Methods, rationale, and design for a remote pharmacist and navigator-driven disease management program to improve guideline-directed medical therapy in patients with type 2 diabetes at elevated cardiovascular and/or kidney risk.

AIM: Describe the rationale for and design of Diabetes Remote Intervention to improVe use of Evidence-based medications (DRIVE), a remote medication management program designed to initiate and titrate guideline-directed medical therapy (GDMT) in patients with type 2 diabetes (T2D) at elevated cardiovascular (CV) and/or kidney risk by leveraging non-physician providers. METHODS: An electronic health record based algorithm is used to identify patients with T2D and either established atherosclerotic CV disease (ASCVD), high risk for ASCVD, chronic kidney disease, and/or heart failure within our health system. Patients are invited to participate and randomly assigned to either simultaneous education and medication management, or a period of education prior to medication management. Patient navigators (trained, non-licensed staff) are the primary points of contact while a pharmacist or nurse practitioner reviews and authorizes each medication initiation and titration under an institution-approved collaborative drug therapy management protocol with supervision from a cardiologist and/or endocrinologist. Patient engagement is managed through software to support communication, automation, workflow, and standardization. CONCLUSION: We are testing a remote, navigator-driven, pharmacist-led, and physician-overseen management strategy to optimize GDMT for T2D as a population-level strategy to close the gap between guidelines and clinical practice for patients with T2D at elevated CV and/or kidney risk.

Characterizing obesity in a large health care delivery system.

OBJECTIVES: To characterize the prevalence of obesity and associated health care use within an integrated health care system in California. STUDY DESIGN: Cross-sectional study using electronic health records. METHODS: Primary care patients 18 years and older receiving care at Sutter Health between 2015 and 2020 were included in the study. Obesity was classified and health care utilization was ascertained at index and during the follow-up periods. Differences in prevalence by demographic and clinical characteristics among patients with and without obesity were assessed. Logistic regression was used to estimate the relationship between obesity class and health care utilization (outpatient encounters). RESULTS: Of the 1,094,790 primary care patients included in the analysis, 35% were classified as having obesity, defined as a body mass index of 30 kg/m2 or more or 25 kg/m2 or more for Asian individuals. Obesity prevalence was greater in Hispanic patients (46%) than in non-Hispanic White patients (30%). Patients without obesity had fewer outpatient visits (mean [SD], 3.7 [3.8]) than those with class 1 (4.1 [4.0]), class 2 (4.6 [4.4]), and class 3 (5.2 [4.8]) obesity. In the fully adjusted regression model, the odds of being a high utilizer among patients with obesity were 1.1 (class 1), 1.2 (class 2), and 1.3 (class 3) times that of patients without obesity (P < .001). CONCLUSION: Obesity prevalence is high among patients in the Sutter Health system, varying by race/ethnicity, and was associated with increased outpatient visit utilization. There is a need for greater awareness of the impact of obesity and the specific patient populations affected by the disease.

User Engagement Clusters of an 8-Week Digital Mental Health Intervention Guided by a Relational Agent (Woebot): Exploratory Study.

BACKGROUND: With the proliferation of digital mental health interventions (DMHIs) guided by relational agents, little is known about the behavioral, cognitive, and affective engagement components associated with symptom improvement over time. Obtaining a better understanding could lend clues about recommended use for particular subgroups of the population, the potency of different intervention components, and the mechanisms underlying the intervention's success. OBJECTIVE: This exploratory study applied clustering techniques to a range of engagement indicators, which were mapped to the intervention's active components and the connect, attend, participate, and enact (CAPE) model, to examine the prevalence and characterization of each identified cluster among users of a relational agent-guided DMHI. METHODS: We invited adults aged 18 years or older who were interested in using digital support to help with mood management or stress reduction through social media to participate in an 8-week DMHI guided by a natural language processing-supported relational agent, Woebot. Users completed assessments of affective and cognitive engagement, working alliance as measured by goal and task working alliance subscale scores, and enactment (ie, application of therapeutic recommendations in real-world settings). The app passively collected data on behavioral engagement (ie, utilization). We applied agglomerative hierarchical clustering analysis to the engagement indicators to identify the number of clusters that provided the best fit to the data collected, characterized the clusters, and then examined associations with baseline demographic and clinical characteristics as well as mental health outcomes at week 8. RESULTS: Exploratory analyses (n=202) supported 3 clusters: (1) "typical utilizers" (n=81, 40%), who had intermediate levels of behavioral engagement; (2) "early utilizers" (n=58, 29%), who had the nominally highest levels of behavioral engagement in week 1; and (3) "efficient engagers" (n=63, 31%), who had significantly higher levels of affective and cognitive engagement but the lowest level of behavioral engagement. With respect to mental health baseline and outcome measures, efficient engagers had significantly higher levels of baseline resilience (P<.001) and greater declines in depressive symptoms (P=.01) and stress (P=.01) from baseline to week 8 compared to typical utilizers. Significant differences across clusters were found by age, gender identity, race and ethnicity, sexual orientation, education, and insurance coverage. The main analytic findings remained robust in sensitivity analyses. CONCLUSIONS: There were 3 distinct engagement clusters found, each with distinct baseline demographic and clinical traits and mental health outcomes. Additional research is needed to inform fine-grained recommendations regarding optimal engagement and to determine the best sequence of particular intervention components with known potency. The findings represent an important first step in disentangling the complex interplay between different affective, cognitive, and behavioral engagement indicators and outcomes associated with use of a DMHI incorporating a natural language processing-supported relational agent. TRIAL REGISTRATION: ClinicalTrials.gov NCT05672745; https://classic.clinicaltrials.gov/ct2/show/NCT05672745.

Engagement, Satisfaction, and Mental Health Outcomes Across Different Residential Subgroup Users of a Digital Mental Health Relational Agent: Exploratory Single-Arm Study.

BACKGROUND: Mental illness is a pervasive worldwide public health issue. Residentially vulnerable populations, such as those living in rural medically underserved areas (MUAs) or mental health provider shortage areas (MHPSAs), face unique access barriers to mental health care. Despite the growth of digital mental health interventions using relational agent technology, little is known about their use patterns, efficacy, and favorability among residentially vulnerable populations. OBJECTIVE: This study aimed to explore differences in app use, therapeutic alliance, mental health outcomes, and satisfaction across residential subgroups (metropolitan, nonmetropolitan, or rural), MUAs (yes or no), and MHPSAs (yes or no) among users of a smartphone-based, digital mental health intervention, Woebot LIFE (WB-LIFE). WB-LIFE was designed to help users better understand and manage their moods and features a relational agent, Woebot, that converses through text-based messages. METHODS: We used an exploratory study that examined data from 255 adults enrolled in an 8-week, single-arm trial of WB-LIFE. Analyses compared levels of app use and therapeutic alliance total scores as well as subscales (goal, task, and bond), mental health outcomes (depressive and anxiety symptoms, stress, resilience, and burnout), and program satisfaction across residential subgroups. RESULTS: Few study participants resided in nonmetropolitan (25/255, 10%) or rural (3/255, 1%) areas, precluding estimates across this variable. Despite a largely metropolitan sample, nearly 39% (99/255) resided in an MUA and 55% (141/255) in an MHPSA. There were no significant differences in app use or satisfaction by MUA or MHPSA status. There also were no differences in depressive symptoms, anxiety, stress, resilience, or burnout, with the exception of MUA participants having higher baseline depressive symptoms among those starting in the moderate range or higher (Patient Health Questionnaire-8 item scale≥10) than non-MUA participants (mean 16.50 vs 14.41, respectively; P=.01). Although working alliance scores did not differ by MHPSA status, those who resided in an MUA had higher goal (2-tailed t203.47=2.21; P=.03), and bond (t203.47=1.94; P=.05) scores at day 3 (t192.98=2.15; P=.03), and higher goal scores at week 8 (t186.19=2.28; P=.02) as compared with those not living in an MUA. CONCLUSIONS: Despite the study not recruiting many participants from rural or nonmetropolitan populations, sizable proportions resided in an MUA or an MHPSA. Analyses revealed few differences in app use, therapeutic alliance, mental health outcomes (including baseline levels), or satisfaction across MUA or MHPSA status over the 8-week study. Findings suggest that vulnerable residential populations may benefit from using digital agent-guided cognitive behavioral therapy. TRIAL REGISTRATION: ClinicalTrials.gov NCT05672745; https://clinicaltrials.gov/study/NCT05672745.

Changes in stress, burnout, and resilience associated with an 8-week intervention with relational agent "Woebot".

Background: Research investigating the potential for digital mental health interventions with integrated relational agents to improve mental health outcomes is in its infancy. By delivering evidence-based mental health interventions through tailored, empathic conversations, relational agents have the potential to help individuals manage their stress and mood, and increase positive mental health. Aims: The aims of this study were twofold: 1) to assess whether a smartphone app delivering mental health support through a relational agent, Woebot, is associated with changes in stress, burnout, and resilience over 8 weeks, and 2) to identify demographic and clinical factors associated with changes in these outcomes. Method: This exploratory, non-randomized, single-armed, open-labeled trial was conducted from May to July 2022. A total of 256 adults (mean age 39 ± 13.35; 72 % females) recruited through social media advertising enrolled in the study. Participants completed an 8-week intervention period during which they were invited to use a smartphone app called Woebot-LIFE that delivers cognitive behavioral therapy through a relational agent called "Woebot". Participant-reported measures of stress, burnout, and resilience were collected at Baseline, and Week 8. Changes in these outcomes during the study period were assessed. Bivariate and stepwise multiple regression modeling was used to identify sociodemographic and clinical factors associated with observed changes over the 8-week study period. Results: Exposure to Woebot-LIFE was associated with significant reductions in perceived stress and burnout and significantly increased resilience over the 8-week study period. A greater reduction in stress was observed among those with clinically elevated mood symptoms (i.e., Patient Health Questionnaire-8 or Generalized Anxiety Disorder 7-item scores ≥10) at baseline compared to those without; however, the differences in the improvements in resilience scores and burnout between the two groups were not statistically significant. Although a difference in the magnitude of change in stress was observed for participants with and without clinically elevated mood symptoms at baseline, significant improvements in stress, burnout, and resilience over the 8-week study period were observed for both groups. Bivariate analyses showed that race, insurance type, and baseline level of resilience were associated with changes in each of the outcomes, though baseline resilience was the only factor that remained significantly associated with changes in the outcomes in the stepwise multiple regression analyses. Conclusion: Results of this single-arm, exploratory study suggest that conversational agent-guided mental health interventions such as Woebot-LIFE may be associated with reduced stress and burnout and increased resilience in both clinical and non-clinical populations.

The economic burden of systemic lupus erythematosus in commercially- and medicaid-insured populations in the United States.

OBJECTIVE: To estimate the economic burden of systematic lupus erythematous (SLE), stratified by disease severity, in commercially- and Medicaid-insured US populations. METHODS: Adults (≥18 years) with SLE treated with antimalarials, selected biologics, immunosuppressants, and systemic glucocorticoids (2010-2014) were identified within the commercial and Medicaid insurance IBM MarketScan® databases (index date = first SLE medication claim). Both cohorts were stratified into mild (receiving antimalarial or glucocorticoid monotherapy ≤5 mg/day) versus moderate/severe SLE (receiving glucocorticoids >5 mg/day, biologic, immunosuppressant, or combination therapy) during a 6-month exposure period. All-cause healthcare utilization and costs were evaluated during the 12 months following the exposure period. RESULTS: Among 8231 commercially-insured patients, 32.6% had mild and 67.4% had moderate/severe SLE by our definition. Among 802 Medicaid-insured patients, 25.2% had mild and 74.8% had moderate/severe SLE. Adjusted mean total healthcare costs, excluding pharmacy, for moderate/severe SLE patients were higher than for mild SLE patients in the commercially-insured ($39,021 versus $23,519; p < 0.0001) and Medicaid-insured populations ($56,050 versus $44,932; p = 0.06). In both SLE severity populations total unadjusted costs were significantly higher among Medicaid-insured than commercially-insured patients. CONCLUSION: Commercially-insured patients with treatment suggesting moderate/severe SLE incurred significantly higher adjusted mean healthcare costs, excluding pharmacy, compared with mild SLE patients. While not reaching statistical significance, moderate/severe Medicaid-insured patients had higher costs then mild SLE patients. Total unadjusted healthcare costs were significantly higher among Medicaid-insured than commercially-insured patients. These differential costs are important to consider and monitor when implementing interventions to improve health and reduce healthcare spending for SLE.

The Effect of Early Response to GLP-1 RA Therapy on Long-Term Adherence and Persistence Among Type 2 Diabetes Patients in the United States.

BACKGROUND: Treatment adherence and persistence are crucial to achieve glycemic control in patients with type 2 diabetes (T2D). Early response to a new therapy may lead to improved treatment adherence and associated outcomes. OBJECTIVE: To assess the effect of early response to glucagon-like peptide-1 receptor agonist (GLP-1 RA) therapy, as indicated by reduced hemoglobin A1c (A1c) and body weight, on long-term adherence and persistence. METHODS: Adults aged ≥ 18 years with T2D initiated with GLP-1 RA therapy after January 1, 2010, were identified from the IBM Explorys Therapeutic Dataset. Patients were required to have health care utilization ≥ 6 months before and ≥ 18 months after the index prescription. Changes in A1c and body weight from baseline through 6 months were assessed for all patients; early response was defined by > 1% reduction in A1c and > 3% reduction in body weight within 3-6 months. Adherence (assessed as the proportion of days covered [PDC] ≥ 80%) and nonpersistence/discontinuation (indicated by a gap in therapy ≥ 60 days) over 18 months were evaluated among early responders versus nonresponders. Multivariable logistic regression was used to assess the effect of early response to GLP-1 RA therapy on adherence and discontinuation over 18 months. RESULTS: Among 8,329 identified patients, 33.3% and 31.2% experienced early response as indicated by reductions in A1c > 1% point and in body weight > 3% from baseline, respectively. Significantly higher proportions (P < 0.001) of early responders in both reduced A1c and body weight were adherent over 18 months compared with patients without an early response (A1c: 45.0% vs. 37.1%; body weight: 43.3% vs. 38.0%). Significantly lower proportions (P < 0.001) of early responders discontinued over 18 months compared with patients without an early response (A1c: 61.4% vs. 67.9%; body weight: 61.9% vs. 67.5%). After controlling for baseline demographic and clinical characteristics including baseline weight, baseline A1c, oral antidiabetes drug use, insulin use, and the presence of comorbidity of diabetes, patients were more likely to be adherent over 18 months if they had reductions in A1c > 1% (OR = 1.59, 95% CI = 1.36-1.85) or body weight reduction > 3% (OR = 1.18, 95% CI = 1.02-1.36) at 3-6 months compared with those without an early response. Similarly, the early responders had significantly lower likelihood of discontinuation compared with those without early response (A1c > 1%; OR = 0.62, 95% CI = 0.53-0.72; body weight > 3%; OR = 0.81, 95% CI = 0.70-0.94). CONCLUSIONS: Early response to GLP-1 RA therapy was associated with significantly increased adherence and reduced likelihood of discontinuation. DISCLOSURES: Funding to conduct this study was provided to IBM Watson Health by Novo Nordisk A/S. The analysis was conducted independently by IBM Watson Health. Novo Nordisk A/S and IBM Watson Health collaborated on study design and interpretation of results. At the time of this study, Durden and Laing were employed by IBM Watson Health and received funding from Novo Nordisk to conduct this study. Fowler is employed by IBM Watson Health. Panton and Mocevic were employed by Novo Nordisk while this study was conducted. A portion of these results were presented at the AMCP Managed Care & Specialty Pharmacy Annual Meeting 2018; April 23-26, 2018; Boston, MA, where it was awarded with a bronze ribbon.

Incidence of secondary myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML) in patients with ovarian or breast cancer in a real-world setting in the United States.

OBJECTIVE: Real-world data on patients with cancer developing secondary malignancies such as myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML) are lacking. This study assessed the incidence and impact of select DNA-damaging therapy exposure on risk of secondary MDS and AML in patients with ovarian cancer (OC) or breast cancer (BC). METHODS: Adults with a first observed OC or BC diagnosis (index date) between 1/1/2000 and 6/30/2014 were identified from MarketScan® Commercial and Medicare databases. Patients had ≥12 months of pre-index and ≥1 month of post-index continuous health plan enrollment. Incidence of MDS/AML was evaluated over a variable-length period following the index date for each cancer cohort. Risk factors for secondary MDS/AML, including duration of DNA-damaging therapy exposure, were assessed using Poisson regression. RESULTS: Study selection criteria identified 23,862 patients with OC and 281,473 patients with BC (mean [SD] follow-up: 35.8 [31.4] and 46.0 [37.2] months, respectively). Incidence of MDS/AML was 2.77 and 1.44 per 1000 person-years among patients with OC and BC, respectively. Within both cohorts, incidence of MDS and AML was higher among patients exposed than those not exposed to select DNA-damaging therapy (alkylating agents, antimetabolites, platinum-based antineoplastic agents, and topoisomerase inhibitors). Duration of exposure to DNA-damaging therapy was a significant risk factor for developing MDS/AML during follow-up. CONCLUSIONS: Data suggest that there is likely a background risk of secondary MDS/AML associated with use of DNA-damaging therapies in earlier lines of chemotherapy and it is elevated in subcohorts exposed to select DNA-damaging therapies.

The Direct and Indirect Costs Associated With Overactive Bladder Within a Commercially-Insured Population in the United States.

OBJECTIVE: To quantify the burden associated with overactive bladder (OAB) within a commercially-insured United States (US) population. METHODS: Adults with OAB identified from the MarketScan databases (2008 to 2013) were propensity score matched 1:1 to non-OAB controls. Per-patient-per-month (PPPM) direct healthcare costs, and indirect costs attributable to workplace absence and short-term disability (STD), were estimated. RESULTS: Adjusted PPPM healthcare costs were higher for OAB patients than matched controls for both direct costs ($3003 vs $1123; P < 0.0001) and indirect costs due to STD ($114 vs $98; P < 0.05). There was no difference in the indirect costs due to absence between the OAB cases and controls. CONCLUSIONS: The direct healthcare costs of OAB patients are substantial. Additional research is needed to quantify the impact of OAB on workplace productivity. Improved management of OAB symptoms may reduce costs and enhance patient quality of life.

The economic burden of overactive bladder (OAB) and its effects on the costs associated with other chronic, age-related comorbidities in the United States.

AIMS: The prevalence of OAB increases with age and is associated with several chronic comorbidities. However, the impact of OAB on the healthcare costs of patients with such comorbidities is not well-understood. This study aimed to quantify the impact of OAB on healthcare costs and assess the potential moderating effects of OAB on the costs of patients with chronic comorbidities. METHODS: Adults with evidence of OAB/OAB-related therapy between 1/1/2008-12/31/2013 were identified from two large, administrative claims databases. Per-patient-per-month (PPPM) expenditures for OAB cases were estimated and compared to those of propensity score-matched subjects without OAB. Costs were modeled using ordinary least squares regression including main effects and interactions of chronic depression, dementia, diabetes, hypertension, and osteoporosis with OAB. Values for the comparisons were calculated on the original dollar scale using smearing estimators. RESULTS: A total of 110 059 pairs of OAB cases and matched non-OAB controls were identified. The mean, multivariable-adjusted, PPPM all-cause costs of OAB cases from the model without interactions were $3003, compared to $1123 for matched controls (P < 0.0001). In the model assessing the interactions of chronic comorbidities with OAB, those OAB patients with comorbid depression, dementia, diabetes, hypertension, and osteoporosis incurred significantly higher costs than controls with these comorbidities. The synergistic effect of these interactions was estimated to be $95-$574 PPPM. CONCLUSIONS: Within this US-based population, the healthcare costs of OAB patients were more than 2.5 times those of similar patients without OAB. Additionally, patients with OAB and chronic, age-related comorbidities incurred higher healthcare costs than non-OAB controls with the same comorbidities.

Two-year persistence and compliance with osteoporosis therapies among postmenopausal women in a commercially insured population in the United States.

This retrospective, observational study assessed 2-year persistence and compliance by treatment, route of administration, and dosing frequency in postmenopausal women initiating a new osteoporosis therapy. Two-year persistence and compliance rates were higher in women receiving injectables compared with oral agents. PURPOSE: This study extends previous studies limited to 1-year follow-up by examining persistence with osteoporosis therapies over a 2-year period and compares short- and long-term trends in persistence and compliance among postmenopausal women with commercial or Medicare supplemental insurance in the USA. METHODS: This retrospective, observational cohort study enrolled women ≥50 years newly initiating osteoporosis therapy between January 1 and December 31, 2012 (i.e., the index date), with continuous enrollment ≥14 months before and ≥24 months after their index date. Persistence (continuous therapy without a >60-day gap) and compliance with the index therapy were evaluated at 2 years of follow-up. Multivariable logistic regression was used to compare the odds of persistence and compliance across treatment and dosing regimens. RESULTS: This study included 43,543 patients with mean (standard deviation) age 65 (10) years. At 2 years of follow-up, persistence and compliance were higher for patients treated with injectable agents (ranging from 34 to 41%, excluding an every-3-month injection) than those treated with oral agents (ranging from 20 to 31%). Additionally, patients initiating oral bisphosphonates (except risedronate once daily), raloxifene (daily), or zoledronic acid (annually) had significantly lower odds of persistence compared with denosumab (every 6 months). CONCLUSIONS: Patients initiating injectable therapies had greater persistence and compliance at 2 years than those initiating oral therapies. Patients initiating an every-6-month injection had significantly higher persistence compared with those initiating more frequently dosed (e.g., daily and weekly) oral or injectable agents.

Clinical and Economic Outcomes Associated With the Timing of Initiation of Basal Insulin in Patients With Type 2 Diabetes Mellitus Previously Treated With Oral Antidiabetes Drugs.

PURPOSE: In patients with type 2 diabetes mellitus (T2DM) not achieving glycemic targets using oral antidiabetes drugs (OADs), studies suggest that timely insulin initiation has clinical benefits. Insulin initiation at the early versus late stage of disease progression has not been explored in detail. This retrospective database analysis investigated clinical and economic outcomes associated with the timing of insulin initiation in patients with T2DM treated with ≥1 OAD in a real-world US setting. METHODS: This study linked data from the Truven Health MarketScan(®) Commercial database, Medicare Supplemental database, and Quintiles Electronic Medical Records database. A total of 1830 patients with T2DM were included. Patients were grouped according to their OAD use before basal insulin initiation (1, 2, or ≥3 OADs) as a proxy for the timing of insulin initiation. Clinical and economic outcomes were evaluated over 1 year of follow-up. FINDINGS: During follow-up the 1 OAD group, compared with the 2 and ≥3 OADs groups, had a greater reduction in glycosylated hemoglobin A1c (-1.7% vs -1.0% vs -0.9%, respectively; P < 0.0001), greater achievement of glycemic target (38.2% vs 26.7% vs 19.6%, respectively; P < 0.0001), and a lower incidence of hypoglycemia (2.7% vs 6.6% vs 5.0%, respectively; P = 0.0002), with no difference in total health care costs ($21,167 vs $21,060 vs $20,133, respectively). IMPLICATIONS: This study shows that early insulin initiation (represented by the 1 OAD group) may be clinically beneficial to patients with T2DM not controlled with OADs, without adding to costs. This supports the call for timely initiation of individualized insulin therapy in this population.

Predictors of glycemic control and diabetes-related costs among type 2 diabetes patients initiating therapy with liraglutide in the United States.

OBJECTIVE: Liraglutide has been shown to significantly improve glycemic control and reduce body weight while minimizing the risk of hypoglycemia in adult patients with type 2 diabetes (T2D). This study aimed to identify characteristics that predict clinical and economic outcomes associated with liraglutide therapy in clinical practice in the US. METHODS: Using the Truven Health MarketScan Laboratory Database, glycemic control (A1C <7%) and diabetes-related costs were evaluated in T2D patients initiating liraglutide between January 1, 2010 and June 30, 2012. Patients were required to have ≥1 post-index claim for liraglutide and A1C values at baseline and 6 months follow-up. All valid values of baseline A1C were included. Patients previously treated with GLP-1 receptor agonist(s) or insulin, or with evidence of type 1 diabetes, pregnancy, or gestational diabetes during the study period were excluded. Multivariable regression models were used to identify predictors of glycemic control and diabetes-related costs. RESULTS: Of 417 patients newly treated with liraglutide, 54.0% achieved glycemic control (A1C <7%) during follow-up. Factors associated with increased odds of glycemic control during follow-up were: being female, POS/EPO health plan type, baseline A1C, early liraglutide initiation (0-1 prior oral anti diabetics [OADs] vs ≥2), adherence to liraglutide (defined as the proportion of days covered [PDC]), and diabetic retinopathy. Being female, earlier liraglutide initiation (0-1 prior OADs), and higher patient share of liraglutide costs were associated with significantly lower diabetes-related costs during follow-up. Factors associated with significantly higher post-index diabetes-related costs were: higher baseline A1C, baseline use of sulfonylureas, and diabetic retinopathy. CONCLUSIONS: Within this commercially-insured population of T2D patients treated with liraglutide, gender, baseline A1C, early liraglutide initiation (0-1 prior OADs), diabetic retinopathy, better adherence, and patient share of liraglutide costs were associated with increased odds of achieving glycemic control and the odds of having higher or lower diabetes-related costs.

Persistance and Compliance with Osteroporosis Therapies Among Women in a Commercially Insured Population in the United States.

BACKGROUND: Prior research has shown that rates of persistence and compliance with osteoporosis therapies are associated with significantly fewer vertebral, nonvertebral, and hip fractures. A number of studies have examined medication-taking behavior with oral bisphosphonates and teriparatide, and these 1-year persistence rates have ranged from 39.9% to 56.7%. Limited real-world data are available regarding persistence and compliance rates with newer therapies such as denosumab, a RANK ligand inhibitor administered every 6 months as a subcutaneous injection.  OBJECTIVE: To assess persistence and compliance rates over 1 year with newly initiated osteoporosis therapies, including denosumab, alendronate, ibandronate, risedronate, raloxifene, and teriparatide, within a cohort of commercially insured women.  METHODS: Health insurance claims data derived from Truven Health Analytics MarketScan Commercial Claims and Encounters and Medicare Supplemental and Coordination of Benefits databases (2010-2013) were used to conduct this retrospective cohort study. Adult females aged 18 years and older newly initiated on denosumab, raloxifene, teriparatide, or oral bisphosphonates (alendronate, ibandronate, or risedronate) between January 1, 2012, and March 31, 2012, were identified for inclusion. The date of the first qualifying osteoporosis prescription claim was defined as the index date. Patients were required to have at least 24 months of pre-index and at least 12 months of post-index continuous enrollment with medical and pharmacy benefits. Outcomes of patients initiating zoledronic acid (administered intravenously once yearly) were not assessed because a 12-month follow-up period would be insufficient for tracking persistence and compliance for this medication. Patients with Paget's disease of the bone, osteogenesis imperfecta, hypercalcemia, malignant cancer and metastasis, human immunodeficiency virus, and patients receiving preventive treatment for risk of breast cancer or denosumab in the pre-index period were excluded from the study. A subcohort of women aged 50 years and older at high risk for fracture (indicated by 1 or more of the following: aged ≥ 70 years, a pre-index fracture, or pre-index use of osteoporosis therapy that was discontinued at least 3 months prior to index) was analyzed separately. Propensity score weighting was used to adjust for differences in baseline demographic and clinical characteristics. Persistence, indicated by continuous use of the index therapy without a gap of 60 days or more; medication coverage ratio (MCR), the proportion of days covered by the index therapy; and compliance, defined as an MCR ≥ 0.80, were assessed during the 12-month follow-up. Logistic regression was used to estimate the odds of persistence and compliance for the treatment groups of interest. RESULTS: 10,863 female patients newly initiating osteoporosis medications (mean [SD] age: 66.2 [11.5] years) were identified. In the pre-index period, 35.8% of patients had a diagnosis of osteoporosis, while 11.5% had a diagnosis of osteopenia. Pre-index osteoporosis treatment was identified in 29.1% of patients, and 13.6% had an osteoporosis-related fracture in the pre-index period. Propensity score weight-adjusted 12-month persistence with the index medication varied from 28.9% to 35.1% for oral bisphosphonate users, 42.0% for raloxifene users, 59.1% for teriparatide users, and 68.3% for denosumab users (P less than 0.0001). The adjusted mean [SD] MCR was highest among patients treated with denosumab (0.83 [0.21]), followed by teriparatide (0.67 [0.31]), raloxifene, (0.57 [0.34]), ibandronate (0.54 [0.32]), alendronate (0.51 [0.33]), and risedronate (0.46 [0.33]; P less than 0.0001). The odds of being persistent and compliant across treatments favored denosumab (OR = 1.59 to 5.56, P less than 0.05 for persistence; OR = 2.44 to 7.69, P less than 0.0001 for compliance). Results were similar in the subcohort of women aged 50 years and older at high risk for fracture (n = 6,187; mean [SD] age: 71.9 [10.9] years). The odds of being persistent and compliant across treatments also favored denosumab (OR = 1.62 to 5.75, P less than 0.0001 for persistence; OR = 2.36 to 7.25, P less than 0.0001 for compliance). CONCLUSIONS: In a U.S. setting, rates of persistence and compliance over 12 months were higher among women initiating denosumab compared with those initiating other osteoporosis therapies.

Evidence-to-policy gap on hepatitis A vaccine adoption in 6 countries: Literature vs. policymakers' beliefs.

BACKGROUND: National vaccine adoption decisions may be better understood by linking multiple data sources. When examining countries' decisions to adopt the hepatitis A vaccine, applying multiple research methods can facilitate assessments of gaps between evidence and policy. We conducted a literature review on hepatitis A and stakeholder interviews about decisions to adopt the vaccine in six countries (Chile, India, South Korea, Mexico, Russia, and Taiwan). METHODS: A systematic literature review was conducted across five literature databases. The review identified and abstracted 340 articles, supplemented by internet search. In addition, we interviewed 62 experts and opinion leaders on hepatitis A and/or vaccines. Data from the two sources were analyzed to identify gaps around epidemiologic data, economic data, and barriers/facilitators of hepatitis A vaccine adoption. RESULTS: Epidemiologic data gaps were found in Chile and Russia, where stakeholders believed data to be more solid than the literature documented. Economic data on hepatitis A was found to be weak across all countries despite stakeholders' agreement on its importance. Barriers and facilitators of vaccine adoption such as political will, prioritization among vaccines, and global or local recommendations were discussed more by stakeholders than the literature. Stakeholders in India and Mexico were not concerned with the lack of data, despite growing recognition in the literature of the epidemiological transition and threat of outbreaks. CONCLUSIONS: Triangulation of results from two methods captured a richer story behind vaccine adoption decisions for hepatitis A. The discrepancy between policymakers' beliefs and existing data suggest a decline in priority of hepatitis A or weak investment in data collection. Filling the confirmed data gaps in seroprevalence or economic data is important to help guide policy decisions. Greater communication of the risk of hepatitis A and the benefits of the vaccine may help countries undergoing the epidemiologic transition.

Economic burden of systemic lupus erythematosus flares and comorbidities in a commercially insured population in the United States.

OBJECTIVE: To estimate the medical and productivity-related cost burden of systemic lupus erythematosus (SLE) flares and comorbidities in a commercially insured population. METHODS: Using administrative data, annual medical costs and indirect costs because of work loss were calculated for adult SLE patients, including flare severity and SLE-related comorbidity subsets, and a matched control group without SLE. RESULTS: Adjusted annualized medical costs were $18,952, $4305, $914, and $441 greater for SLE patients with severe, moderate, mild, and no flares, respectively, during follow-up than those of the matched controls. Medical costs also varied by SLE-related comorbidity. Adjusted annualized indirect costs of work loss because of absence and short-term disability were $1867 and $1602 greater, respectively, for SLE patients than for controls. CONCLUSIONS: SLE imposes a substantial cost burden to both patients and their employers.

Incremental Healthcare Costs and Outpatient Antifungal Treatment of Patients with Aspergillosis in the United States.

Objectives: To evaluate the total and outpatient economic burden of aspergillosis, and to describe the outpatient antifungal treatment of aspergillosis within a large, commercially-insured population in the United States. Methods: Adults with at least one medical claim with an aspergillosis diagnosis (International Classification of Disease 9th Revision Clinical Modification [ICD-9-CM] code 117.3 or 484.6) between 07/01/04-03/01/11 were identified from the MarketScan Research Databases. Patients had ≥6 months of pre-index and ≥1 month of post-index continuous health plan and pharmacy benefit enrollment and no pre-index diagnosis of aspergillosis. Aspergillosis cases were propensity score-matched to a sample of controls without aspergillosis. Outpatient antifungal therapy and total and outpatient healthcare resource utilization were evaluated in the post-index period. General linear models were used to estimate costs, which were adjusted by the length of follow-up. Incremental costs were calculated between cohorts and a bootstrap procedure was used to produce corresponding variation and 95% confidence interval estimates. Results: Aspergillosis cases (N=5,499; mean age: 57.8 years; 48.6% female; 64.2% with cancer) were matched to 5,499 controls (mean age: 58.3 years; 48.4% female; 60.6% with cancer). Two-thirds of the aspergillosis cases had no outpatient prescription for an antifungal within 30 days of index; for those with outpatient antifungal therapy, voriconazole was the most commonly prescribed agent (60.9%). Average adjusted total and outpatient expenditures were greater for aspergillosis patients during follow-up than those of the matched controls ($26,680 and $9,248 greater, respectively). Conclusions: The economic burden of aspergillosis is substantial. Patients with aspergillosis utilize significantly more healthcare resources and thus incur greater healthcare costs than do similar patients without aspergillosis.

Predictors of Treatment with Duloxetine or Venlafaxine XR among Adult Patients Treated for Depression in Primary Care Practices in the United Kingdom.

Background. Knowledge about real-world use of duloxetine and venlafaxine XR to treat depression in the UK is limited. Aims. To identify predictors of duloxetine or venlafaxine XR initiation. Method. Adult depressed patients who initiated duloxetine or venlafaxine XR between January 1, 2006 and September 30, 2007 were identified in the UK's General Practice Research Database. Demographic and clinical predictors of treatment initiation with duloxetine and venlafaxine XR were identified using logistic regression. Results. Patients initiating duloxetine (n = 909) were 4 years older than venlafaxine XR recipients (n = 1286). Older age, preexisting unexplained pain, respiratory disease, and pre-period use of anticonvulsants, opioids, and antihyperlipidemics were associated with increased odds of initiating duloxetine compared to venlafaxine XR. Pre-period anxiety disorder was associated with decreased odds of receiving duloxetine. Conclusion. Initial treatment choice with duloxetine versus venlafaxine XR was primarily driven by patient-specific mental and medical health characteristics. General practitioners in the UK favor duloxetine over venlafaxine XR when pain conditions coexist with depression.

Healthcare utilization among patients with depression before and after initiating duloxetine in the United Kingdom.

OBJECTIVE: Duloxetine is indicated for treatment of major depressive disorders in the UK. While clinical trials have documented its clinical effectiveness, little is known regarding the relationship between duloxetine use and healthcare utilization in community practice. This study quantifies the impact of treatment with duloxetine on healthcare utilization among patients with depression and those with depression and co-existing pain. METHODS: Depressed adults initiating duloxetine during 1/1/2006-9/30/2007 were identified from the General Practice Research Database (GPRD). All-cause hospitalization, accident/emergency visits, specialist referrals, and analgesic use in the 12 months before (pre-period) and after (post-period) duloxetine initiation were compared. Generalized Estimating Equation models evaluated the pre-post change in the odds of hospitalization. RESULTS: Nine hundred and nine patients were identified, 413 had pre-period unexplained pain (UPain). Rates of hospitalization declined from the pre- to the post-period. Fewer UPain patients received analgesics post-duloxetine initiation. Multivariate analyses confirmed that the odds of hospitalization were lower after duloxetine initiation. UPain patients with pre-period anticonvulsant use had lower odds of hospitalization in the post-period and the reduction in odds was significantly larger than that of patients without pre-period anticonvulsants. While patients with pre-period anxiolytic use, alcohol/drug dependence, or sleep disorders did not show statistically significant pre-post change in the odds of hospitalization, these changes were significantly different from patients without these conditions. LIMITATIONS: The study did not include a comparison group of patients who were non-users of duloxetine. Prevalence of chronic conditions might be under-estimated due to coding in the GPRD. Medications were assumed to be taken as prescribed. Study results are not generalizable beyond the population covered by the UK's primary care system. CONCLUSIONS: All-cause hospitalization rates lowered among depressed patients and fewer UPain patients received analgesics post-duloxetine initiation. The reduction in the odds of hospitalization was most pronounced among UPain patients receiving pre-period anticonvulsants.

Health care resource utilization and costs in a commercially insured population of patients with bipolar disorder type I and frequent psychiatric interventions.

BACKGROUND: Bipolar disorder type I (BP-I) is one of the most expensive behavioral diagnoses in the United States. Characterizing patient populations that consume significant resources would be useful for designing and implementing additional resources and targeted interventions to reduce the costs of BP-I. OBJECTIVE: This analysis compared the characteristics, health care resource utilization, and costs of commercially insured patients with BP-I (indicating a history of manic or mixed episodes) and frequent psychiatric interventions (FPIs) versus those without FPIs. METHODS: This retrospective study used data from commercial insurance claims to identify adults with FPIs (≥2 clinically significant events [CSEs]) or without FPIs during a 12-month identification period (year 1). CSEs included emergency department (ED) visits or hospitalizations with a principal diagnosis of BP-I, the addition of a new medication to the observed treatment regimen, or a ≥50% increase in BP-I medication dose. Demographic and clinical characteristics were evaluated during the identification period, and health care resource utilization and costs were evaluated during a 12-month follow-up period (year 2). RESULTS: Data from 7620 patients with FPIs and 11,571 without FPIs were included (women, 67.1% and 59.9%, respectively; P < 0.001). Of patients with FPIs in the identification period, 22.2% continued to have FPIs in the follow-up period. In the follow-up period, the group with FPIs had a greater proportion of patients with psychiatric-related inpatient hospitalizations (14.6% vs 2.8%) and ED visits (11.6% vs 2.7%) [corrected], a longer mean hospital length of stay (11.74% vs 8.24 days) [corrected], and greater adjusted mean psychiatric-related costs ($6617 vs $3276) and all-cause health care costs ($14,091 vs $9357) compared with the group without FPIs (all, P < 0.001). The risks for a psychiatric-related hospitalization and an ED visit during the follow-up period were significantly greater in the group with FPIs compared with the group without (odds ratios, 4.86 and 3.76, respectively; both, P < 0.01). CONCLUSIONS: In this retrospective analysis, FPIs were associated with a greater number of FPIs during follow-up, ∼2-fold the psychiatric-related costs, and 1.5-fold the all-cause health care costs compared with no FPIs. These data highlight the economic burden of FPIs and the potential for health care cost reductions from improved management options in these patients.