Real-world use of inotuzumab ozogamicin is associated with lower health care costs than blinatumomab in patients with acute lymphoblastic leukemia in the first relapsed/refractory setting.

Aim: To compare all-cause and acute lymphoblastic leukemia (ALL)-related healthcare resource utilization (HCRU) and costs among patients receiving inotuzumab ozogamicin (InO) and blinatumomab (Blina) for ALL in the first relapsed/refractory (R/R) setting. Patients & methods: We studied retrospective claims for adult commercial and Medicare Advantage enrollees with ALL receiving InO (n = 29) or Blina (n = 23) from 1 January 2015 to 16 February 2021. Mean per-patient-per-month (PPPM) HCRU and total costs were described and multivariable-adjusted PPPM total all-cause and ALL-related predicted costs were calculated. Results: Mean monthly ALL-related hospitalizations were the same for patients receiving InO and Blina (PPPM = 0.8 stays); however, the length of ALL-related hospital stay was almost twice as long among patients receiving Blina versus InO (ALL-related: InO = 7.6 days; Blina = 14.1 days; p = 0.346). In multivariable models, total ALL-related costs were 43% lower for InO compared with Blina (PPPM costs: InO = $93,767; Blina = $163,470; p = 0.021). Conclusion: In the first R/R setting, patients who used InO had significantly lower all-cause and ALL-related costs compared with patients who used Blina, in part driven by hospitalization patterns.

Suicide-specific mortality among patients with treatment-resistant major depressive disorder, major depressive disorder with prior suicidal ideation or suicide attempts, or major depressive disorder alone.

BACKGROUND: The impact of treatment-resistant depression (TRD) or prior suicidal ideation/suicide attempt (SI/SA) on mortality by suicide among patients with major depressive disorder (MDD) is not well known. This retrospective, observational, descriptive cohort study characterized real-world rates of suicide-specific mortality among patients with MDD with or without TRD or SI/SA. METHODS: Adult patients with MDD among commercially insured and Medicare enrollees in Optum Research Database were included and assigned to three cohorts: those with treatment-resistant MDD (TRD), those with MDD and SI/SA (MDD+SI/SA), and those with MDD without TRD or SI/SA (MDD alone). Suicide-specific mortality was obtained from the National Death Index. The effects of demographic characteristics and SI/SA in the year prior to the end of observation on suicide-specific mortality were assessed. RESULTS: For the 139,753 TRD, 85,602 MDD+SI/SA, and 572,098 MDD alone cohort patients, mean age ranged from 55 to 59 years and the majority were female. At baseline, anxiety disorders were present in 53.92%, 44.11%, and 21.72% of patients with TRD, MDD+SI/SA, and MDD alone, respectively. Suicide-mortality rates in the three cohorts were 0.14/100 person-years for TRD, 0.27/100 person-years for MDD+SI/SA, and 0.04/100 person-years for MDD alone. SI/SA during the year prior to the end of observation, younger age, and male sex were associated with increased suicide risk. CONCLUSIONS: Patients with TRD and MDD+SI/SA have a heightened risk of mortality by suicide compared with patients with MDD alone. Suicide rates were higher in patients with recent history versus older or no history of SI/SA, men versus women, and those of young age versus older age.

The Role of Physician Specialty in the Underutilization of Standard-of-Care Treatment Intensification in Patients With Metastatic Castration-sensitive Prostate Cancer.

PURPOSE: We evaluate utilization of treatment intensification of androgen deprivation therapy with androgen receptor pathway inhibitor/docetaxel for metastatic castration-sensitive prostate cancer patients across physician specialties. MATERIALS AND METHODS: This retrospective study identified patients with metastatic castration-sensitive prostate cancer in the Optum Research Database between 2014 and 2019. Adult men with ≥1 claim for metastatic disease within 90 days before or any time after the first prostate cancer claim who received androgen deprivation therapy were included. Physician specialty, determined from medical/pharmacy claims during each line of therapy, was categorized as urologist only, oncologist only, both (urologists and oncologists), or other (other specialties). Treatment intensification and patient characteristics were analyzed descriptively. RESULTS: Of 4,675 patients, 16% were treated by urologists only, 20% by oncologists only, 63% by both, and 1.1% by others. The most frequent first line of therapy was androgen deprivation therapy ± first-generation nonsteroidal antiandrogens (>50%). Androgen deprivation therapy + docetaxel use declined over time, while androgen deprivation therapy + androgen receptor pathway inhibitor use increased. Patients seen by oncologists or both were younger, had fewer comorbidities, and were likelier to receive treatment intensification compared to those treated by urologists. By 2019, however, treatment intensification remained <40% from oncologists only or both, and <15% from urologists only. In the second and third lines of therapy, androgen deprivation therapy + androgen receptor pathway inhibitor was the most prescribed regimen across specialties (>50%). CONCLUSIONS: Treatment intensification was underused in first lines of therapy across urology and oncology specialties despite evidence of improved survival. In subsequent lines, androgen deprivation therapy + androgen receptor pathway inhibitor was prescribed more frequently across specialties. These results underscore the need for earlier treatment intensification by urologists and oncologists.

Clinical and economic burden of chronic rhinosinusitis with nasal polyposis: A U.S. administrative claims analysis.

Background: Limited data exist on the clinical and economic burden of chronic rhinosinusitis with nasal polyposis (CRSwNP). Objective: To describe patient characteristics, health-care resource utilization (HCRU), and health-care costs among patients with CRSwNP with and without comorbid asthma (primary analysis) and with surgical management of nasal polyps (secondary analysis). Methods: This was a retrospective study of patients diagnosed with CRSwNP conducted using administrative claims data from January 1, 2013, through March 31, 2019. Study outcomes were assessed over a 2-year follow-up. Results were stratified by baseline asthma status (primary analysis) and presented separately for patients with surgically managed CRSwNP (secondary analysis). Results: The primary analysis included 10,999 patients with CRSwNP (2649 with asthma, 8350 without asthma). Patients with versus without asthma had higher medication use, HCRU, and all-cause medical costs (mean ± standard deviation $34,667 ± $42,234 versus $27,122 ± $45,573; p < 0.001) across the full follow-up period. CRSwNP-related medical costs were significantly higher for patients with versus without asthma in year 2 of follow-up. In the surgical management analysis (n = 4943), most categories of medication use and CRSwNP-related HCRU declined from baseline levels during follow-up, and CRSwNP-related pharmacy costs in year 2 were less than half of baseline levels. Conclusion: Patients diagnosed with CRSwNP and asthma had a greater burden of illness than those without asthma. Higher CRSwNP-related medical costs in year 2 of follow-up for patients with asthma may indicate worsening symptoms over time. Among patients with surgically managed CRSwNP, HCRU and costs increased in year 1 of follow-up but decreased below baseline levels in year 2, potentially reflecting improved symptom severity.

Trends and Characteristics of Global Initiative for Chronic Obstructive Lung Disease Guidelines-Discordant Prescribing of Triple Therapy Among Patients with COPD.

BACKGROUND: Triple therapy (long-acting muscarinic antagonist [LAMA] plus long-acting beta2-agonist [LABA] plus inhaled corticosteroid [ICS]) is recommended by the Global initiative for chronic Obstructive Lung Disease (GOLD) for moderate-to-severe chronic obstructive pulmonary disease (COPD) with a history of frequent and/or severe exacerbation(s) and dyspnea while using dual bronchodilators. However, many patients receive triple therapy contrary to these recommendations. This study describes factors associated with GOLD-discordant triple therapy initiation. METHODS: This retrospective analysis included patients aged 40 and above, with ≥1 COPD diagnosis, who initiated triple therapy (initiation=index date) during the period January 1, 2014 to December 31, 2018 and had ≥12 months pre-index continuous enrollment (baseline). Triple therapy comprised ≥30 days of overlapping LAMA, LABA, and ICS treatments (open triple therapy), or single-inhaler fluticasone furoate/umeclidinium/vilanterol (closed triple therapy). Cohorts were defined based on the absence of baseline maintenance medication use ("maintenance-naïve"), and/or exacerbations ("exacerbation-discordant"), or "dual-discordant" (discordant on both measures). All triple therapy initiators, overall and for each cohort, were described, and predictors of GOLD-discordant triple therapy initiation were identified. RESULTS: Among 21,711 triple therapy initiators, 34.4% were maintenance-naïve, 61.9% exacerbation-discordant, and 22.2% dual-discordant. Triple therapy initiation appeared to increase during the period 2016 to 2018. In 2018 alone, 31.9% and 58.3% of open triple therapy patients were maintenance-naïve and exacerbation-discordant, respectively, versus 37.6% and 64.4% of closed triple therapy patients. Closed triple therapy initiators had 1.65 times greater risk of dual discordance than open triple therapy initiators. Exacerbation-discordant patients initiating closed triple therapy were 1.61 times more likely to be maintenance-naïve than those initiating open triple therapy. CONCLUSION: A substantial proportion of COPD patients initiating triple therapy do not meet GOLD recommendations regarding exacerbation history and/or prior maintenance therapy. Compared with open triple therapy, closed triple therapy initiators were more likely to be dual discordant.

Burden of illness and costs associated with eosinophilic granulomatosis with polyangiitis: evidence from a managed care database in the United States.

BACKGROUND: Data on the clinical and economic burden of eosinophilic granulomatosis with polyangiitis (EGPA) are limited. OBJECTIVE: To assess the real-world clinical and economic outcomes of patients diagnosed with EGPA vs patients with asthma (present in > 90% of EGPA cases) receiving treatment in the United States. METHODS: This retrospective cohort study (HO-17-17742) used administrative claims data (July 1, 2007-May 31, 2017) from the Optum Research Database. Eligible patients were aged at least 18 years at index (first date that patients met the EGPA or asthma cohort definition), with a minimum of 6 months of continuous health plan coverage before the index (baseline) period and 12 months following and including the index date (follow-up period). Patients with EGPA were identified either via published algorithms using claim code combinations for conditions and medications (before October 1, 2015) or via a claim with the EGPA ICD-10-CM code (M30.1, after October 1, 2015). Patients with asthma were identified based on ICD-9-CM and ICD-10-CM diagnosis codes and at least 3 pharmacy asthmarelated medication claims within a year of diagnosis. Outcomes included all-cause health care costs (primary), all-cause health care resource utilization (HCRU), systemic corticosteroid (SCS) use, and EGPA relapses requiring hospitalization and EGPA-related (based on EGPA-related HCRU) relapses during the follow-up period (all secondary). EGPA and asthma cohorts were matched (1:3) via propensity score matching based on demographic, insurance, and index timing covariates. RESULTS: 8,904 patients were included in the matched EGPA (n = 2,226) and asthma (n = 6,678) cohorts (mean [SD] age: 59.7 [14.2] vs 59.6 [14.7] years; Quan-Charlson Comorbidity Index scores: 1.8 [1.7] vs 0.8 [1.4]). During follow-up, mean (SD) all-cause costs ($49,593 [$88,161] vs $21,122 [$40,110]; P < 0.001), all-cause HCRU (P < 0.001), and the proportion of patients with 1 or more SCS claims (72.3% vs 66.9%; P < 0.001) were significantly greater in the EGPA vs asthma cohorts, respectively. Mean daily SCS dose (43.6-45.5 mg/day) was similar between cohorts; patients with EGPA had significantly (P < 0.001) longer periods taking SCS doses at least 4 mg/day (mean [SD]: 64.9 [95.6] vs 14.6 [39.3] days) and at least 7 mg/day (52.8 [82.0] vs 12.1 [30.6] days). 35.2% (n = 784/2,226) and 44.1% (n = 981/2,226) of patients with EGPA experienced a minimum of 1 EGPA relapse requiring hospitalization, and at least 1 EGPA-related relapse, respectively. Mean (SD) total all-cause costs were greater than 3-fold higher in patients with vs without a relapse requiring hospitalization ($92,825 [$128,562] vs $26,087 [$38,082]; P < 0.001) and for patients with vs without an EGPA-related relapse ($78,081 [$120,775] vs $27,145 [$35,584]; P < 0.001). CONCLUSIONS: Patients with EGPA have more comorbidities, greater health care costs and HCRU, and use SCS more frequently than patients with asthma. Additionally, more than one third of patients with EGPA experienced disease relapses over 12 months. These results highlight the high disease burden in patients with EGPA and the need for improved treatment options. DISCLOSURES This study was funded by GlaxoSmithKline (GSK ID: HO-17-17742). Bell is an employee of GSK and holds stock/share options in GSK. Blauer-Peterson is an employee of Optum, which was funded by GSK to conduct the study. Mao was an employee of Optum at the time the study was conducted. The authors report no other potential conflicts of interest. These data have previously been presented as a poster at the American College of Rheumatology/Association of Rheumatology Health Professionals Annual Meeting, Chicago, IL, October 19-24, 2018.

Cesarean birth and maternal morbidity among Black women and White women after implementation of a blended payment policy.

OBJECTIVE: To test whether Minnesota's blended payment policy had differential effects on cesarean use and maternal morbidity among black women and white women in Minnesota, as compared to six control states. DATA SOURCES/STUDY SETTING: Claims data from births to Medicaid fee-for-service beneficiaries, 2006-2012, in Minnesota (policy state) and six control states (Wisconsin, Iowa, Illinois, Oregon, Idaho, and Montana). STUDY DESIGN: The key study intervention was Minnesota's blended payment policy, which established one single payment rate for uncomplicated vaginal and cesarean births in 2009. The primary outcome was cesarean birth, and secondary outcomes were maternal morbidity (composite), postpartum hemorrhage, and chorioamnionitis. Policy effects were assessed using race-stratified comparative interrupted time series analysis. PRINCIPAL FINDINGS: Following policy implementation, cesarean use decreased among both black and white women in Minnesota compared to control states; this decline was larger among black women (-2.88 percent 3-year cumulative decline, from a prepolicy cesarean rate of 22.2 percent) than among white women (-1.32 percent, P = .0013). Postpartum hemorrhage increased, with larger increases among black women (1.20 percent 3-year cumulative increase), compared with white women (0.48 percent, P < .001) in Minnesota compared with control states. CONCLUSIONS: Policy-related declines in cesarean use after Minnesota's blended payment policy were larger in black women. Increases in postpartum hemorrhage signal potential unintended consequences of policy-related cesarean reduction.

Impact of Endometriosis Diagnostic Delays on Healthcare Resource Utilization and Costs.

INTRODUCTION: Endometriosis symptoms are nonspecific and overlap with other gynecologic and gastrointestinal diseases, leading to long diagnostic delays. The burden of endometriosis has been documented; however, little is known about the impact of diagnostic delays on healthcare costs leading up to diagnoses. The purpose of this study was to examine the economic impact of diagnostic delays on pre-diagnosis healthcare utilization and costs among patients with endometriosis. METHODS: This was a retrospective database study of adult patients with a diagnosis of endometriosis from 1 January 2004 to 31 July 2016. Patients had continuous health plan enrollment 60 months prior to and 12 months following the earliest endometriosis diagnosis and ≥ 1 pre-diagnosis endometriosis symptom (dyspareunia, generalized pelvic pain, abdominal pain, dysmenorrhea, or infertility). Patients were assigned to short (≤ 1 year), intermediate (1-3 years), or long (3-5 years) delay cohorts based on the length of their diagnostic delay (time from first symptom to diagnosis). Healthcare resource utilization and costs were calculated and compared by cohort in the 60-month pre-diagnosis period. RESULTS: A total of 11,793 patients were included in the study, of which 37.7% (4446/11,793), 27.0% (3179/11,793), and 35.3% (4168/11,793) had short, intermediate, and long delays, respectively. Patients with intermediate or long diagnostic delays had consistently more all-cause and endometriosis-related emergency visits and inpatient hospitalizations in the pre-diagnosis period than patients with short delays. Pre-diagnosis all-cause healthcare costs were significantly higher among patients with longer diagnostic delays, averaging $21,489, $30,030, and $34,460 among patients with a short, intermediate, and long delay, respectively (p < 0.001 for all pairwise comparisons). Endometriosis-related costs accounted for 12.5% ($3553/$28,376) of all-cause costs and followed a similar pattern. CONCLUSION: Patients with endometriosis who had longer diagnostic delays had more pre-diagnosis endometriosis-related symptoms and higher pre-diagnosis healthcare utilization and costs compared with patients who were diagnosed earlier after symptom onset, providing evidence in support of earlier diagnosis.

Clinical characteristics and treatment patterns among US patients with HIV.

OBJECTIVES: Describe the clinical characteristics and treatment patterns of patients with HIV-1 who have commercial or Medicare health insurance in the United States. STUDY DESIGN: Retrospective cohort study. METHODS: Administrative claims for adult commercial and Medicare health plan enrollees with evidence of HIV-1 and antiretroviral therapy (ART) between January 1, 2007, and March 31, 2017, were assessed. Current and previous complete ART regimens were identified using a claims-based algorithm. Results were stratified by treatment status and insurance type. RESULTS: Of 18,699 eligible patients, 5027 (27%) had no previous ART regimens; 15,275 (82%) had commercial insurance. Mean age was 47.5 years. Common comorbidities included hyperlipidemia, cardiovascular disease, hypertension, depression, and anxiety. The mean number of ART regimens was 1.43, with 31% of patients having 2 or more regimens. Mean (SD) daily pill burden was higher in patients with more than 1 ART regimen over time (5.7 [6.0] pills) or with Medicare insurance (9.2 [8.0] pills) than in patients with no previous ART (1.9 [4.4] pills) or with commercial insurance (3.7 [4.7] pills). Overall, 60% of patients achieved 90% or greater adherence to their ART regimen and 16% had a prescription filled for any contraindicated medication to an ART during their regimen. CONCLUSIONS: This descriptive study demonstrated that people living with HIV enrolled in Medicare have a significant amount of comorbidities and total pill burden. Although advancements in ART have significantly improved life expectancy and quality of life for people living with HIV, it is important to take into account individual complexities such as comorbidities and pill burden when selecting ART regimens.

Impact of Pain Severity and Opioid Use on Health Care Resource Utilization and Costs Among Patients with Knee and Hip Osteoarthritis.

BACKGROUND: Osteoarthritis (OA) is the most common form of arthritis. The primary symptom of OA-pain-increases the disease burden by negatively affecting daily activities and quality of life. Opioids are often prescribed for treating pain in patients with OA but have questionable benefit-risk profiles. There is limited evidence on the economic impact of pain severity and opioid use among patients with OA. OBJECTIVES: To (a) evaluate the association of pain severity with health care resource utilization (HRU) and costs among patients with knee/hip OA and (b) characterize the association of opioid use with HRU and costs while controlling for pain severity. METHODS: Using deterministically linked health care claims data and electronic health records from the Optum Research Database, this retrospective cohort study included commercial and Medicare Advantage Part D enrollees who were diagnosed with knee/hip OA during the January 1, 2010-December 31, 2016 time period and had ≥ 1 pain score (11-point Likert scale: 0 = no pain, 10 = worst possible pain) between the first OA diagnosis date and October 2016. The index date was the date of the evaluated pain score; HRU and costs were observed over the 3-month postindex period. For patients with multiple pain scores, each episode required a 3-month post-index follow-up period. Generalized estimating equation models, adjusted for multiple observation panels per patient and baseline variables that may contribute to HRU and costs (age, sex, race/ethnicity, region, insurance type, integrated delivery network, body mass index, pain medication use, provider specialty, Charlson Comorbidity Index score, and other select comorbid conditions), were used to estimate all-cause and OA-related costs expressed as per patient per month (PPPM). Comparisons were performed for moderate (score 4-6) and severe (score 7-10) pain episodes versus no/mild pain episodes (score 0-3) and those with baseline opioid use versus those without. RESULTS: Included were 35,861 patients with knee/hip OA (mean age 66.5 years; 64.7% women) who had 70,716 pain episodes (58% mild, 23% moderate, 19% severe, and 37.0% with baseline opioid use). When controlling for other potential confounding factors, moderate/severe pain episodes were associated with higher all-cause and OA-related HRU than mild pain episodes. Relative to mild pain episodes, moderate/severe pain episodes were also associated with significantly higher adjusted average all-cause PPPM costs ($1,876/$1,840 vs. $1,602), and OA-related PPPM costs ($550/$577 vs. $394; all P < 0.05). Baseline opioid use was associated with significantly higher all-cause PPPM costs versus no opioid use (mild, $1,735 vs. $1,492; moderate, $2,034 vs. $1,755; severe, $2,100 vs. $1,643, all P < 0.001), and a higher likelihood of incurring OA-related costs relative to those without (P < 0.001). CONCLUSIONS: These results provide evidence of the economic impact of opioid use and inadequate pain control by demonstrating that increased pain severity and opioid use in patients with OA were independently associated with higher HRU and costs. Additional studies should confirm causality between opioid use and HRU and costs, taking into consideration underlying OA characteristics. DISCLOSURES: Funding for this study was contributed by Regeneron Pharmaceuticals and Teva Pharmaceutical Industries. Wei is an employee at Regeneron Pharmaceuticals, with stock ownership. Gandhi was an employee at Teva Pharmaceutical Industries, with stock ownership, at the time of this study. Blauer-Peterson and Johnson are employees of Optum, which was contracted to conduct the research for this study.

Assessment of COPD-related outcomes in patients initiating a once daily or twice daily ICS/LABA.

BACKGROUND: Use of inhaled corticosteroids and long acting beta agonist (ICS/LABA) combination therapy has been shown to decrease the frequency of exacerbations in patients with chronic obstructive pulmonary disease (COPD). In this population, adherence to treatment is associated with better disease control and lower risk of COPD-related exacerbations in the future. Using a treatment with a more convenient regimen or easier-to-use device could improve patient adherence, improve disease control, decrease the frequency of exacerbations and minimize the COPD-related economic burden. Real-world information on the impact on healthcare costs and exacerbation risk of initiating once-daily or twice daily ICS/LABA in this patient population is limited. The objective of this study was to assess COPD-related healthcare costs, adherence, and exacerbations in COPD patients initiating treatment with fluticasone furoate/vilanterol 100/25 (FF/VI) or budesonide/formoterol 160/4.5 (BUD/F) using a large managed care database in the US. METHODS: This was a retrospective cohort study among COPD patients initiating FF/VI or BUD/F between January 01, 2014 and June 30, 2016. The analysis used the Optum Research Database (ORD) which contains patients from commercial and Medicare Advantage Prescription Drug (MAPD) plans. The study included new initiators of ICS/LABA as either FF/VI or BUD/F for COPD, ≥40 years of age at index, ≥15 months of continuous enrollment (12 months pre-index and ≥3 months post-index). New users of FF/VI or BUD/F were matched on baseline characteristics using propensity score matching (PSM) methods. Multivariate models including ordinary least squares regression, Lin's regression, logistic regression, and Cox proportional hazards were used to assess differences between the cohorts on outcomes of interest. RESULTS: A total of 18,652 subjects met all inclusion and exclusion criteria with 5044 initiating FF/VI and 13,608 initiating BUD/F. Of these, 9026 subjects were matched at a 1:1 ratio (4513 patients in each cohort) and were included in the final analyses. Proportion of days covered (PDC), was significantly better for FF/VI (mean PDC [SD]: FF/VI: 0.46 [0.31], BUD/F: 0.41 [0.29], p < 0.001) while FF/VI was associated with a 9% lower risk (adj. hazard ratio (HR): 0.91, 95% CI: 0.85-0.96) of having a moderate or severe COPD-related exacerbation. However, COPD-related healthcare costs were not significantly different, $11,521 vs $10,986, p = 0.41 for FF/VI and BUD/F, respectively. CONCLUSIONS: Patients initiating once-daily FF/VI were more adherent, and were associated with a lower risk of subsequent COPD-related exacerbations compared with twice-daily BUD/F, however this was not associated with a significant difference in costs. (GSK Study HO1617333/206702).

Assessment of Adherence and Asthma Medication Ratio for a Once-Daily and Twice-Daily Inhaled Corticosteroid/Long-Acting ß-Agonist for Asthma.

BACKGROUND: Although efficacy and safety of fluticasone furoate/vilanterol (FF/VI) and budesonide/formoterol (BUD/F) have been demonstrated in clinical studies, real-world comparisons of utilization have not been performed. OBJECTIVE: To compare similar patients with asthma initiating FF/VI or BUD/F on measures of adherence, persistence, and the asthma medication ratio (AMR). METHODS: This was a retrospective cohort study of commercial and Medicare Advantage with Part D enrollees initiating FF/VI or BUD/F for asthma. Adult patients (≥18 years) with at least 15-month (12-month preindex and 3-month postindex) continuous enrollment and 1 or more asthma diagnosis code were eligible for the study. Patients with a history of fixed-dose inhaled corticosteroid/long-acting ß-agonist and other respiratory disorders (chronic obstructive pulmonary disease, cystic fibrosis, acute respiratory failure) in the baseline period were excluded. Propensity-score matching was used to balance cohorts on baseline characteristics. Logistic regression and Cox-proportional hazard models were used to assess differences. RESULTS: A total of 9951 patients met all criteria. After propensity-score matching, 1725 patients were matched in each cohort. Subjects who initiated FF/VI had a significantly higher mean proportion of days covered (P < .001), had 86% greater odds of having a proportion of days covered value of greater than or equal to 0.80 (adjusted odds ratio, 1.86; 95% CI, 1.51-2.30), 26% lower risk of discontinuation (adjusted hazard ratio, 0.74; 95% CI, 0.69-0.79), and 36% greater odds of an AMR of greater than or equal to 0.50 (adjusted odds ratio, 1.36; 95% CI, 1.23-1.50) compared with BUD/F. CONCLUSIONS: Adherence and treatment persistence were low in both cohorts; however, patients initiating once-daily FF/VI were more likely to be adherent, have an AMR of greater than or equal to 0.5, and were less likely to discontinue therapy compared with patients initiating twice-daily BUD/F (GlaxoSmithKline Study HO1617302/206482).

Rates of escalation to triple COPD therapy among incident users of LAMA and LAMA/LABA.

BACKGROUND: Improved outcomes have been reported for patients with chronic obstructive pulmonary disease (COPD) receiving combination long-acting muscarinic antagonist/long-acting ß2-agonist (LAMA/LABA) therapy compared with LAMA monotherapy. However, little is known about the relative characteristics of these patients and their rates of escalation to triple therapy (TT, combining a LAMA, LABA, and inhaled corticosteroid). This study aimed to characterize patients initiating treatment with the LAMA tiotropium (TIO) and the fixed-dose LAMA/LABA combination therapy umeclidinium/vilanterol (UMEC/VI), and to compare rates of escalation to TT between patients receiving these therapies. METHODS: Retrospective study of patients with COPD enrolled in a US health insurance plan during 2013-2015 and newly initiated on TIO or UMEC/VI. Patients were ≥40 years of age at index (date of therapy initiation) with continuous enrollment for 12 months pre-index and ≥30 days post-index. LAMA users were propensity score matched 1:1 to LAMA/LABA users, with TT initiation rates reported by cohort using pharmacy claims. RESULTS: 35,357 patients initiating on TIO and 2407 patients initiating on UMEC/VI were identified. After propensity score matching, the rate of TT initiation was significantly higher in new TIO users (n = 1320) than in new UMEC/VI users (n = 1320) (0.92 vs 0.49 per 100 months of exposure, respectively; p < 0.001). Relative to the UMEC/VI cohort, the TIO cohort had an 87% higher risk of TT initiation (hazard ratio: 1.87; 95% confidence interval: 1.4-2.5; p = 0.001). CONCLUSIONS: Patients receiving UMEC/VI progressed to TT more slowly, and were at lower risk of progressing to TT, than patients receiving TIO.

Glycaemic impact of treatment intensification in patients with type 2 diabetes uncontrolled with oral antidiabetes drugs or basal insulin.

AIMS: To investigate the impact of treatment intensification (TI) on glycaemic outcomes in patients with type 2 diabetes with glycated haemoglobin A1c (A1C) ≥7% after ≥6 months of treatment with 2 oral antidiabetes drugs (OADs) or basal insulin (BI). MATERIALS AND METHODS: Data were extracted from the Optum administrative claims database from 1 January 2009 to 31 August 2015. Patients with TI ≤6 months after the first A1C ≥7% (index date) were compared with patients with no TI (NTI). TI included addition of OAD, GLP-1 receptor agonist or premixed insulin in OAD and BI cohorts, addition of BI and/or bolus insulin in the OAD cohort and addition of bolus insulin or increasing BI dose in the BI cohort. Change from the index A1C value and hypoglycaemia events was compared at 12 months after TI after adjusting for confounders. RESULTS: A total of 3990/28 123 (14.2%) and 10 425/16 140 (65%) of eligible adults in the OAD and BI cohorts, respectively, underwent TI. These patients showed greater adjusted A1C change vs NTI patients (OAD cohort: -0.59% vs -0.25%; BI cohort: -0.30% vs -0.16%; P < .001 for both comparisons), but with higher hypoglycaemia rates (OAD cohort: odds ratio [OR] 1.68; P < .001; BI cohort: OR: 1.23; P = .004) at follow-up. CONCLUSIONS: Clinical inertia appears to be a significant issue in this population. Although associated with more frequent hypoglycaemia, these results demonstrate that timely TI improves A1C levels, highlighting the need for new and improved agents to effectively manage glycaemia while reducing hypoglycaemia risk.

Healthcare costs for allergic rhinitis patients on allergy immunotherapy: a retrospective observational study.

OBJECTIVE: Subcutaneous immunotherapy (SCIT) for allergic rhinitis (AR) has been shown to control symptoms for up to several years following treatment discontinuation, but the effect of SCIT on healthcare costs for commercially insured patients is unknown. The objective of this study was to compare healthcare costs and resource utilization for patients with AR who received SCIT compared with those who discontinued SCIT shortly after initiation. METHODS: This retrospective cohort study evaluated medical and pharmacy claims from the Optum Research Database from January 2009 through February 2014 for adults and pediatric patients with >7 (continuers) vs. ≤7 (discontinuers) injection visits for SCIT within 60 days of initiation. RESULTS: After 1:1 propensity score matching, each cohort included 6710 patients. Continuers were less likely than discontinuers to use oral corticosteroids (27.7% vs. 29.6%, p = .018), or to have ≥1 respiratory-related emergency room visit (5.4% vs. 6.5%, p = .008) and ≥1 inpatient stay (1.1% vs. 1.7%; p = .002). Continuers were more likely than discontinuers to have ≥1 AR-related office (98.8% vs. 94.6%, p < .001) or outpatient visit (2.4% vs. 1.7%, p = .002). Continuers had greater mean total AR-related costs than discontinuers ($1918 vs. $646, p < .001). Unadjusted mean total respiratory-related costs were lower for continuers than discontinuers, although the difference was not statistically significant ($1589 vs. $1785, p = .077); when adjusted with a generalized linear model, these costs were significantly lower among continuers (p < .001). CONCLUSIONS: Continued SCIT use is associated with decreased emergency room visits and inpatient stays, decreased oral corticosteroid use, and lower respiratory-related costs, compared with early discontinuation.

Uptake and Utilization of Practice Guidelines in Hospitals in the United States: the Case of Routine Episiotomy.

BACKGROUND: The gap between publishing and implementing guidelines differs based on practice setting, including hospital geography and teaching status. On March 31, 2006, a Practice Bulletin published by the American College of Obstetricians and Gynecologists (ACOG) recommended against the routine use of episiotomy and urged clinicians to make judicious decisions to restrict the use of the procedure. OBJECTIVE: This study investigated changes in trends of episiotomy use before and after the ACOG Practice Guideline was issued in 2006, focusing on differences by hospital geographic location (rural/urban) and teaching status. METHODS: In a retrospective analysis of discharge data from the Nationwide Inpatient Sample (NIS)-a 20% sample of US hospitals-5,779,781 hospital-based births from 2002 to 2011 (weighted N = 28,067,939) were analyzed using multivariable logistic regression analysis to measure odds of episiotomy and trends in episiotomy use in vaginal deliveries. RESULTS: The overall episiotomy rate decreased from 20.3% in 2002 to 9.4% in 2011. Across all settings, a comparatively larger decline in episiotomy rates preceded the issuance of the ACOG Practice Guideline (34.0% decline), rather than following it (23.9% decline). The episiotomy rate discrepancies between rural, urban teaching, and urban nonteaching hospitals remained steady prior to the guideline's release; however, differences between urban nonteaching and urban teaching hospitals narrowed between 2007 and 2011 after the guideline was issued. CONCLUSION: Teaching status was a strong predictor of odds of episiotomy, with urban nonteaching hospitals having the highest rates of noncompliance with evidence-based practice. Issuance of clinical guidelines precipitated a narrowing of this discrepancy.

Clinical characteristics, healthcare costs, and resource utilization in hepatitis C vary by genotype.

BACKGROUND: In the United States, approximately 3 million people are infected with hepatitis C virus (HCV). Genotypes of HCV variably affect disease progression and treatment response. However, the relationships between HCV genotypes and liver disease progression, healthcare resource utilization, and healthcare costs have not been fully explored. RESEARCH DESIGN AND METHODS: In this retrospective study of patients with chronic hepatitis C (CHC), healthcare claims from a large US health plan were used to collect data on patient demographic and clinical characteristics. MAIN OUTCOME MEASURES: Main outcome measures include healthcare resource utilization (HCRU) and healthcare costs. Linked laboratory data provided genotype and select measures to determine liver disease severity. RESULTS: The sample (mean age 50.6 years, 63.5% male) included 10,331 patients, of whom 79.1% had genotype (GT)1, 12.8% had GT2, and 8.1% had GT3. Descriptive analyses demonstrated variation by HCV genotype in liver and non-liver related comorbidities, liver disease severity, and healthcare costs. The highest percentage of patients with liver-related comorbidities and advanced liver disease was found among those with GT3. Meanwhile, patients with GT2 had lower HCRU and the lowest costs, and patients with GT1 had the highest total all-cause costs. These differences may reflect differing rates of non-liver-related comorbidities and all-cause care. Multivariable analyses showed that genotype was a significant predictor of costs and liver disease severity: compared with patients having GT1, those with GT3 were significantly more likely to have advanced liver disease. Patients with GT2 were significantly less likely to have advanced disease and more likely to have lower all-cause costs. LIMITATIONS: Results may not be generalizable to patients outside the represented commercial insurance plans, and analysis of a prevalent population may underestimate HCRU and costs relative to a sample of treated patients. CONCLUSIONS: These results suggest that liver disease progression varies by genotype and that CHC patients with GT3 appear to have more severe liver disease. These findings highlight the importance of effective HCV treatment for all patients and support guidelines for treatment of high-risk patients, including those with GT3.

Evaluation of mortality and readmissions following hospitalization with heart failure.

OBJECTIVE: To examine the association of patient/clinical characteristics with mortality and readmission following a heart failure (HF)-related hospitalization. RESEARCH DESIGN AND METHODS: Claims data, linked to laboratory, race/ethnicity, and mortality data, from a large US health plan were utilized to identify individuals with ≥1 inpatient claim with a diagnosis code for HF (1 January 2008-30 September 2012). Study variables were analyzed using descriptive and multivariable approaches to identify patient/clinical characteristics associated with post-discharge outcomes. MAIN OUTCOME MEASURES: Primary outcomes included post-discharge mortality and readmission. RESULTS: A total of 126,214 individuals were identified with a HF-related hospitalization; 19.1% with data to calculate chronic kidney disease (CKD) stage. For the overall sample, mortality probability was 4.9% and 13.4% at 1 and 6 months post-discharge, respectively (4.5% and 12.4% for subset with calculated CKD stage), while readmission (all-cause) probability was 14.8% and 39.6% at 1 and 6 months post-discharge, respectively (18.4% and 44.5% for subset with calculated CKD stage). Within the subset with calculated CKD stage, mortality and readmission probabilities differed by CKD stage (p < 0.001), with decreased renal function corresponding with increased risk of mortality and readmission. After multivariable adjustment, increasing age was associated with increased risk of mortality, while advancing CKD stage, various index hospitalization variables (i.e., pre-admission emergency room visit, intensive care unit during hospitalization), and baseline all-cause hospitalization were associated with both increased risk of mortality and all-cause 1 month readmission. CONCLUSIONS: Calculated CKD, various index hospitalization variables, and baseline all-cause hospitalization were associated with increased risk of mortality and all-cause 1 month readmission among patients hospitalized with HF. Risk of post-discharge readmission and mortality increased with worse renal function, suggesting that improved management of this subset may reduce the burden and cost of this disease. Key study limitations include those related to retrospective claims-based studies and that renal function data were available for a subset of study patients.

Modeling the Cost-Effectiveness of Doula Care Associated with Reductions in Preterm Birth and Cesarean Delivery.

BACKGROUND: One in nine US infants is born before 37 weeks' gestation, incurring medical costs 10 times higher than full-term infants. One in three infants is born by cesarean; cesarean births cost twice as much as vaginal births. We compared rates of preterm and cesarean birth among Medicaid recipients with prenatal access to doula care (nonmedical maternal support) with similar women regionally. We used data on this association to mathematically model the potential cost-effectiveness of Medicaid coverage of doula services. METHODS: Data came from two sources: all Medicaid-funded, singleton births at hospitals in the West North Central and East North Central US (n = 65,147) in the 2012 Nationwide Inpatient Sample, and all Medicaid-funded singleton births (n = 1,935) supported by a community-based doula organization in the Upper Midwest from 2010 to 2014. We analyzed routinely collected, de-identified administrative data. Multivariable regression analysis was used to estimate associations between doula care and outcomes. A probabilistic decision-analytic model was used for cost-effectiveness estimates. RESULTS: Women who received doula support had lower preterm and cesarean birth rates than Medicaid beneficiaries regionally (4.7 vs 6.3%, and 20.4 vs 34.2%). After adjustment for covariates, women with doula care had 22 percent lower odds of preterm birth (AOR 0.77 [95% CI 0.61-0.96]). Cost-effectiveness analyses indicate potential savings associated with doula support reimbursed at an average of $986 (ranging from $929 to $1,047 across states). CONCLUSIONS: Based on associations between doula care and preterm and cesarean birth, coverage reimbursement for doula services would likely be cost saving or cost-effective for state Medicaid programs.

ReCAP: Treatment Patterns and Cost of Care Associated With Initial Therapy Among Patients Diagnosed With Operable Early-Stage Human Epidermal Growth Factor Receptor 2-Overexpressed Breast Cancer in the United States: A Real-World Retrospective Study.

PURPOSE: Overexpression of the human epidermal growth factor receptor 2 (HER2) protein negatively affects survival in breast cancer. This study aimed to assess real-world treatment patterns and costs associated with resected nonmetastatic HER2-positive breast cancer in the United States. PATIENTS AND METHODS: Commercially insured patients with HER2-positive breast cancer were identified from oncology registry data linked to a large US commercial administrative claims database. Treatment patterns and health care use and costs in the initial phase of care were examined. RESULTS: Among the 915 patients who met the study criteria, 662 (72%) were hormone receptor (HR) positive, and 253 (28%) were HR negative. Overall, 72% (n = 662) of patients received HER2-targeted therapy (HR positive, 69% v HR negative, 80%; P < .01), specifically trastuzumab. The most common treatment regimens, regardless of HR status, were carboplatin, docetaxel, and trastuzumab (47% of patients) during neoadjuvant therapy and carboplatin, docetaxel, and trastuzumab ± hormone therapy (30% of patients) during adjuvant therapy. Overall unadjusted cost of treatment per patient per month (HR positive, $11,906 v HR negative, $14,367; P < .001) was mainly cancer related (HR positive, $10,513 v HR negative, $13,073; P < .001). Adjusted 12-month cost was $176,779 (HR positive, $167,088 v HR negative, $180,226; P > .05). CONCLUSION: Although trastuzumab-based therapy is considered standard of care among patients with HER2-positive early-stage breast cancer, approximately 28% of these patients did not receive HER2-targeted therapy. Additional studies are warranted to examine whether patients who have not received targeted therapy are eligible for and would benefit from an HER2-targeted approach.