Real-world clinical outcomes and treatment patterns in patients with MDD treated with vortioxetine: a retrospective study.

BACKGROUND: This study included evaluation of the effectiveness of vortioxetine, a treatment for adults with major depressive disorder (MDD), using patient-reported outcome measures (PROMs) in a real-world setting. METHODS: This retrospective chart review analyzed the care experiences of adult patients with a diagnosis of MDD from Parkview Physicians Group - Mind-Body Medicine, Midwestern United States. Patients with a prescription for vortioxetine, an initial baseline visit, and ≥ 2 follow-up visits within 16 weeks from September 2014 to December 2018 were included. The primary outcome measure was effectiveness of vortioxetine on depression severity as assessed by change in Patient Health Questionnaire-9 (PHQ-9) scores ~ 12 weeks after initiation of vortioxetine. Secondary outcomes included changes in depression-related symptoms (i.e., sexual dysfunction, sleep disturbance, cognitive function, work/social function), clinical characteristics, response, remission, and medication persistence. Clinical narrative notes were also analyzed to examine sleep disturbance, sexual dysfunction, appetite, absenteeism, and presenteeism. All outcomes were examined at index (start of vortioxetine) and at ~ 12 weeks, and mean differences were analyzed using pairwise t tests. RESULTS: A total of 1242 patients with MDD met inclusion criteria, and 63.9% of these patients had ≥ 3 psychiatric diagnoses and 65.9% were taking ≥ 3 medications. PHQ-9 mean scores decreased significantly from baseline to week 12 (14.15 ± 5.8 to 9.62 ± 6.03, respectively; p < 0.001). At week 12, the response and remission rates in all patients were 31.0% and 23.1%, respectively, and 67% continued vortioxetine treatment. Overall, results also showed significant improvements by week 12 in anxiety (p < 0.001), sexual dysfunction (p < 0.01), sleep disturbance (p < 0.01), cognitive function (p < 0.001), work/social functioning (p = 0.021), and appetite (p < 0.001). A significant decrease in presenteeism was observed at week 12 (p < 0.001); however, no significant change was observed in absenteeism (p = 0.466). CONCLUSIONS: Using PROMs, our study results suggest that adults with MDD prescribed vortioxetine showed improvement in depressive symptoms in the context of a real-world clinical practice setting. These patients had multiple comorbid psychiatric and physical diagnoses and multiple previous antidepressant treatments had failed.

Incremental burden of relapse in patients with major depressive disorder: a real-world, retrospective cohort study using claims data.

BACKGROUND: Relapse is common in major depressive disorder (MDD). In this study, we evaluated the incremental health care burden of relapse in patients with MDD. METHODS: This real-world retrospective cohort study used administrative medical and pharmacy claims data to identify commercially insured adult patients in the United States diagnosed with MDD who initiated a new antidepressant between January 1, 2012, and September 30, 2017. All-cause health care resource utilization, total costs, and medication adherence were evaluated in two cohorts: patients with and patients without relapse. Relapse was defined as suicide attempts, psychiatric hospitalization, mental health-related emergency department (ED) visit, use of electroconvulsive therapy, or reinitiation of treatment after a gap ≥6 months. RESULTS: The study population included 14,186 patients (7093 baseline-matched patients per cohort). The mean follow-up period was 27.5 and 26.0 months for patients with and patients without relapse, respectively. Patients with relapse had significantly higher rates of hospitalization (16.6% vs 8.5%; p < .0001) and ED visits (54.8% vs 34.7%; p < .0001) than patients without relapse. The total costs for patients with relapse were significantly higher ($12,594 vs $10,445;  p < .0001). Patients with relapse were also less adherent to antidepressants (mean proportion of days covered, 0.43 vs 0.49; p < .0001). CONCLUSIONS: Relapse of MDD was associated with increased total costs and health care utilization and lower adherence to antidepressants. Reducing the risk of relapse may result in a reduction of the associated health care burden; however, findings may only be generalizable to patients with commercial insurance.

Incremental burden of comorbid major depressive disorder in patients with type 2 diabetes or cardiovascular disease: a retrospective claims analysis.

BACKGROUND: The estimated prevalence of comorbid major depressive disorder (. MDD) is 11% in patients with type 2 diabetes (T2D) and 15-20% in those with cardiovascular disease (CVD). Comorbid MDD continues to be a significant source of economic burden to the healthcare system. METHODS: We assessed the incremental healthcare burden of comorbid MDD in patients with T2D or CVD. This real-world, retrospective, administrative claims study analyzed commercially insured adults with T2D or CVD diagnosed on at least 2 separate claims within 12 months of each other (between January 1, 2011, and September 30, 2018). CVD included congestive heart failure, peripheral vascular disease, coronary heart disease, and cerebrovascular disease. The study compared patients with and without MDD with either T2D or CVD. Study assessments included all-cause healthcare resource utilization (proportion of patients with hospitalization, emergency department [ED] visits, and outpatient visits) and cost. RESULTS: Patients were matched by propensity score for demographics and baseline characteristics, resulting in similar baseline characteristics for the respective subcohorts. After matching, 22,892 patients with T2D (11,446 each with and without MDD) and 28,298 patients with CVD (14,149 each with and without MDD) were included. At follow-up, patients with T2D and MDD had significantly higher rates of hospitalization (26.1% vs 17.4%, P < 0.0001) and ED visits (55.3% vs 43.0%, P < 0.0001) than those observed in patients without MDD. The total cost for patients with T2D and MDD at follow-up was significantly higher than for those without MDD ($16,511 vs $11,550, P < 0.0001). Similarly, at follow-up, patients with CVD and MDD had significantly higher rates of hospitalization (45.4% vs 34.1%, P < 0.0001) and ED visits (66.5% vs 55.4%, P < 0.0001) than those observed in patients without MDD. Total cost at follow-up for patients with CVD and MDD was significantly higher than for those without MDD ($25,546 vs $18,041, P < 0.0001). CONCLUSIONS: Patients with either T2D or CVD and comorbid MDD have higher total all-cause healthcare utilization and cost than similar patients without MDD. Study findings reinforce the need for appropriate management of MDD in patients with these comorbid diseases, which in turn may result in cost reductions for payers. TRIAL REGISTRATION: Not applicable.

Mental health diagnoses and services utilization vary by wage level.

OBJECTIVES: The relationship between employee wage status and mental health care utilization has not been characterized in large-scale analyses. This study assessed health care utilization and cost patterns for mental health diagnoses according to wage category among employees with health insurance. STUDY DESIGN: This was an observational, retrospective cohort study for the year 2017 among 2,386,844 adult full-time employees (254,851 with mental health disorders; subgroup of 125,247 with depression) enrolled in self-insured plans in the IBM Watson Health MarketScan research database. METHODS: Participants were stratified into annual wage categories: $34,000 or less; more than $34,000 to $45,000; more than $45,000 to $69,000; more than $69,000 to $103,000; and more than $103,000. Health care utilization and costs were analyzed via regression analyses. RESULTS: Prevalence of diagnosed mental health disorders was 10.7% (9.3% in the lowest-wage category); prevalence of depression was 5.2% (4.2% in the lowest-wage category). Severity of mental health, and specifically depression episodes, was greater in lower-wage categories. All-cause utilization of health care services was higher in patients with mental health diagnoses vs the total population. Among patients with mental health diagnoses, specifically depression, utilization was highest in the lowest- vs highest-wage category for hospital admissions, emergency department visits, and prescription drug supply (all P < .0001). All-cause health care costs were higher in the lowest- vs highest-wage category among patients with mental health diagnoses ($11,183 vs $10,519; P < .0001), specifically depression ($12,206 vs $11,272; P < .0001). CONCLUSIONS: Lower mental health condition prevalence and greater use of high-intensity health care resources highlight the need to more effectively identify and manage mental health conditions among lower-wage workers.

Effectiveness of vortioxetine for major depressive disorder in real-world clinical practice: US cohort results from the global RELIEVE study.

Introduction: Effective treatment of major depressive disorder (MDD) involves addressing both depressive and functional symptoms, increasing patients' overall sense of well-being and quality of life (QoL). Methods: RELIEVE was an international observational, prospective study in patients ≥18 years with a current diagnosis of a major depressive episode (MDE) initiating vortioxetine in routine clinical practice; outcomes for the cohort of participants from the United States are presented here. Functioning was assessed at weeks 12 and 24 versus baseline using the Sheehan Disability Scale (SDS). Secondary effectiveness analyses assessed changes from baseline to weeks 12 and 24 in functioning, depression severity, cognitive symptoms, sexual function, and QoL. Results: 244 participants had an average of 8.2 previous MDEs; mean duration of their current MDE at baseline was 93.5 weeks. Vortioxetine was used as second- or later-line treatment for 80.5% of participants. Least-squares mean (SE) SDS total score significantly decreased from baseline by 7.19 (0.52) points at week 12 and 8.19 (0.56) points at week 24 (p < 0.0001 for both). Significant improvements were also reflected across SDS subscores, depression severity, cognitive function, sexual function, and QoL. Healthcare resource utilization and productivity parameters also improved. Adverse events were observed in 21.8% of patients, with nausea being the most common (7.3%). Conclusion: This real-world study demonstrated improvements in functioning, depressive symptoms, and cognitive function in patients with MDD treated with vortioxetine in routine clinical practice in the cohort of patients enrolled in the United States. Outcomes were consistent with the efficacy and safety profile of vortioxetine in randomized controlled trials.

Characterizing primary care for patients with major depressive disorder using electronic health records of a US-based healthcare provider.

BACKGROUND: Major depressive disorder (MDD) is predominantly managed in primary care. However, primary care providers (PCPs) may not consistently follow evidence-based treatment algorithms, leading to variable patient management that can impact outcomes. METHODS: We retrospectively analyzed adult patients with MDD seen at Geisinger, an integrated health system. Utilizing electronic health record (EHR) data, we classified patients as having MDD based on International Classification of Disease (ICD)-9/10 codes or a Patient Health Questionnaire (PHQ)-9 score ≥5. Outcomes assessed included time to first visit with a PCP or behavioral health specialist following diagnosis, antidepressant medication switching, persistence, healthcare resource utilization (HRU), and treatment costs. RESULTS: Among the 38,321 patients with MDD managed in primary care in this study, significant delays between diagnosis with antidepressant prescribing and follow-up PCP visits were observed. There was also considerable variation in care following diagnosis. Overall, 34.9% of patients with an ICD-9/10 diagnosis of MDD and 41.3% with a PHQ-9 score ≥15 switched antidepressants. An ICD-9/10 diagnosis, but not moderately severe to severe depression, was associated with higher costs and HRU. More than 75% of patients with MDD discontinued antidepressant medication within 6 months. LIMITATIONS: The study population was comparable with other real-world studies of MDD, but study limitations include its retrospective nature and reliance on the accuracy of EHRs. CONCLUSIONS: Management of patients with MDD in a primary care setting is variable. Addressing these gaps will have important implications for ensuring optimal patient management, which may reduce HRU and treatment medication costs, and improve treatment persistence.

Adherence and persistence among patients with major depressive disorder enrolled in the vortioxetine tAccess Patient Support Program.

OBJECTIVE: The tAccess Patient Support Program (PSP) is a personalized support program for patients prescribed vortioxetine therapy. We assessed the impact of the tAccess PSP on adherence to and persistence with vortioxetine among adult patients with major depressive disorder (MDD). METHODS: A retrospective observational cohort study was conducted in patients with MDD receiving vortioxetine who were enrolled in the tAccess PSP. Eligible patients were 18 to 64 years of age and had ≥1 vortioxetine claim and ≥1 inpatient/outpatient medical MDD claim during the 12 months preceding or on the index date, defined as the date of the earliest vortioxetine claim. Study outcomes included medication adherence (proportion of days covered [PDC], adherent ≥80%) and persistence (the total number of days on therapy without a ≥30-day gap) at 90, 180, and 365 days. Additionally, persistence was reported for a subset of patients meeting the standardized Healthcare Effectiveness Data and Information Set (HEDIS) Antidepressant Medication Management (AMM) criteria (the percentage of adults aged 18-64 years who remained on an antidepressant for ≥84 days or ≥180 days), as defined by the National Committee for Quality Assurance. These data were reviewed alongside current HEDIS AMM data for commercially insured patients meeting the standardized metric. RESULTS: The study identified a total of 2635 patients with an MDD diagnosis and ≥90 days of follow-up time and a subset of 2238 patients meeting HEDIS AMM criteria. Mean PDC among all patients with MDD was 0.78, with 58.3% of patients achieving PDC ≥80%. During the 90-day follow-up, 62.1% of patients with MDD were persistent on vortioxetine. Among the subset of patients who met HEDIS AMM criteria, persistence was 83.4% and 69.9% at 84 and 180 days, respectively. In comparison, in 2017, HEDIS AMM criteria for antidepressant persistence were met by 67.8% of commercially insured patients at 84 days and 51.8% at 180 days. CONCLUSIONS: These initial results, reviewed alongside recent available HEDIS AMM data, suggest that the tAccess PSP may be beneficial in addressing treatment adherence and persistence in patients with MDD.

Physicians' perspectives on the treatment of osteoporosis patients with bisphosphonates.

BACKGROUND: Noncompliance with bisphosphonate therapy among osteoporosis patients attenuates the reduction of fracture risk. The objective of this study was to assess physicians' prescribing considerations, preferences for osteoporosis treatments, and perceptions of patients' compliance with oral bisphosphonates. METHODS: This was an online survey of US physicians identified in the HealthCore Integrated Research Database (HIRD(SM)) as prescribing oral bisphosphonates to women aged ≥55 years. The survey gauged physicians' prescribing considerations and preferences for various types of osteoporosis medications. The physicians were asked to predict patient persistence and compliance, and rate various reasons for noncompliance. RESULTS: Bone mineral density, long-term medication use (eg, corticosteroids), and a history of fracture were ranked as major considerations by 94.9%, 88.6%, and 86.7% of participating physicians (N=158), respectively, when deciding whether to treat an osteoporosis patient. Most physicians expressed a preference for prescribing weekly or monthly oral bisphosphonates, for both newly diagnosed patients (54.4% and 34.2%, respectively) and long-term users of oral bisphosphonates (40.5% and 36.1%, respectively). Most physicians (23.4% always, 58.9% sometimes) incorporated a drug holiday into their prescribing patterns. Although most physicians predicted that more than half of the patients would comply with the prescribed medication for at least a year, 17.7% predicted that less than half of the patients would be compliant in the 1st year, and 29.7% predicted the same result for compliance beyond 1 year. In the opinion of the majority of physicians, the major reasons for noncompliance with oral bisphosphonates were intolerance of a medication due to a gastrointestinal condition (71.5%) and medication side effects (69.6%). CONCLUSION: US physicians consider several relevant risk factors when deciding whether to prescribe pharmacotherapy and exhibit a preference for weekly or monthly regimens. The physicians estimated a substantial minority of the patients to be noncompliant with oral bisphosphonates, for reasons including primarily gastrointestinal intolerance and medication-related side effects.

Economic burden of hepatitis B infection among patients with diabetes.

Despite ACIP recommendation and cost-effectiveness established in those 19-59 y old diabetes patients the uptake of Hepatitis B vaccine in diabetes patients is low. There is need to highlight the impact of Hepatitis B virus (HBV) infection in diabetes patients in terms of healthcare utilization and costs to recognize the burden of HBV in this population. This retrospective claims analysis included patients with diabetes and HBV (cases; n=1,236) and those with diabetes without HBV (controls; n=4,944), identified by ICD-9-CM diagnosis codes. Cases were matched with 4 controls using propensity score matching. Healthcare utilization and cost were compared; incremental effect of HBV infection was assessed using multivariate analysis. In the adjusted analyses, the mean number of hospitalizations (0.6 vs 0.4), outpatient service visits (34.2 vs. 20.4), and office visits (10.9 vs. 9.8) were 41%, 68%, and 11% higher, respectively, in cases vs. controls (all p<0.05). Gastroenterologist visits (0.8 vs. 0.2) and infectious disease visits (0.1 vs. 0.0) were 80% and 18% higher in subset of case and controls with these events. Cases ($39,435) incurred $16,397 incremental total costs compared with controls ($23,038). Medical ($30,968 vs. $17,765) and pharmacy costs ($8,029 vs. $5,114) were both significantly higher for cases (p < 0.0001). Healthcare utilization and costs were higher among patients with diabetes and HBV than in those with diabetes alone. These results provide evidence supporting the need for HBV vaccination among unvaccinated diabetes patients.

Determinants of high cost in multiple sclerosis patients: a claims and chart review study.

OBJECTIVE: To identify factors associated with high cost multiple sclerosis (MS) patients using integrated administrative claims and medical charts data. METHODS: This study identified newly diagnosed MS patients (≥18 years) in a large United States managed care claims database between 1 January 2007 and 30 April 2011 using the ICD-9-CM code (340.xx). Mean annualized MS-related costs higher than the third quartile were categorized as high cost, lower than the first quartile as low, and the rest as medium. Patients were compared across cohorts with descriptive and inferential statistics. Baseline high cost factors were identified with multivariable logistic regression models. RESULTS: Administrative claims (n = 4342) and medical chart records (n = 400) data was evaluated. Mean (SD) annualized MS-related costs were $6313 ($14,177) for patients overall and $18,398 ($24,483) for high cost patients. Inpatient costs accounted for the largest proportion (49.69%) of MS-related costs among high cost patients. MS relapses and MS-related comorbidities were more prevalent in the high cost patients. In the multivariable analyses, patients with baseline use of antidepressants or corticosteroids, baseline muscle weakness, and initial treatment from a non-neurologist were likelier to be high cost MS patients. LIMITATIONS: MS-related clinical information was not completely available from medical chart data. The specificity of true MS-related costs may have been limited and the definition of the cost-based cohort segmentations was arbitrary. CONCLUSIONS: Overall, baseline use of MS-related medications, the presence of baseline MS-related comorbidities, MS relapses, and MS-related hospitalizations were significantly associated with high cost patients. Future comparative effectiveness studies of currently approved disease modifying therapies for MS may help to identify best strategies for individual patients to minimize clinical events that are associated with high disease related costs.

A Retrospective Administrative Claims Database Evaluation of the Utilization of Belimumab in US Managed Care Settings.

PURPOSE: Belimumab is an approved therapy for the treatment of systemic lupus erythematosus (SLE). This study examined the real-world utilization patterns of belimumab and standard SLE therapies in patients after regulatory approval of belimumab in the United States. METHODS: A retrospective, observational study of belimumab users in the HealthCore Integrated Research Database was conducted using administrative claims data (GlaxoSmithKline Clinical Study Register Study ID: 114955). The overall population for analysis was composed of patients who were prescribed belimumab, had ≥6 months pre- and ≥6 months post-index medical and pharmacy eligibility, and at least 1 medical claim for SLE. Patients' clinical and demographic characteristics, treatment history, treatment patterns of belimumab, utilization of other medications, all-cause resource utilization, and costs were assessed. No hypotheses were tested. FINDINGS: All patients who were prescribed belimumab had an SLE claim. Patients who met all eligibility criteria (n = 155) were primarily female (94.2%; mean [SD] age, 44 [12] years) and 94.2% had used standard SLE therapies during the pre- and post-index periods. The majority had moderate SLE disease severity pre-index, and there was a small shift (approximately 8%) from moderate to mild SLE after initiation of belimumab. Two thirds of patients remained on belimumab therapy at 6 months post-index. The percentage of patients with any claim for oral corticosteroids remained stable; however, the point estimate for mean daily dose decreased slightly in months 3 to 6 post-index. Inpatient hospital admissions decreased slightly in the post-index period. The point estimate for total costs (excluding belimumab) decreased after initiation of belimumab, although overall total health care costs (including belimumab) increased. IMPLICATIONS: All patients with a belimumab prescription had an SLE diagnosis on at least 1 medical claim, and the vast majority of those meeting all eligibility criteria had previously used a standard SLE therapy. Disease severity improved for a number of patients while on belimumab treatment and modest corticosteroid dose reductions were observed in later months. After initiating belimumab, health care costs (excluding belimumab) decreased. GlaxoSmithKline Clinical Study Register Study ID: 114955.