Optimizing Computer-Aided Diagnosis with Cost-Aware Deep Learning Models.

Classical machine learning and deep learning models for Computer-Aided Diagnosis (CAD) commonly focus on overall classification performance, treating misclassification errors (false negatives and false positives) equally during training. This uniform treatment overlooks the distinct costs associated with each type of error, leading to suboptimal decision-making, particularly in the medical domain where it is important to improve the prediction sensitivity without significantly compromising overall accuracy. This study introduces a novel deep learning-based CAD system that incorporates a cost-sensitive parameter into the activation function. By applying our methodologies to two medical imaging datasets, our proposed study shows statistically significant increases of 3.84% and 5.4% in sensitivity while maintaining overall accuracy for Lung Image Database Consortium (LIDC) and Breast Cancer Histological Database (BreakHis), respectively. Our findings underscore the significance of integrating cost-sensitive parameters into future CAD systems to optimize performance and ultimately reduce costs and improve patient outcomes.

Out-of-Pocket Costs for Long-Acting Injectable and Oral Antipsychotics Among Medicare Patients With Schizophrenia.

OBJECTIVE: The authors sought to describe out-of-pocket (OOP) costs among beneficiaries with schizophrenia differing in Medicare Part D low-income subsidy (LIS) status. METHODS: National 100% Medicare claims were used to identify all adult fee-for-service Medicare Part D beneficiaries with schizophrenia who used antipsychotics in 2019 (N=283,813). Proportions of patients by LIS status, OOP costs per prescription, and annual OOP costs were reported. Results were stratified by type of antipsychotic received (oral antipsychotic [OAP], first-generation long-acting injectable [FGA-LAI], or second-generation long-acting injectable [SGA-LAI]). RESULTS: In the final sample, 90.3% of beneficiaries had full LIS status, paying minimal copayments (29.6% institutionalized full LIS, paying $0; 42.2% noninstitutionalized full LIS, ≤100% federal poverty level [FPL], paying $1.25-$3.80; and 18.5% noninstitutionalized full LIS, >100% FPL, paying $3.40-$8.50). Only 0.9% of the sample received partial LIS status, and 8.8% had a non-LIS status. Non-LIS beneficiaries had the highest OOP costs, followed by partial LIS beneficiaries. Before entering catastrophic coverage, median OOP costs per prescription for generic OAPs, brand-name OAPs, FGA-LAIs, and SGA-LAIs were $10.85, $171.97, $26.09, and $394.28, respectively, for non-LIS beneficiaries and $3.69, $105.82, $9.35, and $229.20, respectively, for partial LIS beneficiaries. The annual total OOP costs varied substantially by LIS status (full LIS, $0-$130.79; partial LIS, $458.96; non-LIS, $998.81). CONCLUSIONS: Most Medicare beneficiaries with schizophrenia qualified for full LIS and faced minimal OOP costs for both OAPs and LAIs. The remainder (i.e., partial LIS and non-LIS beneficiaries) faced substantial OOP costs, both per prescription and annually, especially for SGA-LAIs.

Racial and Ethnic Disparities in Long-Acting Injectable Antipsychotic Use in a National Sample of Medicare Beneficiaries With Schizophrenia.

This cross-sectional study assesses the racial and ethnic disparities in long-acting injectable antipsychotic use in a national sample of Medicare beneficiaries with schizophrenia.

Continuity of care among patients newly initiated on second-generation oral or long-acting injectable antipsychotics during a schizophrenia-related inpatient stay.

BACKGROUND: Maintaining continuity of care after schizophrenia-related hospitalization is challenging for patients and healthcare providers and systems. Prior evidence suggests that second-generation long-acting injectable antipsychotics (SGLAIs) may reduce the risk of treatment nonadherence and readmission versus oral atypical antipsychotics (OAAs). Therefore, quality measures were compared between patients initiated on SGLAIs and OAAs in the United States. METHODS: Adults newly initiated on an SGLAI or OAA during a schizophrenia-related inpatient stay were identified in HealthVerity databases (01/2015-12/2020); the index date was the hospital discharge date. Patients had continuous health insurance coverage for pharmacy and medical services for 6 months pre-admission and post-discharge from the inpatient stay and ≥1 pharmacy or medical claim (i.e. treatment as indicated by the observed insurance claims) for an antipsychotic other than the index SGLAI or OAA in the 6 months pre-admission. Antipsychotic use and adherence, and schizophrenia-related readmissions and outpatient visits were compared during the 6-month period post-discharge. Characteristics between cohorts were balanced using inverse probability weights. RESULTS: Post-discharge, only 36.9% and 40.7% of weighted SGLAI (N = 466) and OAA (N = 517) patients had ≥1 pharmacy or medical claim for the antipsychotic initiated during the inpatient stay, among whom SGLAI patients were 4.4 times more likely to be adherent to that antipsychotic compared to OAA patients (p < .001). Additionally, SGLAI patients were 2.3 and 3.0 times more likely to have a pharmacy or medical claim for and be adherent to any antipsychotic relative to OAA patients (including index antipsychotic; all p < .001). Within 7 and 30 days post-discharge, 1.7% and 13.0% of SGLAI patients and 4.1% and 12.6% of OAA patients had a readmission. Further, SGLAI patients were 51% more likely to have an outpatient visit compared to OAA patients (p = .044). CONCLUSIONS: Less than half of patients initiated on antipsychotics during a schizophrenia-related inpatient stay continued the same treatment post-discharge. However, SGLAI patients were more likely to be adherent to the initiated antipsychotic and to have an outpatient visit, which may suggest improved continuity of care post-discharge relative to OAA patients.

Antipsychotic utilization, healthcare resource use and costs, and quality of care among fee-for-service Medicare beneficiaries with schizophrenia in the United States.

BACKGROUND: No research to date has examined antipsychotic (AP) use, healthcare resource use (HRU), costs, and quality of care among those with schizophrenia in the Medicare program despite it serving as the primary payer for half of individuals with schizophrenia in the US. OBJECTIVES: To provide national estimates and assess regional variation in AP treatment utilization, HRU, costs, and quality measures among Medicare beneficiaries with schizophrenia. METHODS: Cross-sectional descriptive analysis of 100% Medicare claims data from 2019. The sample included all adult Medicare beneficiaries with continuous fee-for-service coverage and ≥1 inpatient and/or ≥2 outpatient claims with a diagnosis for schizophrenia in 2019. Summary statistics on AP use; HRU and cost; and quality measures were reported at the national, state, and county levels. Regional variation was measured using the coefficient of variation (CoV). RESULTS: We identified 314,888 beneficiaries with schizophrenia. About 91% used any AP; 20% used any long-acting injectable antipsychotic (LAI); and 14% used atypical LAIs. About 28% of beneficiaries had ≥1 hospitalization and 47% had ≥1 emergency room (ER) visits, the vast majority of which were related to mental health (MH). Total annual all-cause, MH, and schizophrenia-related costs were $23,662, $15,000 and $12,109, respectively. Among those with hospitalizations, 18.4% and 27.3% had readmission within 7 and 30 days and 56% and 67% had a physician visit and AP fill within 30 days post-discharge, respectively. Overall, 81% of beneficiaries were deemed adherent to their AP medications. Larger interstate variations were observed in LAI use than AP use (CoV: 0.21 vs 0.02). County-level variations were larger than state-level variations for all measures. CONCLUSIONS: In this first study examining a national sample of Medicare beneficiaries with schizophrenia, we found low utilization rates of LAIs and high levels of hospital admissions/readmissions and ER visits. State and county-level variations were also found in these measures.

Real-world calibration and transportability of the Disease Recovery Evaluation and Modification (DREaM) randomized clinical trial in adult Medicaid beneficiaries with recent-onset schizophrenia.

BACKGROUND: The Disease Recovery Evaluation and Modification study (DREaM; NCT02431702) assessed the benefit of initiating paliperidone palmitate (PP), a long-acting injectable antipsychotic, in patients with recent-onset schizophrenia or schizophreniform disorder. OBJECTIVE: To determine whether reductions in psychiatric hospitalizations with early initiation of PP vs oral antipsychotic (OAP) therapy observed in a DREaM post hoc analysis are transportable to a real-world population of patients with recent-onset schizophrenia. METHODS: Patients enrolled in DREaM were randomized to receive OAP or PP for 9 months, after which OAP recipients were re-randomized to receive OAP or PP for another 9 months. We used this design to form treatment arms: OAP-OAP, OAP-PP, and PP-PP. Inclusion/exclusion criteria were used to identify a Medicaid Managed Care (MMC) OAP-treated cohort of 1,000 patients diagnosed with schizophrenia using IBM Truven databases from 2015 to 2019. The MMC cohort was combined with the subset of patients diagnosed with schizophrenia enrolled in DREaM from US sites (N = 45, 43, and 44 for OAP-OAP, OAP-PP, and PP-PP, respectively). Propensity scores for the MMC cohort were estimated using baseline variables identified via double-lasso regression. Estimated propensity scores were used to weight psychiatric hospitalizations in the DREaM OAP-OAP group and compared with observed MMC OAP cohort psychiatric hospitalizations. After the successful calibration of the DREaM OAP-OAP group, similar approaches were taken for the OAP-PP and PP-PP groups to transport DREaM effects to MMC data. RESULTS: Standardized mean differences in baseline covariates between DREaM treatment arms and MMC groups were substantially reduced after calibration. The 18-month cumulative numbers of psychiatric hospitalizations per patient (SE) were 0.83 (0.14) for the MMC cohort, 0.43 (0.14) for the unweighted OAP-OAP, and 0.80 (0.37) for the calibrated OAP-OAP. The difference between the calibrated OAP-OAP and MMC was not statistically significant (difference, 0.03 [95% CI = -0.67 to 0.81]), indicating successful calibration. The mean difference in 18-month cumulative psychiatric hospitalizations relative to the MMC cohort was -0.77 (95% CI = -1.08 to -0.47) for OAP-PP and -0.83 (95% CI = -1.15 to -0.60) for PP-PP. CONCLUSIONS: Our study demonstrates that results from the DREaM OAP-OAP group reflect psychiatric hospitalizations in a real-world population when calibrated using specific baseline characteristics. Transporting the DREaM effects, we find that using OAP-PP and PP-PP treatment strategies for patients with recent-onset schizophrenia in the MMC population could reduce psychiatric hospitalizations compared with the use of OAP. These findings, along with the potential reduction in associated costs, should be considered when assessing the value of PP formulations. DISCLOSURES: Dr Basu reports consulting fees through Salutis Consulting LLC related to this work. Dr Mavros is a former employee of the Janssen Pharmaceutical Companies of Johnson & Johnson, Inc, and holds stock in the company. Ms Benson, Dr Fu, Ms Patel, and Dr Brown are employees of Janssen Scientific Affairs, LLC, and hold stock in Johnson & Johnson. This research was funded by Janssen Scientific Affairs, LLC. The sponsor was involved in the study design; collection, analysis, and interpretation of data; and development and review of the manuscript. All authors had full access to the study data and take responsibility for data integrity and the accuracy of the analyses. All authors provided direction and comments on the manuscript, reviewed and approved the final version prior to submission, made the final decision about where to publish these data, and approved submission to this journal.

Adherence, Persistence, Readmissions, and Costs in Medicaid Members with Schizophrenia or Schizoaffective Disorder Initiating Paliperidone Palmitate Versus Switching Oral Antipsychotics: A Real-World Retrospective Investigation.

INTRODUCTION: Long-acting injectable antipsychotic agents have been suggested to improve adherence and patient outcomes in schizophrenia or schizoaffective disorder. The purpose of this study was to assess medication use patterns (i.e., medication adherence, persistence), hospital and emergency department readmissions, and total direct medical costs of Oklahoma Medicaid members with schizophrenia or schizoaffective disorder switching from an oral antipsychotic (OAP) to once-monthly paliperidone palmitate (PP1M) or to another OAP (OAP-switch). METHODS: A historical cohort analysis was conducted from 1 January 2016 to 31 December 2020 among adults aged ≥ 18 and ≤ 64 years with schizophrenia or schizoaffective disorder who were previously treated with an OAP. The first claim for PP1M or a new OAP defined the study index date. Members who transitioned from PP1M to 3-month formulation (PP3M) were included (i.e., PP1M/PP3M). Proportion of days covered (PDC), 45-day treatment gaps, 30-day readmissions to hospitals or emergency department, and total direct medical costs were assessed using multivariable, machine-learning least absolute shrinkage, and selection operator (Lasso) regressions controlling for numerous demographic, clinical, mental health, and provider characteristics. RESULTS: Among 295 Medicaid members meeting full inclusion criteria, 183 involved PP1M/PP3Ms (44 PP1M cases transitioned to PP3M) and 112 involved an OAP-switch. The multivariable-adjusted odds of readmission were significantly associated with a 45-day treatment gap (p < 0.05) and non-adherence (i.e., PDC < 80%) (p < 0.05). Relative to PP1M/PP3Ms, the multivariable analyses also indicated that OAP-switch was associated with an 18.5% lower PDC, 92.3% higher number of 45-day treatment gaps, and an approximately 90% higher odds of all-cause 30-day readmission (p < 0.05). The adjusted pre- to post-index change in cost was approximately 49% lower for OAP-switches versus PP1M/PP3Ms (p < 0.001), although unadjusted post-index costs did not differ between groups (p = 0.440). CONCLUSION: This real-world investigation of adult Medicaid members with schizophrenia or schizoaffective disorder observed improved adherence and persistence with fewer readmissions with PP1M/PP3Ms versus OAP-switches.

Health care resource utilization and costs in patients receiving long-acting injectable vs oral antipsychotics: A comparative analysis from the Disease Recovery Evaluation and Modification (DREaM) study.

BACKGROUND: Given relapse frequency early in the course of schizophrenia, recently diagnosed patients may benefit from longacting injectable antipsychotics, which are associated with reduced risk of relapse and hospitalization compared with oral antipsychotics (OAPs). OBJECTIVE: To compare health care resource utilization (HCRU) and costs in patients with recent-onset schizophrenia treated with continuous paliperidone palmitate (PP) or continuous OAP or who switched from OAP to PP. METHODS: In this analysis, we combined the 2 randomized phases of the prospective, open-label Disease Recovery Evaluation and Modification (DREaM) clinical study using the principal stratification method to generate 3 treatment strategies: continuous PP for 18 months (PP-PP), continuous OAP for 18 months (OAP-OAP), and initial OAP switched to PP after 9 months (OAP-PP). HCRU metrics included psychiatric hospitalizations, psychiatric and nonpsychiatric emergency department visits, and ambulatory visits. Costs were analyzed using generalized linear models with inverse-probability weighting based on time-varying probabilities of exposure. Robust SEs were estimated using individual-level clustered bootstrapping. Subgroup analyses were performed by region and prior antipsychotic use (< 6 vs ≥ 6 months). RESULTS: A total of 181 patients were included in the PP-PP (n = 61), OAP-OAP (n = 61), and OAP-PP (n = 59) groups. The majority of patients (73%) were enrolled at study sites in the United States, and 48% had received an antipsychotic for less than 6 months prior to study entry. Baseline characteristics were well balanced, and no significant differences in discontinuation rates were observed across treatment strategies. Compared with OAP-OAP, significantly lower cumulative HCRU and costs were apparent before 9 months in the PP-PP group and after 9 months in the OAP-PP group. The cumulative 18-month effects of PP-PP and OAP-PP vs OAP-OAP on the number of psychiatric hospitalizations were ‒0.28 (95% CI = ‒0.51 to ‒0.08) and ‒0.27 (95% CI = ‒0.50 to 0.04), respectively, and those on cumulative mean per-patient total health care costs (in 2020 USD) were -$2,867 (95% CI = ‒$5,133 to ‒$750) and ‒$2,789 (95% CI = ‒$5,155 to ‒$701), respectively. Subgroup analyses indicated a greater reduction in psychiatric hospitalizations and costs with PP-PP or OAP-PP relative to OAP-OAP in patients with less than 6 vs 6 or more months of prior antipsychotic therapy. CONCLUSIONS: Continuous early use of PP in adults with recentonset schizophrenia significantly reduced psychiatric hospitalizations and associated estimated costs compared with OAP; these effects were particularly notable for patients with a shorter duration of prior antipsychotic use. As this was a post hoc analysis of a study that was not powered for HCRU assessments, future studies calibrating these effects to larger real-world populations will be useful. DISCLOSURES: Dr Basu reports consulting fees through Salutis Consulting LLC related to this work. Ms Benson, Dr Turkoz, Ms Patel, Dr Baker, and Dr Brown are employees of Janssen Scientific Affairs, LLC, and stockholders of Johnson & Johnson, Inc. This research was funded by Janssen Scientific Affairs, LLC. The sponsor was involved in the study design; collection, analysis, and interpretation of data; development and review of the manuscript; and decision to submit the manuscript for publication.

National and regional description of healthcare measures among adult Medicaid beneficiaries with schizophrenia within the United States.

AIMS: Provide the first national description across the US of variations in healthcare measures in 2018 among Medicaid beneficiaries with schizophrenia. MATERIALS AND METHODS: Adult beneficiaries with ≥2 diagnoses for schizophrenia, and continuous enrollment with consistent geographical data in all of 2018 were identified from Transformed Medicaid Statistical Information System (T-MSIS) Analytic Files (TAF) data for 45 of 50 states. Antipsychotic (AP) utilization rates, including long-acting injectable APs (LAIs), quality metrics, and all-cause healthcare resource utilization and costs for claims submitted to Medicaid were reported nationally and by state. Pearson correlation evaluated associations between LAI utilization and total healthcare costs at state and county levels. RESULTS: Across the US 688,437 patients with schizophrenia were identified. The AP utilization rate was 51% (state range: 24-77%), while the LAI utilization rate was 13% (range: 4-26%). The proportion of patients adherent to any AP was 56% (range: 19-73%). Within 30 days post-discharge from an inpatient admission, 22% (range: 8-58%) of patients had an outpatient visit, and 12% (range: 4-48%) had a readmission. The proportion of patients with ≥1 inpatient admission and ≥1 emergency room visit was 34% (range: 19-82%) and 45% (range: 20-70%). Per-patient-per-year total healthcare costs averaged $32,920 (range: $717-$93,972). At the county level, a weak negative correlation was observed between LAI utilization and total healthcare costs. LIMITATIONS: This study included Medicaid beneficiaries enrolled with pharmacy and medical benefits, including beneficiaries dually eligible for Medicare; results cannot be generalized to the overall schizophrenia population or those with other payer coverage. CONCLUSIONS: In 2018, half of beneficiaries with schizophrenia did not submit any claims for APs to Medicaid, nearly half had an emergency room visit, and one-third had an inpatient admission. Moreover, healthcare measures varied considerably across states. These findings may indicate unmet treatment needs for Medicaid beneficiaries with schizophrenia.

Schizophrenia is a severe mental disorder that poses a large health, social, and cost burden to patients and society. While treatment with antipsychotic medications can reduce the number of relapses and hospitalizations, many patients do not adhere to treatment, which can lead to poor symptom control and further use of healthcare services. Interestingly, these measures of schizophrenia care seem to vary across US states. Therefore, we ran the first study to describe the regional differences in antipsychotic use, measures of quality of care, healthcare use, and healthcare costs among Medicaid-insured patients across the US in 2018.Our results showed that only half of patients used antipsychotics in 2018 (with a range of 24­77% across states) and the proportion of patients adherent to antipsychotic treatment was low (range of 19­73%). Additionally, nearly half of all patients had an emergency room visit (range of 20­70%), and one-third had an inpatient admission (range of 19­82%). These findings highlight large variations in antipsychotic use, performance measures, and healthcare use, possibly due to regional differences in unmet needs in schizophrenia care for Medicaid-insured patients in the US. Since use of inpatient and emergency room services was consistently high in specific states or regions, and yearly healthcare costs per patient varied from $717­$93,972 (mean = $32,920), there may be a particularly high burden in certain areas of the country where patients with schizophrenia may potentially be experiencing multiple relapses. Further research is needed to identify policies that may help narrow these regional differences.

Patient Journey of Veterans with Schizophrenia: An Analysis of Treatment Patterns, Healthcare Resource Utilization and Costs.

INTRODUCTION: Little is known about the burden of schizophrenia among United States veterans early after diagnosis. This retrospective study describes treatment patterns, healthcare resource utilization (HRU) and healthcare costs among veterans with a recent schizophrenia diagnosis. METHODS: Adults with a schizophrenia diagnosis recorded between 1 April 2014 and 31 December 2017 and no history of schizophrenia over the preceding 12 months were identified from a Veterans Health Administration (VHA) database. Continuous enrollment in the VHA was required for ≥ 12 months before and after the index date when the first schizophrenia diagnosis code was identified. Baseline characteristics and follow-up treatment patterns, HRU and costs were examined descriptively. RESULTS: The study population (20,389 patients) had a high baseline mental health comorbidity burden. Despite a schizophrenia diagnosis, 32.1% of patients received no antipsychotic medication during the follow-up period. Among those with ≥ 1 antipsychotic prescription fill, 64.0% received ≥ 1 oral antipsychotic (OAP) therapy and 11.6% received ≥ 1 long-acting injectable (LAI). A delay was observed between diagnosis and treatment for both OAPs (39.0 ± 67.2 days) and LAIs (69.4 ± 96.2 days). Adherence to therapy (defined as proportion of days covered ≥ 80%) was greater with LAIs (34.5%) vs OAPs (27.3%). Inpatient stays were reported for 33.8% of patients during the 12-month follow-up period, and 5.5% of patients had readmissions. All-cause inpatient stay costs with 12-month follow-up equaled $7999 per patient per year. CONCLUSIONS: These data indicate that pharmacotherapy after a recent diagnosis of schizophrenia in the VHA system is suboptimal, and that these patients face a considerable burden in terms of hospitalization, other HRU, and healthcare costs.

Real-world analysis of insurance churn among young adults with schizophrenia using the Colorado All-Payer Claims Database.

BACKGROUND: Most patients with schizophrenia are diagnosed in their early twenties and often have commercial insurance at diagnosis. These young adults can experience changes in insurance coverage, that is, "churn," which can lead to disruptions in care. OBJECTIVE: To examine the frequency, speed, and type of insurance churn events in a young adult schizophrenia population with commercial insurance coverage at diagnosis. METHODS: The Colorado All-Payer Claims Database, containing insurance claims data from commercial and public insurers for Colorado residents, was used for the study. Eligible patients were required to have at least 1 inpatient or 2 outpatient claims for schizophrenia or schizoaffective disorder, be of age 18-34 years at index, have previous insurance coverage for 12 consecutive months, and have commercial insurance at diagnosis. These patients were 1:5 propensity score matched (PSM) with nonschizophrenia members. Percentages of members on different insurance types were calculated monthly to assess churn events. Cohorts were compared using descriptive statistics, Cox proportional hazards, and generalized estimating equation models. RESULTS: The matched schizophrenia and nonschizophrenia cohorts comprised 501 and 2,510 members, respectively. Before PSM, cohorts were imbalanced (schizophrenia cohort had a younger median age and higher proportion of males). After matching, the cohorts were similar in terms of the matched baseline characteristics. Previous mental health disorders were more common in the schizophrenia cohort (75%) than in the nonschizophrenia cohort (26%). The proportion of members with at least 1 churn event for the schizophrenia and nonschizophrenia cohorts, respectively, were 53.8% vs 36.5% after 12 months and 84.6% vs 69.2% after 48 months. Time to first churn event was significantly shorter in the schizophrenia cohort (16 months) than the nonschizophrenia cohort (23 months; P < 0.001). Schizophrenia cohort members had 64.1 and 56.8 churn events per 1,000 members per month vs 43.0 (P ≤ 0.001) and 42.8 (P = 0.011) churn events for nonschizophrenia cohort members in the first and second 6-month periods, respectively. Proportions of members in the schizophrenia and nonschizophrenia cohorts on public insurance, respectively, were 22.9% vs 6.9% after 12 months and 52.4% and 10.7% after 48 months. In the schizophrenia cohort, the most common churn event type was from commercial to public insurance rather than to a different commercial insurance; notably, 41% of members were still on a commercial plan 4 years after diagnosis. CONCLUSIONS: Young adults with schizophrenia experienced churn events more rapidly and more frequently than those without schizophrenia for the first 4 years studied after the index date. These disruptions may be associated with reduced access to care and treatment gaps in this vulnerable patient population. DISCLOSURES: This research was sponsored by Janssen Scientific Affairs, LLC. Pesa, Benson, and Patel are employees of Janssen Scientific Affairs, LLC, and are stockholders of Johnson & Johnson. Potluri, Rotter, and Papademetriou are employees of SmartAnalyst Inc, and their work on this study was funded by Janssen Pharmaceuticals. A version of this study was presented as a poster at the Psych Congress 2020 Virtual Experience, September 10-13, 2020.

Economic burden to commercial payers of young adults with schizophrenia in Colorado.

AIMS: The primary objective was to examine direct costs and health resource utilization (HRU) among commercially insured young adults with schizophrenia (SCZ) in Colorado. MATERIALS AND METHODS: The Colorado All-Payer Claims Database, covering approximately 76% of the insured Colorado population was used. Members aged 18-34, with and without SCZ, having commercial insurance were included. All-cause, mental health (MH) related and non-MH related per patient per month (PPPM) costs and per hundred patients per month (PHPPM) HRU were compared between an SCZ cohort and a propensity score matched non-SCZ cohort before and after index date up to 48 months. RESULTS: Five hundred and one patients with SCZ and 2,510 matched individuals without SCZ were included. HRU and costs were higher for SCZ patients both pre- and post-index date. Pre-index, there were 32.3 (24.0 MH; 8.4 non-MH) PHPPM more office visits; 2.1 (2.7 MH) PHPPM more admissions; 104.8 (67.02 MH; 37.7 non-MH) PHPPM more prescriptions in the SCZ cohort (all p<.01). After index date, the SCZ cohort had 89.6 (81.3 MH; 9.2 non-MH) more PHPPM office visits, 7.2 (6.1 MH; 0.9 non-MH) PHPPM more admissions, and 181.6 (123.1 MH; 58.6 non-MH) PHPPM more prescriptions (all p<.001). All-cause costs in the pre-index period were $457 PPPM ($373 MH) higher for the SCZ cohort (p<.001). In the post-index period, all-cause costs for the SCZ cohort were $1,687 PPPM ($1,258 MH; $412 non-MH) higher (all p<.001). Approximately, 40% of patients with SCZ were on commercial insurance after four years compared with approximately 75% in the non-SCZ cohort. LIMITATIONS: This study was based on data from a single state, thus may not be generalizable to other states. CONCLUSIONS: Healthcare costs and HRU for young adults diagnosed with SCZ are significantly more burdensome to commercial payers than matched patients without SCZ, both before and after an official SCZ diagnosis.

Prevalence, incidence and economic burden of schizophrenia among Medicaid beneficiaries.

OBJECTIVE: To estimate the prevalence, incidence and economic burden of schizophrenia among Medicaid beneficiaries. METHODS: Annual prevalence and incidence of schizophrenia among adult Medicaid beneficiaries were estimated during 2012-2017, by state and across six states (IA, KS, MS, MO, NJ and WI). The pooled estimate of the economic burden of schizophrenia was obtained during 1998Q1-2018Q1 across six states; adults with ≥2 diagnoses of schizophrenia were matched 1:1 to schizophrenia-free controls. The last observed schizophrenia diagnosis (schizophrenia cohort) or the last service claim (control cohort) with ≥12 months of continuous Medicaid enrollment before/after it defined the index date. Healthcare resource utilization (HRU) and costs ($2018 USD) incurred 12 months post-index were compared between cohorts. The economic burden of schizophrenia was also evaluated among young adults (18-34 years). RESULTS: Annual prevalence of schizophrenia ranged between 2.30% and 2.71% and annual incidence between 0.31% and 0.39% during 2012-2016. In 2017, only states with the highest incidence and prevalence rates (KS, MS, MO) had data, resulting in higher prevalence (4.01%) and incidence (0.52%). For the economic burden, adults with schizophrenia (N = 158,763) had higher HRU and incurred $14,087 higher healthcare costs versus controls (mean: $28,644 vs. $14,557), driven by $4677 higher long-term care costs (all p < .001). Young adults with schizophrenia incurred $14,945 higher healthcare costs versus controls, driven by $3473 higher inpatient costs (p < 0.001). CONCLUSIONS: Annual prevalence and incidence of schizophrenia varied by state but remained stable over time. Adults with schizophrenia incurred greater HRU and costs relative to adults without schizophrenia; the burden appeared comparable among young adults.

Economic burden in Medicaid beneficiaries with recently relapsed schizophrenia or with uncontrolled symptoms of schizophrenia not adherent to antipsychotics.

BACKGROUND: Patients with schizophrenia struggle with disease relapses and uncontrolled symptoms, which can either result in or be a result of non-adherence to antipsychotics (APs). The economic burden of such patients is hypothesized to be substantial. OBJECTIVE: To evaluate the economic burden of recently relapsed schizophrenia or of uncontrolled symptoms of schizophrenia with non-adherence to APs in Medicaid beneficiaries. METHODS: Adults with ≥ 2 schizophrenia diagnoses and controls without schizophrenia were identified in Medicaid data (1997Q1-2018Q1) from Iowa, Kansas, Mississippi, Missouri, New Jersey, and Wisconsin. The index date was the last observed schizophrenia diagnosis (cohort with schizophrenia) or the last service claim (control cohort) with ≥ 12 months of continuous Medicaid enrollment before and after it. Cohorts were matched 1:1 using propensity scores. After matching, two subgroups were identified among adults with schizophrenia: (1) patients with schizophrenia and a recent relapse (≥ 1 schizophrenia-related inpatient or emergency department claim ≤ 60 days before or on the index date) and (2) patients with uncontrolled symptoms of schizophrenia (≥ 2 schizophrenia-related hospitalizations) and non-adherence to APs (proportion of days covered < 80%) in the 12-month pre-index period. Previously matched controls were then subset to patients in each subgroup and their matched pairs without schizophrenia, thus maintaining the 1:1 matching ratio. Healthcare resource utilization (HRU) and costs ($2018 USD) in the 12-month post-index (observation) period were compared between matched pairs using adjusted regression models. RESULTS: Among 158,763 patients with schizophrenia, 18,771 (11.8%) had a recent relapse (mean age 50.5 years; 48.6% female, 51.4% male) and 13,697 (8.6%) were not adherent to APs and had uncontrolled symptoms of schizophrenia (mean age 47.1 years; 48.0% female, 52.0% male). During the observation period, patients with recently relapsed schizophrenia and those non-adherent to APs with uncontrolled symptoms of schizophrenia had significantly higher HRU relative to their controls without schizophrenia. Patients with recently relapsed schizophrenia had mean total healthcare costs $21,862 higher relative to their controls ($37,424 vs $15,563), driven by $8,486 higher mean long-term care costs (all P < 0.001). Patients non-adherent to APs with uncontrolled symptoms of schizophrenia had adjusted mean total healthcare costs $20,787 higher relative to their controls ($38,337 vs $15,241), driven by $8,019 higher adjusted mean inpatient costs (all P < 0.001). Additional total healthcare costs incurred by patients with recently relapsed schizophrenia and those of patients non-adherent to APs with uncontrolled symptoms of schizophrenia exceeded by 55.2% and 47.6%, respectively, incremental total healthcare costs incurred by all patients with schizophrenia ($14,087). CONCLUSIONS: Patients with recently relapsed schizophrenia and those non-adherent to AP therapy with uncontrolled symptoms of schizophrenia incurred higher HRU and costs relative to patients without schizophrenia. Additional healthcare costs of these subgroups of patients with schizophrenia appeared higher than in the overall population with schizophrenia. DISCLOSURES: This study was supported by Janssen Scientific Affairs, LLC. The sponsor was involved in the study design, data collection, data analysis, manuscript preparation, and publication decisions. Pilon, Lafeuille, Zhdanava, Côté-Sergent, Rossi, and Lefebvre are employees of Analysis Group, Inc., a consulting company that has provided paid consulting services to Janssen Scientific Affairs, LLC, which funded the development and conduct of this study and manuscript. Patel, Joshi, and Lin are employees of Janssen Scientific Affairs, LLC and stockholders of Johnson & Johnson. Part of the material in this manuscript has been presented at the US Psych Congress, October 3-6, 2019, San Diego, CA, and at the Virtual ISPOR Meeting, May 18-20, 2020.

Characteristics and Healthcare Burden of Patients with Schizophrenia Treated in a US Integrated Healthcare System.

BACKGROUND: Schizophrenia is one of 15 major causes of disability worldwide and is responsible for more than USD 150 billion in annual healthcare costs in the United States. Although the burden of schizophrenia as measured by healthcare resource utilization (HRU) is known to be considerable, data generally come from claims databases or healthcare systems/payors representing only a subset of patients, such as Medicare/Medicaid recipients. A broader understanding of HRU across the schizophrenia patient population would help identify underserved groups and inform strategies for improving healthcare delivery. AIMS OF THE STUDY: This observational study examined overall HRU and the influence of sociodemographic factors in adult patients with schizophrenia receiving care in a US integrated healthcare system. METHODS: A retrospective cohort study was conducted using data from electronic medical records (EMRs). Patients were required to have at least two diagnostic codes for schizophrenia recorded in the EMR within a 12-month period from January 2009 to June 2018, and to have received active care (≥ 1 in-system healthcare visit every six months) for at least 12 months before and after the index date (the earlier of the schizophrenia diagnosis dates). Patients were followed until no longer receiving active care or the end of the study. Patient characteristics were assessed during the 12-month pre-index period, and inpatient, readmission, emergency room (ER), and outpatient visits and antipsychotic prescriptions were described during follow-up. Findings were reported overall and in subgroups by race/ethnicity, age, and sex. RESULTS: The study cohort included 2,941 patients (mean age, 48.3 years; 54.5% male, 51.8% black, 45.8% with Medicare). During the follow-up period (mean, 4.6 years), inpatient hospital stays were common, with at least one all-cause, mental health-related, or schizophrenia-related inpatient visit occurring for 48.7%, 47.3%, and 38.8% of patients, respectively. Hospital readmissions within 30 days of an all-cause inpatient visit occurred in 20.4% of patients, with 14.5% of patients readmitted within 30 days of a schizophrenia-related inpatient visit. More than two-thirds of patients had ER visits, and 40.7% had schizophrenia-related ER visits. Only 46.7% of patients with a schizophrenia-related inpatient visit and 58.5% of patients with a mental health-related inpatient visit had a 30-day outpatient follow-up visit. Subgroup analyses revealed that a larger proportion of non-Hispanic black vs non-Hispanic white patients had 30-day outpatient follow-up visits, ER visits, mental health specialist visits, and antipsychotic prescriptions. Moreover, older age was associated with fewer ER and mental health specialist visits and less use of injectable and second-generation antipsychotics, and women were less likely than men to receive antipsychotic therapy, particularly injectable medications. DISCUSSION: Patients with schizophrenia receiving care in a US integrated healthcare system had considerable acute HRU and suboptimal rates of routine and follow-up care. Inequities in schizophrenia burden and care were observed in demographic subgroups. IMPLICATIONS FOR HEALTH POLICIES: Population health management strategies focusing on efficient resource allocation and improving healthcare quality are needed to reduce the burden of schizophrenia. Differential findings by race/ethnicity, age, and sex indicate the need for optimizing approaches to care in these subgroups.

Risk of subsequent relapses and corresponding healthcare costs among recently-relapsed Medicaid patients with schizophrenia: a real-world retrospective cohort study.

AIMS: To compare adherence, rates of subsequent schizophrenia-related relapses, healthcare resource utilization, and healthcare costs among Medicaid beneficiaries with schizophrenia who initiated once-monthly paliperidone palmitate (PP1M) versus a new oral atypical antipsychotic (OAA) following a recent schizophrenia-related relapse. METHODS: Six-state Medicaid data (01/2009-03/2018) were used to identify adults with schizophrenia initiated on PP1M or OAA (index date) within 30 days following a schizophrenia-related relapse (defined as a schizophrenia-related inpatient or emergency room visit). Patients were required to have 12 months of continuous eligibility before (baseline) and after (observation) the index date. Differences in baseline characteristics between PP1M and OAA patients were accounted for using 1:3 matching. RESULTS: After matching, characteristics were well-balanced between PP1M (N=208, mean age=39 years, 35.6% female) and OAA patients (N=624, mean age=40 years, 34.6% female). During the 12-month observation period, the mean proportion of days covered for the index medication was 41.2% in the PP1M cohort and 34.7% in the OAA cohort (p=.008). Relative to the OAA cohort, PP1M patients were 33% (p=.013) less likely to have a subsequent relapse and had 29% (p=.004) fewer all-cause inpatient admissions per-patient-per-year (PPPY). Consequently, a significant mean reduction of $6273 in medical costs PPPY (p=.028) was observed, which fully offset the $4770 (p<.001) increase in pharmacy costs PPPY and resulted in a numerical but not statistically significant, decrease in total healthcare costs of $1503 PPPY (p=.621) relative to OAA patients. CONCLUSIONS: Among patients with a recent schizophrenia-related relapse, PP1M was associated with a lower risk of subsequent relapse while remaining a cost neutral therapeutic option compared to OAAs.

Healthcare Resource Utilization and Costs Among Patients With Schizophrenia Switching From Oral Risperidone/Paliperidone to Once-Monthly Paliperidone Palmitate: A Veterans Health Administration Claims Analysis.

BACKGROUND: Schizophrenia is associated with high health care resource utilization and treatment costs. OBJECTIVE: This study compared treatment patterns, health care resource utilization, and medical costs before and after a switch from oral antipsychotic drug (risperidone or paliperidone [RIS/PALI]) therapy to the long-acting injectable once-monthly paliperidone palmitate (PP1M) in patients with schizophrenia. METHODS: Data for adult patients (aged ≥18 years) with at least 1 diagnosis of schizophrenia who initiated treatment with oral RIS/PALI ≥6 months before switching and had continuous health plan enrollment during the study period before and after the switch were extracted from the Veterans Health Administration database. Treatment patterns, health care resource utilization, and costs were compared between the period 6 or 12 months before and after switching directly from oral RIS/PALI to PP1M. RESULTS: The analysis included 676 and 493 patients in the 6-month and 12-month cohorts, respectively. Adherence to oral RIS/PALI during the 12 months preswitch was 11.0% and 22.1% as measured by proportion of days covered and medication possession ratio ≥80%, respectively. During the 12 months postswitch, adherence to PP1M was 27.0% and 35.9%, respectively. Among patients treated with oral RIS/PALI, from 12 months pre- to 12 months post-PP1M switch, fewer all-cause inpatient stays (2.2 vs 1.1, respectively; P < 0.05) and a shorter mean length of inpatient stay (28.1 and 14.0 days, respectively; P < 0.05) were observed. This pattern was similar for both the number of mental health- and schizophrenia-related inpatient stays and length of stay. Compared with 12 months pre-PP1M switch, significantly higher mean numbers of all-cause outpatient visits and pharmacy visits were observed at 12 months postswitch. In line with health care resource utilization findings, at 12 months pre- versus 12 months post-PP1M switch we observed decreases in all-cause inpatient stay costs ($41,886 vs $20,489; P < 0.05) and increases in outpatient visit costs ($22,005 vs $29,069; P < 0.05). Findings for the 6-month cohort followed a similar pattern. CONCLUSIONS: Post-PP1M switch, a decrease in total medical costs fully offset an increase in pharmacy costs, resulting in similar total costs. The findings suggest potential economic benefits of switching patients with schizophrenia from oral RIS/PALI to PP1M in the Veterans Health Administration.

Transitioning from oral risperidone or paliperidone to once-monthly paliperidone palmitate: a real-world analysis among Veterans Health Administration patients with schizophrenia who have had at least one prior hospitalization.

Objective: To address gaps in the literature on healthcare resource utilization (HRU) and costs among patients with schizophrenia and prior hospitalization who transition from oral risperidone or paliperidone (oral ris/pali) to once-monthly paliperidone palmitate (PP1M) in a real-world setting by comparing treatment patterns, HRU, and costs 12-months pre- and post-transition to PP1M among Veterans Health Administration (VHA) patients affected by schizophrenia who have had ≥1 hospitalization.Methods: VHA patients with schizophrenia (aged ≥18 years) who initiated oral ris/pali, had ≥1 all-cause inpatient stay, and transitioned to PP1M from January 2015-March 2017 were included from the VHA database. The first transition date to PP1M was identified as the index date. Patients were required to have continuous health plan eligibility for 12 months pre- and post-PP1M. Outcomes were compared using the Wilcoxon signed-rank and McNemar's test, as appropriate.Results: The study included 319 patients (mean [SD] age = 51.6 [4.2] years) during 12 months of baseline and follow-up. During pre-PP1M transition, 7.2% of the patients were adherent (proportion of days covered [PDC] ≥ 80%) to oral ris/pali. Post-PP1M transition, 27.6% of the patients were adherent to PP1M. Comparison of HRU outcomes from the pre- to post-PP1M transition revealed significantly lower all-cause inpatient stays (3.5 vs 1.4, p < .0001) and shorter inpatient length of stay (43.4 vs 18.3 days, p < .0001). Similar trends were seen for mental health and schizophrenia-related HRU. Cost outcome comparison indicated significantly lower all-cause inpatient costs ($64,702 vs $24,147, p < .0001), total medical costs ($87,917 vs $56,947, p < .0001), and total costs ($91,181 vs $69,106, p < .0001). A similar trend was observed for mental health and schizophrenia-related costs.Conclusions: Transitioning from oral ris/pali to PP1M may significantly improve HRU and provide potential cost savings in VHA patients with schizophrenia and ≥1 prior hospitalization.

Factors Associated with the Initiation of Long-Acting Injectable Paliperidone Palmitate Versus Aripiprazole Among Medicaid Patients with Schizophrenia: An Observational Study.

INTRODUCTION: Factors underlying the selection of antipsychotics for patients with schizophrenia are poorly understood. This study investigated variables associated with initiation of treatment with the long-acting injectables paliperidone palmitate (LAI-PP) and aripiprazole LAI (LAI-AP) in Medicaid patients with schizophrenia. METHODS: Adults with at least one medical or pharmacy claim for LAI-PP or LAI-AP from 1 January 2013 to 31 December 2016 were selected from the IBM® MarketScan® Medicaid Database. The date of the first LAI-PP or LAI-AP claim was the index date. Patients who had at least two medical claims, on different days, for a schizophrenia diagnosis and at least 12 months of continuous health plan enrollment prior to index date were included in the analysis. Multivariable logistic regression was performed to determine the factors associated with the initiation of LAI-PP versus LAI-AP. RESULTS: Of included patients, 5501 initiated LAI-PP and 1449 initiated LAI-AP. Patients more likely to initiate LAI-PP versus LAI-AP were older, male, or African American (all p < 0.01). Patients with obesity (odds ratio [OR] 0.84; 95% confidence interval [CI] 0.71, 0.98), post-traumatic stress disorder (OR 0.76; 95% CI 0.63, 0.92), or prior oral antipsychotic use (OR 0.66; 95% CI 0.55, 0.79) were less likely to initiate LAI-PP; whereas, patients with nonorganic psychoses (OR 1.35; 95% CI 1.18, 1.55) or prior use of other injectable antipsychotics (OR 1.26; 95% CI 1.09, 1.47) were more likely to initiate LAI-PP versus LAI-AP. Patients with at least two all-cause hospitalizations were 1.37 times more likely to initiate LAI-PP vs LAI-AP (OR 1.37; 95% CI 1.18, 1.60). CONCLUSION: Factors associated with initiating LAI-PP and LAI-AP differed. Notably, patients who initiated LAI-PP had greater prior use of medical services than LAI-AP patients. Understanding prescribing practices may help optimize treatment strategies and improve disease management. FUNDING: Janssen Scientific Affairs, LLC.

Patient blood transfusion management: discharge hemoglobin level as a surrogate marker for red blood cell utilization appropriateness.

BACKGROUND: Blood transfusion management strategies minimize transfusion-associated risks, enhance outcomes, and reduce costs. We explored an association of discharge hemoglobin (Hb) with pretransfusion Hb, transfusion indications, and red blood cell (RBC) transfusions. We stipulate that patients with discharge Hb concentrations greater than 10.0 g/dL, or even 9.0 g/dL, received excessive RBC transfusions. STUDY DESIGN AND METHODS: We examined aggregate data from five hospitals and for one of the hospitals, the focus hospital, we reviewed patient records for a period of 6 months. Data analyses included number of RBC units transfused and Hb values before transfusion, after transfusion, and at discharge. RESULTS: In aggregate, 27% to 47% patients had discharge Hb levels greater than 10.0 g/dL. At the focus hospital, 27% had a discharge Hb level greater than 10 g/dL and 50.3% had a discharge Hb level greater than 9.0 g/dL. At the focus hospital, the mean Hb trigger for transfusion was a Hb level of 7.3 g/dL; the mean posttransfusion Hb level was 9.3 g/dL and mean discharge Hb level was 9.2 g/dL. Overall, 76% of the transfusions were of an even number of RBC units. CONCLUSION: In aggregate, overutilization exceeded 20%. At the focus hospital, approximately one-quarter of patients receiving transfusions had a Hb concentration greater than 10.0 g/dL at discharge. Transfused patients' discharge Hb concentration represents an effective indicator for retrospective monitoring of transfusion appropriateness. In light of the large number of patients receiving even number transfusions, reviewing Hb levels after transfusion of each RBC unit could reduce unnecessary transfusions. Retrospective review of discharge Hb data focuses providers on transfusion outcomes and affords an educational opportunity for blood utilization management.