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Atrial fibrillation (AF) is a recognized adverse consequence associated with all Bruton's tyrosine kinase inhibitors used to treat chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL); however, real-world time to discontinuation (TTD) and time to next treatment (TTNT) of CLL/SLL patients with a high baseline AF/stroke risk remain unknown.Patients with CLL/SLL from a nationwide electronic health record-derived database (February 12, 2013-January 31, 2021) initiating first-line (1L) or second or later-line (2L+) treatment with ibrutinib or other regimens on or after February 12, 2014 (index date) were analyzed. Kaplan-Meier survival analysis was used to assess TTD and TTNT among all patients, patients with high AF risk (CHARGE-AF risk score ≥10.0%), and patients at high risk of stroke (CHAIn 1L/2L+, 2190/1851 patients received ibrutinib and 4388/4135, were treated with other regimens. Median TTD for ibrutinib was similar regardless of AF/stroke-related risk (1L: all patients, 15.7 months; high AF risk, 11.7 months; high stroke risk, 13.7 months; similar results in 2L+). Median TTNT was significantly longer for ibrutinib vs. other regimens (1L: not reached vs. 45.9 months; 2L+: not reached vs. 23.6 months; both P.05), including among those with high AF/stroke risk. TTNT was similar between all patients and high-risk cohorts in 1L and 2L+ (all P.05).This study highlights that elevated baseline AF/stroke-related risk does not adversely impact TTD and TTNT outcomes associated with ibrutinib use. Additionally, TTNT was significantly longer for patients treated with ibrutinib vs. other regimens.

To describe prostate-specific antigen (PSA) response and treatment adherence, overall and stratified by race, for patients with non-metastatic castration-resistant prostate cancer (nmCRPC) treated with apalutamide.Electronic medical records representing 63 urology practices from the United States were used to conduct this study. Patients with ≥2 apalutamide prescription fills and ≥12 months of prior prostate cancer management were identified. Patients were followed from apalutamide initiation until a switch to another antineoplastic treatment, death, or end of data availability (October 4, 2019). PSA response (≥50% decline from baseline PSA) and apalutamide adherence rates are described for the overall nmCRPC population treated and also stratified by race (Black and non-Black cohorts).Overall, 193 patients with nmCRPC were initiated on apalutamide. Thirty-three patients were Black (17.1%), 138 were non-Black (71.5%), and the remaining had an unknown racial background. The mean baseline PSA level for the overall, Black, and non-Black cohorts, was 7.0 ng/mL, 10.5 ng/mL, and 5.6 ng/mL, respectively. At 12 months of follow-up, PSA response was 86.0%, 93.1%, and 85.9% for the overall, Black, and non-Black cohorts, respectively. During a mean follow-up period of 333 days, 352 days, and 326 days, adherence was 93.6%, 90.1%, and 94.5% for the overall, Black and non-Black cohorts, respectively.This real-world study of patients with nmCRPC initiated on apalutamide showed that PSA response was robust and consistent with clinical trial data. Moreover, both Black and non-Black patients demonstrated high treatment adherence.

This study assessed the healthcare resource utilization (HRU) and cost burden of patients with major depressive disorder (MDD) and acute suicidal ideation or behavior (SIB; MDSI) versus those with MDD without SIB and those without MDD.Adults were selected from the MarketScan® Databases (10/2015-02/2020). The MDSI cohort received an MDD diagnosis within 6 months of a claim for acute SIB (index date). The index date was a random MDD claim in the MDD without SIB cohort and a random date in the non-MDD cohort. Patients had continuous eligibility ≥12 months pre- and ≥1 month post-index. HRU and costs were compared during 1- and 12-month post-index periods between MDSI and control cohorts matched 1:1 on demographics.The MDSI cohort included 73,242 patients (mean age 35 years, 60.6% female, 37.2% Medicaid coverage). At 1 month post-index, the MDSI cohort versus the MDD without SIB/non-MDD cohorts had 12.8/67.2 times more inpatient admissions and 3.3/8.9 times more emergency department visits; they had 2.9 times more outpatient visits versus the non-MDD cohort (all p 0.001). The MDSI cohort had incremental mean healthcare costs of $5255 and $6674 per-patient-month versus the MDD without SIB and non-MDD cohorts (all p 0.001); inpatient costs drove up to 89.5% of incremental costs. At 12 months post-index, HRU and costs remained higher in MDSI versus control cohorts.SIB are underreported in claims; unobserved confounders may cause bias.MDSI is associated with substantial excess healthcare costs driven by inpatient costs, concentrated in the first month post-index, and persisting during the following year.

Prior observational studies suggest rivaroxaban is safe and effective among patients with morbid obesity who suffered a venous thromboembolism (VTE) event, but existing data are more limited in the broader population of VTE patients with obesity. This study assessed VTE recurrence, major bleeding, healthcare resource utilization, and healthcare costs among VTE patients with obesity who received rivaroxaban versus warfarin. VTE patients with obesity who initiated rivaroxaban or warfarin after a first VTE (index date) were identified from the IQVIA PharMetrics® Plus database (01/02/2011–09/30/2019). The follow-up period spanned from the index date until health plan disenrollment, end of data availability, cancer diagnosis/treatment, end of the 12 month post-index period, or (for the analysis of major bleeding) anticoagulant discontinuation or switch. Patient characteristics were balanced using inverse probability of treatment weighting. The weighted rivaroxaban (N = 8666) and warfarin cohorts (N = 5946) were well balanced (mean age = 51 years, females = 52%). Over a 9.6 months mean observation period, rivaroxaban users had a significantly lower risk of VTE recurrence [7.0% vs. 8.2%, HR(95% CI) = 0.85(0.75;0.97)] and a similar risk of major bleeding [4.1% vs. 3.6%, HR(95% CI) = 1.11(0.89;1.37)] relative to warfarin users at 12 months. Relative to warfarin users, rivaroxaban users had significantly fewer all-cause outpatient visits [RR(95% CI) = 0.71(0.70;0.74)]. The higher pharmacy costs incurred by rivaroxaban recipients (cost difference = $1252) were offset by lower medical costs (cost difference = − $2515, all p

Background Patients with high-risk, newly diagnosed multiple myeloma (HR-NDMM) who are ineligible for autologous stem cell transplant (ASCT) have limited first-line treatment options. Recent meta-analyses evaluating the impact of incorporating daratumumab in the backbone regimen on progression-free survival (PFS) have found mixed results in these patients. Materials and Methods A pooled analysis of patient-level data for ASCT-ineligible patients with HR-NDMM [ie, del(17p), t(4;14), t(14;16)] from the MAIA and ALCYONE trials; stratified by study identifier and adjusting for cytogenetic abnormality subtype, baseline performance status, International Staging System stage, myeloma type, and renal impairment; was conducted. Impact of daratumumab on PFS and rates of complete response or better (≥CR), minimal residual disease (MRD)-negative CR, very good partial response or better (≥VGPR), and overall response (ORR) was compared to control. Results Among 101 patients in the daratumumab and 89 patients in the control cohort, median follow-up was 43.7 months. Daratumumab reduced the risk of progression or death by 41% (adjusted hazard ratio for PFS [95% confidence interval (CI)] = 0.59 [0.41-0.85]) versus control. At 36 months, the estimated proportion of patients who did not progress and were still alive was 41.3% in the daratumumab and 19.9% in the control cohort. Rates of ≥CR (41.6% vs. 22.5%), MRD-negative CR (24.8% vs. 5.6%), ≥VGPR (75.2% vs. 46.1%), and ORR (92.1% vs. 74.2%) were higher for daratumumab versus control. Conclusion These findings demonstrate that incorporation of daratumumab in frontline treatment regimens reduced the risk of progression or death and improved response rates among ASCT-ineligible HR-NDMM patients.

To compare treatment patterns of United States (US) veterans stable on innovator infliximab (IFX) who switched to an IFX biosimilar (switchers) or remained on innovator IFX (continuers).US Veterans Healthcare Administration data (01/2012-12/2019) were used to identify adults with rheumatoid arthritis (RA), psoriatic arthritis (PsA), plaque psoriasis (PsO), ankylosing spondylitis (AS), or Crohn's disease and ulcerative colitis (i.e. inflammatory bowel disease [IBD]), treated with innovator or biosimilar IFX. Index date was the first IFX biosimilar administration for switchers or a random innovator IFX administration for continuers. Patients were required to have ≥5 innovator IFX administrations during the 12 months pre-index (prevalent population). Patients with ≥12 months of observation prior to the first innovator IFX administration were analyzed as the primary population (incident population), and data were assessed from start of innovator IFX. Inverse probability of treatment weighting was used to balance baseline characteristics between cohorts. Treatment patterns were evaluated post-index; continuers were censored before switching to IFX biosimilar. Discontinuation was defined as switching to another biologic (including innovator IFX) or having ≥120 days between 2 consecutive index treatment records.In the incident population, mean [median] duration of follow-up was 737 [796] days among switchers (Patients switching from innovator to biosimilar IFX were more likely to discontinue treatment and switch to another innovator biologic (notably back to innovator IFX) than those remaining on innovator IFX; however, reasons for discontinuation and switching are unknown.

To provide a comprehensive evaluation of the economic burden associated with attention-deficit/hyperactivity disorder (ADHD) among children and adolescents from a US societal perspective.Direct healthcare costs of children (5-11 years) and adolescents (12-17 years) with ADHD were obtained using claims data from the IBM MarketScan Research Databases (01/01/2017-12/31/2018). Direct non-healthcare and indirect costs were estimated based on literature and government publications. Each cost component was estimated using a prevalence-based approach, with per-patient costs extrapolated to the national level.The total annual societal excess costs associated with ADHD were estimated at $19.4 billion among children ($6,799 per child) and $13.8 billion among adolescents ($8,349 per adolescent). Education costs contributed to approximately half of the total excess costs in both populations ($11.6 billion [59.9%] in children; $6.7 billion [48.8%] in adolescents). Other major contributors to the overall burden were direct healthcare costs ($5.0 billion [25.9%] in children; $4.0 billion [29.0%] in adolescents) and caregiving costs ($2.7 billion [14.1%] in children; $1.6 billion [11.5%] in adolescents).Cost estimates were calculated based on available literature and/or governmental publications due to the absence of a single data source for all costs associated with ADHD. Thus, the quality of cost estimates is limited by the accuracy of available data as well as the study populations and methodologies used by different studies.ADHD in children and adolescents is associated with a substantial economic burden that is largely driven by education costs, followed by direct healthcare costs and caregiver costs. Improved intervention strategies and policies may reduce the clinical and economic burden of ADHD in these populations.

BACKGROUND: Attention-deficit/hyperactivity disorder (ADHD) is associated with substantial clinical burden as individuals transition to adulthood, including higher rates of comorbidities, mortality, incarceration, and psychiatric hospitalizations than in individuals without ADHD. These higher rates likely contribute to substantial economic burden as well. OBJECTIVE: To provide a comprehensive evaluation of the economic burden associated with ADHD in the US adult population. METHODS: Direct health care costs were obtained by using claims data from the IBM MarketScan Research Databases (January 1, 2017, through December 31, 2018). Direct non-health care costs and indirect costs were estimated on the basis of the literature and government publications. Excess costs incurred by adults with ADHD during 2018 were evaluated from a societal perspective; per-patient costs were extrapolated to the national level. RESULTS: An estimated 8.7 million adults live with ADHD in the United States, resulting in a total societal excess cost attributable to ADHD of $122.8 billion ($14,092 per adult). Excess costs of unemployment ($66.8 billion; 54.4%) comprised the largest proportion of the total, followed by productivity loss ($28.8 billion; 23.4%) and health care services ($14.3 billion; 11.6%). CONCLUSIONS: ADHD in adults is associated with substantial economic burden. DISCLOSURES: This study was funded by Otsuka Pharmaceutical Development & Commercialization, Inc. (Otsuka). The study sponsor contributed to and approved the study design, participated in the interpretation of data, and reviewed and approved the manuscript. Schein is an employee of Otsuka. Gagnon-Sanschagrin, Davidson, Kinkead, Cloutier, Guerin, and Lefebvre are employees of Analysis Group, Inc., a consulting company that provided paid consulting services to Otsuka to develop and conduct this study and write the manuscript. Adler has received research support from Shire/Takeda, Sunovion, and Otsuka; consulting fees from Bracket, Shire/Takeda, Sunovion, Otsuka, the State University of New York (SUNY), the National Football League (NFL), and Major League Baseball (MLB); and royalty payments (as inventor) from New York University (NYU) for license of adult ADHD scales and training materials. Childress has received research support from Allergan, Takeda/Shire, Emalex, Akili, Ironshore, Arbor, Aevi Genomic Medicine, Neos Therapeutics, Otsuka, Pfizer, Purdue, Rhodes, Sunovion, Tris, KemPharm, Supernus, and the US Food and Drug Administration; was on the advisory board of Takeda/Shire, Akili, Arbor, Cingulate, Ironshore, Neos Therapeutics, Otsuka, Pfizer, Purdue, Adlon, Rhodes, Sunovion, Tris, Supernus, and Corium; received consulting fees from Arbor, Ironshore, Neos Therapeutics, Purdue, Rhodes, Sunovion, Tris, KemPharm, Supernus, Corium, Jazz, and Tulex Pharma; received speaker fees from Takeda/Shire, Arbor, Ironshore, Neos Therapeutics, Pfizer, Tris, and Supernus; and received writing support from Takeda/Shire, Arbor, Ironshore, Neos Therapeutics, Pfizer, Purdue, Rhodes, Sunovion, and Tris. Part of the material in this study was presented as a poster at the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) 2021 Virtual Meeting; May 17-20, 2021.

Aims: In light of the extended overall survival and improved quality of life provided by advanced prostate cancer (PC) oral therapies, this study aimed to describe treatment adherence to advanced PC oral therapies and evaluate associated patient characteristics and subsequent healthcare resource utilization (HRU). Patients & methods: Patients with advanced PC initiating apalutamide, enzalutamide or abiraterone acetate were identified from administrative data (October 1, 2014–September 30, 2019). Adherence and persistence at six months postinitiation were used to evaluate patient factors and HRU. Results: Aged ≥75 years, Black race, chemotherapy use and higher pharmacy paid amounts were associated with poor adherence/persistence, which translated to higher HRU. Conclusions: Strategies to increase adherence and persistence may improve patient outcomes and associated HRU.

OBJECTIVE This study evaluated body mass index (BMI) and weight changes in people living with human immunodeficiency virus (HIV-1; PLWH) initiated on single-tablet darunavir/cobicistat/emtricitabine/tenofovir alafenamide (DRV/c/FTC/TAF) or bictegravir/FTC/TAF (BIC/FTC/TAF). METHODS Electronic medical records (EMR) data for treatment-naive or virologically suppressed adults with HIV-1 who initiated treatment with DRV/c/FTC/TAF or BIC/FTC/TAF (index date) were obtained from Decision Resources Group's EMR (7/17/2017-3/1/2020). Inverse probability of treatment weighting was used to account for differences in baseline characteristics between the two cohorts. BMI and weight changes from pre-index to 3, 6, 9, and 12 months following the index date were compared using weighted mean differences (MDs). The time until an increase in BMI or weight ≥5% or ≥10% was compared using weighted hazard ratios (HRs). RESULTS The weighted DRV/c/FTC/TAF and BIC/FTC/TAF cohorts comprised 1,116 and 1,134 PLWH, respectively (mean age=∼49 years, females: ∼28%). Larger increases in BMI and weight from pre-index to each post-index time points were observed in PLWH initiating BIC/FTC/TAF vs DRV/c/FTC/TAF (12 months: MD in BMI =1.23 kg/m2, p

Purpose: This study provides a contemporary assessment of the treatment patterns, health care resource utilization (HRU) and costs among metastatic castration-sensitive prostate cancer (mCSPC) patients in the U.S. Materials and Methods: Adults with mCSPC were selected from Optum's de-identified Clinformatics® Data Mart Database (Commercial insurance/Medicare Advantage [COM/MA]; January 1, 2014–July 31, 2019) or Medicare Fee-for-Service (FFS; January 1, 2014–December 31, 2017). The index date was the first metastatic disease diagnosis date on/after the first prostate cancer diagnosis (without prior evidence of castration resistance). Patients were observed for 12 months pre-index (baseline) through their mCSPC period (from index until castration resistance or followup end). First-line (1L) mCSPC therapy was assessed during the mCSPC period; all-cause HRU and health plan-paid costs per-patient-per-year (PPPY) were measured during baseline and mCSPC periods. Results: Among 6,517 COM/MA and 13,324 Medicare-FFS mCSPC patients over ∼10 months (median mCSPC period), 38% and 48% remained untreated/deferred treatment, and 45% and 46% received 1L androgen deprivation therapy (ADT) monotherapy, respectively. 1L abiraterone acetate and docetaxel were used among 7% and 6% of COM/MA and 1% and 2% of Medicare-FFS patients, respectively. HRU increased from baseline to mCSPC period, resulting in increased health plan-paid costs from $21,201 to $108,767 in COM/MA and from $16,819 to $69,639 PPPY in Medicare-FFS. Conclusions: This study highlights the limited use of newer therapies that improve survival in men with mCSPC in the U.S. HRU and costs increased substantially after onset of metastasis. Given the emergence of newer effective mCSPC therapies, further evaluation of future real-world mCSPC treatment patterns and outcomes is warranted.

To assess treatment patterns in adults with attention-deficit/hyperactivity disorder (ADHD) and associated healthcare costs in a real-world US setting. Claims data from the IBM MarketScan Commercial Subset (Q1/2014-Q4/2018) was used to identify adults diagnosed with ADHD who newly initiated on ADHD treatment (index date). Treatment sequences were defined using an algorithm; for each sequence, the regimen comprised all ADHD-related agents observed within 30 d of the first agent during the 12-month study period. Treatment changes included discontinuation, switch, add-on, and drop. Treatment characteristics were described for the first treatment regimen observed. Total adjusted annual healthcare costs were compared between patients with no treatment change and patients with 1, 2, and ≥3 treatment changes. Among 122,881 adults with ADHD, the majority initiated a stimulant (95.1%) as their first treatment regimen observed; 9.3% of patients initiated combination therapy of ≥2 ADHD-related agents, and 34.9% of patients had psychotherapy. After an average first treatment regimen duration of 7.1 months, 50.2% of patients experienced a treatment change (22.5% discontinued, 17.5% switched, 5.3% had an add-on, and 4.6% had a treatment drop). Among those who discontinued, 44.8% did so within the first month of initiation. Mean annual healthcare costs were higher among patients with at least 1 treatment change compared to those with no treatment changes; excess costs increased with each additional treatment change. Treatment changes were commonly observed and were associated with excess healthcare cost, emphasizing the unmet treatment needs of adults with ADHD in the US.

To estimate the prevalence, incidence and economic burden of schizophrenia among Medicaid beneficiaries.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).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 (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.

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

Background Patients with peripheral artery disease (PAD) treated with lower extremity revascularization are at increased risk of major atherothrombotic vascular events (acute limb ischemia (ALI), major non-traumatic lower-limb amputation, myocardial infarction (MI), ischemic stroke, and cardiovascular (CV)-related death). This study assessed the incidence of major atherothrombotic vascular events, venous thromboembolism (VTE) events and rates of subsequent lower extremity revascularizations in the real-world among patients with PAD after revascularization. Methods Patients aged ≥50 years with PAD who underwent peripheral revascularization were identified from Optum Clinformatics Data Mart claims database (Q1/2014-Q2/2019). The first lower extremity revascularization after PAD diagnosis was defined as index date. Incidence rates of major atherothrombotic vascular events (i.e., composite of ALI, major non-traumatic lower-limb amputation, MI, ischemic stroke, and CV-related death) and VTE were assessed during follow-up as the number of events divided by patient-years of observation (censored at the first event). Rates of subsequent revascularizations and VTE were estimated overall and compared between patients with major atherothrombotic vascular events and those without. Results Of the 38,439 patients included, 6,675 (17.4%) had a major atherothrombotic vascular event during a median follow-up of 1.0 year. The composite major atherothrombotic vascular and VTE incidence rates were 13.81/100 patient years and 1.77/100 patient years, respectively, and 40.2% of patients experienced subsequent revascularizations. Patients with a post-revascularization major atherothrombotic vascular event had significantly higher rates of subsequent revascularizations (64.6% vs. 35.1%, standardized difference [SD] ≥10%) and VTE (4.6% vs. 2.1%, SD ≥10%) versus those without. Conclusion One-in-six PAD patients aged ≥50 years who underwent peripheral revascularization experienced a major atherothrombotic vascular event within one year, and consequently, experienced higher rates of subsequent revascularizations compared with those without a major atherothrombotic vascular event post-revascularization. These findings highlight the need to improve strategies to prevent major atherothrombotic vascular events after revascularization.

PURPOSE This study assessed treatment patterns in patients with mantle cell lymphoma (MCL) and compared health care resource utilization (HRU) and costs of ibrutinib with or without rituximab (I ± R) versus chemoimmunotherapy (CIT) in patients with relapsed/refractory MCL. METHODS For this retrospective cohort study, adults with MCL observed between May 13, 2013, and June 30, 2019, were identified using Optum's de-identified Clinformatics Data Mart Database. Treatment patterns were described among patients who received ≥1 line of therapy (LOT). HRU and costs (payer's perspective) were compared between patients treated with I ± R and CIT in the second or later line (2L+) of therapy. To account for differences in baseline characteristics between the 2 cohorts, inverse probability of treatment weighting was used. Monthly HRU and costs starting from I ± R or CIT treatment initiation (index date) were compared during the first Oncology Care Model (OCM) episode (ie, first 6 months) postindex and during the observed duration of I ± R or CIT LOT (index LOT) using rate ratios (RRs) and mean monthly cost differences (MMCDs), respectively. FINDINGS Among 1346 patients with ≥1 LOT (median follow-up, 15.3 months), 870 (64.6%) were treated with CIT in the first line. Only 348 (25.9%) had a 2L of therapy, of whom 110 (31.6%) were treated with CIT and 98 (28.2%) with an ibrutinib-based therapy. A total of 300 patients were included for the comparison of HRU and costs between 2L+ I ± R and 2L+ CIT. The weighted cohorts (after inverse probability of treatment weighting) included 149 patients treated with I ± R (mean age, 71.6 years; 73.7% men) and 151 treated with CIT (mean age, 71.5 years; 76.2% men). During the first OCM episode and during the index LOT, the I ± R cohort had significantly fewer monthly days with outpatient services compared to the CIT cohort (OCM, RR = 0.63 [P < 0.001]; index LOT, RR = 0.73 [P = 0.004]). Compared to the CIT cohort, the I ± R cohort incurred significantly higher monthly pharmacy costs (MMCDs: OCM, 9938 US dollars [USD] [P < 0.001]; index LOT, 8920 USD [P < 0.001]) that were fully offset by lower monthly medical costs (MMCDs: OCM, -19,373 USD [P < 0.001]; index LOT, -13,548 USD [P < 0.001]), resulting in monthly total health care cost savings (MMCDs, OCM, -9435 USD [P < 0.001]; index LOT , -4628 USD [P = 0.01]). IMPLICATIONS Over a median follow-up of 15.3 months, most patients with MCL were treated with CIT in the first line, and only one fourth had a 2L therapy. Patients with relapsed/refractory MCL treated with I ± R had significantly fewer days with outpatient services and lower monthly total health care costs versus those treated with CIT during the first OCM episode and the index LOT.

OBJECTIVE Chronic thromboembolic pulmonary hypertension (CTEPH) is a rare disease that often follows pulmonary embolism (PE). Screening for CTEPH is challenging, often delaying diagnosis and worsening prognosis. Predictive risk models for CTEPH could help identify at-risk patients, but existing models require multiple clinical inputs. We developed and validated a predictive risk model for CTEPH using health insurance claims that can be used by payers/quality-of-care organizations to screen patients post-PE. METHODS Adult patients newly diagnosed with acute PE (index date) were identified from the Optum De-identified Clinformatics Extended DataMart (January 2007-March 2018; development set) and IBM MarketScan (January 2008-June 2019; validation set) databases. Predictors were identified 12 months before or on the index PE. Risk of "likely CTEPH" was assessed post-PE based on CTEPH-related diagnoses and procedures since the CTEPH diagnosis code (ICD-10-CM: I27.24) was not available until 1 October 2017. Stepwise variable selection was used to build the model using the development set; model validation was subsequently conducted using the validation set. RESULTS The development set included 93,428 patients, of whom 11,878 (12.7%) developed likely CTEPH. Older age (odds ratios [OR] = 1.16-1.49), female (OR = 1.09), unprovoked PE (i.e. without thrombotic factors; OR = 1.14), hypertension (OR = 1.07), osteoarthritis (OR = 1.08), diabetes (OR = 1.07), chronic obstructive pulmonary disease (OR = 1.11), obesity (OR = 1.21) were associated with higher odds of likely CTEPH, and oral anticoagulants with lower odds (OR= 0.50, all p

Resting energy expenditure (REE; i.e., the calorie amount required for 24 h during a non-active period) is an important parameter in nutritional rehabilitation of patients with anorexia nervosa (AN). This study determined whether age, body mass index, AN duration/subtype/specific symptoms/clinical severity, cognitive function alterations, and psychiatric comorbidities influenced REE or the difference between the calculated and estimated REE. Patients with AN who were followed at a daycare treatment facility between May 2017 and January 2020 (n = 138) underwent a complete assessment that included the MINI, Eating Disorder Examination Questionnaire, d2 test of attention, body fat composition by bioelectrical impedance analysis (BIA) and REE measurement by indirect calorimetry (REEIC). AN subtype (N = 66 for restrictive subtype and N = 69 for non-restrictive subtype; p = 0.005), free-fat mass (3 years). Overall, REE was higher in patients with restrictive than non-restrictive AN. In the absence of BIA measures, REE-estimating equations should take into account AN duration.

Provide the first national description across the US of variations in healthcare measures in 2018 among Medicaid beneficiaries with schizophrenia.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.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.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.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 24–77% across states) and the proportion of patients adherent to antipsychotic treatment was low (range of 19–73%). Additionally, nearly half of all patients had an emergency room visit (range of 20–70%), and one-third had an inpatient admission (range of 19–82%). 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.

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

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

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.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.After matching, characteristics were well-balanced between PP1M (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.

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

To develop algorithms to identify metastatic castration-sensitive prostate cancer (mCSPC) patients and castration-resistant prostate cancer (mCRPC) patients, using health claims data and laboratory test results.A targeted literature review summarized mCSPC and mCRPC patient selection criteria previously used in real-world retrospective studies. Novel algorithms to identify mCSPC and mCRPC were developed based on diagnosis codes indicating hormone sensitivity/resistance, prostate-specific antigen (PSA) test results, and claims for castration and mCRPC-specific treatments. These algorithms were applied to claims data from Optum Clinformatics Extended DataMart (Date of Death) Databases (commercial insurance/Medicare Advantage [COM/MA]; 01 January 2014-31 July 2019) and Medicare Fee-for-Service (Medicare-FFS; 01 January 2014-31 December 2017).Previous real-world studies identified mCSPC primarily based on metastasis diagnosis codes, and mCRPC based on mCRPC-specific drugs. Using the current study's algorithms, 7034 COM/MA and 19,981 Medicare-FFS patients were identified as having mCSPC, and 2578 COM/MA and 11,554 Medicare-FFS as having mCRPC. Most mCSPC patients were identified based on evidence of being hormone/castration-naive. Patients were identified as having mCRPC most commonly based on rising PSA (COM/MA), or at the metastasis diagnosis date if it occurred after castration (Medicare-FFS). Among patients with mCSPC, 14-17% had evidence of progression to castration resistance during a median 1-year follow-up period, mostly based on use of mCRPC-specific drugs.Comprehensive algorithms based on claims and laboratory data were developed to identify and distinguish patients with mCSPC and mCRPC. This will facilitate appropriate identification of mCSPC and mCRPC patients based on health claims data and better understanding of patient unmet needs in real-world settings.

Peripheral artery disease (PAD), often treated with lower extremity revascularization, is associated with risk of major atherothrombotic vascular events (acute limb ischemia [ALI], major non-traumatic lower-limb amputation, myocardial infarction [MI], ischemic stroke, cardiovascular death). This study aims to assess healthcare resource utilization and costs of such events among patients with PAD after revascularization.Patients aged ≥50 years with PAD who were treated with lower-extremity revascularization were identified from Optum Clinformatics Data Mart claims database (01/2014-06/2019). The first lower extremity revascularization after PAD diagnosis was defined as the index date. Patients had ≥6 months of health plan enrollment before the index date. Patients were followed until the earliest of 1) end of enrollment or data; 2) diagnosis of atrial fibrillation or venous thromboembolism; or 3) oral anticoagulant use. All-cause healthcare resource use per-patient-year was compared before and after a major atherothrombotic vascular event post-revascularization among those with an event. Additionally, event-related healthcare costs per-patient-year were reported for each event type.Of the 38,439 PAD patients meeting the study criteria, 6,675 (17.4%) had a major atherothrombotic vascular event. On average, patients were observed for 7.3 months before an event and 6.2 months after an event. Patients with an event had significantly higher all-cause healthcare resource use versus similar metrics pre-event (e.g. inpatient visits among those with ALI: 3.5 ± 5.8 post-event vs. 2.0 ± 8.1 pre-event,Data do not contain clinical information. Additionally, results are limited to commercially insured and Medicare Advantage beneficiaries.Patients with PAD who experience major atherothrombotic vascular events post-revascularization have considerably higher healthcare resource use and costs compared with similar metrics pre-event. Therefore, reducing the rate of such events could reduce overall healthcare costs for this population.

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

Aims Patients with cancer are at high risk of venous thromboembolism (VTE), which entails a high economic burden. The risk of cancer-associated VTE can be assessed using the Khorana score (KS), a validated VTE risk prediction algorithm. This study compared healthcare costs associated with different KS in a population of patients newly diagnosed with cancer. Methods The Optum® Clinformatics® DataMart database (01/01/2012-09/30/2017) was used to select adult patients with ≥1 hospitalization or ≥2 outpatient claims with a cancer diagnosis (index date) initiated on systemic therapy or radiation therapy. Patients were classified in mutually exclusive cohorts based on KS (i.e., KS =0, 1, 2 or ≥3). The observation period spanned from index to the earliest among end of data availability, death, end of insurance coverage, or 12 months. Results In total 6,194 patients (KS =0: 2,488; KS =1: 2,125; KS =2: 1,074; KS ≥3: 507) were included. On average, patients were aged 68 years, 48-52% were female, and the Quan-Charlson comorbidity index ranged between 1.1 and 1.4. Over the observation period, all-cause total healthcare costs per patient per month (PPPM) were $8,826 (KS =0), $11,598 (KS =1), $14,028 (KS =2), and $16,211 (KS ≥3). Using the KS =0 cohort as reference, adjusted PPPM costs were $2,506, $4,775, and $6,452 higher in the KS =1, KS =2 cohort, and KS ≥3 cohorts, respectively. Hospitalization and outpatient costs were the main drivers of these differences. Similar results were found for VTE-related costs, which represented 4-11% of the total all-cause cost difference between KS cohorts. Limitations Residual confounders; results may not be generalized to patients with other insurance plans or those who received treatments other than systemic therapy or radiation therapy. Conclusions This real-world analysis found that cancer patients at higher risk of VTE (based on KS) incurred significantly greater all-cause and VTE-related healthcare costs compared with cancer patients at lower risk of VTE.

To evaluate hypomethylating agent (HMA) persistence in patients with myelodysplastic syndromes (MDS), and examine its association with healthcare resource utilization (HRU) and progression to acute myeloid leukemia (AML). A total of 2,400 adults diagnosed with MDS initiating HMAs were included from IBM MarketScan databases during 1/1/2011–3/31/2018. The index date was HMA initiation following MDS diagnosis. Patients were classified according to their persistence status by the end of a fixed ‘landmark period’ of 4 months post-index. Median persistence to HMAs was 5.6 months (95% CI: 5.2, 6.1); HMA non-persistence increased with time. Non-persistent patients had a significantly higher non-HMA-related HRU burden than persistent patients [adjusted incidence rate ratios, outpatient visits: 1.12 (95% CI: 1.10, 1.14); inpatient visits: 1.48 (95% CI: 1.30, 1.69); emergency department visits 1.30 (95% CI: 1.12, 1.50); all p-values < 0.001]. All-cause and HMA-related outpatient visits were lower among non-persistent patients, likely because of fewer HMA administration-related visits. The incidence rate of AML was numerically, although not significantly, higher in non-persistent patients, when starting follow-up at the end of the landmark period. When follow-up began at the index date, non-persistent patients had a significantly higher rate of AML [adjusted hazard ratio, 1.88 (95% CI: 1.53, 2.32); p-value < 0.001]. HMA non-persistence, which increased over time, was associated with significantly higher non-HMA-related HRU, and numerically higher AML progression in MDS patients initiating HMAs. Future studies should evaluate predictors of HMA non-persistence in this patient population.

To assess the total cost of testing associated with next-generation sequencing (NGS) versus polymerase chain reaction (PCR) testing strategies among patients with metastatic non-small cell lung cancer (mNSCLC) from a Medicare and US commercial payer’s perspective. A decision tree model considered testing for genomic alterations in EGFR, ALK, ROS1, BRAF, KRAS, MET, HER2, RET, NTRK1 among patients with newly diagnosed mNSCLC using (1) liquid or tissue biopsy NGS tests, (2) exclusionary mutation (KRAS) test followed by sequential PCR tests, (3) sequential PCR tests, or (4) hotspot panel PCR tests. The alteration test sequence followed clinical guideline recommendations. Inputs based on literature, expert opinion, or assumptions included prevalence of mNSCLC, proportion of patients using each testing strategy (50% NGS [90% tissue, 10% liquid], 10% exclusionary, 10% sequential, 30% hotspot), proportion testing positive for each genomic mutation, rebiopsy rates, and costs for testing and associated medical care. Time to appropriate targeted therapy initiation and total costs were calculated for NGS, each PCR testing strategy, and all PCR strategies combined. Among a hypothetical plan of 1,000,000 members (75% commercial, 25% Medicare), 1,119 patients were estimated to have mNSCLC and be eligible for testing. Estimated mean time to appropriate targeted therapy was 2 weeks for NGS and 6 weeks for PCR (sequential: 9 weeks, exclusionary: 8 weeks, hotspot: 3 weeks). Mean per patient costs were $4,932 for NGS and $6,605 for PCR (exclusionary: $5,563, sequential: $6,263, hotspot: $7,066). Per patient costs were higher from a commercial perspective (NGS: $6,225; PCR: $8,430) relative to Medicare (NGS: $2,099; PCR: $2,646); nevertheless, NGS was the least costly testing strategy across plan types. NGS was associated with the fastest time to appropriate targeted therapy initiation and lowest total cost of testing compared to PCR testing strategies for newly diagnosed patients with mNSCLC.

Background The Khorana score (KS) clinical algorithm is used to predict VTE risk in cancer patients. The study objective was to evaluate VTE and survival rates among patients newly diagnosed with cancer and stratified by KS in a real‐world population. Methods Data from the Optum® Clinformatics® DataMart database between 01/01/2012–09/30/2017 was used to identify adults with ≥ 1 hospitalization or ≥ 2 outpatient claims with a cancer diagnosis (index date). Only patients who were initiated on chemotherapy or radiation therapy were included. Patients were classified based on KS (KS = 0, 1, 2 or ≥ 3). Time‐to‐first VTE and survival were evaluated from the index date to the earliest among end of data availability or insurance coverage, death, or 12 months post‐index using Kaplan‐Meier (KM) analyses. Results A total of 2,488 (KS = 0); 2,125 (KS = 1), 1,074 (KS = 2), and 507 (KS ≥ 3) cancer patients were included. The 12‐month KM rates of VTE were 3.1%, 5.4%, 7.9%, and 14.9% (associated median time to VTE of 2.7, 3.0, 1.4, and 1.7 months) among KS = 0, 1, 2, and ≥ 3 cohorts, respectively. Corresponding adjusted hazard ratios (95% CIs) relative to the KS = 0 cohort were 1.72 (1.25‐2.38), 2.46 (1.73‐3.50), and 4.99 (3.40‐7.31) for the KS = 1, 2, and ≥ 3 cohorts, respectively (all P, This cohort study evaluated the risk of VTE and survival rates among patients newly diagnosed with cancer and stratified by Khorana score (KS) in a real‐world population. The present findings indicate that the rates of VTE significantly increased with KS, confirming its predictive ability. Moreover, VTE was associated with lower survival rates within each KS cohort.

To quantify the long-term direct and indirect costs among patients with Crohn's disease (CD) and specific subgroups of these patients in the United States from the private payer's perspective.This retrospective study used the OptumHealth Care Solutions, Inc database (01 January 1999-31 March 2017) to match (1:5) adult patients with ≥2 claims for CD to patients without inflammatory bowel disease (IBD). Patterns observed during follow-up (i.e. biologics, opioids, or steroids; CD-related surgery; moderate-to-severe disease; and comorbidities) were used to identify CD subgroups. Comparisons of healthcare resource utilization, work loss days, and direct and indirect work loss-related costs were made between matched cohorts. Descriptive analyses of costs were conducted within each CD subgroup.There were 6,715 and 33,575 patients in the CD and non-IBD cohorts, respectively. The direct burden was significantly higher in the CD cohort compared to the non-IBD cohort, with 0.34 inpatient admissions per patient per year (PPPY) versus 0.12 (217% increase;Severity of CD was determined based on claims-based algorithms due to the lack of access to medical files. Absenteeism was imputed based on claims data, and presenteeism was not assessed.The direct healthcare and indirect work loss-related costs of patients with CD was significantly higher compared to patients without IBD over an average follow-up of 5 years.

Objective: Growing evidence suggests that the use of integrase strand transfer inhibitors (INSTIs) is associated with greater weight gain than other antiretroviral therapies; as a result, United States (US)-based treatment guidelines were updated to reflect this and raise clinicians’ awareness. This real-world study describes demographics and compares weight/body mass index (BMI) change between insured US patients with human immunodeficiency virus (HIV-1) initiating a protease inhibitor (PI) or INSTI. Methods: A retrospective longitudinal study was conducted using Decision Resources Group’s Real World Data Repository (7/17/2017-6/1/2019). Adult patients with HIV-1 who initiated a new PI or INSTI on or after 7/17/2018 (index date) and had ≥12 months of continuous pre-index clinical activity were included. Baseline characteristics were balanced using inverse probability of treatment weighting. The proportion of patients with ≥5% weight/BMI increases and mean weight/BMI change from pre- to post-index were evaluated. Outcomes were compared using odds ratios (ORs) and mean differences (MDs). Results: 20,367 patients (9,993 PI and 10,374 INSTI) were included. Baseline characteristics were well-balanced (mean age =50 years; ∼30% females in both cohorts). Pre- and post-index weight and BMI measurements were available in 429 and 430 PI patients, and 397 and 383 INSTI patients, respectively. Mean time between index and last post-index measurements was ∼7 months. Patients using PI-based regimens were 39% and 49% less likely to experience ≥5% weight and BMI increase than those using INSTI-based regimens, respectively (OR [≥5% weight gain] = 0.61; p = 0.014; OR [≥5% BMI gain] = 0.51; p 2; p Conclusions: Relative to patients initiating a new INSTI, patients initiating a new PI were less likely to experience ≥5% weight/BMI gain post-index. Additionally, mean weight/BMI gain was lower in the PI than in the INSTI cohort.

Objective: To assess the real-world use of home health services (HHS) among patients with major depressive disorder (MDD) with and without treatment-resistant depression (TRD).Methods: Adults (18–6...

Recent evidence has demonstrated that, over 12 months, pharmacy costs associated with switching nonadherent recently relapsed patients from oral atypical antipsychotics (OAAs) to once-monthly paliperidone palmitate (PP1M) were offset by reduced relapse rates and schizophrenia-related health care costs. In addition, earlier use of PP1M may generate greater cost savings.To project the long-term economic impact when a proportion of nonadherent patients with a recent relapse switch from OAAs to PP1M.A 36-month decision-tree model with twelve 3-month cycles was developed from a Medicaid payer's perspective. The target population was nonadherent, recently relapsed OAA patients. At equal adherence, probability of relapse was equal between PP1M and OAAs, and OAA patients were nonadherent until treatment switch. Event rates (adherence, relapse, and switch) and cost inputs (pharmacy and relapse) were based on the literature, and rates remained constant. Outcomes included number of relapses, pharmacy costs, and relapse costs (2017 U.S. dollars) at years 1, 2, and 3. One-way sensitivity (OSA) and probabilistic sensitivity analyses (PSA) evaluated the effect of varying model inputs on health plan and per-patient level costs.Based on a hypothetical health plan of 1 million members, 3,037 OAA patients were recently relapsed and nonadherent. Compared with continuing OAAs, switching 5% of patients (n = 152) to PP1M resulted in net cost savings of $674,975, $723,298, and $562,310 at the plan level; $4,445, $4,764, and $3,703 per patient switched per year; and $0.0562, $0.0603, and $0.0469 per member per month in years 1, 2, and 3, respectively, resulting in total plan-level savings of$1.9 million over 3 years. A total of 221 relapses were avoided (year 1: 92; year 2: 72; and year 3: 57). In years 1, 2, and 3, respectively, total annual plan-level schizophrenia-related costs were $114.1 million, $107.2 million, and $105.8 million when all patients switched to PP1M before any subsequent relapse (n = 3,037); $123.4 million, $109.6 million, and $106.7 million when patients switched to PP1M after a first subsequent relapse (n = 2,631); and $127.6 million, $121.6 million, and $117.0 million when all patients remained on OAAs. The cost per patient switched to PP1M was lower when all patients received PP1M before a subsequent relapse versus after their first subsequent relapse at all years (year 1: $37,559 vs. $45,089; year 2: $35,288 vs. $36,321; and year 3: $34,826 vs. $35,155). OSA demonstrated consistent net cost savings per patient switched, ranging from $640 to $10,484 (year 1); $1,774 to $9,245 (year 2); and $1,354 to $7,026 (year 3). PSA demonstrated 96.3%, 99.7%, and 99.7% of iterations were cost saving in years 1, 2 and 3, respectively.Pharmacy costs associated with switching nonadherent OAA patients with a recent relapse to PP1M were offset by reduced relapse rates and health care costs at years 1, 2, and 3, with earlier use of PP1M resulting in increased cost savings at all years.This research was funded by Janssen Scientific Affairs. Pilon, Morrison, Lefebvre, and Shak are employees of Analysis Group, a consulting company that received research grants from Janssen Scientific Affairs to conduct this study. El Khoury and Kim are employees of Janssen Scientific Affairs. At the time this study was conducted, Llaneza was an employee of HireGenics, which provided services to Janssen Scientific Affairs for the study. Part of the material in this manuscript was presented at the Academy of Managed Care Pharmacy 2019 Annual Meeting; March 25-29, 2019; San Diego, CA.

Objective: Patients with cancer are at high risk for developing primary but also recurrent venous thromboembolism (VTE). This study examined healthcare utilization (HRU) and costs related to VTE re...

Daratumumab was approved for multiple myeloma (MM) in 2015. While its safety and efficacy are well documented, there is limited real-world information on its use and outcomes in patients of different races.We conducted a retrospective chart review of adult patients with MM initiating daratumumab in any line of therapy (LOT) between November 2015 and May 2020. De-identified data were retrieved from 2 US clinical sites; patient characteristics, treatment patterns, and response rate were described for black and white patients, stratified by LOT. Overall response rate (ORR), progression-free survival (PFS), and time to next LOT (TTNT) were compared between black and white patients initiating daratumumab in second line (2L) or later, adjusting for age and number of prior lines.Two hundred and fifty-two patient charts (89 black, 163 white) were extracted. Black patients were younger at diagnosis (61.7 vs. 67.0 years) and had a similar proportion of females (black: 44.9%, white: 46.6%). Black patients had longer time between MM diagnosis and daratumumab initiation (43.2 vs. 34.1 months) and received more prior LOTs (median 3.0 vs. 2.0). ORR for black and white patients initiating daratumumab in 1L was 100.0%, with very good partial response or better in 75.0% and 66.7%, respectively. Similar trends were observed in 2L and 3L+. There were no significant differences in ORR, PFS, or TTNT between groups.Daratumumab had similar clinical outcomes (ORR, PFS, and TTNT) in black and white patients. Black patients initiated daratumumab later in their treatment, suggesting potential discrepancies in access to new MM treatments.

This study aimed to characterize patients with treatment-resistant depression (TRD) initiating esketamine or conventional therapies.Adults with major depressive disorder (MDD) were selected from the IBM MarketScan Databases. A claims-based algorithm identified patients with evidence of TRD, defined as initiation of a new antidepressant therapy after 2 different antidepressant trials of adequate dose and duration during the most recent major depressive episode. Patients receiving treatment on/after March 5, 2019 (esketamine approval date for TRD), were classified to the esketamine cohort if they newly initiated esketamine (index date) or to the TRD conventional therapies cohorts if they newly initiated electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS), or pharmacologic therapies (index date was the therapy initiation date, prioritizing ECT, then TMS, then pharmacologic antidepressant therapies). Patient characteristics in the 6 months before therapy initiation were described.The esketamine cohort included 246 patients (mean age, 46.5 years; 63.0% female), and the TRD conventional therapies cohorts included 104,164 patients (mean age, 46.9 years; 74.8% female; 0.4% initiated ECT, 1.2% initiated TMS). During the 6 months preindex, in the esketamine and TRD conventional therapies cohorts, 77.6% and 41.4% received psychotherapy and 82.9% and 34.2% had a psychiatrist visit, respectively. Most patients had outpatient care for MDD in the esketamine (91.9%) and TRD conventional therapies (63.6%) cohorts; 57.3% and 21.0% received care at specialized mental health care settings. MDD was classified as "severe" among 81.3% and 35.1% of patients in the esketamine and TRD conventional therapies cohorts . Preindex mental health-related (MHR) inpatient admissions and emergency department visits were identified in 12.2% and 16.3% of the esketamine cohort and in 8.2% and 10.3% of the TRD conventional therapies cohort. Before therapy initiation, 34.6% and 17.6% of the esketamine and TRD conventional therapies cohorts received ≥3 unique antidepressants. Suicidal ideation or behavior was observed in 8.5% and 3.6% of the esketamine and TRD conventional therapies cohorts pretherapy initiation. Mean monthly all-cause health care costs in the esketamine cohort were $2532 (58.2% MHR); in the TRD conventional therapies cohorts, costs were $1873 (32.4% MHR).Among patients with TRD, those initiating esketamine relative to conventional therapies displayed higher MDD severity, used more MHR inpatient/emergency department services and antidepressant treatments, and incurred higher health care costs 6 months pretherapy initiation. These findings suggest potential benefits of identifying and treating patients with TRD earlier with more effective treatments and should inform payers in consideration of esketamine coverage.

The COVID-19 pandemic has claimed the lives of more than 800,000 people in the United States (US) and has been estimated to carry a societal cost of $16 trillion over the next decade. The availability of COVID-19 vaccines has had a profound effect on the trajectory of the pandemic, with wide-ranging benefits. We aimed to estimate the total societal economic value generated in the US from COVID-19 vaccines. We developed a population-based economic model informed by existing data and literature to estimate the total societal value generated from COVID-19 vaccines by avoiding COVID-19 infections as well as resuming social and economic activity more quickly. To do this, we separately estimated the value generated from life years saved, healthcare costs avoided, quality of life gained, and US gross domestic product (GDP) gained under a range of plausible assumptions. Findings from our base case analysis suggest that from their launch in December 2020, COVID-19 vaccines were projected to generate $5.0 trillion in societal economic value for the US from avoided COVID-19 infections and resuming unrestricted social and economic activity more quickly. Our scenario analyses suggest that the value could range between $1.8 and $9.9 trillion. Our model indicates that the most substantial sources of value are derived from reduction in prevalence of depression ($1.9 trillion), gains to US GDP ($1.4 trillion), and lives saved from fewer COVID-19 infections ($1.0 trillion). Constructed as a projection from December 2020, our model does not account for the Delta or future variants, nor does it account for improvements in COVID-19 treatment. The magnitude of economic benefit from vaccination highlights the need for coordinated policy decisions to support continued widespread vaccine uptake in the US.

Evaluate systemic therapy utilization patterns and outcomes by line of therapy among patients with advanced/recurrent endometrial cancer (EC) treated in the United States. This retrospective observational study used the Optum Clinformatics Extended Data Mart Date of Death database (1 January 2004–31 December 2019) and included de-identified data from adult patients with advanced/recurrent EC who were treated with first-line (1L) platinum-based chemotherapy and initiated second-line (2L) anti-neoplastic therapy. The index date was the date of 1L therapy initiation. The number and sequence of treatments received and the proportion of patients who received each type of treatment for each line of therapy were evaluated. To account for new drug approvals, patients first treated in 2018 or 2019 were also assessed separately. Among the 1317 patients who met all eligibility criteria, 520 (39.5%) and 235 (17.8%) patients received 3 or 4+ lines of treatment, respectively, during a median total follow-up time of 25.2 months (range, 2.5–173.3 months) following the index date. Chemotherapy, including platinum- and non-platinum-based regimens, was the most common treatment across all lines of therapy: 2L, 80.0%; 3L, 66.2%; 4L+, 80.4%. Overall, 2.5%, 2.3%, and 8.9% of 2L, 3L, and 4L + patients, respectively, received anti-program death 1 (anti-PD-1) immunotherapies. In patients first treated in 2018 and 2019 (n = 163), 9.8% of patients received anti-PD-1 immunotherapy in the 2L. In the overall population, median time to next treatment (TTNT) was 19.3, 10.5, and 8.1 months for patients undergoing 2L, 3L, and 4L treatment, respectively. Among patients with advanced/recurrent EC treated with 1L platinum-based therapy in clinical practice, chemotherapy was the most common treatment choice across all lines of therapy. Immunotherapy use was low overall but increased in patients who started treatment in 2018 or 2019. Overall, median TTNT decreased as lines of therapy increased.

Background Historical vaccination coverage in economically disadvantaged, ethnic minority, non-affluent white and agricultural populations in the US has lagged coverage in more affluent urban and suburban white populations due to a variety of social and economic factors. In the current COVID-19 pandemic, sociocultural and economic challenges continue to present significant obstacles to achieving equitable uptake of COVID-19 vaccines. The goal of this study was to qualitatively assess perceptions of key US healthcare stakeholders of the most significant barriers to COVID-19 vaccine access and equity to better characterize their expected impact on US communities. Methods After conducting a targeted literature review (TLR), we hypothesized 20 high-impact barriers which included structural and logistical barriers, capturing systemic challenges to vaccine accessibility, and attitudinal and informational barriers, affecting patient willingness to pursue vaccination. We developed a qualitative discussion guide, which included both open-ended and closed-ended questions, and interview stimulus material to conduct one-on-one in-depth interviews to assess the expected prevalence, severity, and persistence of these 20 high-impact barriers, which were hypothesized based on TLR. As a part of this qualitative study, we conducted one-on-one in-depth interviews with a diverse set of 15 US healthcare stakeholders who were involved in the COVID-19 vaccine rollout in states with relatively disparate vaccination rates by ethnicity. These stakeholders were selected to reflect an array of roles in the COVID-19 vaccine rollout, including infectious disease specialists, pharmacists, community advocacy representatives, and partners of local governments involved in the COVID-19 vaccine rollout and community education. Results Respondents identified limited vaccination sites in rural settings and technology-related barriers as the most prevalent and severe structural and logistical barriers in US communities. Respondents assessed COVID-19 vaccine safety concerns and politically motivated skepticism to be the most prevalent and severe attitudinal and informational barriers. Respondents cited proliferation of mobile vaccination clinics and local community messaging to endorse vaccines as the most effective solutions to these top structural and attitudinal barriers. Respondents expected politically motivated skepticism to be the most significant and persistent barrier to broader vaccine uptake in the US. Conclusions Our study suggests that attitudinal barriers, particularly politically motivated skepticism, are likely to remain the most persistent challenges to widespread vaccination against COVID-19 in the US.

Patients with Anorexia Nervosa (AN) present many nutritional deficiencies (macro- and often also micro-nutrients), possibly explained by their inadequate food intake. Previous studies reported that selenium (Se) deficiency is common in the general population. As Se can be easily added as a supplement, the goal of this study was to evaluate the clinical impact of Se deficiency in patients with AN.This cross-sectional study concerned 153 patients with AN (92.9% women) followed at the Eating Disorder Unit of Lapeyronie Academic Hospital, Montpellier, France. Patients underwent an extensive neuropsychological assessment, and completed validated questionnaires. Blood samples were collected for Se quantification. Results were compared with the t-test, Mann-Whitney U, and Chi square tests, and univariate linear and multivariate logistic regression models.Se plasma levels were below the cut-off of 80 µg/L in 53.6% (N = 82) of patients. AN onset was earlier in patients with Se deficiency, (p = .005), whereas disease duration was comparable between groups (p = .77). General eating disorder symptomatology in the past 28 days (Eating Disorder Examination Questionnaire) was more severe in patients with Se deficiency (p = .010). The suicide risk (MINI International Neuropsychiatric Evaluation) tended to be higher (p = .037), and suicide attempt history was more frequent (28.39% vs 9.85%, p = .004) in patients with low Se levels. Se plasma concentration was negatively correlated with the performance in the temporal delayed discounting task (p = .006).Our findings suggest that in patients with AN, Se plasma concentration might be implicated in disease severity and suicide risk. The finding that Se deficiency in patients with AN was associated only with reward-related processes, but not with other psychological functions suggests the selective involvement of dopamine-related pathways. Our results suggest that it might be useful to monitor the plasma micronutrient profile in patients with AN. Future studies should determine whether Se supplementation in AN might improve clinical outcomes.

Background Daratumumab, a CD38 monoclonal antibody, has demonstrated efficacy as monotherapy and combination therapy across several indications, both among newly-diagnosed and refractory patients with multiple myeloma (MM). However, there is limited evidence on treatment patterns and effectiveness of daratumumab in the real-world setting, particularly in first line (1 L). This study aimed to describe real-world treatment patterns and clinical outcomes among patients initiating daratumumab across different lines of therapy. Methods A retrospective chart review of adult patients with MM initiating daratumumab between November 2015 and March 2021 was conducted at two clinical sites in the United States. De-identified patient-level data were abstracted in an electronic case report form. Patient characteristics and treatment patterns were described. Clinical outcomes including overall response rate (ORR), progression-free survival, and time to next line of therapy were reported using descriptive statistics and stratified by line of therapy (1 L, second line [2 L] or third line or later [3 L+]). A sub-group analysis evaluated treatment patterns and ORR among patients re-treated with daratumumab. Results A total of 299 patients were included in the study (mean age: 68 years; 55% male). Among them, 26 were 1 L patients, 66 were 2 L patients, and 207 were 3 L+ patients; 110 patients (36.8%) received a stem cell transplant prior to daratumumab initiation. The mean duration of follow-up was 10 months among 1 L patients and 19 months among 2 L and 3 L+ patients. Patients who initiated daratumumab in 1 L had a 100% ORR, while those initiating in 2 L and 3 L+ had an ORR of 78.8 and 65.2%, respectively. Among re-treated patients, ORR was 66.7% during the first treatment segment, and 52.9% during the second treatment segment. Kaplan-Meier rates of progression-free survival at 12 months were 89.9, 75.2, and 53.1% among patients who initiated daratumumab in 1 L, 2 L, and 3 L+, respectively. Kaplan-Meier rates of time to next line of therapy at 12 months were 94.1, 73.4, and 50.0% among patients who initiated daratumumab in 1 L, 2 L, and 3 L+, respectively. Conclusions These findings suggest that daratumumab-based regimens are an effective treatment option across all lines of therapy, with highest response rate in 1 L.

Diagnosis of nonalcoholic steatohepatitis (NASH) relies on liver biopsy. Noninvasive tools would be useful to target patients to refer for a biopsy. We aimed to determine the diagnostic value of the triglycerides and glucose (TyG) index, an insulin-resistance indicator, to predict NASH.Our study included grade II-III obese patients aged 18-65 years undergoing bariatric surgery and included in the COMET (COllection of MEtabolic Tissues) biobank (NCT02861781). Liver biopsies performed during bariatric surgery were collected from the biobank along with blood derivatives. Biopsies were analysed according to the steatosis, activity and fibrosis (SAF) scoring system to diagnose NASH, nonalcoholic fatty liver disease (NAFLD), and fibrosis. Logistic regression models were performed to identify factors predicting NASH, NAFLD, and fibrosis.Of 238 analysed subjects (mean age 43±12 years, 33.6% men), 29% had type 2 diabetes. Steatosis was present in 67.2%, while NASH and advanced fibrosis (stage F3) were diagnosed in 18.1% and 2.9% respectively. TyG index was independently associated with NASH (odds ratio (OR): 4.7 [95% confidence interval: 2.3;9.5] P0.0001), NAFLD (OR: 2.0 [1.1;3.7] P = 0.03) and stages 2-3 fibrosis (OR: 4.0 [1.5;10.8] P = 0.007). NASH was also predicted by gamma-glutamyl transferase (GGT) with an area under the ROC curve: 0.79 [0.71;0.87 P = 0.04] for GGT and TyG index combined.In our cohort of severely obese patients, TyG index, when associated with GGT level, exhibited high diagnostic performance to predict NASH. Although validation in larger populations is needed, this result may be of considerable clinical value to predict need for liver biopsy.

This study synthesized evidence regarding the prevalence of post-traumatic stress disorder (PTSD) in the United States (US).A systematic literature review (SLR) identified recently published (2015-2019) observational studies of PTSD prevalence in the USData from 38 identified articles were categorized by population, diagnostic criteria, and lookback period. Among civilians, point prevalence ranged from 8.0% to 56.7%, 1-year prevalence from 2.3% to 9.1%, and lifetime prevalence from 3.4% to 26.9%. In military populations, point prevalence ranged from 1.2% to 87.5%, 1-year prevalence from 6.7% to 50.2%, and lifetime prevalence from 7.7% to 17.0%. Within these ranges, several estimates were derived from relatively high quality data; these articles are highlighted in the review. Prevalence was elevated in subpopulations including emergency responders, refugees, American Indian/Alaska Natives, individuals with heavy substance use, individuals with a past suicide attempt, trans-masculine individuals, and women with prior military sexual trauma. Female sex, lower income, younger age, and behavioral health conditions were identified as risk factors for PTSD.PTSD prevalence estimates varied widely, partly due to different study designs, populations, and methodologies, and recent nationally representative estimates were lacking. Efforts to increase PTSD screening and improve disease awareness may allow for a better detection and management of PTSD.

Aim: Evaluate healthcare resource utilization (HRU) and costs associated with rivaroxaban and warfarin among nonvalvular atrial fibrillation (NVAF) patients with obesity and polypharmacy. Materials & methods: IQVIA PharMetrics ® Plus (January 2010–September 2019) data were used to identify NVAF patients with obesity (BMI ≥30 kg/m 2 ) and polypharmacy (≥5 medications) initiated on rivaroxaban or warfarin. Weighted rate ratios and cost differences were evaluated post-treatment initiation. Results: Rivaroxaban was associated with significantly lower rates of HRU, including hospitalization (rate ratio [95% CI]: 0.83 [0.77, 0.92]). Medical costs were reduced in rivaroxaban users (difference [95% CI]: -US$6868 [-US$10,628, -US$2954]), resulting in significantly lower total healthcare costs compared with warfarin users (difference [95% CI]: -US$4433 [-US$8136, -US$582]). Conclusion: Rivaroxaban was associated with lower HRU and costs compared with warfarin among NVAF patients with obesity and polypharmacy in commercially insured US patients.