Real-World Treatment Patterns and Characteristics Among Patients with Agitation and Dementia in the United States: Findings from a Large, Observational, Retrospective Chart Review.

BACKGROUND: Few studies have examined patient characteristics and treatment patterns among patients with dementia and agitation in the United States (US). OBJECTIVE: To examine real-world treatment patterns and characteristics of patients with agitation related to dementia who were treated with antipsychotics in US residential care and community-based settings. METHODS: This retrospective chart review collected US physician-level data from patients 55 to 90 years old initiated on an antipsychotic medication for the treatment of agitation related to dementia from January 2018 to May 2018. Clinical characteristics and treatment patterns were assessed overall and stratified by residential care and community-based settings. RESULTS: A total of 313 participating physicians, 59.5% of whom were primary care physicians, abstracted 801 patient charts (residential care: n = 312; community-based: n = 489). Of patients with agitation who were initiated on an antipsychotic, most patients (74.5%) were initiated within 3 months of the onset of their studied agitation episode, and 62.8% experienced multiple agitation episodes before initiation. While non-pharmacological therapies are recommended first-line approach for agitation in dementia, use of non-pharmacological therapy before initiation of antipsychotics was reported for only 37.8% of patients in residential care and 21.3% in community-based settings. CONCLUSION: Most patients were initiated on an antipsychotic treatment after multiple episodes of agitation and largely without initial non-pharmacological therapy, suggesting that current treatment guideline recommendations for first-line non-pharmacological intervention may not be adequately followed in clinical practice. Understanding the clinical burden and treatment patterns among dementia patients with agitation is imperative for effective disease management.

Institutionalization risk and costs associated with agitation in Alzheimer's disease.

INTRODUCTION: Agitation in individuals with Alzheimer's disease (AD) may predict institutionalization. This study assessed the incremental risk and costs associated with agitation in individuals with AD. METHODS: A retrospective analysis of the National Alzheimer's Coordinating Center Uniform Data Set (June 2005-February 2018) was conducted. Incremental risk of institutionalization associated with agitation was estimated and used with the number of institutionalized individuals with AD and agitation and costs of living by residential setting in the United States (literature-based), to estimate incremental institutionalization costs. RESULTS: The analysis included 11,348 individuals with AD: 6603 (58.2%) with and 4745 (41.8%) without agitation. Compared with individuals without agitation, those with agitation were 20% more likely to be institutionalized (odds ratio = 1.20; 95% CI = 1.08-1.33). Total incremental cost of institutionalization associated with agitation was $4.3 billion ($50,588/individual). DISCUSSION: Agitation is associated with a higher risk of institutionalization among patients with AD, which translates into a substantial economic burden.

Real-World Economic Outcomes of Brexpiprazole and Extended-Release Quetiapine Adjunctive Use in Major Depressive Disorder.

PURPOSE: Major depressive disorder (MDD) is a chronic mental disorder with a substantial clinical and economic burden. Despite the efficacy of adjunctive atypical antipsychotics (AAP) for augmentation in patients with major depressive disorder (MDD) who failed first-line antidepressant therapy (ADT), little is known of the impact of AAP choices on healthcare resource use and costs in real-world practice. Therefore, this study compared real-world healthcare utilization and costs in patients with MDD treated with brexpiprazole or extended-release (XR) quetiapine as adjunctive treatment to ADT. PATIENTS AND METHODS: Adults with MDD starting adjunctive treatment with brexpiprazole (n=844) or extended-release (XR) quetiapine (n=688) were identified in the adjudicated health plan claims data (07/2014 - 09/2016). Resource use and healthcare costs in the 6 months following treatment initiation were compared between non-matched populations, and between propensity score-matched groups, and by multivariable regression analyses. RESULTS: During follow-up, unadjusted all-cause hospitalization (6.6% vs 12.5%) and ED visits (17.0% vs 27.5%) were lower with brexpiprazole compared to quetiapine XR (both p<0.001). Brexpiprazole-treated patients had significantly lower mean medical costs (US$6,421 vs US$8,545, p=0.0123) but higher mean pharmacy costs (US$7,401 vs US$4,691, p<0.0001) than quetiapine XR-treated patients did. Total healthcare costs were not significantly different between the two cohorts. Propensity score-matched comparisons of 397 patients in each cohort showed no statistically significant difference in all-cause hospitalization, ED visits, and total healthcare costs; and significantly lower medical costs (US$5,719 vs US$8,602, p=0.0092) but higher pharmacy costs (US$7,091 vs US$5,091, p=0.0007) in brexpiprazole compared to quetiapine XR. In multivariable regressions, brexpiprazole was associated with 16.1% lower medical costs (p=0.0186) and 9.4% higher total healthcare costs (p=0.0463) as compared to quetiapine XR. CONCLUSION: Significantly lower medical costs were observed in patients with MDD treated with brexpiprazole vs quetiapine XR.

Treatment patterns and burden of behavioral disturbances in patients with dementia in the United States: a claims database analysis.

BACKGROUND: Although patients with dementia frequently experience neuropsychological symptoms (NPS) such as agitation, which profoundly impacts patients, caregivers, and the healthcare system, few studies have evaluated the associated burden of agitation or agitation-related symptoms in dementia. METHODS: This retrospective analysis of claims data from the Truven Health MarketScan® database (2012-2015) compared clinical characteristics, treatment patterns, healthcare resource utilization, and costs among patients with dementia with behavioral disturbances (BD) versus patients with dementia without BD. Existing BD diagnosis codes 294.11 or 294.21 were used as a means to identify patients with agitation/agitation-related symptoms. RESULTS: From a starting sample of 6.4 million beneficiaries, 103,402 patients with dementia were identified, of whom 16,440 (16%) had BD during an average of 17 months of follow-up. Patients with BD had significantly more medical and psychiatric comorbidities and greater comedication use (i.e., antidementia drugs, antidepressants, and antipsychotics; all values, P < .0001) compared with patients without BD. A significantly greater number of hospitalizations, hospital days, outpatient hospital/clinic visits, number of skilled nursing visits, and number of patients with hospice visit were reported during follow-up in patients with BD compared with patients without BD (all values, P <  0.0001). Costs were also significantly higher among patients with BD versus those patients without BD ($42,284 vs. $32,640, respectively; P <  0.0001). CONCLUSIONS: Patients with dementia with BD had a higher prevalence of comorbidities, greater use of comedications, and greater healthcare utilization and costs than patients with dementia without BD.

Early initiation of long-acting injectable antipsychotic treatment is associated with lower hospitalization rates and healthcare costs in patients with schizophrenia: real-world evidence from US claims data.

Objective: Early initiation of antipsychotic treatment in schizophrenia is associated with improved outcomes. This study aimed to determine if initiation of long-acting injectable (LAI) antipsychotic treatment early in a new schizophrenia episode is associated with lower hospitalization rates and healthcare costs in a real-world setting. Methods: This retrospective (January 1, 2007-June 30, 2016) cohort analysis used claims from Truven Health Analytics MarketScan Commercial, Medicaid, and Medicare Supplemental databases. In adults ≥18 years with a new episode of schizophrenia, two mutually exclusive cohorts were identified based on time from first recorded schizophrenia diagnosis date to first date of LAI initiation (index date): ≤1 year (early initiators) and >1 year (late initiators). Logistic and general linear regression models were performed to estimate adjusted hospitalization rate and healthcare costs in a 1-year follow-up, controlling patient demographic and clinical characteristics, insurance type, baseline all-cause hospitalizations and ED visits, and baseline psychiatric medication use. Results: Of the subjects, 32% (n = 1388) initiated treatment early and 68% (n = 2978) initiated treatment later. In risk-adjusted models, all-cause hospitalization rates were 22.2% (95% CI = 19.9-24.6%) in early initiators and 26.9% (95% CI = 25.2-28.7%) in late initiators (p = .002). Of early initiators, 14.1% (95% CI = 12.3-16.1%) had a psychiatric hospitalization vs 19.2% (95% CI = 17.7-20.8%) of late initiators (p < .001). Adjusted psychiatric healthcare costs were significantly lower in early initiators compared with late initiators [mean (95% CI) = $21,545 (20,355-22,734) vs $24,132 (23,330-24,933)] (p < .001). Conclusions: LAI initiation within 1 year of a new schizophrenia episode led to lower hospitalization rates and healthcare costs compared with LAI initiation more than 1 year after a new episode.

Medication Adherence, Health Care Utilization, and Costs in Patients With Major Depressive Disorder Initiating Adjunctive Atypical Antipsychotic Treatment.

PURPOSE: The purpose of this study was to compare medication adherence, health care utilization, and cost among patients receiving adjunctive treatment for major depressive disorder (MDD) with brexpiprazole, quetiapine, or lurasidone. METHODS: Using Truven Health MarketScan® Commercial, Medicaid, and Medicare Supplemental Databases, we identified adults with MDD initiating adjunctive treatment with brexpiprazole, quetiapine, or lurasidone (index atypical antipsychotic [AAP]). We compared medication adherence and persistence measured by proportion of days covered (PDC) and treatment duration of index AAP, all-cause and psychiatric hospital care (hospitalization or emergency department visit), and medical costs during 6-month follow-up. Models performed included logistic regression for hospital care, linear regression for PDC and cost, and Cox proportional hazards regression for time to discontinuation, adjusting for demographic, clinical, and utilization differences during the 6 months before index AAP. FINDINGS: The total sample included 778 brexpiprazole, 626 lurasidone, and 3458 quetiapine therapy initiators. Adjusting for baseline differences, the risk of discontinuation of index AAP was statistically significantly higher for quetiapine than for brexpiprazole (hazard ratio [HR] = 1.13; 95% CI, 1.02-1.25; P = 0.023) and did not differ between lurasidone and brexipiprazole (HR = 1.14; 95% CI, 1.00-1.29; P = 0.054). The adjusted rate of all-cause hospitalization or emergency department visit in the postindex period was lowest for brexpiprazole at 27.4% (95% CI, 24.0%-31.0%), compared with 31.1% (95% CI, 27.3%-35.2%) for lurasidone and 35.3% (95% CI, 33.5%-37.1%) for quetiapine (P< 0.001 for all comparisons). Quetiapine users had increased all-cause costs compared with brexpiprazole users (estimate = $2309; 95% CI, $31-$4587; P = 0.047); all-cause medical costs did not differ between lurasidone and brexpiprazole (estimate = $913; 95% CI, $-2033 -$3859; P = 0.543). Adjusted psychiatric hospital care, psychiatric costs, and PDC did not differ significantly among the groups. IMPLICATIONS: In patients with MDD and a variety of insurance types, brexpiprazole use was associated with statistically significantly lower risks of discontinuation, risk of hospital care (hospitalization and ED visits), and all-cause medical costs compared with adjunctive quetiapine. Differences between brexpiprazole and lurasidone were not statistically significant. These findings suggest that drug choice is associated with subsequent health care utilization and costs.

Hospitalization risk factors in antipsychotic-treated schizophrenia, bipolar I disorder or major depressive disorder.

AIM: To examine hospitalization risk factors in antipsychotic-treated patients with schizophrenia, bipolar I disorder (BD-I) or major depressive disorder (MDD). PATIENTS & METHODS: Using Truven Health MarketScan® Commercial, Medicaid and Medicare Supplemental data (01/01/2012-06/30/2016), logistic regression models were performed to identify risk factors for both psychiatric and all-cause hospitalization in three separate analyses. RESULTS: Significant risk factors included prior hospitalization (schizophrenia: odds ratio [95% CI]: 2.83 [2.50-3.21; psychiatric]; 2.58 [2.31-2.87; all-cause]; BD-I: 2.42 [2.23-2.63]; 2.09 [1.96-2.23]; MDD: 2.81 [2.49-3.16]; 2.21 [2.03-2.40]), previous antipsychotic treatment (schizophrenia: 1.71 [1.52-1.93]; 1.31 [1.18-1.46]; BD-I: 1.33 [1.23-1.44]; 1.22 [1.14-1.30]; MDD: 1.31 (1.11-1.54); 1.17 (1.04-1.32) and substance abuse (schizophrenia: 1.42 [1.27-1.60]; 1.37 [1.23-1.53]; BD-I: 1.72 [1.58-1.86]; 1.61 [1.50-1.72]; MDD: 1.90 [1.68-2.15] and 1.55 [1.41-1.71]). CONCLUSION: Prior hospitalization, previous antipsychotic treatment and substance abuse were associated with increased hospitalization risk in schizophrenia, BD-I or MDD.

Atypical antipsychotic adherence is associated with lower inpatient utilization and cost in bipolar I disorder.

AIMS: This study explored the association between medication adherence to oral atypical antipsychotics (AAP) and both psychiatric hospitalization and associated costs in bipolar I disorder (BD-I) in a real-world setting. MATERIALS AND METHODS: This retrospective study used the Truven Health MarketScan Medicaid, Commercial, and Medicare Supplemental Claims Databases. Adults were identified if they had BD-I and initiated an AAP treatment during the study identification period (July 1, 2015-June 30, 2016 for Medicaid, July 1, 2015-March 31, 2016 for Commercial and Medicare Supplemental) and had ≥6-month continuous enrollment before (baseline) and after (follow-up) the first day of treatment. Medication adherence was measured by the proportion of days covered (PDC) and grouped as: fully-adherent (PDC ≥80%), partially-adherent (40% ≤ PDC <80%), and non-adherent (PDC <40%). Logistic and linear regression models were conducted to estimate the risk of psychiatric hospitalization and costs during the 6-month follow-up period. RESULTS: The final sample consisted of 5,892 (32.0%) fully-adherent, 4,246 (23.1%) partially-adherent, and 8,250 (44.9%) non-adherent patients. The adjusted rate of psychiatric hospitalization during the follow-up period was lower in the fully-adherent (6.0%) vs partially- (8.3%) or non-adherent (8.8%) groups (p < 0.001). Using the fully-adherent cohort as the reference group, the odds of psychiatric hospitalization were significantly higher for the partially-adherent (OR = 1.42; 95% CI = 1.23-1.64) and non-adherent (1.51; 1.33-1.71) cohorts. The mean adjusted psychiatric hospitalization cost over 6 months among hospitalized patients was lower for the fully-adherent cohort ($11,748), than the partially-adherent ($15,051 p = 0.002) or non-adherent cohorts ($13,170, not statistically significant). LIMITATIONS: The medication adherence measures relied on prescription claims data, not actual use. CONCLUSIONS: In the treatment of BD-I, better medication adherence to AAP was associated with fewer psychiatric hospitalizations. Among hospitalized patients, fully-adherent patients had statistically significantly lower psychiatric costs than partially-adherent ones. These findings suggest that improving adherence to AAP in BD-I may be a valuable goal from both clinical and economic perspectives.

Earlier Versus Later Augmentation with an Antipsychotic Medication in Patients with Major Depressive Disorder Demonstrating Inadequate Efficacy in Response to Antidepressants: A Retrospective Analysis of US Claims Data.

INTRODUCTION: There is little evidence regarding the most effective timing of augmentation of antidepressants (AD) with antipsychotics (AP) in patients with major depressive disorder (MDD) who inadequately respond to first-line AD (inadequate responders). The study's objective was to understand the association between timing of augmentation of AD with AP and overall healthcare costs in inadequate responders. METHODS: Using the Truven Health MarketScan® Medicaid, Commercial, and Medicare Supplemental databases (7/1/09-12/31/16), we identified adult inadequate responders if they had one of the following indicating incomplete response to initial AD: psychiatric hospitalization or emergency department (ED) visit, initiating psychotherapy, or switching to or adding on a different AD. Two mutually exclusive cohorts were identified on the basis of time from first qualifying event date to first date of augmentation with an AP (index date): 0-6 months (early add-on) and 7-12 months (late add-on). Patients were further required to be continuously enrolled 1 year before (baseline) and 1 year after (follow-up) index date. Patients with schizophrenia or bipolar disorder diagnoses were excluded. General linear regression was used to estimate adjusted healthcare costs in the early versus late add-on cohort, controlling for baseline demographic and clinical characteristics, insurance type, medications, and ED visits or hospitalizations. RESULTS: Of the 6935 identified inadequate responders, 68.7% started an AP early and 31.3% late. At baseline, before AP augmentation, patients in the early add-on cohort had higher psychiatric comorbid disease burden (47.3% vs. 42.5%; p < 0.001) and higher inpatient utilization [mean (SD) 0.41 (0.72) vs. 0.27 (0.67); p < 0.001] than in late add-on cohort. During follow-up, the adjusted total all-cause healthcare cost was significantly lower in the early vs. late add-on cohort ($18,864 vs. $20,452; p = 0.046). CONCLUSION: Findings of this real-world study suggest that, in patients with MDD who inadequately responded to first-line AD treatment, adding an AP earlier reduces overall healthcare costs. FUNDING: Otsuka Pharmaceutical Development and Commercialization, Inc. and Lundbeck.

The conceptual relevance of assessment measures in patients with mild/mild-moderate Alzheimer's disease.

INTRODUCTION: This study aims to evaluate the conceptual relevance of four measures of disease activity in patients with mild/mild-moderate Alzheimer's disease (AD): (1) the Alzheimer's Disease Assessment Scale-Cognitive Subscale; (2) the Alzheimer's Disease Cooperative Study-Activities of Daily Living Inventory; (3) the Neuropsychiatry Inventory; and (4) the Dependence Scale. METHODS: A conceptual model depicting patient experience of mild AD was developed via literature review; concepts were compared with the items of the four measures. Relevance of the concepts included in the four measures was evaluated by patients with mild AD in a survey and follow-up interviews. RESULTS: The four measures assessed few of the symptoms/impacts of mild AD identified within the literature. Measured items addressing emotional impacts were deemed most relevant by participants but were included in the measures only superficially. DISCUSSION: The four assessment measures do not appear to capture the concepts most relevant to/important to patients with mild/mild-moderate AD.

Medication Adherence and Discontinuation of Aripiprazole Once-Monthly 400 mg (AOM 400) Versus Oral Antipsychotics in Patients with Schizophrenia or Bipolar I Disorder: A Real-World Study Using US Claims Data.

INTRODUCTION: Few studies have compared adherence between long-acting injectable antipsychotics, especially for newer agents like aripiprazole once-monthly 400 mg (AOM 400; aripiprazole monohydrate) and oral antipsychotics, in patients with schizophrenia or bipolar I disorder (BD-I) in a real-world setting. METHODS: Two separate retrospective cohort analyses using Truven MarketScan data from January 1, 2012 to June 30, 2016 were conducted to compare medication adherence and discontinuation in patients with schizophrenia or BD-I who initiated treatment with AOM 400 vs. patients changed from one oral antipsychotic monotherapy to another. Adherence was defined as proportion of days covered (PDC) ≥ 0.80 in the year following the index date. Linear regression models examined the association between AOM 400 and oral antipsychotic cohorts and medication adherence. Kaplan-Meier curves and Cox regression estimated time to and risk of discontinuation, while adjusting for baseline covariates. A sensitivity analysis was conducted using a combination of propensity score matching and exact matching to create matched cohorts. RESULTS: Final cohort sizes were as follows-Schizophrenia: AOM 400 n = 408, oral antipsychotic n = 3361; BD-I: AOM 400 n = 413, oral antipsychotic n = 15,534. In patients with schizophrenia, adjusted mean PDC was higher in patients in the AOM 400 cohort vs. the oral antipsychotic cohort (0.57 vs. 0.48 P < 0.001), and patients in the oral antipsychotic cohort had a higher risk of discontinuing treatment vs. the AOM 400 cohort (HR 1.45, 95% CI 1.29-1.64). For patients with BD-I, adjusted mean PDC was higher for the AOM 400 cohort (0.59 vs. 0.44, P < 0.001), and patients in the oral antipsychotic cohort had a higher risk of discontinuation (HR 1.71, 95% CI 1.53-1.92). CONCLUSIONS: In a real-word setting, AOM 400 resulted in a significantly higher percentage of patients with a PDC ≥ 0.80 and significantly longer time to treatment discontinuation compared to patients with schizophrenia or BD-I who received treatment with an oral antipsychotic. FUNDING: Otsuka Pharmaceutical Development and Commercialization, Inc. and Lundbeck.

Health Care Resource Use, Costs, and Diagnosis Patterns in Patients With Schizophrenia and Bipolar Disorder: Real-world Evidence From US Claims Databases.

PURPOSE: Schizophrenia (SCZ) and bipolar disorder (BD) are typically viewed as nonconcurrent psychiatric disorders, yet patients may experience mood and SCZ symptoms simultaneously. Several studies have shown overlap between SCZ and BD symptoms and susceptibility genes. This study explored the following: (1) patterns of administrative claims; (2) demographic characteristics and comorbidities; (3) health care resource use; and (4) health care costs in patients with diagnoses of SCZ, type I BD (BD-I), and both in a real-world setting. METHODS: This study was a retrospective cohort trial using 4.5years (January 1, 2012-June 30, 2016) of Truven MarketScan commercial, Medicaid, and Medicare supplemental databases. We considered a patient to have a new episode of SCZ if he or she had 1 inpatient claim or 2 outpatient claims for SCZ within the identification period (January 1, 2013-June 30, 2015). BD-I was defined in an analogous way. Three study cohorts were defined: (1) SCZ alone (cohort I), met the claims-based diagnostic criteria for SCZ; (2) BD-I alone (cohort II), met the claims-based diagnostic criteria for BD-I; and (3) BD-I and SCZ (cohort III), met the claims-based diagnostic criteria for both SCZ and BD-I. FINDINGS: Of the 63,725 patients in the final sample, 11.5% (n = 7336) had a new episode of SCZ alone (cohort I), 80.8% (n = 51,480) had a new episode of BD-I alone (cohort II), and 7.7% (n = 4909) had new episodes of both SCZ and BD-I (cohort III). Considering cohort III, 18.8% (n = 927) received both diagnoses on the same day. In the year after diagnosis, the cohort having a diagnosis of both SCZ and BD-I (cohort III) had the highest all-cause hospitalization rates (67.4% vs 39.5% in SCZ alone and 33.7% in BD-I alone) and the highest mean (SD) number of emergency department visits (3.44 [7.1] vs 1.39 [3.5] in SCZ alone and 1.29 [3.2] in BD-I alone). All-cause total health care costs were highest in the cohort having a diagnosis of both SCZ and BD-I (mean [SD]), $51,085 [$62,759]), followed by the SCZ alone cohort ($34,204 [$52,995]), and the BD-I alone cohort ($26,396 [$48,294]). IMPLICATIONS: Our analyses indicate that a substantial number of patients received diagnoses of both SCZ and BD-I, based on claims, in a 2.5-year period. Patients with a diagnosis of both SCZ and BD-I had higher health care utilization and costs than patients with either diagnosis alone. We identified differential patient characteristics, utilization of medications and health care services, and health care costs among the cohorts.

Changes in healthcare resource use and costs associated with early versus delayed initiation of atypical antipsychotic adjunctive treatment in major depressive disorder.

AIMS: The study compared all-cause and major depressive disorder (MDD)-related healthcare resource use (HRU) and costs in patients with MDD treated with atypical antipsychotic (AAP) adjunctive therapy early or later in treatment. MATERIALS AND METHODS: Adults with MDD and antidepressant treatment (ADT) who newly initiated adjunctive aripiprazole, brexpiprazole, lurasidone, or quetiapine between October 1, 2014 and September 30, 2015 were identified in the IQVIA Real-World Data Adjudicated Claims database; the index date was the date of the first AAP claim. Patients were stratified into three cohorts: AAP initiated in the first year (Y1); in the second year (Y2); and more than 2 years (Y3) of first ADT use. Within each cohort, HRU and costs were compared between the 12 months before and after the index date. Pre-post changes in HRU and costs were then compared between cohorts. RESULTS: Five hundred and six (36.7%) patients were categorized as Y1; 252 (18.3%) as Y2; and 622 (45.1%) as Y3. AAP use was associated with significantly decreased rates of all-cause and MDD-related hospitalization and emergency department visits, and increased rates of pharmacy fills and physician office visits; and the magnitude of changes was largest in cohort Y1. Cohort Y1 had the largest reductions in mean (±SD) all-cause medical costs per patient (-$10,496 ± $85,022, p = .015) compared to Y2 (-$2,474 ± $85,022, p = .572) and Y3 (-$472 ± $31,334, p = .823), mainly due to the reduction in hospitalization. After adjusting for differences in baseline characteristics, the largest reductions in hospitalization and medical costs were observed in cohort Y1. Similar increases in all-cause pharmacy costs were seen in all cohorts. A similar trend in costs was observed in MDD-related healthcare services. LIMITATIONS AND CONCLUSIONS: AAP treatment was associated with reductions in all-cause and MDD-related medical costs, primarily in decreased hospitalization. The reductions were largest among patients who initiated treatment in the first year.

Medication adherence and discontinuation of long-acting injectable versus oral antipsychotics in patients with schizophrenia or bipolar disorder.

AIMS: To examine medication adherence and discontinuation in two separate groups of patients with schizophrenia or bipolar disorder (BD), who began receiving a long-acting injectable antipsychotic (LAI) versus those who changed to a different oral antipsychotic monotherapy. MATERIALS AND METHODS: The Truven Health Analytics MarketScan Multi-State Medicaid claims database was used to identify patients with schizophrenia; Truven Health Analytics MarketScan Commercial and Medicaid claims databases were used to identify patients with BD. The analyses included adult patients (≥18 years) who either began receiving an LAI (no prior LAI therapy) or changed to a different oral antipsychotic (monotherapy). The first day of initiating an LAI or changing to a new oral antipsychotic was the index date. Linear and Cox regression models were conducted to estimate medication adherence (proportion of days covered [PDC]) and time to medication discontinuation (continuous medication gap ≥60 days), respectively. Models adjusted for patient demographic and clinical characteristics, baseline medication use, and baseline ED or hospitalizations. RESULTS: Patients with schizophrenia (N = 5638) who began receiving LAIs had better medication adherence (5% higher adjusted mean adherence) during the 1 year post-index period and were 20% less likely to discontinue their medication during the entire follow-up period than patients who changed to a different oral antipsychotic monotherapy, adjusting for differences between LAI users and oral users. Similarly, patients with BD (N = 11,344) who began receiving LAIs also had 5% better medication adherence and were 19% less likely to discontinue their medication than those using oral antipsychotics. LIMITATIONS: Clinical differences unmeasurable in this database may have been responsible for the choice of LAI versus oral antipsychotics, and these differences may be responsible for some of the adherence advantages observed. CONCLUSIONS: This real-world study suggests that patients with schizophrenia or BD who began receiving LAIs had better medication adherence and lower discontinuation risk than those who changed to a different oral antipsychotic monotherapy.

All-cause hospitalization and associated costs in patients with schizophrenia or bipolar disorder initiating long-acting injectable antipsychotics.

OBJECTIVE: To compare all-cause hospitalization and associated costs among patients with schizophrenia or bipolar disorder (BD) treated with long-acting injectable antipsychotics (LAIs). METHODS: The Truven MarketScan Medicaid claims database was used to identify patients with schizophrenia; MarketScan Medicaid and commercial claims databases were used to identify BD. Adult patients with ≥1 LAI claim from January 1, 2013-June 30, 2014 (ID period) were identified. The first day of LAI initiation was the index date; patients were followed for ≥1 year. Logistic and general linear regression models were used to estimate the risk of hospitalization and associated costs. RESULTS: Adjusted analyses showed that, in the schizophrenia cohort, risks of hospitalization were statistically significantly higher in the haloperidol [OR (95% CI) = 1.51 (1.05-2.16); HR (95% CI) = 1.35 (1.05-1.73)] and risperidone [OR (95% CI) = 1.58 (1.07-2.33); HR (95% CI) = 1.33 (1.01-1.74)] cohorts than in the aripiprazole once monthly extended release (AOM 400) cohort. Similarly, in patients with BD, risks of hospitalization were significantly higher in haloperidol [OR (95% CI) = 1.49 (1.01-2.19); HR (95% CI) = 1.33 (1.03-1.73)] and risperidone [OR (95% CI) = 1.78 (1.19-2.66); HR (95% CI) = 1.33 (1.01-1.75)] than in AOM400. No statistically significant differences in hospitalization costs were observed in either disease group. CONCLUSIONS: Although the study results may be subject to confounding variables that are not contained in claims databases, such as disease severity, it appears that AOM400 may be more effective than haloperidol and risperidone LAIs among patients with schizophrenia or BD.

Cost-effectiveness of brexpiprazole adjunctive treatment for major depressive disorder.

BACKGROUND: Major depressive disorder (MDD) is a debilitating psychiatric illness with a high cost burden. This analysis evaluates the cost-effectiveness of adjunctive brexpiprazole versus comparator branded adjunctive treatment for MDD and background antidepressant therapy (ADT) alone from a US payer perspective. METHODS: An economic model was developed to assess the cost-effectiveness of brexpiprazole versus comparator adjunctive treatment and ADT alone on total direct medical costs using a 6-week cycle time frame for a total of 48 weeks, with treatment response and remission as primary outcomes. The model consisted of 3 parts, 1 to represent the acute treatment phase and 2 to represent the maintenance stage. RESULTS: In the base-case analysis, brexpiprazole as reference treatment resulted in cost per additional responder ranging from $19,442-$48,745 and cost per additional remitter ranging from $27,196-$71,839 versus comparator treatments over 48 weeks. Sensitivity analyses showed treatment with brexpiprazole was more costly, but more clinically effective in all probabilistic simulations. LIMITATIONS: This representation of disease natural history over 48 weeks may not account for all possible health states. Resource utilization on treatment was estimated using the resource use data from previous trials, and may overestimate medical costs compared to the real-world setting. Treatment comparators were limited to branded therapies, and head-to-head studies were not available to obtain data inputs. CONCLUSION: Compared to other branded adjunctive therapies, brexpiprazole increases response and remission at 6 weeks; medical care cost savings were observed with the use of brexpiprazole. These findings may assist clinicians and formulary decision makers when selecting treatment for MDD.

Pharmacoeconomic comparison of aripiprazole once-monthly and paliperidone palmitate from a head-to-head clinical trial in schizophrenia: a US analysis.

Schizophrenia presents a substantial clinical and economic burden to the health-care system. In QUAlity of LIfe with AbiliFY Maintena (QUALIFY), a randomized head-to-head study of aripiprazole once-monthly 400 mg (AOM 400) compared with paliperidone palmitate (PP; 78-234 mg/mo), AOM 400 demonstrated greater improvement in health-related quality of life and functioning in patients with stable schizophrenia. The present analysis used health economics assessment data collected during the QUALIFY study to determine the direct medical and pharmacy costs and the cost-effectiveness associated with each treatment over 6 months. Compared with those receiving PP, patients receiving AOM 400 incurred significantly lower direct total costs ($8908±186 vs $9675±190, p=0.005) and treatment costs ($7967±113 vs $8706±116, p<0.001). Effectiveness results in the subset of patients included in the cost analyses were similar to the overall population: mean (95% CI) improvement in Heinrichs-Carpenter Quality of Life Scale total score was greater with AOM 400 (5.97 [3.87; 8.08]) compared with PP (2.85 [0.56; 5.08]). Likewise, Clinical Global Impression-Severity improved more in the AOM 400 group (-0.59 [-0.71; -0.47]) compared with PP group (-0.37 [-0.46; -0.27]). Therefore, the analysis of data from stabilized patients with schizophrenia in the QUALIFY study indicated that AOM 400 is associated with lower health-care costs and greater effectiveness compared with PP and thus represents the economically dominant strategy.

Hospital Readmission Rates Among Patients With Schizophrenia Treated With Long-Acting Injectables or Oral Antipsychotics.

OBJECTIVE: This study analyzed hospital readmission rates of patients with schizophrenia who were treated with long-acting injectable antipsychotics (LAIs) or with oral antipsychotics after being discharged from a hospitalization. METHODS: Medical claims of patients with schizophrenia who were ages 18-64 and had a first hospitalization for a serious mental illness (index hospitalization, October 2007 through September 2012) and at least one prescription for a first- or second-generation antipsychotic were analyzed from the Truven Health MarketScan Multi-State Medicaid Database. Analyses were conducted for patients with a sole diagnosis of schizophrenia (N=1,450) and for all patients with schizophrenia (N=15,556), which added patients with a codiagnosis of bipolar disorder or major depressive disorder. Probability of rehospitalization for any cause at 30 and 60 days after the initial hospitalization was assessed with multivariate logistic regression and propensity score matching (PSM) methods. The PSM model matched age, preindex use of LAIs or short-acting injectables, and select comorbidities between the LAI and the oral antipsychotics groups. RESULTS: LAIs were associated with significantly lower probability of rehospitalization compared with oral antipsychotics at 60 days for schizophrenia-only patients (adjusted odds ratio [AOR]=.60, 95% confidence interval [CI]=.41-.90) and for all patients (AOR=.70, CI=.52-.95). The absolute difference in probability of rehospitalization for all patients was significantly lower by 5.0% at 60 days in the LAI group compared with the oral antipsychotics group. CONCLUSIONS: Compared with use of oral antipsychotics, use of LAIs was associated with fewer readmissions of Medicaid patients with schizophrenia within 60 days after an index hospitalization.