Lenalidomide maintenance post-transplantation in newly diagnosed multiple myeloma: real-world outcomes and costs.

Aim: To compare real-world outcomes and costs among patients with newly diagnosed multiple myeloma receiving lenalidomide-only maintenance (Len-Mt) versus no maintenance after autologous hematopoietic stem cell transplantation. Patients & methods: Time to next treatment (TTNT) was evaluated; costs were calculated for 0-12, 12-24 and 24-36 months postindex date. Results: Len-Mt cohort had longer TTNT (HR: 0.43; p < 0.0001). Per-patient per-month costs during months 0-12 were higher among patients, receiving Len-Mt (USD 13,095 vs USD 8910; p < 0.0001), due to higher pharmacy costs - outpatient costs were lower. During months 12-24 and 24-36, outpatient costs were similar in both cohorts; total and pharmacy costs remained elevated for patients receiving Len-Mt. Conclusion: Len-Mt improved TTNT, initially reduced outpatient costs, but resulted in higher overall and pharmacy costs.

Racial disparities in treatment patterns and outcomes among patients with multiple myeloma: a SEER-Medicare analysis.

The objective of the study was to assess racial disparities in the treatment and outcomes among white, African American, and Hispanic patients with multiple myeloma (MM). Patients with an MM diagnosis from the Surveillance Epidemiology and End Results (SEER)-Medicare (2007-2013) database were included. Continuous Medicare enrollment for 6 months before (baseline) and after MM diagnosis was required unless death occurred. Time from MM diagnosis to novel therapy initiation and autologous stem cell transplant (ASCT), overall survival (OS), and MM-specific survival (MSS) was evaluated. Unadjusted and multivariable regressions compared African Americans and Hispanics vs whites. Trends of novel therapy and ASCT use across MM diagnosis years were assessed using linear regression models. The study included 3504 whites, 858 African Americans, and 468 Hispanics. African Americans and Hispanics had a longer time from MM diagnosis to novel therapy initiation vs whites (median: 5.2 and 4.6 vs 2.7 months, respectively). All cohorts had an increasing trend of novel therapy initiation within 6 months of MM diagnosis, particularly whites (all P < .05). Median MSS was significantly longer for African Americans (5.4 years) than whites (4.5 years; P < .05), and was comparable for Hispanics and whites. Median OS was similar overall (2.6-2.8 years). ASCT rate within 1 year of MM diagnosis rose among whites and African Americans (P < .05), but not Hispanics, who were less likely to receive ASCT vs whites. Significant variations in novel therapy and ASCT use were observed among different racial/ethnic groups with MM. Although OS was similar, both African Americans and Hispanics may not be fully benefitting from the introduction of novel therapies, as they receive them later than whites.

Treatment Patterns and Clinical and Economic Outcomes in Patients With Newly Diagnosed Multiple Myeloma Treated With Lenalidomide- and/or Bortezomib-containing Regimens Without Stem Cell Transplant in a Real-world Setting.

BACKGROUND: Real-world data in patients with newly diagnosed multiple myeloma (NDMM) are sparse. Using United States claims databases, we analyzed treatment patterns, clinical outcomes, and health care utilization and costs in patients receiving lenalidomide- and/or bortezomib-containing therapy. MATERIALS AND METHODS: Patient claims were obtained from a large commercial and Medicare database (October 2009 to May 2015). Patients with NDMM who received lenalidomide- and/or bortezomib-containing therapy and did not receive stem cell transplant (SCT) were analyzed. Duration of treatment (DOT), time to next treatment (TTNT), and health care utilization and costs were evaluated. RESULTS: Of 3075 patients, 1767 received doublet therapy (814 lenalidomide-dexamethasone [Rd], 953 bortezomib-dexamethasone [Vd]) and 464 received triplet therapy (318 lenalidomide-bortezomib-dexamethasone [RVd], 146 cyclophosphamide-bortezomib-dexamethasone [CyBord]). Rd versus Vd resulted in longer median DOT (12.0 vs. 5.9 months; P < .0001) and median TTNT (36.7 vs. 24.4 months; P = .0005). Year 1 costs were greater with Rd versus Vd (Δ = $14,964; P = .0009), primarily owing to higher pharmacy costs; outpatient physician visits and chemotherapy administration costs were lower. Median DOT (14.8 vs. 9.0 months; P < .0001) and median TTNT (35.7 vs. 22.3 months; P = .0007) were longer with RVd versus CyBord; year 1 costs were comparable. CONCLUSIONS: In this study of patients with NDMM ineligible for transplant, the median duration of therapy was approximately 70% of that in clinical trial observations. Lenalidomide therapy versus Vd and CyBord resulted in longer DOT, which correlated with longer TTNT, and higher pharmacy costs, which were partially offset by lower outpatient and chemotherapy administration costs.

Treatment Outcomes and Health Care Resource Utilization in Patients With Newly Diagnosed Multiple Myeloma Receiving Lenalidomide-only Maintenance, Any Maintenance, or No Maintenance: Results from the Connect MM Registry.

PURPOSE: Maintenance therapy after autologous stem cell transplantation (ASCT) improves clinical outcomes in multiple myeloma (MM), but the effect of continued treatment with lenalidomide-only maintenance, or any maintenance, on health care resource utilization (HCRU) is largely unknown. METHODS: Here we present an analysis of HCRU and clinical outcomes in a cohort of patients from the Connect MM registry, the largest, ongoing, observational, prospective US registry of patients with symptomatic newly diagnosed MM. In this study, patients with newly diagnosed MM who completed induction and single ASCT without subsequent consolidation received lenalidomide-only maintenance (n = 180), any maintenance (n = 256), or no maintenance (n = 165). HCRU (hospitalization, surgery/procedures, and concurrent medications [growth factors, bisphosphonates, or neuropathic pain medication]) was assessed starting from 100 days post-ASCT for up to 2 years. FINDINGS: Although the rates of hospitalization per 100 person-years were similar across groups at the end of years 1 and 2, the median duration of hospitalization was numerically longer with no maintenance. The rates of use of growth factors, bisphosphonates, and neuropathic pain medication were generally similar in all 3 groups. The receipt of any maintenance was associated with significantly reduced use of neuropathic pain medications during year 1. Of note, lenalidomide-only maintenance was associated with significantly longer progression-free survival (54.5 vs 30.4 months; hazard ratio [HR] = 0.58; 95% CI, 0.43-0.79; P = 0.0005) and overall survival (OS) (median OS not reached in either group; HR = 0.45; 95% CI, 0.28-0.73; P = 0.001) compared with no maintenance. Likewise, the group treated with any maintenance had significantly longer median progression-free survival (44.7 vs 30.4 months; HR = 0.62; 95% CI, 0.47-0.82; P = 0.0008) and OS (median OS not reached in either group; HR = 0.50; 95% CI, 0.33-0.76; P = 0.001) than did the group that did not receive maintenance. IMPLICATIONS: These findings suggest that in this largely community-based study population, post-ASCT maintenance therapy, including lenalidomide-only maintenance, improves clinical outcomes without negatively affecting HCRU. ClinicalTrials.gov identifier: NCT01081028.

Assessing the Effect of Adherence on Patient-reported Outcomes and Out of Pocket Costs Among Patients With Multiple Myeloma.

BACKGROUND: The present study characterized the effect of multiple myeloma (MM) on work productivity, health care resource usage, and out of pocket costs (OOPCs) and examined the association of adherence with quality of life (QoL) and productivity loss. MATERIALS AND METHODS: The present cross-sectional study included 162 patients categorized by their 4-item Morisky Medication Adherence Scale (MMAS-4) score (4 vs. ≤ 3). Online surveys included the Work Productivity and Activity Impairment questionnaire, Functional Assessment of Cancer Therapy-Multiple Myeloma (FACT-MM), and MM-specific questions. RESULTS: On average, patients reported FACT-MM scores of 98.5 ± 29.3, absenteeism of 18.3% ± 17.8%, presenteeism of 51.8% ± 30.2%, overall work productivity impairment of 57.3% ± 31.7%, and activity impairment of 49.9% ± 29.5% in the previous 7 days. During the previous 3 months, the mean OOPCs were $709 ± $1307; prescription medications accounted for 55% of these costs. Patients attended 4.1 ± 4.6 visits to oncologists or hematologists during that time, which accounted for 45% of the OOPCs. Patients spent an average of 6.8 ± 8.3 hours at MM-related monthly appointments, and 35.2% reported frustration while at the doctor's office. Patients with an MMAS-4 score of 4 reported higher FACT-MM scores (106.9 vs. 89.2; P < .001). Patients with an MMAS-4 score of ≤ 3 reported greater activity impairment (56.5% vs. 39.8%; P = .015) and feeling overwhelmed or frustrated with rescheduling MM appointments (64.0% vs. 26.0%; P = .002). CONCLUSION: MM was associated with significant workplace and functional impairment, high OOPCs, and frequent office visits. High medication adherence was associated with better outcomes across these domains. As survival for patients with MM improves, patient QoL should be considered to enhance these outcomes.

Cost-effectiveness of Pomalidomide, Carfilzomib, and Daratumumab for the Treatment of Patients with Heavily Pretreated Relapsed-refractory Multiple Myeloma in the United States.

PURPOSE: Pomalidomide plus low-dose dexamethasone (POM-d), daratumumab monotherapy (DARA), and carfilzomib monotherapy (CAR) have been approved for use in the treatment of patients with heavily pretreated relapsed-refractory multiple myeloma (RRMM) in the US, based on findings from the MM-002, SIRIUS, and PX-171-003-A1 studies, respectively. The objective of this study was to assess the cost-effectiveness of POM-d, DARA, and CAR in this patient population from a US payer's perspective. METHODS: A cost-effectiveness model was developed to estimate the cost and health outcomes over a 3-year time horizon in 3 health states: progression-free, post-progression, and death. The main efficacy data source was a matching-adjusted indirect comparison using data from the aforementioned studies. Direct medical costs were considered, including: treatment acquisition and administration (initial line and subsequent line), pre- and post-medication, prophylaxis treatment, adverse event management, and health care resource utilization. Sensitivity analyses were conducted. A scenario analysis that assumed equal efficacy across all 3 treatments was conducted. Costs, life-years, and quality-adjusted life-years were estimated and discounted at 3% per annum. FINDINGS: Over 3 years, the use of POM-d was associated with similar life-years and quality-adjusted life-years gained compared with DARA and CAR (incremental: life-years, +0.02 and +0.07, respectively; quality-adjusted life-years, +0.01 and +0.05), and with a cost less than that of DARA (-$8,919) and similar to that of CAR (-$195). Sensitivity analyses illustrated that the results were sensitive to progression-free survival, treatment duration, and drug costs. An equal efficacy scenario resulted in cost-savings relative to those of both DARA and CAR (-$11,779 and -$12,595). IMPLICATIONS: POM-d may be a cost-effective treatment option relative to DARA or CAR in heavily pretreated patients with RRMM in the US.

Real-World Treatment Patterns, Time to Next Treatment, and Economic Outcomes in Relapsed or Refractory Multiple Myeloma Patients Treated with Pomalidomide or Carfilzomib.

BACKGROUND: Negligible real-world evidence exists for later line treatment of multiple myeloma (MM) to assist treatment decisions or reimbursement models, such as episode-based payments. OBJECTIVE: To describe the treatment patterns and clinical/economic outcomes when pomalidomide or carfilzomib is used for relapsed/refractory MM. METHODS: A U.S. claims database was used to identify MM patients with an initial pomalidomide or carfilzomib claim (index date) between February 1, 2013, and February 28, 2015, which was assumed to be relapse therapy. Treatment regimens were defined as all MM chemotherapy observed within 60 days of index. Patients receiving pomalidomide and carfilzomib within 60 days of index were excluded. Time to next treatment (TTNT), a progression proxy, was defined as the addition of a new agent > 60 days from index or as treatment restart following a > 90-day therapy gap. Cost estimations used plan-allowed amounts. Descriptive statistics were used to compare outcomes between treatment groups, and regression models were used to adjust for baseline patient characteristics. RESULTS: There were 454 patients initiating treatment with pomalidomide (n = 264) or carfilzomib (n = 190) during the index period. The most frequent initial regimens for pomalidomide patients included pomalidomide + dexamethasone (47.0%) and pomalidomide alone (33.0%); the most frequent regimens for carfilzomib patients were carfilzomib alone (45.3%) and carfilzomib + dexamethasone (14.7%). The most frequent next line treatment for pomalidomide patients who progressed was the addition of (14.0%) or switch to (15.0%) carfilzomib ± dexamethasone and for carfilzomib patients, the most frequent next line treatment was pomalidomide + dexamethasone (9.3%) and carfilzomib alone or carfilzomib + dexamethasone + cyclophosphamide (6.7% each). The median (95% CI) TTNT for pomalidomide patients was 11.9 (10.7-14.8) compared with 9.4 (7.7-10.0) months for carfilzomib (P = 0.060). For patients followed to progression (pomalidomide: n = 100, 37.9%; carfilzomib: n = 75, 39.5%), mean TTNT was longer for patients initiating therapy with pomalidomide (6.9 months) versus carfilzomib (5.3 months, P = 0.016). When adjusted for baseline confounders, pomalidomide patients had a nonsignificant longer time to a subsequent treatment line. Inpatient encounters observed during the index line were very low (mean = 1) for both groups; outpatient encounters were fewer in pomalidomide patients. Adjusted analyses revealed inpatient encounters were higher (P = 0.005), while outpatient use was lower in pomalidomide patients (P = 0.006). Unadjusted median costs incurred during the initial line were similar between the 2 groups (pomalidomide: $102,805; carfilzomib: $127,203; P = 0.110) but significantly lower in pomalidomide patients after adjusting for baseline characteristics (P = 0.013). Unadjusted per patient per month (PPPM) costs incurred over the entire follow-up period were lower in pomalidomide-initiated patients ($18,298 vs. $24,734, P = 0.001) but not statistically significant in adjusted analyses (P = 0.230). CONCLUSIONS: A longer time to a subsequent line of therapy was observed in pomalidomide patients compared with carfilzomib patients, although the difference lost significance in adjusted analyses. Compared with carfilzomib, pomalidomide patients were observed to have lower unadjusted median PPPM costs over the entire post-index period and lower adjusted mean monthly costs during initial therapy. DISCLOSURES: Funding for this study was provided by Celgene. Chen, McGuiness, and Wade are employees of QuintilesIMS, which was contracted by Celgene to undertake this research. McGuiness also owns stock in Pfizer. Parikh, Abouzaid, Purnomo, and Hussein are employees of Celgene and participated fully in the development and approval of the manuscript. Portions of the results of this research were previously presented at the American Society of Clinical Oncology (ASCO) 2016 Annual Meeting; June 3-7, 2016; Chicago, Illinois. Study concept and design were contributed by Chen, Parikh, Abouzaid, McGuiness, and Wade. Chen and McGuiness took the lead in data collection, along with Wade, and data interpretation was performed by Hussein and Wade, with assistance from the other authors. The manuscript was written by McGuiness, Chen, and Wade, with assistance from Parikh and Abouzaid, and revised by McGuiness and Hussein, along with the other authors.

Cohort analysis assessing medical and nonmedical cost associated with obesity in the workplace.

OBJECTIVE: Quantify the impact of employee overweight and obesity on costs, absence days, and self-reported productivity. METHODS: Employees' retrospective body mass index (BMI) values (kg/m(2)) from 2003 to 2011 health appraisal data defined three cohorts: BMI < 27, 27 ≤ BMI < 30, BMI ≥ 30. Medical, pharmacy, sick leave, short-term disability, long-term disability, and workers' compensation costs and absence days, and Health Productivity Questionnaire responses were compared using regression modeling, controlling for demographics, salary, and index year. RESULTS: Among 39,696 (BMI < 27), 14,281 (27 ≤ BMI < 30), and 18,801 (BMI ≥ 30) eligible employees, per-employee adjusted total annual costs were $4258, $4873, and $6313, respectively. Medical, pharmacy, sick leave, workers' compensation costs and days were higher for higher-BMI cohorts (P < 0.01). Employees with BMI ≥ 30 kg/m(2) had the most short-term disability costs and days and least productivity (P < 0.001). CONCLUSIONS: Employees with higher BMI levels are associated with significantly more costs and absences and lower self-reported productivity.

Economic burden associated with extrapyramidal symptoms in a medicaid population with schizophrenia.

No studies have assessed the economic impact of extrapyramidal symptoms due to atypical antipsychotics in schizophrenia. To assess healthcare resource use and medical costs associated with extrapyramidal symptoms in patients with schizophrenia. A retrospective analysis of Marketscan(®) Medicaid Multi-State Database (2004-2009) was conducted. Patients with schizophrenia and newly initiated on an AAP were included. Patients with and without extrapyramidal symptoms were matched using propensity-score matching. Healthcare utilization and costs were assessed in the 12-month follow-up period using logistic and two-part (gamma) regression models. Of 4,621 patients, 583 (12.6 %) had extrapyramidal symptoms. Patients with extrapyramidal symptoms had significantly more schizophrenia-related and all-cause hospitalizations and schizophrenia-related emergency room visits, as well as significantly higher schizophrenia-specific and all-cause total healthcare, inpatient, and prescription drug costs compared to patients without extrapyramidal symptoms. Extrapyramidal symptoms in patients with schizophrenia is associated with increased healthcare resource utilization and higher medical costs.

Compliance to fingolimod and other disease modifying treatments in multiple sclerosis patients, a retrospective cohort study.

BACKGROUND: Adherence to disease-modifying therapies (DMTs) results in the reduction of the number and severity of relapses and delays the progression of multiple sclerosis (MS). Patients with lower adherence rates experience more inpatient visits and higher MS-related medical costs. Fingolimod, the first oral DMT approved by the US Food and Drug Administration, may improve the access and compliance to MS treatment when compared to injectable DMTs. METHODS: This retrospective cohort study used pharmacy claims from Medco Health Solutions, Inc., of patients who initiated DMTs between October 2010 and February 2011. Initiation was defined as no prescription fills for the same DMT in the prior 12 months. Patients without a DMT prescription fill 12 months before the index date were considered naïve users. Compliance was measured via proportion of days covered (PDC) and medication possession ratio (MPR) for 12 months post-index. Discontinuation was defined as a ≥60-day gap of index DMT supply. Cox proportional hazard models compared time to discontinuation between cohorts. RESULTS: Of 1,891 MS patients (mean age: 45.7; female: 76.4%), 13.1% initiated fingolimod, 10.7% interferon beta-1b, 20.0% intramuscular interferon beta-1a, 18.8% subcutaneous interferon beta-1a, and 37.4% glatiramer acetate. Patients initiating fingolimod had highest average PDC and MPR in both experienced (fingolimod: mean PDC=0.83, 73.7% with PDC≥0.8; mean MPR=0.92, 90.5% with MPR≥0.8) and naïve DMT users (fingolimod: mean PDC=0.80, 66.7% with PDC≥0.8; mean MPR=0.90, 87.4% with MPR≥0.8). The proportion of patients discontinuing index DMT within 12 months was significantly lower for the fingolimod cohort (naïve: 31.3%; experienced: 25.7%). Adjusted results found that patients receiving self-injected DMTs discontinued significantly sooner than fingolimod users. This association was generally stronger in experienced DMT users. CONCLUSIONS: Fingolimod initiators were more compliant, less likely to discontinue treatment, and discontinued later than patients who initiated self-injected DMT.

Direct and indirect cost burden associated with multiple sclerosis relapses: excess costs of persons with MS and their spouse caregivers.

BACKGROUND: MS relapses are unpredictable and can be concerning to patients and their caregivers. OBJECTIVE: To assess the direct and indirect cost burden associated with relapses of different severities in MS patients and with MS relapse frequency on spouse caregivers. METHODS: Using a U.S. insurance claims and employee disability database (1999-2011), we studied adult MS patients (ICD-9-CM: 340.x) and their spouse caregivers. A previously published algorithm to identify relapses was used to stratify: (1) MS patients into cohorts of no, low/moderate, and high severity relapse based on the most severe relapse within one year of follow-up (if any); (2) caregivers into cohorts of no, less, and more frequent relapses based on the overall frequency of relapses of their spouse. Adjusted cost differences and 95% confidence intervals evaluating the yearly incremental costs at 12 months of follow-up (MS patients) and overall (caregivers) associated with relapses are reported. RESULTS: Among the 9421 MS patients (N: no relapse=7686; low/moderate severity relapse=1220; high severity relapse=515) identified, both relapse cohorts incurred significantly higher annual incremental direct costs than the no relapse cohort (low/moderate severity=$8269 [6565-10,115]; high severity=$24,180 [20,263-28,482]) and indirect costs (low/moderate severity=$1429 [759-2147]; high severity=$2714 [1468-4035]). More frequent relapses versus no relapse also translated into a significantly greater cost burden for caregivers (direct+indirect=$1725 [376-2885]) but less frequent relapses did not. CONCLUSIONS: Relapse severity was significantly and increasingly associated with greater direct and indirect costs in MS patients. More frequent relapses also translated into a significant cost burden in spouse caregivers.

Cardiometabolic consequences of therapy for chronic schizophrenia using second-generation antipsychotic agents in a medicaid population: clinical and economic evaluation.

OBJECTIVE: We assessed the potential clinical and economic impact of coronary heart disease (CHD) and diabetes arising after the use of second-generation ("atypical") antipsychotic agents for the treatment of chronic schizophrenia. We compared the use of these medications in patients with a higher risk of cardiometabolic adverse events (in a higher-risk scenario) and in patients with a lower risk (in a lower-risk scenario). Our U.S.-based analysis estimated the costs of CHD and diabetes arising from antipsychotic medication-related cardiometabolic effects. METHODS: We constructed a health economic model to predict the 5-year incidence of CHD and diabetes and associated costs after treatment. In this cost-consequence model, we used CHD risk functions derived from the Framingham Heart Study and diabetes risk functions derived from the Atherosclerosis Risk in Communities (ARIC) study. Patient characteristics and treatment effects on cardiometabolic risk factors were estimated from the Clinical Trials of Antipsychotic Treatment Effectiveness (CATIE) study. We evaluated two cost-consequence scenarios: the incidence of CHD and diabetes predicted for 1,000 patients with chronic schizophrenia in a higher-risk scenario based on data from CATIE associated with olanzapine (Zyprexa) and in a lower-risk scenario with ziprasidone (Geodon). We evaluated rates of adverse outcomes for each scenario and the cost of treatment for CHD and diabetes. All costs were reported in 2011 U.S. dollars. Because Medicaid is often the payer for patients with chronic schizophrenia, all costs in this analysis were derived from the perspective of Medicaid. RESULTS: Over a period of 5 years in 1,000 patients with chronic schizophrenia, the higher-risk scenario with olanzapine showed a 9% increased incidence of CHD and a 59% increased incidence of diabetes, compared with no change in treatment from baseline. By contrast, the lower-risk scenario with ziprasidone showed a 9% reduced incidence of CHD and a 10% reduced incidence of diabetes. The higher-risk scenario led to increased CHD-related costs of $83,206 and to increased diabetes-related costs of $456,399. CONCLUSION: Our study underscores the importance of monitoring the established risk factors for CHD and diabetes in patients using second-generation antipsychotic drugs. Lower-risk agents from this class may lead to substantially decreased costs in the management of CHD and diabetes when compared with higher-risk agents.

Analysis of the relationship between psoriasis symptom severity and quality of life, work productivity, and activity impairment among patients with moderate-to-severe psoriasis using structural equation modeling.

BACKGROUND: Plaque psoriasis is a chronic disease characterized by scaly plaques on the skin that can itch and bleed. Psoriasis covering over 10% of the body is classified as moderate to severe, and can impact patient quality of life. OBJECTIVES: To assess the relationship between plaque psoriasis self-reported severity symptoms and health-related quality of life, work productivity, and activity impairment among patients with moderate-to-severe psoriasis. METHODS: The study sample included 199 patients recruited from internet panels, of which 179 respondents had plaque psoriasis and 20 had plaque and inverse psoriasis. Itching, pain, and scaling symptoms were studied. A structural equation modeling framework was used to estimate the effect of these symptoms on patient outcomes. First, each severity variable was regressed on a set of covariates to generate a predicted severity score. These predicted values were placed in a second-stage model with patient mental and physical scores (Short-Form 12 questionnaire), work productivity, and activity impairment indicators as dependent variables. RESULTS: Itching severity had a marginal negative effect (P < 0.06) on patients' Short-Form 12 physical and mental component scores. Pain severity also negatively affected physical and mental health scores (P < 0.02). Patients were more likely to miss work because of itching (odds ratio [OR]: 2.31, 95% confidence interval [CI]: 1.30, 4.10), pain (OR: 1.78, 95% CI: 1.25, 2.52), and scaling (OR: 2.15, 95% CI: 1.31, 3.52) symptoms. These symptoms also lowered self-reported productivity. As itching (OR: 1.74, 95% CI: 1.03, 2.95), scaling (OR: 1.84, 95% CI: 1.16, 2.90), and pain symptoms (OR: 1.53, 95% CI: 1.12, 2.09) increased, so did the odds that a patient would be less productive at work. CONCLUSION: Plaque psoriasis significantly affects patient quality of life. In addition to greater mental and physical pain, patients are more likely to miss work and have diminished productivity as symptom severity increases.

Health care utilization and costs among patients with AD with and without dysphagia.

OBJECTIVE: To assess health care utilization and associated costs among patients with Alzheimer disease (AD), with and without dysphagia. METHODS: MarketScan Commercial and Medicare databases were analyzed. Patients with a diagnosis of AD with and without dysphagia between October 2006 and September 2010 were included. Acetylcholinesterase inhibitor usage, the number of outpatient and emergency room (ER) visits and hospitalizations, and associated health care costs were assessed. All variables were measured 1 year after the initial diagnosis of AD at the patient level. Patients with dysphagia were matched to patients without dysphagia using propensity score-matching (PSM) methods. Regression models were conducted to compare utilization and costs between the 2 groups. RESULTS: A total of 485 patients with dysphagia and 8492 patients without dysphagia were included. Before matching, patients with dysphagia were older (81.1 vs. 79.8 y), and had higher Charlson Comorbidity Index scores (2.4 vs. 1.7). After matching, all baseline covariates were not statistically different between the 2 groups. Multivariate regression results showed that patients with dysphagia had a higher likelihood of all-cause hospitalizations [odds ratio (OR)=2.26, 95% confidence interval (CI)=1.70-2.99, P=0.001] and all-cause ER visits (OR=1.45, 95% CI=1.12-1.87, P=0.007) compared with patients without dysphagia; they also had a higher likelihood for AD-related hospitalizations and ER visits. The difference in all-cause total health care, ER, and hospitalization costs between patients with and without dysphagia were $3620 (95% CI=$2863-$4375), $258 (95% CI=$241-$274), and $3547 (95% CI=$3325-$3770), respectively. CONCLUSIONS: This study suggests that patients with AD and dysphagia have higher health care utilization and costs compared with patients without dysphagia.

Patient adherence to transdermal rivastigmine after switching from oral donepezil: a retrospective claims database study.

OBJECTIVE: To examine patient adherence before and after switching from donepezil to the rivastigmine patch. METHODS: This retrospective cohort study used the MarketScan Commercial and Medicare data sets (2004 to 2009). Patients with a diagnosis of Alzheimer disease who were new donepezil users and were subsequently switched to the rivastigmine patch were included. The proportion of days covered (PDC) and PDC difference between donepezil and the rivastigmine patch were calculated from the time of initiation to the switch, capped at 1 year after the first respective claim. PDC was calculated as the number of days with drugs available divided by the number of days in the respective follow-up periods. RESULTS: The sample included 772 patients (mean age 77 y; 58% female). The mean time between switching from donepezil to the rivastigmine patch was 579 (SD=317.3) days. The mean PDC for the rivastigmine patch was highest among patients who switched within 3 months (80.4% vs. 90.7%; P=0.04) and within 7 to 9 months (61.3% vs. 71.0%; P=0.05) of initiating donepezil. When adherence was analyzed in increments of 1 year, patients who switched to the rivastigmine patch within the first year of treatment had significantly greater adherence to rivastigmine compared with those who were on donepezil (PDC 69.3% vs. 60.6%; P=0.0004). CONCLUSIONS: Switching from donepezil to the rivastigmine patch seems to be associated with increased adherence, especially in patients who switched within the first year of initiating donepezil.

Resource utilization and costs associated with insomnia treatment in patients with major depressive disorder.

OBJECTIVE: To estimate resource utilization and costs associated with insomnia treatment among newly treated patients with major depressive disorder (MDD). METHOD: Data from the MarketScan(®) Research Databases (Commercial Claims and Encounters, Medicare Supplemental and Coordination of Benefits, and Health and Productivity Management) were analyzed. Patients aged ≥ 18 years with a first prescription claim for an antidepressant between January 1, 2006, and December 31, 2007 (index date), were included in the analysis if they had ≥ 1 MDD diagnosis (ICD-9-CM criteria) in the 12 months prior to the claim and 24 months of continuous insurance coverage. Patients were categorized into 2 groups on the basis of the presence or absence of insomnia medication during the 12 months following the index date. Multivariate analyses were conducted to compare all-cause and MDD-related hospitalization and emergency room (ER) visits and costs in the year following the index date between patients with and without insomnia medication. Covariates for adjustment included age, gender, region, health plan type, baseline comorbidities, and health care utilization. RESULTS: The total sample size was 87,461 newly treated MDD patients with a mean (SD) age of 43.5 (15.1) years; 67% were women. Among newly treated patients, 10,339 (11.8%) took insomnia medication. Patients taking insomnia medication were significantly more likely to be hospitalized (OR = 1.84, 95% CI = 1.73-1.96 for all cause; OR = 1.50, 95% CI = 1.43-1.57 for MDD related; P < .0001) and to have ER visits (OR = 4.25, 95% CI = 3.65-4.95 for all cause; OR = 2.51, 95% CI = 2.24-2.81 for MDD related; P < .0001) than the patients not taking insomnia medication. Adjusted all-cause health care costs were $3,918 (95% CI = $3,599-$4,290) higher and MDD-related health care costs were $537 (95% CI = $492-$586) higher in the insomnia medication cohort compared with controls in the 12-months following the index date. Patients taking insomnia medication had $1,162 more indirect costs for short-term disability compared to the control group (95% CI = $746-$1,684). CONCLUSIONS: The use of insomnia medications in newly treated patients with MDD appears to be associated with increased health care resource utilization and higher total and depression-related direct and indirect medical costs.

Predictors of medication nonadherence and hospitalization in Medicaid patients with bipolar I disorder given long-acting or oral antipsychotics.

PURPOSE: To assess rates and predictors of medication nonadherence and hospitalization among patients with bipolar I disorder. METHODS: This was a retrospective cohort analysis of Medicaid patients who were aged ≥ 18 years, had ≥ 1 inpatient or ≥ 2 outpatient medical claims indicating bipolar I disorder (ICD-9-CM codes 296.0x-296.1x, 296.4x-296.7x), and filled ≥ 1 prescription for antipsychotic medication between January 1, 2004, and December 31, 2006. Patients were followed for 1 year from the date of first (index) antipsychotic prescription. Patients were required to be continuously eligible for Medicaid without dual Medicare eligibility from 1 year before (baseline) through 1 year after (follow-up) index, and were required to receive ≥ 1 additional antipsychotic during follow-up. Descriptive statistics and predictors of medication nonadherence (medication possession ratio <0.8) and hospitalization were generated. RESULTS: A total of 9410 patients met study eligibility criteria with a mean age of 38 years; 74% were female and 75% were white. Approximately 31% and 57% had baseline diagnoses of substance abuse and other psychiatric conditions, respectively. During follow-up, roughly 60% of patients were nonadherent and 40% of patients were hospitalized for any reason (37% psychiatric-related). Multivariate analysis showed that new antipsychotic starts, younger patients, those with a baseline concomitant substance abuse diagnosis, those taking a baseline antidepressant, and those with a baseline psychiatric hospitalization had significantly higher risk of nonadherence. Baseline psychiatric hospitalization, baseline substance abuse or other psychosis diagnosis, baseline use of an anxiolytic, anticholinergic, or anticonvulsant, and nonadherence to therapy in the follow-up period were significant predictors of increased risk of hospitalization. LIMITATIONS: This analysis did not attempt to evaluate the complex relationships among treatment type, adherence, hospitalization, and other variables. CONCLUSIONS: Study results showed that the risk of nonadherence is relatively high and confirmed that nonadherence is associated with a greater risk of hospitalization.

Prevalence and risk of polypharmacy among the elderly in an outpatient setting: a retrospective cohort study in the Emilia-Romagna region, Italy.

BACKGROUND: Polypharmacy, the simultaneous taking of many medications, has been well documented and is a topic of much concern for those looking to improve the quality of care for the elderly. Elderly patients often develop complicated and multifactorial health states that require extensive pharmacotherapy, leaving this population at risk for exposure to drug-drug interactions and other adverse events. Previous literature supports an association between an increase in the rate of adverse events as the number of drugs taken by a patient increases. OBJECTIVE: We sought to evaluate the prevalence of polypharmacy, and to determine patient characteristics that are predictive of exposure to polypharmacy, in the elderly population of the Emilia-Romagna region in Italy. METHODS: We conducted a retrospective cohort study of the 2007 Emilia-Romagna outpatient pharmacy database linked with patient information available from a demographic file of approximately 1 million Emilia-Romagna residents aged ≥65 years. The cohort comprised 887,165 elderly subjects who had at least one prescription filled during the study year. Using the WHO's defined daily dose (DDD) to determine the duration of treatment for a given drug, we defined a polypharmacy episode as overlapping treatment with five or more medications occurring for at least 1 day. The prevalence of polypharmacy was measured together with subject characteristics found to be predictive of polypharmacy exposure. RESULTS: A total of 349,689 elderly people in the population (39.4%) were exposed to at least one episode of polypharmacy during the study period. The prevalence of polypharmacy substantially increased with age and with a higher number of chronic conditions. Over 35% of those exposed to polypharmacy were exposed for 101 or more days of the year. The top three classes of medications involved in polypharmacy were antithrombotics, peptic ulcer disease and gastro-oesophageal reflux disease agents, and ACE inhibitors. The odds of exposure to polypharmacy were higher for older subjects, males and subjects living in urban areas. CONCLUSIONS: This study provides evidence that the prevalence of polypharmacy in the elderly in Emilia-Romagna is substantial. Educational programmes should be developed to inform clinicians about the magnitude of the polypharmacy phenomenon and the patient characteristics associated with polypharmacy. Raising physicians' awareness of polypharmacy may help to ensure safe, effective and appropriate use of medication in the elderly.