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Maryia Zhdanava,1 H Lynn Starr,2 Todor I Totev,3 Patrick Lefebvre,1 Aditi Shah,1 Kristy Sheng,4 Dominic Pilon1 1Analysis Group, Inc., Montréal, QC, Canada; 2Janssen Scientific Affairs, LLC, Titusville, NJ, USA; 3Analysis Group, Inc., Boston, MA, USA; 4Analysis Group, Inc., Menlo Park, CA, USACorrespondence: Maryia Zhdanava, Manager at Analysis Group, Inc, 1190 Avenue des Canadiens-de-Montréal, Suite, 1500, Montréal, QC, H3B 0G7, Canada, Tel +1 514-394-4469, Email Masha.Zhdanava@analysisgroup.comPurpose: To describe changes due to the COVID-19 pandemic in the prescribing of long-acting antipsychotics (LAI) for schizophrenia, patient outcomes, and patient and healthcare provider (HCP) attitudes regarding COVID-19 vaccination in the United States (US).Methods: An anonymous online survey was administered to US-based LAI prescribers with a psychiatry specialty in May 2021. Information on prescriber and clinical practice characteristics, LAI prescribing, patient outcomes, and attitudes toward COVID-19 vaccination was collected and described.Results: Of the 401 LAI prescribers meeting survey criteria, 64.6% reported that LAI prescribing remained unchanged (increase: 19.2%, decrease: 14.0%). The majority did not switch patients from LAIs to oral antipsychotics (OAP; 63.3%) or to LAI formulations with lower frequency of administration (68.1%); most prescribers switched the same number of patients from OAPs to LAIs during the pandemic as in previous practice (65.1%). Half of LAI prescribers (50.1%) reported antipsychotic adherence as unchanged among most patients; 44.6% reported symptom control/relapse frequency as unchanged. Most prescribers believed their patients with schizophrenia should be prioritized for COVID-19 vaccination (74.1%) and encouraged all patients to obtain a COVID-19 vaccine (84.0%). However, 64.1% of prescribers reported hesitancy among some patients about vaccines’ safety; 51.4% reported that some patients were willing to be vaccinated despite the hesitancy, 48.6% indicated that some patients perceived COVID-19 vaccines as safe, effective, and important.Conclusion: LAI prescribing and prescriber-reported antipsychotic adherence in patients with schizophrenia remained largely unchanged approximately one year after the start of COVID-19. Focused efforts to overcome patients’ COVID-19 vaccine hesitancy are warranted.Keywords: adherence, antipsychotics, COVID-19, physician survey, prescribing habits, schizophrenia

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

To describe real-world use of esketamine (ESK) intranasal spray and healthcare outcomes among patients with treatment-resistant depression (TRD) in the United States (US). Adults with TRD initiated on ESK (index date) between 5 March 2019 (US approval date for TRD) and 31 October 2020 were sampled from IBM MarketScan Research Databases. TRD was defined as claims for ≥2 unique antidepressants during the same major depressive episode. Subgroups of the TRD cohort with comorbid cardiometabolic conditions, pain, anxiety disorder, and substance use disorder (SUD) were identified. Patients had ≥6 months of continuous health plan eligibility pre- and post-index. The TRD cohort comprised 269 patients; comorbidity subgroups included 123 (cardiometabolic), 144 (pain), 189 (anxiety disorder), and 58 (SUD) patients. Proportion of patients completing ≥8 ESK sessions (number of sessions in induction phase) was 61.3% in the TRD cohort and ranged from 60.2% (cardiometabolic subgroup) to 72.4% (SUD subgroup) in subgroups. Median frequency of induction sessions was every 5–8 days among the TRD cohort and subgroups. Mean mental health–related inpatient costs reduced from pre- to post-index periods in the TRD cohort (mean ± standard deviation [median] costs per-patient-per-6-months: $3,480 ± $13,328 [$0] pre-ESK initiation; $3,262 ± $16,666 [$0] post-ESK initiation; mean difference: –$218) and subgroups (largest decrease in cardiometabolic subgroup: $4,864 ± $14,271 [$0]; $2,792 ± $15,757 [$0]; –$2,072). Mean mental health–related emergency department (ED) costs decreased in the TRD cohort ($608 ± $2,525 [$0]; $269 ± $1,143 [$0]; –$339) and subgroups (largest decrease in the SUD subgroup: $1,403 ± $3,752 [$0]; $351 ± $868 [$0]; –$1,052). This is a descriptive analysis; sample size for some comorbidity subgroups is small. The majority of patients completed ESK induction phase, and most dosing intervals were longer than the label recommendation. In this descriptive analysis, mental health–related inpatient and ED costs trended lower post-ESK initiation.

To describe real-world esketamine nasal spray access and use as well as healthcare resource use (HRU) and costs among adults with evidence of major depressive disorder (MDD) with suicidal ideation or behavior (MDSI). Adults with ≥1 claim for esketamine nasal spray and evidence of MDSI 12 months before/on the date of esketamine initiation (index date) were selected from Clarivate’s Real World Data product (01/2016–03/2021). Patients initiated esketamine on/after 03/05/2019 (esketamine approval for treatment-resistant depression; later approved for MDSI on 08/05/2020) were included in the overall cohort. Esketamine access (measured as approved/abandoned/rejected claims) and use were described post-index; HRU and healthcare costs (2021 USD) were described over 6 months pre- and post-index. Among 269 patients in the overall cohort with esketamine pharmacy claims, 46.8% had the first pharmacy claim approved, 38.7% had it rejected, and 14.5% abandoned their claim; 169 patients were initiated on esketamine in the overall cohort (mean age 40.9 years, 62.1% female); 45.0% had ≥8 esketamine treatment sessions (recommended per label) with a mean [median] of 85.0 [58.5] days from index to 8th session (per label 28 days). Among 115 patients with ≥6 months of data post-index, in the 6-month pre- and post-index, respectively, 37.4 and 19.1% had all-cause inpatient admissions, 42.6 and 33.9% had emergency department visits, 92.2 and 81.7% had outpatient visits; mean ± standard deviation all-cause monthly total healthcare costs were $8,371±$15,792 and $6,486±$7,614, respectively. This was a descriptive claims-based analysis; no formal statistical comparisons were performed due to limited sample size as data covered up to 24 months of esketamine use in the US clinical setting. Nearly half of patients experience access issues with first esketamine nasal spray treatment session. All-cause HRU and healthcare costs trend lower in the 6 months after relative to 6 months before esketamine initiation. Major depressive disorder (MDD), or clinical depression, can sometimes be accompanied by preoccupation with suicide along with suicidal behavior. Patients diagnosed with MDD with suicidal ideation or behavior (MDSI) can vary in their reactions to this condition, and some never seek treatment. This study investigated treatment patterns in real-world clinics of a recently approved nasal spray therapy, esketamine, which helps improve depressive symptoms in patients with MDSI. The study results highlight challenges related to esketamine treatment access, particularly for the first treatment session. Still, healthcare resource utilization and healthcare costs trended lower following treatment initiation with esketamine in MDSI, suggesting the potential benefits of esketamine in mitigating the clinical and economic burden of MDSI among those who gain access to the drug. Streamlining the approval process by health plan providers to remove hindrances related to compliance with plan requirements may ensure more timely access to esketamine for MDSI.

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

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

BACKGROUND Sustained use of biologics and small molecule/advanced therapy has proven to be effective for controlling disease activity in ulcerative colitis (UC). The anti-interleukin agent ustekinumab was recently approved for UC in 2019. This study aimed to describe real-world ustekinumab persistence among patients with UC attaining the maintenance phase. METHODS Adults with UC selected from the Komodo Health’s comprehensive dataset had the first claim for ustekinumab (index date) between 10/21/2019 and 08/13/2021. Patients had ≥12 months of continuous insurance eligibility pre-index (baseline period), ≥1 claim with a diagnosis of UC at baseline or on the index date and persisted to their first subcutaneous ustekinumab claim (maintenance phase). Patients with diagnoses for other immune disorders at baseline or diagnoses for Crohn’s disease at any time were excluded. Persistence to ustekinumab was defined as absence of a therapy exposure gap of >120 days between days of supply or end of follow-up. Composite endpoints were persistence while being corticosteroid-free (no corticosteroids with ≥14 days of supply after day 90 post-index), and persistence while on monotherapy (no immunomodulators/non-index biologics or advanced therapies). Persistence endpoints were described post-maintenance phase until the earlier of 12 months, end of insurance eligibility, or data. Kaplan-Meier curves were used to assess persistence outcomes in all patients and among patients without prior biologic/advanced therapy exposure pre-index (bio-naïve). RESULTS 778 patients attaining the ustekinumab maintenance phase were selected, 236 (30.3%) were bio-naïve (Fig. 1). Mean follow-up time post-index was 13.5 months overall and 12.7 months for bio-naïve patients. By 12 months post-maintenance, 73.2% of all patients and 75.5% of bio-naïve patients were persistent to ustekinumab (Fig. 2). Additionally, amongst patients who were persistent and corticosteroid-free between the index date and the start of maintenance phase, 47.0% of all patients and 55.1% of bio-naïve patients remained persistent and corticosteroid-free 12 months after their first maintenance claim. Further, among patients who were persistent on monotherapy at the start of maintenance phase, 63.6% of all patients and 68.1% of bio-naïve patients remained persistent on monotherapy at 12 months. CONCLUSIONS In this study, 12 months after their first ustekinumab maintenance claim for UC, most patients who attained the maintenance phase were persistent to treatment, around half of patients who were also corticosteroid-free at the start of the maintenance phase remained persistent and corticosteroid-free, and most patients who were persistent on monotherapy at the start of the maintenance phase remained persistent on monotherapy.

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

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

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.

Maryia Zhdanava,1 H Lynn Starr,2 Patrick Lefebvre,1 Todor I Totev,3 Aditi Shah,1 Kristy Sheng,4 Dominic Pilon1 1Analysis Group, Inc, Montréal, Quebec, Canada; 2Janssen Scientific Affairs, LLC, Titusville, NJ, USA; 3Analysis Group, Inc, Boston, MA, USA; 4Analysis Group, Inc, Menlo Park, CA, USACorrespondence: Maryia Zhdanava, Analysis Group, Inc, 1190 avenue des Canadiens-de-Montréal, Suite 1500, Montréal, Quebec, H3B 0G7, Canada, Tel +1 514-394-4469, Email Masha.Zhdanava@analysisgroup.comPurpose: To describe factors that enable the routine use of long-acting injectable antipsychotics (LAIs) for appropriate patients in the current clinical practice, including changes in LAI prescribing due to the COVID-19 pandemic and expectations for prescribing in 2021 in the United States (US).Methods: Frequent LAI prescribers recruited from a nationwide panel in 2020 completed an online survey regarding practice characteristics, perspectives on healthcare system conditions enabling routine use of LAIs, and prescribing patterns and changes in patterns during the COVID-19 pandemic.Results: Of 408 prescribers who completed the survey, 77.7% were physicians and 59.1% had ≥ 10 years of psychiatry practice. More than half of frequent prescribers (57.1%) reported treating > 20% of their patients with schizophrenia with LAIs. The American Psychiatric Association (APA) guideline was followed by 64.0% of prescribers. Most prescribers identified poor adherence to antipsychotics as a circumstance when LAIs are recommended (94.9%) and patient/caregiver involvement in treatment decisions as a key factor impacting the decision to prescribe LAIs (97.3%). Most prescribers reported that LAI prescribing rates were unchanged in 2020 (59.8%). Similar proportions of prescribers expected no change (44.1%) or an increase (42.9%) in LAI prescribing rates in 2021. The number of patients followed, cost of treatment, and availability of staff to administer LAIs were the main driving factors identified by prescribers expecting an increase in LAI prescribing rates.Conclusion: LAIs were commonly recommended to patients with poor adherence, and patient/caregiver involvement was an important factor affecting prescribers’ treatment decisions. LAI prescribing rates remained unchanged during the COVID-19 pandemic in 2020.Keywords: COVID-19, healthcare providers, long-acting injectable antipsychotics, prescribing patterns, schizophrenia

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

To compare health care resource utilization (HRU) and costs among commercially insured patients with nasal polyposis (NP) with and without recurrence after endoscopic sinus surgery (ESS).Retrospective matched cohort study.Adults with initial ESS or an NP excision after a new NP diagnosis were identified in Optum's Clinformatics Data Mart Database (October 1, 2014-December 31, 2019).The index date was the date of NP recurrence, identified with a claims-based algorithm for the recurrent cohort, or a random date for the nonrecurrent cohort. Patients in both cohorts were matched 1:1 on baseline characteristics (12 months preindex) via propensity scores and exact matching factors. Annual HRU and costs (2019 US$) were compared between the matched cohorts at 12 months postindex.NP recurrence was identified among 3343 of 16,693 patients with initial ESS; after matching, each cohort comprised 1574 patients (median age, 54 years; 40% female) with similar baseline health care costs (recurrent, $34,420; nonrecurrent, $33,737). At 12 months postindex, the recurrent cohort had higher HRU, including 36% and 51% more outpatient and emergency department visits, respectively (allNP recurrence is associated with a substantial economic burden, which appears to be driven by outpatient services.

BACKGROUND Treatment of Crohn’s disease (CD) may require biologics. Dose escalation may be necessary to maintain efficacy, while adverse events or non-response may lead to treatment discontinuation. This analysis aimed to generate real-world evidence of persistence to ustekinumab versus adalimumab while on labeled maintenance dose (United States [US] prescribing information) among bio-naïve patients with CD in the US. METHODS Adults with CD initiated on ustekinumab or adalimumab from 09/23/2016 (approval of ustekinumab for CD in the US) to 08/01/2019 were selected from a de-identified health insurance claims database (IQVIA PharMetrics® Plus). Patients who used other biologics indicated for CD or had diagnoses for other autoimmune disorders in the 12 months before the initiation of the index agent (baseline) were excluded. Cohorts were balanced on baseline characteristics using inverse probability of treatment weights. Persistence to the index agent while on labeled maintenance dose was defined as (1) absence of gaps between days of therapy supply >120 days for ustekinumab (twice the 8-week on-label maintenance dosing interval) or >60 days for adalimumab (twice the mode of days of supply in claims) and (2) absence of any dose change during the maintenance phase relative to the dose per US label. It was assessed from the index date until the earliest of discontinuation (event), dose change during the maintenance phase (censoring), or the last day of index agent supply before the end of follow-up (censoring). Weighted Kaplan-Meier and Cox proportional hazards models were used to assess the outcome at 12 months post-index. RESULTS 948 bio-naïve patients with CD were included in the ustekinumab cohort (mean age 42.5 years old; 58.1% female) and 4,143 in the adalimumab cohort (mean age 42.3 years old; 56.7% female). During the baseline period, 8.4% and 9.2% previously had CD-related surgery, 66.6% and 67.7% used corticosteroids, and 25.9% and 26.3% used immunomodulators in the ustekinumab and adalimumab cohorts, respectively. At 12 months post-index, a higher proportion of patients in the ustekinumab cohort versus adalimumab cohort were persistent to the index biologic while on labeled maintenance dose (74.1% vs 65.4%; Fig. 1). Patients in the ustekinumab versus adalimumab cohort had a 47% higher rate of persistence while on labeled maintenance dose (hazard ratio [HR] 1.47; 95% confidence interval [CI]: 1.25-1.73; P-value: CONCLUSIONS Bio-naïve patients with CD initiated on ustekinumab were significantly more persistent while on labeled maintenance dose compared to patients initiated on adalimumab. These results are consistent with previous work, which demonstrated significantly higher persistence to the index agent and a trend of lower dose escalation rates among bio-naïve patients with CD initiating ustekinumab versus adalimumab.

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

Biologics are a standard therapy for patients with moderate-to-severe psoriasis, yet treatment persistence is essential to achieve disease control. Compared with other biologics, ustekinumab has been associated with lower rates of discontinuation and better adherence among patients with psoriasis, but prior studies have included limited data from the period after approval of self-administration for ustekinumab. This study was conducted to assess discontinuation risk among patients with plaque psoriasis initiating ustekinumab or other biologics.Adults with psoriasis and one or more claim for ustekinumab, secukinumab, adalimumab, or ixekizumab were identified in Optum's de-identified Clinformatics Data Mart Database (1 January 2010 to 30 June 2019). Treatment discontinuation was defined as a gap in days of therapy supply based on (1) each drug's per-label frequency of administration (main analysis) or (2) 90 days (sensitivity analysis). Differences in baseline characteristics between the ustekinumab and other cohorts were adjusted with entropy balancing. Risk of discontinuation was compared with Cox proportional hazard models.Overall, 2230 patients were included in the ustekinumab cohort, with 1807 in the secukinumab, 4483 in the adalimumab, and 535 in the ixekizumab cohorts (mean age 49.0 years, 49.3% female for all cohorts). In the main analysis, risk of discontinuation for the ustekinumab cohort was 62.2% lower than for adalimumab, 46.4% lower than for secukinumab, and 43.8% lower than for ixekizumab cohorts (all p 0.001). Sensitivity analyses revealed no significant differences between the ustekinumab and other cohorts.Patients with psoriasis initiating ustekinumab had lower risk of treatment discontinuation compared with other biologics when discontinuation was based on each drug's per-label frequency of administration. This finding may help inform choice of biologic based on compliance.

BACKGROUND In Crohn’s disease (CD), dose escalation on biologic therapy may be required to maintain effectiveness, while adverse events or non-response, among other factors, may lead to lack of persistence. Understanding persistence while on labeled maintenance dose is particularly important in bio-experienced patients with CD, as they may have reduced response to subsequent lines of therapy. This analysis compared persistence while on labeled maintenance dose among bio-experienced patients on ustekinumab versus adalimumab in the United States (US). METHODS Adults with CD initiated on ustekinumab or adalimumab (index date) between 09/23/2016 (ustekinumab approval for CD in the US) and 08/01/2019 were selected from IBM® MarketScan® Commercial Database. Patients were bio-experienced (≥1 claim for another CD-indicated biologic in the 12 months baseline period pre-index date). Patients with other auto-immune diseases at baseline were excluded. Cohorts were balanced on baseline characteristics using inverse probability of treatment weights. Persistence to the index agent while on labeled maintenance dose was defined as (1) no gaps between days of therapy supply >120 days for ustekinumab (2 x 8-week on-label maintenance dose interval) or >60 days for adalimumab (2 x days of supply mode) and (2) no dose change relative to the US label maintenance dose. It was assessed from index date until the earliest of discontinuation (event), dose change during maintenance phase (censoring), or last day of supply (censoring). Weighted Kaplan-Meier and Cox proportional hazards models adjusted for baseline classes of biologics were used to assess the outcome at 12 months post-index. RESULTS 903 bio-experienced patients with CD were included in the ustekinumab cohort (mean age 40.9 years old; 57.1% female) and 525 in the adalimumab cohort (mean age 41.3; 56.3% female). During the baseline period, 71.1% and 72.6% used corticosteroids, 41.2% and 40.8% used immunomodulators, and 11.1% and 12.6% had a prior CD-related surgery, in the ustekinumab and adalimumab cohorts, respectively. At 12 months post-index, the probability of persisting on the index biologic while on labeled maintenance dose was higher in the ustekinumab cohort versus adalimumab cohort (78.8% vs. 67.8%; Fig. 1). Patients in the ustekinumab versus adalimumab cohort had a 71% higher rate of persistence while on labeled maintenance dose (hazard ratio [HR] 1.71; 95% confidence interval: 1.31-2.23; P-value: CONCLUSIONS Bio-experienced patients with CD initiated on ustekinumab were significantly more persistent while on labeled maintenance dose compared to patients initiated on adalimumab. These results confirm results on persistence to biologics in bio-experienced patients with CD from a prior study.

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.

Objective Estimates of prevalence and burden of treatment-resistant depression (TRD) vary widely in the literature. This study evaluated the prevalence and burden of TRD and the share of TRD in the burden of medication-treated major depressive disorder (MDD) using the most commonly accepted definition of TRD and a novel bottom-up approach. Methods Prevalence and health care burden of TRD were estimated by synthetizing inputs across 4 similarly designed claims studies in adults covered by Medicare, Medicaid, commercial plans, and the US Veterans Health Administration (VHA). Productivity (absenteeism and presenteeism) and unemployment burden were estimated based on inputs from a study conducted with data from the Kantar National Health and Wellness Survey (NHWS; 2017). A targeted literature search for additional inputs was performed. A cost model was developed to estimate the burden of TRD and medication-treated DSM-5-defined MDD in the United States. Study outcomes were the 12-month prevalence of TRD and the annual health care, productivity, and unemployment burden of TRD and medication-treated MDD in the United States. Results The estimated 12-month prevalence of medication-treated MDD in the United States was 8.9 million adults, and 2.8 million (30.9%) had TRD. The total annual burden of medication-treated MDD among the US population was $92.7 billion, with $43.8 billion (47.2%) attributable to TRD. The share of TRD was 56.6% ($25.8 billion) of the health care burden, 47.7% ($8.7 billion) of the unemployment burden, and 32.2% ($9.3 billion) of the productivity burden of medication-treated MDD. Conclusions TRD is associated with disproportionate health care costs and unemployment, suggesting potentially large economic and societal gains with effective management.

Little is known about the economic burden of treatment-resistant depression (TRD) in patients with physical conditions.To assess health care resource utilization (HRU) and costs, work loss days, and related costs in patients with TRD and physical conditions versus patients with the same conditions and non-TRD major depressive disorder (MDD) or without MDD.Adults aged65 years with MDD treated with antidepressants were identified in the OptumHealth Care Solutions database (July 2009-March 2017). Patients who received a diagnosis of MDD and initiated a third antidepressant regimen (index date) after 2 regimens of adequate dose and duration were defined as having TRD. Patients with non-TRD MDD and without MDD were assigned a random index date. Patients with6 months of continuous health plan eligibility pre- or post-index; a diagnosis of psychosis, schizophrenia, bipolar disorder/mania, dementia, and developmental disorders; and/or no baseline physical conditions (cardiovascular, metabolic, and respiratory disease or cancer) were excluded. Patients with TRD were matched 1:1 to each of the non-TRD MDD and non-MDD cohorts based on propensity scores. Per patient per year HRU, costs, and work loss outcomes were compared up to 24 months post-index date using negative binominal and ordinary least square regressions.A total of 2,317 patients with TRD (mean age, 47.6 years; 63.1%, female; mean follow-up, 19.7 months) had ≥ 1 co-occurring key physical condition (cardiovascular, 52.5%; metabolic, 48.2%; respiratory, 16.4%; and cancer, 9.5%). Relative to non-TRD MDD and non-MDD cohorts, respectively, patients with TRD had 46% and 235% more inpatient admissions, 28% and 128% more emergency department visits, and 53% and 155% more outpatient visits (allIn patients with physical conditions, those with TRD had higher HRU and health care costs, work loss days, and associated costs compared with non-TRD MDD and non-MDD cohorts.This study was sponsored by Janssen Scientific Affairs (JSA), which was involved in all aspects of the research, including the design of the study; the collection, analysis, and interpretation of data; writing of the report; and the decision to submit the report for publication. Joshi and Daly are employed by JSA. Zhdanava, Pilon, Rossi, Morrison, and Lefebvre are employees of Analysis Group, which received funding from JSA for conducting this study and has received consulting fees from Novartis Pharmaceuticals and GSK, unrelated to this study. Kuvadia is employed by Integrated Resources, which has provided research services to JSA unrelated to this study; Joshi reports past employment by and stock ownership in JohnsonJohnson; Nelson reports advisory board, data and safety monitoring board, and consulting fees from Assurex, Eisai, FSV-7, JSA, Lundbeck, Otsuka, and Sunovion and royalties from UpToDate, unrelated to this study. This work was presented at AMCP Nexus 2019, held in National Harbor, MD, from October 29 to November 1, 2019.

Background Omalizumab was approved for the treatment of chronic idiopathic urticaria (CIU)/chronic spontaneous urticaria (CSU) in the United States in March 2014. Objective This study sought to describe real-world omalizumab use, in the United States, in a large cohort of patients with CIU/CSU. Methods Patients with CIU/CSU (ages ≥12 years) initiated on omalizumab (index date) with ≥12 months of pre- and postindex data were identified in the an insurance claims data base (January 1, 2013, to July 31, 2016). Treatment patterns, including the dosing regimen and continuous use of omalizumab (no gaps for ≥60 days), were described during the 12-month postindex follow-up period. Results A total of 1546 patients (mean ± standard deviation [SD] ages, 44 ± 14.5 years; 73.1% women) were identified. Most of the patients (84.5%) were initiated on omalizumab 300-mg dose; 90% maintained the initial dose, 7.5% had a dose increase, and 4.6% had a dose decrease. The mean ± SD omalizumab treatment duration was 9.1 ± 3.8 months, the mean ± SD number of omalizumab administrations was 8.3 ± 4.8, and the mean ± SD administration frequency was 44 ± 29 days. A proportion of the patients continuously treated with omalizumab for 6, 9, and 12 months was 67.3, 54.8, and 47.4%, respectively. Among the patients who discontinued omalizumab for ≥3 months (39.8%), 21% restarted the treatment after a mean ± SD of 4.4 ± 1.3 months. The proportion of patients who used other CIU/CSU-related medications decreased pre- to postindex (94.8 to 81.1%), with the highest decrease observed in oral corticosteroids (75.7 to 49.9%). Conclusion In this large real-world study, the majority of the patients with CIU/CSU were initiated on a 300-mg omalizumab dose and treated without titration up or down for 9 months on average. Most of the patients were continuously treated with omalizumab for ≥6 months, and one-fourth of the patients who discontinued treatment resumed it. Moreover, compared with baseline levels, the use of other CIU/CSU-related medications was lower after omalizumab initiation, with the most prominent decrease observed in oral corticosteroids.

Introduction Few studies have described chronic idiopathic/spontaneous urticaria (CIU/CSU) healthcare burden in adults, while this information remains largely unknown in children. We aimed to describe treatment patterns, healthcare resource utilization (HRU), and costs in CIU/CSU pediatric patients, as well as to compare HRU and costs in CIU/CSU and CIU/CSU-free pediatric patients. Methods Medicaid claims from four states (09/01/2013–03/31/2016) were used to identify patients less than 12 years old. The CIU/CSU cohort included patients with either at least two claims for idiopathic, other, or unspecified urticaria at least 6 weeks apart, or at least one claim for urticaria and at least one claim for angioedema at least 6 weeks apart (index date defined as the first claim). The control cohort included patients without urticaria/angioedema claims (index date randomly assigned). Patients without at least 6 months of continuous Medicaid eligibility pre- and post-index were excluded. HRU and costs were compared between propensity score-matched cohorts during the post-index follow-up. Results A total of 548 CIU/CSU patients (mean [SD] age 4.5 [3.3] years; 51.3% male) were matched 1:1 with controls. In the CIU/CSU cohort, 51.8% used non-sedating prescription H1-antihistamines, 24.3% used oral corticosteroids, and 23.5% used other prescription H1-antihistamines; 13.5% consulted allergist/immunologists and 2.4% consulted dermatologists in the first 6 months of follow-up. Compared to controls, CIU/CSU patients had significantly more per patient per year (PPPY) inpatient (incidence rate ratio [IRR] 2.05), outpatient (IRR 2.20), and emergency department (IRR 1.64) visits (all p values

To assess the burden of treatment-resistant depression (TRD) among privately insured patients with anxiety disorder and/or substance use disorders (SUD). Adults p p N = 310/cohort), patients with TRD had more work loss days (54) and higher work loss-related costs ($13,674) vs patients with non-TRD MDD (32 days; $7131) and without MDD (17 days; $4798; all p In patients with an anxiety disorder and/or SUD, TRD was associated with higher HRU, healthcare costs, work loss days and work loss-related costs.

The objective was to assess the association of Medicaid coverage gaps with health care resource utilization (HRU) and costs of patients with schizophrenia. Patients with schizophrenia were identified from the Medicaid database. The beginning of the first eligible gap was defined as the index date. Per-patient per-month (PPPM) HRU and costs before versus after a gap were assessed, and the association between gap duration and PPPM HRU and costs was examined up to 12 months post index. Together with 95% confidence intervals, HRU differences were reported in rate ratios (RRs), and cost differences were reported in 2016 US dollars. A subgroup of males with substance use disorder (SUD; risk factors for incarceration) also was analyzed. Total PPPM health care costs increased significantly by $711.04 following a coverage gap (

Background: Although clinical trials documented omalizumab's efficacy in U.S. patients with chronic idiopathic urticaria (CIU), the real-world evidence on its long-term effectiveness is lacking. Objective: To assess omalizumab use and the long-term response in a large sample of U.S. real-world patients. Methods: Patients with CIU and ≥ 12 years old who were initiated on omalizumab (index date) and with ≥ 6 months of postindex data were identified in an electronic medical record system (2007-2018). Omalizumab use was described. Provider assessments of disease control and course, and patient-reported symptoms were compared at 6-month intervals postindex versus baseline in the patients with values available at both time points. Results: A total of 1096 patients (mean age, 44.1 years; 74.7% women) were followed up for a mean of 19 months postindex. Patients, predominantly initiated on a 300-mg dose, received a mean of 15 omalizumab administrations and were treated continuously for a mean of 14.2 months. At 6 months postindex versus baseline, the patients (n = 708) were more likely to be well controlled (odds ratio [OR] 31.68 [95% confidence interval {CI}, 17.20-58.36]) with an improved disease course (OR 15.73 [95% CI, 11.33-21.85]). Moreover, the patients (n = 373) were less likely to report itching (OR 0.39 [95% CI, 0.21-0.76]), rash (OR 0.59 [95% CI, 0.45-0.78]), and swelling (OR 0.46 [95% CI, 0.36-0.59]). Benefits associated with omalizumab treatment were sustained through month 24 and beyond. Conclusion: This real-world study showed that the patients who received a mean of 15 omalizumab administrations over a mean of 14.2 months experienced, starting at 6 and through 24 months after omalizumab initiation and beyond, improved CIU control, course, and symptoms.

This analysis assessed healthcare costs associated with progression of chronic kidney disease (CKD) in patients with type 2 diabetes (T2D). Adults (90 days later. Non-progression required an eGFR indicating same stage within 12 months and eGFR confirmation of same stage >12 months post-index. Per-patient per-month (PPPM) healthcare costs evaluated from index to the earliest of end of eligibility or data were compared between progressors and non-progressors by baseline CKD Stage, and adjusted costs were compared using multivariate linear regressions. Of the 204,767 patients selected, 4.8% progressed ≥1 CKD Stage within a year. Progressors were older (72.5 vs. 64.5 years), more likely to be female (55.6% vs. 51.2%) and had a higher Diabetes Complications Severity Index (2.12 vs. 1.17) compared to non-progressors. Healthcare costs PPPM for progressors vs. non-progressors were $2,685 vs. $1,659 for baseline normal eGFR, $3,131 vs. $2,003 for G3a, $5,138 vs. $2,396 for G3b and $14,400 vs. $3,475 for G4. Among patients with confirmed progression status, progressors represented 4.1%, 8.5%, 5.5% and 4.2% of those from normal eGFR, G3a, G3b and G4, respectively. Controlling for baseline characteristics, the adjusted incremental post-index healthcare costs associated with progressors were $674 for baseline normal eGFR, $947 for G3a, $2,625 for G3b, and $10,704 for G4. All comparisons tested at p Disclosure L. Blonde: Consultant; Self; Gilead Sciences, Inc., Janssen Pharmaceuticals, Inc., Merck & Co., Inc., Novo Nordisk Inc., Sanofi US. Research Support; Self; Janssen Pharmaceuticals, Inc., Lexicon Pharmaceuticals, Inc., Merck & Co., Inc., Novo Nordisk Inc., Sanofi US. Speaker's Bureau; Self; Janssen Pharmaceuticals, Inc., Novo Nordisk Inc., Sanofi US. J.A. Vassalotti: Advisory Panel; Self; Merck & Co., Inc. Consultant; Self; Janssen Pharmaceuticals, Inc., KPMG. D. Pilon: Other Relationship; Self; Janssen Scientific Affairs, LLC., Novartis Pharmaceuticals Corporation. W. Wynant: Consultant; Self; AbbVie Inc., Bristol-Myers Squibb Company, Daiichi Sankyo Company, Limited, Genentech, Inc., GlaxoSmithKline plc., Janssen Scientific Affairs, LLC., Novartis Pharmaceuticals Corporation, Novartis Pharmaceuticals Corporation, Taiho Pharmaceutical Co., Ltd. M. Zhdanava: Other Relationship; Self; Janssen Scientific Affairs, LLC., Novartis Pharmaceuticals Corporation. P. Lefebvre: Research Support; Self; Janssen Scientific Affairs, LLC. J. Voelker: Consultant; Self; Janssen Scientific Affairs, LLC. R. Bailey: Employee; Self; Janssen Scientific Affairs, LLC. Stock/Shareholder; Self; Johnson & Johnson. M. Durkin: Employee; Self; Janssen Scientific Affairs, LLC. Funding Janssen Scientific Affairs, LLC

Purpose Biomarkers, including blood eosinophils (EoS) and fractional exhaled nitric oxide (FeNO), may affect omalizumab outcomes in allergic asthma, but evidence in the literature remains mixed. This study assessed omalizumab outcomes in real-world patients with allergic asthma stratified by pretreatment biomarker levels. Methods Patients with allergic asthma aged ≥12 years initiated on omalizumab with ≥12 months of data after index were identified in the Allergy Partners electronic medical records (2007–2018). Patients with ≥1 diagnosis of chronic obstructive pulmonary disease in combination with ≥10 pack-years of smoking, cystic fibrosis, Alpha-1 antitrypsin deficiency, bronchiectasis, interstitial lung disease, and sarcoidosis in the 12 months before or after index were excluded. Patients were stratified by pretreatment EoS (≥/ Findings A total of 77 and 86 patients were stratified into the high and low EoS strata, respectively, and 56 patients into each of the intermediate-high and low FeNO strata. Compared with 6 months before index, mean difference (MD) in ACT scores at 6 months after index reached the minimally important difference of ≥3 points in high (MD = 3.75; 95% CI, 2.05–5.45) and low (MD = 4.56; 95% CI, 2.86–6.26) EoS, as well in the intermediate-high (MD = 3.75; 95% CI, 1.95–5.55) and low (MD = 3.55; 95% CI, 1.53–5.57) FeNO strata. Statistically significant improvements in mean FEV1 were observed in the high EoS (MD = 0.22 L/s; 95% CI, 0.08–0.35 L/s) and intermediate-high FeNO (MD = 0.13 L/s; 95% CI, 0.03–0.24 L/s) strata but not in the lower strata. In terms of mean FEV1% predicted, a statistically significant improvement was observed in high EoS stratum (MD = 4.95%; 95% CI, 0.60%–9.30%). Results that compared 12 months after versus before index date were similar. Implications Omalizumab was associated with statistically significant improvements in ACT scores largely reaching or exceeding minimally important difference across biomarker levels and with a statistically significant improvement in lung function more evident in high biomarker strata. Although response varied by biomarkers for some outcomes, all strata indicated improvements on ≥1 measure. Real-world patients with allergic asthma could benefit from omalizumab regardless of pretreatment biomarker levels, suggesting that pretreatment biomarker levels might not inform response.

Aim: To assess the 5-year healthcare resource utilization (HRU) and direct payer costs following allogeneic hematopoietic stem cell transplants (HSCTs) in acute lymphoblastic leukemia pediatric patients using data from two large US administrative databases. Patients & methods: Among the 209 patients with acute lymphoblastic leukemia, HRU and costs were described over the up to 5 years after the HSCT. Results: HRU and costs following the HSCTs were substantial. The highest average costs and most intensive HRU were observed within the first year following the HSCTs (49 outpatient visits; 29 laboratory service visits; 68 inpatient days), with a first year cost of US$683,099 and substantial costs over the following years. Conclusion: HRU and direct costs associated with allogeneic HSCTs are substantial.

Among patients with major depressive disorder (MDD), those with treatment-resistant depression (TRD) have a higher economic burden. However, the healthcare resource utilization (HRU) and costs may vary by severity status in TRD patients. This study quantified the incremental economic burden of severity status in TRD patients.In a US database of privately insured employees and dependents (07/01/2009-03/31/2015), a claims-based algorithm identified adult TRD patients who were stratified into mild, moderate, and severe cohorts based on the information in the last observed MDD ICD-9-CM code. HRU and costs of moderate and severe cohorts were compared to those of the mild cohort during the 2-year follow-up after the first antidepressant claim.Among 6411 TRD patients, 455 (7.1%) were identified as mild, 2153 (33.6%) as moderate, and 1455 (22.7%) as severe. Moderate and severe patients compared to mild had 45% and 150% more inpatient admissions, 65% and 164% more inpatient days, 18% and 54% more emergency department visits and 8% and 10% more outpatient visits per-patient-per-year (PPPY), respectively (all-cause; all p 0.05). Mean all-cause direct total healthcare costs were $12,123, $16,885, and $18,911 PPPY in mild, moderate, and severe patients, respectively. The all-cause total healthcare cost differences adjusted for baseline characteristics amounted to $3455 in moderate and $5150 in severe versus mild patients, respectively (PPPY; all p 0.05).Not all TRD patients had a severity specifier; the severity specifier was not cross-validated against a depression scale.Increased severity status is associated with incremental economic burden in TRD patients.

Objectives: To compare comorbidity-related outcomes, adherence to antipsychotics (APs), healthcare resource utilization (HRU), and costs pre- and post-transition to once-every-3-months paliperidone palmitate (PP3M) in commercially-insured patients with schizophrenia. Methods: Adults with ≥1 claim for PP3M, ≥2 schizophrenia diagnoses, and adequate treatment with once-monthly paliperidone palmitate (PP1M; i.e. no gap of >45 days in PP1M coverage for ≥4 months, same PP1M dosage for the last two PP1M claims, and appropriate PP1M to PP3M dosing conversion) were selected from the IQVIA PharMetrics Plus database (May 2014–February 2018). Generalized estimating equation models adjusted for repeated measurements were used to compare patient characteristics, adherence to APs, HRU, and costs during the 6-month period pre- vs post-transition to PP3M. Results: Of 152 included patients, the mean age was 41.0 years and 36.2% were females. Post-PP3M transition, patients were less likely to have a claim with a diagnosis for substance-related and addictive disorders (odds ratio [OR] = 0.57), psychoses (OR = 0.57), diabetes without chronic complication (OR = 0.72), and drug abuse (OR = 0.64; all p p = .007), compared to the period pre-PP3M transition. There was no significant difference in HRU pre- vs post-transition. All-cause total (mean monthly cost difference [MMCD] = $242), pre-rebate pharmacy (MMCD = $65), and medical costs (MMCD = $176) remained similar pre- vs post-transition (all p > .05). Conclusions: Transitioning to PP3M was associated with an improvement in adherence and in comorbidity-related outcomes related to substance-related and addictive disorders, psychoses, diabetes without chronic complication, and drug abuse. These findings suggest PP3M may enhance comorbidity-related outcomes and adherence while remaining cost neutral.

BACKGROUND Chronic idiopathic urticaria (CIU)/spontaneous urticaria (CSU) is defined by the presence of wheals, angioedema, or both for ≥6 weeks, with or without an identifiable trigger. Real-world health care data among children with CIU/CSU remain scarce. OBJECTIVES To describe treatment patterns, health care resource utilization (HRU), and costs in pediatric patients with CIU/CSU (

Clinical trials and real-world studies reported that canagliflozin (CANA) improved HbA1c, blood pressure (BP), and weight in patients with type 2 diabetes mellitus (T2DM). This study examines if previous results hold regionally and within specific patient sub-groups.Adults with T2DM and ≥12 months of clinical activity before the first CANA prescription (index) were identified in electronic medical records (January 1, 2012-February 15, 2017) from a network of hospitals in Florida. Quality measures were described at baseline and 3, 6, 9, and 12 months post-index. Selected thresholds were HbA1c 7%, BP 140/90 mmHg, and weight loss ≥5%. Sub-groups included patients ≥65 years old, with African American race, with CANA dose increase, initiating CANA in an endocrinology setting, and initiating CANA in a primary care setting.Overall, 1,259 patients (mean age = 56.7 years; 51.2% female, 70.4% White) were identified. Among patients with a baseline HbA1c ≥ 7%, 16.1% had an HbA1c 7% 3 months following CANA initiation, and the mean HbA1c decreased from 8.8% to 8.1%. Among patients with a baseline systolic BP ≥140 mmHg or diastolic BP ≥ 90 mmHg, 59.3% attained a systolic BP 140 mmHg and 77.3% a diastolic BP 90 mmHg after 3 months. HbA1c and BP responses were sustained through 12 months. The proportion of patients with a weight loss from baseline ≥5% increased from 17.0% at 3 months to 31.1% at 12 months. Consistent trends were observed for all sub-groups.In CANA-treated patients and patient sub-groups from a network of Florida hospitals, improvements in quality measures and response durability were similar to clinical trials and other real-world studies.

BACKGROUND Omalizumab is approved in patients with moderate-to-severe allergic asthma with symptoms uncontrolled, despite the mainstay therapy. OBJECTIVE Electronic medical records (EMR) were used to increase the knowledge of omalizumab effectiveness in a real-world setting. METHODS Patients with uncontrolled moderate-to-severe allergic asthma, ages ≥12 years old, initiated on omalizumab (index date), with ≥12 months of pre- and postindex data, were identified in an EMR data base. An Asthma Control Test score (≥20 is considered well controlled), forced expiratory volume in 1 second as a percentage of the predicted value (

Background Although the symptoms of major depressive disorder (MDD) are often manageable with pharmacotherapy, response to first-line antidepressant treatment is often less than optimal. This study describes long-term treatment patterns in MDD patients in the United States and quantifies the economic burden associated with different treatment patterns following first-line antidepressant therapy. Methods MDD patients starting first-line antidepressant monotherapy and having continuous enrollment ≥12 months before and ≥24 months following the index date (i.e., the first documented prescription fill) were selected from the Truven Health Analytics MarketScan (2003–2014) database. Based on the type of first treatment change following initiation, six treatment cohorts were defined a priori (“persistence”; “discontinuation”; “switch”; “dose escalation”; “augmentation”; and “combination”). Treatment patterns through the fourth line of therapy within each cohort, healthcare resource utilization (HCRU), and cost analyses were restricted to patients with adequate treatment duration (defined as ≥42 days) in each line (analysis sub-sample, N = 21,088). HCRU and costs were described at the cohort and pattern levels. Treatment cohorts representing