Treatment Patterns, Acute Healthcare Resource Use, and Costs of Patients with Treatment-Resistant Depression Completing Induction Phase of Esketamine in the United States.

BACKGROUND: This study aimed to understand treatment patterns, acute healthcare use, and cost patterns among adults with treatment-resistant depression (TRD) who completed induction treatment with esketamine nasal spray in the United States (US). Per label, induction is defined as administration twice a week for 4 weeks, after which maintenance is started on a weekly basis for 4 weeks, and thereafter, patients are treated weekly or bimonthly. METHODS: Adults with one or more esketamine claim (index date) on or after March 5, 2019 were selected from Optum's de-identified Clinformatics® Data Mart Database (January 2016-June 2022). Before the index date, patients had evidence of TRD and ≥ 12 months of continuous insurance eligibility (baseline period). Patients with eight or more esketamine treatment sessions were included in the main cohort. A subgroup included patients with one or more baseline mental health (MH)-related inpatient (IP) admission or emergency department (ED) visit (i.e., prior acute healthcare users). Treatment patterns were described during the follow-up period (index date until earliest of end of insurance eligibility or data); acute healthcare (i.e., IP and ED) resource use and costs (2021 US dollars) were reported during the baseline and follow-up periods. RESULTS: Of the 322 patients in the main cohort, 111 comprised the subgroup of prior acute healthcare users. During the follow-up period, mean time from index date to eighth esketamine session was 73.2 days in the main cohort and 78.8 days in the subgroup (per label, 28 days). Further, 75.2% of the main cohort and 73.9% of the subgroup completed four or more esketamine maintenance sessions following induction. In the main cohort, mean all-cause acute healthcare costs per patient per month (PPPM) decreased from baseline ($837) to follow-up ($770). Similar reductions were observed for mean MH-related acute healthcare costs PPPM (baseline $648, follow-up $577). In the subgroup, mean all-cause acute healthcare costs PPPM also decreased (baseline $2323, follow-up $1423), driven by mean MH-related acute healthcare costs PPPM (baseline $1880, follow-up $1139). Mean all-cause acute healthcare use per ten patients per month remained largely stable from baseline to follow-up in the main cohort (IP days: baseline 2.24, follow-up 2.13; ED visits: baseline 1.33, follow-up 1.45) and decreased in the subgroup (IP days: baseline 6.38, follow-up 4.56; ED visits: baseline 2.58, follow-up 2.41). Trends in mean MH-related acute healthcare use were similar. CONCLUSION: Patients generally required more time than label recommendation to complete esketamine induction treatment, and most went on to have 12 or more esketamine sessions. Completion of induction treatment correlated with reductions in mean all-cause and MH-related acute healthcare costs. Larger reductions were seen in the subgroup of prior acute healthcare users.

A Cross-Sectional Study of Patient Out-of-Pocket Costs for Antipsychotics Among Medicaid Beneficiaries with Schizophrenia.

BACKGROUND: Patient affordability is an important nonclinical consideration for treatment access among patients with schizophrenia. OBJECTIVE: This study evaluated and measured out-of-pocket (OOP) costs for antipsychotics (APs) among Medicaid beneficiaries with schizophrenia. METHODS: Adults with a schizophrenia diagnosis, ≥ 1 AP claim, and continuous Medicaid eligibility were identified in the MarketScan® Medicaid Database (1 January 2018-31 December 2018). OOP AP pharmacy costs ($US 2019) were normalized for a 30-day supply. Results were descriptively reported by route of administration [ROA; orals (OAPs), long-acting injectables (LAIs)], generic/branded status within ROAs, and dosing schedule within LAIs. The proportion of total (pharmacy and medical) OOP costs AP-attributable was described. RESULTS: In 2018, 48,656 Medicaid beneficiaries with schizophrenia were identified (mean age 46.7 years, 41.1% female, 43.4% Black). Mean annual total OOP costs were $59.97, $6.65 of which was AP attributable. Overall, 39.2%, 38.3%, and 42.3% of beneficiaries with a corresponding claim had OOP costs > $0 for any AP, OAP, and LAI, respectively. Mean OOP costs per patient per 30-day claim (PPPC) were $0.64 for OAPs and $0.86 for LAIs. By LAI dosing schedule, mean OOP costs PPPC were $0.95, $0.90, $0.57, and $0.39 for twice-monthly, monthly, once-every-2-months, and once-every-3-months LAIs, respectively. Across ROAs and generic/branded status, projected OOP AP costs per-patient-per-year for beneficiaries assumed fully adherent ranged from $4.52 to $13.70, representing < 25% of total OOP costs. CONCLUSION: OOP AP costs for Medicaid beneficiaries represented a small fraction of total OOP costs. LAIs with longer dosing schedules had numerically lower mean OOP costs, which were lowest for once-every-3-months LAIs among all APs.

Esketamine nasal spray for major depressive disorder with acute suicidal ideation or behavior: description of treatment access, utilization, and claims-based outcomes in the United States.

AIMS: 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). METHODS: 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. RESULTS: 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. LIMITATIONS: 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. CONCLUSIONS: 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.

Treatment patterns, healthcare utilization, and costs of patients with treatment-resistant depression initiated on esketamine intranasal spray and covered by US commercial health plans.

AIMS: 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). METHODS: 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. RESULTS: 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). LIMITATIONS: This is a descriptive analysis; sample size for some comorbidity subgroups is small. CONCLUSIONS: 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.

Health care resource use, short-term disability days, and costs associated with states of persistence on antidepressant lines of therapy.

AIMS: 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). METHODS: 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. RESULTS: 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 < .001) versus persistence on the early-line therapy. This resulted in $374 higher mean PPPM all-cause health care costs (95% CI = 265, 470; p < .001) during evaluation versus persistence on the early line therapy. The evaluation state was associated with 89% more short-term disability days (OR [95% CI] = 1.89 [1.49, 2.57] and $212 higher mean PPPM short-term disability costs (95% CI = 64, 259) relative to persistence on the early line (both p < .001). Moreover, during persistence on a later line, mean PPPM all-cause health care costs were $141 higher (95% CI = 13, 242; p = .028) relative to the early line. LIMITATIONS: Medication may have been dispensed but not actually taken. CONCLUSIONS: 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.

Use of Disease Activity Score (DAS28) and Routine Assessment of Patient Index Data 3 (RAPID3) for Assessment of Rheumatoid Arthritis Disease Activity, in the Indian Setting.

INTRODUCTION: Patient outcomes in rheumatoid arthritis (RA) have significantly improved with the advent of disease modifying anti rheumatic drugs and the newer biological agents. Various scoring systems available for monitoring disease activity in RA have not yet been put into full use in patient management in India. We aim to study the disease activity score 28 (DAS28) and Routine assessment of patient index 3 (RAPID3), their correlation and patient outcomes in RA. MATERIALS AND METHODS: The study was conducted between March 2011-May 2011. A total of 81 patients were included. Patient's history was noted. Clinical examination for tender and swollen joint counts was performed. DAS28 was calculated. MDHAQ was administered to each patient in a language they understood and responses noted. Correlation between DAS28 and RAPID3 was studied using Pearson's correlation coefficient. RESULTS: RAPID3 and DAS28 showed Pearson's correlation coefficient of 0.8699 (p<0.001). Of the 53 patients who met with DAS28 severity criteria of >5.1, 82.7% showed similar results with RAPID3 suggesting severe disease activity. (X2 = 33.512 and p<0.001). A greater proportion of those whose DMARD initiation was 2 years after disease onset, had higher disease activity as compared to those with earlier initiation.

Assessment of Direct Oral Anticoagulant Prescribing and Monitoring Pre- and Post-Implementation of a Pharmacy Protocol at a Community Teaching Hospital.

Background: Direct oral anticoagulants (DOACs) have become popular alternatives to vitamin K antagonists for the treatment and prevention of thromboembolic diseases; however, there are limited data regarding the appropriate use of DOACs in clinical practice. To ensure safety and efficacy of these medications, it is important that decisions regarding their use in patients rely on the available evidence. Objective: The purpose of this study was to evaluate the appropriateness of DOAC prescribing in adult patients before and after the implementation of a pharmacist-driven DOAC protocol. Methods: Data were collected on adult patients admitted to a community teaching hospital who received DOAC therapy for at least 2 days between January and March 2015 (pre-intervention group) and between January and March 2016 (post-intervention group). These data were analyzed to measure inappropriately prescribed DOACs, defined based on DOAC indication, renal function, drug interactions, and other pertinent patient-specific factors. Prior to the start of data collection for the post-intervention group, a pharmacist-driven protocol was developed and implemented. DOAC education was provided to pharmacists, including an evidence-based prescribing table to guide appropriate DOAC therapy. Comparisons were made between the pre-intervention and post-intervention groups to determine the impact of the pharmacist-driven service on appropriate DOAC prescribing. Results: Fifty patients were analyzed in the pre-intervention group compared with 85 patients in the post-intervention group, with a total of 333 and 816 doses administered, respectively. Of the total doses administered, 32.4% were considered inappropriate in the pre-intervention group compared with 13.8% in the post-intervention group (adjusted odds ratio [OR], 0.42, 95% CI, 0.19-0.96; p = 0.039). Conclusions: Implementing a pharmacist-driven DOAC service significantly improved appropriate prescribing of these agents. Provider education regarding DOAC use is essential to further increase appropriate prescribing of DOACs, optimize patients' therapy, and prevent adverse drug events.

Assessment of Various Risk Factors for Success of Delayed and Immediate Loaded Dental Implants: A Retrospective Analysis.

INTRODUCTION: Ever since its introduction in 1977, a minimum of few months of period is required for osseointegration to take place after dental implant surgery. With the passage of time and advancements in the fields of dental implant, this healing period is getting smaller and smaller. Immediate loading of dental implants is becoming a very popular procedure in the recent time. Hence, we retrospectively analyzed the various risk factors for the failure of delayed and immediate loaded dental implants. MATERIALS AND METHODS: In the present study, retrospective analysis of all the patients was done who underwent dental implant surgeries either by immediate loading procedure or by delayed loading procedures. All the patients were divided broadly into two groups with one group containing patients in which delayed loaded dental implants were placed while other consisted of patients in whom immediate loaded dental implants were placed. All the patients in whom follow-up records were missing and who had past medical history of any systemic diseases were excluded from the present study. Evaluation of associated possible risk factors was done by classifying the predictable factors as primary and secondary factors. All the results were analyzed by Statistical Package for the Social Sciences (SPSS) software. Kaplan-Meier survival analyses and chi-square test were used for assessment of level of significance. RESULTS: In delayed and immediate group of dental implants, mean age of the patients was 54.2 and 54.8 years respectively. Statistically significant results were obtained while comparing the clinical parameters of the dental implants in both the groups while demographic parameters showed nonsignificant correlation. CONCLUSION: Significant higher risk of dental implant failure is associated with immediate loaded dental implants. Tobacco smoking, shorter implant size, and other risk factors play a significant role in predicting the success and failure of dental implants. CLINICAL SIGNIFICANCE: Delayed loaded dental implant placement should be preferred as they are associated with decreased risk of implant failure.