Real-World Treatment Patterns among Patients with Advanced Gastric Cancer in South Korea.

PURPOSE: The purpose of this study was to understand patient treatment patterns, outcomes, and healthcare resource use in cases of metastatic and/or locally recurrent, unresectable gastric cancer (MGC) in South Korea. MATERIALS AND METHODS: Thirty physicians reviewed charts of eligible patients to collect de-identified data. Patients must have received platinum/fluoropyrimidine first-line therapy followed by second-line therapy or best supportive care, had no other primary cancer, and not participated in a clinical trial following MGC diagnosis. Data were summarized using descriptive statistics. Kaplan-Meier analysis was used to describe survival. RESULTS: Of 198 patients, 73.7% were male, 78.3% were diagnosed with MGC after age 55 (mean, 61.3 years), and 47.0% were current or former smokers. The majority of tumorswere located in the antrum/pylorus (51.5%). Metastatic sites most often occurred in the peritoneum (53.5%), lymph nodes (47.5%), and liver (38.9%). At diagnosis, the mean Charlson comorbidity indexwas 0.4 (standard deviation, 0.6). The most common comorbidities were chronic gastritis (22.7%) and cardiovascular disease (18.7%). Most patients (80.3%) received second-line treatment. Single-agent fluoropyrimidine was reported for 22.0% of patients, while 19.5% were treated with irinotecan and a fluoropyrimidine or platinum agent. The most common physician-reported symptoms during second-line treatment were nausea/vomiting (44.7%) and pain (11.3%), with antiemetics (44.7%), analgesics (36.5%), and nutritional support (11.3%) most often used as supportive care. Two-thirds of inpatient hospitalizations were for chemotherapy infusion. Outpatient hospitalization (31.6%) and visits to the oncologist (58.8%) were common among second-line patients. CONCLUSION: Most patients received second-line treatment, although regimens varied. Understanding MGC patient characteristics and treatment patterns in South Korea will help address unmet needs.

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.

The prevalence and economic impact of prescription opioid-related side effects among patients with chronic noncancer pain.

OBJECTIVES: To estimate the prevalence of opioid-related side effects among patients with chronic noncancer pain (CNCP) who initiated opioids and compare healthcare costs of patients with and without side effects using patient survey, medical charts, and claims data. PATIENTS, PARTICIPANTS: Patients initiating opioids, who were aged ≥18 years, had ≥1 pain diagnosis, and did not have cancer, were identified through claims data and medical records from a Central Massachusetts medical group practice and mailed surveys between October 2010 and July 2012. MAIN OUTCOMES MEASURES: Prevalence of opioid-related side effects was estimated from patient surveys, charts, and claims data within 90 days after opioid initiation (study period). Study period healthcare costs were compared between patients with and without side effects (self-reported problematic side effects or side effects recorded in medical charts or claims). RESULTS: Among patients with CNCP who initiated opioids and completed the survey (N = 167), the average age was 53 years, and 62.9 percent were women. Based on the survey, charts, and claims, 91.6 percent, 15.0 percent, and 19.2 percent of patients, respectively, had ≥1 opioid-related side effect. Overall, 59.3 percent of patients reported having ≥1 problematic side effect or side effect recorded in charts or claims. In the analysis that controlled for baseline characteristics and resource use, patients with versus without side effects had higher mean study period healthcare costs ($3,347 vs $2,521, p = 0.049). CONCLUSIONS: Prevalence of opioid-related side effects among patients with CNCP who initiated opioids was substantially higher based on patient survey than from charts or claims. Opioid-related side effects were associated with significantly higher healthcare costs.

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.

Matching-adjusted indirect comparison of adalimumab vs etanercept and infliximab for the treatment of psoriatic arthritis.

OBJECTIVES: No head-to-head trial has compared the efficacy of adalimumab vs etanercept and infliximab for psoriatic arthritis (PsA). This study implements a matching-adjusted indirect comparison technique to address that gap. METHODS: Patient-level data from a placebo-controlled trial of adalimumab (ADEPT) were re-weighted to match average baseline characteristics from pivotal published trials of etanercept and infliximab. ADEPT patients were re-weighted by odds of enrollment in comparator trials, estimated using logistic regression. Matched-on characteristics included PsA duration, age, gender, severity, active psoriasis, and concomitant treatment. After matching, placebo-adjusted treatment arms were compared at weeks 12 (or 14) and 24. Outcomes included ACR20/50/70, PsARC, HAQ, and modified TSS. PASI50/75/90 were compared for patients with active psoriasis. Cost per responder (CPR) was assessed in the US and Germany using matching-adjusted end-points and drug list prices. Statistical significance was assessed using weighted t-tests. RESULTS: After matching, adalimumab-treated patients had greater placebo-adjusted rates of ACR70 and PASI50/75/90 at week 24 compared with etanercept (all p < 0.05). Adalimumab patients had a higher placebo-adjusted rate of ACR70 than infliximab at week 14 (p = 0.034). Adalimumab treatment had lower CPR for ACR70 and PASI50/75/90 compared with etanercept at week 24, in both the US and Germany (all p < 0.02). Adalimumab had lower CPR than infliximab for all outcomes at week 24 (all p < 0.05). CONCLUSION: Adalimumab is associated with higher ACR70 and PASI50/75/90 response rates than etanercept at week 24 and a higher ACR70 response rate than infliximab at week 14. Adalimumab has significant advantages over etanercept and infliximab in CPR across multiple end-points. KEY LIMITATIONS: The matching-adjusted indirect comparison method cannot account for unobserved differences in patient characteristics across trials, and only a head-to-head randomized clinical trial can fully avoid the limitations of indirect comparisons. CPR findings are limited to the US and German markets, and may not be generalizable to other markets with different relative pricing.

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.

Healthcare costs and workloss burden of patients with chemotherapy-associated peripheral neuropathy in breast, ovarian, head and neck, and nonsmall cell lung cancer.

Objective. Chemotherapy-associated peripheral neuropathy (CAPN) is a painful side-effect of chemotherapy. This study assesses healthcare and workloss costs of CAPN patients with breast, ovarian, head/neck, or non-small cell lung cancer (NSCLC) from a third-party payor/employer perspective. Research Design and Methods. Patients with qualifying tumors, and claims for chemotherapy and services indicative of peripheral neuropathy (PN) within 9-months of chemotherapy (cases) were identified in a administrative claims database. Cases were matched 1 : 1 to controls with no PN-related claims based on demographics, diabetes history and propensity for having a diagnosis of PN during the study period (based on resource use and comorbidities in a 3-month baseline period). Average all-cause healthcare costs, resource use and workloss burden were determined. Results. Average healthcare costs were $17,344 higher for CAPN cases than their non-CAPN controls, with outpatient costs being the highest component (with cases having excess costs of $8,092). On average, each CAPN case had 12 more outpatient visits than controls, and spent more days in the hospital. Workloss burden was higher for cases but not statistically different from controls. Conclusion. This study establishes that breast, ovarian, head/neck, or NSCLC patients with CAPN have significant excess healthcare costs and resource use.

Changes in utilization and costs for patients with rheumatoid arthritis, 1997 to 2006.

BACKGROUND: Rheumatoid arthritis (RA) is a chronic autoimmune disease that often results in joint pain, inflammation and bone erosions. Perhaps the most notable change in RA treatment during the last decade is the advent of biologics, and, in particular, anti-tumour necrosis factor agents. Given these advances, it is useful to assess how healthcare and work-loss costs of patients with RA have changed. OBJECTIVE: Our objective was to assess changes in healthcare utilization and costs from 1997 to 2006 for patients diagnosed with RA. METHODS: Two cohorts (1997 and 2006) of patients with RA and matched controls were identified from two administrative claims databases along with subsamples of employed patients and matched controls. The analysis focused on the more homogeneous employee subsample. We compared annual excess co-morbidity rates, resource utilization and healthcare and work-loss costs per patient between the 1997 (n = 279) and 2006 cohorts (n = 837) with difference-in-differences methodology. Results with p < 0.05 were considered statistically significant. RESULTS: In the employee subsample, there were no statistically significant differences in the excess prevalence of non-RA co-morbidities or Charlson Co-morbidity Index results, except for cardiovascular disease, which decreased by 11.1%. Excess number of ED visits and days hospitalized decreased by 1.1 visits/patient and 0.9 days/patient, respectively, while rheumatologist visits increased by 0.9 visits/patient. Excess per-patient direct costs were unchanged. However, drug costs increased by $US633/patient, but medical costs decreased by $US618/patient (not significant) [year 2006 values]. CONCLUSION: For employed patients with RA, there were significant reductions in per-patient excess hospital days, as well as ED visits, and no changes in excess total direct costs over time. New treatments introduced during the study period may be associated with cost savings that offset changes in employee utilization of drug and medical services. In addition, the reductions in excess ED visits and hospital days suggest improvements in patient quality of life.

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.

Direct and indirect costs of patients treated with extended-release oxymorphone HCl or controlled-release oxycodone HCl.

OBJECTIVE: Compare direct and indirect costs of oxymorphone extended-release ('oxymorphone') and oxycodone controlled-release ('oxycodone') users. METHODS: Patients, aged 18+, with ≥1 claim for oxymorphone/oxycodone, Q2:2006-Q4:2009, were selected from a de-identified private payer claims database and observed from the first such claim ('index date') until the earliest of: use of comparator drug; end of continuous eligibility; 12 months ('study period'). Patients with claims for any formulation of the comparator drug during the first 30 days of the study period were excluded. Direct (medical and drug) costs paid by private insurers were reported for patients aged 18-64 (n = 8354) and 65+(n = 3515), as well as sub-sets without cancer (n = 7090 and n = 2444, respectively). Indirect costs (medically-related absenteeism and disability) were reported for all employees, aged 18-64 (n = 1313), and employees without cancer (n = 1146). Multivariate models were used to estimate risk-adjusted costs controlling for patient characteristics. RESULTS: Oxymorphone users, aged 18-64, had lower drug costs ($693 vs $763, p = 0.0035) and similar medical costs ($1875 vs $1976, p = 0.3570) per patient-month compared with oxycodone users (mean follow-up 236 and 280 days, respectively). Indirect costs were not different ($662 vs $670, p = 0.9370). Oxymorphone users, aged 65+, had similar Medicare supplemental drug costs ($533 vs $588, p = 0.0840) and lower medical costs ($459 vs $747, p < 0.0001). Results were comparable for subsets without cancer. LIMITATIONS: Patients with concomitant use of oxymorphone and oxycodone were excluded. CONCLUSIONS: Oxymorphone users incur lower risk-adjusted costs in several cost categories, compared with oxycodone users, and no higher costs in any of the examined categories.

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.

Direct and indirect costs of employees with treatment-resistant and non-treatment-resistant major depressive disorder.

OBJECTIVE: Treatment-resistant depression (TRD) imposes substantial cost from the perspective of employers. The objective of this study was to assess direct healthcare costs and indirect (disability and medical-related absenteeism) costs associated with TRD compared with non-treatment-resistant major depressive disorder (MDD). METHODS: Employees with one or more inpatient, or two or more outpatient/other MDD diagnoses (ICD-9-CM: 296.2x, 296.3x) from 2004 through 2007, ages 18-63 years, were selected from a claims database. Employees who initiated a third antidepressant following two antidepressant treatments of adequate dose and duration or who met published TRD criteria were classified as TRD likely (N = 2312). The index date was the date of the first antidepressant, starting 1/1/2004. The control group was an age- and sex-matched cohort of employees with MDD but without TRD. All had continuous eligibility during the 6-month pre-index (baseline) and 24-month post-index (study) period. McNemar tests were used to compare baseline comorbidities. Wilcoxon signed-rank tests were used to compare costs from employer perspective. RESULTS: TRD-likely employees were on average 48 years old, and 64.8% were women. Compared with MDD controls, TRD-likely employees had significantly higher rates of mental-health disorders, chronic pain, fibromyalgia, and higher Charlson Comorbidity Index. Average direct 2-year costs were significantly higher for TRD-likely employees ($22,784) compared with MDD controls ($11,733), p < 0.0001. Average indirect costs were also higher among TRD-likely employees ($12,765) compared with MDD controls ($6885), p < 0.0001. LIMITATIONS: Limitations of claims data related to accuracy of diagnosis coding and lack of clinical information apply to this study. CONCLUSIONS: Based on comorbidities and healthcare resources used, patients with TRD appeared to represent a clinically complex subgroup of individuals with MDD. TRD was associated with significant cost burden.

Clinical outcomes and medical care costs among medicare beneficiaries receiving therapy for peripheral arterial disease.

BACKGROUND: Peripheral arterial disease (PAD) is a common disorder with multiple options for treatment, ranging from medical interventions, surgical revascularization, and endovascular therapy. Despite the explosive advances in endovascular therapy, cost-effective methods of care have not been well defined. We analyze therapeutic strategies, outcomes, and medical cost of treatment among Medicare patients with PAD. METHODS AND RESULTS: Patients who underwent therapy for PAD were identified from a 5% random sample of Medicare beneficiaries from Medicare Standard Analytic Files for the period 1999-2005. Clinical outcomes (death, amputation, new clinical symptoms related to PAD) and direct medical costs were examined by chosen revascularization options (endovascular, surgical, and combinations). One-year PAD prevalence increased steadily from 8.2% in 1999 to 9.5% in 2005. The risk-adjusted time to first post-treatment clinical outcome was lowest in those treated with "percutaneous transluminal angioplasty (PTA) or atherectomy and stents" (HR, 0.829; 95% CI, 0.793-0.865; p < 0.001) and stents only (HR, 0.904; 95% CI, 0.848-0.963; p = 0.002) compared with PTA alone. The lowest per patient risk-adjusted costs during the quarter of the first observed treatment were associated with "PTA and stents" ($15,197), and stents only ($15,867). Risk-adjusted costs for surgical procedures (bypass and endarterectomy) were $27,021 during the same period. Diabetes was present in 61.7% of the PAD population and was associated with higher risks of clinical events and higher medical costs compared with PAD patients without diabetes. CONCLUSION: The clinical and economic burden of PAD in the Medicare population is substantial, and the interventions used to treat PAD are associated with differences in clinical and economic outcomes. Prospective cost-effectiveness analyses should be included in future PAD therapy trials to inform payers and providers of the relative value of available treatment options.

Comparison of health care use and costs in newly diagnosed and established patients with fibromyalgia.

UNLABELLED: In 2004, the American Pain Society (APS) issued evidence-based fibromyalgia treatment recommendations. The objective of this claims database analysis is to describe prescription and medical use in patients with newly diagnosed and established fibromyalgia. Privately insured patients with 2+ myalgia/myositis claims (1999 to 2005) were categorized as newly diagnosed or established; this dichotomy involves comparisons between prediagnosis (S1) and postdiagnosis (S2) stages in the newly diagnosed and between newly diagnosed (S2) and established patients (S3). Use of APS guideline medications increased across stages: selective serotonin reuptake inhibitors (SSRIs) (S1, S2, S3: 20.6%, 22.9%, 25.3%), serotonin norepinephrine reuptake inhibitors (SNRIs) (4.5%, 6.4%, 8.9%), pregabalin/gabapentin (5.4%, 7.4%, 8.8%), benzodiazepines (19.0%, 21.1%, 24.2%), non-benzodiazepine sedatives (9.1%, 11.5%, 13.7%) (all P < .0001), and opioids (39.5%, 43.3%, 43.9%; S1 vs S2, P < .0001; S2 vs S3, P = .2835). Use of multiple therapeutic classes also increased across stages: 3+ classes (7.1%, 9.6%, 11.8%) (all P < .0001). Office visits to providers increased, on average, after diagnosis: primary care (70.9%, 78.3%, 76.3%; all P < .0001), chiropractors (28.8%, 51.1%, 53.3%; all P < .0001), rheumatologists (4.2%, 9.9%, 10.5%; S1 vs S2, P < .0001; S2 vs S3, P = .0595), mental health (6.4%, 7.3%, 8.3%; S1 vs S2, P < .0001, S2 vs S3, P = .0003). Average health care costs rose after diagnosis in the newly diagnosed group (S1: $6555 vs S2: $8654, P < .0001). PERSPECTIVE: This paper investigates prescription drug and medical care use with respect to stages of fibromyalgia diagnosis. Established fibromyalgia patients use more medical resources and have higher rates of concomitant medication use than newly diagnosed fibromyalgia patients. Findings can help educate providers regarding optimal drug treatment patterns in this population.

Comparing the treatment patterns of patients with schizophrenia treated with olanzapine and quetiapine in the Pennsylvania Medicaid population.

OBJECTIVE: Compare treatment patterns for patients with schizophrenia treated with olanzapine versus quetiapine in the Pennsylvania Medicaid population. METHODS: Patients (18-64 years) with a diagnosis of schizophrenia (ICD-9-CM: 295.xx) and treated with olanzapine or quetiapine were identified from the Pennsylvania Medicaid claims database (1999-2003). Patients were continuously enrolled in the 12-month pre- and 12-month post-initiation periods. To control for selection bias, propensity score method with optimal matching algorithm was used to match patients from the two treatment groups. The key study outcomes including rates of augmentation, polypharmacy, discontinuation, and switching were analyzed using Kaplan-Meier survival analysis. Medication possession ratio and use of concurrent psychotropic drugs were also compared between the two groups. RESULTS: A total of 2321 quetiapine and 6929 olanzapine patients were identified. In all, 2321 pairs of patients were matched between the two groups and they had similar baseline characteristics. Over the 12-month study period, olanzapine patients had a better medication adherence (0.47 vs. 0.43; p < 0.0001), and were less likely to use other psychotropic medications concomitantly (all p < 0.05). Olanzapine patients had a significantly lower risk of augmentation and polypharmacy with other antipsychotics. The 6-month augmentation rates with antipsychotics were 12.9% and 16.7% for olanzapine and quetiapine, respectively (p < 0.05); the polypharmacy rates with any antipsychotics were 12.5% and 18.6% for olanzapine and quetiapine, respectively (p < 0.001). No significant differences were observed for discontinuation and switching between the two treatment groups. Sensitivity analysis with a 60-day minimum monotherapy requirement showed similar results. LIMITATIONS: This study's limitations include the analysis of a single Medicaid state, which may limit the generalizability to the entire Medicaid population with schizophrenia or to all patients with schizophrenia. CONCLUSION: This large Medicaid claims database analysis showed that olanzapine patients were significantly more compliant to treatment and less likely to augment or have polypharmacy with antipsychotics during the course of treatment compared to quetiapine patients.

Employees with fibromyalgia: medical comorbidity, healthcare costs, and work loss.

OBJECTIVES: To compare 2005 health care resources among matched samples of employees with fibromyalgia (FM), osteoarthritis (OA), and controls. METHODS: Using a claims database of privately insured individuals, FM and OA samples were derived from those with two or more disease-specific claims in 1999 to 2005 (> or =1 in 2002 to 2005). RESULTS: Total costs for employees with FM ($10,199) approached OA costs ($10,861, P = 0.3758) and were significantly higher than controls ($5274, P < 0.0001). Cost components varied across disease-specific samples (direct medical: FM $7286 vs OA $8325, P < 0.0287; pharmacy: FM $1630 vs OA $1341; indirect: FM $2913 vs OA $2537, P < 0.0001). Employees with FM had more claims than OA for psychiatric diagnoses, chronic fatigue, and most pain conditions. Use of multiple prescription drug classes was common in both samples. CONCLUSIONS: FM imposes significant economic burden. Work loss contributes substantially to the impact.

Prevalence, referral patterns, testing, and surgery in aortic valve disease: leaving women and elderly patients behind?

BACKGROUND AND AIM OF THE STUDY: The prevalence of aortic valve disease is not well defined, and it is not known to what degree gender and age affect testing and surgery for this condition. The study aim was to describe the prevalence of aortic valve disease in the United States population by extrapolating from administrative claims databases; and to investigate differences associated with gender and age in referral, diagnostic testing, and aortic valve replacement (AVR). METHODS: A claims database of approximately five million privately insured beneficiaries and a 5% sample of Medicare beneficiaries were queried for patients with aortic valve disease. Prevalence was calculated by age group and gender, and extrapolated to the 2005 US population. The proportion of patients with a cardiologist or cardiovascular surgeon visit, performance of echocardiography or stress testing, and AVR within a year of diagnosis was determined. RESULTS: The extrapolated prevalence of aortic valve disease in the US in 2005 was 1.8% (approximately 5.2 million people); in persons aged > or =65 years, prevalence was 10.7%. Women were seen by a specialist, underwent diagnostic tests and underwent AVR at rates significantly lower than men, as did patients aged > or =80 years compared to those aged 65-79 years. AVR was performed at approximately half the rate in women (1.4%) compared to men (2.7%, p <0.001), and in patients aged > or =80 years (1.1%) compared to those aged 65-79 years (2.5%, p <0.001). CONCLUSION: In 2005, approximately 5.2 million adults in the US were estimated to have a diagnosis of aortic valve disease. Advanced age and female gender were associated with lower rates of specialist visits, diagnostic testing, and AVR.

Assessing the economic impact of chronic conditions in postmenopausal women.

The ageing of the US population and the recognised importance of preventative care has led to a growing body of research regarding the morbidity and mortality associated with chronic diseases in postmenopausal women. According to the National Institute of Health, postmenopausal women have a significant increase in risk for a number of debilitating diseases, including osteoporosis, breast cancer and cardiovascular disease. In addition, recently published studies prompted patients, clinicians and payers to re-examine the risks and benefits of a well-accepted therapy to treat postmenopausal symptoms. The objective of this paper is to provide a framework for assessing the economic impact of disorders affecting postmenopausal women, with a particular focus on osteoporosis, breast cancer and cardiovascular disease. This framework considers the prevalence of these conditions, the profiles of women suffering from each of them and prevailing patterns of treatment for these disorders. Taken together, these factors are used to analyse the overall economic impact of postmenopausal disorders and to provide an expert opinion in this context.

Economic burden of osteoporosis, breast cancer, and cardiovascular disease among postmenopausal women in an employed population.

BACKGROUND: Postmenopausal women have a significant risk of developing a number of chronic conditions including osteoporosis (OP), breast cancer (BrCa), and cardiovascular disease (CVD). These diseases can result in significant direct (medical treatment) and indirect (workplace) costs. The objective of this study is to assess these costs among an employed population. METHODS: Deidentified medical and disability claims data from seven large employers (n = 585,441) were analyzed from 1998 through 2000 for female employees, age 50-64 years. Medical claim ICD-9CM codes were used to identify patients treated for: OP (n = 2,314), BrCa (n = 555), and CVD (n = 1,710). Each disease cohort was compared to a random sample of 50- to 64-year-old female employees (n = 7,575). Descriptive and multivariate techniques were used to characterize direct and indirect costs attributable to each condition. RESULTS: Average annual direct costs were higher (p < .001) for female employees treated for OP (6,259 dollars), BrCa (13,925 dollars), or CVD (12,055 dollars) when compared with the random sample (2,951 dollars). In addition, average annual indirect costs associated with OP (4,039 dollars), BrCa (8,236 dollars), and CVD (4,990 dollars) were higher (p < .001) than indirect costs for the random sample (2,292 dollars). Even when controlling for each disease-state cohort's demographics and disease-specific comorbidities, patients treated for OP, BrCa, and CVD continued to have significantly greater direct and indirect costs (p < .001) than the random sample. CONCLUSIONS: Chronic conditions such as OP, BrCa, and CVD, which occur more frequently in women after menopause, impose a significant financial burden. Greater health care utilization and work-loss prevalence among women treated for these conditions contribute to these additional costs.

Depression and fibromyalgia: treatment and cost when diagnosed separately or concurrently.

OBJECTIVE: Depression and fibromyalgia (FM) are often coincident. Both syndromes share common symptoms and impose significant economic burdens. This study compared claims for treatment and costs of FM plus depression with those for FM or depression alone. METHODS: Administrative claims data from a national Fortune 100 manufacturer were used to identify 3 mutually exclusive patient cohorts based on claims with a diagnosis for: FM only, depression only, and FM plus depression. A fourth cohort comprised a random sample of 10% of the employer's overall beneficiary population. Cohorts were compared for demographics, comorbid conditions, and healthcare resources utilization. Mean direct (treatment) costs were calculated and indirect (work loss) costs imputed, and these were assessed using Student's t test and Bonferroni adjustments. RESULTS: Mean annual employer payments (direct plus indirect costs) per patient were 5,163 dollars for FM only, 8,073 dollars for depression only, 11,899 dollars for FM plus depression, and 2,486 dollars for the overall sample. Mean incremental employer payments (i.e., above those for the random sample) per patient with FM plus depression were 9,413 dollars, an amount more than the sum of incremental costs for those with FM or depression alone (8,264 dollars). These costs are consistent with costs of other chronic diseases. CONCLUSION: Patients with FM plus depression are high users of healthcare services. As in studies that established relationships between depression and other medical conditions, incremental costs for patients with FM plus depression were more than additive of costs for each condition alone.