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Introduction Pre-existing conditions relevant for adverse events (AE) and the potential for drug–drug interactions (DDIs) may limit safe pharmacotherapeutic augmentation options for patients with major depressive disorder (MDD). This concern may be heightened among patients with treatment-resistant depression (TRD), who often have comorbid medical disorders. Methods Adults with MDD and ≥ 1 antidepressant claim within the first observed major depressive episode were identified in the MarketScan® Databases. Those initiating a new regimen after two regimens at adequate dose and duration were considered to have TRD. The index date was defined at TRD onset or on a random antidepressant claim among patients with non-TRD MDD. Pre-existing conditions 12 months pre-index and potential DDIs 3 months pre/post-index associated with specific non-antidepressant augmentation therapies, including atypical antipsychotics (APs), buspirone, psychostimulants, anticonvulsants, thyroid hormone, and lithium were compared between 1:1 matched TRD and non-TRD MDD cohorts. Results Overall, 3414 patients with TRD and non-TRD MDD (mean age 39.7 years, 69% female) were matched. Relative to non-TRD MDD, patients with TRD had 33% higher likelihood of ≥ 1 pre-existing condition relevant for AEs listed in product labels of non-antidepressant augmentation therapies (p

Background and Objective Suicidal ideation or behavior are core symptoms of major depressive disorder (MDD). This study aimed to understand heterogeneity among patients with MDD and acute suicidal ideation or behavior. Methods Adults with a diagnosis of MDD on the same day or 6 months before a claim for suicidal ideation or behavior (index date) were identified in the MarketScan® Databases (10/01/2014–04/30/2019). A mathematical algorithm was used to cluster patients on characteristics of care measured pre-index. Patient care pathways were described by cluster during the 12-month pre-index period and up to 12 months post-index. Results Among 38,876 patients with MDD and acute suicidal ideation or behavior, three clusters were identified. Across clusters, pre-index exposure to mental healthcare was revealed as a key differentiator: Cluster 1 (N = 16,025) was least exposed, Cluster 2 (N = 5640) moderately exposed, and Cluster 3 (N = 17,211) most exposed. Patients whose MDD diagnosis was first observed during their index event comprised 86.0% and 72.8% of Clusters 1 and 2, respectively; in Cluster 3, all patients had an MDD diagnosis pre-index. Within 30 days post-index, in Clusters 1, 2, and 3, respectively, 79.3%, 85.2%, and 88.2% used mental health services, including outpatient visits for MDD. Within 12 months post-index, 61.5%, 91.5%, and 84.6% had one or more antidepressant claim, respectively. Per-patient index event costs averaged $5614, $6645, and $5853, respectively. Conclusions Patients with MDD and acute suicidal ideation or behavior least exposed to the healthcare system pre-index similarly received the least care post-index. An opportunity exists to optimize treatment and follow-up with mental health services. Supplementary Information The online version contains supplementary material available at 10.1007/s40273-021-01042-5.

Introduction Previous evidence demonstrated that patients with schizophrenia consumed substantial healthcare resources in an integrated healthcare system. This study evaluated the impact of initiating once-monthly paliperidone palmitate (PP1M) on healthcare resource utilization (HRU) among patients with schizophrenia treated in a US integrated healthcare system. Methods This retrospective study used electronic medical records from Atrium Health. Adults with at least two diagnoses of schizophrenia who received an initial PP1M dose between September 2009 and April 2019 (the corresponding date defined the index date) and at least one subsequent dose within 90 days were included. Additionally, patients were required to have received active care (at least one healthcare visit every 6 months) during 12-month pre- and post-index periods and at least one oral antipsychotic prescription during the 12-month pre-index period. Inpatient, emergency room (ER), and outpatient visits were compared over 12-month pre- versus post-index periods within the same cohort using McNemar’s and Wilcoxon signed rank tests. Findings were reported for all patients and separately in patients with at least one schizophrenia relapse (schizophrenia-related inpatient or ER visit) during the 12-month pre-index period. Results The study cohort included 210 patients (mean age 34.2 years, 69.5% male, 39.1% had Medicaid). From the 12-month pre- to post-index period, the proportion of patients with visits and mean number of visits reduced for all-cause inpatient (67.6% to 22.4%, 1.2 to 0.4), 30-day readmission (12.4% to 2.4%, 0.2 to 0.1), and ER (68.6% to 45.7%, 2.3 to 1.2) visits, whereas the mean number of outpatient visits increased (8.7 to 11.6) (all P

Patients with schizophrenia often struggle with medication adherence and may benefit from the use of a long-acting injectable antipsychotic, including once-monthly paliperidone palmitate (PP1M), which was previously demonstrated to improve outcomes compared with oral antipsychotics. This study assessed the impact of initiating PP1M therapy on medication adherence, health care resource use (HRU), and costs among Medicaid beneficiaries with schizophrenia and a prior schizophrenia relapse.A 6-state Medicaid database (from quarter 1 of 2009 to quarter 1 of 2018) was used to identify adults with ≥2 schizophrenia diagnoses who started PP1M therapy on or after January 1, 2010. The index date was the first PP1M claim. Patients had ≥12 months of continuous Medicaid enrollment before and after the index date, ≥1 oral antipsychotic claim in the 12 months before the index date, and ≥1 relapse (proxied as a schizophrenia-related inpatient admission or emergency department [ED] visit) during the 12 months before the index date. Generalized estimating equations were used to compare adherence to antipsychotics (proportion of days covered ≥80%), HRU, and costs (reported in 2018 US dollars) in the 12 months after versus before the index date. Sensitivity analyses were conducted (1) accounting for the minimum and cumulative price inflation Medicaid rebates for pharmacy costs of branded psychiatric medications, (2) among patients with ≥2, ≥3, and ≥4 prior schizophrenia-related inpatient admissions or ED visits, (3) among patients not adherent to antipsychotic treatment before the index date, and (4) among patients switching to PP1M directly from oral risperidone or paliperidone.A total of 1725 patients met the study inclusion criteria (mean age, 39.5 years; 43% female). After versus before the index date, patients were 93% more likely to be adherent to antipsychotic treatment (P 0.01). The likelihood of inpatient admissions and ED visits decreased by 89% and 49% (all P 0.01) after initiating PP1M therapy. The number of inpatient days decreased by 31% (P 0.01) and the number of ED visits by 16% (P = 0.03). Pharmacy costs increased by $514 per-patient-per-month (PPPM), whereas medical costs, driven by inpatient costs, decreased by $391 PPPM (all P 0.01). Sensitivity analyses yielded similar trends. Notably, total health care cost savings of $231 PPPM were observed after accounting for the cumulative Medicaid rebate for costs of branded psychiatric medications (P 0.01).In Medicaid beneficiaries with relapsed schizophrenia, transitioning from oral antipsychotics to PP1M was associated with improved adherence to antipsychotics and decreased use of inpatient and ED services. Increased pharmacy costs after the initiation of PP1M were offset by decreased medical costs. After applying the cumulative Medicaid rebate, including the price inflation rebate for costs of branded psychiatric medications, initiation of PP1M therapy resulted in statistically significant health care cost savings.

Antipsychotics with reduced dosing frequency may improve adherence and clinical outcomes for patients with schizophrenia. This study compared treatment patterns, healthcare resource utilization (HRU), and costs between Medicaid beneficiaries with schizophrenia treated with once-monthly paliperidone palmitate (PP1M) and those who transitioned to once-every-three-months paliperidone palmitate (PP3M).Adults with schizophrenia were identified in a four-state Medicaid database (18 May 2014 to 31 March 2019). The index date was the first PP3M claim (PP3M cohort), or a random PP1M claim (PP1M cohort), following ≥4 months of continuous PP1M treatment among patients with ≥12 months of continuous Medicaid enrollment pre- and post-index. Adherence (proportion of days covered by the index treatment ≥80%), persistence (no gap90/30 days in the PP3M/PP1M supply), HRU, and costs were compared during the 12-month post-index period between cohorts matched 1:1.Among 2374 patients identified, 374 remained in each cohort after matching (mean age 42 years; 30.5% female). Compared to the PP1M cohort, the PP3M cohort was 2.39 times more likely to be adherent (Medicaid beneficiaries who transitioned to PP3M had higher adherence and persistence, and a reduced likelihood of hospitalization relative to those who continued treatment with PP1M. The results suggest potential clinical value to transitioning eligible patients to PP3M.

To compare health care resource utilization (HCRU), short-term disability days, and costs between states of persistence on antidepressant lines of therapy after evidence of treatment-resistant depression (TRD). Patients with major depressive disorder (MDD) were identified in the IBM MarketScan Commercial and Medicare Supplemental Databases (01/01/2013���03/04/2019), Multi-State Medicaid Database (01/01/2013���12/31/2018), and Health Productivity Management Database (01/01/2015���12/31/2018). The index date was the date of the first evidence of TRD during the first observed major depressive episode. The follow-up period was divided into 45-day increments and categorized into persistence states: (1) evaluation (first 45 days after evidence of TRD); (2) persistence on the early line after evidence of TRD; (3) persistence on a late line; and (4) non-persistence. HCRU, short-term disability days, and costs were compared between persistence states using multivariate generalized estimating equations. Among 10,053 patients with TRD, the evaluation state was associated with higher likelihood of all-cause inpatient admissions (odds ratio [OR; 95% confidence interval (CI)] = 1.79 [1.49, 2.14]), emergency department visits (OR [95% CI] = 1.23 [1.12, 1.34]), and outpatient visits (OR [95% CI] = 3.83 [3.51, 4.18]; all p p p p = .028) relative to the early line. Medication may have been dispensed but not actually taken. Higher costs during the first 45 days after evidence of the presence of TRD and during persistence on a late line relative to persistence on the early-line therapy suggest there are benefits to using more effective treatments earlier.

Objective:This study compared health care use and costs among patients with treatment-resistant versus treatment-responsive depression across Medicaid, Medicare, and commercial payers.Methods:A ret...

Gang Li,1 Alexander Keenan,2 Mehmet Daskiran,1 Maju Mathews,3 Isaac Nuamah,3 Camille Orman,3 Kruti Joshi,4 Arun Singh,3 Annabelle Godet,5 Katalin Pungor,6 Srihari Gopal3 1Janssen Research & Development, LLC, Raritan, NJ, USA; 2Janssen Research & Development, LLC, Pennington, NJ, USA; 3Janssen Research & Development, LLC, Titusville, NJ, USA; 4Janssen Pharmaceuticals, Titusville, NJ, USA; 5Janssen-Cilag France, Issy-les-Moulineaux, Ile-de-France, France; 6Janssen-Cilag Germany, Neuss, North Rhine-Westphalia, GermanyCorrespondence: Gang LiEisai Inc., 4 Heitz Lane, Hillsborough, NJ, 08844, USATel +1 908 566-2730Email ligang8844@gmail.comPurpose: Relapse and treatment adherence to paliperidone palmitate once-monthly (PP1M) and three-monthly (PP3M) formulations in patients with schizophrenia were evaluated and compared using health claims data.Patients and Methods: Data (June 2015&boxh;June 2018) obtained from the MarketScan® Multi-State Medicaid Database were retrospectively analyzed. Patients aged ≥ 18 years with ≥ 1 claim for schizophrenia diagnosis prior to and/or at index date (i.e., date of first PP3M prescription record for PP3M patients and same month/year as the matched PP3M patients for PP1M patients) and continuous enrollment in the insurance plan for ≥ 12 months prior to index date (baseline) were included. PP1M cohort included patients who received ≥ 4 PP1M doses. PP3M patients were matched with PP1M patients (1:3) using propensity score matching and prevalent new user design. Outcome measures were relapse rate, time to relapse, proportion of days covered (PDC), and level of treatment adherence defined by PDC in five levels. Time to relapse was compared by Kaplan–Meier survival curves and log-rank test with the hazard ratio calculated using Cox proportion hazards model; PDC by t-test, and relapse rate and PDC categories by chi-square test.Results: A total of 1564 patients (428 PP3M and 1136 PP1M) were included. Relapse rate was lower in PP3M cohort (10.5%) compared with PP1M cohort (15.7%). Incidence rate of relapse was 8.98/100 person-years (PY) in PP3M cohort and 13.81/100 PY in PP1M cohort. After a mean (SD) follow-up of 456.1 (240.28) days in PP3M cohort and 465.4 (237.95) days in PP1M cohort, PP3M patients had a significantly lower relapse risk (hazard ratio: 0.65, 95% CI: 0.47, 0.90) than PP1M patients. Treatment adherence was significantly (p< 0.0001) higher in PP3M versus PP1M cohort.Conclusion: Risk of relapse was significantly lower, and treatment adherence was significantly higher in PP3M cohort compared with PP1M cohort. Higher treatment adherence was associated with lower relapse rate.Keywords: health claims, paliperidone palmitate, relapse rate, schizophrenia, three-monthly, treatment adherence

Aim: To assess associations between relapses and psychosocial outcomes in adult patients with schizophrenia treated in United States (US) healthcare settings.Methods: Data were derived from a point-in-time survey of psychiatrists and their patients with schizophrenia conducted across the US, France, Spain, China, and Japan between July and October 2019. For the purposes of this analysis, only data from US practitioners and patients were included. Disease-specific programmes (DSPs) are large surveys with a validated methodology conducted in clinical practise; they describe current disease management, disease burden, and associated treatment effects (clinical and physician-perceived). Participating psychiatrists completed patient record forms for their next 10 consecutive adult consulting patients with schizophrenia, with the same patients invited to voluntarily complete a patient self-completion (PSC) questionnaire. Surveys contained questions on the patients' disease background, treatment history, prior hospitalisation due to schizophrenia relapse and a series of psychosocial outcomes. Associations between relapses in the last 12 months and psychosocial outcomes were examined using multiple regression.Results: A total of 124 psychiatrists provided data on 1,204 patients. Of these, 469 patients (mean age, 39.6 years; 56.5% male) had known hospitalisation history for the last 12 months and completed a PSC; 116 (24.7%) patients had ≥1 relapse. Compared to patients without relapses, patients who relapsed were more likely to be homeless, unemployed, previously incarcerated, and currently have difficulties living independently (all p < 0.05). Patients who experience a relapse also had greater working impairment and poorer quality of life compared with those who did not relapse. In general, psychosocial outcomes became poorer with an increasing number of relapses.Conclusions: In this population of patients with schizophrenia from the US, relapse was significantly associated with poor psychosocial outcomes, with a greater number of relapses predicting worse outcomes. Early intervention to reduce the risk of relapse may improve psychosocial outcomes in patients with schizophrenia.

Aims: Among patients with schizophrenia, poor adherence and persistence with oral atypical antipsychotics (OAA) often results in relapse and hospitalization. Second-generation antipsychotic...

Objective Estimates of prevalence and burden of treatment-resistant depression (TRD) vary widely in the literature. This study evaluated the prevalence and burden of TRD and the share of TRD in the burden of medication-treated major depressive disorder (MDD) using the most commonly accepted definition of TRD and a novel bottom-up approach. Methods Prevalence and health care burden of TRD were estimated by synthetizing inputs across 4 similarly designed claims studies in adults covered by Medicare, Medicaid, commercial plans, and the US Veterans Health Administration (VHA). Productivity (absenteeism and presenteeism) and unemployment burden were estimated based on inputs from a study conducted with data from the Kantar National Health and Wellness Survey (NHWS; 2017). A targeted literature search for additional inputs was performed. A cost model was developed to estimate the burden of TRD and medication-treated DSM-5-defined MDD in the United States. Study outcomes were the 12-month prevalence of TRD and the annual health care, productivity, and unemployment burden of TRD and medication-treated MDD in the United States. Results The estimated 12-month prevalence of medication-treated MDD in the United States was 8.9 million adults, and 2.8 million (30.9%) had TRD. The total annual burden of medication-treated MDD among the US population was $92.7 billion, with $43.8 billion (47.2%) attributable to TRD. The share of TRD was 56.6% ($25.8 billion) of the health care burden, 47.7% ($8.7 billion) of the unemployment burden, and 32.2% ($9.3 billion) of the productivity burden of medication-treated MDD. Conclusions TRD is associated with disproportionate health care costs and unemployment, suggesting potentially large economic and societal gains with effective management.

Objectives To create and validate a model to predict depression symptom severity among patients with treatment‐resistant depression (TRD) using commonly recorded variables within medical claims databases. Methods Adults with TRD (here defined as > 2 antidepressant treatments in an episode, suggestive of nonresponse) and ≥ 1 Patient Health Questionnaire (PHQ)‐9 record on or after the index TRD date were identified (2013–2018) in Decision Resource Group's Real World Data Repository, which links an electronic health record database to a medical claims database. A total of 116 clinical/demographic variables were utilized as predictors of the study outcome of depression symptom severity, which was measured by PHQ‐9 total score category (score: 0–9 = none to mild, 10–14 = moderate, 15–27 = moderately severe to severe). A random forest approach was applied to develop and validate the predictive model. Results Among 5,356 PHQ‐9 scores in the study population, the mean (standard deviation) PHQ‐9 score was 10.1 (7.2). The model yielded an accuracy of 62.7%. For each predicted depression symptom severity category, the mean observed scores (8.0, 12.2, and 16.2) fell within the appropriate range. Conclusions While there is room for improvement in its accuracy, the use of a machine learning tool that predicts depression symptom severity of patients with TRD can potentially have wide population‐level applications. Healthcare systems and payers can build upon this groundwork and use the variables identified and the predictive modeling approach to create an algorithm specific to their population., In this study, we created and validated a machine learning model using commonly recorded variables within a medical claims database to predict depression symptom severity of patients with TRD based on Patient Health Questionnaire (PHQ)‐9 scores available within an electronic health record (EHR) database. The model was found to predict depression symptom severity category from the three possible severity category choices with an overall accuracy of 62.7%. Of the 116 clinical and demographic variables evaluated in our study, six were found to be the most important predictors. To our knowledge, this is the first study which attempts to predict depression symptom severity of patients with TRD using clinical and demographic characteristics in a medical claims database.

Evidence is limited on the economic burden associated with treatment-resistant depression (TRD) among US veterans. We evaluated the economic burden among patients with major depressive disorder (MDD) with and without TRD, and those without MDD in the Veterans Health Administration (VHA). Three cohorts were identified using VHA claims data (01APR2014-31MAR2018). Patients with MDD (aged ≥18) who failed ≥2 antidepressant treatments of adequate dose and duration were defined as having TRD; patients with MDD not meeting this criterion constituted the non-TRD MDD cohort (index: first antidepressant claim). The non-MDD cohort included those without MDD diagnosis (index: randomly assigned). Patients with psychosis, schizophrenia, manic/bipolar disorder, or dementia in the 6-month pre-index period were excluded. Patients with non-TRD MDD and non-MDD were matched 1:1 to patients with TRD based on demographic characteristics (age, gender, race, index year). Health care resource utilization (HRU) and costs were analyzed during the post-index period using a negative binomial model and ordinary least squares regression model, respectively. After 1:1 exact matching, 10,449 patients were included in each cohort (mean age: 48.9 years). Patients with TRD had higher per patient per year (PPPY) HRU than non-TRD MDD (all-cause inpatient visits: incidence rate ratio [IRR]: 1.70 [95% confidence interval: 1.57–1.83]) and non-MDD (IRR: 5.04 [95% confidence interval: 4.51–5.63]), and incurred higher total all-cause health care costs PPPY than non-TRD MDD (mean difference: $5,906) and non-MDD (mean difference: $11,873; all p Among US veterans, TRD poses a significant incremental economic burden relative to non-TRD MDD and non-MDD.

Little is known about the economic burden of treatment-resistant depression (TRD) in patients with physical conditions.To assess health care resource utilization (HRU) and costs, work loss days, and related costs in patients with TRD and physical conditions versus patients with the same conditions and non-TRD major depressive disorder (MDD) or without MDD.Adults aged65 years with MDD treated with antidepressants were identified in the OptumHealth Care Solutions database (July 2009-March 2017). Patients who received a diagnosis of MDD and initiated a third antidepressant regimen (index date) after 2 regimens of adequate dose and duration were defined as having TRD. Patients with non-TRD MDD and without MDD were assigned a random index date. Patients with6 months of continuous health plan eligibility pre- or post-index; a diagnosis of psychosis, schizophrenia, bipolar disorder/mania, dementia, and developmental disorders; and/or no baseline physical conditions (cardiovascular, metabolic, and respiratory disease or cancer) were excluded. Patients with TRD were matched 1:1 to each of the non-TRD MDD and non-MDD cohorts based on propensity scores. Per patient per year HRU, costs, and work loss outcomes were compared up to 24 months post-index date using negative binominal and ordinary least square regressions.A total of 2,317 patients with TRD (mean age, 47.6 years; 63.1%, female; mean follow-up, 19.7 months) had ≥ 1 co-occurring key physical condition (cardiovascular, 52.5%; metabolic, 48.2%; respiratory, 16.4%; and cancer, 9.5%). Relative to non-TRD MDD and non-MDD cohorts, respectively, patients with TRD had 46% and 235% more inpatient admissions, 28% and 128% more emergency department visits, and 53% and 155% more outpatient visits (allIn patients with physical conditions, those with TRD had higher HRU and health care costs, work loss days, and associated costs compared with non-TRD MDD and non-MDD cohorts.This study was sponsored by Janssen Scientific Affairs (JSA), which was involved in all aspects of the research, including the design of the study; the collection, analysis, and interpretation of data; writing of the report; and the decision to submit the report for publication. Joshi and Daly are employed by JSA. Zhdanava, Pilon, Rossi, Morrison, and Lefebvre are employees of Analysis Group, which received funding from JSA for conducting this study and has received consulting fees from Novartis Pharmaceuticals and GSK, unrelated to this study. Kuvadia is employed by Integrated Resources, which has provided research services to JSA unrelated to this study; Joshi reports past employment by and stock ownership in JohnsonJohnson; Nelson reports advisory board, data and safety monitoring board, and consulting fees from Assurex, Eisai, FSV-7, JSA, Lundbeck, Otsuka, and Sunovion and royalties from UpToDate, unrelated to this study. This work was presented at AMCP Nexus 2019, held in National Harbor, MD, from October 29 to November 1, 2019.

Aim: To compare adherence, healthcare utilization and costs among real world, Medicare-eligible patients with schizophrenia using long-acting injectable paliperidone palmitate (PP) versus oral atypical antipsychotics. Patients & methods: Historical cohort study used Medicare Advantage claims data. Inverse probability of treatment weighting was applied to adjust for baseline differences. 12-month adherence, healthcare utilization and costs were compared. Results: Patients using PP were more adherent (proportion of days covered ≥0.8; 48.1 vs 32.6%; p Conclusion: Compared with patients using oral atypical antipsychotics, PP had lower hospitalizations and medical costs with greater medication adherence accompanied by higher pharmacy costs.

Aim: Compare medication utilization, costs and healthcare resource use in schizophrenia patients with substance-related disorders initiated on once-monthly paliperidone palmitate (PP1M) or an oral atypical antipsychotic (OAA). Materials & methods: Data from six Medicaid states (07/2009–03/2015) were used to compare outcomes between PP1M and OAA patients. Results: PP1M patients had higher 12-month antipsychotic adherence and persistence than OAA patients. PP1M patients had lower medical (mean monthly cost difference [MMCD] = US$-191, p = 0.020), higher pharmacy (MMCD = US$250, p Conclusion: PP1M was associated with higher antipsychotic adherence and persistence, and similar total costs versus OAA.

Study ObjectivesTo describe characteristics of veterans with MDD and the different treatment regimens received during the first observed and treated major depressive episode (MDE).MethodsA retrospective study was performed using the Veterans Health Administration (VHA) database from 4/1/2015 to 2/28/2019 (study period), supplemented with Medicare Part A/B/D data from 4/1/2015 to 12/31/2017. Adult veterans with ≥1 MDD diagnosis in the VHA database between 10/1/2015 and 2/28/2017 (index date) were included if they received ≥1 line of therapy (LOT) within a complete MDE. An MDE was considered as starting on the date of the first observed MDD diagnosis preceded by ≥6 months depression-free period (i.e. a period without an MDD diagnosis or antidepressant (AD) use); an MDE was considered as ended on the date of the last MDD diagnosis or the end of the medication supply of the last AD/augmentation medication, whichever came last and then followed by ≥6 months depression-free period. An MDE was required to begin and end during the study period. A LOT was defined as ≥1 AD at adequate dose and duration (≥6 weeks of continuous therapy with no gaps longer than 14 days) with or without an augmenting medication. Patients were required to have VA benefit enrollment for ≥6 months before (baseline) and ≥24 months after index (follow-up). Patient baseline demographic and clinical characteristics as well as the number and type of LOTs (up to the first six LOTs) received during the first observed and treated MDE were evaluated.ResultsOverall, 40,240 veterans with MDD were identified (mean ± standard deviation [SD] age: 50.9±16.3 years).The majority were male (83.9%), White (63.4%), and non-Hispanic (88.6%); 60.1% were unemployed or retired at some point during the study period. The most commonly observed baseline comorbidities included hypertension (27.5%), hyperlipidemia (20.8%), post-traumatic stress disorder (17.5%), and diabetes (14.8%). During the first observed and treated MDE (mean ± SD duration: 14.7 ± 8.6 months), patients received a mean of 1.6±1.0 LOTs, with 36.5% and 14.6% of patients receiving ≥2 and ≥3 LOTs, respectively; 0.8% of patients received ≥6 LOTs. The most commonly observed therapies were SSRI monotherapy (58.9%) followed by SNRI monotherapy (8.8%) in LOT1; SSRI monotherapy followed by AD augmented with anticonvulsants in LOT2 (SSRI monotherapy: 48.7%; AD augmentation with anticonvulsants:12.1%) and LOT3 (SSRI monotherapy: 43.5%; AD augmentation with anticonvulsants:15.0%).ConclusionsThis study used an episodic approach to evaluate the current standard of care among veterans with MDD. During the first observed and treated MDE, about one in seven veterans received ≥3 LOTs, suggesting presence of treatment-resistant MDD. Monotherapy with SSRIs or SNRIs and combination therapies of AD with anticonvulsants were the most common therapies in the first three LOTs.FundingJanssen Scientific Affairs, LLC

Objective The objective of this study was to compare persistence, costs, and healthcare resource utilization in patients with schizophrenia and cardiometabolic comorbidities treated with once-monthly paliperidone palmitate or an oral atypical antipsychotic. Methods Medicaid data from six states (07/2009–03/2015) were used to identify adults with schizophrenia and cardiometabolic comorbidities initiated on once-monthly paliperidone palmitate or an oral atypical antipsychotic (index date) on 01/2010 or after. Persistence to index medication at 12 months (no gap ≥ 90 days) was compared between patients taking once-monthly paliperidone palmitate and an oral atypical antipsychotic using Chi-squared tests. The 12-month post-index healthcare costs and healthcare resource utilization were compared using multivariate ordinary least squares and Poisson regression, respectively. Results Selected patients taking once-monthly paliperidone palmitate (n = 371) were younger (mean age: 45.0 vs. 47.5 years, standardized difference = 24%) than patients taking oral atypical antipsychotics (n = 8296). Persistence at 12 months was higher in patients taking once-monthly paliperidone palmitate (40 vs. 33%, p = 0.006). Adjusted all-cause medical costs were lower in patients taking once-monthly paliperidone palmitate vs. patients taking oral atypical antipsychotics (mean monthly cost differences = US $ − 369, p = 0.004) while all-cause pharmacy costs were higher (mean monthly cost differences = US $279, p

Dominic Pilon,1 Kruti Joshi,2 Neeta Tandon,2 Marie-Hélène Lafeuille,1 Rhiannon L Kamstra,1 Bruno Emond,1 Patrick Lefebvre2 1Groupe d’analyse, Ltée, Montréal, QC, Canada; 2Janssen Scientific Affairs, LLC, Titusville, NJ, USA Background: Poor antipsychotic (AP) adherence is a key issue in patients with schizophrenia. First-generation antipsychotic (FGA) and second-generation antipsychotic (SGA) long-acting injectable therapies (LAI) may improve adherence compared to oral antipsychotics (OAP). The objective of the study was to compare treatment adherence and persistence in Medicaid patients with schizophrenia initiated on first-generation long-acting injectable therapies (FGA-LAI) or second-generation long-acting injectable therapies (SGA-LAI) versus OAP.Methods: Adults with schizophrenia initiated on FGA-LAI, SGA-LAI, or OAP on or after January 2010 were identified using a six-state Medicaid database (January 2009– March 2015). Outcomes were assessed during the 12 months following treatment initiation. Index medication adherence was assessed using the proportion of days covered ≥80%, while persistence was assessed as no gap of ≥30, ≥60, or ≥90 days between days of supply. Outcomes were compared between FGA/SGA-LAI and OAP cohorts using chi-squared tests and adjusted odds ratios (OR).Results: During follow-up, AP polypharmacy was more common in FGA-LAI patients (N=1,089; 36%; P=0.029) and less common in SGA-LAI patients (N=2,209; 27%; P

To assess the burden of treatment-resistant depression (TRD) among privately insured patients with anxiety disorder and/or substance use disorders (SUD). Adults p p N = 310/cohort), patients with TRD had more work loss days (54) and higher work loss-related costs ($13,674) vs patients with non-TRD MDD (32 days; $7131) and without MDD (17 days; $4798; all p In patients with an anxiety disorder and/or SUD, TRD was associated with higher HRU, healthcare costs, work loss days and work loss-related costs.

BackgroundPrevious studies have assessed the incremental economic burden of treatment-resistant depression (TRD) versus non-treatment-resistant major depressive disorder (i.e., non-TRD MDD) in commercially-insured and Medicaid-insured patients, but none have focused on Medicare-insured patients.ObjectiveTo assess healthcare resource utilization (HRU) and costs of patients with TRD versus non-TRD MDD or without major depressive disorder (MDD; i.e., non-MDD) in a Medicare-insured population.MethodsAdult patients were retrospectively identified from the Chronic Condition Warehouse de-identified 100% Medicare database (01/2010-12/2016). MDD was defined as ≥1 MDD diagnosis and ≥1 claim for an antidepressant. Patients initiated on a third antidepressant following two antidepressant treatment regimens of adequate dose and duration were considered to have TRD. The index date was defined as the date of the first antidepressant claim for the TRD and non-TRD MDD cohorts, and as a randomly imputed date for the non-MDD cohort. Patients with TRD were matched 1:1 to non-TRD MDD patients and randomly selected non-MDD patients based on propensity scores. Analyses were also performed for a subset of patients aged ≥65.ResultsOf 29,543 patients with MDD, 3,225 (10.9%) met the study definition of TRD; 157,611 were included in the non-MDD cohort. Matched patients with TRD and non-TRD MDD were, on average, 58.9 and 59.0 years old, respectively. The TRD cohort had higher per-patient-per-year (PPPY) HRU than the non-TRD MDD (e.g., inpatient visits: incidence rate ratio [IRR] = 1.36) and non-MDD cohorts (e.g., inpatient visits: IRR = 1.84, all PConclusionAmong Medicare-insured patients, those with TRD had higher HRU and costs compared to those with non-TRD MDD and non-MDD.

Objective Our objective was to assess healthcare resource utilization (HRU) and costs among patients with major depressive disorder (MDD) with and without treatment-resistant depression (TRD) and those without MDD in US Integrated Delivery Networks (IDNs). Methods This was a retrospective matched-cohort study. The Optum© Integrated Claims Electronic Health Record de-identified database was used to identify adult patients with TRD (January 2011–June 2017) across US IDNs. TRD patients were propensity score matched 1:1 with non-TRD MDD and non-MDD patients on demographics. Rates of HRU and costs were compared up to 2 years following the first antidepressant pharmacy claim (or randomly imputed date for non-MDD patients) using negative binomial and ordinary least squares regressions, respectively, with 95% confidence intervals (CIs) from nonparametric bootstraps (costs only) adjusted for baseline comorbidity index and costs. Results All 1582 TRD patients were matched to non-TRD MDD and non-MDD patients and evaluated. TRD patients were on average 46 years old, and 67% were female. Mean duration of observation was 20.1, 19.6, and 17.9 months in the TRD, non-TRD MDD, and non-MDD cohorts, respectively. Patients with TRD had significantly higher rates of HRU than did non-TRD MDD patients (inpatient visits 0.35 vs. 0.16 per patient per year [PPPY]; adjusted incidence rate ratio [IRR] 2.04 [95% CI 1.74–2.39]) and non-MDD patients (0.35 vs. 0.09 PPPY, adjusted IRR 3.05 [95% CI 2.54–3.66]). TRD patients incurred significantly higher costs PPPY than did non-TRD MDD patients ($US25,807 vs. 13,701, adjusted cost difference $US9479 [95% CI 7071–11,621]) and non-MDD patients ($US25,807 vs. 8500, adjusted cost difference $US11,433 [95% CI 8668–13,876]). Conclusions HRU and costs associated with TRD are significant in US IDNs. Electronic supplementary material The online version of this article (10.1007/s41669-019-0154-z) contains supplementary material, which is available to authorized users.

[This corrects the article DOI: 10.1371/journal.pone.0223255.].

This retrospective longitudinal cohort study aimed to compare treatment patterns, healthcare resource utilization (HRU), and costs in patients with schizophrenia treated with second-generation antipsychotic long-acting injectables (SGA-LAIs): biweekly risperidone LAI versus once-monthly paliperidone palmitate.Patients who initiated risperidone LAI or paliperidone palmitate between 1 July 2007 and 31 December 2012 (index date) were identified from the Truven MarketScan Commercial, Medicare Supplemental, and Medicaid Multi-State insurance databases. Outcomes were assessed 12 months after the index date. Propensity score matching (1:1) based on patients' demographics and comorbidities was conducted. Outcome differences between the two cohorts were evaluated using t-tests for continuous variables, chi-square tests for categorical variables, and Wilcoxon rank-sum tests for count and cost variables. Regression models estimated the difference in medication use and adherence, likelihood of HRU, number of HRU events, and healthcare costs when comparing risperidone LAI versus paliperidone palmitate, while further adjusting for patient characteristics and pre-index HRU.Patient characteristics were well balanced between the two cohorts (n = 499 each). Significantly lower discontinuation rates (36.5% vs. 53.3%; p 0.001) and longer days of LAI coverage (233.6 vs. 131.7 days; p 0.001) were observed in the paliperidone palmitate cohort versus the risperidone LAI cohort, respectively. Patients treated with paliperidone palmitate were 12.5 (95% confidence interval [CI]: 9.0-17.8) and 11.7 (95% CI: 8.0-17.4) times more likely to be adherent based on medication possession ratio and proportion of days covered, respectively (p 0.001). Patients treated with paliperidone palmitate had reduced likelihood of hospitalization (adjusted odds ratio [95% CI]: 0.72 [0.55-0.95]), fewer emergency department (ED) visits (adjusted incidence rate ratio [aIRR]: 0.67 [0.61-0.73]) and reduced length of inpatient stay (aIRR: 0.86 [0.82-0.90]), which resulted in lower monthly inpatient hospitalization costs (-$77.58; p = 0.038) and ED visits (-$9.77; p = 0.021) relative to risperidone LAI.Pharmacy costs were derived from health plan payment in the claims data and do not account for any discounts or rebates. This may have overestimated the branded drug costs in this analysis.These findings highlight the value of once-monthly paliperidone palmitate in the treatment of patients with schizophrenia.

This study assessed real-world treatment patterns and antipsychotic (AP) medication adherence among commercially insured US patients with schizoaffective disorder (SCA). Continuously insured adults aged 18 years or older with a diagnosis of SCA from January 1, 2009, to December 31, 2012, were identified from the Clinformatics Data Mart database. Patients were categorized into 2 cohorts: incident or prevalent SCA. Demographics and clinical characteristics were evaluated during the baseline period. Use of psychiatric medications and adherence to AP medications were evaluated during a 12-month follow-up period after index diagnosis of SCA. Of the overall study population (N = 2713; mean age, 40.2 y; 52.7% female), 1961 patients (72.3%) (mean age, 38.7 y; 51.3% female) had incident SCA, and 752 patients (27.7%) (mean age, 43.9 y; 56.5% female) had prevalent SCA. Antipsychotics were used by 74.8% of patients in the overall study population during the follow-up period. The most commonly prescribed oral AP was risperidone (23.9%), followed by quetiapine (21.4%) and aripiprazole (20.4%). Use of any long-acting injectable APs in the overall study population during the follow-up period was less than 3%. A total of 49.0% and 38.0% of the overall study population had medication possession ratios and proportion of days covered for APs of 80% or greater, respectively. Overall use of long-acting injectable APs for the treatment of SCA is low, and adherence to AP medications, measured by both medication possession ratio and proportion of days covered, is suboptimal among patients with SCA in the real-world setting.

Among patients with major depressive disorder (MDD), those with treatment-resistant depression (TRD) have a higher economic burden. However, the healthcare resource utilization (HRU) and costs may vary by severity status in TRD patients. This study quantified the incremental economic burden of severity status in TRD patients.In a US database of privately insured employees and dependents (07/01/2009-03/31/2015), a claims-based algorithm identified adult TRD patients who were stratified into mild, moderate, and severe cohorts based on the information in the last observed MDD ICD-9-CM code. HRU and costs of moderate and severe cohorts were compared to those of the mild cohort during the 2-year follow-up after the first antidepressant claim.Among 6411 TRD patients, 455 (7.1%) were identified as mild, 2153 (33.6%) as moderate, and 1455 (22.7%) as severe. Moderate and severe patients compared to mild had 45% and 150% more inpatient admissions, 65% and 164% more inpatient days, 18% and 54% more emergency department visits and 8% and 10% more outpatient visits per-patient-per-year (PPPY), respectively (all-cause; all p 0.05). Mean all-cause direct total healthcare costs were $12,123, $16,885, and $18,911 PPPY in mild, moderate, and severe patients, respectively. The all-cause total healthcare cost differences adjusted for baseline characteristics amounted to $3455 in moderate and $5150 in severe versus mild patients, respectively (PPPY; all p 0.05).Not all TRD patients had a severity specifier; the severity specifier was not cross-validated against a depression scale.Increased severity status is associated with incremental economic burden in TRD patients.

Objectives: To compare comorbidity-related outcomes, adherence to antipsychotics (APs), healthcare resource utilization (HRU), and costs pre- and post-transition to once-every-3-months paliperidone palmitate (PP3M) in commercially-insured patients with schizophrenia. Methods: Adults with ≥1 claim for PP3M, ≥2 schizophrenia diagnoses, and adequate treatment with once-monthly paliperidone palmitate (PP1M; i.e. no gap of >45 days in PP1M coverage for ≥4 months, same PP1M dosage for the last two PP1M claims, and appropriate PP1M to PP3M dosing conversion) were selected from the IQVIA PharMetrics Plus database (May 2014–February 2018). Generalized estimating equation models adjusted for repeated measurements were used to compare patient characteristics, adherence to APs, HRU, and costs during the 6-month period pre- vs post-transition to PP3M. Results: Of 152 included patients, the mean age was 41.0 years and 36.2% were females. Post-PP3M transition, patients were less likely to have a claim with a diagnosis for substance-related and addictive disorders (odds ratio [OR] = 0.57), psychoses (OR = 0.57), diabetes without chronic complication (OR = 0.72), and drug abuse (OR = 0.64; all p p = .007), compared to the period pre-PP3M transition. There was no significant difference in HRU pre- vs post-transition. All-cause total (mean monthly cost difference [MMCD] = $242), pre-rebate pharmacy (MMCD = $65), and medical costs (MMCD = $176) remained similar pre- vs post-transition (all p > .05). Conclusions: Transitioning to PP3M was associated with an improvement in adherence and in comorbidity-related outcomes related to substance-related and addictive disorders, psychoses, diabetes without chronic complication, and drug abuse. These findings suggest PP3M may enhance comorbidity-related outcomes and adherence while remaining cost neutral.

Objectives The aim was to compare adherence to antipsychotics (APs), healthcare resource utilization (HRU), and costs before and after once-every-3-months paliperidone palmitate (PP3M) initiation in patients with schizophrenia. Methods Medicaid data (Iowa, Kansas, and Missouri; 1/2014–3/2017) were used to identify adults with at least one PP3M claim, ≥ 12 months of pre-index enrollment, and at least two schizophrenia diagnoses. Adequate treatment with once-monthly paliperidone palmitate (PP1M) was required pre-PP3M transition. Generalized estimating equations were used to assess linear trends in adherence to APs, HRU, and costs over the four quarters pre-PP3M transition, and to compare monthly HRU and costs 6 months pre- and 12 months post-PP3M transition as well as adherence to APs 12 months pre- and post-PP3M transition. Results Among 324 patients initiated on PP3M, the mean age was 41.4 years and 36.1% were females. Over the four quarters pre-PP3M transition, the monthly number of emergency room visits, medical costs, and inpatient costs decreased, while pharmacy costs and adherence to APs increased. For patients with ≥ 12 months of follow-up (n = 151), adherence to APs (66.2 vs. 70.2%, p = 0.3758), total (US$3371 vs. US$3456; p = 0.7000), pharmacy (US$1805 vs. US$1870; p = 0.2960), and medical costs (US$1565 vs. US$1586; p = 0.9040) remained similar pre- and post-PP3M transition, while mean monthly number of 1-day mental institute visits (1.71 vs. 1.51; p

Purpose The aim of this study was to conduct a systematic literature review on the burden of schizophrenia in privately insured US patients. Materials and methods A systematic literature review of English language peer-reviewed journal articles of observational studies published from 2006 to 2016 was conducted using EMBASE/MEDLINE databases. Abstracts covering substantial numbers of patients with schizophrenia or schizoaffective disorder (i.e., N ≥ 100) were included for full-text review. Articles that did not clearly specify private insurance types were excluded. Results A total of 25 studies were reviewed; 10 included only privately insured patients; and 15 included a mix of different types of insurance. The review of the clinical burden of schizophrenia revealed the following: compared to patients with no mental disorders, those with schizophrenia had significantly increased odds of systemic disorders and both alcohol and substance abuse. Antipsychotic (AP) adherence was low, ranging from 31.5% to 68.7%. The medication possession ratio for AP adherence ranged from 0.22 to 0.73. The review of the health economic burden of schizophrenia revealed the following: patients with a recent (vs. chronic) diagnosis of schizophrenia had significantly higher frequencies of emergency department visits and hospitalizations and greater length of stay (LOS) and total annual per-capita costs. Mean all-cause hospitalizations and LOS decreased significantly after (vs. before) initiating long-acting injectable APs (LAIs). Patients also had significantly decreased mean all-cause, and schizophrenia-related, hospitalization costs after initiating LAIs. Total direct per-capita costs of care (but not pharmacy costs) for patients who were nonadherent to their oral APs within the first 90 days of their index event were significantly higher (vs. early adherent patients). Despite these potential benefits, only 0.25%-13.1% of patients were treated with LAIs across all studies. Conclusion Privately insured US patients with schizophrenia experience a substantial clinical and health economic burden related to comorbidities, acute care needs, nonadherence, and polypharmacy and have relatively low use of LAIs. Further study is warranted to understand prescribing patterns and clinical policies related to this patient population.

This study evaluated the biopsychosocial characteristics of adults undergoing substance abuse evaluation with potential schizophrenia/psychotic disorder, or possible schizophrenia/psychosis-like symptoms, compared with those with no schizophrenia/psychosis-like symptoms. A cross-sectional, observational study examined 170,201 adults, aged 18 to 30, who completed the Addiction Severity Index-Multimedia Version (ASI-MV). Approximately 10% were classified as having possible schizophrenia/psychosis-like symptoms or potential schizophrenia/psychotic disorder. These patients were more likely to exhibit moderate to extreme severity on employment, medical, legal, substance use, social, and psychiatric status than nonsymptomatic patients. The potential schizophrenia or psychotic disorder cohort was also more likely to have ever experienced physical abuse (odds ratio [OR] = 4.30, 95% confidence interval [CI] = 4.12-4.48) and/or sexual abuse (OR = 4.32, 95% CI = 4.15-4.51) versus the no schizophrenia/psychosis-like symptoms cohort. Findings support a recommendation for routine screening for mental health issues, particularly schizophrenia/psychosis-like symptoms, for adults entering substance use disorder treatment settings. This may increase the likelihood of appropriate and earlier intervention.

The aim of this article was to describe and compare treatment patterns, health care resource utilization (HRU), and health care costs before and after transition in veterans with schizophrenia who were transitioned from paliperidone palmitate given once monthly (PP1M) to paliperidone palmitate given every 3 months (PP3M) according to prescribing-information guidelines.This retrospective, longitudinal study was conducted using electronic health records data from the Veterans Health Administration (VHA). Veterans were eligible for inclusion if they were aged 18years or older, had ≥1 dispensation of PP3M, were enrolled with VHA benefits for ≥24 months prior to transition to PP3M, had ≥1 schizophrenia diagnosis, were transitioned to PP3M according to prescribing-information guidelines (operationalized as no gap in PP1M treatment of45days during the 4 months prior to PP3M transition, with the same dosage in the last 2 PP1M dispensations), and had appropriate dose conversion. Treatment patterns, HRU, and costs 6 months pre and post PP3M transition were described and compared using the McNemar test and the Wilcoxon signed rank test.Of the 277 veterans identified, the majority were men (92.8%); the median age was 56.5years. Among 197 veterans who had at least 6 months of follow-up pre and post PP3M transition, oral antipsychotic use was significantly decreased (from 49.7% to 43.1%; P = 0.0326). Additionally, the mean number of days spent in an inpatient setting (41.4vs 21.6; P = 0.0164), the mean number of outpatient visits per patient (31.0vs 25.6; P0.0001), and the mean total health care costs ($27,745vs $23,772; P = 0.0050) were significantly decreased.After transitioning to PP3M treatment, veterans had significantly reduced use of oral antipsychotics, HRU, and costs. Although generalizability may be limited due to the veteran population and to those who transitioned according to PP3M prescribing guidelines, future studies in other patient populations may be used to extend these conclusions.

The objective of this economic model was to estimate the difference in medical costs among patients treated with paliperidone palmitate once-monthly injectable antipsychotic (PP1M) vs placebo, based on clinical event rates reported in the 15-month randomized, double-blind, placebo-controlled, parallel-group study of paliperidone palmitate evaluating time to relapse in subjects with schizoaffective disorder.Rates of psychotic, depressive, and/or manic relapses and serious and non-serious treatment-emergent adverse events (TEAEs) were obtained from the long-term paliperidone palmitate vs placebo relapse prevention study. The total annual medical cost for a relapse from a US payer perspective was obtained from published literature and the costs for serious and non-serious TEAEs were based on Common Procedure Terminology codes. Total annual medical cost differences for patients treated with PP1M vs placebo were then estimated. Additionally, one-way and Monte Carlo sensitivity analyses were conducted.Lower rates of relapse (-18.3%) and serious TEAEs (-3.9%) were associated with use of PP1M vs placebo as reported in the long-term paliperidone palmitate vs placebo relapse prevention study. As a result of the reduction in these clinical event rates, the total annual medical cost was reduced by $7140 per patient treated with PP1M vs placebo. One-way sensitivity analysis showed that variations in relapse rates had the greatest impact on the estimated medical cost differences (range: -$9786, -$4670). Of the 10,000 random cycles of Monte Carlo simulations, 100% showed a medical cost difference$0 (reduction) for patients using PPIM vs placebo. The average total annual medical differences per patient were -$8321 for PP1M monotherapy and -$6031 for PPIM adjunctive therapy.Use of PP1M for treatment of patients with schizoaffective disorder was associated with a significantly lower rate of relapse and a reduction in medical costs compared to placebo. Further evaluation in the real-world setting is warranted.

OBJECTIVE To compare treatment patterns and Medicaid spending between schizophrenia patients initiating once-monthly paliperidone palmitate (PP1M) and oral atypical antipsychotics (OAAs) within four comorbid populations: cardiovascular disease (CVD), diabetes, hypertension and obesity. METHODS Five-state Medicaid data identified comorbid adults with schizophrenia initiating PP1M or OAAs (index) from September 2009 balanced with inverse probability of treatment weighting. Chi-squared and t-tests compared index antipsychotic (AP) exposure (no gap >90 days) duration, AP polypharmacy, and index AP adherence (proportion of days covered ≥80%) and persistence (no gap ≥60 days) at 12 months post-index. Linear models with a non-parametric bootstrap procedure compared costs. RESULTS PP1M patients consistently had longer index AP exposure (e.g. CVD: 244 vs. 189 days; p

Since May 2015, adult patients with schizophrenia adequately treated with once monthly paliperidone palmitate (PP1M) may be transitioned to once-every-three-months paliperidone palmitate (PP3M). This study aims to describe baseline characteristics and treatment patterns of patients with schizophrenia initiated on PP3M in a real-world setting.Pharmacy and medical claims from May 2014 to September 2016 for adult patients with schizophrenia initiated on PP3M (index date) in the Symphony Health Solutions database were analyzed. The cohort consisting of all patients and the one restricted to those transitioning from PP1M as per prescribing guideline recommendations were considered. Baseline characteristics were assessed during the 12 month baseline period. PP1M treatment patterns, proportion of days covered (PDC) by mental-health-related medications, and healthcare resource utilization (HRU) patterns were evaluated for each baseline quarter. PP3M treatment patterns were assessed post-index.Among the 1545 adult patients initiated on PP3M who formed the first cohort, 68.8% transitioned from PP1M based on prescribing guidelines and on an adaptation of the strict clinical trial protocol for PP1M to PP3M transition, forming the second cohort. In both cohorts, the proportion of patients with a PDC ≥80% for antipsychotics, antidepressants, anxiolytics, and mood stabilizers increased while the proportion of patients with ≥1 emergency room, inpatient, or outpatient visit decreased in baseline quarters closer to PP3M initiation. Among patients with ≥4 months of follow-up after the first dose, 85-88% had a second dose. Similarly, among those with ≥4 months of follow-up after the second dose, 87-90% received a third dose.Patients initiated on PP3M demonstrated decreased HRU and increased adherence in quarters closer to PP3M initiation, and were persistent on their PP3M treatment.

Almost half of all patients diagnosed with schizophrenia have a history of substance abuse (SA). However, data on treatment of schizophrenia with paliperidone palmitate (PP) among patients with comorbid SA are limited. The objective of this study was to compare all-cause and SA-related health care resource utilization and costs in veterans with schizophrenia and co-occurring SA who were treated with PP versus oral atypical antipsychotics (OAAs).Veterans Health Administration electronic health record data were used to conduct a retrospective longitudinal study in veterans with schizophrenia who initiated PP or OAA between January 1, 2010 and June 30, 2016, had ≥12 months of enrollment before treatment initiation (baseline), were diagnosed with SA, and had ≥1 Global Assessment of Functioning score during baseline. Differences in baseline characteristics were adjusted for using inverse probability of treatment weighting. Adjusted cost differences and incidence rate ratios (IRR) for the association between PP versus OAA and all-cause and SA-related health care costs and health care resource utilization in the 12 months after treatment initiation were estimated with corresponding 95% CIs using weighted linear and Poisson regression models, respectively.Of 6872 veterans in the study, 1684 (25%) and 5188 (75%) were treated with PP and OAA, respectively. After adjustment, PP was associated with fewer all-cause inpatient (IRR = 0.88; 95% CI, 0.85 to 0.90), mental health-related inpatient (IRR = 0.88; 95% CI, 0.85 to 0.91), and long-term care stays (IRR = 0.53; 95% CI, 0.44 to 0.64), but more frequent mental health intensive case management visits (IRR = 1.51; 95% CI, 1.49 to 1.53) compared with OAA (all P0.001). Similarly, PP was associated with significantly lower rates of SA-related inpatient stays (IRR = 0.80; 95% CI, 0.77 to 0.83), mental health stays (IRR = 0.85; 95% CI, 0.82 to 0.88), long-term care stays (IRR = 0.22; 95% CI, 0.15 to 0.32), and outpatient visits (IRR = 0.78; 95% CI, 0.77 to 0.79) than OAA (all P0.001). Relative to OAA, patients treated with PP also had lower mean annual all-cause (cost difference = -$10,473; 95% CI, -$17,827 to -$3491) and SA-related (cost difference = -$8457; 95% CI, -$12,710 to -$3638) medical costs (all P0.001).PP was associated with significant total medical cost savings resulting from fewer hospitalizations and lower rates of SA-related health care resource utilization compared with OAA in patients with schizophrenia and comorbid SA. Thus, PP appears to be a valuable treatment option for patients in this subpopulation.

Background Nonadherence to antipsychotic treatment increases the likelihood of relapse and progressive symptomatology in patients with schizophrenia. Atypical long-acting injectables, including paliperidone palmitate (PP), may increase adherence and improve symptoms. This study compared and assessed predictors of treatment patterns and symptom remission among schizophrenia patients treated with PP versus atypical oral antipsychotic therapy (OAT) in community behavioral health organizations (CBHOs). Methods This retrospective cohort analysis evaluated 763 patients with schizophrenia and new (PP-N; N = 174) or continuing (PP-C; N = 308) users of PP, or new users of OAT (N = 281) at enrollment in the REACH-OUT study (2010–2013). Treatment outcomes assessed at 1 year were discontinuation, and adherence, measured by proportion of days covered (PDC) or medication possession ratio (MPR). Remission status was assessed using the Structured Clinical Interview for Symptoms of Remission (SCI-SR). A machine learning platform, Reverse Engineering and Forward Simulation (REFS™), was used to identify predictors of study outcomes. Multivariate Cox and generalized linear regressions estimated the adjusted hazard ratios (HRs) or odds ratios (ORs) with 95% confidence intervals. Results Among PP-N users, 27% discontinued their initial treatment regimen versus 51% (p

The importance of improvement in the ejection fraction to the prognosis of revascularized patients with ischaemic left ventricular (LV) dysfunction is uncertain.Eighty-seven patients with ischaemic LV dysfunction (mean ejection fraction 29 ± 8% by biplane Simpson's) had dobutamine echocardiography before revascularization (coronary bypass graft surgery-81, percutaneous intervention-6). Follow-up echocardiograms were performed a mean of 4.8 ± 6.2 months after revascularization. An 8% increase in the ejection fraction was considered significant (two times the inter-observer difference of 3.7%). Patients were followed for cardiac death. During a mean follow-up of 5.2 ± 3.9 years, there were 20 (23%) cardiac deaths. Class 3/4 heart failure, increasing low-dose wall motion score, increasing % non-viable myocardium, and digoxin use in follow-up were univariate predictors of death. Beta-blocker use, ejection fraction improvement, angina, aspirin use, and increasing fractional shortening were univariate predictors of survival. Ejection fraction improvement [P= 0.02, hazard ratio (HR) = 0.26], digoxin use in follow-up (P= 0.006, HR = 5.85), and low-dose wall motion score (P= 0.017, HR = 4.78) were independent predictors of outcome. In step-wise analysis, low-dose wall motion score added incremental prognostic value to ejection fraction improvement (P= 0.003), and digoxin use in follow-up (P= 0.003) added incremental value to a low-dose score and ejection fraction improvement.Ejection fraction improvement is an independent predictor of long-term outcome in revascularized patients but viability (low-dose wall motion score) and digoxin use in follow-up are also independent predictors and add incremental prognostic value to ejection fraction improvement.

While atypical long-acting injectable antipsychotics (LAIs) offer the potential for increased adherence, access to medication poses challenges that may hinder their use. Janssen Connect * *Janssen Connect is a registered trade name of Janssen Scientific Affairs, LLC, Titusville, NJ, USA. (JC), a comprehensive information and assistance program, was designed to help patients who received a Janssen LAI initiate and maintain treatment after their health care professional (HCP) determined that the medication was the most clinically appropriate option. We conducted a formative and impact evaluation on early medication adherence of patients enrolled in JC and prescribed paliperidone palmitate.Using the program administrative files (December 2010-April 2014), 9354 patients whose HCP ordered paliperidone palmitate were included. Patient demographics, clinical characteristics, and request of JC program offerings were reported overall, and compared between patients requesting the injection center versus those who did not. Medication adherence based on the first 6 months of treatment while in the program and defined as achieving ≥80% proportion of days covered (PDC) was measured for patients receiving ≥2 paliperidone palmitate injections (n = 2659). Logistic models evaluated the association between requests for injection centers on medication adherence.Mean age of program enrollees was 40.6 (standard deviation = 13.9 years), 59.3% were men, and 42.5% were Medicare covered. While in the program, 79.9% did not experience a medication gap of ≥7 weeks and 87.0% achieved adherence. Injection center request was associated with medication adherence (adjusted odds ratio (aOR) ≤5 months: 0.03; 95% confidence interval (CI): 0.02-0.05; ≥6 months: aOR: 4.16; 95% CI: 2.72-6.36).The data sources used were designed for program implementation and not for research purposes.The high percentage of patients requesting injection center support and medication shipment in addition to other insurance-related program offerings signals the need for and value of a comprehensive support program for patients seeking LAI therapy. Providing patients with the option of alternative and more conveniently located injection centers may help them start and maintain their treatment.

Purpose: To compare medication adherence rates for once-weekly (QW) versus once-daily (QD) dosing regimens in patients with chronic disease. Methods: A systematic literature review was conducted to identify articles published in Englishlanguage journals examining the rate of adherence to medications in patients with chronic disease. Relevant studies were identified from January 2002 through August 2013 using PubMed, EMBASE, and the Cochrane Library databases. Twenty-two published observational studies reporting adherence were identified by 2 independent reviewers, and 7 articles reported relevant measures for analysis. All studies were conducted in patients with osteoporosis. Metaanalyses estimated (1) mean difference (MD) in adherence (defined using the mean medication possession ratio [MPR]) between QW and QD dosing groups and (2) odds ratio (OR) for adherence (defined using an MPR cutoff of Z80%) for QW versus QD dosing. Heterogeneity was assessed using Cochran’ sQ and I 2 values, and meta-analyses used both fixed- and random-effects models. Findings: The random-effects meta-analysis revealed a significantly greater MPR with QW compared with QD dosing (pooled MD ¼ 12.29%; 95% CI, 10.76%–13.82%; n ¼ 9 [data reported in 7 publications]). Because of the high level of heterogeneity (I 2 ¼ 83.4%), the fixed-effects model results were not appropriate to report for the pooled MD. When examining the OR for adherence, both fixed- and random-effects models provided similar results due to the low level of heterogeneity (I 2 ¼ 7.9%; n ¼ 5 [data reported in 3 publications]). Using either model, the pooled odds of being adherent (MPR Z80%) in the QW dosing group was approximately 1.9 times the odds in the QD dosing group (random-effects OR ¼ 1.90; 95% CI, 1.81–2.00; fixed-effects OR ¼ 1.92; 95% CI, 1.84–1.99). Implications: In our meta-analysis, QW dosing was associated with better adherence levels and greater odds of being adherent compared with QD dosing in patients with osteoporosis. (Clin Ther. 2015;37:1813– 1821) & 2015 Elsevier HS Journals, Inc. All rights reserved.

A 49 year old female with repaired tetralogy of Fallot and previously normal exercise capacity presented with abdominal pain, fatigue, and dyspnea three months after a visit to Peru. Initially she was treated for possible pancreatitis without improvement. Physical exam revealed jugular venous