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.

Impact of headache frequency and preventive treatment failure on quality of life, disability, and direct and indirect costs among individuals with episodic migraine in the United States.

OBJECTIVE: To evaluate unmet needs among individuals with episodic migraine (EM) in the United States (US). BACKGROUND: Data are limited on the impact of headache frequency (HF) and preventive treatment failure (TF) on the burden of migraine in the US. METHODS: A retrospective, cross-sectional analysis of 2019 National Health and Wellness Survey (NHWS) data was conducted from an opt-in online survey that identified respondents (aged ≥18 years) in the US with self-reported physician-diagnosed migraine. Participants were stratified by HF (low: 0-3 days/month; moderate-to-high: 4-14 days/month) and prior preventive TF (preventive naive; 0-1 TF; ≥2 TFs). Comparisons were conducted between preventive TF groups using multivariable regression models controlling for patient demographic and health characteristics. RESULTS: Among individuals with moderate-to-high frequency EM, the NHWS identified 397 with ≥2 TFs, 334 with 0-1 TF, and 356 as preventive naive. The 36-item Short-Form Health Survey (version 2) Physical Component Summary scores were significantly lower among those with ≥2 TFs, at a mean (standard error [SE]) of 41.4 [0.8] versus the preventive-naive 46.8 [0.9] and 0-1 TF 44.5 [0.9] groups; p < 0.001 for both). Migraine Disability Assessment Scale scores were significantly higher in the ≥2 TFs, at a mean (SE) of 37.7 (3.9) versus preventive-naive 26.8 (2.9) (p < 0.001) and 0-1 TF 30.1 (3.3) (p = 0.011) groups. The percentages of time that respondents experienced absenteeism (mean [SE] 21.6% [5.5%] vs. 13.4% [3.6%]; p = 0.022), presenteeism (mean [SE] 55.0% [8.3%] vs. 40.8% [6.5%]; p = 0.015), overall work impairment (mean [SE] 59.4% [5.6%] vs. 45.0% [4.4%]; p < 0.001), and activity impairment (mean [SE] 56.8% [1.0%] vs. 44.4% [0.9%]; p < 0.001) were significantly higher in the ≥2 TFs versus preventive-naive group. Emergency department visits (preventive-naive, p = 0.006; 0-1 TF, p = 0.008) and hospitalizations (p < 0.001 both) in the past 6 months were significantly higher in the ≥2 TFs group. Direct and indirect costs were significantly higher in the ≥2 TFs (mean [SE] $24,026 [3460]; $22,074 [20]) versus 0-1 TF ($10,897 [1636]; $17,965 [17]) and preventive-naive ($11,497 [1715]; $17,167 [17]) groups (p < 0.001 for all). Results were similar in the low-frequency EM group. CONCLUSIONS: In this NHWS analysis, individuals with more prior preventive TFs experienced significantly higher humanistic and economic burden regardless of HF.

Impact of formulary-related pharmacy claim rejections of cariprazine on health care utilization and treatment patterns among patients with bipolar I disorder.

BACKGROUND: Formulary restrictions, intended to limit inappropriate medication use and decrease pharmacy costs, may prevent or delay patients with bipolar I disorder from initiating cariprazine, a dopamine D3-preferring D3/D2 and serotonin 5HT1A receptor partial agonist that is approved to treat manic/mixed or depressive episodes associated with bipolar I disorder. Little is known about the downstream consequences of formulary-related cariprazine prescription rejections. OBJECTIVE: To evaluate the impact of formulary-related cariprazine claim rejections on health care resource utilization (HCRU) and treatment patterns among patients newly prescribed cariprazine for bipolar I disorder. METHODS: Symphony Health Integrated Dataverse was used to identify commercially insured adults (aged ≥18 years) with bipolar I disorder and at least 1 pharmacy claim for cariprazine (rejected because of formulary restrictions or approved; date of the first claim is the index date) from March 2015 through October 2020. Formulary-related rejection reasons included noncoverage, prior authorization requirement, and step therapy requirement. Baseline characteristics were evaluated during the 12 months pre-index and balanced between rejected and approved cohorts using 1:2 propensity score matching. HCRU outcomes included all-cause and mental health (MH)-related hospitalizations, emergency department (ED) visits, and outpatient visits. Treatment patterns were analyzed descriptively and included treatment delay and atypical antipsychotic use. HCRU was reported per patient-year and compared between cohorts using rate ratios; 95% CIs and P values were calculated using nonparametric bootstrap procedures. RESULTS: The matched rejected and approved cohorts comprised 1,554 and 3,108 patients, respectively. The rejected cohort had 22% more all-cause and 24% more MH-related hospitalizations per patient-year vs the approved cohort (rate ratio [95% CI], all-cause: 1.22 [1.01-1.48], P = 0.024; MH-related: 1.24 [1.01-1.55], P = 0.044). ED and outpatient visits were numerically, but not significantly, greater in the rejected cohort. Of patients in the rejected cohort, 34.7% never received an atypical antipsychotic and 76.8% never received cariprazine. For those who later received cariprazine or another atypical antipsychotic, the average treatment delay was approximately 6 months (188 days) and approximately 4 months (123 days) after the initial rejection, respectively. CONCLUSIONS: Patients with bipolar I disorder and formulary-related cariprazine claim rejections experienced significantly more hospitalizations than patients whose initial claim was approved; ED and outpatient visits were similar between cohorts. Less than a quarter of patients whose initial claim was rejected later received cariprazine, and more than one-third never received any atypical antipsychotic. To our knowledge, this is the first study to evaluate the impact of formulary-related rejections of cariprazine on HCRU and treatment patterns in patients with bipolar I disorder.

Impact of headache frequency and preventive medication failure on quality of life, functioning, and costs among individuals with migraine across several European countries: need for effective preventive treatment.

BACKGROUND: Data are limited regarding the combined impact of headache frequency and failure of preventive medication (efficacy and/or tolerability) on the humanistic/economic burden of migraine. METHODS: A retrospective, cross-sectional analysis of 2020 National Health and Wellness Survey (NHWS) data was conducted. An opt-in online survey identified adults in France, Germany, Italy, Spain, and United Kingdom with self-reported physician-diagnosed migraine. Participants with ≥ 4 monthly headache days (MHDs) were stratified by prior preventive medication use/failure (preventive naive; 0-1 failure; ≥ 2 failures). Quality-of-life and economic outcomes were compared among groups using generalized linear modeling. RESULTS: Among individuals with ≥ 4 MHDs (n = 1106), the NHWS identified 298 (27%) with ≥ 2 failures, 308 (28%) with 0-1 failure, and 500 (45%) as preventive naive. Individuals with ≥ 2 failures versus preventive-naive individuals had significantly lower scores on the 12-Item Short Form Survey Physical Component Summary (42.2 vs 44.1; P < 0.005), numerically higher scores on the Mental Component Summary (39.5 vs 38.5; P = 0.145), significantly higher scores on the Migraine Disability Assessment (39.1 vs 34.0; P < 0.05), and significantly higher prevalence of depression symptoms (62% vs 47%; P < 0.001) and anxiety symptoms (42% vs 31%; P < 0.01). The ≥ 2 failures group versus the preventive-naive group also had significantly more functional impairment as assessed by mean numbers of migraine-specific missed work days (7.8 vs 4.3) and household activities days (14.3 vs 10.6) in the past 6 months (P < 0.001) as well as the prevalence of absenteeism (19% vs 13%), overall work impairment (53% vs 42%), and activity impairment (53% vs 47%) (all P < 0.05). Emergency department visits (0.7 vs 0.5; P = 0.001) and hospitalizations (0.5 vs 0.3; P < 0.001) in the past 6 months were significantly higher in the ≥ 2 failures group versus the preventive-naive group, while indirect costs (€13,720 vs €11,282) and the proportion of individuals with non-adherence during the past 7 days (73% vs 64%) were numerically higher. CONCLUSIONS: Increased burden, quality-of-life impairment, and functional impairment exist among individuals with migraine experiencing ≥ 4 MHDs and more treatment failures. While cause and directionality cannot be determined, these results suggest the need for effective preventive migraine treatments.

Treatment patterns, health care resource utilization, and costs associated with use of atypical antipsychotics as first vs subsequent adjunctive treatment in major depressive disorder.

BACKGROUND: Major depressive disorder (MDD) is a highly prevalent mental health condition associated with substantial economic burden. Inadequate response to first-line antidepressant monotherapy is common, with most patients requiring 1 or more changes in their treatment regimen. Adjunctive treatment with atypical antipsychotics (AAs) is a guideline-recommended treatment option in patients with inadequate response. However, patients often cycle through multiple treatments before receiving adjunctive AAs, and the economic impact of this delay is unknown. OBJECTIVE: To describe adjunctive treatment patterns among patients with MDD and compare health care resource utilization (HCRU) and costs between patients whose first adjunctive therapy included an AA and those who received an AA after other adjunctive treatments. METHODS: The Merative MarketScan Commercial Database (January 1, 2014, to June 30, 2019) was used to identify patients with administrative claims meeting the following inclusion criteria: adults with newly diagnosed MDD (first observed MDD diagnosis = index diagnosis date); continuous health insurance for at least 6 months pre-index and at least 3 months post-index; and initiation of MDD treatment within 60 days post-index. Lines of therapy (LOTs), HCRU, and costs were analyzed in patients who received AA adjunctive therapy, including those who initiated AAs as the first adjunctive treatment and those who initiated AAs as subsequent adjunctive treatment. RESULTS: Of 508,830 patients meeting inclusion criteria, 121,060 (24%) received adjunctive treatment and 20,797 (4%) received an AA as adjunctive therapy. Mean time to adjunctive therapy initiation was approximately 7.3 months for AA adjunctive therapy. Patients who initiated an AA as their first adjunctive therapy compared with patients who initiated an AA as their subsequent adjunctive therapy had fewer LOTs on average (0.9 LOTs vs 3.9 LOTs) and shorter time between index diagnosis date and initiation of an AA (5 months vs 12 months). Subsequent AA initiators had significantly greater HCRU than first AA initiators (driven primarily by outpatient visits) and incurred significantly higher total health care costs, with mean all-cause and mental health-related health care cost differences per patient per year of $2,441 and $1,762, respectively (both P < 0.05). CONCLUSIONS: Less than 5% of patients in this study received an adjunctive AA as part of their MDD treatment regimen, suggesting underutilization of this recommended therapeutic approach. Patients who received an AA as their first adjunctive treatment regimen had lower HCRU and health care costs than subsequent AA initiators. Along with published evidence of clinical benefits, this potential impact on economic burden should be considered when making treatment choices for patients with inadequate response to antidepressants.

Clinical and Healthcare Resource Use Outcomes between Dual-plane and Prepectoral Techniques in Implant-based Breast Reconstruction: A Multicenter Retrospective Study.

This multicenter, retrospective study compared clinical outcomes and healthcare resource use in patients who underwent dual-plane (DP) or prepectoral (PP) implant-based breast reconstruction (IBR) after mastectomy in the United States. Methods: Medical records were selected for patients at five sites undergoing immediate one-stage direct-to-implant (first hospitalization) or two-stage IBR (first and second hospitalization) using either DP or PP. Inverse probability of treatment weighting was used to adjust for potential confounders. Complications and healthcare resource use were assessed with logistic regression; pain severity was assessed with ordinary least-squares regression. Results: After inverse probability of treatment weighting, data from 255 patients (DP = 130, PP = 125) and 441 breasts (DP = 226, PP = 215) were analyzed. Mean pain severity scores were lower with PP versus DP immediately after IBR for first (P = 0.0002) and second hospitalizations (P = 0.0145), and before discharge for first (P < 0.0001) and second hospitalizations (P = 0.0002). A greater proportion of PP versus DP patients had a shorter hospital length of stay (≤ 23 hours) for first hospitalization (P = 0.0052); proportions were similar for second hospitalization (P = 0.5499). Intravenous narcotics were prescribed less frequently to PP versus DP patients during first (61.1% versus 69.8%, respectively; P = 0.1486) and second (37.5% versus 55.3%, respectively; P = 0.0172) hospitalizations. Complication rates were low in both groups after first hospitalization discharge (DP: 13.6%, PP: 12.5%, P = 0.7225). Conclusion: This retrospective study suggests that the PP technique in IBR may offer benefits related to clinical outcomes and health resource utilization; however, larger studies, including randomized controlled trials, are needed to confirm.