All-cause Inpatient Admissions Research Articles

Understanding Data and Opportunities Focused on Value: A Single-Center Experience in Headache Care.

Headache syndromes are highly prevalent, disabling, and costly. Our goals were to (1) describe headache care delivery and costs in a system and (2) identify opportunities for the system to collect, organize, or analyze health care data to facilitate value-based headache care delivery. We performed a descriptive, retrospective cohort study using data from a large integrated health system (July 2018-July 2021). We assigned individuals into a reference (REF) or headache group based on headache-related ICD diagnoses. The primary exposure variable, applied to the headache group, was the headache specialty seen most after the incident headache diagnosis: primary care (PC), neurology (NEU), or headache subspecialist (HS). Outcomes of interest were per member per month all-cause costs, per episode costs, all-cause utilization, and headache utilization. Variables included age, sex, insurance contract, and the Adjusted Clinical Groups (ACG) concurrent risk score. We calculated univariate statistics for clinical indicators and outcomes for each group. For outcome variables, we also report these statistics after adjustment for ACG risk score. We identified 22,700 (14%) individuals in the headache groups and 138,818 (86%) individuals in the reference group (REF). Within the headache groups, 84% received care from PC, 14% from NEU, and 2% from HS. The average ACG risk scores increased across exposure groups. In both unadjusted and after risk adjustment analyses, total cost of care (TCOC) was highest in NEU and HS, and the largest drivers of TCOC were outpatient facility costs, followed by inpatient facility costs. HS had the highest pharmacy and professional costs. After risk adjustment, all-cause inpatient admissions and headache-related ED visits were roughly similar, although there was increasing use of outpatient PC and NEU visits across exposure groups. Individuals seen by a NEU or HS had higher medical morbidity, higher health care utilization, and higher costs than those who receive care from PC. Outcome data were either not available or not structured to determine the value of neurologic expertise in headache care or within a particular headache care pathway. To clarify neurology's value in primary headache disorders, we encourage health system leaders to adopt an economic evaluation framework.

Healthcare Resource Utilization and Associated Costs in Patients With Chronic Graft-Versus-Host Disease Post-Allogeneic Hematopoietic Stem Cell Transplantation in England

Limited evidence suggests chronic graft-versus-host disease (cGvHD) following allogeneic hematopoietic stem cell transplantation (allo-HSCT) increases healthcare resource utilization (HCRU) and costs. However, this burden has not been well characterized in England. This study assesses secondary care HCRU and costs for patients following allo HSCT in England with cGvHD and patients who did not develop graft-versus-host disease (GvHD). Further stratification was performed among patients who did or did not subsequently receive high-cost therapies for the treatment of cGvHD. This descriptive, retrospective cohort study used Hospital Episode Statistics (HES) data from April 2017 to March 2022. HES data captures information on reimbursed diagnoses and procedures from all National Health Service (NHS) secondary care admissions and attendances in England. High-cost drugs as defined by NHS England are recorded in HES, these drugs and other procedures including plasma exchange, were used to identify patients with cGvHD who were in receipt of high-cost therapies. HCRU and costs were described for patients with cGvHD following allo-HSCT (n = 721) and were matched with patients with no evidence of GvHD following allo-HSCT (n = 718). HCRU and costs were also described for the subset of patients with cGvHD (n = 198) following receipt of high-cost therapies and patients with cGvHD prior to or without such therapies (n = 523). A higher proportion of patients with cGvHD had at least one inpatient or intensive care unit (ICU) admission or emergency care attendance than patients without GvHD (inpatient: 74.6% versus 66.6%; emergency care: 39.3% versus 30.5%; ICU: 7.4% versus 4.7%; respectively); whilst the proportion of patients with an outpatient attendance were similar for both groups (outpatient: 80.3% versus 84.1%; respectively). The cost across all secondary care settings was higher for patients with cGvHD than patients without GvHD, with a mean cost of inpatient admissions of £17,339 per patient-year for those with cGvHD versus £8548 per patient-year in patients without GvHD. A higher proportion of patients who received high-cost therapies for the treatment of cGvHD had at least one secondary care admission or attendance, than patients who did not (inpatient: 85.4% versus 66.4%; ICU: 7.1% versus 5.4%; outpatient: 87.9% versus 76.7%; emergency care: 44.4% versus 36.5%; respectively). Patients who were treated with high-cost therapies for the treatment of cGvHD had a greater mean number (14.6 versus 8.2 per patient-year, respectively) for all-cause inpatient admissions after treatment than patients who did not. In all secondary care settings, the total cost per patient-year was higher for patients who received high-cost therapies for the treatment of cGvHD, than for those who did not. Patients who were treated with high-cost therapies for the treatment of cGvHD had a greater mean cost (£21,137 versus £15,956 per patient-year, respectively) for all-cause inpatient admissions than patients who did not. This study demonstrates that cGvHD and the use of associated high-cost therapies impacts healthcare activity and costs across various secondary care settings in England more than patients without GvHD and patients with cGvHD who received no high-cost therapies.

Impact of a tubeless, disposable insulin pump on emergency department visits and inpatient admissions among a Medicare population.

A tubeless, disposable insulin pump (Omnipod DASH Insulin Management System, Insulet Corporation) has demonstrated improved glycemic outcomes for people with diabetes who require insulin. The impact of the system on downstream health care events has not been studied. To assess health care resource utilization for a Medicare population before and after starting tubeless, disposable insulin pump therapy. This retrospective, observational analysis used data from the Centers for Medicare & Medicaid Services 100% Research Identifiable Files. Study outcomes included change in event rates for diabetes-related emergency department (DRED) visits, all-cause emergency department (ACED) visits, diabetes-related inpatient (DRIP) admissions, and all-cause inpatient (ACIP) admissions among Medicare beneficiaries who started the tubeless, disposable insulin pump in 2020 (postpump observation period) as compared with the same duration and calendar period in 2019 (prepump observation period) with no pump use. Subgroup analyses were performed based on Medicare entitlement reason, diabetes type, and diagnosis status for depressive disorder. A total of 811 users met the criteria for analysis: 46.2% had type 2 diabetes, a majority (59.2%) were aged 65 years or older, and 37.0% had a diagnosis for depressive disorder. Significant reductions were observed for DRED of -46.9% (95% CI = -63% to -23%); ACED of -29.0% (95% CI = -37% to -20%); ACIP of -19.9% (95% CI = -32% to -6%). DRIP rates declined notably (-36.6%; 95% CI = -61% to 4%). Event rates observed across subgroups demonstrated consistent downward trends; however, not all were statistically significant. These findings demonstrate that use of the tubeless, disposable insulin pump was associated with reductions in DRED, ACED, and ACIP. Our results provide real-world evidence to support the use of the tubeless, disposable insulin pump among Medicare beneficiaries who require insulin, regardless of diabetes type or Medicare entitlement reason. Additional studies are recommended to further evaluate the effect of insulin pumps on health care utilization among the Medicare population and other insurance populations.

Predictors of High Healthcare Cost Among Patients with Generalized Myasthenia Gravis: A Combined Machine Learning and Regression Approach from a US Payer Perspective.

High healthcare costs could arise from unmet needs. This study used random forest (RF) and regression methods to identify predictors of high costs from a US payer perspective in patients newly diagnosed with generalized myasthenia gravis (gMG). Adults with gMG (first diagnosis = index) were selected from the IQVIA PharMetrics® Plus database (2017-2021). Predictors of high healthcare costs were measured 12 months pre-index (main cohort) and during both the 12 months pre- and post-index (subgroup). Top 50 predictors of high costs [≥ $9404 (main cohort) and ≥$9159 (subgroup) per-patient-per-month] were identified with RF models; the magnitude and direction of association were estimated with multivariable modified Poisson regression models. The main cohort and subgroup included 2739 and 1638 patients, respectively. In RF analysis, the most important predictors of high costs before/on the index date were index MG exacerbation, all-cause inpatient admission, and number of days with corticosteroids. After the index date, these were immunoglobulin and monoclonal antibody use and number of all-cause outpatient visits and MG-related encounters. Adjusting for the top 50 predictors, post-index immunoglobulin use increased the risk of high costs by 261%, monoclonal antibody use by 135%, index MG exacerbation by 78%, and pre-index all-cause inpatient admission by 27% (all p < 0.05). This analysis links patient characteristics both before the formal MG diagnosis and in the first year to high future healthcare costs. Findings may help inform payers on cost-saving strategies, and providers can potentially shift to targeted treatment approaches to reduce the clinical and economic burden of gMG.

Bleeds and resource use in hemophilia B: retrospective observational study.

To describe people with hemophilia B (PWHB) in the US who experience bleeds despite factor replacement therapy and to quantify the associated burden from the third-party payer perspective. Observational study of adult male PWHB treated with factor IX replacement therapy identified from the PharMetrics Plus claims data from 2010 to 2019. Patients with medically recorded bleeds (MRBs) were identified using diagnostic codes. Rates and rate ratios of inpatient admissions, emergency department (ED) visits, and outpatient visits among PWHB with and without MRBs were estimated. The presence of comorbidities was identified using diagnostic codes, and the analysis was stratified by age group. There were 345 PWHB with MRBs and 252without MRBs. More than half of PWHB with MRBs (56.8%) had 1 or more comorbidity vs 39.3% of PWHB without MRBs. The prevalence of anxiety and depression was high in PWHB, regardless of bleed status and age group, whereas the prevalence of other comorbidities increased with age group. The rate of all-cause inpatient admissions for PWHB with MRBs was 14.8 per 100 person-years (95%CI, 12.8-17.1), 2.5 times higher than for PWHB without MRBs. The rate of all-cause ED visits for PWHB with MRBs was 67.6per 100 person-years (95% CI, 63.2-72.3), 2.7 times higher than for those without MRBs. This study reports significant resource use and clinical burden among PWHB who seek medical care. PWHB with MRBs had considerable all-cause resource use compared with PWHB without MRBs. The prevalence of mental illness was consistently high across all age groups.

Esketamine nasal spray for major depressive disorder with acute suicidal ideation or behavior: description of treatment access, utilization, and claims-based outcomes in the United States

AimsTo describe real-world esketamine nasal spray access and use as well as healthcare resource use (HRU) and costs among adults with evidence of major depressive disorder (MDD) with suicidal ideation or behavior (MDSI).MethodsAdults with ≥1 claim for esketamine nasal spray and evidence of MDSI 12 months before/on the date of esketamine initiation (index date) were selected from Clarivate’s Real World Data product (01/2016–03/2021). Patients initiated esketamine on/after 03/05/2019 (esketamine approval for treatment-resistant depression; later approved for MDSI on 08/05/2020) were included in the overall cohort. Esketamine access (measured as approved/abandoned/rejected claims) and use were described post-index; HRU and healthcare costs (2021 USD) were described over 6 months pre- and post-index.ResultsAmong 269 patients in the overall cohort with esketamine pharmacy claims, 46.8% had the first pharmacy claim approved, 38.7% had it rejected, and 14.5% abandoned their claim; 169 patients were initiated on esketamine in the overall cohort (mean age 40.9 years, 62.1% female); 45.0% had ≥8 esketamine treatment sessions (recommended per label) with a mean [median] of 85.0 [58.5] days from index to 8th session (per label 28 days). Among 115 patients with ≥6 months of data post-index, in the 6-month pre- and post-index, respectively, 37.4 and 19.1% had all-cause inpatient admissions, 42.6 and 33.9% had emergency department visits, 92.2 and 81.7% had outpatient visits; mean ± standard deviation all-cause monthly total healthcare costs were $8,371±$15,792 and $6,486±$7,614, respectively.LimitationsThis was a descriptive claims-based analysis; no formal statistical comparisons were performed due to limited sample size as data covered up to 24 months of esketamine use in the US clinical setting.ConclusionsNearly half of patients experience access issues with first esketamine nasal spray treatment session. All-cause HRU and healthcare costs trend lower in the 6 months after relative to 6 months before esketamine initiation.

Comparison of Real-World Costs, Healthcare Resource Utilization, and Comorbidity-Related Costs Between Ixekizumab and Secukinumab Among Biologic-Experienced Patients with Psoriasis Over 18 Months in the USA.

Data on real-world healthcare costs for ixekizumab (IXE) and secukinumab (SEC) in biologic-experienced patients with psoriasis are limited. This study compared real-world costs and healthcare resource utilization between IXE and SEC in biologic-experienced patients with psoriasis over an 18-month follow-up period in the USA. Adult patients with a diagnosis of psoriasis between 1 March, 2015 and 31 October, 2019 were identified using health insurance claims data from IBM Watson Health MarketScan®. The index date was the date of the first IXE or SEC claim. Biologic-experienced patients with one or more pre-period claims for biologic drugs were identified. Inverse probability of treatment weighting was used to reduce cohort imbalances. All-cause and psoriasis-related direct healthcare costs along with index drug costs were estimated during the follow-up and reported as per patient per month. Discount factors published by the Institute for Clinical and Economic Review were applied to psoriasis-related biologics to adjust pharmacy costs. A total of 411 IXE and 780 SEC users were included. After weighting, all-cause inpatient admissions were similar between IXE (9.5%) and SEC users (10.3%). Weighted, mean ± standard deviation per patient per month all-cause healthcare costs were higher in IXE users ($6670 ± $2910) than in SEC users ($6239 ± $3903; p = 0.049). Psoriasis-related and monthly index drug costs were higher in IXE users ($5609 ± $2009; p < 0.001 and $4688 ± $1994; p < 0.001, respectively) than in SEC users ($5095 ± $2291 and $3853 ± $1977, respectively). After Institute for Clinical and Economic Review adjustment, mean per patient per month all-cause ($4363 ± $2576 vs $4398 ± $3517) and psoriasis-related costs ($3302 ± $1264 vs $3253 ± $1504) were similar between the groups. Institute for Clinical and Economic Review- and adherence-adjusted mean per patient per month index drug costs were similar between IXE and SEC users (p = 0.339). Institute for Clinical and Economic Review-adjusted all-cause and psoriasis-related costs were comparable between IXE and SEC users among biologic-experienced patients over an 18-month follow-up period.

Real-World Resource Utilization and Productivity Loss Among Patients With Myasthenia Gravis in Sweden: A Nationwide Population-Based Study

Objective To assess annual healthcare resource utilization including inpatient admission and outpatient visits, employment status, and sickness absence associated with myasthenia gravis (MG). Background MG is a rare, chronic and debilitating autoimmune neuromuscular disease characterized by muscle weakness and fatigue that leads to hallmark symptoms including ptosis, dysphagia, dyspnea and limb weakness. Nearly 10% of patients are estimated to have treatment-refractory MG. Design/Methods Data were linked from four longitudinal nationwide population-based registries in Sweden. Patients with = 1 diagnosis of MG (ICD-10 G70.0) from 01/01/2001 to 12/30/2017 were selected. Date of 1st MG diagnosis in the national patient register was designated as index date. The healthcare resource use, employment status, and sickness absence for all cause and associated with MG within 1-year post-index period were evaluated. Results A total of 4,339 patients with newly diagnosed MG were identified from 2001 and 2017. Mean (±SD) age at index date was 59.8 (±19.5) years; 54% were female. During the first year post-MG diagnosis, 50.6% of patients) had = 1 MG-related inpatient admission and 23.6% spent &gt;1 month as an inpatient. Most patients (89.3%, n = 3,875) had = 1 specialist visits for MG and 16.1% had &gt;5 visits during 1-year post-index period. 58.9% of patients had = 1 all-cause inpatient admission and 97.5% of patients used = 1 outpatient specialist services in the same period. Among patients of working age with =1-year follow-up (n = 2,006), 37.3% of them were not employed; among those in employment (n = 1,250), 44.6% reported = 1 sickness absences within 1-year post-index period. Conclusions Patients with MG require considerable care both for MG and comorbidities over a period of years. An important sub-population of patients (e.g., those with MG crisis) may be the intensive users of both inpatient and outpatient care. Future research needs to detail treatment pattern and outcomes in this population.

Burden of Hospitalization before and after a Disease Progression Following Triple-Class Exposure in Patients with Relapsed and Refractory Multiple Myeloma

Introduction: Multiple myeloma (MM) is a plasma cell malignancy with various clinical complications. Patients with relapsed and refractory multiple myeloma (RRMM) often suffer from disease progression and cycle through multiple treatments, including those from the same drug classes that they have failed before. Disease progression is usually associated with significant burden, including high health care resource utilization (HCRU) and costs. However, no current known literature quantifies HCRU and costs before and after disease progression in RRMM patients who have been exposed to multiple classes of therapies. This study aims to describe and compare hospitalization use and associated costs before and after disease progression in patients with RRMM who are triple-class exposed (TCE; defined as exposure to a proteosome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody). Methods: This retrospective cohort study used the Optum Clinformatics® Data Mart database from 1/1/2012 to 12/31/2021. Adults with ≥2 diagnosis codes for MM (ICD-10-CM: C90.0x) ≥30 days apart and who received a subsequent line of therapy (LOT) after becoming TCE were included. The start of a subsequent LOT after TCE was used as a surrogate to define disease progression, and the initiation date of the latest of such LOTs was defined as the index date if multiple eligible LOTs were observed for the same patient. Patients were also required to have ≥6-month continuous enrollment (CE) in medical and pharmacy plans before and after index. Patient characteristics were described at index and during the 6-month baseline period. A 2-month pre-post analysis was performed to compare all-cause inpatient admissions, intensive care unit (ICU) stays, hospitalization length of stay, and direct inpatient costs. Categorical variables were compared using McNemar's test, and counts and costs were compared using paired generalized linear models. Subgroup analyses were performed in patients with commercial insurance or Medicare Advantage. Results: A total of 523 patients met the study criteria. The mean age was 70.2 years, 63.1% were White, 51.2% were female, 72.5% had Medicare Advantage, the mean Quan-Charlson comorbidity index was 4.2, and 34.8% had ≥4 prior LOTs within the CE period containing the index date. The proportion of patients who had an all-cause inpatient admission (20.1% vs 12.8%, P = 0.0008) and an ICU stay (6.5% vs 1.9%, P = 0.0004) were significantly higher during the 2-month post- versus pre-index period. During the 2-month post-index period, patients on average had significantly more all-cause inpatient admissions (0.29 vs 0.16, P <0.0001). The mean inpatient length of stay for the cohort was numerically higher during the 2-month post- versus pre-index period (1.67 vs 1.07 days, P = 0.0751). The mean per-month cost of all-cause hospitalization was significantly higher during the 2-month post- versus pre-index period ($3,590.81 vs $1,267.18, P = 0.0008). The majority of the all-cause hospitalization use and costs (>90%) were MM-related. Similar trends were observed among commercial and Medicare Advantage patients. Conclusions: This study found a pronounced increase in hospitalization and costs in the 2 months immediately following disease progression in RRMM patients who are TCE. The data may support economic assessment and value framework for innovative treatments with significant prolonged progression-free survival. In addition, there is a need to focus on multifaceted efforts to improve overall well-being and the total cost of care for patients with RRMM.

Impact of a subcutaneous casirivimab and imdevimab clinic in outpatients with symptomatic COVID-19: A single-center, propensity-matched cohort study.

To evaluate the success of a clinic for subcutaneous administration of casirivmab and imdevimab (REGEN-COV; Regeneron) for treatment of patients with symptomatic mild to moderate coronavirus disease 2019 (COVID-19) in terms of preventing disease progression and healthcare utilization. This retrospective single-center, propensity-matched cohort study examined healthcare utilization outcomes for patients who received subcutaneous casirivimab and imdevimab at a pharmacist-led clinic of an academic health system. Eligible patients were treated between August 1, 2021, and January 5, 2022, and were at high risk for COVID-19 disease progression. Treatment patients were propensity matched with high-risk control patients with a diagnosis of COVID-19 in the same timeframe who did not receive casirivimab and imdevimab. Patients were followed for 30 days for collection of data on inpatient admissions, emergency department visits, and mortality. Risk of a 30-day healthcare utilization event was assessed and tested for statistical significance utilizing McNemar's test. A total of 585 patients who received treatment with subcutaneous casirivimab and imdevimab were matched with 585 patients who did not receive casirivimab and imdevimab therapy. Patients who received casirivimab and imdevimab had significantly lower risk of a 30-day all-cause inpatient admission event than untreated patients (relative risk reduction, 62.4%; P < 0.0001). Treated patients also had a significantly lower risk of 30-day all-cause emergency department visit than untreated subjects (relative risk reduction, 36.5%; P = 0.0021). There were 6 mortality events in the untreated group and no mortality events in the treatment group. This study provides evidence for the effectiveness of a subcutaneous casirivimab and imdevimab clinic in preventing progression of symptomatic mild to moderate COVID-19.

Impact of Breast Cancer Pathways on ER utilization and hospitalization.

423 Background:Optum’s Cancer Guidance Program promotes value-based care by ensuring that treatments follow evidence-based guidelines and encouraging the use of cancer therapy pathways. Criteria for selection of treatments for pathways include efficacy, toxicity and cost so Pathways could be expected to decrease emergency room utilization and hospitalizations that result from adverse events of therapy. We conducted this study to evaluate the impact of Pathways adherence (on vs. off Pathways) on hospital inpatient and emergency department utilization among commercially insured members with breast cancer. Methods: This cross-sectional matched case-control study used medical claims and prior authorization data to evaluate 12 months of program experience (11/1/2019 – 10/31/2020). Individuals were included if they were 19+ years old, enrolled in the health plan, had actively treated breast cancer (breast cancer diagnosis and 1+ cancer related treatment procedure), and had a cancer drug therapy prior authorization during the study period. On Pathway cases were matched to off Pathway controls with propensity score and outcomes were measured using generalized linear models. The propensity score was estimated using demographic characteristics, cost/utilization preceding the prior authorization request, and clinical indicators (HER2 status, advanced disease, adjuvant vs neoadjuvant therapy, multiple lines of therapy, ECOG /Karnofsky, regimen emetic risk). Outcomes were measured across the member’s treatment episode from first month of active cancer treatment to 3 months after last month of active cancer treatment. Results: Compared to those who were off Pathway (n = 1,001), patients treated with a Pathways regimen (n = 1,001) had 18% lower (p-value = 0.03) all-cause inpatient admissions, 14% lower (p-value = 0.10) cancer-related inpatient admissions, 18% lower (p-value = 0.11) all-cause emergency department visits, no difference in (p-value = 1.00) cancer-related inpatient bed days, 8% lower (p-value = 0.31) all-cause emergency department visits, and 1% lower (p-value = 0.92) cancer-related emergency department visits. Conclusions: Treatment with a Pathway regimen was associated with fewer all-cause and cancer-related visits to inpatient hospitalizations and fewer all-cause inpatient bed days.

Higher rates of all-cause mortality and resource utilization during episodes-of-care for diabetic foot ulceration

AimsOur primary objective was to determine whether all-cause rates of mortality and resource utilization were higher during periods of diabetic foot ulceration. In support of this objective, a secondary objective was to develop and validate an episode-of-care model for diabetic foot ulceration. MethodsWe evaluated data from the Medicare Limited Data Set between 2013 and 2019. We defined episodes-of-care by clustering diabetic foot ulcer related claims such that the longest time interval between consecutive claims in any cluster did not exceed a duration which was adjusted to match two aspects of foot ulcer episodes that are well-established in the literature: healing rate at 12 weeks, and reulceration rate following healing. We compared rates of outcomes during periods of ulceration to rates immediately following healing to estimate incidence ratios. ResultsThe episode-of-care model had a minimum mean relative error of 4.2% in the two validation criteria using a clustering duration of seven weeks. Compared to periods after healing, all-cause inpatient admissions were 2.8 times more likely during foot ulcer episodes and death was 1.5 times more likely. ConclusionsA newly-validated episode-of-care model for diabetic foot ulcers suggests an underappreciated association between foot ulcer episodes and all-cause resource utilization and mortality.

The Economic Burden of Recurrence in Triple-Negative Breast Cancer Among Working Age Patients in the United States.

Triple-negative breast cancer (TNBC) is associated with a high recurrence risk. However, the magnitude of direct and indirect costs associated with recurrence is lacking in the literature. Adults 18-65years old diagnosed with TNBC were identified from the OptumHealth Reporting and Insights claims database (1999-2017) and stratified by recurrence. For patients with recurrence, theindex date was defined as 30days before recurrence; for patients without recurrence, it was randomly assigned based on the distribution of time between first treatments and index dates of the recurrence cohort. All-cause and breast cancer-related healthcare resource utilization (HRU), direct and indirect costs, and work loss up to 1 year were compared between cohorts using generalized linear models. Kaplan-Meier analyses and Cox proportional hazards models compared the risk of leaving the workforce. Among the 2340 patients analyzed, mean age was 54years and > 75% of patients had stage 0-2 cancer. Among the 1170 patients with recurrence, 236 were categorized as having metastatic recurrence and 934 as having locoregional recurrence. Relative to patients without recurrence, those with recurrence had significantly higher all-cause and breast cancer-related HRU. For instance, adjusted incidence rates (IRs) for all-cause inpatient admissions were 3.67 and 10.19 times higher for patients with locoregional and metastatic recurrence, respectively (p < 0.001). Adjusted all-cause healthcare costs were $8575/month higher for metastatic recurrence and $3609/month higher for locoregional recurrence vs. patients without recurrence (p < 0.001). Adjusted IRs for work loss days were approximately two times higher for locoregional and metastatic recurrence vs. without recurrence (p < 0.001). Patients with locoregional recurrence incurred $335/month more indirect costs vs. patients without recurrence; those with metastatic recurrence incurred $769/month more (p < 0.05). Patients with recurrence had a 63% higher rate of leaving the work force (p = 0.003). The incremental direct and indirect economic burden associated with recurrent TNBC is substantial relative to non-recurrence.

Real-World Outcomes and Costs Following 6 Months of Treatment with the Long-Acting Injectable (LAI) Aripiprazole Lauroxil for the Treatment of Schizophrenia.

BackgroundContinuous antipsychotic therapy is recommended as part of long-term maintenance treatment of schizophrenia, and gaps in antipsychotic treatment have been associated with increased risks of relapse and rehospitalization. Because the use of long-acting injectable (LAI) antipsychotics may reduce the likelihood of undetected medication gaps, initiating an LAI medication may affect resource utilization and costs. The LAI aripiprazole lauroxil (AL) was approved in the United States (US) in 2015 for the treatment of schizophrenia in adults.ObjectiveThe objective of this retrospective observational cohort study was to examine treatment patterns, resource utilization, and costs following initiation of AL for the treatment of schizophrenia in adults.MethodsA retrospective analysis of Medicaid claims data identified a cohort of patients (N = 485) starting AL shortly after Food and Drug Administration approval in October 2015. Treatment patterns, resource utilization, and costs were compared 6 months before and after treatment initiation. Subgroup analyses were conducted based on the type of antipsychotic (LAI, oral, or none) received before initiation of AL.ResultsOver 6 months of follow-up, patients received an average of 4.6 injections out of a maximum of six (77%). After initiating AL, all-cause inpatient admissions decreased by 22.4%; other significant reductions were observed in mental health–related admissions and emergency room (ER) visits. All-cause inpatient costs decreased by an average of US$2836 per patient (p < 0.05) in the 6-month post-AL period, whereas outpatient pharmacy costs increased by US$4121 (p < 0.05), resulting in no significant difference in overall costs between the pre- and post-AL periods. The subgroup of patients who had been prescribed an oral antipsychotic before starting AL had significant reductions in proportion of patients with inpatient and ER visits and costs, but also reported a significant increase in pharmacy costs.ConclusionsAL was associated with a significant reduction in inpatient costs and an increase in outpatient pharmacy costs, resulting in no changes in total healthcare costs over 6 months. The adherence rate and reductions in inpatient use may indicate the potential for greater clinical stability among patients initiated on AL compared with their previous treatment.Supplementary InformationThe online version contains supplementary material available at 10.1007/s40263-021-00849-2.

Adverse Events, Resource Use, and Economic Burden in Patients with Mantle Cell Lymphoma in the United States

Introduction : In patients with mantle cell lymphoma (MCL), adverse events (AEs) can impair patient adherence to planned therapeutic regimens. In addition, moderate to severe AEs generally require medical attention and therefore are often associated with increased health care resource use (HRU) and costs. Real-world data on HRU and costs associated with MCL and its treatments are sparse in current literature. The goals of this study were: (1) assess HRU and direct costs of MCL; (2) examine variation in costs across treatment types; and (3) document the economic burden associated with MCL treatment-related AEs.Methods :A retrospective cohort analysis was performed using MarketScan databases that contain employer- and health-plan-sourced administrative claims data, including information on diagnoses, procedures, and associated utilization of health care services for over 60 million privately insured individuals across the US. Cost information in the data include patient copay, coinsurance, charges, and the actual amounts paid by the payers. Patients were included if they were aged ≥18 years, had at least two medical claims on separate dates with a diagnosis code for MCL (ICD-9-CM code 200.4x or ICD-10-CM code C83.1x) during July 2010-June 2015, and were continuously enrolled in medical and drug plans for ≥12 months before the date of first MCL diagnosis (ie, study index date). Patients with evidence of MCL diagnosis or MCL treatment in the 12 months before the study index date were excluded. Mean per-patient monthly HRU and costs were assessed overall and by care setting (eg, inpatient, outpatient, pharmacy). Both all-cause and MCL-related costs were calculated; all cost data, adjusted to 2016 US dollars using the Medical Care component of the US Consumer Price Index, were assessed from the payer's perspective. The incremental HRU and costs associated with AEs were assessed by stratifying these measures according to patients' AE status (AE or no AE) and the number of AEs experienced (0, 1-2, 3-5, ≥6) during follow-up. Additionally, subgroup analyses were conducted to assess the association of AEs with mean HRU and costs among patients receiving specific regimens. All analyses were descriptive in nature.Results :In total, 783 patients with MCL (median age, 65 years [range, 19-99 years]) met the study selection criteria. Mean (standard deviation [SD]) all-cause and MCL-related monthly costs were $8393 ($16,276) and $6730 ($14,779), respectively. Inpatient admission costs ($4817 [$14,267]) and office visit costs ($1493 [$3250]) were the largest drivers of total all-cause costs. Among patients receiving systemic therapies, mean all-cause monthly costs were highest for rituximab/cyclophosphamide/doxorubicin/vincristine (R-CHOP), followed by ibrutinib monotherapy, bendamustine/rituximab (B-R), and rituximab alone (including rituximab maintenance therapy) (Figure 1); prescription drug costs were highest in patients receiving ibrutinib ($14,038 [$21,936]). The median length of stay per all-cause inpatient admission was 3.0 days (range, 2-4) among patients with no AE, which increased to 5.2 days (range, 1-50) among those with six or more AEs, as observed during all available follow-up (Figure 2). A corresponding increase in the length of stay per admission was also observed, with increasing numbers of AEs. The mean (SD) all-cause monthly costs were $4298 ($10,082) among those with no AEs and more than twofold higher ($10,335 [$16,868]) among those with at least six AEs during follow-up (Figure 3).Conclusions :This is the largest series of patients with MCL in which real-world economic burden data have been reported. Our results demonstrate that the economic burden of MCL is substantial, with mean monthly costs varying considerably by treatment regimen and care setting. We found that inpatient admissions and office visits were the largest drivers of total costs for patients treated with R-CHOP, B-R, and rituximab, while prescription drug costs were the largest component of total costs for patients receiving ibrutinib. Patients experiencing more AEs were observed to have higher monthly costs than those experiencing few AEs. [Display omitted] DisclosuresKarve:AstraZeneca: Employment, Other: Stocks. Nagar:RTI Health Solutions: Research Funding. Goyal:RTI Health Solutions: Research Funding. Kaye:RTI Health Solutions: Research Funding. Mato:Regeneron: Research Funding; TG Therapeutics: Membership on an entity's Board of Directors or advisory committees, Research Funding; Portola: Research Funding; Janssen: Consultancy; Pharmacyclics: Research Funding; DTRM: Research Funding; Celgene: Consultancy, Membership on an entity's Board of Directors or advisory committees; Gilead Sciences, Inc.: Membership on an entity's Board of Directors or advisory committees; AbbVie: Consultancy, Research Funding; Acerta: Research Funding; AstraZeneca: Consultancy; Kite: Consultancy.

811-P: Durable Insulin Pumps vs. Multiple Daily Injections for Type 1 Diabetes: Health Care Utilization and A1C

Objectives: The healthcare utilization benefits associated with insulin pump therapy compared to multiple daily injections (MDI) therapy are not well known. This study sought to compare the impact of using a durable insulin pump versus MDI therapy on healthcare utilization and A1C among individuals with type 1 diabetes (T1D). Methods: This population-based, longitudinal analysis used a large repository of healthcare claims data to compare diabetes-related and all-cause inpatient admissions (IP) and emergency room (ER) visits in individuals with T1D using durable pumps (N=1,286) versus MDI (N=3,854). The study period was June 1, 2017 to July 31, 2019. The study index date was assigned to the first date of pump use in the pump cohort and a random index date was assigned to the MDI cohort. Continuous insurance enrollment 1-year before and 1-year after adoption/index date was required. Generalized linear model regression was used to test the difference-in-difference effect of therapy type on rates of utilization and A1C. The U.S. Agency for Healthcare Research and Quality (AHRQ) Prevention Quality Indicator (PQI) algorithm was used to define diabetes-related utilization. Results: Individuals on insulin pump therapy had a significant decrease in IP utilization compared to little change among individuals using MDI therapy (-41% vs. +3%, p=0.01), and similar decreases in ER utilization (-27% vs. -16%, p=0.64). Combining diabetes-related IP and ER utilization, individuals on insulin pump therapy experienced a decrease of 34% compared to decrease of 8% among those using MDI therapy (p= 0.02). Individuals on insulin pump therapy also experienced a larger decrease in A1C (-7% vs. -1%, p=&amp;lt;0.0001). Conclusions: Compared to MDI therapy, use of a durable insulin pump associated with a significantly smaller increase in diabetes-related healthcare utilization and A1C over time. Disclosure M. Shah: Employee; Self; Medtronic. C. Zhu: Employee; Self; Medtronic. K. Wherry: Employee; Self; Medtronic.

Is chimeric antigen receptor T cell (CART) a destination procedure? Lower socioeconomic class who live farther from center have less access to CART.

e18562 Background: Axicabtagene ciloleucel and tisagenlecleucel are commercially available CD19 chimeric antigen receptor T-cell (CART) therapies for B cell malignancies. Manufacturing pharmaceutical companies require patients to stay within 2 hours of the center for 4 weeks post infusion. Most centers require local lodging for that period if residence is over 30 minutes away. Financial burden may limit access. We therefore hypothesized that those who were likely to receive CART therapies were from higher income neighborhoods or lived closer to the facility. Methods: Since most patients get admitted for CART infusion, we used the Vizient CDB database for CART infusion admissions as well as other admissions. Patients over the age of 18 yrs who got commercially available CART between 2018 to 2020 were included. Distance was calculated in miles from patient zip code to treating center. Using census data, lower income neighborhoods (less than $40,000 median household income) were flagged. Results: 81 centers administered CART. We calculated the distance in miles between the patient and the center for both CART admissions as well as for all-cause inpatient admissions. Most admissions (81.2% all-cause vs 78.6% CART) were from neighborhoods with median income &gt; $40,000. Most of the low-income admissions were from neighborhoods &lt;10 miles (13.3% all admissions vs 15.7% CART). 80.6% of all CART patients came from neighborhoods over 10 miles, with 38.2% living over 60 miles away, while only 15.4% all-cause admissions were from &gt; 60 miles. (p&lt;.0001) While 74.9% of higher income CART patients lived beyond 10 miles from center, only 5.7% CART patients lived beyond 10 miles. Results summarized in Table. Conclusions: Most CART patients lived over 10 miles from the center, however less than 10% of them were from lower income neighborhoods. Neighborhood location relative to center and household income influence access and need to be addressed.[Table: see text]

Real world experience with standalone immunotherapy regimens: Immune-related adverse events, healthcare utilization and cost among patients with commercial or Medicare Advantage insurance.

2625 Background: Immunotherapy is a fast growing class of cancer therapy. We evaluated the rates of immune-related adverse events (irAEs), healthcare utilization, and costs up to 1 year post-index among patients using monotherapy (PD-1/PD-L1 inhibitor) and combination therapy (PD-1/PD-L1 with CTLA-4 inhibitors). Methods: We reviewed claims from the HealthCore Integrated Research Database (HIRD), which contains commercially insured/Medicare Advantage members and captures clinical, utilization, and cost measures. We analyzed both the monotherapy (M) and combination therapy (C) cohorts focusing on members with ≥ 6 months of baseline continuous medical and pharmacy coverage. Descriptive and multi-variate analyses were performed. Results: The C cohort had 904 and M had 9,084 patients, with mean ages of 58 and 64 years, respectively. Prominent cancer types were melanoma for C and lung for M. The most common incident irAEs (%) for C vs. M were: endocrinopathies (27.7, 14.7), hepatitis (17.1, 7.7), nephritis (21.0, 14.0), neuropathy (6.6, 7.0), followed by colitis, dermatitis, and myocarditis. After adjustment, C therapy showed greater risk of all-cause inpatient admissions (OR 2.27, 95% CI 1.93, 2.66), all-cause emergency department (ED) visits (OR 1.55, 95% CI 1.33, 1.81) and irAE-related visits (See table). Mean adjusted all-cause cost difference for C vs M was +$43,747 (95% CI $38,440, $49,427). In age ≥65 subset, 222 received C and 4,208 received M. C therapy patients had more irAE-related hospitalizations (45.3% vs. 57.7%, p=0.0004). Costs were similar to the main cohort. Conclusions: C therapy showed greater incident irAE rates, increased utilization and medical costs compared to M therapy. Limitations include less precise ascertainment of irAEs in claims data and generalizability only to those with commercial or Medicare Advantage insurance. Our study highlights the increased toxicity and cost tradeoffs involved in choosing combination immunotherapy over monotherapy.[Table: see text]

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.

Health care resource use, short-term disability days, and costs associated with states of persistence on antidepressant lines of therapy

Aims 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). Methods 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. Results 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 < .001) versus persistence on the early-line therapy. This resulted in $374 higher mean PPPM all-cause health care costs (95% CI = 265, 470; p < .001) during evaluation versus persistence on the early line therapy. The evaluation state was associated with 89% more short-term disability days (OR [95% CI] = 1.89 [1.49, 2.57] and $212 higher mean PPPM short-term disability costs (95% CI = 64, 259) relative to persistence on the early line (both p < .001). Moreover, during persistence on a later line, mean PPPM all-cause health care costs were $141 higher (95% CI = 13, 242; p = .028) relative to the early line. Limitations Medication may have been dispensed but not actually taken. Conclusions 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.