Achievement of individualized targets declined from 69.8% (95% CI 66.5-73.0%) to 63.8% (95% CI 60.1-67.5%). The percentage with HbA1c >9.0% increased from 12.6% (95% CI 10.5-14.8%) to 15.5% (95% CI 12.9-18.2%). Achievement of individualized targets varied by age group and presence of comorbidities, but exhibited similar trends as general target achievement. CONCLUSIONS: Despite the development of many new medications to treat diabetes during the past decade, the proportion of patients achieving glycemic control targets has not improved. FUNDING: Intarcia Therapeutics.

The Expected Net Present Value of Developing Weight Management Drugs in the Context of Drug Safety Litigation.

BACKGROUND: Following withdrawals, failures, and significant litigation settlements, drug product launches in the anti-obesity category slowed despite a large and growing unmet need. Litigation concerns, a more risk-averse regulatory policy, and the difficulty of developing a product with a compelling risk-benefit profile in this category may have limited innovators' expected return on investment and restricted investment in this therapeutic area. OBJECTIVE: The objective of the study was to estimate perceived manufacturer risk associated with product safety litigation and increased development costs vs. revenue expectations on anticipated return on investment and to determine which scenarios might change a manufacturer's investment decision. METHODS: Expected net present value of a weight-management drug entering pre-clinical trials was calculated for a range of scenarios representing evolving expectations of development costs, revenue, and litigation risk over the past 25 years. These three factors were based on published estimates, historical data, and analogs from other therapeutic areas. RESULTS: The main driver in expected net present value calculations is expected revenue, particularly if one assumes that litigation risk and demand are positively correlated. Changes in development costs associated with increased regulatory concern with potential safety issues for the past 25 years likely did not impact investment decisions. CONCLUSIONS: Regulatory policy and litigation risk both played a role in anti-obesity drug development; however, product revenue-reflecting efficacy at acceptable levels of safety-was by far the most important factor. To date, relatively modest sales associated with recent product introductions suggest that developing a product that is sufficiently efficacious with an acceptable level of safety continues to be the primary challenge in this market.

The Relationship between Local Economic Conditions and Acute Myocardial Infarction Hospital Utilization by Adults and Seniors in the United States, 1995-2011.

OBJECTIVE: To assess the association between aggregate unemployment and hospital discharges for acute myocardial infarction (AMI) among adults and seniors, 1995-2011. DATA SOURCES/STUDY SETTING: Community hospital discharge data from states collected for the Healthcare Cost and Utilization Project (HCUP) State Inpatient Databases (SID) and economic data from the Bureau of Labor Statistics, 1995-2011. STUDY DESIGN: Quarterly time series study of unemployment and aggregate hospital discharges in local areas using fixed effects to control for differences between local areas. DATA COLLECTION/EXTRACTION METHODS: Secondary data on inpatient stays and unemployment rates aggregated to micropolitan and metropolitan areas. PRINCIPAL FINDINGS: For both adults and seniors, a 1 percentage point increase in the contemporaneous unemployment rate was associated with a statistically significant 0.80 percent (adults) to 0.96 percent (seniors) decline in AMI hospitalization during the first half of the study but was unrelated to the economic cycle in the second half of the study period. CONCLUSIONS: The study found evidence that the aggregate relationship between health and the economy may be shifting for cardiovascular events, paralleling recent research that has shown a similar shift for some types of mortality (Ruhm 2013), self-reported health, and inpatient use among seniors (McInerney and Mellor 2012).

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 relationship between 11 health risks and medical and productivity costs for a large employer.

OBJECTIVE: To evaluate the relationship between modifiable health risks, and health and productivity related expenditures and predict cost savings from improvements in the health risk profile of a large US employer. METHODS: Information was collected on 11 modifiable health risks for active employees who completed a health assessment and enrolled in a noncapitated health plan. These risks were related to employer medical care costs and employee productivity. Multivariate analyses were performed to estimate costs associated with high risk, as well as potential savings from reducing risk prevalence among employees. RESULTS: Health risks with the greatest impact on total medical care costs included obesity, high blood pressure, high blood glucose, high triglycerides, and inadequate exercise. CONCLUSIONS: Modifiable health risks are associated with higher employer costs. Targeted programs that address these risks are expected to yield substantial savings.

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 impact of weight gain or loss on health care costs for employees at the Johnson & Johnson Family of Companies.

OBJECTIVE: To quantify the impact of weight gain or weight loss on health care costs. METHODS: Employees completing at least two health risk assessments during 2002 to 2008 were classified as adding, losing, or staying at high/low risk for each of the nine health risks including overweight and obesity. Models for each risk were used to compare cost trends by controlling for employee characteristics. RESULTS: Employees who developed high risk for obesity (n = 405) experienced 9.9% points higher annual cost increases (95% confidence interval: 3.0%-16.8%) than those who remained at lower risk (n = 8015). Employees who moved from high to lower risk for obesity (n = 384), experienced annual cost increases that were 2.3% points lower (95% confidence interval: -7.4% to 2.8%) than those who remained high risk (n = 1699). CONCLUSIONS: Preventing weight gain through effective employee health promotion programs is likely to result in cost savings for employers.

Cost burden of treatment resistance in patients with depression.

OBJECTIVE: To develop a claims-based scale for treatment-resistant depression (TRD) and estimate the associated direct cost burden. STUDY DESIGN: Retrospective, observational study of patients receiving antidepressant therapy between January 2000 and June 2007 (N = 78,477). METHODS: The Massachusetts General Hospital (MGH) clinical staging method for treatment resistance (assigning points for adequate trials of antidepressant medication, upward dose titration, extended duration, augmentation, and electroconvulsive therapy) was applied to claims data from the MarketScan Research Databases over a 24-month time period. Direct expenditures were measured over a subsequent 12-month period. Patients identified as having TRD (MGH score >or=3.5) (n = 22,593) were matched to depressed patients without TRD using propensity score methods. Regression models estimated the relationship between TRD and expenditures, controlling for sociodemographics, health plan type, and health status. Similar regression models estimated costs for an antidepressant-only version of the scale (MGH-AD). RESULTS: Treatment resistance among depressed patients was associated with 40% higher medical care costs (P <.001). The MGH-AD score was associated with an increasing gradient in direct costs. Annual costs for patients with mild TRD (MGH-AD 3.5-4) were $1530 higher than those for non-TRD patients, and costs for patients with complex TRD (MGH-AD >or=6.5) were $4425 higher than those for non-TRD patients (all P <.001). A 1-point increase in the MGH-AD score was associated with a $590 increase in annual costs (P <.001). CONCLUSIONS: Early identification of TRD patients, using a claims-based algorithm, may support targeted interventions for these patients.