Panel Interview of ONcology practices with Emergent Experience of teclistamab in the Real world: the TecPIONEER Study.

OBJECTIVE: To understand clinicians' current teclistamab step-up dosing (SUD) model and how they envision future administration models, as well as perceived barriers and facilitators to these models in day-to-day clinical practice. METHODS: Interviews of clinicians with RW experience administering teclistamab, with a subsequent roundtable discussion to discuss interview findings. Topics of interest included managing adverse events (AE), and handling logistics of SUD and transition of care (ToC). RESULTS: 20 clinicians representing 19 practices participated. Of 14 practices administering inpatient teclistamab SUD, 12 (86%) utilized a single admission. A day 1-3-5 dosing schedule with a 7-day length of stay was planned in 10/14 (71%). The remaining 5 practices employed outpatient or hybrid SUD. SUD models depended on cellular therapy experience, patient volume, and monitoring capabilities. Clinicians desired to administer SUD outpatient for convenience and reduced healthcare resource use. 11% of practices reported using tocilizumab for cytokine release syndrome (CRS) prophylaxis, whilst it was uniformly used to treat grade 2+ CRS. Corticosteroids were the preferred treatment for neurotoxicity. Infection prophylaxis with intravenous immunoglobulin was reported by 89% of practices. Patient- and institution-level factors affected decision-making of transitioning patients back to referring sites after SUD. CONCLUSION: The results consolidated practice-based experiences and indicated diverse RW SUD models and patient management strategies in practices with familiarity with teclistamab AE management and ToC protocols. Inpatient SUD is common, with expectations that approaches will evolve toward outpatient or community-based administration. Further research is needed to investigate outcomes of different care models and AE management strategies.

Multiple myeloma is a blood cancer that forms in plasma cells. Teclistamab is a new treatment for patients with multiple myeloma who have received prior treatment but for whom their multiple myeloma has come back or stopped responding to treatment multiple times. Because teclistamab works differently than other existing multiple myeloma treatments, there is a need to understand how oncologists who have experience with teclistamab are managing their patients in order to inform best practices for use by more healthcare providers. We interviewed oncologists that treat patients with multiple myeloma to understand their experiences with teclistamab, including how they manage initial dosing (step-up dosing) processes, treat adverse events, and transition patients to outpatient or external clinics for continued care. Most practices were administering step-up dosing of teclistamab in an inpatient setting soon after teclistamab became a treatment option, with a high level of desire to move the initial dosing to an outpatient setting in the near future. Those that were already administering step-up dosing in an outpatient setting had models unique to their practice. Oncologists described numerous processes for monitoring and managing adverse events of the treatment, including treating patients with preventative medications and regularly monitoring vital signs throughout step-up dosing. Oncologists expected that their teclistamab administration processes will likely evolve over time as they gain more familiarity with the treatment, and will need to consider patient-level factors to administer step-up dosing in an outpatient setting.

Patient perspectives on BCMA-targeted therapies for multiple myeloma: a survey conducted in a patient advocacy group.

Background: Advances in multiple myeloma (MM) treatment have shifted the therapeutic landscape. Understanding patients' perspectives can assist physicians in helping patients make informed decisions. This study aimed to understand the patient decision-making process and gain insights into patient perspectives on B-cell maturation antigen (BCMA)-targeted therapies for MM. Methods: An 18-question survey was completed by patients with MM enrolled in HealthTree® Cure Hub, an online portal helping patients with plasma cell dyscrasias navigate their disease. Results: From October 28, 2022, to January 12, 2023, 325 patients with MM participated in the survey. The mean age (standard deviation) of the respondents was 66 (8) years; 54% were female and 90% were White. Among 218 patients with complete clinical records in the database, the median (min, max) lines of therapy (LOT) was 2 (1,16). Among 61 (28%) patients who had received ≥4 LOTs, 55 (90%) were triple-class exposed. Of the 290 patients who responded to the question about openness to new therapies, 76 (26%) were open to trying a new therapy immediately and 125 (43%) wanted more information on safety and efficacy. Most respondents reported likely or very likely to try a BCMA CAR T-cell therapy (60%) or a bispecific antibody (74%) and some needed more information to decide (16% for CAR T-cell therapy and 13% for bispecific antibody). The most requested information included efficacy, side effects (SEs), eligibility, and administration process for both CAR T-cell and bispecific therapies. When 2 therapies with the same efficacy and duration of response were offered, 69% of respondents would prefer the therapy with a lower risk of severe SEs but requires continuous dosing with no treatment-free interval, and 31% preferred a therapy given once followed by a treatment-free interval but with a potentially higher risk of severe SEs. To receive an effective therapy, the top acceptable trade-offs included frequent monitoring of SEs and initiating a new therapy in a hospital setting, and the least acceptable compromise was caregiver burden. Conclusions: This study found a high level of openness in patients with MM to try BCMA-targeted therapies. Information on efficacy, safety, availability, and eligibility may assist patients on decision-making.

The Burden of Neuropsychiatric Disorders in Medicaid Patients Living With HIV-1 Treated With Integrase Inhibitor or Protease Inhibitor Antiretroviral Therapies.

Objective: Data are scarce regarding the incidence of neuropsychiatric events (NPEs) in people living with human immunodeficiency virus (HIV)-1 taking integrase inhibitor (INI)- or protease inhibitor (PI)-based regimens. This study evaluated the prevalence, incidence, and economic burden of NPEs among people living with HIV-1 who were newly treated with INI- or PI-based regimens in a Medicaid population.Methods: A retrospective cohort study was conducted using administrative claims from the IBM MarketScan Multi-State Medicaid Database (January 1, 2014-December 31, 2018). Treatment-naive and treatment-experienced adults with HIV-1 newly treated with an INI- or PI-based regimen were included. Outcomes included NPE prevalence during the 12-month baseline period, prevalence of existing and incidence of new-onset NPEs during the 6-month post-index period, and total all-cause and NPE-related costs between treatment cohorts. Baseline characteristics between the 2 cohorts were balanced using inverse probability treatment weighting.Results: In the INI (n = 3,929) and PI (n = 3,916) cohorts, mean (SD) ages were 44.87 (12.81) and 44.36 (11.85) years, and 41.7% and 41.3% were female, respectively. High proportions of patients in both cohorts had NPEs during the 12-month baseline period. Among patients with no baseline NPEs, adjusted NPE incident rate ratios (95% CIs) during the post-index period were as follows: any, 1.15 (1.00-1.33); chronic, 1.18 (0.98-1.42); and acute, 1.16 (0.96-1.39). Mean all-cause and NPE-related costs were similar between cohorts.Conclusions: In this study of the Medicaid population, the prevalence and incidence of NPEs, as well as health care costs, were similar among people living with HIV-1 newly treated with an INI- or PI-based regimen.

Inconsistencies in the days supply values reported in pharmacy claims databases for biologics with long maintenance intervals.

BACKGROUND: Days supply values reported in large administrative claims databases are commonly used to estimate drug exposure and quantify adherence and persistence with prescribed therapy. In recent claims database studies assessing treatment patterns for biologic therapies, a high frequency of 28-31-days supply values has been observed for therapies with label-recommended maintenance dosing intervals longer than 4 weeks. Such inconsistencies suggest potential inaccuracy of days supply data. OBJECTIVE: To confirm the existence and describe the extent of inconsistencies in the reported days supply values and the documented fill intervals among prescription claims from administrative claims databases for 2 different biologics with label-recommended maintenance dosing intervals longer than 4 weeks and 2 biologics with intervals less than or equal to 4 weeks. METHODS: Using data from 2 large US administrative claims databases (IBM MarketScan Commercial Claims and Encounters and the Optum Clinformatics Data Mart Socio-economic Status [SES]), the reported days supply values and associated intervals between consecutive fills for 2 biologics with maintenance dosing intervals longer than 4 weeks (guselkumab and ustekinumab) and 2 with intervals less than or equal to 4 weeks (adalimumab and ixekizumab) were described. For all fill pairs with reported days supply values of 28-31 days, the percentage with inconsistent fill intervals (defined as >45 days or >60 days) was calculated. RESULTS: Across all datasets, the proportions of fill pairs with inconsistent days supply values and fill intervals (ie, days supply values of 28-31 days but fill intervals of >45 days) were 41.8%-73.4% for guselkumab, 33.4%-59.4% for ustekinumab, 8.5%-9.5% for adalimumab, and 7.3%-11.4% for ixekizumab. The same trend was observed across these biologics when using more than 60 days to define an inconsistent fill interval. Unlike adalimumab and ixekizumab, a wide distribution of fill intervals was observed among guselkumab and ustekinumab fill pairs with 28-31 days supply values, with peaks evident at approximately 28-31 days as well as around the label-recommended maintenance dosing intervals for these therapies (56 or 84 days). CONCLUSIONS: This study demonstrated a large discrepancy between days supply values and fill intervals reported in administrative claims data for biologics with label-recommended maintenance dosing intervals longer than 4 weeks (ie, guselkumab and ustekinumab), potentially suggesting widespread underestimation of days supply values for these therapies. Such inconsistencies in the reported days supply values may lead to underestimation of treatment adherence and persistence for these biologics, which could be mitigated by systematic data imputation. DISCLOSURES: This study was funded by Janssen Scientific Affairs, LLC. Ms Xu and Drs Ferrante, Fitzgerald, Pericone, and Wu are employees of Janssen Scientific Affairs, LLC, and shareholders of Johnson & Johnson, of which Janssen Scientific Affairs, LLC, is a wholly owned subsidiary. Funding for programming support and medical writing and editorial assistance was provided by Janssen.

Improved Prediction of Body Mass Index in Real-World Administrative Healthcare Claims Databases.

INTRODUCTION: To continue closing the gap between the predictive modeling and its real-world application, we report a new data-to-prediction pipeline that advanced the state-of-the-art predictive performance of body mass index (BMI) classifications by integrating siloed claims databases via a common data model. METHODS: This study adapted the ensemble-based methodology of the baseline prediction model and focused on removing the silos in the claims databases. We applied the Super Learner machine learning algorithm (SLA) to learn a combined dataset consisting of 50% data from the Optum Date of Death database and 50% data from the IBM MarketScan Commercial Claims and Encounters (CCAE), and omitted the commonly used one-hot-encoding step and used multi-categorical variables directly in the feature engineering process. These developments were then optimized via a standard cross-validation scheme and the performance was evaluated on a holdout test set. RESULTS: Sociodemographic and clinical characteristics were used with (denoted as SLA1) and without (denoted as SLA2) baseline BMI values to predict BMI classifications (≥ 30, ≥ 35, and ≥ 40 kg/m2). Although the newly implemented SLA1 performed similarly to the previous model, with the area under the receiver operating characteristic curve (ROC AUC) being approximately 88% for all BMI classifications, specificity ranging from 90% to 96%, and accuracy ranging from 88% to 93%. The new SLA2 achieved consistently better performance on all metrics across all BMI classes. In particular, the new SLA2 achieved 77-79% in ROC AUC, increasing from the previously reported level (73%). Its specificity improved to the range of 76-90% from 71-86%. Its accuracy improved to the range of 77-86% from 73-80%. Its recall (i.e., sensitivity) improved to the range of 64-78% from 60-76%. CONCLUSIONS: This study demonstrates dramatic improvements in the prediction of BMI across classifications using integrated databases in a common data model for the generation of real-world evidence.

Drug Adherence and Persistence of Patients with Moderate to Severe Psoriasis Treated with Biologic Medications in a US Commercially Insured Population.

BACKGROUND: Adalimumab (ADA), certolizumab pegol (CER), etanercept (ETA), guselkumab (GUS), ixekizumab (IXE), secukinumab (SEC), and ustekinumab (UST) are biologic medications approved in the USA for the treatment of moderate to severe psoriasis. We examined drug adherence and persistence of patients with moderate to severe psoriasis who initiated these seven biologic medications. METHODS: Adult patients with ≥1 pharmacy/medical claim for any of the seven psoriasis medications and ≥1 diagnosis of psoriasis in the previous 6 months between July 1, 2014 and June 30, 2019 were selected from the IBM MarketScan® Commercial Claims and Encounters Database. The index date was defined as the date of the first prescription fill. Patients were required to have continuous health plan enrollment during the 6 months prior to their index date and ≥9 months after. Patients were grouped into seven study cohorts based upon their index biologic medication. Adherence was measured using the proportion of days covered (PDC) and defined by a PDC ≥80%. Adherence and persistence with index biologic medications were examined during fixed follow-up periods of 3, 6, and 9 months, with a subpopulation analysis carried out among patients with 12 months of follow-up. RESULTS: Among psoriasis patients with ≥9 months of continuous enrollment included in the study population, the number of those who initiated each biologic medication was 10,324 for ADA, 431 for CER, 3,092 for ETA, 821 for GUS, 1,766 for IXE, 4,132 for SEC, and 5,441 for UST. The mean age at the time of initiating biologic treatment was 46.9 years. During the 9-month follow-up period, the proportions of adherent patients (i.e., PDC ≥80%) were numerically higher among those treated with UST (59.9%) and GUS (56.9%), followed by those treated with SEC (46.1%), IXE (45.5%), ADA (44.7%), ETA (33.9%), and CER (22.0%). The proportions of patients who were persistent with their index biologic medication during the 9-month follow-up period were numerically higher among those treated with UST (70.1%) and GUS (67.8%), followed by those treated with IXE (47.3%), SEC (46.9%), ADA (28.7%), CER (14.8%), and ETA (10.7%). CONCLUSIONS: In this large healthcare claims database analysis of psoriasis patients treated with seven different biologic medications, adherence was numerically higher among those treated with UST or GUS. UST and GUS were also associated with numerically greater persistence.

Treatment adherence and persistence of seven commonly prescribed biologics for moderate to severe psoriasis and psoriatic arthritis in a U.S. commercially insured population.

BACKGROUND: Adalimumab (ADA), certolizumab pegol (CER), etanercept (ETA), guselkumab (GUS), ixekizumab (IXE), secukinumab (SEC), and ustekinumab (UST) are biologics approved for the treatment of psoriasis (PsO) and psoriatic arthritis (PsA). We examined adherence and persistence among PsO patients with comorbid PsA who initiated treatment with any of these biologics. METHODS: Adult patients with ≥1 pharmacy/medical claim for any of these seven biologics, and ≥1 diagnosis of both PsO and PsA were selected from the MarketScan Commercial database (July 2014-June 2019). Adherence and persistence rates were examined among the seven study cohorts during fixed follow-up periods (3, 6, 9, and 12 months). RESULTS: Among patients with ≥9 months of continuous enrollment, 3,251 initiated ADA, 418 CER, 1,563 ETA, 126 GUS, 422 IXE, 1,596 SEC, and 1,267 UST. During the 9-month follow-up period, the proportions of adherent patients were numerically highest among those treated with GUS (59.5%) and UST (57.0%), followed by SEC (47.9%), IXE (47.6%), ADA (46.8%), ETA (37.4%), and CER (22.0%); persistence rates were also numerically highest among those treated with GUS (65.9%) and UST (65.7%). LIMITATIONS: Adjustment for potential confounders was not conducted. CONCLUSIONS: Adherence and persistence rates were numerically highest among patients who initiated GUS and UST.

The burden of neuropsychiatric disorders in patients living with HIV-1 treated with antiretroviral therapies-A perspective from US Medicaid data.

BACKGROUND: People with human immunodeficiency virus (HIV)-1 face challenges with treatment adherence for various reasons, including consideration of neuropsychiatric disorders and neuropsychiatric adverse reactions associated with antiretroviral therapy (ART). METHODS: A retrospective cohort study was conducted using administrative claims data from the IBM MarketScan® Multi-State Medicaid Database (1/1/2014-12/31/2017). Adults (≥18 years) diagnosed with HIV-1 and newly initiated on antiretroviral therapy with continuous health plan enrollment were included. Primary outcome was the 6-month period prevalence of neuropsychiatric events (NPEs) of interest after ART initiation. RESULTS: Among 1971 newly treated patients included in the study, mean age (standard deviation [SD]) was 38.5 (12.7) years, and 41.4% were female. During the 6 months after ART initiation, 51.4% of patients had a claim for ≥1 NPE versus 30.3% of matched patients without HIV. Among newly treated patients, the most common (≥10%) NPE claims were for depression (42.2%), anxiety (15.8%), headache (11.9%), and bipolar/manic depression (10.1%). Also in this group, the mean (SD) total all-cause healthcare cost during the 6-month post-ART initiation was $16,632 ($33,928), of which $2914 ($18,233) was NPE-related. CONCLUSIONS: In summary, in this Medicaid study of people newly initiated on ART, there was a high prevalence of NPEs, and incremental NPE-associated costs were considerable.

Body Mass Index Variable Interpolation to Expand the Utility of Real-world Administrative Healthcare Claims Database Analyses.

INTRODUCTION: Administrative claims data provide an important source for real-world evidence (RWE) generation, but incomplete reporting, such as for body mass index (BMI), limits the sample sizes that can be analyzed to address certain research questions. The objective of this study was to construct models by implementing machine-learning (ML) algorithms to predict BMI classifications (≥ 30, ≥ 35, and ≥ 40 kg/m2) in administrative healthcare claims databases, and then internally and externally validate them. METHODS: Five advanced ML algorithms were implemented for each BMI classification on a random sampling of BMI readings from the Optum PanTher Electronic Health Record database (2%) and the Optum Clinformatics Date of Death (20%) database, while incorporating baseline demographic and clinical characteristics. Sensitivity analyses with oversampling ratios were conducted. Model performance was validated internally and externally. RESULTS: Models trained on the Super Learner ML algorithm (SLA) yielded the best BMI classification predictive performance. SLA model 1 utilized sociodemographic and clinical characteristics, including baseline BMI values; the area under the receiver operating characteristic curve (ROC AUC) was approximately 88% for the prediction of BMI classifications of ≥ 30, ≥ 35, and ≥ 40 kg/m2 (internal validation), while accuracy ranged from 87.9% to 92.8% and specificity ranged from 91.8% to 94.7%. SLA model 2 utilized sociodemographic information and clinical characteristics, excluding baseline BMI values; ROC AUC was approximately 73% for the prediction of BMI classifications of ≥ 30, ≥ 35, and ≥ 40 kg/m2 (internal validation), while accuracy ranged from 73.6% to 80.0% and specificity ranged from 71.6% to 85.9%. The external validation on the MarketScan Commercial Claims and Encounters database yielded relatively consistent results with slightly diminished performance. CONCLUSION: This study demonstrated the feasibility and validity of using ML algorithms to predict BMI classifications in administrative healthcare claims data to expand the utility for RWE generation.

Treatment adherence and persistence of five commonly prescribed medications for moderate to severe psoriasis in a U.S. commercially insured population.

OBJECTIVE: To evaluate medication discontinuation, persistence, and adherence of moderate to severe psoriasis patients treated with adalimumab, apremilast, etanercept, secukinumab, and ustekinumab. METHODS: Adult patients diagnosed with psoriasis and ≥1 psoriasis pharmacy or medical claim of any of the five psoriasis medications (index date) and continuous insurance enrollment were included from the Optum Clinformatics database during the intake period (7/1/2014-9/30/2017). Medication discontinuation, persistence, medication possession ratio (MPR), and proportion of days covered (PDC) were evaluated during a 12-month post-index follow-up period, using three gap definitions. RESULTS: Among the study population (n = 8524), 34.4% initiated adalimumab, 25.7% apremilast, 9.0% etanercept, 7.1% secukinumab, and 23.7% ustekinumab. Mean age ranged from 48.7 to 52.2 years. For all three gap definitions, discontinuation was lowest and persistence greatest among ustekinumab treated patients (48.4% and 59.8%, respectively using the default definition). A greater proportion of ustekinumab patients had an MPR ≥80% (81.8%) than adalimumab (67.9%), apremilast (54.9%), etanercept (56.4%), and secukinumab (68.0%) patients. Also, 50.6% of ustekinumab patients had a PDC ≥80% versus 35.6%, 23.9%, 19.5%, and 41.7% of adalimumab, apremilast, etanercept, and secukinumab patients, respectively. CONCLUSIONS: Although heterogeneity across cohorts may explain some medication utilization differences, ustekinumab was associated with lower discontinuation and greater persistence and adherence.

Real-World Comparative Effectiveness of Canagliflozin Versus Empagliflozin and Dapagliflozin in Patients with Type 2 Diabetes in the United States.

INTRODUCTION: While several sodium glucose co-transporter 2 (SGLT2) inhibitors are approved as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus (T2DM), there are no clinical trial data providing head-to-head comparisons of the efficacy and safety of these therapies. Real-world analyses can provide valuable evidence on the effectiveness of competing treatments. This study compared the real-world glycemic effectiveness of SGLT2 inhibitors in individuals with T2DM. METHODS: Patients who initiated canagliflozin 300 mg versus empagliflozin 25 mg or dapagliflozin 10 mg were identified from the Optum® De-identified Clinformatics® Extended Data Mart-Date of Death database and propensity score matched. Achievement of HbA1c < 8.0% (Healthcare Effectiveness Data and Information Set [HEDIS] target) and > 9.0% (HEDIS poor control) after 6 months of treatment was calculated. RESULTS: Post-baseline HbA1c was similar in the canagliflozin and empagliflozin cohorts (7.65% versus 7.57%), as was percent of patients with HbA1c < 8.0% or > 9.0%. Post-baseline HbA1c was lower with canagliflozin versus dapagliflozin (7.58% versus 7.74%; P = 0.0247). The canagliflozin cohort was more likely to achieve HbA1c < 8.0% than the dapagliflozin cohort (P = 0.0292); the likelihood of achieving HbA1c > 9.0% was similar. CONCLUSION: In patients with T2DM, HbA1c outcomes were similar with canagliflozin and empagliflozin. Patients on canagliflozin versus dapagliflozin were more likely to have a lower HbA1c and reach HbA1c < 8.0% after 6 months. These results may provide important information for clinicians as they decide the appropriate treatment for their patients with T2DM.

Comparison of Healthcare Resource Utilization and Costs between Rivaroxaban and Warfarin for Nonvalvular Atrial Fibrillation in a Skilled Nursing Facility Setting.

BACKGROUND: Use of direct-acting oral anticoagulants for patients with nonvalvular atrial fibrillation (NVAF) in skilled nursing facilities (SNFs) is increasing. Rivaroxaban is commonly used in this setting as an alternative to warfarin, based on comparable or increased efficacy in preventing stroke and a similar or lower risk of major bleeding. OBJECTIVE: The aim of this study was to compare healthcare resource utilization (HCRU) and costs between NVAF patients receiving rivaroxaban or warfarin in SNFs. METHODS: This retrospective study examined de-identified claims from Optum® Clinformatics® Extended Data Mart (1 January 2013-31 December 2017). Eligible patients had an AF diagnosis, were prescribed rivaroxaban or warfarin during an SNF stay, and had one or more such prescriptions filled in the 6 months preceding the stay. Patients were excluded if they received another oral anticoagulant or had evidence of valvular heart disease, mitral stenosis, or organ/tissue transplant. HCRU, mean number of events, and all-cause healthcare costs during the index SNF stay were reported. Results were also reported on a per-patient-per-month (PPPM) basis. Exploratory analyses at different time periods were also conducted. RESULTS: Overall, 4423 rivaroxaban patients and 22,796 warfarin patients were identified prior to inverse probability of treatment weighting adjustment. Index SNF stay was significantly shorter among rivaroxaban-treated patients (35.8 ± 35.8 days) versus warfarin (40.1 ± 46.3 days; p < 0.0001). During the SNF stay, overall HCRU was lower for the rivaroxaban cohort versus the warfarin cohort. All-cause total costs were significantly reduced for rivaroxaban ($6450 ± $10,379) versus warfarin ($7640 ± $16,556; p < 0.0001), and similar results were observed when calculated on a PPPM basis. During the 1-year post-index period, PPPM all-cause total costs were significantly lower with rivaroxaban versus warfarin ($4135 vs. $4561; p < 0.0001). CONCLUSION: In this SNF setting, HCRU and costs were lower among patients with NVAF who were experienced users of rivaroxaban compared with those who were experienced users of warfarin. These findings may help inform clinical decision making to reduce the economic burden of NVAF among older adults in SNFs.

Descriptive analysis of the economic burden of treatment resistance in a major depressive episode.

Objectives: To assess characteristics and healthcare costs associated with pharmacologically treated episodes of treatment-resistant depression (TRD) in patients with major depressive disorder (MDD).Methods: Patients aged ≥18 years with continuous health plan enrollment for ≥12 months before and after a newly observed MDD diagnosis (observed between 1 January 2010 and 31 December 2015) were included in this retrospective claims-based analysis. A pharmacologically treated episode was defined as beginning at the date of the first MDD diagnosis and ending when a gap of 180 days occurred between MDD diagnoses, or when a gap of 180 days occurred following the end of the antidepressant (AD)/antipsychotic (AP) drug supply. When such a gap occurred, the episode end date was determined to be either the date of the last MDD diagnosis or date of the end of AD/AP drug supply, whichever was later. An episode was considered TRD if ≥3 AD regimens occurred. Episode duration, medication regimens used, and relapse hospitalization were reported for TRD and non-TRD MDD episodes. Total all-cause and per-patient-per-month (PPPM) healthcare costs (in 2016 $) were estimated.Results: Of 48,440 patients identified with ≥1 AD-treated MDD episode, the mean (SD) age was 39 (15) years, and 62% were female. Of all episodes, 7% were TRD, with a mean duration of 571 (285) days vs. 200 (198) days for non-TRD MDD episodes. Mean total all-cause costs were $19,626 ($44,160) for TRD and $7440 ($25,150) for non-TRD MDD episodes.Conclusions: Results show TRD episodes are longer and costlier than non-TRD MDD episodes, and that higher costs are driven by episode duration. Longer episodes imply protracted suffering for patients with TRD and increased burden on caregivers. Effective intervention to shorten TRD episodes may lessen disease burden and reduce costs.

Total cost of care for castration-resistant prostate cancer in a commercially insured population and a medicare supplemental insured population.

Background: The total cost of healthcare for patients with castration-resistant prostate cancer (CRPC) is an important component for assessing value of treatment options. The need for real-world evidence has increased with the introduction of oral targeted therapies for metastatic and nonmetastatic disease. In this study, we examined patient healthcare costs during periods of nonmetastatic CRPC (nmCRPC) and metastatic CRPC (mCRPC).Methods: This retrospective cohort study captured data from claims in the Truven Health MarketScan Commercial and Medicare Supplemental (Medigap) databases (1/1/2012-12/31/2016). Male patients (≥18 years) with ≥1 prostate cancer diagnosis, a subsequent metastatic diagnosis, and prescription claim for an mCRPC-indicated therapy (index date) were included. Patients were considered to have nmCRPC during the 12-month period prior to mCRPC if they had ≥1 claim for androgen deprivation therapy. Unadjusted all-cause healthcare resource utilization (HRU) and associated costs in 2016 USD per patient per year (PPPY) were determined for nmCRPC and mCRPC periods.Results: Patients included from the Commercial database (N = 449) had an average age of 59.4 ± 4.5 (standard deviation) years and a mean Quan Charlson Comorbidity Index (QCI) score of 2.8 ± 1.6. Among patients included from the Medigap database (N = 1,173), the mean age was 78.6 ± 7.2 years and mean QCI score was 3.3 ± 2.0. Across all healthcare resource types, HRU was approximately 1.5-2.5 times greater after a diagnosis of metastasis for both study populations. For commercially insured patients, total all-cause healthcare costs increased 6.2-fold from the nmCRPC to mCRPC periods ($29,192 to $182,156 PPPY). Likewise, among Medigap patients, total all-cause healthcare costs increased 5.1-fold from the nmCRPC to mCRPC periods ($27,549 to $139,847).Conclusions: In this study, the cost of care during 2012-2016 was substantially higher for mCRPC than nmCRPC, underscoring the value of interventions that may delay progression to metastases in high-risk individuals.

Healthcare resource utilization and costs among nonvalvular atrial fibrillation patients initiating rivaroxaban or warfarin in skilled nursing facilities: a retrospective cohort study.

Objective: Atrial fibrillation (AF) is present in up to 17% of patients in skilled nursing facilities (SNFs). This study compared healthcare resource utilization (HRU) and costs between AF patients initiating rivaroxaban or warfarin in SNFs.Methods: Using de-identified claims from Optum Clinformatics Extended Data Mart (1 January 2013 to 31 December 2017), this retrospective cohort study indexed AF patients with first SNF admission during which rivaroxaban or warfarin was initiated within 3 days of admission. To adjust for selection bias, inverse probability of treatment weighting (IPTW) was applied for baseline characteristics. Logistic regression and generalized linear models were used to compare HRU and costs.Results: 519 rivaroxaban and 1129 warfarin patients met inclusion criteria. After IPTW, the cohorts were well balanced for baseline characteristics. The average length of index SNF stay was 32.07 and 37.44 days for rivaroxaban and warfarin patients, respectively. During SNF stay, rivaroxaban patients had 27% lower odds of hospitalization (p < .0001), 2.7 fewer international normalized ratio (INR) tests per-patient-per-month (PPPM; p < .001), and 2.3 fewer pathology/laboratory encounters PPPM (p < .0001) than warfarin patients. All-cause healthcare costs were $2638 lower with rivaroxaban versus warfarin (p < .0001) during the index SNF stay, with lower medical costs (p < .0001) but higher pharmacy costs (p < .0001). Total all-cause healthcare costs 100 days post-index SNF were $8746 lower with rivaroxaban versus warfarin (p < .0001).Conclusions: In the SNF setting, AF patients treated with rivaroxaban had 5-day shorter length of stay, lower HRU, and lower all-cause total and medical costs compared to warfarin, despite higher treatment costs. These findings may help inform clinical decision-making to reduce economic burden.

Risk of childhood wheeze and asthma after respiratory syncytial virus infection in full-term infants.

BACKGROUND: Most studies addressing the association between RSV and recurrent wheezing (RW) and asthma have been conducted in patients at risk for lung morbidity. Data in full-term infants are limited. METHODS: The risk of RW/asthma during the first 5 years of life in full-term infants hospitalized with RSV during the first year (Y) of life was estimated using 2010-16 data from three claims databases in USA (Truven MarketScan Commercial Claims and Encounters Database [CCAE], Truven Health MarketScan Multi-State Medicaid [MDCD], and Optum Clinformatics Extended Data Mart-Socio-Economic Status [SES]). Full-term infants with and without RSV infection and ≥ 2 years of continuous health plan enrollment from birth were included. Incidence rates of RW/asthma, cumulative incidence, adjusted incidence rate ratios (aIRR), and odds ratios (aOR) were calculated. RESULTS: During the 16-year study, 38,494 (CCAE), 62 846 (MDCD), and 23 099 (SES) matched infant pairs were included in each cohort. In the CCAE database, RW/asthma incidence/1000 patient-years (69.7 vs 28.7, aIRR: 2.4 [2.3-2.5]); cumulative incidence (17.6%-25.2% vs 5.0%-11.4%); and aOR (Y2: 4.1 [3.9-4.4]; Y3: 3.2 [3.0-3.3]; Y4: 2.9 [2.7-3.1]; Y5: 2.6 [2.5-2.9]) were higher in the RSV vs. non-RSV cohort. Results in the SES insured population were comparable, while cumulative incidence and aIRR were higher in the Medicaid population (MDCD). CONCLUSION: Although there are limitations in this study, including possible coding errors and missing covariates, we showed that full-term infants with severe RSV infection during the first year of life, spanning several respiratory seasons and a geographically diverse population, are at significant risk of RW/asthma during childhood.

Rivaroxaban versus warfarin treatment among morbidly obese patients with venous thromboembolism: Comparative effectiveness, safety, and costs.

INTRODUCTION: Limited data exist on direct-acting oral anticoagulants in morbidly obese patients with venous thromboembolism (VTE). We compared clinical and health/economic outcomes with rivaroxaban versus warfarin for VTE treatment in morbidly obese patients. MATERIALS AND METHODS: This retrospective 1:1 propensity score matched cohort study analyzed data from 2 US claims databases. VTE patients initiating rivaroxaban or warfarin were identified who had diagnosis codes for morbid obesity (ICD-9:278.01,V85.4; ICD-10:E66.01,E66.2,Z68.4) 12 months pre- or 3 months post-initiation and followed ≥3 months. Intent-to-treat (ITT) and on-treatment (OT) analyses were conducted using conditional logistic regression and generalized linear models to compare recurrent VTE and major bleeding risks, healthcare resource utilization (HRU), and per patient per year (PPPY) costs. RESULTS: In total, 2890 matched pairs of morbidly obese VTE patients initiating rivaroxaban or warfarin were identified. Risks of recurrent VTE (ITT: OR: 0.99; 95% CI: 0.85-1.14) and major bleeding (OT: OR: 0.75; 95% CI: 0.47-1.19) were similar for cohorts. Anti-Factor Xa laboratory measurement was performed on <1% of rivaroxaban cohort. Hospitalizations (OR: 0.86; 95% CI: 0.77-0.96) and outpatient visits (OR: 0.23; 95% CI: 0.10-0.56), were lower with rivaroxaban versus warfarin (ITT analysis). Average total medical costs PPPY were $2829 lower with rivaroxaban versus warfarin ($34,824 vs $37,653), mainly driven by hospitalization costs. Total healthcare costs (including pharmacy) were similar ($43,034 vs $44,565). CONCLUSIONS: Morbidly obese VTE patients receiving rivaroxaban had similar risks of recurrent VTE and major bleeding versus warfarin. Rivaroxaban treatment yielded significantly less HRU and total medical costs, with similar total healthcare costs between groups.

An episode level evaluation of the treatment journey of patients with major depressive disorder and treatment-resistant depression.

BACKGROUND: Many patients with major depressive disorder (MDD) fail to respond to antidepressant (AD) pharmacotherapy. The objectives of this study were to characterize MDD and treatment-resistant depression (TRD) at the level of pharmacologically treated episodes and to describe the sequential treatment patterns by lines of therapy (LOT) in the first two episodes. METHODS: Adults (≥18 years of age) with continuous enrollment ≥12 months before and after the first MDD diagnosis and treated with an AD, with or without an MDD-indicated antipsychotic (AP), were identified (1/1/2010-12/31/2015). The MDD episode started on the date of MDD diagnosis that was preceded by a clean period without any MDD diagnosis. The MDD episode ended on the last MDD diagnosis or the end of the days' supply of AD/AP medication, whichever came last. TRD was defined as an MDD episode with ≥3 AD/AP regimens. Measured outcomes included episode duration, number of LOT, relapse hospitalization, and sequential treatment patterns of MDD episode stratified by TRD and non-TRD episodes. RESULTS: Of 48,440 patients who received AD/AP in the 1st MDD episode, 3,317 (6.8%) of episodes were considered TRD. Mean duration of 1st TRD episodes was 571 days, mean number of AD/AP LOTs was 3.47, and 13.7% involved relapse hospitalization. Mean duration of 1st non-TRD episodes was 200 days, mean number of AD/AP LOTs was 1.21, and 9.6% involved relapse hospitalization. Among 1st MDD episodes, 25.5% had a second LOT; 7.3% had a third LOT. Most patients received selective serotonin reuptake inhibitors (SSRIs) as the first LOT (63.0%), and the plurality of regimens were SSRIs in second (44.9%) and third LOT (41.1%). CONCLUSIONS: Compared to non-TRD episodes, TRD episodes were longer and more often involved relapse hospitalizations. SSRIs were the most common treatment; treatment changes and potential treatment unresponsiveness were frequent among MDD patients.

Prevalence and economic burden of comorbid anxiety and depression among patients with moderate-to-severe psoriasis.

Objective: To describe the prevalence and costs of anxiety and depression among moderate-to-severe psoriasis (PsO) patients in a commercially-insured US population.Methods: The IBM MarketScan Commercial database was used to select adults with moderate-to-severe PsO (≥1 PsO diagnosis and ≥1 systemic or biologic medication) within each calendar year from 2014 to 2016. Adults with no diagnosis of PsO or similar disorders were randomly selected (2014-2016) and matched 1:1 to PsO patients to compare the prevalence of anxiety and depression each year. Moderate-to-severe PsO patients identified in 2014 with continuous enrollment through 2015 were stratified into those with treated anxiety and/or depression (≥1 anxiety or depression diagnosis plus any anxiolytics, antidepressants, or antipsychotics within 30 days) vs those without anxiety/depression, and then matched 1:1 to determine the incremental burden of treated anxiety/depression among PsO patients. All-cause and PsO-related healthcare costs were compared between the matched cohorts using generalized linear models.Results: In total, 69,644 matched PsO and non-PsO patients were identified in 2014, 61,478 in 2015, and 66,880 in 2016. The prevalence of anxiety/depression among PsO patients increased more than for matched controls, from 18.2% vs 12.2% in 2014 (p < 0.01) to 19.6% vs 13.1% in 2016 (p < 0.01). Prevalence of treated anxiety/depression followed the same trend, with increases from 14.5% vs 8.9% in 2014 (p < 0.01) to 15.9% vs 9.9% in 2016 (p < 0.01). For patients with moderate-to-severe PsO, unadjusted incremental all-cause healthcare costs associated with treated anxiety/depression were $8,077 (p < 0.01); 91% was due to utilization of medical services such as hospitalizations, ER visits, office visits, and other outpatient services (all p < 0.01).Conclusions: The prevalence of psychiatric disorders is higher among PsO patients than the general population, and the incremental burden of treated anxiety/depression is substantial. Further research is needed, but PsO treatments that improve psychiatric symptoms such as anxiety/depression may benefit patients and reduce their economic burden.

Comparative effectiveness, safety, and costs of rivaroxaban and warfarin among morbidly obese patients with atrial fibrillation.

BACKGROUND: There are limited data regarding clinical outcomes and healthcare resource utilization of direct oral anticoagulants (DOACs) in patients with atrial fibrillation (AF) who are morbidly obese (body mass index >40 kg/m2 or body weight >120 kg). METHODS: Using data from 2 US healthcare claims databases, we identified patients initiating rivaroxaban or warfarin who had ≥1 medical claim with an AF diagnosis, a diagnostic code for morbid obesity (ICD-9: 278.01, V85.4%; ICD-10: E66.01%, E66.2%, Z68.4%), and a minimum continuous enrollment of 12 months before and 3 months after treatment initiation. Patients were excluded if they had mitral stenosis, a mechanical heart valve procedure, an organ/tissue transplant, or an oral anticoagulant prescription prior to the index date. Rivaroxaban and warfarin patients were 1:1 propensity score matched. Conditional logistic regression was used to compare ischemic stroke/systemic embolism and major bleeding risk. Generalized linear models were used to compare healthcare resource utilization and costs. RESULTS: A total of 3563 matched pairs of morbidly obese AF patients treated with rivaroxaban or warfarin were identified. The majority (81.4%) of patients in the rivaroxaban cohort were receiving the 20 mg dose. The rivaroxaban and warfarin cohorts were well balanced after propensity score matching. The risks of ischemic stroke/systemic embolism and major bleeding were similar for rivaroxaban and warfarin users (stroke/systemic embolism: 1.5% vs 1.7%; odds ratio [OR]: 0.88; 95% confidence interval [CI]: 0.60, 1.28; P = .5028; major bleeding: 2.2% vs 2.7%; OR: 0.80; 95% CI: 0.59, 1.08; P = .1447). Total healthcare costs including medication costs per patient per year (PPPY) were significantly lower with rivaroxaban versus warfarin ($48,552 vs $52,418; P = .0025), which was primarily driven by lower hospitalization rate (50.2% vs 54.1%; P = .0008), shorter length of stay (7.5 vs 9.1 days; P = .0010), and less outpatient service utilization (86 vs 115 visits PPPY; P < .0001). CONCLUSIONS: Morbidly obese AF patients treated with rivaroxaban had comparable risk of ischemic stroke/systemic embolism and major bleeding as those treated with warfarin, but lower healthcare resource utilization and costs.