Prevalence of Cardiovascular and Cancer Risk Factors Among Rheumatoid Arthritis Patients Prescribed JAKi and TNFi: A MarketScan by Merative Cross-Sectional Study.

OBJECTIVE: To determine the prevalence of baseline risk factors for cardiovascular outcomes and cancer among commercially insured rheumatoid arthritis (RA) patients during their first dispensed treatment for either TNFi or JAKi. METHODS: Patients with RA from 8/16/2019-3/31/2022 were identified in the Merative MarketScan® Commercial and Medicare databases. The first dispensed TNFi or JAKi was the index date and baseline risk factors were assessed among patients continuously eligible for 12-months pre-index. Patients were stratified into "elevated" risk categories: age≥65 years, smoking, and/or a history of Major Adverse Cardiovascular Event (MACE), Venous Thromboembolism (VTE), or cancer. The prevalence of modifiable risk factors was also reported: hypertension, hyperlipidemia, obesity, and diabetes. The crude prevalence and prevalence difference (PD) were reported. RESULTS: A total of 12,673 patients [TNFi (n=7,748; 61%) and JAKi (n=4,925; 39%)] met inclusion criteria. The prevalence of "elevated" risk was the same for all TNFi (n=2,051; 26%) and JAKi (n=1,262; 26%) patients. Compared to patients at low risk, patients with an elevated risk also had a higher prevalence of at least one primary modifiable risk factor for both JAKi [79% vs. 58%; PD: 21% (95%CI: 18%-24%)] and TNFi [81% vs. 60%; PD: 21% (95%CI: 19%-23%)] patients. CONCLUSION: In recent years, JAKi and TNFi were used in similar proportions to treat RA among commercially insured patients at elevated cardiovascular and cancer risk. Because uncontrolled disease, modifiable comorbidities, and treatment with JAKi are associated with these adverse events, future studies evaluating how practice patterns may be affected by the emergence of safety data will be of value.

Comparison of Treatment Patterns in Patients with Migraine Initiating Calcitonin Gene-Related Peptide Monoclonal Antibodies: A Retrospective Real-World US Study.

Background: Calcitonin gene-related peptide monoclonal antibodies (CGRP mAbs) are indicated for migraine prevention in the United States. Limited data comparing real-world treatment patterns for CGRP mAbs are available. Objective: To compare the treatment patterns among patients with migraine initiating galcanezumab, fremanezumab, and erenumab. Methods: This retrospective study included adult patients with one or more claims for a self-injectable CGRP mAb (galcanezumab, fremanezumab, or erenumab), with continuous enrollment in medical and pharmacy benefits for 12 months pre-index and 6 and 12 months post-index using MerativeTM MarketScan® Commercial and Medicare databases from May 2017 through March 2021. Propensity-score matching was used to address confounding by observed covariates. Outcomes analyzed included proportion of days covered (PDC), medication-possession ratio (MPR), persistence (≤60-day gap), treatment discontinuation, and switch to a non-index drug. Descriptive X2 and t-test analyses were conducted. Results: At the 12-month follow-up, matched galcanezumab and fremanezumab cohorts each comprised 2674 patients and the galcanezumab and erenumab cohorts 3503 each. The mean (SD) PDC and MPR were both 0.6 (0.3) across all cohorts. Based on PDC ≥0.80 and MPR ≥0.80, a greater proportion of galcanezumab vs fremanezumab (46.2% vs 43.7%, p=0.053; 46.8% vs 44.3%, p=0.053) and galcanezumab vs erenumab (46.2% vs 44%, p=0.156; 46.7% vs 44.5%, p=0.262), respectively, initiators were adherent. Compared to galcanezumab, fremanezumab (248.0 days vs 236.5 days, p=0.001), and erenumab (247.8 days vs 241.7 days, p=0.061) initiators had lower mean persistence. Galcanezumab initiators were less likely to discontinue treatment than fremanezumab (47.8% vs 51.7%, p=0.005) and erenumab (47.7% vs 50.2%, p=0.040) initiators. Across cohorts, most switchers initiated onabotulinum toxin A as subsequent treatment. Similar results were observed for 6-month follow-up cohorts. Conclusion: Patients with migraine who initiated treatment with galcanezumab showed higher persistence and lower treatment discontinuation rates than those initiating either fremanezumab or erenumab.

Optimal site of care for administration of extended half-life respiratory syncytial virus (RSV) antibodies to infants in the United States (US).

INTRODUCTION: New extended half-life antibodies for the single-dose prevention of medically attended (MA) respiratory syncytial virus (RSV) lower respiratory tract infection (LRTI) have been developed for administration to all infants before or during their first RSV season. For infants born during the season, administration as soon as feasible after birth would provide optimal protection and minimize access disparities. The objective of this study was to assess the time from birth hospitalization discharge to the first outpatient visit (FOV) among US infants in order to determine optimal site of administration for the extended half-life antibody. MATERIAL AND METHODS: This retrospective, observational, time-to-event analysis uses the Merative™ MarketScan® Commercial and Multi-State Medicaid Databases. Time to FOV is reported separately for the COVID-19 and recent pre-COVID-19 eras and for commercially insured and Medicaid infants. RESULTS: Overall, 73.8 % of Medicaid infants had an FOV within 5 days as compared to 84.7 % of commercially insured infants. Estimates were higher during the COVID-19 era. Urban commercially insured infants had much higher FOV completion than their counterparts. Among Medicaid infants, urban Black and rural White infants were least likely to complete their FOV within 5 days of birth hospitalization discharge. DISCUSSION AND CONCLUSION: FOV within 5 days after birth hospitalization discharge for Medicaid infants is substantially lower than that of commercially insured infants. Approximately 1 in 4 Medicaid infants and 1 in 8 infants with commercial insurance did not have an outpatient visit within 5 days of birth hospitalization discharge. For US infants born during the RSV season, administration of extended half-life RSV antibodies in the newborn nursery prior to discharge would ensure optimal uptake and minimize access disparities.

A real-world analysis of hybrid CDA and ACDF compared to multilevel ACDF.

BACKGROUND: Multilevel anterior cervical discectomy and fusion (mACDF) is the gold standard for multilevel spinal disease; although safe and effective, mACDF can limit regular spinal motion and contribute to adjacent segment disease (ASD). Hybrid surgery, composed of ACDF and cervical disc arthroplasty, has the potential to reduce ASD by retaining spinal mobility. This study examined the safety of hybrid surgery by utilizing administrative claims data to compare real-world rates of subsequent surgery and post-procedural hospitalization within populations of patients undergoing hybrid surgery versus mACDF for multilevel spinal disease. METHODS: This observational, retrospective analysis used the MarketScan Commercial and Medicare Database from July 2013 through June 2020. Propensity score matched cohorts of patients who received hybrid surgery or mACDF were established based on the presence of spinal surgery procedure codes in the claims data and followed over a variable post-period. Rates of subsequent surgery and post-procedural hospitalization (30- and 90-day) were compared between hybrid surgery and mACDF cohorts. RESULTS: A total of 430 hybrid surgery patients and 2,136 mACDF patients qualified for the study; average follow-up was approximately 2 years. Similar rates of subsequent surgery (Hybrid: 1.9 surgeries/100 patient-years; mACDF: 1.8 surgeries/100 patient-years) were observed for the two cohorts. Hospitalization rates were also similar across cohorts at 30 days post-procedure (Hybrid: 0.67% hospitalized/patient-year; mACDF: 0.87% hospitalized/patient-year). At 90 days post-procedure, hybrid surgery patients had slightly lower rates of hospitalization compared to mACDF patients (0.23% versus 0.42% hospitalized/patient-year; p < 0.05). CONCLUSIONS: Findings of this real-world, retrospective cohort study confirm prior reports indicating that hybrid surgery is a safe and effective intervention for multilevel spinal disease which demonstrates non-inferiority in relation to the current gold standard mACDF. The use of administrative claims data in this analysis provides a unique perspective allowing the inclusion of a larger, more generalizable population has historically been reported on in small cohort studies.

Heterogeneity of the long-term economic burden of severe sickle cell disease: a 5-year longitudinal analysis.

BACKGROUND: Sickle cell disease (SCD) is a lifelong burdensome disorder of heterogenic expression. This study investigated the longer-term economic burden of severe presentation of SCD. As SCD treatment landscapes evolve toward curative intent gene therapies, understanding how SCD-associated costs may change over the patient lifetime will be important for medical decision-making. METHODS: Patients with severe presentation of SCD (presence of acute vaso-occlusive events [VOEs] or history of stroke and/or other disease-related sequelae), were identified within the MarketScan Commercial and Medicare Supplemental and Multi-state Medicaid Databases from 1/1/2010 to 12/31/2018. The first SCD claim served as the index date and patients were followed over a 5-year post-period. Clinical characteristics and healthcare resource utilization and costs were assessed over follow-up for eligible cohorts of commercial and Medicaid patients with severe SCD presentation and age-based subgroups (<18, 18-30, and ≥31). RESULTS: A total of 4,487 patients, primarily insured via Medicaid (79.2%), qualified for the analysis. Patients evidenced persistent VOEs over follow-up; prevalence of most comorbidities increased with age. Mean total healthcare costs over the 5-year follow-up were $275,143 (SD± $406,770) and $362,728 (SD± $620,189) in the commercial and Medicaid samples, respectively. Disease severity, assessed by the number of VOEs and utilization of inpatient and emergency services, peaked in the 18-30 year group in both samples. These groups also evidenced the highest mean healthcare costs over the 5-year follow-up at $344,776 (SD± $434,521) and $671,321 (SD± $938,764) in the commercial and Medicaid samples respectively. CONCLUSION: Results indicate high clinical need and economic burden among patients with severe presentation of SCD. These findings not only highlight the need for improved therapeutic options to limit or prevent disease progression, but also start to provide insight on lifetime costs of SCD that will be needed in the evaluation of emerging curative intent therapies.

Burden of EPS in commercial patients with schizophrenia initiating atypical antipsychotics.

OBJECTIVES: Extrapyramidal symptoms (EPS) affect 15% to 30% of patients with schizophrenia treated with antipsychotics and have been associated with poor outcomes. This study examined the incidence and economic burden of EPS in patients with schizophrenia initiating atypical antipsychotics (AAPs). STUDY DESIGN: Retrospective analysis of secondary deidentified administrative claims database. METHODS: Patients with schizophrenia initiating AAPs with no prior EPS were identified in the MarketScan Commercial and Medicare Supplemental databases from January 1, 2012, to December 31, 2018. Incidence of EPS (diagnosis or medication use) was assessed in the year following AAP initiation. Annual all-cause and schizophrenia-related health care resource utilization (HCRU) and costs were assessed in cohorts who did or did not develop EPS in the year following first EPS claim (EPS cohort) or randomly assigned index date (non-EPS cohort). Multivariate regression was used to compare all-cause and schizophrenia-related total health care costs and inpatient admissions between cohorts. RESULTS: A total of 3558 patients with schizophrenia newly initiating AAPs were identified; 22.1% developed EPS in the year following AAP initiation (incidence: 26.9 cases per 100 person-years). Multivariate analyses revealed that patients with EPS had 34% higher odds of all-cause (odds ratio [OR], 1.3361; 95% CI, 1.0770-1.6575; P < .01) and 84% increased odds of schizophrenia-related (OR, 1.8436; 95% CI, 1.0434-2.4219; P < .0001) inpatient admission compared with the non-EPS cohort. The EPS cohort also evidenced significantly higher adjusted all-cause ($26,632 vs $21,273; P < .001) and schizophrenia-related ($9018 vs $4475; P < .0001) costs compared with the non-EPS cohort. CONCLUSIONS: The 20% of patients who developed EPS in the year following AAP initiation evidenced significantly increased HCRU and costs over the postindex period. Schizophrenia therapies with reduced EPS risk are needed to improve patient care.

The impact of remission duration on the long-term economic burden of acute myeloid leukemia among patients without hematopoietic stem cell transplant in the United States.

BACKGROUND AND AIMS: Acute myeloid leukemia (AML) prognosis is poor, with sustained remission occurring in <35% of young adults and <15% of older adults. This descriptive study examined the potential benefit of prolonged remission on the economic burden of AML. METHODS: Using the IBM MarketScan Commercial and Medicare Supplemental databases, we identified newly diagnosed patients with AML without hematopoietic stem cell transplantation from January 1, 2012 to December 31, 2018; AML diagnosis was the index date. Patients had 6 months of pre-index eligibility and were followed until the end of continuous eligibility, study data, or death. Active treatment and supportive care cohorts were defined; duration-of-remission subgroups (0 to <3, 3 to <6, 6 to <12, and ≥12 months) were established among active treatment patients with remission. Healthcare service utilization and costs were reported over follow-up and mutually exclusive treatment, remission, and post-relapse periods. RESULTS: This study included 1,558 active treatment and 1,127 supportive care patients who were followed for a median of 232 and 62 days, respectively. Over follow-up, active treatment and supportive care patients incurred mean ± standard deviation all-cause healthcare costs of $55,723 ± $61,994 and $68,596 ± $100,375 per-patient-per-month (PPPM), respectively. Decreasing PPPM costs were observed with increased remission duration (0 to <3 months: $71,823 ± $62,635; 3 to <6 months: $54,262 ± $44,734; 6 to <12 months: $35,287 ± $23,699; and ≥12 months: $15,615 ± $10,560). Although median follow-up varied by up to 5-fold, total costs were largely similar across duration-of-remission subgroups (0 to <3 months: $438,569 ± $332,675; 3 to <6 months: $590,411 ± $598,245; 6 to <12 months: $482,902 ± $369,115; and ≥12 months: $448,867 ± $316,133). CONCLUSIONS: The economic burden of AML is substantial, even among untreated patients. Further, among patients with remission, longer durations in remission are associated with reduced PPPM healthcare costs, suggesting that remission-prolonging treatments could help mitigate healthcare costs.

The incidence and economic burden of extrapyramidal symptoms in patients with schizophrenia treated with second generation antipsychotics in a Medicaid population.

BACKGROUND: Extrapyramidal symptoms (EPS) are common side-effects of second-generation antipsychotics (SGA), that can negatively impact patient quality-of-life, and are associated with increased morbidity and mortality. This study examined the incidence and burden of EPS in patients with schizophrenia initiating SGAs. METHODS: Patients with schizophrenia initiating SGAs were identified in the MarketScan Multi-state Medicaid database from 1 January 2012 to 31 December 2018. Incidence of EPS (identified via ICD-9/ICD-10 diagnoses and medications) was assessed during the 12-months following SGA initiation. Cohorts with and without EPS were defined. Multivariate models were used to examine all-cause and schizophrenia-related hospitalizations and total costs in the 12 months following the first EPS claim (EPS) or randomly assigned index date (Non-EPS) while controlling for multiple baseline covariates. Logistic regression was used for hospitalization and two-part models were used for skewed cost data. RESULTS: A total of 11,642 patients with schizophrenia filled a prescription for an SGA; of which, 2,468 (21.2%) experienced EPS in the first year. The age- and gender-matched EPS group and non-EPS group included 2,295 and 5,607 patients, respectively. Multivariate analyses confirmed that EPS patients had 25% higher odds of all-cause (OR = 1.25; 95% CI = 1.11-1.40) and 75% increased odds of schizophrenia-related (OR = 1.75; 95% CI = 1.53-2.00) inpatient admissions compared to non-EPS patients. Multivariate adjustment of post-period costs between groups also found significant differences in both all-cause (EPS: $27,408 vs. non-EPS: $22,489, p < 0.001) and schizophrenia-related (EPS:$12,833 vs. non-EPS:$8,077, p < 0.0001) costs between the EPS and non-EPS cohorts. CONCLUSIONS: Over one-fifth of patients initiating treatment with atypical antipsychotics in this study developed EPS in the 12 months following SGA initiation. Extrapyramidal side-effects associated with atypical antipsychotics increase the risk of hospitalization and contribute to higher healthcare costs. For patients with schizophrenia, treatment options that minimize the risk of EPS may reduce the economic burden associated with the disease.

Clinical and economic burden of intravenous paclitaxel or nab-paclitaxel for metastatic breast cancer.

BACKGROUND: Intravenous (IV) taxane therapy for metastatic breast cancer (mBC) has been associated with toxicities and demanding dosing schedules, which can limit treatment effectiveness. OBJECTIVES: To assess treatment patterns, toxicities, and costs in women with mBC initiating IV paclitaxel or IV nab-paclitaxel. METHODS: Adult women diagnosed with BC from January 1, 2014, to September 30, 2018, were identified in the MarketScan Commercial and MarketScan Medicare Supplemental databases. Women had a metastatic disease diagnosis and newly initiated treatment with IV paclitaxel/nab-paclitaxel (first administration date was considered the index date), and continuous enrollment for at least 12 months prior to and at least 3 months following the index date. Treatment discontinuation, dose reductions, toxicities, and health care utilization and costs per patient per month (PPPM) were assessed over the full follow-up and the index line of IV paclitaxel/nab-paclitaxel therapy (Index LOT). RESULTS: The sample included 8890 women aged 54.6 (±10.9) years, followed for 18.9 (±13.5) months. Most (82.0%) initiated IV paclitaxel/nab-paclitaxel monotherapy; 83.1% had early discontinuation (<18 weeks of treatment) of the Index LOT. Among the 6943 women eligible for the dose-change analysis, 42.4% evidenced an IV paclitaxel/nab-paclitaxel dose reduction ≥10% during the Index LOT. The most common toxicities during the Index LOT were gastrointestinal upset (30.5%), myelotoxicity (27.0%), infection (26.2%), general symptoms (25.9%), and chemotherapy-induced peripheral neuropathy (22.7%). Over follow-up, 39.7% of women had an inpatient admission and 43.0% had an emergency department visit. The mean of all-cause total costs was $11,991 PPPM, while BC-related total costs were $5320 PPPM. CONCLUSIONS: Many mBC patients initiating IV paclitaxel/nab-paclitaxel experienced dose reductions, toxicities, and/or early discontinuation of the Index LOT, which may limit treatment effectiveness. More tolerable treatments with reduced dosing complexity could improve mBC treatment and help contain costs.

Chemotherapy-induced peripheral neuropathy in metastatic breast cancer patients initiating intravenous paclitaxel/nab-paclitaxel.

BACKGROUND: Intravenous (IV) taxanes for metastatic breast cancer (mBC) are associated with toxicities, such as chemotherapy-induced peripheral neuropathy (CIPN), which can detrimentally impact outcomes. OBJECTIVE: To assess the impact of CIPN on clinical and economic outcomes in women with mBC, initiating IV paclitaxel/ nab-paclitaxel. METHODS: Adult women in the MarketScan Commercial and Medicare Supplemental Database with a mBC diagnosis, initiating IV paclitaxel or IV nab-paclitaxel (index date = first administration) from November 1, 2013, to September 30, 2018, who had no prior neuropathy diagnoses, and continuous enrollment 12 months prior to and ≥ 3 months following index were selected. Propensity score-matched CIPN and non-CIPN cohorts were defined, based on postindex CIPN diagnosis. Clinical characteristics and all-cause and breast cancer (BC)-related health care utilization and costs per patient per month (PPPM) were compared between matched CIPN and non-CIPN cohorts during follow-up. RESULTS: Among the 5870 women with mBC initiating IV paclitaxel/nab-paclitaxel, 42.7% developed CIPN. The matched cohorts each included 1950 women. Patients with CIPN were more likely to have a dose reduction (46.1% vs 38.2%, P < .001) or develop depression, diabetes, insomnia, liver dysfunction, or arthritis compared with the non-CIPN cohort, P < .05. Patients with CIPN were more likely to have an inpatient admission (39.2% vs 34.9%, P < .01) or emergency department visit (46.7% vs 35.6%, P < .001), as well as all-cause and BC-related costs that were $1102 and $725 PPPM higher, respectively, than women without CIPN (P < .01). CONCLUSIONS: CIPN was common in women, following IV paclitaxel/nab-paclitaxel treatment and was associated with dose reductions, the development of comorbidities, and elevated health care costs. Therapies for mBC that offer increased tolerability are needed to help improve patient outcomes and control costs.

Increasing rate of diagnosed childhood mental illness in the United States: Incidence, prevalence and costs.

Objective: This study examined the rate and economic burden of pediatric mental illness from 2012 to 2018. Study design: Observational, retrospective analysis of administrative healthcare data. Methods: This retrospective study of the MarketScan Commercial Research Database included calendar year-based samples (2012-2018) of children aged 4-17 with continuous medical, pharmacy, and mental health/substance abuse coverage for the year of interest and prior year. Incidence and prevalence rates of overall and specific mental illness diagnoses were calculated based on the appearance of diagnosis codes on claims: alcohol/substance abuse, depression, anxiety, eating disorders, bipolar, schizophrenia, developmental disorders, attention deficit/hyperactivity, and conduct disorders. Annual direct medical costs were compared between children with any mental illness and a matched non-mental illness control population. Results: Between 2.4 and 4.1 million children qualified for each calendar year sample. From 2012 to 2018, there was a 34.6% increase in the prevalence of mental illness. Attention deficit/hyperactivity, conduct disorders, anxiety, and depression were the most common conditions, while eating disorders, anxiety, and depression presented the greatest increases at 96%, 95%, and 73% respectively. Children with a mental illness incurred significantly greater medical costs compared to matched controls in all years assessed (2018 comparison: $6,055±$27,198 vs. $1,629±$7,274; p < 0.001). Conclusions: Childhood mental illness diagnoses have increased substantially in the United States from 2012 to 2018. In addition to patient impacts, mental health diagnoses also place a notable burden on the healthcare system via increased medical costs. As mental illness is known to be underdiagnosed, the true rate of mental illnesses among children is likely even greater.

Benchmarking HIV Quality Measures Across US Payer Types.

Despite advances in antiretroviral therapy (ART), human immunodeficiency virus (HIV) remains a significant issue in the United States. Early diagnosis, continuous treatment access/adherence, and long-term care engagement help patients benefit fully from ART; however, a shortfall in care engagement remains, potentially leading to poorer health outcomes. This analysis benchmarks rates of health care quality and process measures to identify areas for improvement. This retrospective, claims-based, real-world cohort study assessed the percentage of prevalent (existing) and incident (newly diagnosed) patients with HIV with commercial or public health insurance meeting 4 National Quality Forum (NQF)-endorsed, 1 Pharmacy Quality Alliance (PQA), and 3 Centers for Disease Control and Prevention (CDC) measures over a 4-year period. Most prevalent patients consistently met the NQF-endorsed prescribed ART and gaps in visits measures. Longer-term visit frequency measure rates were well below the 90% Joint United Nations Programme on HIV/AIDS target. Proportion of prevalent patients meeting each NQF-endorsed measure was maintained/increased with increasing age in 2015-2016. Substantially fewer incident patients than prevalent patients met NQF-endorsed measures across all measurement periods, particularly for visit frequency (32%-51%). PQA ART adherence was low (36%-73%). CDC receipt of care rates were high (83%-92%), whereas retention in care rates were low (67%-72%) among prevalent patients. For incident patients, linkage to care rates were consistently low (21%-44%). This study benchmarks current US HIV care engagement and highlights the need for improvement in early care engagement, ART adherence and long-term retention of care among patients with HIV.

The longitudinal effect of biologic use on patient outcomes (disease activity, function, and disease severity) within a rheumatoid arthritis registry.

INTRODUCTION: Biologics effectively manage symptoms and disease activity in rheumatoid arthritis (RA), but their long-term effects remain unclear. METHOD: Longitudinal data were examined from the Brigham and Women's Rheumatoid Arthritis Sequential Study (BRASS) registry. Linear regression modeled the effect of biologic exposure on changes in disease activity (Disease Activity Score-28 with C-reactive protein [DAS28-CRP]), functional status (modified Health Assessment Questionnaire [mHAQ]), and RA severity (Routine Assessment of Patient Index Data [RAPID3]). Biologic exposure was the ratio of time on a biologic relative to time participating in the BRASS cohort. RESULTS: The analysis included 1395 RA patients, 82.3% female, with 6783 unique study visits from 2003 to 2015. At the patient's first visit, mean (SD) age was 56.3 (14.2) years and mean (SD) duration of RA was 12.7 (11.9) years. Average follow-up duration was 5.59 years (range, 1-13). Over time, DAS28-CRP, mHAQ, and RAPID3 scores decreased as the biologic exposure ratio increased. In repeated measures regression models, increased biologic exposure was significantly associated with decreased DAS28-CRP score (ß = - 0.647; P < 0.001), decreased mHAQ score (ß = - 0.096; P < 0.001), and decreased RAPID3 score (ß = - 0.724; P < 0.001) during follow-up. Methotrexate use at baseline predicted decreased DAS28-CRP, mHAQ, and RAPID3 scores during follow-up. Biologic use at baseline predicted increased DAS28-CRP or mHAQ during follow-up. CONCLUSIONS: Increased biologic exposure is associated with decreased disease activity, function impairment, and RA severity. Future studies should examine whether earlier initiation of biologics improves patient outcomes in RA. TRIAL REGISTRATION: ClinicalTrials.gov , NCT01793103 Key Points • Biologics effectively manage symptoms and disease activity in rheumatoid arthritis (RA), but their long-term effects remain unclear. • In this analysis of longitudinal annual population samples of 1395 RA patients in the Brigham and Women's Rheumatoid Arthritis Sequential Study (BRASS) registry, disease activity, function, and severity scores improved as time on biologic therapy increased. • In repeated measures regression models, time on biologic therapy was a significant predictor of improved outcomes for disease activity, function, and RA severity. • Further studies should examine whether earlier initiation of biologics limits the long-term effect of inflammation on RA outcomes.

Health Care Resource Utilization and Costs Associated With Switching Biologics in Rheumatoid Arthritis.

PURPOSE: Although biologics are effective in managing rheumatoid arthritis (RA), many patients experience at least one biologic switch during treatment. A switch in biologic treatment can occur for medical or nonmedical reasons. Changes to treatment regimens, even in patients previously stable on therapy, can have clinical and cost implications. This study examined health care resource use and costs incurred with switching from an anti-tumor necrosis factor (TNF) medication in a population of patients with RA. METHODS: A retrospective analysis of patients with RA identified in Truven Commercial Claims and Encounters database (January 1, 2009, to December 13, 2013) was conducted. Patients were required to show evidence of new initiation of treatment with a biologic medication (index date) and continuous eligibility from 6 months before to 12 months after index. Patients were segmented into a continuous biologic group and a biologic switch group, the latter being further divided into switch from anti-TNF to anti-TNF (A-A subgroup) and switch from anti-TNF to a treatment with other mechanism of action (A-O subgroup). Means (SD) and medians of resource use and cost outcomes were calculated over the 12-month postindex period; multivariate models controlling for demographics, biologic switch, and preindex health, resource use, and costs were constructed. FINDINGS: The total sample comprised 18,070 patients, with 16,643 qualifying for the continuous group and 1427 qualifying for the overall switch group. The overall switch group was more likely to utilize physician office, emergency department, and pharmacy services compared to the continuous group. Consequently, the overall switch group incurred greater total health care costs compared to the continuous group ($41,482 vs $36,557 per patient per annum; p < 0.05). Within the switch group, the A-O subgroup had significantly greater outpatient, medical, and total health care expenditures compared to those in the A-A subgroup. Regression analyses revealed that increased baseline utilization and costs, worse health, and older age were associated with increased utilization and costs over the follow-up period. Switching of biologics was associated with an approximate increase of US $4000 per patient per annum in total health care costs. IMPLICATIONS: These findings suggest that switching biologic agents in patients with RA may be accompanied by increased total health care costs. Efforts to optimize patient response to initial biologic therapy and to reduce unnecessary switching, such as for nonmedical reasons, may help to mitigate these costs.

The Effectiveness of Intravenous Golimumab Administered Directly After Infliximab in Rheumatoid Arthritis Patients.

PURPOSE: For patients with rheumatoid arthritis (RA) who do not respond or lose response to anti-tumor necrosis factor (TNF) biologics, switching to a different anti-TNF can be an effective means to manage symptoms and disease progression. This study examined the utilization and effectiveness of intravenous golimumab within a real-world population of patients with RA switching directly from infliximab, a potent anti-TNF. METHODS: Patient charts (n = 113) were collected from five US-based rheumatology practices. Patient demographics, treatment characteristics, infliximab and intravenous golimumab utilization data, and Clinical Disease Activity Index (CDAI), Patient Global Assessment (PtGA), Physician Global Assessment (PhGA), and Routine Assessment of Patient Index Data (RAPID3) scores were extracted from charts. The effectiveness of intravenous golimumab was assessed by comparing disease activity status pre- and post-initiation of intravenous golimumab therapy. FINDINGS: Significant decreases in patient disease activity were observed following treatment with intravenous golimumab. Mean CDAI and PhGA scores significantly decreased, and a significantly increased proportion of the population exhibited low disease activity or remission in the post intravenous golimumab period (p < 0.05). Limited changes were observed through the RAPID3 and PtGA. CONCLUSIONS: Findings from this study indicate that intravenous golimumab is effective in managing RA in a population of patients switching directly from infliximab (mean last dose 7.4 mg/kg).

Heterogeneity of nonadherent buprenorphine patients: subgroup characteristics and outcomes.

OBJECTIVES: To examine patient characteristics and outcomes associated with nonadherence to buprenorphine and to identify specific patterns of nonadherent behavior. STUDY DESIGN: Cross-sectional, retrospective analysis of health claims data. METHODS: Aetna's administrative claims data were used to categorize incident opioid use disorder (OUD) patients based on buprenorphine medication possession ratio (MPR) into adherent (n = 172) and nonadherent (n = 305) groups. Adherent groups were then divided into 5 subgroups based on level of MPR, as well as 2 a priori-defined groups: intermittent adherent (IA) and early treatment discontinuation-no consequences (ETDNC). Groups were compared on patient characteristics and outcomes. RESULTS: Nonadherent members incurred significantly greater healthcare costs and were more likely to relapse (P <.05). The use of high-cost healthcare services increased as a function of decreasing MPR (P <.05). Assessment of the a priori groups revealed IA members to have outcomes similar to nonadherent patients, while ETDNC members exhibited outcomes similar to adherent members. CONCLUSIONS: Administrative claims can be used to define subgroups of buprenorphine-medication assisted treatment (B-MAT) patients. Nonadherence was related to an increased likelihood of relapse, and there is an inverse relationship between MPR and cost. The heterogeneity observed within this sample indicates that treatment regimens effective for 1 subgroup may not be appropriate for all OUD patients. Increased understanding of B-MAT nonadherent subgroups may facilitate development of new interventions and medications specifically designed for nonadherent B-MAT patients, potentially leading to improved outcomes and reduced costs of care.

The association of weight loss with patient experience and outcomes in a population of patients with type 2 diabetes mellitus prescribed canagliflozin.

OBJECTIVE: Type 2 diabetes mellitus (T2DM) is a chronic condition complicated by being overweight or obese. This study used a patient survey to assess health, satisfaction, and diabetes self-management in relation to weight management. METHODS: A survey including the Current Health Satisfaction Questionnaire, Diabetes Distress Scale, and Diabetes Treatment Satisfaction Questionnaire was administered using an online platform to a sample of 205 patients with T2DM prescribed canagliflozin. Patients were placed into 5 groups based on their self-reported weight change since initiation of canagliflozin: Lost >10 lbs, Lost 5-10 lbs, Lost <5 lbs, No Change, and Gained Weight. One-way ANOVAs, Kruskall-Wallis tests, and multivariable regression were used to explore differences between weight loss groups. RESULTS: The majority of patients (66.8%) reported losing weight. Compared to other groups, patients who lost >10 lbs were more likely to be engaged in a weight loss program for at least 6 months. Patients in the Lost >10 lbs and Lost 5-10 lbs groups reported the greatest satisfaction with canagliflozin (p<0.05 for both). Multivariable analyses controlling for patient demographic and treatment characteristics revealed that losing >10 lbs was associated with reduced diabetes distress, improved A1c and blood glucose levels, and decreased perceived frequency of hyperglycemia (p<0.05). CONCLUSION: Increased positive patient outcomes, engagement in diabetes self-management, and medication satisfaction were observed among patients who reported weight loss. These findings suggest that a T2DM regimen that includes canagliflozin as part of a weight loss regimen can help improve patient outcomes and experiences with T2DM.

Assessment of Rheumatoid Arthritis Quality Process Measures and Associated Costs.

The objective was to examine the relationship between health care costs and quality in rheumatoid arthritis (RA). Administrative claims were used to calculate 8 process measures for the treatment of RA. Associated health care costs were calculated for members who achieved or did not achieve each of the measures. Medical, pharmacy, and laboratory claims for RA patients (International Classification of Diseases, Ninth Revision, Clinical Modification 714.x) were extracted from the Optum Clinformatics Datamart database for 2011. Individuals were predominately female and in their mid-fifties. Measure achievement ranged from 55.9% to 80.8%. The mean cost of care for members meeting the measure was $18,644; members who did not meet the measures had a mean cost of $14,973. Primary cost drivers were pharmacy and office expenses, accounting for 42.4% and 26.3% of total costs, respectively. Regression analyses revealed statistically significant associations between biologic usage, which was more prevalent in groups attaining measures, and total expenditure across all measures (Ps < 0.001). Pharmacy costs were similar between both groups. Individuals meeting the measures had a higher proportion of costs accounted for by office visits; those not meeting the measures had a higher proportion of costs from inpatient and outpatient visits. These findings suggest that increased quality may lead to lower inpatient and outpatient hospital costs. Yet, the overall cost of RA care is likely to remain high because of intensive pharmacotherapy regimens.

An Assessment of the AGA and CCFA Quality Indicators in a Sample of Patients Diagnosed with Inflammatory Bowel Disease.

BACKGROUND: Inflammatory bowel disease (IBD) is a chronic relapsing disease characterized by activation of the mucosal immune system and inflammation of the gastrointestinal tract. Management of IBD places a significant burden on the health care system because of the complexity of treatment, variability in patient outcomes, and chronic nature of the disease.  OBJECTIVE: To investigate the American Gastroenterological Association (AGA) and Crohn's and Colitis Foundation of America's (CCFA) quality measurement sets in a sample of IBD patients. METHODS: Fourteen quality measures were restated for application to a claims database and calculated using Optum Clinformatics DataMart database. Selected measures were calculated over calendar year 2011. RESULTS: Performance measures ranged from 0.4% for AGA measure 9, prophylaxis for venous thromboembolism, to 66.9% for AGA measure 8, testing for Clostridium difficile. CCFA outcome measures ranged from 0.6% qualifying for CCFA O10, report of fecal incontinence, to 32.9% for CCFA O1, prednisone usage. In addition to Clostridium difficile testing, the use of appropriate corticosteroid-sparing therapy (51.1%) and testing for latent tuberculosis before initiating anti-tumor necrosis factor therapy (45.0%) were the highest achieved measures. CONCLUSIONS: This is the first examination of IBD quality measures using administrative claims. Rates of achievement across measures were variable and likely affected by the ability to calculate certain measures with claims data. Future studies should further examine measurement of IBD quality indicators in claims data to assess the validity of claims-based analyses and to ascertain whether measure attainment translates into better overall health or IBD-related outcomes.

Prescribing Patterns of Intravenous Golimumab for Rheumatoid Arthritis.

PURPOSE: The use of intravenous golimumab (GLM-IV), in combination with methotrexate, was approved by the US Food and Drug Administration in July 2013 for the treatment of moderate to severe, active rheumatoid arthritis (RA). GLM-IV is available in 50-mg vials, and the prescribing information specifies a dosing regimen of 2 mg/kg at 0 and 4 weeks and then every 8 weeks thereafter. The purpose of this study was to examine the patterns of prescribing and administration of GLM-IV, including the demographic, clinical, and utilization characteristics of patients with RA newly treated with GLM-IV. METHODS: Rheumatology practices across the continental United States were solicited for a chart-review study. Inclusion criteria were: (1) diagnosis of RA; (2) current treatment with GLM-IV; (3) age ≥18 years; and (4) lack of pregnancy (in female patients). Physicians were offered a monetary incentive for each eligible chart provided. An electronic case-report form was developed to aid in the chart data extraction and included fields for demographic characteristics, available comorbid diagnoses, prior RA treatments, and doses and dates of GLM-IV administration. FINDINGS: A total of 117 eligible patient charts from 15 rheumatologist practices were reviewed. The patient sample was predominantly female (81.2%), with a mean (SD) age of 55.4 (14.5) years. A total of 55.6% of patients had evidence of biologic treatment before receiving GLM-IV, and 53% had at least 1 comorbid condition. In total, 300 individual GLM-IV infusions from this sample were reviewed. Due to the relatively recent approval of GLM-IV use by the US Food and Drug Administration, the majority of patients in this sample (69.2%) had received only between 2 and 4 infusions at the time of the review. For infusion records with valid dose data, the mean number of administered vials was 3.6 (0.8) (total dose, 180 mg); the majority of patients received a dose consistent with the prescribed dose of 2 mg/kg. Combination therapy with methotrexate was observed in the charts of a minority of patients (27.4%). The mean interval between induction and the first follow-up infusion was 32.9 (11.4) days, with a mean maintenance interval of 56.5 (13.3) days. IMPLICATIONS: This analysis provides an early glimpse of the patterns of prescribing GLM-IV. Overall, patients appeared to have been receiving GLM-IV in accordance with Food and Drug Administration labeling; although the rate of prescribing methotrexate was low, dosages and administration intervals were within the expected ranges.