Cross-sectional analysis of pharmaceutical industry payments to authors of clinical practice guidelines for bipolar disorder and major depressive disorder in Japan.

OBJECTIVE: Clinical practice guidelines (CPGs) are essential for standardising patient care based on evidence-based medicine. However, the presence of financial conflicts of interest (COIs) among CPG authors can undermine their credibility. This study aimed to examine the extent and size of COIs among authors of psychiatry CPGs in Japan. METHODS: This cross-sectional analysis of disclosed payments from pharmaceutical companies assesses the prevalence and magnitude of personal payments for lecturing, consulting and writing to CPGs for bipolar disorder and major depressive disorder in Japan between 2016 and 2020. RESULTS: This study found that 93.3% of authors received payments over a 5-year period, with total payments exceeding US$4 million. The median payment per author was US$51 403 (IQR: US$9982-US$111 567), with a notable concentration of payments among a small number of authors, including the CPG chairperson. Despite these extensive financial relationships, only a fraction of authors disclosed their COIs in the CPGs. These large amounts of personal payments were made by pharmaceutical companies manufacturing new antidepressants and sleeping aids listed in the CPGs. CONCLUSIONS: This study found that more than 93% of authors of CPGs for major depressive disorder and bipolar disorder in Japan received considerable amounts of personal payments from the pharmaceutical industry. The findings highlight deviations from international COI management standards and suggest a need for more stringent COI policies for psychiatry CPGs in Japan.

The Humanistic and Economic Burden Associated with Major Depressive Disorder: A Retrospective Cross-Sectional Analysis.

INTRODUCTION: Major depressive disorder (MDD) is a debilitating and costly condition. This analysis characterized the health-related quality of life (HRQoL), health care resource utilization (HCRU), and costs between patients with versus without MDD, and across MDD severity levels. METHODS: The 2019 National Health and Wellness Survey was used to identify adults with MDD, who were stratified by disease severity (minimal/mild, moderate, moderately severe, severe), and those without MDD. Outcomes included HRQoL (Short Form-36v2 Health Survey, EuroQol Five-Dimension Visual Analogue Scale, utility scores), HCRU (hospitalizations, emergency department [ED] visits, health care provider [HCP] visits), and annualized average direct medical and indirect (workplace) costs. A subgroup analysis was conducted in participants with MDD and prior medication treatment failure. Participant characteristics and study outcomes were evaluated using bivariate analyses and multivariable regression models, respectively. RESULTS: Cohorts comprised 10,710 participants with MDD (minimal/mild = 5905; moderate = 2206; moderately severe = 1565; severe = 1034) and 52,687 participants without MDD. Participants with MDD had significantly lower HRQoL scores than those without (each comparison, P < 0.001). Increasing MDD severity was associated with decreasing HRQoL. Relative to participants without MDD, participants with MDD reported more HCP visits (2.72 vs 5.64; P < 0.001) and ED visits (0.18 vs 0.22; P < 0.001) but a similar number of hospitalizations. HCRU increased with increasing MDD severity. Although most patients with MDD had minimal/mild to moderate severity, total direct medical and indirect costs were significantly higher for participants with versus without MDD ($8814 vs $6072 and $5425 vs $3085, respectively, both P < 0.001). Direct and indirect costs were significantly higher across all severity levels versus minimal/mild MDD (each comparison, P < 0.05). Among patients with prior MDD medication treatment failure (n = 1077), increasing severity was associated with significantly lower HRQoL and higher total indirect costs than minimal/mild MDD. CONCLUSION: These results quantify the significant and diverse burdens associated with MDD and prior MDD medication treatment failure.

This study described the burdens associated with major depressive disorder. To accomplish this, we compared outcomes from a national health survey between patients who had a diagnosis of major depressive disorder and those who did not. Participants with major depressive disorder were further characterized by the severity of their symptoms. The first outcome was health-related quality of life and the second outcome was the amount of health visits, such as the number of hospitalizations, emergency department visits, and visits with health care providers. Finally, health care-related costs and workplace-related costs were evaluated. Survey participants with major depressive disorder had lower health-related quality of life scores compared with those without major depressive disorder. Increasing severity of major depressive disorder was linked with decreasing health-related quality of life. Participants with major depressive disorder also reported more health care provider and emergency department visits relative to participants without the disorder, although they both reported a similar number of hospitalizations. Both health care-related and workplace-related costs were higher in participants with major depressive disorder than in those without major depressive disorder, and costs were higher among participants with more severe symptoms compared with minimal/mild symptoms. Among participants who had major depressive disorder and reported that their current medication had replaced an old medication because of a lack of response, increasing major depressive disorder severity was associated with significantly lower health-related quality of life scores and higher total workplace-related costs versus minimal/mild major depressive disorder.

Understanding the Relationship Between Depression Symptom Severity and Health Care Costs for Patients With Treatment-Resistant Depression.

Objective: To examine whether measures of depression symptom severity could improve understanding of health care costs for patients with major depressive disorder (MDD) or treatment-resistant depression (TRD) from the health plan perspective.Methods: In this retrospective cohort study within an integrated health system, cohorts consisted of 2 mutually exclusive groups: (1) adults with TRD based on a standard treatment algorithm and (2) adults with MDD, but no TRD, identified through ICD-9/10-CM codes. Depression severity was measured using the Patient Health Questionnaire-9 (PHQ-9). Patterns of health care resource utilization (HRU) and costs were compared between the TRD and MDD groups overall and within the groups at different symptom levels. A general linear model with a γ distribution and log link for cost outcomes, logistic regression for binary outcomes, and negative binomial regression for count outcomes were used.Results: Patients with TRD (n = 24,534) had greater comorbidity than those in the MDD group (n = 17,628). Mean age in the TRD group was 52.8 years versus 48.2 for MDD (P < .001). Both groups were predominantly female (TRD: 72.8% vs MDD: 66.9%; P < .001). Overall, the TRD group had greater costs than the MDD group, with 1.23 times (95% CI, 1.21-1.26; P < .001) greater total cost on average over 1 year following index date. Within both groups, those with severe symptoms had greater total mean (SD) costs (TRD: moderate: $12,429 [$23,900] vs severe: $13,344 [$22,895], P < .001; low: $12,220 [$31,864] vs severe: $13,344 [$22,895], P < .001; MDD: moderate: $8,899 [$20,755] vs severe: $10,098 [$22,853]; P < .001; low: $8,752 [$25,800] vs severe: $10,098 [$22,853], P < .001).Conclusions: MDD and TRD impose high costs for health systems, with increasing costs as PHQ-9 symptom severity rises. Better understanding of subgroups with different symptom levels could improve clinical care by helping target interventions.

Identifying Conditions With High Prevalence, Cost, and Variation in Cost in US Children's Hospitals.

Importance: Identifying high priority pediatric conditions is important for setting a research agenda in hospital pediatrics that will benefit families, clinicians, and the health care system. However, the last such prioritization study was conducted more than a decade ago and used International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) codes. Objectives: To identify conditions that should be prioritized for comparative effectiveness research based on prevalence, cost, and variation in cost of hospitalizations using contemporary data at US children's hospitals. Design, Setting, and Participants: This retrospective cohort study of children with hospital encounters used data from the Pediatric Health Information System database. Children younger than 18 years with inpatient hospital encounters at 45 tertiary care US children's hospitals between January 1, 2016, and December 31, 2019, were included. Data were analyzed from March 2020 to April 2021. Main Outcomes and Measures: The condition-specific prevalence and total standardized cost, the corresponding prevalence and cost ranks, and the variation in standardized cost per encounter across hospitals were analyzed. The variation in cost was assessed using the number of outlier hospitals and intraclass correlation coefficient. Results: There were 2 882 490 inpatient hospital encounters (median [interquartile range] age, 4 [1-12] years; 1 554 024 [53.9%] boys) included. Among the 50 most prevalent and 50 most costly conditions (total, 74 conditions), 49 (66.2%) were medical, 15 (20.3%) were surgical, and 10 (13.5%) were medical/surgical. The top 10 conditions by cost accounted for $12.4 billion of $33.4 billion total costs (37.4%) and 592 815 encounters (33.8% of all encounters). Of 74 conditions, 4 conditions had an intraclass correlation coefficient (ICC) of 0.30 or higher (ie, major depressive disorder: ICC, 0.49; type 1 diabetes with complications: ICC, 0.36; diabetic ketoacidosis: ICC, 0.33; acute appendicitis without peritonitis: ICC, 0.30), and 9 conditions had an ICC higher than 0.20 (scoliosis: ICC, 0.27; hypertrophy of tonsils and adenoids: ICC, 0.26; supracondylar fracture of humerus: ICC, 0.25; cleft lip and palate: ICC, 0.24; acute appendicitis with peritonitis: ICC, 0.21). Examples of conditions high in prevalence, cost, and variation in cost included major depressive disorder (cost rank, 19; prevalence rank, 10; ICC, 0.49), scoliosis (cost rank, 6; prevalence rank, 38; ICC, 0.27), acute appendicitis with peritonitis (cost rank, 13; prevalence rank, 11; ICC, 0.21), asthma (cost rank, 10; prevalence rank, 2; ICC, 0.17), and dehydration (cost rank, 24; prevalence rank, 8; ICC, 0.18). Conclusions and Relevance: This cohort study found that major depressive disorder, scoliosis, acute appendicitis with peritonitis, asthma, and dehydration were high in prevalence, costs, and variation in cost. These results could help identify where future comparative effectiveness research in hospital pediatrics should be targeted to improve the care and outcomes of hospitalized children.

The Prevalence and National Burden of Treatment-Resistant Depression and Major Depressive Disorder in the United States.

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.

Characteristics of hospital encounters and associated economic burden of patients with major depressive disorder and acute suicidal ideation or behavior.

OBJECTIVES: Relatively little is known about the hospital experience among patients with major depressive disorder (MDD) and acute suicidal ideation or behavior (MDSI). The objectives of this study were to examine hospital encounter characteristics, including the associated economic burden and risk of subsequent hospital encounters of patients with MDSI in the US. METHODS: In this retrospective analysis, patients ≥18 years of age with a hospital encounter (emergency department [ED] visit or inpatient admission) were selected from the de-identified Premier Hospital database between 1 January 2017 and 30 September 2018. Patients were required to have MDD as the primary and acute suicidal ideation or behavior as a secondary discharge diagnosis or vice versa. Patient demographics and characteristics of hospital encounters were examined. Rates and costs of subsequent all-cause and MDD-related hospital encounters 6 months following initial discharge were also evaluated. RESULTS: The study population consisted of 123,179 patients with a hospital encounter for MDSI (mean age: 38 years, 50.9% female, 74.6% White); 50.2% were treated in the ED only (mean ± standard deviation cost: $693±$630), while 49.8% were admitted as inpatients ($6,478±$7,001). Among those with ED visits, very few (7.0%) received an antidepressant (AD). Among those with an inpatient admission, 87.2% received ≥1 AD and 39.0% received AD augmentation. Overall rates and costs of subsequent all-cause and MDD-related hospital encounters were 22.3% ($5,136±$11,791) and 12.0% ($3,722±$9,621), respectively; nearly half of subsequent encounters (41.3% and 44.3%, respectively) occurred in the first month following initial discharge. CONCLUSIONS: This analysis of patients with MDSI presenting to US hospitals shows heterogeneity in treatment and a concentration of costly subsequent hospital encounters within 1-month post discharge, suggesting that healthcare systems may benefit from examination of current care pathways for this vulnerable patient population.

Health care resource utilization and costs associated with nonadherence and nonpersistence to antidepressants in major depressive disorder.

BACKGROUND: Nonadherence and nonpersistence to antidepressants in major depressive disorder (MDD) are common and associated with poor clinical and functional outcomes and increased health care resource utilization (HCRU) and costs. However, contemporary real-world evidence on the economic effect of antidepressant nonadherence and nonpersistence is limited. OBJECTIVE: To assess the effect of nonadherence and nonpersistence to antidepressants on HCRU and costs in adult patients with MDD enrolled in U.S. commercial and Medicare supplemental insurance plans. METHODS: This was a retrospective new-user cohort study using administrative claims data from the IBM MarketScan Commercial and Medicare Supplemental databases from January 1, 2010, to December 31, 2018. We identified adult patients with MDD aged ≥ 18 years who initiated antidepressant therapy for a new MDD episode between January 1, 2011, and December 31, 2017. Twelve-month total all-cause HCRU and costs (2019 U.S. dollars) were characterized for patients who were adherent/nonadherent and persistent/nonpersistent to antidepressants at 6 months. Adherence was defined as having proportion of days covered (PDC) ≥ 80%, and persistence was defined as having continuous antidepressant therapy without a ≥ 30-day gap. Multivariable negative binomial regression and 2-part models adjusted for baseline characteristics were used to estimate incidence rate ratios (IRRs) for HCRU and incremental costs of nonadherence and nonpersistence, respectively. RESULTS: A total of 224,645 patients with MDD (commercial: n = 209,422; Medicare supplemental: n = 15,223) met all study inclusion criteria. Approximately half of patients were nonadherent (commercial: 48%; Medicare supplemental: 50%) or nonpersistent (commercial: 49%; Medicare supplemental: 52%) to antidepressants at 6 months. After controlling for baseline characteristics, nonadherent patients experienced significantly more inpatient hospitalizations (commercial, adjusted IRR [95% CI]: 1.34 [1.29 to 1.39]; Medicare supplemental: 1.19 [1.12 to 1.28]) and emergency room (ER) visits (commercial, adjusted IRR [95% CI]: 1.43 [1.40 to 1.45]; Medicare supplemental: 1.28 [1.21 to 1.36]) compared with adherent patients. Similar results were observed in nonpersistent patients. Adjusted mean differences revealed that nonadherent and nonpersistent patients accumulated significantly higher medical costs (commercial: $568 [95% CI: $354 to $764] and $491 [$284 to $703]; Medicare supplemental: $1,621 [$314 to $2,774] and $1,764 [$451 to $2,925]), inpatient costs (commercial: $650 [$490 to $801] and $564 [$417 to $716]; Medicare supplemental: $1,546 [$705 to $2,308] and $1,567 [$778 to $2,331]), and ER costs (commercial: $130 [$115 to $143] and $129 [$115 to $142]; Medicare supplemental: $82 [$23 to $150] and $80 [$18 to $150]), and incurred significantly lower pharmacy costs (commercial: -$561 [-$601 to -$521] and -$576 [-$616 to -$540]; Medicare supplemental: -$510 [-$747 to -$227] and -$596 [-$830 to -$325]) compared with adherent and persistent patients, respectively. CONCLUSIONS: This study found more hospitalizations and ER use and higher total medical costs among patients who were nonadherent and nonpersistent to antidepressants at 6 months. Strategies that promote better adherence and persistence may lower HCRU and medical costs in patients with MDD. DISCLOSURES: This study was sponsored by Allergan, which was involved in the study design; data collection, analysis, and interpretation of data; and decision to present these results. Ta was supported by a training grant provided to the University of Washington by Allergan at the time this study was conducted. Tung and Gillard are employees of Allergan. Oliveri is an employee of Genesis Research. Sullivan and Devine have no financial disclosures. This study was presented as a poster at AMCP 2020 (Virtual Meeting), April 21-24, 2020.

A retrospective chart review study to quantify the monthly medical resource use and costs of treating patients with treatment resistant depression in the United Kingdom.

INTRODUCTION: Major depressive disorder (MDD) is a globally prevalent chronic psychiatric illness with a significant disease impact. As many as 30% of patients with MDD do not adequately respond to two therapies and are considered to be treatment resistant. This study aimed to quantify healthcare costs associated with treatment resistant depression (TRD) in the UK. METHODS: A retrospective chart review of patients with TRD was conducted in primary and secondary care settings over a 2 year period. Data abstracted from medical records of patients included demographics, clinical characteristics and healthcare resource utilization (HCRU; number of consultations, use of Crisis Resolution and Home Treatment Teams [CRHTTs], non-drug and drug interventions, and hospitalizations). HCRU per patient per month (28 days) was calculated for three health states: major depressive episode (MDE), remission and recovery. Unit costs were from the British National Formulary (BNF) and the Personal Social Services Research Unit (PSSRU). RESULTS: A total of 295 patients with TRD were recruited between January 2016 and May 2018. The mean age of the total sample was 43.3 years; 60.3% were female. Costs per patient, per 28 days, were highest in the MDE state, with the average cost (£992) mainly driven by consultations, non-drug treatment, hospitalizations and CRHTT, with a considerable fall in costs as patients moved into remission and subsequent recovery. CONCLUSION: The results suggest that antidepressant treatments for TRD that are more effective in reducing the time spent in an MDE health state, and helping patients achieve remission and recovery, are essential for reducing the overall HCRU and costs in patients with TRD. Cost of TRD in the UK Strengths and limitations of this study This observational study of TRD is the first to assess the HCRU impact associated with different predefined health states. Using retrospective data from both primary and secondary care physicians from regions across the UK ensures a representative real-world patient population. One limitation is that the selection of patients is based on criteria that define TRD that rely on physician judgement. Although the study captures direct HCRU costs, the indirect costs of lost productivity and care are not included in the overall burden. This study has defined the current clinical management of patients with TRD in the UK and provides an estimate of the associated HCRU and associated costs.

Cost-effectiveness of vortioxetine compared with levomilnacipran and vilazodone in patients with major depressive disorder switching from an initial antidepressant.

Introduction: Many patients with major depressive disorder (MDD) do not achieve remission with their first antidepressant (AD), resulting in a high burden due to treatment failure. Vortioxetine is a valid treatment option for patients with MDD only partially responding to their first AD. Characterization of vortioxetine's potential benefits versus other approved treatments is important. Areas covered: The cost-effectiveness of vortioxetine, including cognitive outcomes, was modeled in comparison with levomilnacipran and vilazodone for patients switched to these medications after inadequate responses to a first AD. Expert opinion: Vortioxetine was associated with incremental quality-adjusted life-year (QALY) gains versus levomilnacipran (0.008) or vilazodone (0.009). Vortioxetine was dominant versus levomilnacipran and cost-effective versus vilazodone (incremental cost-effectiveness ratio [ICER],33,829 USD/QALY). In sensitivity analyses using residual cognitive dysfunction rates (vortioxetine, 49%; levomilnacipran, 58%, and vilazodone, 64%), incremental QALY gains for vortioxetine versus levomilnacipran (0.0085) or vilazodone (0.0109) were found. Vortioxetine remained dominant versus levomilnacipran and cost-effective versus vilazodone (ICER, 27,633 USD/QALY). ICER reduction was found with cognition outcomes inclusion. This model provides additional support for considering vortioxetine for patients requiring a switch of MDD treatments, although its conclusions are limited by the data available for inclusion. Additional research and real-world trials are needed to confirm the findings.

Assessment of Behavioral Health Services Use Among Low-Income Medicare Beneficiaries After Reductions in Coinsurance Fees.

Importance: Medicare has historically imposed higher beneficiary coinsurance for behavioral health services than for medical and surgical care but gradually introduced parity between 2009 and 2014. Although Medicare insures many people with serious mental illness (SMI), there is limited information on the impact of coinsurance parity in this population. Objective: To examine the association between coinsurance parity and outpatient behavioral health care use among low-income beneficiaries with SMI. Design, Setting, and Participants: This cohort study used Medicare claims data for a 50% national sample of lower-income Medicare beneficiaries from January 1, 2007, to December 31, 2016. The study sample included patients with SMI (schizophrenia, bipolar disorder, or major depressive disorder). Data analysis was performed from August 1, 2018, to July 15, 2020. Exposures: Reduction in behavioral health care coinsurance from 50% to 20% between January 1, 2009, and January 1, 2014. Main Outcomes and Measures: Total annual spending for outpatient behavioral health care visits and the percentage of beneficiaries with an annual outpatient behavioral health care visit overall, with a prescriber, and with a psychiatrist. A difference-in-difference approach was used to compare outcomes before and after the reduction in coinsurance for beneficiaries with and without cost-sharing decreases. Linear regression models with beneficiary fixed effects that adjusted for time-changing beneficiary- and area-level covariates were used to examine changes in outcomes. Results: The study included 793 275 beneficiaries with SMI in 2008; 518 893 (65.4%) were younger than 65 years (mean [SD] age, 57.6 [16.1] years), 511 265 (64.4%) were female, and 552 056 (69.6%) were White. In 2008, the adjusted percentage of beneficiaries with an outpatient behavioral health care visit was 40.7% (95% CI, 40.4%-41.0%) among those eligible for the cost-sharing reduction and 44.9% (95% CI, 44.9%-45.0%) among those with free care. The mean adjusted out-of-pocket costs for outpatient behavioral health care visits decreased from $132 (95% CI, $129-$136) in 2008 to $64 (95% CI, $61-$66) in 2016 among those with reductions in cost-sharing. The adjusted percentage of beneficiaries with behavioral health care visits increased to 42.2% (95% CI, 41.9%-42.5%) in the group with a reduction in coinsurance and to 47.2% (95% CI, 47.0%-47.3%) in the group with free care. The cost-sharing reduction was not positively associated with visits (eg, relative change of -0.76 percentage points [95% CI, -1.12 to -0.40 percentage points] in the percentage of beneficiaries with outpatient behavioral health care visits in 2016 vs 2008). Conclusions and Relevance: This cohort study found that beneficiary costs for outpatient behavioral health care decreased between 2009 and 2014. There was no association between cost-sharing reductions and changes in behavioral health care visits. Low levels of use in this high-need population suggest the need for other policy efforts to address additional barriers to behavioral health care.

A retrospective analysis to estimate the healthcare resource utilization and cost associated with treatment-resistant depression in commercially insured US patients.

OBJECTIVE: The economic burden of commercially insured patients in the United States with treatment-resistant depression and patients with non-treatment-resistant major depressive disorder was compared using data from the Optum Clinformatics™ claims database. METHODS: Patients 18-63 years on antidepressant treatment between 1/1/13 and 9/30/13, who had no treatment claims for depression 6 months before the index date (first antidepressant dispensing), and who had a major depressive disorder or depression diagnosis within 30 days of the index date, were included. Treatment-resistant depression was defined as receiving 3 antidepressant regimens during 1 major depressive disorder episode. Patients with treatment-resistant depression were matched with patients with non-treatment-resistant major depressive disorder at a 1:4 ratio using propensity score matching. The study consisted of 1-year baseline (pre-index) and 2-year follow-up (post index) periods. Cost outcomes were compared using a generalized linear model. RESULTS: 2,370 treatment-resistant depression and 9,289 non-treatment-resistant major depressive disorder patients were included. In year 1 of the follow-up period, compared with non-treatment-resistant major depressive disorder, patients with treatment-resistant depression had: more emergency department visits (odds ratio = 1.39, 95% confidence interval = 1.24-1.56); more inpatient hospitalizations (odds ratio = 1.73, 95% confidence interval = 1.46-2.05); longer hospital stays (mean difference vs non-treatment-resistant major depressive disorder = 2.86, 95% confidence interval = 0.86-4.86 days); and more total healthcare costs (mean difference vs non-treatment-resistant major depressive disorder = US$3,846, 95% confidence interval = $2,855-$4,928). These patterns remained consistent in year 2 of the follow-up period. CONCLUSION: Treatment-resistant depression was associated with higher healthcare resource utilization and costs versus non-treatment-resistant major depressive disorder in this commercially insured cohort of patients in the United States.

Factors associated with 30-day readmissions following medical hospitalizations among Medicaid beneficiaries with schizophrenia, bipolar disorder, and major depressive disorder.

While evidence suggests that adults with serious mental illness have an elevated rate of 30-day readmissions after medical hospitalizations, most studies are of patients who are privately insured or Medicare beneficiaries, and little is known about the differential experiences of people with schizophrenia, bipolar disorder, and major depression. We used the Truven Health Analytics MarketScan® Medicaid Multi-State Database to study 43,817 Medicaid enrollees from 11 states, age 18-64, who were discharged from medical hospitalizations in 2011. Our outcome was unplanned all-cause readmissions within 30 days of discharge. In a multivariable analysis, compared to those with no SMI, people with schizophrenia had the highest odds of 30-day readmission (aOR: 1.46, 95% CI: 1.33-1.59), followed by those with bipolar disorder (aOR: 1.25, 95% CI: 1.14-1.38), and those with major depressive disorder (aOR: 1.18, 95% CI: 1.06-1.30). Readmissions also were more likely among those with substance use disorders, males, those with Medicaid eligibility due to disability, patients with longer index hospitalizations, and those with 2 or more medical co-morbidities. This is the first large-scale study to demonstrate the elevated risk of hospital readmission among low-income, working-age adults with schizophrenia. Given their greater psychological, social, and economic vulnerability, our findings can be used to design transition interventions and service delivery systems that address their complex needs.

Economic Burden of Treatment-Resistant Depression in Privately Insured U.S. Patients with Physical Conditions.

BACKGROUND: Little is known about the economic burden of treatment-resistant depression (TRD) in patients with physical conditions. OBJECTIVE: 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. METHODS: Adults aged < 65 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 with < 6 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. RESULTS: 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 (all P < 0.05). Health care costs were $22,541 in the TRD cohort, $17,450 in the non-TRD MDD cohort, and $10,047 in the non-MDD cohort, yielding cost differences of $5,091 (vs. non-TRD MDD) and $12,494 (vs. non-MDD; all P < 0.01). In patients with work loss data available (n = 278/cohort), those with TRD had 2.0 and 2.9 times more work loss as well as $8,676 and $10,323 higher work loss costs relative to those with non-TRD MDD and without MDD, respectively (all P < 0.001). CONCLUSIONS: In 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. DISCLOSURES: 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 Johnson & Johnson; 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.

The benefits and costs of changing treatment technique in electroconvulsive therapy due to insufficient improvement of a major depressive episode.

BACKGROUND: Electroconvulsive therapy (ECT) technique is often changed after insufficient improvement, yet there has been little research on switching strategies. OBJECTIVE: To document clinical outcome in ECT nonresponders who were received a second course using high dose, brief pulse, bifrontotemporal (HD BP BL) ECT, and compare relapse rates and cognitive effects relative to patients who received only one ECT course and as a function of the type of ECT first received. METHODS: Patients were classified as receiving Weak, Strong, or HD BP BL ECT during three randomized trials at Columbia University. Nonresponders received HD BP BL ECT. In a separate multi-site trial, Optimization of ECT, patients were randomized to right unilateral or BL ECT and nonresponders also received further treatment with HD BP BL ECT. RESULTS: Remission rates with a second course of HD BP BL ECT were high in ECT nonresponders, approximately 60% and 40% in the Columbia University and Optimization of ECT studies, respectively. Clinical outcome was independent of the type of ECT first received. A second course with HD BP BL ECT resulted in greater retrograde amnesia immediately, two months, and six months following ECT. CONCLUSIONS: In the largest samples of ECT nonresponders studied to date, a second course of ECT had marked antidepressant effects. Since the therapeutic effects were independent of the technique first administered, it is possible that many patients may benefit simply from longer courses of ECT. Randomized trials are needed to determine whether, when, and how to change treatment technique in ECT.

Improving Cost-effectiveness and Access to Cognitive Behavior Therapy for Depression: Providing Remote-Ready, Computer-Assisted Psychotherapy in Times of Crisis and Beyond.

INTRODUCTION: There is growing evidence that computer-delivered or computer-assisted forms of cognitive behavior therapy (CCBT) are helpful, but cost-effectiveness versus standard therapies is not well established. OBJECTIVE: To evaluate the cost-effectiveness of a therapist-supported method for CCBT in comparison to standard cognitive behavior therapy (CBT). METHODS: A total of 154 drug-free major depressive disorder outpatients were randomly assigned to either 16 weeks of standard CBT (up to twenty 50-min sessions) or CCBT using the Good Days Ahead program (including up to 5.5 h of therapist contact). Outcomes were assessed at baseline, weeks 8 and 16, and at 3 and 6 months post-treatment. Economic analyses took into account the costs of services received and work/social role impairment. RESULTS: In the context of almost identical efficacy, a form of CCBT that used only about one third the amount of therapist contact as conventional CBT was highly cost-effective compared to conventional therapy and reduced the adjusted cost of treatment by USD 945 per patient. CONCLUSIONS: A method of CCBT that blended internet-delivered modules and abbreviated therapeutic contact reduced the cost of treatment substantially without adversely affecting outcomes. Results suggest that use of this approach can more than double the access to CBT. Because clinician support in CCBT can be provided by telephone, videoconference, and/or email, this highly efficient form of treatment could be a major advance in remote treatment delivery.

Incremental Health Care Burden of Treatment-Resistant Depression Among Commercial, Medicaid, and Medicare Payers.

OBJECTIVE: This study compared health care use and costs among patients with treatment-resistant versus treatment-responsive depression across Medicaid, Medicare, and commercial payers. METHODS: A retrospective cohort study was conducted by using Truven Health Analytics' commercial (2006-2017; N=111,544), Medicaid (2007-2017; N=24,036), and Medicare supplemental (2006-2017; N=8,889) claims databases. Participants were adults with major depressive disorder who had received one or more antidepressant treatments. Treatment resistance was defined as failure of two or more antidepressant treatments of adequate dose and duration. Annual use (hospitalizations and outpatient and emergency department [ED] visits) and costs were compared across patients by treatment-resistant status in each payer population. Incremental burden of treatment-resistant depression was estimated with regression analyses. Monthly changes in costs during 1-year follow-up were assessed to understand differential cost trends by treatment-resistant status. RESULTS: In the three payer populations, patients with treatment-resistant depression incurred higher health care utilization than those with treatment-responsive depression (hospitalization, odds ratios [ORs]=1.32-1.76; ED visits, ORs=1.38-1.45; outpatient visits, incident rate ratio=1.29-1.54; p<0.001 for all). Compared with those with treatment-responsive depression, those with treatment resistance incurred higher annual costs (from $4,093 to $8,054 higher; p<0.001). Patients with treatment-resistant depression had higher costs at baseline compared with patients with treatment-responsive depression and incurred higher costs each month throughout follow-up. CONCLUSIONS: Treatment-resistant depression imposes a significant health care burden on insurers. Treatment-resistant depression may exist and affect health care burden before a patient is identified as having treatment-resistant depression. Findings underscore the need for effective and timely treatment of treatment-resistant depression.

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

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

Cost effectiveness and cost-utility analysis of a group-based diet intervention for treating major depression - the HELFIMED trial.

Background/objectives: Major depression has a negative impact on quality of life, increasing the risk of premature death. It imposes social and economic costs on individuals, families and society. Mental illness is now the leading cause globally of disability/lost quality life and premature mortality. Finding cost-effective treatments for depression is a public health priority. We report an economic evaluation of a dietary intervention for treating major depression. Methods: This economic evaluation drew on the HELFIMED RCT, a 3-month group-based Mediterranean-style diet (MedDiet) intervention (including cooking workshops), against a social group-program for people with major depression. We conducted (i) a cost-utility analysis, utility scores measured at baseline, 3-months and 6-months using the AQoL8D, modelled to 2 years (base case); (ii) a cost-effectiveness analysis, differential cost/case of depression resolved (to normal/mild) measured by the DASS. Differential program costs were calculated from resources use costed in AUD2017. QALYs were discounted at 3.5%pa. Results: Best estimate differential cost/QALY gain per person, MedDiet relative to social group was AUD2775. Probabilistic sensitivity analysis, varying costs, utility gain, model period found 95% likelihood cost/QALY less than AUD20,000. Estimated cost per additional case of depression resolved, MedDiet group relative to social group was AUD2,225. Conclusions: A MedDiet group-program for treating major depression was highly cost-effective relative to a social group-program, measured in terms of cost/QALY gain and cost per case of major depression resolved. Supporting access by persons with major depression to group-based dietary programs should be a policy priority. A change to funding will be needed to realise the potential benefits.

Canadian economic impact of improved workplace productivity in patients with major depressive disorder treated with vortioxetine.

OBJECTIVE: The AtWoRC study is an interventional, open-label Canadian study that demonstrated significant improvements in cognitive function and workplace productivity in patients with major depressive disorder (MDD) treated with vortioxetine for a current major depressive episode. The objective of the present analysis was to assess the Canadian economic impact of improved workplace productivity based on the AtWoRC study results. METHODS: The economic impact of improved productivity in patients with MDD treated with vortioxetine was assessed over a 52-week period considering productivity loss due to absenteeism and presenteeism using the standard human capital approach and an employer's perspective. Absenteeism was measured with the Work Productivity and Activity Impairment questionnaire; and presenteeism with the Work Limitation Questionnaire. Productivity gains following treatment initiation with vortioxetine were estimated using the difference from baseline. RESULTS: In the AtWoRC study, patients at baseline reportedly missed, in the past 7 days, an average of 8.1 h due to absenteeism and 3.0 h due to presenteeism. Following 52 weeks of treatment with vortioxetine, patients reportedly missed an average of 4.9 h due to absenteeism and 2.0 h due to presenteeism. This improved workplace productivity translated into savings of C$110.64 for 1 week of work following 52 weeks of treatment. The cumulative 52-week economic impact showed potential savings of C$4,550 when factoring in the cost of therapy. CONCLUSION: This study suggested that workplace productivity gain due to an improvement in symptoms of MDD following treatment with vortioxetine will lead to substantial cost savings for the Canadian economy.