Real-world impact of disease on functioning and activity: what is missed when using general instruments to estimate quality-adjusted life years.

OBJECTIVE: Economic evaluations conducted to inform healthcare resource allocation often rely on quality-adjusted life years (QALYs) to measure therapeutic benefit. However, QALYs, with underlying health utilities estimated using the EQ-5D or SF-36, may fail to capture the impact of disease for all patients. How well-being and heath utility differ across several common conditions was explored. METHODS: This study examined eight diseases: arthritis, asthma, cancer, depression, diabetes, heart disease, lung disease and stroke. Health utilities for each disease were obtained from published literature. Other measures of disease burden, including physical functioning, cognitive functioning and physical activity, were estimated from the National Health and Nutrition Examination Survey (NHANES). Group rankings by these measures were compared to rankings by health utility. RESULTS: Health utilities were lowest for patients with depression (0.44), and highest for those with cancer (0.81). Physical functioning was most limited (higher score) among those with stroke (28.2) and had the least impact for cancer (24.4). Physical activity was most impacted by heart disease (27.3) and least impacted by depression (40.7). Cognitive functioning was lowest in stroke (41.6) and highest in asthma (52.0). CONCLUSION: Differences in rankings of disease severity by metric indicate that the results of cost-utility analyses might be biased against treatments for certain diseases. As patient preferences for clinical outcomes vary, the full burden of disease should be considered in evaluations. Restricting access to treatments based on an incomplete estimate of burden could lead to misallocation of resources and a withholding of therapies that patients find valuable.

Economic Burden of Neurologic Toxicities Associated with Treatment of Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma in the United States.

BACKGROUND: Chimeric antigen receptor (CAR) T-cell therapy, which is approved for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL), can be associated with potentially severe and costly neurologic adverse events (AEs). OBJECTIVES: To develop an evidence-based list of treatment-related neurologic AEs in patients with relapsed or refractory DLBCL, including AEs related to CAR T-cell therapies, and to estimate the healthcare costs associated with these neurologic AEs in a real-world setting. METHODS: We identified grade ≥3 neurologic AEs that occurred in ≥2% of patients by reviewing drug prescribing information and published clinical trials with therapies used for relapsed or refractory DLBCL. Data from 3 nationally representative claims databases were used to identify adults with relapsed or refractory DLBCL, who were eligible for the study if they received 1 of 4 types of therapy, including CAR T-cell therapy, high-intensity cytotoxic therapy, low-intensity cytotoxic therapy, or targeted therapies. The rates of neurologic AEs and total healthcare costs were calculated for patients with and without neurologic AEs within 30 days of treatment. The costs were inflated to 2019 first-quarter US dollars. RESULTS: A total of 16 types of neurologic AEs were identified, including 13 events related to CAR T-cell therapy and 5 related to conventional immunochemotherapy regimens, with 2 overlapping event types. Of these AEs, 11 were included in the claims analysis, based on available diagnosis codes. Of the 11,098 adults with relapsed or refractory DLBCL in the study, 118 patients received CAR T-cell therapy, 9483 received a high-intensity cytotoxic therapy, 1259 received a low-intensity cytotoxic therapy, and 238 received a targeted therapy. A total of 299 (2.7%) patients had ≥1 neurologic AEs during the 30-day postindex period. Of these patients, 43 received CAR T-cell therapy (36.4% of the 118 CAR T-cell therapy users). The mean total healthcare cost was $71,982 higher for patients with neurologic AEs than for patients without neurologic AEs. The trend of higher costs in patients with neurologic AEs was consistent across the treatment groups and was most pronounced in CAR T-cell therapy users ($143,309; 95% confidence interval, $5838-$280,779). CONCLUSION: Patients with relapsed or refractory DLBCL who had severe or life-threatening neurologic AEs incur substantially higher costs than their counterparts who do not have neurologic AEs, with the largest cost difference in patients who receive CAR T-cell therapy.

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.

Risk of hospitalization among patients with epilepsy using long versus short half-life adjunctive antiepileptic drugs.

INTRODUCTION: While antiepileptic drugs (AEDs) remain the primary treatment for epilepsy, many patients continue to have seizures. Uncontrolled seizures may be related to AED half-life, since short half-life (SHL) AEDs require more frequent dosing compared with the simplified regimens of long half-life (LHL) AEDs. Long half-life AEDs may also improve seizure control by extending missed dose forgiveness periods. The value of LHL AEDs may be assessed as reduced healthcare utilization. The study's objective was to examine the impact of adding an LHL versus SHL adjunctive AED on the risk of hospitalizations in patients with uncontrolled epilepsy. METHODS: This was a retrospective, longitudinal cohort study using the Symphony Health Solution Patient Integrated Dataverse. Patients ≥12 years old with uncontrolled epilepsy (≥2 medical claims ≥30 days apart) were identified during a study period (8/1/2012-7/31/2017). Patients were selected if they were subsequently initiated an adjunctive AED (excluding modified release formulations), and the prescription date served as the index. Patients were stratified into two mutually exclusive cohorts based on the index AED half-life (≤20 versus >20 h). Poisson regressions with robust error variances were performed for the relative risks (RRs) of all-cause, epilepsy-related, and injury-related hospitalizations. RESULTS: A total of 4984 patients were identified (2705 in the LHL and 2279 in the SHL cohort). Compared with those in the SHL cohort, patients in the LHL cohort were significantly younger [mean (SD, years): 43.9 (18.5) versus 49.2 (17.2), p < 0.001] and were less comorbid [mean (SD) of Charlson comorbidity index: 1.2 (1.8) versus 1.8 (2.2), p < 0.001]. In the one-year postindex date, adjusting for group differences, the risks of both all-cause and epilepsy-related hospitalizations were significantly lower in the LHL cohort than in the SHL cohort [all-cause: 0.84 (95% CI: 0.76-0.93), p = 0.0006; epilepsy-related: 0.83 (0.73-0.94), p = 0.0046].Injury-related hospitalizations did not differ between LHL and SHL cohorts. CONCLUSION: In patients with uncontrolled epilepsy who were initiated on an adjunctive AED, the choice of an LHL versus SHL was associated with significantly lower risks of all-cause and epilepsy-related hospitalizations.

Untangling the clinical and economic burden of hospitalization for cardiac amyloidosis in the United States.

PURPOSE: Cardiac dysfunction is common in amyloid light-chain (AL) amyloidosis, a rare disease caused by extracellular deposition of misfolded immunoglobulin light chains. This study aimed to examine economic/clinical disease burden in hospitalized cardiac amyloidosis patients. PATIENTS AND METHODS: Cardiac amyloidosis patients ≥18 years old hospitalized between 2014 and 2016 were identified in claims if they had ≥1 inpatient claim consistent with amyloidosis and evidence of cardiac dysfunction. Descriptive statistics were reported. RESULTS: 3239 cardiac amyloidosis patients [1795 (55.4%) with concurrent renal disease] were identified. Mean (SD) length of stay was 8.3 (11.1) days. 25.2% were admitted to the intensive care unit. Mean overall hospitalization costs were USD$20,584. In-hospital mortality was 9.0% overall. 16.8% were readmitted within 30 days, with 11.2% dying in-hospital and a mean readmission cost of USD$18,536. CONCLUSION: Hospitalization for cardiac amyloidosis is costly, with high rates of readmission and mortality. Opportunities exist to improve care.

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.

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.

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.

Mortality and healthcare costs in Medicare beneficiaries with AL amyloidosis.

AIMS: Examine mortality and healthcare costs in Medicare beneficiaries with newly diagnosed immunoglobulin light chain (AL) amyloidosis. PATIENTS & METHODS: Cases were identified in 2012-2015 Medicare 5% data with ≥1 inpatient/≥2 outpatient claims consistent with AL amyloidosis and ≥1 AL-specific treatment. Cases were matched 3:1 with disease-free controls. Descriptive statistics were reported. RESULTS: A total of 249 (33.3%) cases were matched to 747 (66.7%) controls. A total of 19.7% of cases died within 1 year of follow-up versus 5.5% of controls; 30.6 versus 11.8% died within 2 years (p < 0.001). Mean (SD) costs in 1-year of follow-up were significantly higher among cases versus controls ($71,040 [65,766] vs $13,722 [27,493]; p < 0.001). CONCLUSION: Mortality was nearly four-times higher, and costs nearly five-times higher in beneficiaries with AL amyloidosis versus controls.

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.

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.

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.

Treatment adherence, healthcare resource utilization, and costs in patients with lung neuroendocrine tumors (lung NETs) in the USA.

OBJECTIVE: To assess first-line treatment adherence, healthcare resource utilization, and costs in lung NET patients initiating pharmacologic treatments. METHODS: In two US claims databases, patients aged ≥18 years with ≥1 inpatient or ≥2 outpatient lung NET claims within 12 months were identified. The first claim for pharmacologic treatments (e.g. somatostatin analogs [SSAs], cytotoxic chemotherapy [CC], targeted therapy [TT]) following diagnosis, between July 1, 2009-December 31, 2014, was defined as the index date. A 6-month pre-index period without any NET treatment, and ≥1-year post-index enrollment were required. Proportion of days covered (PDC) was calculated during follow-up. Descriptive statistics, including means, standard deviations, and frequencies/percentages for continuous and categorical data, respectively, were reported. RESULTS: Of 354 patients with 1-year of follow-up, 252 initiated CC, 89 SSA, 3 TT, and 10 various combinations. Due to sample sizes, the remaining results focus only on CC and SSAs. Mean PDC (SD) was 0.320 (0.176) for CC and 0.673 (0.322) for SSAs; CC users had a mean (SD) of 33.3 (23.8) office visits and 0.79 (1.39) hospitalizations; SSA users had 23.1 (12.4) visits and 0.48 (1.07) hospitalizations. Mean total (SD) annual cost for CC users was $124,383 (135,836) and $98,713 (81,495) for SSA users. Among 163 patients with 2 years of follow-up, the annual mean cost in the second-year was $43,026 lower and $8110 higher than the first-year for CC and SSAs, respectively. CONCLUSIONS: The majority of patients with lung NETs initiated CC; only about one quarter initiated SSA in the first-line. This descriptive study updates the utilization and costs of pharmacologically-treated lung NETs.

Epidemiology of AL amyloidosis: a real-world study using US claims data.

Amyloid light-chain (AL) amyloidosis is a rare disease caused by extracellular deposition of misfolded immunoglobulin light chains. This study aimed to provide an up-to-date estimate of prevalence and incidence of AL amyloidosis in the United States. Using claims databases from years 2007 to 2015, adults ≥18 years old with AL amyloidosis were included if they had (1) at least 1 inpatient or 2 outpatient claims consistent with AL amyloidosis and (2) received 1 AL-specific treatment. Prevalence was calculated as the number of AL patients divided by the number of enrollees on June 30th of each calendar year. Incidence was calculated as the number of patients with AL who were disease-free and enrolled with a health plan for 1 year prior, divided by the number of enrollees with enrollment from July 1st of the previous year to June 30th of each calendar year. The prevalence of AL amyloidosis increased significantly between 2007 and 2015, from 15.5 cases per million in 2007 to 40.5 in 2015, an annual percentage change (APC) of 12% (P < .001). The incidence ranged from 9.7 to 14.0 cases per million person-years (APC, 3%; P = .114) with no statistically significant increase. There was an increase in AL amyloidosis prevalence over a 9-year period coupled with stable incidence rates. Although there is no diagnosis code specific to AL amyloidosis and no validated method for identifying this condition using claims data, extrapolating from our data, there are at least 12 000 adults in the United States living with AL amyloidosis, and the number seems likely to rise.

First-line systemic treatment adherence, healthcare resource utilization, and costs in patients with gastrointestinal neuroendocrine tumors (GI NETs) in the USA.

AIMS: To assess treatment adherence, healthcare resource utilization, and costs in gastrointestinal neuroendocrine tumor (GI NET) patients initiating pharmacologic treatments in the US. METHODS: In two US commercial claims databases, patients ≥18 years with ≥1 inpatient or ≥2 outpatient GI NET claims within 12 months were identified. The first claim for pharmacologic treatments (e.g. somatostatin analogs [SSAs], cytotoxic chemotherapy [CC], targeted therapy [TT]) following diagnosis, between July 1, 2009 - December 31, 2014, was defined as the index date. A 6-month pre-index NET treatment-free period, and ≥1-year post-index enrollment were required. Proportion of days covered (PDC) was calculated during the follow-up period. Outcomes were reported separately for patients with 1- and 2-years post-index enrollment. Descriptive statistics, including means, standard deviations, and frequencies and percentages for continuous and categorical data, respectively, were reported. RESULTS: Of 1,322 patients with 1-year follow-up, 847 initiated SSA, 397 CC, 35 TT, two interferon, and 41 various combinations. Mean (SD) PDC was 0.669 (0.331) for SSA, 0.466 (0.236) for CC, and 0.505 (0.328) for TT. Mean (SD) office visits and hospitalizations, respectively, were 20.5 (13.5) and 0.59 (1.03) for SSA, 30.5 (19.8) and 0.89 (1.45) for CC, and 17.7 (12.5) and 1.23 (1.93) for TT. Total annual cost for patients during year 1 was $99,691 (82,423) for SSA, $134,912 (116,078) for CC, and $158,397 (82,878) for TT. Among 685 patients with 2-years follow-up, annual mean costs in year 2 were $8,071, $58,944, and $36,248 lower than year 1 for SSA, CC, and TT, respectively. LIMITATIONS: Findings may not be generalizable to the US population. Claims are designed for reimbursement, not research. The study may under-estimate costs not covered by insurance. CONCLUSION: This study reports utilization and costs associated with different treatment therapies. Costs were higher in year 1 than year 2. This two-database study offers new information on the magnitude and trends in the cost of pharmacologically-treated GI NETs.

Healthcare resource utilization and costs in amyloid light-chain amyloidosis: a real-world study using US claims data.

AIM: To estimate healthcare utilization and costs in amyloid light-chain (AL) amyloidosis. PATIENTS & METHODS: AL amyloidosis patients were identified in 2007-2015 claims databases if they had ≥1 inpatient/≥2 outpatient claims consistent with AL amyloidosis and received ≥1 AL-specific treatment. Descriptive statistics were reported. RESULTS: 50.1% (n = 3670) were admitted ≥1 time during the year, 11.3% (n = 827) ≥3 times. From 2007 to 2015, bortezomib use increased from 4.6 to 25.3%; melphalan use decreased from 18.9 to 2.0%; costs increased from 92,866 to $114,030. Among incident patients with at least 2 years of follow-up, healthcare utilization and costs decreased from first to second year post-diagnosis. CONCLUSION: AL chemotherapy-based prescribing practices changed. Total annual healthcare costs increased over time among AL amyloidosis patients.