Impact of Atypical Antipsychotics as Adjunctive Therapy on Psychiatric Cost and Utilization in Patients with Major Depressive Disorder.

INTRODUCTION: Patients with major depressive disorder (MDD) incur high costs, despite established treatment options. Adding an atypical antipsychotic (AAP) to antidepressant therapy has shown to reduce depressive symptoms in MDD, but it remains unclear with which adjunctive AAP to initiate. As economic burden is one factor that can influence treatment selection, this study's objective was to evaluate the impact of adjunctive AAP choice on psychiatric costs and healthcare utilization in MDD. MATERIALS AND METHODS: This retrospective cohort study analyzed de-identified data from: (1) IBM® MarketScan® Commercial (C), Medicare Supplemental (MS), and MarketScan Multi-State Medicaid (M) Databases, and (2) Optum® Clinformatics® Datamart. Adult MDD patients were included if they had: initiated adjunctive AAPs during study identification period (7/1/15-9/30/16 MarketScan C/MS, and Optum; 7/1/15-6/30/16 MarketScan M), and ≥12 months of continuous enrollment before (baseline) and after (follow-up) first treatment date. Models included generalized linear models (GLMs) for psychiatric costs (total inpatient and outpatient services, excluding outpatient pharmacy costs), and a two-part model (logistic regression for psychiatric hospitalizations, GLM for psychiatric hospitalization costs among hospitalized patients); models were adjusted for baseline characteristics. RESULTS: The final study sample consisted of 10,325 patients (7657 aripiprazole, 1219 brexpiprazole, 827 lurasidone, 622 quetiapine). Using brexpiprazole as reference, lurasidone and quetiapine users had $1662 and $3894 higher psychiatric costs, respectively. Psychiatric costs were not statistically significantly different between aripiprazole and brexpiprazole (p>0.05). Quetiapine users had $15,159 (p<0.001) higher psychiatric hospitalization costs among those hospitalized, and higher odds of psychiatric hospitalization [2.11 (1.46-3.04); p<0.001] compared to brexpiprazole users. No statistically significant differences observed in psychiatric hospitalization risk comparing aripiprazole and lurasidone with brexpiprazole (p>0.05). CONCLUSION: In MDD, brexpiprazole users had significantly lower psychiatric costs than lurasidone and quetiapine users, and significantly lower psychiatric hospitalization risk than quetiapine users. Adjunctive AAP choice may impact subsequent healthcare costs and utilization in MDD.

Health Care Cost in Patients With Schizophrenia Treated With Brexpiprazole Versus Other Oral Atypical Antipsychotic Therapy.

PURPOSE: Brexpiprazole is an oral atypical antipsychotic (OAA) for the treatment of schizophrenia (SCZ). This study compared all-cause and psychiatric inpatient hospitalization and medical costs in adult patients with SCZ newly treated with brexpiprazole versus other US Food and Drug Administration-approved OAAs in a real-world setting. METHODS: This retrospective cohort study analyzed data from: (1) the IBM MarketScan Commercial and Medicare Supplemental databases, and the MarketScan Multi-State Medicaid database; and (2) the de-identified Optum Clinformatics Datamart. Adult patients were identified if they had SCZ and initiated either brexpiprazole or another OAA during the study identification period (July 1, 2015, to September 30, 2016, for MarketScan Commercial and Medicare Supplemental and for Optum; July 1, 2015, to June 30, 2016, for MarketScan Multi-State Medicaid) and had ≥12 months of continuous enrollment before (baseline) and after (follow-up) the first treatment date. Linear regression analyses were performed to test associations between treatment groups (brexpiprazole vs another OAA) and costs (total and medical); negative binomial regression models were used to estimate number of hospitalizations per year, adjusting for baseline characteristics and medication adherence to index treatment during the 12-month follow-up. FINDINGS: The final study sample consisted of 6254 patients with SCZ: 176 initiated brexpiprazole; 391, ziprasidone; 453, paliperidone; 523, lurasidone; 786, aripiprazole; 1234, quetiapine; 1264, olanzapine; and 1427, risperidone. Controlling for baseline characteristics and medication adherence, the adjusted number of hospitalizations (both all-cause and psychiatric), all-cause total costs, and all-cause medical costs did not differ across groups. Brexpiprazole users had the lowest mean psychiatric costs among all OAA users ($12,013; 95% bootstrap CI, 7488-16,538). Compared with brexpiprazole users, paliperidone (incidence rate ratio [95% CI], 1.52 [1.05-2.19]; P = 0.027) and quetiapine (incidence rate ratio [95% CI], 1.47 [1.04-2.07]; P = 0.029) users had more psychiatric hospitalizations per year. Paliperidone had higher psychiatric costs than brexpiprazole (total, $32,066 [95% bootstrap CI, 28,779-35,353] vs $23,851 [18,907-28,795]; medical, $19,343 [16,294-22,392] vs $12,013 [7488-16,538]). Psychiatric medical costs were also $6744 higher in olanzapine users (95% bootstrap CI, 1694-11,795; P = 0.009) than in brexpiprazole users. IMPLICATIONS: Patients with SCZ treated with brexpiprazole had fewer psychiatric hospitalizations and lower psychiatric costs than those treated with paliperidone. Differences in the number of all-cause hospitalizations and medical costs among treatments were not statistically significant. Although treatment decisions are driven by a number of factors (eg, clinical circumstances and drug costs), choice of OAA may affect health care costs.

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.

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.

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.

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.

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.

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.

A real-world analysis of healthcare costs and relative risk of hyperprolactinemia associated with antipsychotic treatments in the United States.

AIMS: Antipsychotic medications are associated with an increased risk of hyperprolactinemia, but differ in their propensity to cause this complication. This study aimed to assess the economic burden of hyperprolactinemia, and to compare its risk among adult patients using atypical antipsychotics (AAs) with a mechanism of action associated with no/low vs high/moderate prolactin elevation. METHODS: This retrospective cohort study was based on US Commercial and Medicaid claims databases. Healthcare costs were compared between matched hyperprolactinemia and hyperprolactinemia-free cohorts using a two-part model. Risk of hyperprolactinemia was compared between patients receiving AAs with a mechanism of action associated with no/low (no/low prolactin elevation cohort) vs high/moderate prolactin elevation (high/moderate prolactin cohort) using logistic regression. RESULTS: In the commercially insured sample, compared to the hyperprolactinemia-free cohort (n = 499), the hyperprolactinemia cohort (n = 499) was associated with incremental total healthcare costs of $5,732 ($20,081 vs $14,349; p = .004), and incremental medical costs of $3,861 ($13,218 vs $9,357; p = .040), mainly driven by hyperprolactinemia-related costs. In the Medicaid-insured sample, compared to the hyperprolactinemia-free cohort, the hyperprolactinemia cohort was associated with incremental total healthcare costs of $10,773 ($30,763 vs $19,990; p = .004), and incremental medical costs of $9,246 ($20,859 vs $11,613; p = .004), mainly driven by hyperprolactinemia-related and mental health-related costs. The odds of hyperprolactinemia in the no/low prolactin elevation cohort were 4-5-times lower than that in the high/moderate prolactin elevation cohort (odds ratio =0.21; p < .001). LIMITATIONS: Hyperprolactinemia may be under-reported in claims data. CONCLUSIONS: Hyperprolactinemia is associated with substantial healthcare costs. AAs associated with no/low prolactin elevation reduce the risk of hyperprolactinemia by 4-5-times compared to AAs associated with moderate/high prolactin elevation. Treatment options with minimal impact on prolactin levels may contribute to reducing hyperprolactinemia burden in AA-treated patients.

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.

Impact of initiating long-acting injectable antipsychotics on hospitalization in patients with bipolar I disorder.

AIM: To compare risk of hospitalization in patients with bipolar I disorder (BD-I) initiating long-acting injectable antipsychotics (LAIs). MATERIALS & METHODS: Using Truven Health Analytics MarketScan® (Medicaid, Commercial and Medicare Supplemental) databases (2012-2016), patients (≥18 years) with BD-I with a LAI (aripiprazole once monthly [AOM 400], fluphenazine-LAI, haloperidol-LAI, risperidone-LAI and paliperidone-4-week-LAI) were identified. RESULTS: The adjusted odds of having hospitalization were significantly higher in haloperidol-LAI (Odds ratio [95% CI]: 1.39 [1.03-1.87] all-cause; p = 0.029; 1.41 [1.03-1.93] psychiatric-specific; p = 0.032) and risperidone-LAI (1.54 [1.12-2.13]; p = 0.009; 1.68 [1.20-2.37]; p = 0.003) users versus AOM 400 users. Risks of hospitalization did not differ comparing fluphenazine-LAI and paliperidone-LAI users with AOM 400 users. CONCLUSION: AOM 400 may be more beneficial at reducing hospitalization rates in BD-I versus haloperidol-LAI and risperidone-LAI.

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.

Budget impact analysis of long-acting injectable aripiprazole once-monthly 400 mg in bipolar I disorder in the USA.

AIM: To estimate the budget impact (BI) of introducing aripiprazole once-monthly 400 mg/300 mg (AOM 400) in the maintenance monotherapy treatment of bipolar I disorder versus long-acting injectables, oral antipsychotics and best supportive care. METHODS: A BI model was developed from a US-payer perspective using treatment-related, hospitalization and adverse event management cost estimates for a hypothetical 1,000,000-member health plan over a 5-year period. RESULTS: Market share of AOM 400 was predicted to increase from 0.6% in Year 1 (current scenario) to 1.3% in Year 5 (predicted scenario), with predicted increases for paliperidone palmitate, asenapine and cariprazine. Treatment-related costs explained the BI increase, while adverse event and hospitalization costs were reduced. The per member per month incremental cost ranged from US$0.06 to US$0.26 in Years 1-5. The largest increases were predicted for paliperidone palmitate. CONCLUSION: As market shares of atypical antipsychotics are predicted to increase, payers may wish to re-evaluate their use.

Cost-effectiveness of long-acting injectable aripiprazole once-monthly 400 mg in bipolar I disorder in the USA.

AIM: To evaluate the cost-effectiveness of aripiprazole once-monthly 400/300 mg (AOM 400) in maintenance monotherapy treatment of bipolar I disorder (BP-I). METHODS: A de novo lifetime Markov model was developed for BP-I using available data for AOM 400 and relevant comparators. Base-case analysis considered costs and outcomes from the US payer perspective. RESULTS: The cost per quality-adjusted life year gained with AOM 400 versus comparators ranged from US$2007 versus oral asenapine to dominance (i.e., lower cost with quality-adjusted life gain) versus long-acting injectable risperidone, paliperidone palmitate, oral cariprazine and best supportive care. Patients treated with AOM 400 were estimated to have fewer mood episodes and hospitalizations per patient (5.37) than comparators (6.33, asenapine or cariprazine; 6.54, risperidone long-acting injectable; 7.64, paliperidone palmitate; and 8.93, best supportive care). Sensitivity analyses showed results were robust to parameter uncertainty. CONCLUSION: AOM 400 may be considered cost effective in the maintenance monotherapy treatment of BP-I in adults.

The economic burden of bipolar I disorder in the United States in 2015.

BACKGROUND: The current societal costs of bipolar I disorder (BDI) have not been comprehensively characterized in the United States, as previous studies are based on data from two decades ago. METHODS: The costs of BDI were estimated for 2015 and comprised direct healthcare costs, non-healthcare costs, and indirect costs, calculated based on a BDI prevalence of 1%. The excess costs of BDI were estimated as the difference between the costs incurred by individuals with BDI and those incurred by individuals without BD or individuals from the general population. Direct healthcare costs were assessed using three large US claims databases for insured individuals and the literature for uninsured individuals. Direct non-healthcare and indirect costs were based on the literature and governmental publications. RESULTS: The total costs of BDI were estimated at $202.1 billion in 2015, corresponding to an average of $81,559 per individual, while the excess costs of BDI were estimated at $119.8 billion, corresponding to an average of $48,333 per individual. The largest contributors to excess costs were caregiving (36%), direct healthcare costs (21%), and unemployment (20%). In sensitivity analyses, excess costs ranged from $101.2 to $124.3 billion. LIMITATIONS: Direct healthcare costs were calculated based on a BDI diagnosis, thus excluding undiagnosed patients. Direct non-healthcare and indirect costs were based on combined estimates from the literature. CONCLUSIONS: Besides direct healthcare costs, BDI was associated with substantial direct non-healthcare and indirect costs. More effective treatments and practices are needed to optimize therapeutic strategies and contain direct and indirect costs.

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.