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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.

Evidence is limited on the economic burden associated with treatment-resistant depression (TRD) among US veterans. We evaluated the economic burden among patients with major depressive disorder (MDD) with and without TRD, and those without MDD in the Veterans Health Administration (VHA). Three cohorts were identified using VHA claims data (01APR2014-31MAR2018). Patients with MDD (aged ≥18) who failed ≥2 antidepressant treatments of adequate dose and duration were defined as having TRD; patients with MDD not meeting this criterion constituted the non-TRD MDD cohort (index: first antidepressant claim). The non-MDD cohort included those without MDD diagnosis (index: randomly assigned). Patients with psychosis, schizophrenia, manic/bipolar disorder, or dementia in the 6-month pre-index period were excluded. Patients with non-TRD MDD and non-MDD were matched 1:1 to patients with TRD based on demographic characteristics (age, gender, race, index year). Health care resource utilization (HRU) and costs were analyzed during the post-index period using a negative binomial model and ordinary least squares regression model, respectively. After 1:1 exact matching, 10,449 patients were included in each cohort (mean age: 48.9 years). Patients with TRD had higher per patient per year (PPPY) HRU than non-TRD MDD (all-cause inpatient visits: incidence rate ratio [IRR]: 1.70 [95% confidence interval: 1.57–1.83]) and non-MDD (IRR: 5.04 [95% confidence interval: 4.51–5.63]), and incurred higher total all-cause health care costs PPPY than non-TRD MDD (mean difference: $5,906) and non-MDD (mean difference: $11,873; all p Among US veterans, TRD poses a significant incremental economic burden relative to non-TRD MDD and non-MDD.

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.

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.

OBJECTIVE To compare treatment patterns and Medicaid spending between schizophrenia patients initiating once-monthly paliperidone palmitate (PP1M) and oral atypical antipsychotics (OAAs) within four comorbid populations: cardiovascular disease (CVD), diabetes, hypertension and obesity. METHODS Five-state Medicaid data identified comorbid adults with schizophrenia initiating PP1M or OAAs (index) from September 2009 balanced with inverse probability of treatment weighting. Chi-squared and t-tests compared index antipsychotic (AP) exposure (no gap >90 days) duration, AP polypharmacy, and index AP adherence (proportion of days covered ≥80%) and persistence (no gap ≥60 days) at 12 months post-index. Linear models with a non-parametric bootstrap procedure compared costs. RESULTS PP1M patients consistently had longer index AP exposure (e.g. CVD: 244 vs. 189 days; p

Objectives: To compare comorbidity-related outcomes, adherence to APs, healthcare resource utilization (HRU), and costs pre- and post-transition to once-every-three-month 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 IQVIATM PharMetrics Plus database (05/2014-02/2018). Generalized estimating equation models adjusted for repeated measurements were used to compare patient characteristics, adherence to antipsychotics, HRU, and costs during the 6-month period pre- versus post-transition to PP3M. Results: Of 152 included patients, 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 = 0.007), compared to the period pre-PP3M transition. There was no significant difference in HRU pre- versus post-transition. All-cause total (mean monthly cost difference [MMCD]=$242), pre-rebate pharmacy (MMCD=$65), and medical costs (MMCD=$176) remained similar pre- versus post-transition (all P > 0.05). 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.