Treatment patterns in patients with type 2 diabetes mellitus treated with glucagon-like peptide-1 receptor agonists: Higher adherence and persistence with dulaglutide compared with once-weekly exenatide and liraglutide.

AIMS: To compare adherence (proportion of days covered [PDC]), persistence, and treatment patterns among patients with type 2 diabetes mellitus (T2DM) newly initiating glucagon-like peptide-1 receptor agonists (GLP-1RAs). More specifically, the main objectives were to compare dulaglutide vs exenatide once weekly and dulaglutide vs liraglutide. METHODS: Patients with T2DM newly initiating dulaglutide, albiglutide, exenatide once weekly, exenatide twice daily and liraglutide between November 2014 and April 2015 were hierarchically selected from Truven Health's MarketScan Research Databases. Propensity score matching was used to account for selection bias. Adherence to and persistence with the index GLP-1RA, and switching and augmentation patterns were assessed during the 6-month post-index period. RESULTS: Mean adherence for the matched cohorts was significantly higher for dulaglutide than for exenatide once weekly (0.72 vs 0.61; P < .0001) and liraglutide (0.71 vs 0.67; P < .0001). The percentage of patients achieving PDC ≥ 0.80 was significantly higher for dulaglutide compared with exenatide once weekly (54.2% vs 37.9%; P < .0001) and liraglutide (53.5% vs 44.3%; P < .0001). The mean (standard deviation) days on treatment for all matched patients was significantly higher for patients in the dulaglutide cohort compared with those in the exenatide once-weekly (148.4 [55.4] vs 123.6 [61.6]; P < .0001) and liraglutide cohorts (146.0 [56.9] vs 137.4 [60.1]; P < .0001). A significantly lower proportion of patients on dulaglutide discontinued treatment compared with those on exenatide once weekly (26.2% vs 48.4%; P < .0001) and those on liraglutide (28.0% vs 35.6%; P < .0001). CONCLUSIONS: Dulaglutide initiators had significantly higher adherence, were more persistent, and had lower discontinuation rates compared with initiators of exenatide once weekly or liraglutide during the 6-month follow-up period.

The importance of unresolved fatigue in depression: costs and comorbidities.

OBJECTIVE: To assess the cost outcomes of patients with a history of depression and clinically significant fatigue. METHODS: Adults with ≥ 2 claims with depression diagnosis codes identified from the HealthCore Integrated Research Database were invited to participate in this study linking survey data with retrospective claims data (12-mo presurvey and postsurvey periods). Patient surveys included measures for depression (Quick Inventory of Depressive Symptomatology), fatigue (Fatigue Associated with Depression Questionnaire), anxiety (7-item Generalized Anxiety Disorder scale), sleep difficulty (Athens Insomnia Scale), and pain (Brief Pain Inventory). After adjusting for demographic and clinical characteristics using propensity scores, postsurvey costs were compared between patients with and without fatigue using nonparametric bootstrapping methods. RESULTS: Of the 1982 patients who had completed the survey and had complete claims data, 653 patients had significant levels of fatigue. Patients with fatigue reported significantly higher scores, indicating greater severity, on measures of depression, pain, sleep difficulty, and anxiety (all p < 0.05). These patients also had higher levels of overall medication use and were more likely to have lower measures of socioeconomic status than patients without significant levels of fatigue (all p < 0.05). Mean annual total costs were greater for patients with fatigue than those without fatigue ($14,462 vs $9971, respectively, p < 0.001). These cost differences remained statistically significant after adjusting for clinical and demographic differences. CONCLUSIONS: Clinically significant fatigue appears to add to the economic burden of depression. This reinforces the need for aggressive treatment of all symptoms and further examination of the variability of this relationship as patients approach remission.

Duloxetine use in employees with low back pain: treatment patterns and direct and indirect costs.

OBJECTIVE: The study aims to examine real-world effects of duloxetine treatment for low back pain (LBP). METHODS: The study identified employees with ≥1 LBP diagnosis and ≥1 duloxetine prescription within a year after LBP diagnosis from a privately insured claims database (2004-2007). Duloxetine-treated employees were propensity score matched to employees initiating another pharmacological/noninvasive treatment in the same month from LBP diagnosis. Treatment patterns and costs were compared over the 6 months following treatment initiation. RESULTS: Relative to controls, duloxetine-treated employees (N = 753) had significantly lower rates of other pharmacological/noninvasive therapies and a similar LBP surgery rate (1.7% vs 2.8%, P = 0.1573). Duloxetine-treated employees, despite higher pharmacy costs, had similar direct (health care) costs ($4,935 vs $5,649, P = 0.2662), and significantly lower indirect (workloss) costs ($1,723 vs $2,198, P = 0.0036). CONCLUSIONS: Duloxetine treatment in LBP employees was associated with reduced rates of many nonsurgical therapies and lower indirect costs. The findings are limited by the observational study design and unmeasured potential confounders.

Evaluating the utility of existing patient-reported outcome scales in novel patient populations with pancreatic cancer, lung cancer, and myeloproliferative neoplasms using medicare current beneficiary survey data.

BACKGROUND: While there are validated patient-reported outcomes (PRO) instruments for use in specific cancer populations, no validated general instruments exist for use in conditions common to multiple cancers, such as muscle wasting and consequent physical disability. The Medicare Current Beneficiary Survey (MCBS), a survey in a nationally representative sample of Medicare beneficiaries, includes items from three well known scales with general applicability to cancer patients: Katz activities of daily living (ADL), Rosow-Breslau instrumental ADL (IADL), and a subset of physical performance items from the Nagi scale. OBJECTIVE: This study evaluated properties of the Katz ADL, Rosow-Breslau IADL, and a subset of the Nagi scale in patients with pancreatic cancer, lung cancer, and myeloproliferative neoplasms (MPN) using data from MCBS linked with Medicare claims in order to understand the potential utility of the three scales in these populations; understanding patient-perceived significance was not in scope. METHODS: The study cohorts included Medicare beneficiaries aged ≥65 years as of 1 January of the year of their first cancer diagnosis with one or more health assessments in a community setting in the MCBS Access to Care data from 1991 to 2009. Beneficiaries had at least two diagnoses in de-identified Medicare claims data linked to the MCBS for one of the following cancers: pancreatic, lung, or MPN. The Katz ADL, Rosow-Breslau IADL, and Nagi scales were calculated to assess physical functioning over time from cancer diagnosis. Psychometric properties for each scale in each cohort were evaluated by testing for internal consistency, test-retest reliability, and responsiveness by comparing differences in mean scale scores over time as cancer progresses, and differences in mean scale scores before and after hospitalization (for lung cancer cohort). RESULTS: The study cohorts included 90 patients with pancreatic cancer, 863 with lung cancer, and 135 with MPN. Among each cancer cohort, the Katz ADL, Rosow-Breslau IADL, and Nagi scales had acceptable internal consistency (Cronbach's alpha generally between 0.70 and 0.90) and test-retest reliability for consecutive surveys before diagnosis and consecutive surveys after diagnosis (when patients' functioning was more stable). Compared with mean scale scores at the survey 1-2 years before cancer diagnosis (baseline), mean scale scores at the first survey after cancer diagnosis were significantly higher (P < 0.05), indicating worsening, for Katz ADL, Rosow-Breslau IADL, and Nagi scales (items scored 0-1) (0.54 vs. 1.45, 1.15 vs. 2.20, and 2.29 vs. 3.08, respectively, for pancreatic cancer; 0.73 vs. 1.24, 1.29 vs. 2.01, and 2.41 vs. 2.85 for lung cancer; and 0.44 vs. 0.86, 0.87 vs. 1.36, and 1.87 vs. 2.32 for MPN). Among lung cancer patients, scale scores increased significantly following a hospitalization, suggesting a worsening of functional status. CONCLUSIONS: The Katz ADL, Rosow-Breslau IADL, and Nagi scales collected in the MCBS demonstrate acceptable internal consistency and test-retest reliability among patients with pancreatic cancer, lung cancer, and MPN, and are consistent with clinical worsening following diagnosis or hospitalization. These results suggest that using retrospective data may allow researchers to conduct preliminary assessments of existing PRO instruments in new populations of interest and generate useful exploratory disease information before embarking on de novo PRO development.

What do network members know? Network members as reporters of depression among Caucasian-American and African-American older women.

OBJECTIVE: To determine whether family members and friends can be accurate reporters of depression in older women and whether their reports predict diagnostic depression concurrently and across a one-year time interval. METHOD: African-American and Caucasian older women (N = 153; mean age = 75) previously screened for depression nominated network members (NMs) who could be contacted as informants. NMs completed an informant version of the CES-D, described their closeness to the participant, the extent of the participant's support from family and friends, and their assessment of the participant's typical coping strategies. These reports were then used to predict participant CES-D, Hamilton depression scores, and Structured Clinical Interview (SCID) depression diagnoses concurrently and at six-month and one-year intervals. RESULTS: NMs' estimates of participants CES-D status were highly correlated with participants own CES-D scores, and also predicted Hamilton depression scores and SCID diagnoses concurrently and at six months and one year later. NMs' ratings of participants' use of positive coping also predicted depression at six months and one year. CONCLUSION: NMs knew when elderly women were depressed and their reports were accurate predictors of depression even one year later, which implies that elderly depression does not abate spontaneously. Future research should test the possibility that family and friends might be recruited as allies in encouraging earlier treatment and in providing support to older adults through difficult life transitions.

The direct and indirect costs among U.S. privately insured employees with hypogonadism.

INTRODUCTION: While previous studies have noted that hypogonadism (HG) may pose a significant economic and quality-of-life burden, no studies have evaluated the impact of HG on healthcare utilization and costs in the United States. AIM: Compare direct (health care) and indirect (disability leave or medical absence) costs between privately insured U.S. employees with HG and controls without HG. METHODS: The study sample included 4,269 male employees, ages 35-64, with ≥ 2 HG diagnoses (International Classification of Diseases, Ninth Revision, Clinical Modification: 257.2x) or ≥ 1 HG diagnosis and ≥ 1 claim for testosterone therapy, 1/1/2005-3/31/2009, identified from a large, private insurance administrative database that includes medical, prescription drug, and disability claims data. The index date was the most recent HG diagnosis that had continuous eligibility for at least 1 year before (baseline period) and 1 year after (study period). Employees with HG were matched 1:1 on age, region, salaried vs. nonsalaried employment status, and index year to controls without HG. MAIN OUTCOME MEASURES: Descriptive analyses compared demographic characteristics, comorbidities, resource utilization, direct and indirect costs inflated to USD 2009. Multivariate analyses adjusting for baseline characteristics were used to estimate risk-adjusted costs. RESULTS: HG employees and controls had a mean age of 51 years. HG employees compared with controls had higher baseline comorbidity rates, including hyperlipidemia (50.2% vs. 25.3%), hypertension (37.7% vs. 21.1%), back/neck pain (32.0% vs. 15.7%), and human immunodeficiency virus/acquired immunodeficiency syndrome (7.1% vs. 0.3%) (all P < 0.0001). HG employees had higher mean study period direct ($10,914 vs. $3,823) and indirect costs ($3,204 vs. $1,450); HG-related direct costs were $832 (all P < 0.0001). Risk-adjusted direct ($9,291 vs. $5,248) and indirect ($2,729 vs. $1,840) costs were also higher for HG employees (all P < 0.0001). CONCLUSIONS: Employees with HG had higher comorbidity rates and costs compared with controls. Given the low HG-related costs, a primary driver of costs among HG patients appears to be their comorbidity burden.

Duloxetine use in chronic low back pain: treatment patterns and costs.

BACKGROUND: Little is known about the real-world treatment patterns and costs of patients with chronic low back pain (CLBP) who are treated with duloxetine compared with those receiving other non-surgical treatments. OBJECTIVE: Our objective was to compare the real-world treatment patterns and costs between patients with CLBP who initiated duloxetine and matched controls who initiated another non-surgical treatment. METHODS: The study sample was selected from a US privately insured claims database (2004-8). Selected patients were aged 18-64 years, and had a low back pain (LBP) diagnosis (per Healthcare Effectiveness Data and Information Set [HEDIS] specifications) with a subsequent CLBP-qualifying diagnosis recorded ≥90 days after the initial LBP diagnosis. Duloxetine-treated patients had ≥1 duloxetine prescription within 6 months after CLBP diagnosis, no prior duloxetine claim, and continuous eligibility ≥12 months before first LBP diagnosis and ≥6 months after index duloxetine prescription (study period). Because duloxetine patients had higher rates of co-morbidities, 553 duloxetine-treated patients were matched to 553 control patients who initiated another non-surgical LBP treatment based on propensity score and time from first LBP diagnosis to treatment initiation. A subset (n = 103 each) of matched employees with disability data was also analysed to assess work loss. Main outcomes measures included study period treatment rates and direct (medical and drug) costs from a third-party payer perspective and employee indirect (work-loss) costs. McNemar tests were used to compare LBP treatment rates. Bias-corrected bootstrapping t-tests were used to compare costs. RESULTS: After matching, the two groups had balanced baseline characteristics including demographics, LBP diagnostic categories, co-morbidity profiles, resource use, treatment patterns and mean direct costs. During the 6-month study period, matched duloxetine-treated patients had significantly lower rates of other pharmacological therapy (e.g. 56.2% vs 64.9% narcotic opioids, p = 0.0024; 34.9% vs 49.5% NSAIDs, p < 0.0001) and non-invasive therapy (28.8% vs 38.5% chiropractic therapy, p = 0.0007; 25.5% vs 35.4% physical therapy, p = 0.0004; 17.5% vs 28.4% exercise therapy, p < 0.0001) than controls. Duloxetine-treated patients versus controls had similar back surgery rates (2.2% vs 3.8%; p = 0.1127) and similar direct costs ($US7658 vs $US7439; p = 0.8119). Among CLBP employees, duloxetine-treated employees versus controls had lower rates of other non-surgical therapy, similar back surgery rates (0.0% vs 3.9%; p = 0.1250), lower total direct and indirect costs ($US5227 vs $US7299; p = 0.0418), and similar indirect costs ($US1806 vs $US2664; p = 0.0528). CONCLUSIONS: Duloxetine treatment in CLBP patients/employees versus other non-surgical treatment was associated with reduced rates of non-surgical therapies and similar back surgery rates, without increased costs.

Real-world role of tricyclic antidepressants in the treatment of fibromyalgia.

OBJECTIVE: To examine the real-world role of tricyclic antidepressants (TCAs) in fibromyalgia (FM) treatment. METHODS: Using privately insured U.S. administrative claims data, this study examined TCA use for newly diagnosed FM patients. Patients ages 18 to 64 years with ≥ 2 FM diagnoses (ICD-9-CM: 729.1) during Q1:2007 to Q1:2009, no previous FM diagnosis, and continuous eligibility for insurance during the year before and after the first FM diagnosis ("study period") were identified as newly diagnosed (N = 10,129). Treatment with TCAs was examined over the first treatment episode (allowing up to a 45-day gap between refills). A sensitivity analysis was performed excluding patients with depression/anxiety diagnoses during the study period. RESULTS: During the study period, 8.9% of patients with FM used TCAs at anytime, 5.0% used TCAs during the year before FM diagnosis, and 7.2% used TCAs during the year after. The mean (median) duration of the first treatment episode was 150 (58) days. During this episode, 84.0% used other medications concomitantly, with 60.3% using analgesics and 39.6% using other antidepressants. Additionally, 60.8% augmented TCA use with other drugs, 61.8% switched to another drug at the end of their TCA episode, and 22.8% discontinued TCAs without switching. Similar patterns were observed for the subset of patients with no depression or anxiety (N = 7,655). DISCUSSION: Research covering 1999 to 2005 using the same methods found that 15.9% of patients with FM used TCAs during the year before FM diagnosis and 20.7% used TCAs during the year after. These findings suggest that TCA use among the patients with FM is uncommon and may be declining in real-world practice.

Real-world practice patterns, health-care utilization, and costs in patients with low back pain: the long road to guideline-concordant care.

BACKGROUND CONTEXT: Treatment guidelines suggest that most acute low back pain (LBP) episodes substantially improve within a few weeks and that immediate use of imaging and aggressive therapies should be avoided. PURPOSE: Assess the actual practice patterns of imaging, noninvasive therapy, medication use, and surgery in patients with LBP, and compare their costs to those of matched controls without LBP. STUDY DESIGN: A retrospective analysis of claims data from 40 self-insured employers in the United States. PATIENT SAMPLE: The study sample included 211,551 patients, aged 18 to 64 years, with one LBP diagnosis or more (per Healthcare Effectiveness Data and Information Set specification) during 2004 to 2006, identified from a claims database. Patients had continuous eligibility for 12 months or more after their index LBP diagnosis (study period), for 6 months or more before their index diagnosis (baseline period), and no other LBP diagnosis during the baseline period. Patients with LBP were matched to a random cohort of patients without LBP by age, gender, employment status, and index year. OUTCOMES MEASURES: Physiological measures (eg, imaging and diagnostic tests), functional measures (eg, pharmacologic and nonpharmacologic treatment for LBP, health-care resource use), and direct (medical and prescription drug) and indirect (disability and medically related absenteeism) costs were assessed within the year after the LBP diagnosis. METHODS: Univariate analyses described treatment patterns and compared baseline characteristics and study period costs. RESULTS: Patients with LBP had significantly higher rates of baseline comorbidities and resource use compared with controls. Of patients with LBP, 41.6% had imaging mean (median) [standard deviation] 34.3 (0) [78.6] days after the LBP diagnosis. Most patients with LBP (69.4%) used medications starting 51.9 (8) [86.2] days after the diagnosis. Opioids were commonly prescribed early (41.6% of patients; after 82.8 (25) [105.9] days). Of patients with LBP, 2.05% had surgery during the study period. Patients with LBP were likely to have chiropractic treatment first, followed by pharmacotherapy with muscle relaxants and nonsteroidal anti-inflammatory drugs. Except for less surgery, these findings also held for patients with only nonspecific LBP. Patients with LBP had higher mean direct costs compared with controls ($7,211 vs. $2,382, respectively; p<.0001), with surgery patients having mean direct costs of $33,931. CONCLUSIONS: Contrary to clinical guidelines, many patients with LBP start incurring significant resource use and associated expenses soon after the index diagnosis. Achieving guideline-concordant care will require substantial changes in LBP practice patterns.

The association between insomnia severity and healthcare and productivity costs in a health plan sample.

STUDY OBJECTIVES: Insomnia is a chronic condition with significant burden on health care and productivity costs. Despite this recognized burden, very few studies have examined associations between insomnia severity and healthcare and productivity costs. DESIGN: A retrospective study linking health claims data with a telephone survey of members of a health plan in the Midwestern region of the United States. PARTICIPANTS: The total healthcare costs study sample consisted of 2086 health plan members who completed the survey and who had complete health claims data. The productivity costs sample consisted of 1329 health plan members who worked for pay-a subset of the total healthcare costs sample. MEASUREMENTS: Subjects' age, gender, demographic variables, comorbidities, and total health care costs were ascertained using health claims. Insomnia severity and lost productivity related variables were assessed using telephone interview. RESULTS: Compared with the no insomnia group, mean total healthcare costs were 75% larger in the group with moderate and severe insomnia ($1323 vs. $757, P<0.05). Compared with the no insomnia group, mean lost productivity costs were 72% larger in the moderate and severe insomnia group ($1739 vs. $1013, P<0.001). Chronic medical comorbidities and psychiatric comorbidities were positively associated with health care cost. In contrast, psychiatric comorbidities were associated with lost productivity; while, medical comorbidities were not associated with lost productivity. CONCLUSIONS: Health care and lost productivity costs were consistently found to be greater in moderate and severe insomniacs compared with non-insomniacs. Factors associated with lost productivity and health care costs may be fundamentally different and may require different kinds of interventions. Future studies should focus on better understanding mechanisms linking insomnia to healthcare and productivity costs and to understanding whether developing targeted interventions will reduce these costs.

Treatment patterns associated with Duloxetine and Venlafaxine use for Major Depressive Disorder.

BACKGROUND: Duloxetine and venlafaxine extended release (venlafaxine XR) are SNRIs indicated for the treatment of MDD. This study addresses whether duloxetine and venlafaxine XR are interchangeable in their patterns of use with patients who are depressed or are used more selectively based on treatment history, background characteristics, and presenting symptoms. METHODS: This was a retrospective analysis of an administrative insurance claims database. We studied patients in managed care with major depressive disorder (MDD) treated with duloxetine or venlafaxine XR. Predictors of treatment and cost were assessed using Chi-square and logistic regression analyses of demographics and past-year medication use and comorbidities. RESULTS: Patients with MDD treated with duloxetine (n = 9,641) versus venlafaxine XR (n = 8,514) tended to be older, slightly more likely to be female, and treated by a psychiatrist (P < 0.0001). In the prior year, more duloxetine patients (vs. venlafaxine XR) received ≥ 3 unique antidepressants (20.8% vs. 16.6%), ≥ 3 unique pain medications (25.5% vs. 15.6%), and had ≥ 8 unique diagnosed comorbid medical and psychiatric conditions (38.6% vs. 29.1%). The prior 6-month total health care costs were $1,731 higher for duloxetine than for venlafaxine XR and declined for both medications in the 6 months after treatment began. Logistic regression analysis revealed that 61% of duloxetine patients and 61% of venlafaxine XR patients were predictable from prior patient and treatment factors. CONCLUSIONS: Patients with MDD treated with duloxetine tended to have a more complex and costly antecedent clinical presentation compared with venlafaxine XR patients, suggesting that physicians do not use the medications interchangeably.

Comparison of medication adherence and healthcare costs between duloxetine and pregabalin initiators among patients with fibromyalgia.

OBJECTIVE: To examine and compare medication adherence and direct healthcare costs between duloxetine and pregabalin initiators among patients with fibromyalgia. METHODS: A retrospective analysis of commercially insured fibromyalgia patients aged 18 to 64 was conducted among those who initiated duloxetine or pregabalin between January 1, 2006 and December 31, 2006. The first initiation date was defined as the index date. All patients included had continuous enrollment in the 12-month pre- and post-index periods. Each individual was classified in the duloxetine or pregabalin cohort based on the initiating agent. The pregabalin cohort was constructed via propensity scoring controlling for differences in demographics, pre-index clinical and economic characteristics, and pre-index treatment patterns. Medication adherence (ie, medication possession ratio [MPR] and proportion of patients with MPR≥80%) and healthcare costs over the 12 months post-index period were examined between cohorts. RESULTS: The study cohorts included 3,711 duloxetine and 4,111 pregabalin patients with the mean age of 51 years. The common comorbidities included neuropathic pain other than diabetic peripheral neuropathic pain, low back pain, cardiovascular disease, headache, and osteoarthritis. Over 80% of the duloxetine or pregabalin initiators used opioids. Controlling for demographics, pre-index clinical and economic characteristics, and prior medication history, duloxetine patients had significantly higher MPR (0.7 vs. 0.5, P<0.05), higher proportion of patients with MPR≥80% (46.5% vs. 26.4%, P<0.05), but significantly lower total healthcare costs ($19,378 vs. $27,045, P<0.05) over the 12 months post-index period than pregabalin patients. CONCLUSION: Fibromyalgia patients on duloxetine had significantly higher medication adherence, but significantly lower direct healthcare costs than those on pregabalin.

Screening for depression in African American and Caucasian older women.

OBJECTIVE: To assess the performance of a two-choice (yes/no), 10-item shortened form of the CES-D in both African American (AA) and Caucasian (CA) older women. The CES-D is a widely used screening instrument, but its use has been questioned for routine screening because of its length and the complexity of its four-choice format. There is also little data available about its suitability low-income AA respondents. METHOD: Telephone screening for depression followed by in-home diagnostic interviews were conducted in a community sample of 256 CA and 186AA low-income older women who ranged in age from 64 to 94 years. Standard receiver operator curves were plotted to determine the sensitivities and specificities of the screening instrument at different cut-scores against a criterion of SCID-based diagnoses of current major depressive episode (CMDE). RESULTS: Sensitivity and specificity of the 10-item scale and an even shorter 5-item version was slightly higher for AA than for CA women. While both short forms produced significant numbers of false positives against a criterion of CMDE, many of the women identified by the screen did have significant depressive symptomatology. Significantly, fewer AA women received a diagnosis of CMDE primarily because they did not show diminution of functioning associated with their depressive symptoms. CONCLUSION: Short, easy to administer forms of the CES-D can provide useful information in working with older patients. Clinicians should be aware of ethnic differences in symptom expression and levels of functional impairment that are likely to occur in follow-up medical and psychiatric exams.

Prevalence of other diabetes-associated complications and comorbidities and its impact on health care charges among patients with diabetic neuropathy.

INTRODUCTION: Diabetic neuropathy (DN) is a common complication associated with diabetes. This study assesses the prevalence of other diabetes-related complications or comorbidities among DN patients and its marginal contribution to health care charges. METHODS: Using administrative claims database, we studied commercially insured patients below 65 years old with at least one claim of DN anytime from July 2004 through June 2005 (Year 1). Using propensity scoring, a 10:1 ratio of demographically matched controls with diabetes but no DN was constructed. Both DN patients and controls had 12 months of continuous enrollment in Year 1 and Year 2 (July 2005-June 2006). We compared the Year 1 prevalence of other diabetes-associated complications or comorbidities between DN patients and diabetic controls. Controlling for comorbidities, we used multivariate regressions to examine the incremental impact of DN or any other diabetes-related complication or comorbidity on Year 2 health care charges. RESULTS: A higher percentage of DN patients had at least one other diabetes-related complication or comorbidity than diabetic controls. Individuals with DN had a higher prevalence of each individual other diabetes-related complication or comorbidity. Controlling for comorbidities, the presence of any other diabetes-related complication or comorbidity was statistically associated with higher outpatient pharmacy and total charges for both DN patients and controls. Total and outpatient pharmacy charges were also significantly higher for DN patients than for controls, among those with or without any other diabetes-related complications or comorbidities. CONCLUSIONS: DN can occur in the absence of other diabetes-related complications or comorbidities. The presence of DN and any other diabetes-related complications or comorbidities significantly increases health care charges.

Parental depression as a moderator of secondary deficits of depression in adult offspring.

This study examined whether having a depressed parent intensifies the secondary deficits that often co-occur with offspring's depression symptoms. The sample was adult offspring of parents who had been diagnosed with depression 23 years earlier (N = 143) and demographically matched nondepressed parents (N = 197). Respondents completed mailed questionnaires. After controlling for demographic factors, offspring who were more depressed experienced more impairment: physical dysfunction, pain, and disability; anxiety, smoking, and drinking-related problems; poorer social resources; negative events and severe stressors; and reliance on emotional discharge coping. Parental status (depressed or not depressed) was not directly related to offspring impairment once offspring depression symptoms were controlled. However, parental status moderated associations between offspring's depression severity and their impairment: relationships between depression and impairments were generally stronger for offspring of depressed parents than for offspring of nondepressed parents. Depressed individuals who are offspring of depressed parents may be at particular risk for the secondary deficits of depression.

The cost of comorbid depression and pain for individuals diagnosed with generalized anxiety disorder.

Patients with generalized anxiety disorder (GAD) often have comorbid medical and psychiatric disorders and may incur higher costs. In this study, a total of 36,435 GAD patients aged 18 to 64 were identified from a claims database. Patient's total health care and component costs were compared between GAD patients with and without comorbid depression and pain using general linear models. The average total annual cost for all the GAD patients in the study was $7451. Compared with patients with GAD-only, the estimated total cost was $762 higher for GAD with depression (p < 0.001), $2989 higher for GAD with pain (p < 0.001), and $6073 higher for GAD with both depression and pain (p < 0.001). Comorbid depression and pain had significant impact on costs, especially those with pain or with both depression and pain. This suggests that an optimal strategy for GAD should take into account comorbid pain and depression.

Comparing clinical and economic characteristics between commercially-insured patients with diabetic neuropathy and demographically-matched diabetic controls.

OBJECTIVE: To examine medical conditions associated with diabetic neuropathy (DN) and to identify drivers of healthcare charges and utilization using administrative claims. METHODS: The study examined commercially-insured under-age-65 individuals with 24 months continuous enrollment in a large US national health plan. DN patients were identified by having at least one claim with a DN diagnosis between July 2004 and June 2005. A demographically-matched control cohort of patients with diabetes but no DN (10: 1 ratio) was constructed using propensity scoring. Overall illness burden via a comprehensive disease classification, year 2 (July 2005 through June 2006) distribution of charges, and reasons for inpatient admissions and emergency room (ER) visits were compared between DN patients and diabetic controls. Multivariate regressions were used to assess the marginal contribution of DN to healthcare charges and utilization, and the most common reasons for ER and inpatient admissions, controlling for differences in overall illness burden. RESULTS: Both DN patients (n = 8655) and diabetic controls (n = 86 550) had a mean age of 51 years, and 46% were female. Compared with controls, DN patients had more comorbid medical conditions (9.7 vs. 6.8, p < 0.05) and higher total healthcare charges. Controlling for differences in overall illness burden, DN patients had significantly more hospital days (0.67), more ER (0.09), physician office (0.62), and outpatient hospital visits (2.87), and higher total healthcare charges ($5696) than controls (all p < 0.05), with majority of the difference in charges from inpatient service ($3975, p < 0.05). Patients with DN were also far more likely to be hospitalized (ketoacidosis, neurological manifestation, heart disease, skin infection) or have an ER encounter (amputation) for diabetes-related complications. Due to the use of a retrospective claims database, limitations of this analysis include a lack of formal diagnostic testing of patients, inability to measure factors such as disease duration and severity that are not captured in such databases, and the possible lack of generalization from this group of patients with diabetes to other populations. CONCLUSIONS: DN patients had significantly more comorbid medical conditions and higher healthcare charges and utilization than age- and sex-matched diabetic controls. Controlling for differences in overall illness burden, DN patients incurred more ER visits and inpatient admissions.

Comparative and interactive effects of depression relative to other health problems on work performance in the workforce of a large employer.

OBJECTIVES: To present data on the comparative and interactive workplace costs of depression relative to other health problems in the workforce of a large employer. METHODS: The World Health Organization Health and Work Performance Questionnaire was used to assess self-reported health problems and work performance. Survey data were linked to medical-pharmacy claims data. Regression analysis was used to assess comparative effects of depression in the absence and presence of comorbidities on Health and Work Performance Questionnaire measures of work performance. RESULTS: Depression had the largest individual-level effect on work performance of any condition examined. Several comorbid conditions exacerbated the effect of depression, but had no effects in the absence of depression. CONCLUSIONS: Depression is a strong predictor of decrements in work performance. Other conditions that often co-occur with depression, including anxiety and fatigue-sleep disturbance, exacerbate the adverse effect of depression.

Higher costs and therapeutic factors associated with adherence to NCQA HEDIS antidepressant medication management measures: analysis of administrative claims.

OBJECTIVE: To determine if the type of antidepressant drug is related to adherence to National Committee for Quality Assurance (NCQA) Antidepressant Medication Management (AMM) quality measures and to assess the 6-month health care costs among newly diagnosed depressed patients. METHODS: The MarketScan Commercial Claims and Encounter database for medical and pharmacy claims from January 2001 to September 2004 was used to assess adherence to the 3 AMM quality-of-care measures. AMM measures include (a) acute phase, the percentage of eligible members who remained on antidepressant medication continuously for 3 months after the initial diagnosis as determined by at least 84 days supply of antidepressant drugs during the first 114 days following receipt of the index antidepressant; (b) continuation phase, the percentage of eligible members who remained on antidepressant medication continuously for the 6 months after the initial diagnosis as determined by at least 180 days supply of antidepressants during the first 214 days following receipt of the index antidepressant; and (c) practitioner contacts, the percentage of members who received at least 3 follow-up office visits or telephone contacts with health care providers, including at least 1 contact with a practitioner licensed to prescribe (may not necessarily be the prescriber of the antidepressant). A fourth measure, overall adherence, was added, if all 3 AMM measures were met. Multivariate regression models determined demographic, clinical (such as receipt of mental health specialty care, the Charlson Comorbidity Index score, and co-occurring bipolar or schizophrenia), and therapy-related factors associated with outcomes of adherence and costs (paid amounts for insurance-reimbursable health care services for inpatient admissions, emergency department services, outpatient services, and outpatient prescription drugs). Health care expenditures (both total and mental-health-specific costs) were measured for each patient for 6 months following the date of service for the index antidepressant. RESULTS: A total of 60,386 adult patients (10.7%) of 562,898 patients with a depression diagnosis met NCQA inclusion criteria in the AMM Technical Specifications (e.g., aged 18 years or older, newly diagnosed with depression and initiating antidepressant therapy, 365 days of continuous enrollment; patients were excluded if there were missing data on dose or quantity of index drug in pharmacy claims or initiated therapy on 2 or more antidepressants as the index medication, exclusion criteria not in the AMM Technical Specifications). Only 19% of patients achieved overall adherence. Rates for the 3 AMM measures were 39% for practitioner contacts, 65% for acute phase, and 44% for continuation phase. Receipt of mental health specialty care was the only factor that was positively associated with greater adherence on all 4 measures (overall measure: odds ratio [OR]=3.895, 95% confidence interval [CI], 3.72-4.07; acute OR=1.38, 95% CI, 1.33-1.43; continuation OR=1.46, 95% CI, 1.41-1.51; contacts OR=5.83, 95% CI, 5.62-6.06). Most patients were initiated on selective serotonin reuptake inhibitors (SSRIs, 69.5%), followed by venlafaxine (21.4%), tricyclic antidepressants (TCAs, 21.4%), bupropion (11.0%), and other antidepressants (e.g., mirtazapine, nefazadone, trazadone; 7.2%). Before adjustment for confounding factors, patients initiated on venlafaxine, TCAs, or other antidepressants had higher rates of adherence on the overall performance measure versus initiators on SSRIs, but the absolute differences were relatively small: 21.4% for venlafaxine and TCAs and 23.1% for other antidepressants versus 18.5% for SSRIs (P <0.001). Patients initiated on venlafaxine, TCAs, or other antidepressants were also more likely to receive care from a mental health specialist, 16.8%, 15.0%, and 54.8%, respectively, compared with SSRIs (13.0%, all P <0.001). Regression analysis showed that only venlafaxine had a higher OR (1.13; 95% CI, 1.05-1.22) compared with SSRIs for adherence on the overall measure. Initiating dose level was in the target range for 70.0% of all patients (24.9% were below target dose and 5.2% above target dose), and adherent patients on all 3 AMM measures were less likely than nonadherent patients (70.4% vs. 68.4%, P <0.001) to be initiated in the target dose range. After multivariate adjustment, the initiating dose (target vs. high) was a significant factor in explaining adherence to the overall measure (OR=1.26; 95% CI, 1.16- 1.37). Adherent patients had 6-month median unadjusted total health care expenses that were nearly 2 times higher compared with nonadherent patients ($5,169 vs. $2,734) and mental health expenditures that were nearly 3 times higher ($1,922 vs. $677). After adjustment, adherent patients compared with nonadherent patients incurred an additional $644 in mental health expenditures and $806 in overall health care expenditures in the 6 months following initiation of antidepressant therapy. CONCLUSIONS: Only 19% of depressed patients initiated on antidepressants met all 3 criteria set forth in the NCQA Health Plan Employer Data and Information Set (HEDIS) AMM quality-of-care performance measures. Receipt of mental health specialty care was the single factor most strongly associated with quality treatment by these measures. Type and dosage level of initial antidepressant was associated with adherence to the NCQA HEDIS AMM measures, but the absolute difference in rates of adherence were relatively small among types of antidepressants. Costs were higher for guideline-adherent individuals in the 6 months following treatment initiation. These analyses were limited to administrative claims that lack indicators of depression disease severity.

The costs of caring for erectile dysfunction in a managed care setting: evidence from a large national claims database.

PURPOSE: We examined the direct costs of erectile dysfunction (ED) empirically. MATERIALS AND METHODS: A naturalistic cohort study was done in 285,436 patients with ED and 51 health plans that covered 28 million lives nationwide from 1999 through 2001. Based on claims that had an ED related diagnosis code, procedure code or medication code we categorized the cost structure of ED care and calculated the annual costs of ED care per patient with ED, per user and per member monthly for individual and for all categories of ED care. RESULTS: A patient with ED in a health plan spent about an average of 83.91 dollars in 1999, 95.41 dollars in 2000 and 119.26 dollars in 2001 for ED care. In 2001, 37.08% of ED care costs per patient with ED were spent on phosphodiesterase type 5 (PDE-5) inhibitor therapy, 14.36% were spent on physician office visits, 10.19% were spent on diagnosis procedures, 8.45% were spent on testosterone hormone therapy, 3.85% were spent on penile prosthesis implantation, 4.41% were spent on intracavernous injection, 2.68% were spent on alprostadil pellet insertion and 0.81% was spent on vacuum erection devices. Of the 7 commonly used ED treatments PDE-5 inhibitor therapy has the lowest annual cost per user. CONCLUSIONS: In 2001 ED imposed a 122,669 dollars annual burden to a health plan with 100,000 members, that is or 0.108 dollars per member monthly. Each patient with ED spent 119.26 dollars annually for all ED related services or treatments. Of the 7 commonly used treatments PDE-5 inhibitor therapy had the lowest annual cost per user.