Treatment Patterns and Healthcare Resource Utilization Among Newly Diagnosed Psoriasis, Psoriatic Arthritis, Axial Spondyloarthritis, and Hidradenitis Suppurativa Patients with Past Diagnosis of an Inflammatory Condition: A Retrospective Cohort Analysis of Claims Data in the United States.

INTRODUCTION: Psoriasis (PSO), psoriatic arthritis (PsA), axial spondyloarthritis (axSpA), and hidradenitis suppurativa (HS) are chronic inflammatory diseases (CIDs) often diagnosed and treated individually. However, genetic overlaps exist among CIDs, and patients with one are at risk of developing others within the same spectrum. This analysis characterized treatment patterns along with clinical and economic burdens of newly diagnosed CIDs among patients with an additional past diagnosis of PSO, PsA, axSpA, or HS. METHODS: This study used MarketScan® databases to examine demographics, treatment patterns, and healthcare resource utilization for patients with ≥ 1 claim for PSO or HS or ≥ 2 claims for PsA or axSpA, and continuous enrollment in the year before (baseline period) and following (follow-up period) the date of first diagnosis (incident diagnosis). Comorbidities and new CID diagnoses with a past diagnosis of PSO, PsA, axSpA, or HS, were examined. RESULTS: The analysis included 298,794 patients (maximum of 1202 patients with ≥ 1 incident diagnoses): 134,233 had incident PSO; 9914 had incident PsA; 115,194 had incident axSpA; and 40,655 had incident HS. Prevalence of ≥ 1 CID diagnosis among patients with past diagnosis of PSO, PsA, axSpA, or HS was 4959/134,233 (3.7%), 5256/9914 (53.0%), 3205/115,194 (2.8%), and 1180/40,655 (2.9%), respectively. In patients with incident axSpA and past PsA diagnosis, incident axSpA and past HS diagnosis, and incident HS and past PSO diagnosis, steroid and opioid use were high across baseline and follow-up periods and use of biologic disease-modifying antirheumatic drugs increased from baseline to follow-up. Disease-related costs increased absolutely and increased or remained high as a proportion of all-cause costs. CONCLUSION: Patients with newly diagnosed CIDs and additional past diagnosis of PSO, PsA, axSpA, or HS experienced high treatment utilization and healthcare costs. These findings highlight the need for payers, health technology assessment agencies, clinicians, and other stakeholders to explore the co-management of CIDs, rather than treating them separately.

Treatment Patterns of Follicular Lymphoma in the United States: A Claims Analysis.

Background: A consensus is lacking on optimal treatment sequencing for follicular lymphoma (FL), the most common indolent lymphoma. FL is incurable, and many patients require multiple lines of therapy for successive relapses. Guidelines provide numerous recommendations for first-, second-, and third-line therapy; however, treatment patterns in the real world remain poorly understood. Objectives: The primary objective of this study is to evaluate real-world treatment patterns among commercially insured patients with FL in the United States. Methods: A retrospective cohort of patients with newly diagnosed FL was identified from June 2008 to September 2016 using the IBM MarketScan® database. Treatment pattern measures, including time to treatment from diagnosis, days from previous line of therapy, duration of therapy, and distribution of treatment regimens among lines of therapy, were assessed. Descriptive statistics were reported for baseline characteristics, primary outcome, and treatment pattern measures. Results: In total, 4232 patients were identified from the database and 2111 patients received at least 1 line of treatment. The most common first-line treatments included bendamustine + rituximab (39%), rituximab + cyclophosphamide + doxorubicin + vincristine (20%), and rituximab monotherapy (19%). Rituximab monotherapy was the most common second-line (34%) and third or greater line (57%) treatment. The median time from FL diagnosis to initiation of treatment was 50 days (interquartile range [IQR]: 28-191) for first-line treatment, 577 days (IQR: 312-1146) for second-line, and 776 days (IQR: 603-1290) for third-line. Discussion: At a median follow-up of 3.6 years, most patients had 1 or fewer lines of therapy. The use of combination therapy decreased with each line of therapy and the numbers of patients receiving third- or fourth-line therapy were small in this study, potentially due to the short follow-up. Rituximab as monotherapy or in combination was utilized most frequently; however, the variety of other therapies used demonstrates that the standard management of FL remains unclear. Conclusions: Consensus on optimal treatment sequencing is currently lacking, and patients receive a variety of active regimens during routine practice. In this contemporary cohort of patients diagnosed with FL in the United States, rituximab therapy predominated both in monotherapy and in combination.

Increased Healthcare Resource Utilization and Direct and Indirect Costs in Patients with Depression and Comorbid Overactive Bladder: Evidence From a Retrospective, Matched Case-Control Cohort Analysis.

INTRODUCTION: This study sought to compare healthcare resource utilization (HCRU), costs, and workplace productivity among patients with depression, with and without overactive bladder (OAB). METHODS: This retrospective, case-control cohort analysis compares HCRU, costs, and workplace productivity among propensity score matched patients with depression and OAB (case cohort) and patients with depression without OAB (control cohort). Patients were aged 18 years or older, insured/on Medicare, and had diagnosed depression and an antidepressant medication claim pre index. First OAB-related event was index for cases; controls were assigned a proxy (study period 12 months). Comparisons of HCRU and costs and regression models assessed the relationship between OAB and costs. For the workplace productivity subset analyses cases and controls were balanced on baseline covariates for the short-term disability analyses but as they were unbalanced for the absentee analyses, multivariate regression analyses were used for this subset. RESULTS: The study criteria were met by 39,085 cases and 308,736 controls, from which, 37,997 patients were successfully matched 1:1 (mean age 55 years; 81% female). Most depression-related HCRU measures were similar across cohorts; however, outpatient visits, ER visits, and number of unique depression medications were significantly higher (all p < 0.05) among cases. Cases also had 13% higher total depression-related costs (p < 0.0001). Total mean (standard deviation [SD]) depression-related costs were $1796 ($4235) for cases versus $1597 ($3863) for controls (p < 0.0001). For workplace productivity (absentee data: cases [n = 686], controls [n = 642]; short-term disability data: cases [n = 4395], controls [n = 4433]) absentee outcomes were similar across cohorts. However, a higher percentage of cases used short-term disability benefits compared to controls (21.3% versus 16.9%; p < 0.0001) and cases experienced more case days (11.0 versus 8.6 mean days) and received higher mean payments than controls ($1226 versus $1033; p < 0.0001) in this subset. CONCLUSIONS: OAB was associated with 13% higher depression-related costs and 4.4% more cases used short-term disability benefits.

Rosacea Treatment Satisfaction: Matching Adjusted Indirect Treatment Comparison Analysis of Metronidazole Gel or Cream vs Azelaic Acid Foam.

OBJECTIVE: To assess differences in patient-reported treatment side effects and concerns associated with azelaic acid 15% foam (AAF) vs metronidazole cream (MC) and metronidazole gel (MG). METHODS: This study used matching-adjusted indirect comparison (MAIC) to compare patient-reported outcomes from survey data evaluating rosacea treatments. Outcomes of interest included percentages of patients reporting concerns and side effects and measures of importance of the concerns and tolerability of the side effects. Patients in each analysis (MG vs AAF and MC vs AAF) were matched using stabilized inverse propensity scores. RESULTS: When compared to AAF, MG-treated patients more frequently reported concerns with treatment efficacy (54% vs 4%), application (7% vs 3%), and treatment side effects. MC-treated patients more frequently reported concerns with treatment efficacy (61% vs 5%) and dryness (8% vs 5%). AAF-treated patients more frequently reported concerns with cost of treatment compared with MG (7% vs 1%) and MC (9% vs 4%). Among patients reporting concerns, level of importance associated with these concerns was similar for AAF-treated patients compared with MG- and MC-treated patients. When compared to AAF-treated patients, MG-treated patients more frequently reported side effects of dryness (26% vs 15%) and uneven skin tone (3% vs 0%), and MC-treated patients more frequently reported side effects of burning (7% vs 3%), itching (7% vs 5%), and redness (7% vs 5%). MG- and MC-treated patients indicated greater intolerance for reported side effects than AAF-treated patients. CONCLUSIONS: MG- and MC-treated patients more frequently reported treatment concerns and side effects than AAF-treated patients, and tolerability of those side effects was higher for patients treated with AAF. While treatment cost is a more frequent concern in patients treated with AAF, these patients less frequently reported concerns with treatment efficacy and reported similar or greater tolerance to side effects than patients treated with either MC or MG. J Drugs Dermatol. 2020;19(3): doi:10.36849/JDD.2020.3679.

COPD exacerbation costs in the IMPACT study: a within-trial analysis.

OBJECTIVES: Exacerbations account for the greatest proportion of costs associated with chronic obstructive pulmonary disease (COPD). Here we aimed to evaluate, from the US payer perspective, the costs associated with moderate and severe COPD exacerbation events for patients treated with fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) compared with FF/VI or UMEC/VI. STUDY DESIGN: This post hoc, within-trial economic analysis used data derived from the InforMing the PAthway of COPD Treatment (IMPACT) study (NCT02164513). METHODS: Treatment groups within the IMPACT trial received either triple therapy with FF/UMEC/VI (100/62.5/25 mcg) or dual therapy (FF/VI [100/25 mcg] or UMEC/VI [62.5/25 mcg]). The primary end point for this IMPACT post hoc analysis was cost differences between the treatment arms related to 1-year on-treatment combined moderate and severe COPD exacerbation events. RESULTS: The final study sample for this within-trial analysis consisted of 10,355 patients, 49% of whom experienced an on-treatment moderate or severe exacerbation during the study. The mean 1-year on-treatment cost estimate associated with combined moderate and severe exacerbations was highest with UMEC/VI and lowest with FF/UMEC/VI ($6205 vs $4913, respectively). Mean cost differences were statistically significant for all pairwise comparisons of FF/UMEC/VI with FF/VI or UMEC/VI (-$549 [95% CI, -$565 to -$533] and -$1292 [95% CI, -$1313 to -$1272], respectively; both P <.0001). CONCLUSIONS: Treatment with FF/UMEC/VI compared with FF/VI or UMEC/VI in the US healthcare system resulted in lower exacerbation-related costs for combined moderate/severe exacerbation events, as well as moderate and severe exacerbations separately.

Using the Healthy Days Measure to Assess Factors Associated with Poor Health-Related Quality of Life for Patients with Metastatic Breast, Lung, or Colorectal Cancer Enrolled in a Medicare Advantage Health Plan.

This study investigated factors associated with patient-reported health-related quality of life (HRQoL) using the Centers for Disease Control and Prevention's Healthy Days tool for patients with Medicare Advantage undergoing treatment for metastatic breast, lung, and colorectal cancer. In 2015, a total of 6390 patients were mailed surveys regarding factors that may influence their HRQoL, including cancer-related symptoms. HRQoL was measured as the number of physically and mentally unhealthy days experienced in the past 30 days and summed for the total number of unhealthy days. Frequent unhealthy days was defined as ≥14 total unhealthy days in the prior month. Of 1567 respondents, the mean number of total unhealthy days (standard deviation) was 14.0 (11.9) with 46.2% experiencing frequent unhealthy days. On average, patients reported 10.5 (10.5) physically and 6.7 (9.4) mentally unhealthy days. Cancer-related symptoms, particularly pain and fatigue, were significantly associated with increased unhealthy days. In adjusted models, patients with pain had 83% more unhealthy days than patients without pain; patients with fatigue had 104% more unhealthy days than patients without fatigue. Diarrhea/constipation and shortness of breath also were associated with more unhealthy days. Cancer-related symptoms, most notably pain and fatigue, were associated with worse HRQoL for patients with metastatic cancer. Interventions aimed at ameliorating symptoms may improve quality of life for patients undergoing cancer treatment.

Retracted: Using the Healthy Days Measure to Assess Factors Associated with Poor Health-Related Quality of Life for Patients with Metastatic Breast, Lung, or Colorectal Cancer Enrolled in a Medicare Advantage Health Plan.

The article entitled, "Using the Healthy Days Measure to Assess Factors Associated with Poor Health-Related Quality of Life for Patients with Metastatic Breast, Lung, or Colorectal Cancer Enrolled in a Medicare Advantage Health Plan," by Casebeer AW et al, which published online ahead of print in Population Health Management [doi: 10.1089/pop.2018.0024], is being retracted by the authors so that they can remove references to the 8-item Morisky Medication Adherence Scale (MMAS-8) and republish the article without such references. Dr. Casebeer's team obtained a license to use the MMAS-8 scale from Dr. Morisky prior to conducting the study. Nevertheless, after publication of a separate article in the Journal of Patient-Reported Outcomes that also cited the MMAS-8, as the lead author, Dr. Casebeer was contacted by Dr. Morisky who requested that a number of changes be made to the article. Dr. Casebeer and her team have no desire to engage in a dispute with Dr. Morisky and therefore proactively contacted the Editor of Population Health Management and requested that the scale be removed from her published paper. After assessing all of the provided information, the Editor agreed to the authors' request. It is important to note that the retraction of Dr. Casebeer's article is not the result of any misconduct on her part or that of her team. The retraction serves to remove the published version of the article that contains the MMAS-8 scale and a revised version that does not contain the tool or any references to it will be published. The elimination of the scale does not alter the results or conclusions of the study. Population Health Management is committed to upholding the highest standards of peer review and the community it serves.

The relationship between comorbidity medication adherence and health related quality of life among patients with cancer.

BACKGROUND: Studies have demonstrated that comorbidities compound the adverse influence of cancer on health-related quality of life (HRQoL). Comorbidities adversely impact adherence to cancer treatment. Additionally, adherence to medications for comorbidities is positively associated with HRQoL for various diseases. This study used the Center for Disease Control and Prevention's Healthy Days measure of HRQoL to explore the association between HRQoL and adherence to comorbidity medication for elderly patients with cancer and at least one comorbid condition. METHODS: We conducted a cross-sectional survey combined with retrospective claims data. Patients with metastatic breast, lung or colorectal cancer were surveyed regarding their HRQoL, comorbidity medication adherence and cancer-related symptoms. Patients reported the number of physical, mental and total unhealthy days in the prior month. The Morisky Medication Adherence 8-point scale was differentiated into moderate/high (> 6) and low (≤ 6) comorbidity medication adherence. RESULTS: Of the 1847 respondents, the mean age was 69.2 years, most were female (66.8%) and the majority of the sample had Medicare coverage (88.2%). Low comorbidity medication adherence was associated with significantly more total, mental and physical unhealthy days. Low comorbidity medication adherence was associated with the presence of patient-reported cancer-related symptoms. Patients reporting low, as compared to moderate/high, comorbidity medication adherence had 23.4% more unhealthy days in adjusted analysis, P = 0.007. CONCLUSION: The positive association between low comorbidity medication adherence and the number of unhealthy days suggests that addressing barriers to comorbidity medication adherence during cancer treatment may be an avenue for improving or maintaining HRQoL for older patients with cancer and comorbid conditions.

The Relationship Between Guideline-Recommended Initiation of Therapy, Outcomes, and Cost for Patients with Metastatic Non-Small Cell Lung Cancer.

BACKGROUND: Guideline-recommended therapy for metastatic non-small cell lung cancer (mNSCLC) encourages evidence-based treatment; however, there is a knowledge gap regarding the influence of guideline-recommended initiation of therapy on outcomes and cost. OBJECTIVE: To investigate if lack of guideline-recommended initiation of first-line systemic therapy was associated with worse patient outcomes and increased costs for patients with mNSCLC. METHODS: In this retrospective analysis, 1,344 Medicare patients with mNSCLC were identified from Humana data. Performance status (PS) was imputed using procedure, diagnosis, and durable medical equipment codes pre-index. Guideline-recommended initiation of therapy was defined as ≥1 cycle of National Comprehensive Cancer Network-recommended first-line therapy based on age and PS or targeted therapies regardless of age and PS. Demographics and clinical characteristics were compared by guideline-recommended initiation of therapy. A Cox model assessed factors associated with 6-month mortality. End-of-life quality of care indicators included hospital admission and oncology infusions 30 days preceding death and were evaluated using logistic regression models. A generalized linear model assessed the relationship between guideline-recommended initiation of therapy and total health care costs in the 6 months post-index controlling for clinical, demographic, and treatment characteristics. Logistic models for inpatient stays and emergency department visits were also evaluated. RESULTS: Guideline-recommended therapy initiation was observed in 75.5% of patients. Patients not initiating guideline-recommended therapy were older, with a mean (SD) age of 72.5 (6.7) versus 71.2 (6.2) years (P = 0.001), and more frequently identified as having a low-income subsidy (30.0% vs. 16.4%; P < 0.001). Among the 24.6% of patients who died ≤ 6 months post-index, a greater percentage had not initiated guideline-recommended therapy (28.8% vs. 23.2%; P = 0.040). In adjusted models, PS (not initiation of guideline-recommended therapy) was predictive of mortality (patients with poor PS had an 84% higher probability of death [P = 0.014]). Among decedents, 64.2% were hospitalized, and 33.9% had an oncology-related infusion within 30 days of death, with no differences by guideline-recommended initiation of therapy. These end-of-life quality indicators were not associated with guideline-recommended initiation of therapy in adjusted models. Overall, 47.5% of patients who initiated guideline-recommended therapy were hospitalized compared with 55.0% of patients who did not (P = 0.026). Patients initiating guideline-recommended therapy had higher post-index total and oncology-related health care costs and fewer hospitalizations. In models, these differences in costs and hospitalizations were not associated with initiation of guideline-recommended therapy. CONCLUSIONS: Most patients initiated guideline-recommended therapy, with no differences in mortality and quality of care at the end of life by guideline-recommended initiation of therapy, though adherence beyond treatment initiation was not assessed. Unadjusted hospitalization rates were lower and costs were higher for patients who initiated guideline-recommended therapy. These differences were no longer observed after risk adjustment, suggesting that they may have been influenced by patient characteristics, disease progression, and subsequent treatment decisions. DISCLOSURES: This study was sponsored by Genentech. Khoury, Michael, Parikh, and Bunce are employed by Genentech. Casebeer, Drzayich Antol, DeClue, Hopson, Li, and Stemkowski are employed by Comprehensive Health Insights, Humana, which was contracted by Genentech to conduct this study. Sehman is employed by Humana. Based on this research, 2 posters were presented at the Academy of Managed Care Pharmacy Nexus 2017 on October 16-19, 2017, in Dallas, Texas. Another poster was also presented at the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) Annual European Congress on October 29-November 2, 2016, in Vienna, Austria.

Does site-of-care for oncology infusion therapy influence treatment patterns, cost, and quality in the United States?

BACKGROUND: The increase in hospital acquisition of community oncology clinics in the US has led to a shift in the site-of-care (SOC) for infusion therapy from the physician office (PO) to the hospital outpatient (HO) setting. OBJECTIVE: To investigate differences by SOC in treatment patterns, quality, and cost among patients with cancer undergoing first-line infusion therapy. RESEARCH DESIGN AND METHODS: This retrospective analysis identified adult patients from Humana medical claims who initiated infusion therapy from 2008-2012 for five common cancer types in which infusion therapy is likely, including early stage breast cancer; metastatic breast, lung, and colorectal cancers; and non-Hodgkin's lymphoma or chronic lymphocytic leukemia. Differences by SOC in first-line treatment patterns and quality of care at end-of-life, defined as infusions or hospitalizations 30 days prior to death, were evaluated using Wilcoxon-Rank Sum and Chi-square tests where appropriate. Differences in cost by SOC were evaluated using risk-adjusted generalized linear models. MAIN OUTCOME MEASURES: Treatment patterns, quality of care at end of life, healthcare costs. RESULTS: There were differences in duration of therapy and number of infusions for some therapy regimens by SOC, in which patients in the HO had shorter duration of therapy and fewer infusions. There were no differences in quality of care at end-of-life by SOC. Total healthcare costs were 15% higher among patients in HO ($55,965) compared with PO ($48,439), p < .0001. LIMITATIONS: Analyses was restricted to a claims-based population of cancer patients within a health plan. CONCLUSION: This study, in an older, predominantly Medicare Advantage oncology cohort, found differences by SOC in treatment patterns and cost, but not quality. Where differences were found, patients receiving care in the HO had shorter duration of therapy and fewer infusions for specific treatment regimens, but higher healthcare costs than those treated in a PO.

Impact of comorbid conditions in COPD patients on health care resource utilization and costs in a predominantly Medicare population.

BACKGROUND: Patients with chronic obstructive pulmonary disease (COPD) often have multiple underlying comorbidities, which may lead to increased health care resource utilization (HCRU) and costs. OBJECTIVE: To describe the comorbidity profiles of COPD patients and examine the associations between the presence of comorbidities and HCRU or health care costs. METHODS: A retrospective cohort study utilizing data from a large US national health plan with a predominantly Medicare population was conducted. COPD patients aged 40-89 years and continuously enrolled for 12 months prior to and 24 months after the first COPD diagnosis during the period of January 01, 2009, through December 31, 2010, were selected. Eleven comorbidities of interest were identified 12 months prior through 12 months after COPD diagnosis. All-cause and COPD-related hospitalizations and costs were assessed 24 months after diagnosis, and the associations with comorbidities were determined using multivariate statistical models. RESULTS: Ninety-two percent of 52,643 COPD patients identified had at least one of the 11 comorbidities. Congestive heart failure (CHF), coronary artery disease, and cerebrovascular disease (CVA) had the strongest associations with all-cause hospitalizations (mean ratio: 1.56, 1.32, and 1.30, respectively; P<0.0001); other comorbidities examined had moderate associations. CHF, anxiety, and sleep apnea had the strongest associations with COPD-related hospitalizations (mean ratio: 2.01, 1.32, and 1.21, respectively; P<0.0001); other comorbidities examined (except chronic kidney disease [CKD], obesity, and osteoarthritis) had moderate associations. All comorbidities assessed (except obesity and CKD) were associated with higher all-cause costs (mean ratio range: 1.07-1.54, P<0.0001). CHF, sleep apnea, anxiety, and osteoporosis were associated with higher COPD-related costs (mean ratio range: 1.08-1.67, P<0.0001), while CVA, CKD, obesity, osteoarthritis, and type 2 diabetes were associated with lower COPD-related costs. CONCLUSION: This study confirms that specific comorbidities among COPD patients add significant burden with higher HCRU and costs compared to patients without these comorbidities. Payers may use this information to develop tailored therapeutic interventions for improved management of patients with specific comorbidities.

Association between adherence to medications for COPD and medications for other chronic conditions in COPD patients.

BACKGROUND: Patients with COPD often have multiple comorbidities requiring use of multiple medications, and adherence rates for maintenance COPD (mCOPD) medications are already known to be suboptimal. Presence of comorbidities in COPD patients, and use of medications used to treat those comorbidities (non-COPD medications), may have an adverse impact on adherence to mCOPD medications. OBJECTIVE: The objective of the study was to evaluate the association between non-adherence to mCOPD medications and non-COPD medications in COPD patients. METHODS: COPD patients were identified using a large administrative claims database. Selected patients were 40-89 years old and continuously enrolled for 12 months prior to and 24 months after the first identified COPD diagnosis (index date) during January 1, 2009 to December 31, 2010. Patients were required to have ≥1 prescription for a mCOPD medication within 365 days of the index date and ≥1 prescription for one of 12 non-COPD medication classes within ±30 days of the first COPD prescription. Adherence (proportion of days covered [PDC]) was measured during 365 days following the first COPD prescription. The association between non-adherence (PDC <0.8) to mCOPD and non-adherence to non-COPD medications was determined using logistic regression, controlling for baseline patient characteristics. RESULTS: A total of 14,117 patients, with a mean age of 69.9 years, met study criteria. Of these, 40.9% were males and 79.2% were non-adherent to mCOPD medications with a mean PDC of 0.47. Non-adherence to mCOPD medications was associated with non-adherence to 10 of 12 non-COPD medication classes (odds ratio 1.38-1.78, all P<0.01). CONCLUSION: Adherence to mCOPD medications is low. Non-adherence (or adherence) to mCOPD medications is positively related to non-adherence (or adherence) to non-COPD medications, implying that the need to take medications prescribed for comorbid conditions does not adversely impact adherence to mCOPD medications.

Impact of Out-of-Pocket Costs on Prescription Fills Among New Initiators of Biologic Therapies for Rheumatoid Arthritis.

BACKGROUND: Biologic disease-modifying antirheumatic drug (DMARD) therapies are a mainstay of treatment for rheumatoid arthritis (RA), yet high member out-of-pocket (OOP) costs for such therapies may limit patient access to these therapies. OBJECTIVE: To understand whether there is a relationship between OOP costs and the initial fill and subsequent refills of biologic DMARD treatments for RA members. METHODS: Members of a national Medicare Advantage and Prescription Drug (MAPD) plan with an adjudicated (paid or reversed) claim for a biologic DMARD indicated for RA were identified from July 1, 2007, to December 31, 2012, and followed retrospectively. The first adjudicated claim date was the index date. Members were required to have 180 days of continuous enrollment pre- and post-index and ≥ 1 diagnosis for RA (ICD-9-CM: 714.0 or 714.2) during pre-index or ≤ 30 days post-index. Low-income subsidy and Medicaid-Medicare dual-eligible patients were excluded. The analysis used multivariate regression models to examine associations between initial prescription (Rx) abandonment rates and OOP costs and factors influencing the refill of a biologic DMARD therapy based on pharmacy claims. RESULTS: The final sample size included 864 MAPD members with an adjudicated claim for a biologic DMARD. The majority were female (77.4%) and mean age was 63.5 years (SD = 10.9). Most (78%) had conventional nonbiologic DMARD utilization during pre-index. The overall initial abandonment rate was 18.2% for biologic DMARDs, ranging from 1.3% for the lowest OOP cost group ($0-$250) to 32.7% for the highest OOP cost group (> $550; P < 0.0001 for Cochran-Armitage trend test). ORs for abandonment rose from 18.4 to 32.7 to 41.2 for OOP costs of $250.01-$400.00, $400.01-$550.00, and > $550.00 respectively, relative to OOP costs of ≤ $250.00 (all P < 0.0001). Meeting the catastrophic coverage limit and utilization of a specialty pharmacy for the index claim were both associated with a decreased likelihood of abandoning therapy (OR = 0.29 and OR = 0.14, respectively; both P < 0.05). Among the subset of 533 members with a paid claim, 82.4% had at least 1 refill post-index. The negative association between OOP cost and likelihood of refilling an Rx was highly significant (P < 0.0001). CONCLUSIONS: This study suggests that the higher the member OOP cost, the less likely an MAPD member is to initiate or refill a biologic DMARD therapy for RA. Further research is needed to understand reasons for initial Rx abandonment and lack of refills, including benefit design and adverse events.

Racial and gender differences in arteriovenous fistula use among incident hemodialysis patients.

BACKGROUND: Arteriovenous fistula (AVF) use is reported to differ among racial and gender groups. We sought to identify risk factors associated with incident AVF and whether racial and gender differences in AVF use persist after controlling for these factors. METHODS: We evaluated 28,712 incident adult hemodialysis patients (age ≥ 18) from five ESRD networks starting dialysis between June 1, 2005 and May 31, 2006. Data were obtained from the Center for Medicaid and Medicare Services 2728 form. RESULTS: Incident AVF use was reported for 11% of black and 12% of white patients [OR = 0.89 (95% CI: 0.83, 0.96)], and for 9% of females and 13% of males [OR = 0.66 (0.62-0.71)]. After adjusting for facility clustering, blacks were as likely as whites to use an AVF [OR = 1.00 (0.92-1.09)], while gender differences persisted [OR = 0.64 (0.59-0.69)]. Compared to patients with no renal care prior to dialysis initiation, incident AVF use was 16-fold greater among those with ≥ 12 months of nephrology care [OR = 15.99 (13.25-19.29)], 9-fold greater among those with 6-12 months of care [OR = 9.00 (7.45-10.88)] and 7-fold greater among those with at least 6 months of care [OR = 7.13 (5.73-8.88)]. CONCLUSION: Racial, but not gender, differences in incident AVF use were eliminated after accounting for clustering within facilities.

Variability in reasons for hemodialysis catheter use by race, sex, and geography: findings from the ESRD Clinical Performance Measures Project.

BACKGROUND: Race, sex, and geographic differences in hemodialysis vascular access use have been reported, but differences in reasons for catheter use have not been assessed. STUDY DESIGN: Cross-sectional. SETTING & PARTICIPANTS: Data obtained from the 2005 Centers for Medicare & Medicaid Services End-Stage Renal Disease Clinical Performance Measures Project for adult hemodialysis patients. PREDICTORS: Race, sex, and geographic region. OUTCOMES & MEASUREMENTS: Reasons for catheter use were categorized as short term and long term. Race, sex, and geographic associations with reasons were assessed by using bivariate analyses and multivariate logistic regression. RESULTS: Of 8,479 hemodialysis patients, 3,302 (39%) used a fistula, 2,725 (32%) used a graft, and 2,299 (27%) used a catheter. We placed 857 patients with a catheter (37%) in the short-term-reason cohort and 1,404 (61%) in the long-term-reason cohort, and 38 (2%) lacked information to be placed. Reasons for catheter use were independently associated with race, sex, and geographic region. Whites were 43%, 49%, and 34% less likely than African Americans to use a catheter because of graft maturation, graft interruption, and all vascular access sites exhausted and 70% and 40% more likely because of fistula maturation and no fistula or graft surgically planned, respectively. Men were 50% less likely than women to use a catheter because of graft interruption and 80% more likely because of fistula maturation. Geographic end-stage renal disease network was associated with catheter use because of fistula maturation (P = 0.03), no fistula or graft surgically created (P < 0.001), and no fistula or graft surgically planned (P = 0.05). LIMITATIONS: The cross-sectional study design precludes our ability to assess trends over time in reasons for catheter use. Associations were assessed for a limited set of variables. CONCLUSION: Race, sex, and geographic differences in reasons for hemodialysis catheter use exist. Understanding these differences may aid in developing strategies to decrease catheter initiation rates.

Relationship between clinical performance measures and outcomes among patients receiving long-term hemodialysis.

BACKGROUND: Patients receiving long-term hemodialysis have a yearly mortality rate of 15% to 20%. OBJECTIVE: To determine whether attaining clinical performance measures for hemodialysis care is associated with favorable 12-month mortality and hospitalization rates. DESIGN: Cohort study. SETTING: Outpatient hemodialysis centers in the United States. PATIENTS: 15 287 patients who were selected from a 5% random sample of patients receiving long-term hemodialysis. MEASUREMENTS: The authors used data from the Centers for Medicare & Medicaid Services End-Stage Renal Disease Clinical Performance Measures Project from 1999 and 2000. The clinical performance measure targets were hemoglobin value of 110 g/L or greater; serum albumin value of 40 g/L or greater or 37 g/L or greater (bromcresol green and bromcresol purple laboratory methods, respectively); use of a fistula for vascular access; and measured single-pool Kt/V urea value of 1.2 or greater. The outcome measures were death or hospitalization during 1-year follow-up. RESULTS: 8364 patients (54.7%) were hospitalized and 3062 (20.0%) died during the 12-month follow-up period. Six percent of patients did not meet any clinical measure targets, 24% met 1 target, 39% met 2 targets, 24% met 3 targets, and 7% met all 4 targets. The unadjusted 12-month hospitalization and mortality rates for these 5 groups were 60%, 60%, 56%, 49%, and 43% (P < 0.001) and 29%, 25%, 21%, 14%, and 7% (P < 0.001), respectively. The risk for death increased for each additional guideline indicator that was not met: Adjusted hazard ratios were 4.6 (95% CI, 3.3 to 6.4), 3.5 (CI, 2.6 to 4.7), 2.6 (CI, 1.9 to 3.5), and 1.9 (CI, 1.4 to 2.6) for 0, 1, 2, or 3 targets met, respectively, compared with meeting 4 targets (referent). Similarly, the risk for hospitalization increased for each additional guideline indicator that was not met: Adjusted hazard ratios were 1.6 (CI, 1.4 to 1.9), 1.5 (CI, 1.3 to 1.7), 1.3 (CI, 1.1 to 1.5), and 1.1 (CI, 0.98 to 1.3), respectively. LIMITATIONS: It was not possible to determine the roles of severity of illness, other patient factors, or suboptimal care in failure to meet performance measures. CONCLUSIONS: In patients receiving long-term hemodialysis, meeting multiple clinical measure targets is associated with a decrease in hospitalization and mortality rates.