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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 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.

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.

Background: Recent evidence suggests that integrase strand transfer inhibitors are associated with greater weight gain than protease inhibitors in patients with human immunodeficiency virus (HIV-1). Objectives: To describe demographic and clinical characteristics of insured patients with HIV-1 in the United States initiating darunavir/​cobicistat/​emtricitabine/​tenofovir alafenamide (DRV/c/FTC/TAF) or bictegravir/FTC/TAF (BIC/FTC/TAF), assess the differences in weight and body mass index (BMI) change between cohorts up to one year after treatment initiation, and identify the predictors of weight gain associated with each treatment. Methods: The Symphony Health, IDV® database (July 17, 2017 – September 30, 2019) was used to identify treatment naïve or virologically suppressed stable switchers who initiated DRV/c/FTC/TAF or BIC/FTC/TAF (index date) on or after July 17, 2018, were ≥18 years of age on the index date, and had ≥12 months of continuous clinical activity pre-index (baseline period). To account for differences in baseline characteristics, inverse-probability of treatment weighting (IPTW) was used. Mean weight and BMI change from pre- to post-index measurements were compared between weighted cohorts at 3, 6, 9, and 12 months post-index using mean differences. Predictors of weight or BMI gain ≥5% were evaluated at last measurement, for each treatment cohort separately. Results: After IPTW, 452 and 497 patients were included in the DRV/c/FTC/TAF and BIC/FTC/TAF cohorts, respectively. Baseline characteristics were generally well-balanced (mean age=~50 years, female: ~30%), except for the type of antiretroviral therapy from which patients switched. Patients initiated on BIC/FTC/TAF experienced greater weight and BMI increases between the pre-index period and each measurement of the post-index period than patients initiated on DRV/c/FTC/TAF, although results were only statistically significant at 9 months post-index (weight: mean difference=2.50 kg, P=0.005; BMI: mean difference=0.66 kg/m2, P=0.027). A common predictor of weight or BMI gain ≥5% among patients in both cohorts was female gender (DRV/c/FTC/TAF: odds ratio [OR]=5.92, P=0.014; BIC/FTC/TAF: OR=2.00, P Conclusion: Patients in the BIC/FTC/TAF cohort experienced greater weight and BMI increases than patients in the DRV/c/FTC/TAF cohort, with differences reaching statistical significance at 9 months post-index. Weight gain is an important factor to consider when selecting antiretroviral regimens, since it is associated with long-term health consequences. Future studies with larger sample size and longer follow-up time are warranted.

Background Long-acting injectable (LAI) antipsychotics, compared with oral antipsychotics (OA), have been found to significantly improve patient outcomes, including reduced hospitalizations and emergency room (ER) admissions and increased medication adherence among adult patients with schizophrenia. In turn, the clinical benefits achieved may translate into lower economic burden. Real-world evidence of the comparative effectiveness of LAI is needed to understand the potential benefits of LAI outside of the context of clinical trials. This study aimed to provide a comprehensive synthesis of recent published real-world studies comparing healthcare utilization, costs, and adherence between patients with schizophrenia treated with LAI versus OA in the United States. Methods In this systematic literature review, MEDLINE® was searched for peer-reviewed, real-world studies (i.e., retrospective or pragmatic designs) published in English between January 1, 2010 and February 10, 2020. Comparative studies reporting hospitalizations, ER admissions, healthcare costs, or medication adherence (measured by proportion of days covered [PDC]) in adults with schizophrenia treated with LAI versus OA (or pre- vs post-LAI initiation) in the United States were retained. Random effects meta-analyses were conducted among eligible studies to evaluate the association of LAI versus OA use on hospitalizations, ER admissions, healthcare costs, and treatment adherence. A sensitivity analysis among the subset of studies that compared OA with paliperidone palmitate once monthly (PP1M), specifically, was conducted. Results A total of 1083 articles were identified by the electronic literature search, and two publications were manually added subsequently. Among the 57 publications meeting the inclusion criteria, 25 provided sufficient information for inclusion in the meta-analyses. Compared with patients treated with OA, patients initiated on LAI had lower odds of hospitalization (odds ratio [OR] 0.62, 95% confidence interval [CI] 0.54–0.71, n = 7), fewer hospitalizations (incidence rate ratio [IRR] [95% CI] 0.75 [0.65–0.88], n = 9), and fewer ER admissions (IRR [95% CI] 0.86 [0.77–0.97], n = 6). The initiation of LAI was associated with higher per-patient-per-year (PPPY) pharmacy costs (mean difference [MD] [95% CI] $5603 [3799–7407], n = 6), which was offset by lower PPPY medical costs (MD [95% CI] − $5404 [− 7745 to − 3064], n = 6), resulting in no significant net difference in PPPY total all-cause healthcare costs between patients treated with LAI and those treated with OA (MD [95% CI] $327 [− 1565 to 2219], n = 7). Patients initiated on LAI also had higher odds of being adherent to their medication (PDC ≥ 80%; OR [95% CI] 1.89 [1.52–2.35], n = 9). A sensitivity analysis on a subset of publications evaluating PP1M found results similar to those of the main analysis conducted at the LAI class level. Conclusions Based on multiple studies with varying sub-types of patient populations with schizophrenia in the United States published in the last decade, this meta-analysis demonstrated that LAI antipsychotics were associated with improved medication adherence and significant clinical benefit such as reduced hospitalizations and ER admissions compared with OA. The lower medical costs offset the higher pharmacy costs, resulting in a non-significant difference in total healthcare costs. Taken together, these findings provide strong evidence on the clinical and economic benefits of LAI compared with OA for the treatment of schizophrenia in the real world. Supplementary Information The online version contains supplementary material available at 10.1007/s40263-021-00815-y.

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.

Background Some institutions have implemented a daratumumab intravenous rapid-infusion protocol in which patients with multiple myeloma (MM) receive their third and subsequent infusions within ~ 90 min instead of ≥ 3 h. Objective This study sought to understand the utilization, effectiveness, and infusion reactions (IRs) observed in patients with MM who received daratumumab rapid infusions. Methods Electronic medical records from Florida Cancer Specialists & Research Institute were used. Adult patients with MM who received one or more rapid daratumumab infusion (full dose in ≤ 110 min) at their third or later infusion of the first daratumumab-containing regimen (index date: 16 November 2015 to 15 March 2019) were included. IRs included events that (1) occurred ≤ 24 h post-daratumumab infusion or (2) were stated as an IR in the patient charts. Non-IR adverse events (AEs) were events attributed to daratumumab in patient charts that did not meet the IR definition. Results In total, 147 patients received one or more rapid infusion in their first daratumumab-containing regimen. Median time from initial MM diagnosis to index date was 2.5 years. Non-IR AEs occurred in 10.2% of patients during treatment, and 36.7% experienced one or more IR after receiving a daratumumab infusion. No IRs occurred after a rapid infusion. The overall response rate was 91.1% (after rapid infusions only: 71.3%). Conclusions This study provides real-world evidence on the practice patterns of daratumumab rapid infusions in a large community-based oncology clinic system. These results suggest that treatment regimens including daratumumab rapid infusions at the third infusion or later were well-tolerated, and their effectiveness was comparable to that observed in clinical trials. Supplementary Information The online version contains supplementary material available at 10.1007/s40801-020-00226-3.

Timothy Fitzgerald,1 Richard Melsheimer,2 Marie-Hélène Lafeuille,3 Patrick Lefebvre,3 Laura Morrison,3 Kimberly Woodruff,1 Iris Lin,1 Bruno Emond3 1Real World Value & Evidence, Janssen Scientific Affairs, LLC, Titusville, New Jersey, USA; 2Medical Affairs, Janssen Biologics BV, Leiden, the Netherlands; 3Analysis Group, Inc., Montréal, Québec, CanadaCorrespondence: Bruno EmondAnalysis Group, Inc., 1190 Avenue des Canadiens-de-Montreal, Tour Deloitte, Suite 1500, Montréal, QC H3B 0G7, CanadaTel +1 514-394-4455Fax +1 514-394-4461Email Bruno.Emond@analysisgroup.comObjective: To compare switching and discontinuation patterns of patients stable on originator infliximab (IFX) who switched to an IFX biosimilar (switchers) or remained on originator IFX (continuers) in the United States.Methods: Symphony Health Solutions’ Patient Transactional Datasets (10/2012– 03/2019) were used to identify adults with ≥ 2 claims for either rheumatoid arthritis (RA), psoriatic arthritis, plaque psoriasis, ankylosing spondylitis, or inflammatory bowel disease (IBD); and ≥ 1 claim for originator or biosimilar IFX. The index date was the first IFX biosimilar claim for switchers or a random originator IFX claim for continuers. All patients were required to have ≥ 5 originator IFX claims during the 12 months pre-index (prevalent population). The subset of patients with ≥ 12 months of observation prior to the first originator IFX claim was also analyzed (incident population). Switchers were matched 1:3 to continuers. Discontinuation was defined as having ≥ 120 days between 2 consecutive index treatment claims.Results: Prevalent switchers (N=1109) were 3.57-times more likely than continuers (N=3327) to switch to another originator biologic (hazard ratio [HR]=3.57, p< 0.001). Of 249 prevalent switchers who switched to another originator biologic, 200 (80.3%) switched back to originator IFX. Incident switchers (N=571) were 2.55-times more likely than continuers (N=1713) to switch to another originator biologic (HR=2.55, p< 0.001). Of 118 incident switchers who switched to another originator biologic, 90 (76.3%) switched back to originator IFX. Prevalent switchers were 1.25-times more likely than continuers to discontinue index therapy (HR=1.25, p< 0.001). Similar results were observed in RA (prevalent population; switching: HR=3.49, p< 0.001; discontinuation: HR=1.23, p=0.009) and IBD (prevalent population; switching: HR=3.82, p< 0.001; discontinuation: HR=1.29, p=0.003) subgroups.Conclusion: Patients switching from originator to biosimilar IFX were more likely to switch to another originator biologic (notably back to originator IFX) and discontinue index treatment than those remaining on originator IFX; however, reasons for switching are unknown.Keywords: biosimilars, chronic inflammatory disease, treatment discontinuation, infliximab, treatment switching

Wing Chow,1 Prina Donga,1 Aurélie Côté-Sergent,2 Carmine Rossi,2 Patrick Lefebvre,2 Marie-Hélène Lafeuille,2 Hélène Hardy,2 Bruno Emond3 1Real World Value & Evidence, Janssen Scientific Affairs, LLC, Titusville, NJ, USA; 2Analysis Group, Inc., Montréal, QC, Canada; 3Early Compound Development, Janssen Research & Development, LLC, Titusville, NJ, USACorrespondence: Bruno Emond Tel +1 514-394-4455Email Bruno.Emond@analysisgroup.comPurpose: Darunavir, cobicistat, emtricitabine, and tenofovir alafenamide can be used as a single-tablet regimen (STR, DRV/c/FTC/TAF) or multiple-tablet regimen (MTR, DRV/c+FTC/TAF) to treat patients with human immunodeficiency virus (HIV). This study described treatment patterns and predictors of adherence among patients with HIV initiated on DRV/c/FTC/TAF or DRV/c+FTC/TAF.Patients and Methods: A retrospective longitudinal study was conducted using linked claims and electronic medical records from Decision Resources Group’s Real World Data Repository (7/17/2017– 6/1/2019). Treatment-naïve and treatment-experienced virologically suppressed adults with HIV-1 prescribed DRV/c/FTC/TAF or DRV/c+FTC/TAF (index date) were included. Six-month persistence (no treatment gaps > 60 and > 90 days) and adherence (proportion of days covered [PDC]) to the index regimen were evaluated among patients with ≥ 6 months of observation post-index. Predictors of low adherence (PDC< 80%) were evaluated using a logistic regression model.Results: Among 2633 eligible patients (49.5 years old, 29% female, 37% African American/Black), 12% were treatment-naïve pre-index and 88% switched from a previous antiretroviral therapy; 84% initiated DRV/c/FTC/TAF and 16% initiated DRV/c+FTC/TAF. Among 822 DRV/c/FTC/TAF patients with ≥ 6 months of observation post-index, 80% and 86% had no > 60- and > 90-day gaps in DRV/c/FTC/TAF coverage, respectively, while among 204 DRV/c+FTC/TAF patients with ≥ 6 months of observation post-index, 69% and 75% had no > 60- and > 90-day gaps in DRV/c+FTC/TAF coverage, respectively. Mean (median) PDC for the index regimen was 81% (93%) for patients treated with DRV/c/FTC/TAF and 73% (83%) for patients treated with DRV/c+FTC/TAF. Predictors of low adherence included younger age (odds ratio [OR]=2.36, p=0.017), higher Quan-Charlson comorbidity index (OR=1.32, p=0.012), use of MTR regimen at index (OR=1.69, p=0.022), and prior low adherence (OR=2.56, p< 0.001).Conclusion: Among patients initiating a DRV/c-based regimen, those initiating STR had higher 6-month adherence/persistence than those initiating MTR, highlighting the potential benefits of the STR formulation, particularly among younger patients with multiple comorbidities and prior low adherence.Keywords: HIV, protease inhibitors, treatment adherence and compliance, patient compliance, administrative claims, healthcare, electronic health records

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.

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.

Aims The aims of this study were to assess glycemic control, weight loss, and durability of glycemic control in patients initiated on canagliflozin (CANA) versus sitagliptin (SITA). Methods Adults with type II diabetes mellitus initiated on CANA or SITA (index date) were identified from IQVIA™ Real-World Data Electronic Medical Records – US database (03/29/2012–04/30/2016). Inverse probability of treatment weighting accounted for baseline differences between cohorts. Outcomes were compared using weighted Cox regression and Kaplan-Meier curves and included time to reaching HbA1c thresholds ( Results Weighted cohorts were well balanced (NCANA = 14,542; NSITA = 15,151). CANA patients were 12–15% more likely to reach the HbA1c thresholds, 47% more likely to lose ≥5% of body weight, 31% less likely to have a new AHA prescription, 10–15% less likely to fail to maintain HbA1c, and 13–26% less likely to fail to maintain HbA1c or have a new AHA, versus SITA patients. Conclusions CANA patients were more likely to reach HbA1c and weight loss thresholds and maintain HbA1c below threshold versus SITA patients, while being less likely to have a prescription for a new AHA, suggesting more durable glycemic control with CANA.

To model direct medical costs associated with reductions in cardiovascular disease (CVD) events in T2DM patients reported in the CANVAS and EMPA-REG trials, which assessed the cardiovascular safety of canagliflozin and empagliflozin, respectively.Costs were modeled from a US managed care organization (MCO) perspective for the CVD outcomes included in both trials: three-point major adverse cardiovascular event (MACE) and its components (cardiovascular-related death, nonfatal myocardial infarction, nonfatal stroke), as well as heart failure requiring hospitalization. The rate of CVD events averted (difference between study drug and placebo) was projected to the portion of an MCO T2DM population matching the respective trial's inclusion criteria. A targeted literature search for paid amounts directly associated with each CVD event provided the unit costs, which were applied to the projected number of events averted, to calculate costs avoided per member per year (PMPY). One-way sensitivity analyses were performed on events averted, unit costs, and percentages of trial-applicable patients.Based on three-point MACE events averted, costs avoided PMPY of $6.17 (range: $1.27-$10.94) for CANVAS and $2.75 ($0.19-$4.83) for EMPA-REG were estimated. Costs avoided for individual components of MACE ranged from $0.77 to $3.84 PMPY for CANVAS and from -$0.97 (additional costs) to $1.54 for EMPA-REG. PMPY costs avoided for heart failure were $2.72 for CANVAS and $1.32 for EMPA-REG.Models assumed independent, non-recurrent outcomes and were restricted to medical costs directly associated with the trial-reported events. The reductions in CVD events in T2DM patients reported for both CANVAS and EMPA-REG project to a positive cost avoidance for these events in an MCO population. The analysis did not include an assessment of the impact on total cost, as the costs associated with adverse events, drug utilization or other clinical outcomes were not examined.

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

This study aimed to describe treatment sequencing and healthcare costs among chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) patients treated with venetoclax in a US managed care population. CLL/SLL patients initiating venetoclax between 04/11/2016 and 06/30/2019 were selected from Optum’s de-identified Clinformatics Data Mart Database. Costs per-patient-per-month were described during the first 60 days of venetoclax-based treatment (initiation phase) and subsequent post-initiation phase. Based on venetoclax prescribing information, clinical event-related costs were identified through claims for tumor lysis syndrome (TLS) diagnosis, monitoring, prophylaxis, immunoglobulin treatment, neutropenia, thrombocytopenia, infection, renal impairment, hypertension, or cardiac arrhythmia. Statistical testing was not conducted due to small sample size. Twenty-five, 30, and 66 patients initiated venetoclax as their first observed regimen (1L), second observed regimen (2L), and third or later observed regimen (3L+), respectively. Most 2L (56.7%) and 3L+ (74.2%) venetoclax recipients previously received ibrutinib. Mean monthly all-cause costs during the initiation phase were $26,429 (1L cohort), $19,580 (2L cohort), and $23,918 (3L + cohort). Among the 2L cohort, mean monthly all-cause [clinical event-related] (including TLS) costs during initiation and post-initiation phases of venetoclax treatment were $15,506 [$6368] (initiation phase) and $14,318 [$5273] (post-initiation phase; median duration: 3.7 months) for patients receiving 1L ibrutinib, and $24,908 [$12,198] (initiation phase) and $16,905 [$7066] (post-initiation phase; median duration: 3.0 months) for patients not receiving 1L ibrutinib. In this descriptive study, highest mean costs were observed during venetoclax initiation phase. Venetoclax patients previously receiving ibrutinib had lower mean total all-cause and clinical event-related (including TLS) costs during their venetoclax line of therapy than those previously receiving non-ibrutinib therapy.

This retrospective observational study aimed to compare healthcare resource utilization and costs of Medicare beneficiaries with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) who received ibrutinib versus chemoimmunotherapy (CIT) in first line (1 L).Fee-for-service (FFS) and Medicare Advantage (MA) claims data were used to identify adults with a CLL/SLL diagnosis initiating 1 L ibrutinib single agent or CIT between 4 March 2016 and 30 September 2017 (index date). HRU and costs (Medicare spending) were evaluated during 1 L Oncology Care Model (1 L OCM) episodes (the first six months post-index) and over the observed 1 L duration. Patients' baseline characteristics were balanced using inverse probability of treatment weighting. Mean monthly cost differences (MMCDs) obtained from ordinary least square regressions were used to compare costs between ibrutinib and CIT cohorts.In the Medicare FFS dataset (ibrutinib:In Medicare patients with CLL/SLL, 1 L ibrutinib single agent was associated with total monthly cost savings relative to 1 L CIT, driven by lower monthly medical costs that fully offset higher monthly pharmacy costs.

Objective: Prior evaluations of ulcerative colitis (UC)-related costs are dated or encompassed limited follow-up. This study assessed the incremental direct and indirect work loss-related costs of ...

IntroductionFor many, atopic dermatitis (AD) is not adequately controlled with topical regimens. This analysis examined treatment using advanced therapies and associated costs.MethodsThe IQVIA Health Plan Claims data set was analyzed. Patients aged ≥ 12years with AD who newly initiated advanced therapy after the availability of dupilumab (March 28, 2017) and had ≥ 6months continuous enrollment before and after their first advanced therapy claim (index date) were included. Advanced therapies included dupilumab, systemic corticosteroids (SCSs), systemic immunosuppressants (SISs), and phototherapy. A multivariate regression model was used to predict annualized follow-up healthcare costs.ResultsIn total, 1980 patients were included (61.1% female; mean age, 41.2years [SD, 17.4]; 11.3%

Hector Ortega,1 Jean-Pierre Llanos,2 Marie-Hélène Lafeuille,3 Guillaume Germain,3 Mei Sheng Duh,4 Christopher F Bell,2 Susan R Sama,5 Beth Hahn2 1Respiratory, US Medical Affairs, GSK, La Jolla, CA, USA; 2Respiratory, US Medical Affairs, GSK Research Triangle Park, NC, USA; 3Groupe d’analyse, Ltée, Montréal, QC, Canada; 4Analysis Group, Inc., Boston,MA, USA; 5Research Department, Reliant Medical Group, Worcester,MA, USA Purpose: Based on blood and sputum samples, up to 40% of patients with COPD have eosinophilic inflammation; however, there is little epidemiology data characterizing the health care burden within this sub-population. Given that COPD-attributable medical costs in the USA are predicted to approach $50 billion by 2020, we analyzed the effect of blood eosinophil counts and exacerbations on health care resource utilization and costs. Patients and methods: This cross-sectional study used electronic medical records and insurance claims data from the Reliant Medical Group (January 2011–December 2015). Eligible patients were ≥40 years of age, continuously enrolled during the year of interest (2012, 2013, 2014, or 2015), had ≥1 COPD-related code in the preceding year, and documented maintenance therapy use. Patients with ≥1 blood eosinophil count recorded were stratified into 2 cohorts

Objective: To compare achievement of quality goals (HbA1c, weight loss/body mass index [BMI], systolic blood pressure [SBP]), including maintaining HbA1c, between patients with type 2 diabetes mellitus (T2DM) treated with canagliflozin 300 mg (CANA) or a GLP-1 in an actual practice setting. Methods: Adults with T2DM newly initiated on CANA or a GLP-1 were identified from the IQVIATM Real-World Data Electronic Medical Records–US database (2012Q2–2016Q1). To account for differences in baseline characteristics, inverse probability of treatment weighting was used. Outcomes were compared using Cox models (hazard ratios [HRs] and 95% confidence intervals [CIs]) and Kaplan-Meier analyses. Results: CANA (n = 11,435) and GLP-1 (n = 11,582) cohorts had similar attainment of HbA1c 2 (HR [CI] = 1.11 [0.98–1.27]), and achieving SBP Conclusions: This retrospective study in an actual practice setting showed that CANA patients were generally as likely as GLP-1 patients to achieve HbA1c, weight, and blood pressure thresholds, and to maintain glycemic control while being less likely to discontinue treatment and/or have a new anti-hyperglycemic prescribed.

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

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

Background and Objective: Daratumumab, a CD38 monoclonal antibody, was approved for the treatment of multiple myeloma (MM) among previously treated patients in 2015, and among newly diagnosed patients in 2018. While the safety and efficacy of daratumumab has been well documented in clinical trials, there is limited real world information on the use and outcomes of daratumumab in patients of different races. This is of particular relevance for potential health care disparities, as evidence suggests that African American patients with MM receive new therapies later in their disease and may experience different outcomes than White patients (Blood Adv. 2019;3:2986-94, Cancer Med. 2017;6: 2876-85). Therefore, we sought to describe patient characteristics, treatment patterns and outcomes of patients with MM who received daratumumab. Results were stratified by race (i.e., Black vs. White). Methods: We conducted a retrospective chart review of patients with MM initiating daratumumab between 1/2018 and 5/2020. De-identified data were retrieved from two U.S. clinical sites, Levine Cancer Institute (Atrium Health) and Weill Cornell Medicine. Patients were included if they had a confirmed diagnosis of MM and were at least 18 years old at the time of daratumumab initiation (index date). Patients who accessed daratumumab through interventional clinical trials were excluded. Patients were followed from the index date until death, loss to follow-up, or date of chart abstraction, whichever occurred first. Patient characteristics included age, sex, body mass index, MM stage at diagnosis, cytogenetic profile as of the index date, and number of prior regimens. Treatment patterns included type and duration of daratumumab-based regimen. Treatment outcomes included treatment response (as per physician notes and guided by the International Myeloma Working Group consensus criteria) and time to next line of therapy (TTNT; the time between the index date and the initiation of the following line of therapy, censoring at the end of follow-up). All analyses were descriptive and stratified by race. Results: A total of 252 patient charts were extracted: 89 Black (35.3%) and 163 White (64.7%). Black patients were, on average, younger at diagnosis (61.7 years old vs. 67.0) and at the index date (Table 1). The proportion of females was similar across both races (Black: 44.9%, White: 46.6%), and mean body mass index was slightly higher in Black patients (28.7 vs. 26.8). Black patients had longer time between initial MM diagnosis and initiation of daratumumab (43.2 vs. 34.1 months). MM stage at diagnosis, cytogenetic profile at index, and prior regimens were similar between White and Black patients (Table 1). While unknown cytogenetics were most common for both White (45.4%) and Black (59.6%) patients, White patients (20.2%) were twice as likely as Blacks (9.0%) to have high-risk cytogenetics. Black patients received more lines of treatment prior to the initiation of daratumumab (mean 2.9 vs. 2.3), with 55.1% of Black patients receiving 3 or more prior lines. The most common regimen was daratumumab with pomalidomide and dexamethasone (DPd) for both races (Table 1), with use of DPd being particularly common (51.7%) in Black patients. Duration of treatment with daratumumab was similar across races (Table 1). Treatment response was similar across races: among patients initiating daratumumab in first, second and third line or after, respectively, overall response rate was 100.0%, 90.9% and 67.6% for Black patients and 100.0%, 82.9% and 65.4% for White patients. Among patients initiating daratumumab in third line or after, median TTNT was 12.3 months among Black patients and 10.4 months among White patients. Conclusions: Black and White patients had similar overall response rate and comparable TTNT. However, Black patients initiated daratumumab later in their treatment, with more than half of Black patients initiating daratumumab in fourth or later line of therapy, and a lower percentage of Black patients had high-risk cytogenetics, suggesting a potential discrepancy in access to new therapies for MM. These findings were observed in a relatively modest sample size, and therefore interpretation warrants caution. Future studies should investigate whether such a discrepancy in treatment access exists, potential reasons for this discrepancy, and strategies to mitigate the effect of race on access to new therapies in MM. Figure 1 Figure 1. Disclosures Atrash: GSK: Research Funding; AMGEN: Research Funding; Jansen: Research Funding, Speakers Bureau. Thompson-Leduc: Biogen: Consultancy; Novartis: Consultancy; Shire/Takeda: Consultancy; Regeneron: Consultancy; Janssen Scientific Affairs, LLC: Consultancy; BioMerieux: Consultancy; Merck: Consultancy; GlaxoSmithKline: Consultancy; BioFire Diagnostics: Consultancy. Tai: Janssen Scientific Affairs, LLC: Current Employment. Kaila: Janssen Scientific Affairs, LLC: Current Employment. Gray: Janssen Scientific Affairs, LLC: Current Employment, Current holder of individual stocks in a privately-held company. Ghelerter: Janssen Scientific Affairs, LLC: Consultancy; GlaxoSmithKline: Consultancy; Regeneron: Consultancy; Novartis: Consultancy. Lafeuille: Pharmacyclics: Consultancy; Pfizer: Consultancy; Janssen Scientific Affairs, LLC: Consultancy; GlaxoSmithKline: Consultancy. Lefebvre: Regeneron: Consultancy; Novartis: Consultancy; Otsuka: Consultancy; Pfizer: Consultancy; Pharmacyclics: Consultancy; Janssen Scientific Affairs, LLC: Consultancy; GlaxoSmithKline: Consultancy. Rossi: Janssen Scientific Affairs, LLC: Consultancy, Membership on an entity's Board of Directors or advisory committees; Amgen: Consultancy, Membership on an entity's Board of Directors or advisory committees; Sanofi: Consultancy, Membership on an entity's Board of Directors or advisory committees; Bristol-Myers Squibb: Consultancy, Membership on an entity's Board of Directors or advisory committees.

Introduction: Tumor lysis syndrome (TLS) can be a life-threatening complication in patients with hematologic malignancies. In chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), treatment guidelines identify a high risk of TLS for regimens containing anti-CD20-based chemoimmunotherapy (CIT), lenalidomide, obinutuzumab, or venetoclax. Patients who develop TLS require intensive care, adding to the overall clinical and economic burden of CLL/SLL. This study aimed to evaluate the clinical and economic burden of treatment-emergent TLS among patients with CLL/SLL treated with regimens with high risk of TLS. Methods: The IBM MarketScan Research Databases (01/01/2006-04/30/2020) were used to identify adults with CLL/SLL who initiated a CIT-, lenalidomide-, obinutuzumab-, or venetoclax-based regimen on or after 01/01/2007 or upon treatment approval date if post-2007 (index date) and had ≥12 months and ≥30 days of continuous eligibility pre- and post-index date, respectively. Treatment-emergent TLS was defined as developing TLS in the first 90 days of active treatment (based on claims with a TLS diagnosis or laboratory test results). The post-index period was divided into 30-day intervals until the end of the index regimen (earliest of start of next regimen or end of eligibility). Intervals pre-TLS were non-TLS intervals and all intervals starting from the TLS diagnosis were TLS intervals. If TLS occurred after the first 90 days of active treatment (non-treatment-emergent TLS), all intervals were non-TLS intervals and the post-index period was censored at TLS diagnosis. Per-patient-per-month (PPPM) healthcare resource utilization (HRU) and payer paid costs during TLS and non-TLS intervals were compared using rate ratios (RRs) and mean monthly cost differences (MMCDs), respectively, obtained from generalized linear models adjusted for baseline and time-varying confounders. The proportion of patients switching to a next therapy in the first 90 days post-index was compared between patients developing versus not developing TLS using Kaplan-Meier rates with log-rank P-value. Results: Among 6,343 patients with CLL/SLL, 71 (1.1%, mean age: 66.4 years, 26.8% females; 22 treated with venetoclax; mean [median] duration of the entire index regimen: 16.0 [10.0] months) developed TLS during the first 90 days of active treatment and 6,272 (98.9%, mean age: 65.9 years, 34.1% female; 170 treated with venetoclax; mean [median] duration of the entire index regimen: 22.0 [14.5] months) did not. Among all 6,343 patients, there were 1,129 TLS intervals and 138,429 non-TLS intervals observed post-index. All patients incurred considerable cumulative costs over the entire index regimen duration (TLS cohort: $201,200; non-TLS cohort: $158,590). Developing TLS was associated with 1.7 times more inpatient (IP) admissions (P Conclusions: In this study of CLL/SLL patients treated with CIT-, lenalidomide-, obinutuzumab-, or venetoclax-based regimens, TLS led to a significant HRU and cost burden (mostly driven by IP admissions) and a higher rate of treatment switching. Consideration of available treatment options based on patient goals and treatment expectations is warranted before selecting a treatment with a high risk of developing TLS. Figure 1 Figure 1. Disclosures Rogers: AstraZeneca: Consultancy; Genentech: Consultancy, Research Funding; Innate Pharma: Consultancy; Pharmacyclics LLC: Consultancy; Janssen Pharmaceuticals, Inc: Research Funding; Acerta Pharma: Consultancy; AbbVie Inc.: Consultancy, Research Funding; ovartis Pharmaceuticals Corporation: Research Funding. Emond: GlaxoSmithKline: Consultancy; Janssen: Consultancy; Novartis: Consultancy; Pfizer: Consultancy; Pharmacyclics LLC, an AbbVie Company: Consultancy. Côté-Sergent: GlaxoSmithKline: Consultancy; Janssen: Consultancy. Kinkead: Janssen: Consultancy; Otsuka: Consultancy. Lafeuille: Pharmacyclics: Consultancy; Janssen Scientific Affairs, LLC: Consultancy; Pfizer: Consultancy; GlaxoSmithKline: Consultancy. Lefebvre: Pfizer: Consultancy; Pharmacyclics: Consultancy; Otsuka: Consultancy; Janssen Scientific Affairs, LLC: Consultancy; GlaxoSmithKline: Consultancy; Novartis: Consultancy; Regeneron: Consultancy. Huang: Johnson & Johnson: Current equity holder in publicly-traded company; Janssen Scientific Affairs, LLC: Current Employment.

Introduction Patients with high-risk NDMM who are ineligible for autologous stem cell transplant (ASCT) have limited first-line treatment options, and new regimens to improve their outcomes are needed. Daratumumab (Dara) is approved in combination with lenalidomide and dexamethasone (D-Rd) and in combination with bortezomib, melphalan, and prednisone (D-VMP) in ASCT-ineligible NDMM patients, based on the randomized clinical trials (RCTs), MAIA and ALCYONE, respectively. A recent meta-analysis of data from these two RCTs along with ASCT-eligible patients from the CASSIOPEIA RCT demonstrated that incorporation of Dara was associated with improved progression free survival (PFS) in high-risk NDMM patients. The current study builds upon these findings by focusing on the more homogenous population of ASCT-ineligible high-risk patients from MAIA and ALCYONE RCTs, using longer follow-up data, adjusting for patient-level imbalances in baseline characteristics, and evaluating additional efficacy endpoints. Methods A stratified pooled analysis of patient-level data for ASCT-ineligible NDMM patients with high cytogenetic risk [i.e., del(17p), t(4;14), or t(14;16)] from MAIA and ALCYONE RCTs was conducted, adjusting for cytogenetic abnormality subtype, baseline performance status, International Staging System stage, type of multiple myeloma, and renal impairment. The impact of Dara 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), compared to control treatment, was assessed using the study identifier as the stratification factor. Results There were 101 patients in Dara and 89 patients in the control cohort. Median follow-up was 43.7 months. In the adjusted analysis, the risk of progression or death was reduced by 41% in the Dara cohort vs control (hazard ratio [95% confidence interval (CI)] = 0.59 [0.41-0.85]). At 36 months, the proportion of patients who did not progress and were still alive was 41.3% in the Dara and 19.9% in the control cohort. Deeper response was observed in the Dara cohort with higher rates, and adjusted odd ratios (95% CI) for ≥CR (41.6% vs. 22.5%; 2.63 [1.34-5.16]), MRD-negative CR (24.8% vs. 5.6%; 5.50 [1.97-15.34]), ≥VGPR (75.3% vs. 46.1%; 4.03 [2.09-7.78]), and ORR (92.1% vs. 74.2%; 4.88 [1.94-12.27]) compared to control. Conclusion Addition of Dara to backbone regimens resulted in 41% reduction in risk of progression or death among ASCT-ineligible high-risk NDMM patients. Additionally, patients in the Dara cohort had a two-fold higher likelihood of achieving ≥CR and a five-fold higher likelihood of achieving MRD-negative CR relative to control. This study provides additional evidence that the use of Dara based first-line treatment benefits high-risk NDMM patients.

This study compared healthcare resource utilization (HRU), healthcare costs, adherence, and persistence among adult patients with schizophrenia using once-monthly (OM) vs twice-monthly (TM) atypical long-acting injectable (LAI) antipsychotic (AP) therapy.A longitudinal retrospective cohort study was conducted using Medicaid claims data from six states. Patients initiated on aripiprazole or paliperidone palmitate were assigned to the OM cohort; risperidone-treated patients were assigned to the TM cohort. HRU and healthcare costs were assessed during the first 12 months following stabilization on the medication. Adherence was measured using the proportion of days covered (PDC) during the first year of follow-up. Persistence to the index medication was measured during the first 2 years following the index date. Comparison between the cohorts was achieved using multivariable generalized linear models, adjusting for demographic and clinical characteristics.Patients in the OM LAI cohort had lower inpatient HRU and medical costs when compared with patients in the TM cohort. Higher medical costs in the TM LAI cohort offset the higher pharmacy costs in the OM LAI cohort. Mean PDC during the first 12 months of follow-up was higher in the OM cohort than in the TM cohort (0.56 vs 0.50, p .01). Median persistence was longer in the OM cohort than in the TM cohort (7.5 months vs 5.5 months), as was the hazard of discontinuing the index medication (hazard ratio = 0.83, p = .01). Kaplan-Meier rates of persistence at 1 year were higher for OM patients than for TM patients (37.6% vs 29.6%, p .01).This was a Medicaid sample with few aripiprazole LAI patients (5.4% of OM cohort). Medication use was inferred from pharmacy claims.Among Medicaid patients in these six states, OM AP treatment was associated with lower HRU, better adherence and persistence, and similar total costs compared to patients on TM treatment.

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

The effective treatment of schizophrenia requires continuous antipsychotic maintenance therapy. However, poor persistence with treatment is common among patients with schizophrenia. The objective of this study was to compare persistence and hospitalization rates among patients with schizophrenia treated with long-acting injectable (LAI) antipsychotics (i.e. paliperidone palmitate and risperidone) and enrolled in a patient information program (program cohort) with patients treated with oral antipsychotics (OAs) who were not enrolled in a patient information program (nonprogram cohort).Using a quasi-experimental design, data from chart reviews (for program patients) and Medicaid claims (for nonprogram patients) was analyzed. Patients were eligible if they had ≥12 months of pre-index data, ≥6 months of post-index data, and no hospitalization at index.Persistence and hospitalization rates were assessed at 6 months post-index. Propensity score matching was used to control for observed differences in demographics and baseline clinical characteristics. Odds ratios (ORs) were calculated using generalized estimating equation models and adjusted for matched pairs and propensity score.A total of 102 program patients were matched to 408 nonprogram patients with similar baseline characteristics. Adjusted ORs indicated that the persistence rate at 6 months was significantly higher for the program cohort (88.2%) versus the nonprogram cohort (43.9%; OR: 9.70; P .0001). The 6 month post-index hospitalization rate for the program cohort (14.7%) was significantly lower versus the nonprogram cohort after adjustments (22.5%; OR: 0.55; P = 0.0321).The data for the program and nonprogram patients were from two different and independent data sources (healthcare claims and chart reviews, respectively). Results were based on a relatively small number of program LAI patients.Program patients treated with LAI antipsychotics had higher persistence rates and significantly lower adjusted hospitalization rates compared with nonprogram patients treated with OAs.

Mantle cell lymphoma (MCL) is a rare subtype of non-Hodgkin lymphoma (NHL) that accounts for ∼6% of NHL cases in the USA [1]. Median overall survival (OS), now ∼4–5 years, has improved substantiall...

New guidelines for the treatment of human immunodeficiency virus (HIV) advocate for rapid initiation of antiretroviral therapy (ART) ≤ 7 days after HIV diagnosis with agents that have a high genetic barrier to resistance, good tolerability, and convenient dosing.To describe characteristics, time to ART initiation, and health care costs in commercially insured patients living with HIV in the United States who are treated ≤ 60 days after HIV diagnosis.IBM MarketScan Research Databases (January 1, 2012-December 31, 2017) were used to identify ART-naive adults with HIV-1, ≥ 6 months of continuous eligibility before first HIV diagnosis, and ART initiation ≤ 60 days of first diagnosis. ART regimen had to include a protease inhibitor (PI), an integrase strand transfer inhibitor (INSTI), or a non-nucleoside reverse transcriptase inhibitor (NNRTI) with ≥ 2 nucleoside reverse transcriptase inhibitors. Cohorts were formed based on time to ART initiation after diagnosis: ≤ 7 days or 8-60 days. Health care costs were evaluated at 6, 12, 24, and 36 months after diagnosis among patients with ≥ 36 months of continuous eligibility.Among 9,351 patients, median time to treatment was 31.0 days. Patients initiating ART60 days after HIV diagnosis were excluded (N = 2,608 [27.9%]), while 6,743 (72.1%) initiated ART ≤ 60 days after diagnosis and were analyzed; 18.3% and 81.7% were classified in the ≤ 7 days and 8-60 days cohorts, respectively. For all analyzed patients, mean age was 38.0 (SD = 12.0) years and 13.2% were female; 12.7%, 56.2%, and 31.1% initiated a PI, INSTI, or NNRTI-based regimen, respectively. Elvitegravir (32.9%), efavirenz (20.9%), dolutegravir (18.5%), and darunavir (8.5%) were the most commonly used antiretrovirals; most patients (74.3%) were initiated on single-tablet regimens. PI-based regimens were more common in the ≤ 7 days cohort (PI = 18.1%; darunavir = 11.4%) than in the 8-60 days cohort (PI = 11.5%; darunavir = 7.8%). INSTI-based regimens were more common in the 8-60 days cohort (INSTI = 57.7%; elvitegravir = 33.8%) than in the ≤ 7 days cohort (INSTI = 49.2%; elvitegravir = 29.1%). NNRTI-based regimens were as common in the ≤ 7 days (32.7%) and 8-60 days (30.7%) cohorts. Mean total accumulated costs were lower among patients in the ≤ 7 days cohort than in the 8-60 days cohort at all time points analyzed after diagnosis (e.g., 36 months: ≤ 7 days = $109,456; 8-60 days = $116,870). Total per-patient per-month costs decreased over time in the ≤ 7 days (i.e., 6 months = $4,359; 36 months = $3,040) and 8-60 days cohort (6 months = $4,727; 36 months = $3,246).Although 72.1% of patients initiated ART ≤ 60 days after HIV diagnosis, only 18.3% initiated ART ≤ 7 days. Many patients initiating ART ≤ 7 days used suboptimal agents with low rather than high genetic barriers to resistance (i.e., efavirenz and elvitegravir) or agents (dolutegravir) coformulated with other antiretrovirals that require testing to prevent hypersensitivity reactions. Patients in the ≤ 7 days cohort showed lower total health care costs relative to those in the 8-60 days cohort, highlighting the potential long-term benefits of rapid ART initiation.This study was supported by Janssen Scientific Affairs, which was involved in the study design, interpretation of results, manuscript preparation, and publication decisions. Emond, Lefebvre, Lafeuille, and Côté-Sergent are employees of Analysis Group, a consulting company that was contracted by Janssen Scientific Affairs to conduct this study and develop the manuscript. Benson, Tandon, Chow, and Dunn are employees of Janssen Scientific Affairs and stockholders of JohnsonJohnson. Part of the material in this study has been presented at the AMCP 2019 Annual Meeting; March 25-28, 2019; San Diego, CA.

Objective: To evaluate the impact of a 0.2% reduction in glycated hemoglobin (HbA1c) on treatment intensification, poor HbA1c control and HbA1c goal attainment in patients with type 2 diabe...

e18737 Background: Daratumumab (DARA), a CD38 monoclonal antibody, has been approved for the treatment of multiple myeloma (MM) among previously-treated patients since 2015, and among newly-diagnosed patients since 2018. This study aimed to describe real-world treatment response among patients initiating DARA across different lines of therapy since 2018. Methods: A retrospective chart review of adult patients with MM initiating DARA (monotherapy or as part of a combination regimen) between 1/2018 and 5/2020 was conducted at two clinical sites in the US (Levine Cancer Institute & Weill Cornell Medical College). De-identified patient-level data were abstracted in an electronic case report form. Treatment patterns, overall response rate (ORR) and proportion of patients with very good partial response (VGPR) or better were reported using descriptive statistics and stratified by line of therapy (first line [1L], second line [2L] or third line or later [3L+]). Results: A total of 202 patient charts were extracted. Patients were, on average, 65.3 years old at MM diagnosis and 68.1 years old at DARA initiation; 109 (54.0%) were male; 104 (51.5%) were White and 65 (32.2%) were Black or African American; 64 (31.7%) received a stem cell transplant (SCT) prior to the line of DARA initiation. Twenty-one (10.4%), 53 (26.2%) and 128 (63.4%) patients initiated DARA in 1L, 2L and 3L+, respectively. Median follow-up time was 6.2 months for 1L patients and 13.8 months for 2L+ patients. The most common 1L regimen was DARA with bortezomib, lenalidomide ± dexamethasone (DVRd; n=10, 47.6%) followed by DARA with lenalidomide ± dexamethasone (DRd; n=8, 38.1%). The most common 2L regimen was DRd (n=15, 28.3%) followed by DARA with pomalidomide ± dexamethasone (DPd, n=13, 24.5%) and DARA with bortezomib ± dexamethasone (DVd, n=13, 24.5%). The most common regimen in 3L+ was DPd (n=62, 48.4%). Among patients initiating DARA in 1L, 2L or 3L+ the ORR was 100.0%, 81.6% and 76.0%, and the proportion of patients achieving VGPR or better was 73.3%, 65.8% and 51.0%, respectively (Table 1). Median time to treatment response ranged between 2.6 and 2.8 months post-initiation. Conclusions: In this study, patients initiated on DARA had high ORR and rates of VGPR or better, including an ORR of 100% among 1L DARA users. These findings suggest that DARA-based regimens are an effective treatment option across all lines of therapy, with highest response rate in 1L. [Table: see text]

44 Background: Prostate cancer (PC) is associated with a high clinical and economic burden. Advanced oral (AO) therapies have become the standard of care for patients with advanced PC, but real-world data on treatment patterns and their impact on healthcare resource utilization (HRU) are lacking. This study aims to describe treatment adherence, factors associated with adherence, and its impact on HRU in patients with PC initiated on AOs. Methods: Adults with a PC diagnosis initiated on apalutamide, enzalutamide, or abiraterone acetate were identified using Symphony Health Solutions Patient Transactional Databases (10/01/2014-09/30/2019). Patients were included if they had ≥6 months of continuous clinical activity before and after AO initiation (index date) and no other cancer diagnoses. Adherence was defined using the proportion of days covered (PDC) by AOs during the 6-month period following the index date. Patients with a PDC≥80% were considered adherent. Multivariable logistic regression was used to evaluate baseline characteristics associated with AO adherence. All-cause and PC-related HRU was assessed from 6 to 18 months post-index and compared between adherent and non-adherent patients using multivariable Poisson regression. Results: A total of 27,322 patients initiated on an AO were identified. Most patients were aged ≥65 years (81%), were white (60%), had Medicare coverage (48%), and had metastatic PC (56%). At 6 months, 57% of patients were adherent to AOs. Patients aged 55-64 and 65-74 years had greater odds of being adherent versus those aged ≥75 years (24% and 22%, respectively), while Black patients had 17% lower odds of being adherent relative to white patients (all p

BACKGROUND: Compared to oral atypical antipsychotics (OAAs), long-acting injectable antipsychotics require less frequent administration, and thus may improve adherence and reduce risk of relapse in schizoaffective disorder (SAD) patients.OBJECTIVE: To evaluate the impact of once-monthly paliperidone palmitate (PP) versus OAAs on healthcare resource utilization, Medicaid spending, and hospital readmission among SAD patients.METHODS: Using FL, IA, KS, MS, MO, and NJ Medicaid data (01/2009-12/2013), adults with ≥2 SAD diagnoses initiated on PP or OAA (index date) were identified. Baseline characteristics and outcomes were assessed during the 12-month pre- and post-index periods, respectively. Propensity score matching (PSM) and inverse probability of treatment weighting (IPTW) were used to reduce confounding and compare the estimated treatment effect for PP versus OAA.RESULTS: A total of 10,778 OAA-treated patients and 876 PP-treated patients were selected. Compared to OAAs, PP was associated with significantly lower medical costs (PSM: mean monthly cost difference [MMCD]=-$383, pp=0.016), which offset the higher pharmacy costs associated with PP (PSM: MMCD=$270, ppp=0.414; IPTW: MMCD=-$53, p=0.697) for PP versus OAA. Reduced risk of hospitalization (PSM: incidence rate ratio (IRR)=0.85, p=0.128; IPTW: IRR=0.96, p=0.004) and fewer hospitalization days (PSM: IRR=0.74, p=0.008; IPTW: IRR=0.85, pp=0.041).LIMITATIONS: The Medicaid data may not be representative of the nation, or other states and includes pre-rebate pharmacy costs (potentially over-estimated). Also changes in treatment over time were possible.CONCLUSIONS: Total healthcare costs associated with the use of once-monthly PP versus OAAs appeared comparable; higher pharmacy costs for PP users were offset by lower medical costs related to fewer and shorter inpatients visits.

e19138 Background: mCSPC is clinically complex. Although consensus on treatments are evolving, ADT remains the backbone of therapy. This study assessed the proportion of mCSPC patients treated with ADT only or remaining untreated and their HRU during the mCSPC period in the US. Methods: The Optum Clinformatics Extended DataMart was used to identify men with ≥2 claims for prostate cancer (PC), ≥1 claim for metastasis, ≥1 castration sensitivity (CS) indicator (CS diagnosis code [dx]; castration and no prostate-specific antigen [PSA] rise; or hormone/castration naive for ≥18 months [mo] before index [date of 1st metastasis dx on or after 1st PC dx and between 2015-2018]). Patients were excluded if they had a pre-index castration-resistance (CR) indicator (CR dx; castration within ≥90 days pre-index or with PSA rise; or a claim for a drug solely recommended for metastatic CRPC). mCSPC period (F/U) was defined as time from index until CR (i.e., any post-index CR indicator or initiation of abiraterone acetate or docetaxel ≥12 mo after post-index ADT initiation or ≥12 mo post-index for those with no ADT) or end of data. The proportion of patients receiving ADT only or no mCSPC treatment during F/U was reported. Per-patient-per-year (PPPY) all-cause HRU were evaluated during baseline (12 mo pre-index) and F/U. Descriptive statistics were used: n (%) for binary and mean [SD] for continuous variables. Results: A total of 2,825 mCSPC patients were identified (age: 75 [9] years). Of these, 2,181 (77%) received ADT only or no treatment in a F/U of 10.9 [9.0] mo. Among them, there were more patients with ≥1 inpatient (IP) stay or ≥1 emergency room (ER) visit (F/U vs. baseline; IP: 50% vs. 20%; ER: 57% vs. 44%), and patients had more IP stays and ER visits (IP: 2.0 [4.0] vs. 0.3 [0.7] stays; ER: 3.2 [7.1] vs. 1.1 [2.2] visits) and more IP days (27 [61] vs. 3 [11] days) PPPY in F/U vs. baseline. Trends were similar among patients receiving ADT only (N=1,252 [44%]; F/U of 12.6 [9.0] mo; Table). Conclusions: The majority of mCSPC patients were treated with ADT only or remained untreated and incurred substantial HRU. These findings suggest that improvements in therapy and prompt treatment initiation in men with mCSPC are needed to improve outcomes. [Table: see text]

e19354 Background: Ibrutinib (Ibr) is an established standard of care in CLL/SLL patients across lines, regardless of age, comorbidities and risk status. With the introduction of venetoclax (Ven) in the treatment landscape, there is a need to understand the real-world treatment sequencing of targeted oral agents, and the implication of sequencing on HRU/costs. This retrospective study evaluated HRU/costs associated with Ven treatment in various sequencing scenarios, including prior use of Ibr. Methods: Optum Clinformatics Extended DataMart De-Identified Databases (4/11/2015-6/30/2019) were used to identify adults with CLL/SLL treated with Ven (excluding investigational combination therapies). The index date was the start of the first Ven-based line of therapy (index LOT) and the baseline period was the 12-month period pre-index. Mean all-cause HRU/costs per patient per month (PPPM) were calculated during the index LOT and the Ven ramp-up period (first 30 days post-index). Results: Among a total of 11,861 CLL/SLL patients receiving ≥1 LOT, 121 patients (1.0%) were treated with Ven, including 25 patients (64.0% single agent) using Ven in first line (1L cohort), 30 (90.0% single agent) in second line (2L cohort), and 66 (83.3% single agent) in third line or later (3L+ cohort). Mean age was 71.6 years; 33.1% were female; mean baseline Quan-Charlson Comorbidity Index score was 4.7; median follow up from the start of 1L was 25.3 months; median duration of index LOT was 4.2 months. The majority of 2L+ Ven patients were previously treated with Ibr (2L: 56.7%, 3L+: 74.2%). Patients in all 3 cohorts had frequent outpatient (OP) visits PPPM during their index LOT (1L: 4.58; 2L: 4.75; 3L+: 5.71). Total costs PPPM during the index LOT were highest in the 1L cohort (1L: $21,762; 2L: $17,697; 3L+: $20,900), driven by higher OP costs (1L $9,402; 2L: $5,633; 3L+: $7,701). Increased total costs PPPM were observed during Ven ramp-up (1L: $31,707; 2L: $21,036; 3L+: $25,362). Compared to the overall 2L cohort, those treated with Ibr in 1L had lower total costs PPPM (index LOT: $15,350; V ramp-up: $15,882). Conclusions: In this descriptive study, the highest costs PPPM were observed for Ven treatment in the 1L. Prior treatment with Ibr was common among 2L and 3L+ CLL/SLL patients treated with Ven. Among 2L Ven patients, those previously treated with Ibr in 1L had $2,347 and $5,154 lower costs PPPM during 2L and Ven ramp-up, respectively, suggesting that previous Ibr treatment may help reduce costs in subsequent V treatment.

e19408 Background: Ibrutinib is a targeted oral therapy indicated for MCL patients who received ≥1 prior line of therapy (LOT) (conditional approval on 11/13/2013 in the US). This study compared healthcare resource utilization (HRU) and costs of R/R MCL patients treated with ibrutinib ± rituximab (I±R) or CIT in a US-managed care population. Methods: Optum Clinformatics Extended DataMart De-Identified Databases (05/13/2013-6/30/2019) were used to identify adults with MCL receiving I±R or CIT (index date) following ≥1 prior LOT. Patients’ baseline characteristics were balanced using inverse probability of treatment weighting (IPTW). Monthly HRU and costs (plan paid amount) were evaluated during the first Oncology Care Model (OCM) episode (i.e., first 6 months) post-index and during the observed index I±R or CIT LOT (index LOT); and compared using rate ratios (RRs) and mean monthly cost differences (MMCDs), respectively. Results: A total of 146 I±R and 158 CIT patients were identified. Given the small sample size and to ensure outliers were not driving the results, 2 patients with total healthcare costs ≤0.5th and ≥99.5th percentile were excluded from each cohort. After IPTW, 149 and 151 patients were included in the weighted I±R and CIT cohorts, respectively (mean length of index LOT: 12.0 vs 11.0 months). 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

e19131 Background: Given recent advances in treatment options for mCSPC, this study assessed US real-world treatment patterns of mCSPC patients over time. Methods: The Optum Clinformatics Extended DataMart was used to identify men with ≥2 claims for PC, ≥1 claim for metastasis, ≥1 castration sensitivity (CS) indicator (CS diagnosis code [dx]; castration and no prostate-specific antigen [PSA] rise; or hormone/castration naive for ≥18 months [mo] before metastasis). Index (idx) date was the 1st metastasis dx date on or after 1st PC dx and from 2015-2018. Patients were excluded if they had a pre-idx castration-resistance (CR) indicator (CR dx; castration within ≥90 days pre-idx or with PSA rise; or a claim for a drug solely recommended for metastatic CRPC). mCSPC period (F/U) was defined as time from idx until CR (i.e., any post-idx CR indicator or initiation of abiraterone acetate [ABI] or docetaxel [DOC] ≥12 mo after post-idx androgen deprivation therapy [ADT] initiation or ≥12 mo post-idx for those with no ADT) or end of data. mCSPC treatment patterns in F/U were assessed overall and in patients with idx years (yrs) in 2015-2016 and in 2017-2018, separately. Descriptive statistics were used: n (%) for binary and mean [SD] for continuous variables. Results: In the 2,825 mCSPC patients identified (age: 75 [9] yrs; F/U: 10.9 [9.0] mo), 43% were in the 2015/16 cohort (age: 75 [9] yrs; F/U: 15.8 [10.2] mo); and 57% were in the 2017/18 cohort (age: 75 [9] yrs; F/U: 7.2 [4.7] mo). The most common first-line (1L) mCSPC therapy was ADT only (Table), but patients in the 2017/18 cohort had fewer ADT only as 1L (43% vs. 52%) and more 1L ABI (10% vs. 4%) compared to the 2015/16 cohort. About 4% (2015/16: 5%; 2017/18: 3%) of patients received second-line (2L) mCSPC therapies, with ABI (74%) and DOC (25%) as the main 2L therapies observed. In patients receiving 2L mCSPC therapies, the 2017/18 cohort had more 2L ABI (81% vs. 68%) and fewer 2L DOC (19% vs. 30%) compared to the 2015/16 cohort. Conclusions: A large proportion of men with mCSPC were untreated/deferred treatment or were treated with ADT only, highlighting unmet needs in this patient group. As additional therapies for mCSPC become available, this trend is expected to improve, as supported by more recent treatment patterns. [Table: see text]