Evaluating estimated health care resource utilization and costs in patients with myelofibrosis based on transfusion status and anemia severity: A retrospective analysis of the Medicare Fee-For-Service claims data.

BACKGROUND: Myelofibrosis (MF) is a rare but aggressive myeloproliferative neoplasm that commonly affects older patients, with a mean age of onset of older than 60 years. At least a third of patients with primary MF are anemic at diagnosis, and nearly all patients become anemic over time; approximately half require red blood cell transfusions within a year of diagnosis. Anemia and transfusion dependence are leading negative prognostic factors for overall survival and are associated with diminished quality of life and increased health care-related economic burden in patients with MF. OBJECTIVE: To describe baseline characteristics, health care resource utilization (HCRU), and costs as a function of transfusion status and anemia severity in patients diagnosed with MF among the US Medicare Fee-For-Service (FFS) population. METHODS: This retrospective cohort study included patients diagnosed with MF appearing in the 100% Medicare FFS database enrolled between January 1, 2012, and December 31, 2020. Patients were segmented into hemoglobin level cohorts (no, mild, moderate, and severe anemia) and transfusion status cohorts (transfusion independent [TI], transfusion requiring [TR], or transfusion dependent [TD]). Across cohorts, demographics and disease characteristics were assessed at baseline; per patient per month all-cause HCRU and medical and pharmacy costs were reported during follow-up. All results were summarized descriptively. RESULTS: The transfusion status cohort (N = 1,749) included TI (n = 980), TR (n = 559), and TD (n = 210) patients; the anemia severity cohort (N = 365) included patients with no (n = 100), mild (n = 128), moderate (n = 99), and severe (n = 38) anemia. On average, TR and TD patients or those with moderate or severe anemia had numerically higher Deyo-Charlson Comorbidity Index scores than those who were TI or had mild or no anemia. TR and TD cohorts reported numerically greater all-cause outpatient, inpatient, and emergency department utilization vs the TI cohort. All-cause costs were numerically higher in the TD and TR cohorts vs the TI cohort ($14,655 and $14,249 vs $8,191). Incremental increases in HCRU and costs were also observed with increasing anemia severity. All-cause medical and pharmacy costs for no, mild, moderate, and severe anemia cohorts were $4,689, $7,268, $10,439, and $13,590, respectively. CONCLUSIONS: This retrospective analysis of the US Medicare FFS database descriptively evaluated patients by transfusion status and anemia severity and showed that costs and HCRU were numerically lower for patients with transfusion independence compared with those with transfusion dependence. Similar trends were seen when comparing patients based on anemia status, with numerically lower HCRU and cost observed with decreasing anemia severity.

Patterns of Rescue and Maintenance Medication Claims Surrounding an Asthma Exacerbation in Patients Treated as Intermittent or Mild Persistent Asthma.

Purpose: To examine patterns of short-acting ß2-agonist (SABA) and maintenance therapy claims surrounding the subset of severe asthma exacerbations associated with outpatient, urgent care, or emergency department visits or hospitalization (termed serious exacerbations) in patients treated as intermittent or mild persistent asthma. Methods: This was a retrospective study of 2010-2017 administrative claims from MerativeTM MarketScan® US databases for patients ≥12 years filling a SABA prescription for asthma (index). Patients had ≥12 months continuous insurance eligibility pre- and post-index and ≥1 additional SABA and/or maintenance medication fill appropriate for mild persistent asthma post-index. Prescription fills were assessed over 30 days before and after a serious exacerbation event. Results: Of 323,443 patients (mean [standard deviation] age: 34.9 [18.2] years; 62.0% female) treated as intermittent or mild persistent asthma, 51,690 (16.0%) experienced ≥1 serious exacerbation post-index. During the 30 days pre-event, a greater proportion of patients filled a SABA versus maintenance therapy (24.6% vs 19.0%; odds ratio [OR]: 1.39, 95% confidence interval [CI]: 1.35-1.43; p < 0.001); during the 30 days post-event, patients were more likely to fill maintenance medication versus SABA (88.6% vs 67.0%; OR [95% CI]: 3.88 [3.75-4.01]; p < 0.001). The closer in time prior to the event, the greater the likelihood of filling a SABA versus maintenance prescription (OR [95% CI]; 1-7 days pre-event: 1.42 [1.36-1.48]; 8-14 days pre-event: 1.34 [1.27-1.41]; 15-30 days pre-event: 1.18 [1.12-1.24]; all p < 0.001). Over 4.5 times more patients filled a maintenance therapy within 7 days post-event (45,014) versus all 30 days pre-event (9835) (OR [95% CI]: 28.7 [27.7-29.7]; p < 0.001). Conclusion: These patterns of SABA rescue and maintenance fills suggest that a "window of opportunity" may exist to interrupt a serious exacerbation occurrence for patients treated as intermittent or mild persistent asthma if symptoms and inflammation are addressed concomitantly.

Real-world treatment patterns, health care resource utilization, and costs in a US Medicare population with bronchiectasis.

BACKGROUND: Bronchiectasis carries a significant economic burden with high health care expenditures associated with frequent hospitalizations, physician visits, and treatments, including oral and intravenous antibiotics for repeated lung infections, airway-clearance therapy, and oxygen administration. Bronchiectasis exacerbations can contribute to this burden. OBJECTIVE: To estimate US health care resource utilization (HCRU) and costs associated with bronchiectasis and with bronchiectasis exacerbations. METHODS: This retrospective study used the 100% Medicare Fee-for-Service database (January 2014 to December 2020) to compare HCRU and costs among patients with bronchiectasis with those of patients without bronchiectasis (controls). For patients with bronchiectasis, the index date was a randomly selected bronchiectasis claim after more than 1 year of disease history and, for controls, a claim closest to their matched bronchiectasis patient's index date. All patients had continuous enrollment for at least 12 months pre-index (baseline) and at least 12 months post-index. Primary outcomes were all-cause, respiratory-related, and bronchiectasis-related HCRU and health care costs, which were presented by the overall sample and by segmented patient cohorts based on the number of exacerbations during baseline (0, 1, or ≥2). RESULTS: 92,529 patients with bronchiectasis (mean [SD] age, 76.7 [8.8] years; 72.3% female) and 92,529 matched controls qualified for the study. Compared with controls, patients with bronchiectasis presented greater mean (SD) all-cause physician visits (15.4 [10.0] vs 13.2 [9.7]; P < 0.001) and respiratory-related physician visits (5.2 [4.3] vs 1.9 [3.1]), pulmonologist visits (1.9 [2.2] vs 0.3 [1.0]), hospitalizations (0.4 [0.9] vs 0.3 [0.8]), emergency department visits (0.33 [1.0] vs 0.26 [1.0]), and total health care costs ($10,224 [$23,263] vs $6,704 [$19,593]). Respiratory-related HCRU was also greater in patients with more baseline exacerbations, with total health care costs of $8,506, $10,365, and $14,790 for patients with 0, 1, and at least 2 exacerbations, respectively (P < 0.01). CONCLUSIONS: This real-world study demonstrates the high disease burden associated with bronchiectasis and with exacerbations, highlighting the need to improve management and reduce exacerbations.

An assessment of the direct and indirect costs of bladder cancer preceding and following a cystectomy: a real-world evidence study.

INTRODUCTION: To estimate the direct and indirect costs of bladder cancer prior to and following cystectomy in a U.S. sample of patients. METHODS: This retrospective, observational analysis of de-identified patients with bladder cancer utilized the MarketScan Commercial Claims & Encounters and Health & Productivity Management databases. Adult patients with bladder cancer plus ≥ 1 claim for partial or radical cystectomy between 1 October 2015 and 31 December 2020 (date of the cystectomy = index date) and who were continuously enrolled for 6 months pre- (baseline) and post-index (follow-up) were included in the sample. All-cause total healthcare costs and indirect costs associated with short-term and long-term disability (STD and LTD) employer claims were assessed during each of the 6-month baseline and follow-up periods. RESULTS: The study included N = 142 patients; mean age 56 ± 6 years, 76% (male), and 42% had a baseline Deyo-Charlson Comorbidity Index ≥ 2. Baseline mean total all-cause direct healthcare costs were $51,473 ± $48,560 (median: $36,202), and $99,524 ± 86,839 (median: $75,444) during follow-up. At baseline, 32% of patients had ≥ 1 STD claim, equating to a mean 134 ± 303 h lost and $2,353 ± $6,445 in total payments per patient. Follow up STD claims increased 23.4% equating to a mean 218 ± 324 h lost and $3,679 ± $7,795 per patient. Patient LTD claims increased from baseline to follow-up (1-3%), with post-cystectomy LTD claims resulting in 574 ± 490 h lost, and $1,636 ± $1,429 in total payments. Over 85% of the population had a cystectomy related complication, the most common were genitourinary-related (47.9%) and infection/sepsis (33.1%). CONCLUSIONS: Cystectomy was associated with complications and decreased work productivity post-surgery. Findings may aid to inform decisions regarding cystectomy vs. bladder preservation approaches, and underscores an ongoing need to further develop bladder preservation therapies within the bladder cancer treatment landscape.

Gaps in Care Among Uncontrolled Severe Asthma Patients in the United States.

BACKGROUND: Understanding the implementation of key guideline recommendations is critical for managing severe asthma (SA) in the treatment of uncontrolled disease. OBJECTIVE: To assess specialist visits and medication escalation in US patients with SA after events indicating uncontrolled disease (EUD) and associations with health outcomes and social disparity indicators. METHODS: Patients with SA appearing in administrative claims data spanning 2015 to 2020 were indexed hierarchically on asthma-related EUD, including hospitalizations, emergency department visits with systemic corticosteroid treatment, or outpatient visits with systemic corticosteroid treatment. Patients with SA without EUD served as controls. Eligibility included age 12 or greater, 12 months enrollment before and after index, no biologic use, and no other major respiratory disease during the pre-period. Escalation of care in the form of specialist visits and medication escalation, health care resource use, costs, and disease exacerbations were assessed during follow-up. RESULTS: We identified 180,736 patients with SA (90,368 uncontrolled and 90,368 controls). Between 35% and 51% of patients with SA with an EUD had no specialist visit or medication escalation. Follow-up exacerbations ranged from 51% to 4% across EUD cohorts, compared with 13% in controls. Among uncontrolled patients with SA who were Black or Hispanic/Latino, 41% and 38%, respectively, had no specialist visit or medication escalation after EUD, compared with 33% of non-Hispanic White patients. CONCLUSIONS: A substantial proportion of uncontrolled patients with SA had no evidence of specialist visits or medication escalation after uncontrolled disease, and there was a clear relationship between uncontrolled disease and subsequent health care resource use and exacerbations. Findings highlight the need for improved guideline-based care delivery to patients with SA, particularly for those facing social disparities.

Exacerbations and Real-World Outcomes After Single-Inhaler Triple Therapy of Budesonide/Glycopyrrolate/Formoterol Fumarate, Among Patients with COPD: Results from the EROS (US) Study.

Purpose: Triple therapy to prevent exacerbations from chronic obstructive pulmonary disease (COPD) is associated with improved health compared to single and dual-agent therapy in some populations. This study assessed the benefits of prompt administration of budesonide/glycopyrrolate/formoterol fumarate (BGF) following a COPD exacerbation. Patients and methods: EROS was a retrospective analysis of people with COPD using the MORE2 Registry®. Inclusion required ≥1 severe, ≥2 moderate, or ≥1 moderate exacerbation while on other maintenance treatment. Within 12 months following the index exacerbation, ≥1 pharmacy claim for BGF was required. Primary outcomes were the rate of COPD exacerbations and healthcare costs for those that received BGF promptly (within 30 days of index exacerbation) versus delayed (31-180 days) and very delayed (181-365 days). The effect of each 30-day delay in initiation of BGF was estimated using a multivariable negative binomial regression model. Results: 2409 patients were identified: 434 prompt, 1187 delayed, and 788 very delayed. The rate (95% CI) of total exacerbations post-index increased as time to BGF initiation increased: prompt 1.52 (1.39-1.66); delayed 2.00 (1.92-2.09); and very delayed 2.30 (2.20-2.40). Adjusting for patient characteristics, each 30-day delay in receiving BGF was associated with a 5% increase in the average number of subsequent exacerbations (rate ratio, 95% CI: 1.05, 1.01-1.08; p<0.05). Prompt initiation of BGF was also associated with lower post-index annualized COPD-related costs ($5002 for prompt vs $7639 and $8724 for the delayed and very delayed groups, respectively). Conclusion: Following a COPD exacerbation, promptly initiating BGF was associated with a reduction in subsequent exacerbations and reduced healthcare utilization and costs.

Clinical and economic characterization of mild, moderate, and severe systemic lupus erythematosus: Real-world observation across payer channels in the United States.

BACKGROUND: Systemic lupus erythematosus (SLE) is a chronic autoimmune disease affecting as many as 322,000 people in the United States. Because of heterogeneity in both disease course and clinical manifestations, it is critical to identify a prevalent SLE population that includes patients with moderate or severe disease. Additionally, differences in the clinical and economic burden of SLE may exist across payer channels, yet to date this has not been reported in any previous studies. OBJECTIVE: To characterize the clinical and economic burden of SLE across disease severity and payer channels. METHODS: This retrospective study included patients from Merative MarketScan Commercial, Medicare Supplemental, and Medicaid databases from 2013 to 2020 (Commercial/Medicare) or 2013 to 2019 (Medicaid), with at least 1 inpatient or at least 2 outpatient SLE claims and no invalid steroid claims. The index date was a random SLE claim with at least 12 months of disease history. Patients were continuously enrolled 1 year pre-index (baseline) and 1 year post-index and classified with mild, moderate, or severe disease using a published algorithm. Baseline demographics, clinical characteristics, flares, and utilization/costs were compared across disease severity. RESULTS: 22,385 Commercial, 2,035 Medicare, and 8,083 Medicaid patients had SLE. Most Medicaid patients (51.1%) had severe disease. Comorbidity scores increased with disease severity (P < 0.001). 30.7% of Commercial, 34.1% Medicare, and 51.3% Medicaid patients had opioids, which increased with disease severity (P < 0.001). All-cause costs ranged from 1.8- to 2.3-fold for moderate vs mild and 4.2- to 6.5-fold for severe vs mild. Outpatient medical costs accounted for the highest proportion of all-cause costs, except Medicaid patients with severe disease, for whom inpatient costs were highest. Mean (SD) SLE-related annual costs were $23,030 (43,304) vs $1,738 (4,427) in severe vs mild for Commercial, $12,264 (31,896) vs $2,024 (4,998) for Medicare, and $7,572 (27,719) vs $787 (3,797) for Medicaid (P < 0.001). For patients with severe disease in Medicaid, 16.5% and 60.1% had inpatient and emergency department (ED) visits, respectively, vs 10.3% and 26.5% Commercial vs 10.6% and 24.6% Medicare. Mean [SD] flares per year in the baseline period increased from 2.5 [1.7] in mild to 4.6 [1.9] in severe for Commercial, 3.2 [1.9] to 5.0 [2.1] for Medicare, and 2.0 [1.6] to 4.5 [2.0] for Medicaid. CONCLUSIONS: Patients with severe SLE experienced more comorbidities, flares, and utilization/costs. Outpatient costs were the largest driver of all-cause costs for Commercial and Medicare (and Medicaid for mild to moderate SLE). Medicaid beneficiaries had the highest rate of severe SLE, highest use of ED and inpatient services, and highest oral corticosteroid and opioid use but the lowest utilization of disease-modifying treatments. Results demonstrate an unmet need in SLE treatment, especially among patients with moderate to severe disease or Medicaid coverage. DISCLOSURES: This study was funded by AstraZeneca. Drs Wu and Bryant are current employees of AstraZeneca and may own stock and/or options. At the time of the study, Ms Perry and Mr Tkacz were employed by IBM Watson Health, which received funding from AstraZeneca to conduct this study.

Patterns of rescue and maintenance therapy claims surrounding a clinical encounter for an asthma exacerbation.

BACKGROUND: A "window of opportunity" has been proposed where anti-inflammatory therapy administration in response to symptoms could prevent exacerbation. OBJECTIVE: To evaluate rescue and maintenance therapy claims surrounding a severe asthma exacerbation serious enough to require a face-to-face clinical encounter. METHODS: Merative MarketScan research databases (US administrative claims 2011 to 2017) were analyzed for patients aged ≥4 years, with an asthma diagnosis code, who filled short-acting ß2-agonist (SABA) and Global Initiative for Asthma Steps 3 to 5 maintenance therapies. Patients were indexed on a random SABA claim and had 12 months' continuous health plan eligibility pre- and post-index. Serious exacerbations were severe exacerbations requiring systemic corticosteroids prescribed from an outpatient clinic, urgent care or emergency department, or hospitalization for asthma. SABA and maintenance claims 30 days pre- and post-event were analyzed. RESULTS: Of 319,342 patients (30% children 4 to 11 years; 70% adults or adolescents ≥12 years), 27.2% of children and 16.8% of adolescents or adults experienced ≥ 1 serious exacerbation (unadjusted odds ratio [OR], 1.85 [95% confidence interval, 1.81-1.88]). In the 30 days pre-event, 42.6% filled ≥1 SABA (children: 44.3%; adolescents or adults: 41.5%; OR, 1.12 [1.09-1.16]) and 57.4% filled maintenance (children: 59.0%; adolescents or adults: 56.3%; OR, 1.12 [1.08-1.15]). In the 30 days post-event, 61.4% filled SABA (children: 69.7%; adolescents or adults: 55.6%; OR, 1.84 [1.78-1.90]) and 94.8% filled maintenance (children: 98.6%; adolescents or adults: 92.2%; OR, 6.09 [5.45-6.81]). CONCLUSION: Many patients treated as having moderate-to-severe asthma escalate SABA claims before a serious exacerbation, but approximately 40% have no anti-inflammatory maintenance fill, highlighting a "window of opportunity" to prevent exacerbations using inhaled corticosteroids concomitantly with SABA as rescue.

Real-world experience of CAR T-cell therapy in older patients with relapsed/refractory diffuse large B-cell lymphoma.

The emergence of chimeric antigen receptor (CAR) T-cell therapy has changed the treatment landscape for diffuse large B-cell lymphoma (DLBCL); however, real-world experience reporting outcomes among older patients treated with CAR T-cell therapy is limited. We leveraged the 100% Medicare fee-for-service claims database and analyzed outcomes and cost associated with CAR T-cell therapy in 551 older patients (aged ≥65 years) with DLBCL who received CAR T-cell therapy between 2018 and 2020. CAR T-cell therapy was used in third line and beyond in 19% of patients aged 65 to 69 years and 22% among those aged 70 to 74 years, compared with 13% of patients aged ≥75 years. Most patients received CAR T-cell therapy in an inpatient setting (83%), with an average length of stay of 21 days. The median event-free survival (EFS) following CAR T-cell therapy was 7.2 months. Patients aged ≥75 years had significantly shorter EFS compared with patients aged 65 to 69 and 70 to 74 years, with 12-month EFS estimates of 34%, 43%, and 52%, respectively (P = .002). The median overall survival was 17.1 months, and there was no significant difference by age groups. The median total health care cost during the 90-day follow-up was $352 572 and was similar across all age groups. CAR T-cell therapy was associated with favorable effectiveness, but the CAR T-cell therapy use in older patients was low, especially in patients aged ≥75 years, and this age group had a lower rate of EFS, which illustrates the unmet need for more accessible, effective, and tolerable therapy in older patients, especially those aged ≥75 years.

Disparities in Lung Cancer: A Targeted Literature Review Examining Lung Cancer Screening, Diagnosis, Treatment, and Survival Outcomes in the United States.

BACKGROUND: Although incidence and mortality of lung cancer have been decreasing, health disparities persist among historically marginalized Black, Hispanic, and Asian populations. A targeted literature review was performed to collate the evidence of health disparities among these historically marginalized patients with lung cancer in the U.S. METHODS: Articles eligible for review included 1) indexed in PubMed®, 2) English language, 3) U.S. patients only, 4) real-world evidence studies, and 5) publications between January 1, 2018, and November 8, 2021. RESULTS: Of 94 articles meeting selection criteria, 49 publications were selected, encompassing patient data predominantly between 2004 and 2016. Black patients were shown to develop lung cancer at an earlier age and were more likely to present with advanced-stage disease compared to White patients. Black patients were less likely to be eligible for/receive lung cancer screening, genetic testing for mutations, high-cost and systemic treatments, and surgical intervention compared to White patients. Disparities were also detected in survival, where Hispanic and Asian patients had lower mortality risks compared to White patients. Literature on survival outcomes between Black and White patients was inconclusive. Disparities related to sex, rurality, social support, socioeconomic status, education level, and insurance type were observed. CONCLUSIONS: Health disparities within the lung cancer population begin with initial screening and continue through survival outcomes, with reports persisting well into the latter portion of the past decade. These findings should serve as a call to action, raising awareness of persistent and ongoing inequities, particularly for marginalized populations.

Overuse of corticosteroids in patients with immune thrombocytopenia (ITP) between 2011 and 2017 in the United States.

Corticosteroids (CSs) are standard first-line therapy for immune thrombocytopenia (ITP). Prolonged exposure is associated with substantial toxicity; thus guidelines recommend avoidance of prolonged CS treatment and early use of second-line therapies. However, real-world evidence on ITP treatment patterns remains limited. We aimed to assess real-world treatment patterns in patients with newly-diagnosed ITP, using two large US healthcare databases (Explorys and MarketScan) between January 1, 2011 and July 31, 2017. Adults with ITP, ≥12 months of database registration prior to diagnosis, ≥1 ITP treatment, and ≥1 month enrollment following initiation of first ITP treatment were included (n = 4066 Explorys; n = 7837 MarketScan). Information on lines of treatment (LoTs) was collected. As expected, CSs were the most common first-line treatment (Explorys, 87.9%; MarketScan, 84.5%). However, CSs remained by far the most common treatment (Explorys ≥77%; MarketScan ≥85%) across all subsequent LoTs. Second-line treatments such as rituximab (12.0% Explorys; 24.5% MarketScan), thrombopoietin receptor agonists (11.3% Explorys; 15.6% MarketScan), and splenectomy (2.5% Explorys; 8.1% MarketScan) were used much less frequently. CS use is widespread in the US in patients with ITP across all LoTs. Quality improvement initiatives are needed to reduce CS exposure and bolster use of second-line treatments.

Prompt initiation of triple therapy following hospitalization for a chronic obstructive pulmonary disease exacerbation in the United States: An analysis of the PRIMUS study.

BACKGROUND: Severe exacerbations requiring hospitalization contribute a substantial portion of the morbidity and costs of chronic obstructive pulmonary disease (COPD). Triple therapy (inhaled corticosteroid + long-acting ß-agonist + long-acting muscarinic antagonist) is a recommended option for patients who experience recurrent COPD exacerbations or persistent symptoms. Few real-world studies have specifically examined the effect of prompt initiation of triple therapy, specifically among patients hospitalized for a COPD exacerbation. OBJECTIVE: To assess whether prompt initiation of triple therapy following a severe COPD exacerbation was associated with lower risk of subsequent exacerbations and lower health care use and costs and the effects of each 30-day delay of initiation. METHODS: Adults aged 40 years or older with COPD were identified in the Merative MarketScan Databases between January 1, 2010, and December 31, 2019, and were required to meet the following criteria: open or closed triple therapy (date of first closed prescription or last component of open=index treatment date), more than 1 inpatient admission with a primary COPD diagnosis (ie, severe exacerbation) in the prior 12 months (index exacerbation), 12 months of continuous enrollment before (baseline) and after (follow-up) index exacerbation, and absence of select respiratory diseases and cancer. Patients were stratified based on timing of open or closed triple therapy after the index exacerbation: prompt (≤30 days), delayed (31-180 days), or very delayed (181-365 days). Multivariable regression controlled for baseline characteristics (age, sex, insurance type, index year, comorbidities, prior treatment, and prior exacerbations) and estimated the odds of subsequent exacerbations, change in the number of exacerbations, and change in health care costs during 12-month follow-up associated with each 30-day delay of triple therapy initiation. RESULTS: A total of 6,772 patients met inclusion criteria (2,968 [43.8%] prompt, 1,998 [29.5%] delayed, and 1,806 [26.7%] very delayed). The adjusted odds of any exacerbation and a severe exacerbation during 12-month follow-up increased by 13% (odds ratio [95% CI]: 1.13 [1.11-1.15]) and 10% (1.10 [1.08-1.12]), respectively, for each 30-day delay in triple therapy initiation, and the mean number of exacerbations increased by 5.4% (95% CI = 4.7%-6.1%). There was a 3.0% increase (95% CI = 2.2%-3.8%) in mean all-cause costs and a 3.7% increase (95% CI = 2.9%-4.6%) in total COPD-related costs for each 30-day delay of triple therapy initiation. CONCLUSIONS: Longer delays in triple therapy initiation after a COPD hospitalization result in greater risk of subsequent exacerbations and higher health care resource use and costs. Adequate post-discharge follow-up care and earlier consideration of triple therapy may improve clinical and economic outcomes among patients with COPD. DISCLOSURES: This study was funded by AstraZeneca. Dr Evans is employed by Merative, formerly IBM Watson Health, and Mr Tkacz was employed by IBM Watson Health at the time of this study; Merative/IBM Watson Health received funding from AstraZeneca to conduct this study. Mr Pollack, Dr Staresinic, Dr Feigler, and Dr Patel are employed by AstraZeneca. Dr Touchette, Dr Portillo, and Dr Strange are paid consultants to AstraZeneca. Dr Strange also participates in research grants paid to the Medical University of South Carolina by AstraZeneca, CSA Medical, and Nuvaira, and is a consultant to GlaxoSmithKline, Morair, and PulManage regarding COPD.

Systemic Corticosteroid-related Adverse Outcomes and Health Care Resource Utilization and Costs Among Patients with Chronic Rhinosinusitis with Nasal Polyposis.

PURPOSE: Nasal polyps (NPs) develop in 20% to 30% of patients with chronic rhinosinusitis. Severe forms of chronic rhinosinusitis with nasal polyposis (CRSwNP) may be treated with systemic corticosteroids (SCSs), which increase the risk for adverse clinical outcomes. This study compared the incidence of SCS-related adverse outcomes and health care resource utilization and costs between patients with CRSwNP who had SCS exposure and those who did not have SCS exposure. METHODS: This retrospective cohort study used health care claims data from adult patients with CRSwNP identified in the IBMⓇ MarketScanⓇ Databases between January 2003 and June 2019. The first SCS prescription date in SCS users or a matched date in SCS nonusers (controls) represented the index date. Enrollment for ≥1 year before and after the index date was required. SCS-related adverse outcomes and costs were compared between all SCS users and controls, and among subgroups of patients who had claims for 1-3 and ≥4 SCS prescriptions in the 12-month postindex period. Comparisons were also made among SCS users and controls who previously had and did not have NP surgery, and those with and without comorbid asthma. Inverse probability of treatment weights was applied to all comparisons, which were evaluated for a variable-length follow-up period. FINDINGS: SCS users (n = 37,740) had a greater risk for any adverse outcome than controls (n = 7032) (incidence rate ratio [IRR] = 1.10; 95% CI, 1.05-1.16). The risk for adverse outcomes was highest in the subgroups that did not have NP surgery and that had ≥4 SCS claims (n = 2993) versus controls who did not have NP surgery (n = 5078) (IRR = 1.30; 95% CI, 1.18-1.44). Similarly, patients with asthma and ≥4 SCS claims (n = 4195) had a greater risk for SCS-related outcomes versus controls with asthma (n = 1226) (IRR = 1.36; 95% CI, 1.19-1.55). SCS users incurred 60% higher all-cause costs versus non-SCS users (P < 0.001). IMPLICATIONS: In patients with CRSwNP, SCS use was associated with a higher risk for adverse outcomes and with increased health care costs compared with controls without SCS exposure. Alternative treatment strategies that avoid and/or reduce SCS use may decrease health care costs and the risk for adverse outcomes among patients with CRSwNP.

Development of a claims-based flare algorithm for systemic lupus erythematosus.

OBJECTIVE: To develop a claims-based algorithm identifying systemic lupus erythematosus (SLE) flares using a linked claims-electronic medical record (EMR) dataset. METHODS: This study was a retrospective analysis of linked administrative claims and EMR data spanning 1 January 2003 to 31 March 2019. Included were adult SLE patients with at least 12 months of continuous enrollment in claims data, 12 months of clinical activity in EMR, and an absence of malignancies excluding basal and squamous cell carcinoma. Patient follow-up was divided into 30-day windows, and a proxy SLEDAI-2K score based on the EMR data was calculated for each 30-day period. A flare was defined as an increase of at least 4 from the baseline score. A series of potential flare predictor variables identified in claims were based on a combination of established variables from a previous algorithm, with the addition of other SLE-related indicators based on clinical input. Logistic regression models were built to predict monthly SLE flares. RESULTS: Inclusion criteria identified 2427 patients. Results from a logistic model with forward selection capping the number of variables at 10 performed well with a c-statistic of 0.76 and a Brier score of 0.07. The top five predictors were any inpatient admission (OR = 4.76), outpatient office visit (OR = 3.04), MRI (OR = 2.26), ER visit (OR = 2.25), and number of rheumatology visits (OR = 1.75); p < .01 for all. CONCLUSIONS: The final algorithm shows promise in providing an alternative and more streamlined way for identifying likely flares in administrative claims data that will advance the study of SLE within the context of flares.

The use of short-acting bronchodilators and cost burden of asthma across Global Initiative for Asthma-based severity levels: Insights from a large US commercial and managed Medicaid population.

BACKGROUND: Despite the availability of effective treatments, patients with asthma, regardless of severity, remain at risk of severe exacerbations resulting in significant burden to patients, the health care system, and insurance providers. OBJECTIVE: To examine severe exacerbations, treatment patterns, health care resource utilization (HCRU), and costs across all asthma severities. METHODS: In this retrospective study, patients aged 4 years and older filling 1 short-acting (ß2-agonist (SABA) and at least 1 maintenance fill or at least 2 SABAs with or without maintenance fills were identified from administrative claims data from the IBM MarketScan Commercial and IBM MarketScan Multistate Medicaid Research databases (January 2010 to December 2017). Patients were indexed on a random SABA fill (2011-2016) and had 12 months of continuous eligibility pre-index and post-index. Patients were classified into Global Initiative for Asthma (GINA) 2018 severity steps and by asthma control, as measured by SABA fill use in the 12 months pre-index: low (1 SABA fill per year), medium (2-3 SABA fills per year), and high (≥ 4 SABA fills per year); well controlled, not well controlled, and very poorly controlled, respectively. Severe asthma exacerbation events, health care costs, and asthma-related HCRU and costs were assessed relative to asthma severity and asthma control post-index. RESULTS: Of 1,005,522 patients, 50.3% filled GINA Step 1; 19.7% GINA Step 2; 10.9% GINA Step 3; and 19.1% GINA Steps 4-5 treatments. Overall, 953,337 severe exacerbation events occurred (approximately 0.95 events per patient), equating to 0.96, 0.67, 0.83, and 1.28 events per patient for patients filling GINA Step 1 through Steps 4-5, respectively. GINA Step 1 had the highest proportion of patients experiencing at least 1 event (57.0%), followed by GINA Steps 4-5 (55.2%), GINA Step 3 (45.0%), and GINA Step 2 (41.9%) treatments (P < 0.05). For GINA Step 1, 64.4% of well-controlled patients experienced at least 1 exacerbation event vs 50.4% of not well-controlled and 53.0% of very poorly controlled patients (P < 0.05). For patients filling GINA Step 2-5 treatments, a greater proportion of very poorly controlled patients experienced at least 1 exacerbation event vs well-controlled patients (P < 0.05). The average total annual health care cost per patient was $7,148 and total annual asthma-related costs were $1,741. Each additional SABA fill was associated with a 26.0%, 10.8%, and 34.6% increase in incidence of total exacerbations, all-cause costs, and asthma-related costs, respectively (P < 0.05). CONCLUSIONS: In this real-world database study, increased SABA fills and occurrence of exacerbations were correlated and associated with higher all-cause and asthma-related costs across all severities. New treatment paradigms, particularly for rescue therapies, are warranted to improve clinical and cost outcomes in these patients. DISCLOSURES: This analysis was funded by AstraZeneca. Michael Pollack, Hitesh Gandhi, and Ileen Gilbert are employees and stockholders of AstraZeneca and contributed to the design and conduct of the study. AstraZeneca was given an opportunity to review the final version of the manuscript. At the time of the study, Joseph Tkacz was an employee of IBM Watson Health, which received funding from AstraZeneca to conduct this study. Miguel Lanz has received research funding from AstraZeneca, Optinose, and Regeneron and consulting fees and honoraria from ALK, Amgen, AstraZeneca, Novartis, Sanofi, and Regeneron. Njira Lugogo received consulting fees for advisory board participation from Amgen, AstraZeneca, Genentech, GlaxoSmith-Kline, Novartis, Regeneron, Sanofi, and Teva; honoraria for nonspeaker's bureau presentations from GlaxoSmithKline and AstraZeneca; and travel support from AstraZeneca. Her institution received research support from Amgen, AstraZeneca, Avillion, Gossamer Bio, Genentech, GlaxoSmithKline, Regeneron, Sanofi, and Teva.

Clinical and economic burden of uncontrolled severe noneosinophilic asthma.

OBJECTIVES: To quantify the clinical and economic burden of patients with severe asthma with low blood eosinophil counts (BECs) untreated with biologics. STUDY DESIGN: Retrospective cohort study in IBM MarketScan claims database. METHODS: Patients 12 years and older with severe asthma with BEC data were selected between January 1, 2013, and June 30, 2018 (date of the most recent BEC was used as the index date). Inclusion criteria were (1) presence of BEC laboratory test result, (2) continuous enrollment for 12 months preceding and following the index date, (3) meeting the Healthcare Effectiveness Data and Information Set definition of persistent asthma, (4) meeting the Global Initiative for Asthma definition of severe asthma, and (5) an absence of biologic treatment, other respiratory diagnoses, and malignancies 12 months preceding and following the index date. Asthma exacerbations, levels of disease control, and all-cause and asthma-related health care costs were reported during the 12-month postindex period for patients with a BEC less than 300 cells/mcL. RESULTS: The sample included 8073 patients with severe asthma; 78% (n = 6260) presented with a BEC less than 300 cells/mcL. Mean (SD) age of the sample was 54.8 (14.2) years; 64% were female. Eighteen percent of patients had an asthma exacerbation; 19% had either uncontrolled or suboptimally controlled asthma based on the frequency of asthma-related hospital admissions, emergency department visits, or corticosteroid prescription fills. One-year all-cause and asthma-related total health care costs were $25,845 and $2802, respectively. Patients with suboptimally controlled and uncontrolled asthma spent $1471 and $3872 more, respectively, on asthma-related claims compared with patients with controlled asthma. CONCLUSIONS: Among patients with severe asthma with low eosinophils untreated with biologics, there is a high burden of disease among those who have suboptimal disease control, highlighting an unmet need in severe asthma treatment.

PRIMUS - Prompt Initiation of Maintenance Therapy in the US: A Real-World Analysis of Clinical and Economic Outcomes Among Patients Initiating Triple Therapy Following a COPD Exacerbation.

PURPOSE: Patients with chronic obstructive pulmonary disease (COPD) may experience moderate (requiring outpatient care) or severe (requiring hospitalization) disease exacerbations. Guidelines recommend escalation from dual to triple therapy (inhaled corticosteroid + long-acting beta agonist + long-acting muscarinic antagonist) after two moderate or one severe exacerbation in a year. This study examined whether prompt initiation of triple therapy lowers risk of future exacerbations and reduces healthcare costs, compared to delayed/very delayed triple therapy after an exacerbation. PATIENTS AND METHODS: This retrospective observational study of US healthcare claims included patients ≥40 years old with COPD who initiated triple therapy (1/1/2011-3/31/2020) after ≥2 moderate or ≥1 severe exacerbation in the prior year. The earliest of the second moderate or first severe exacerbation was the index date. Patients were stratified by triple therapy timing: prompt (≤30 days post-index), delayed (31-180 days), very delayed (181-365 days). COPD exacerbations, all-cause and COPD-related healthcare utilization and costs were assessed during 12 months post-index (follow-up). Multivariable regression estimated the effect of each 30-day delay in triple therapy on the odds of exacerbations, number of exacerbations, and costs during follow-up, controlling for patient characteristics. RESULTS: A total of 24,770 patients were included: 7577 prompt, 9676 delayed, 7517 very delayed. Each 30-day delay of triple therapy was associated with 11% and 7% increases in the odds of any exacerbation and a severe exacerbation, respectively (odds ratio [95% CI]: 1.11 [1.10-1.13] and 1.07 [1.05-1.08]), a 4.3% (95% CI: 3.9-4.6%) increase in the number of exacerbations, a 1.8% (95% CI: 1.3-2.3%) increase in all-cause costs, and a 2.1% (95% CI: 1.6-2.6%) increase in COPD-related costs during follow-up. CONCLUSION: Promptly initiating triple therapy after two moderate or one severe exacerbation is associated with decreased morbidity and economic burden in COPD. Proactive disease management may be warranted to prevent future exacerbations and lower costs among patients with COPD.

Demographics, Treatment Patterns, and Morbidity in Patients with Exercise-Induced Bronchoconstriction: An Administrative Claims Data Analysis.

PURPOSE: Exercise-induced bronchoconstriction (EIB) is generally treated with short-acting ß2-agonists (SABA) before exercising, to prevent symptoms. Real-world data on treatments and outcomes for patients with EIB alone (EIBalone), or with asthma (EIBasthma), in the USA are limited. This study compared demographics, treatment patterns, morbidity, and costs of treating EIB between these two groups of patients. PATIENTS AND METHODS: Administrative claims from US IBM® MarketScan® Research databases were analyzed retrospectively. Patients aged ≥4 years filling a SABA claim between 1/1/2011 and 12/31/2016 were evaluated. Patients were indexed on a random SABA claim and required to have 12 months' continuous eligibility pre- and post-index, ≥1 maintenance medication and/or SABA fill post-index, and were designated EIBalone or EIBasthma according to diagnostic codes (EIB only or EIB plus asthma, respectively). Descriptive statistics were used. RESULTS: In total, 13,480 patients had EIBalone and 14,862 had EIBasthma. Compared with EIBasthma, the EIBalone group was older (mean[SD] 20.4[13.6] vs 17.8[13.6] years), had more females (60.7% vs 54.7%), and filled fewer SABA claims (1.9[1.4] vs 2.5[2.2]) (all p<0.001). A smaller proportion of patients in the EIBalone than EIBasthma group had maintenance therapy claims (79.9% vs 90.6%, p<0.001). The EIBalone group also had a lower proportion of patients with oral or injectable corticosteroid claims (29.4% vs 32.0%) and asthma and/or EIB-related emergency department (1.0% vs 13.0%) or outpatient visits (65.1% vs 72.3%; all p<0.0001). Annual days' supply of oral corticosteroids was similar between groups (mean[SD] EIBalone: 20.7[30.8] vs EIBasthma: 19.8[28] days). CONCLUSION: Individuals with EIBalone or EIBasthma demonstrate considerable morbidity. New treatment paradigms may be needed to optimize outcomes for both patient groups.

Association of physician specialty with psoriatic arthritis treatment and costs.

OBJECTIVES: To describe current psoriatic arthritis treatment and costs by provider specialty using real-world claims data. STUDY DESIGN: Observational, retrospective cohort study of patients in the IBM MarketScan Commercial and supplemental Medicare databases. METHODS: Eligible patients had newly diagnosed psoriatic arthritis with 12 months of continuous enrollment pre- and post index date for their initial claim. Patients were assigned to 1 of 5 provider specialty cohorts. During the 1-year follow-up period, we collected psoriatic arthritis treatment agent and regimen type and total annual medical and health care costs. We used multivariate regression models to determine the conditional associations of provider specialty with costs. RESULTS: A total of 2132 patients with incident psoriatic arthritis qualified. Most providers were rheumatologists (n = 1365; 64%). Rheumatologists commonly prescribed oral small molecules (methotrexate, 56.3% of prescriptions; sulfasalazine, 8.6%; apremilast, 7.0%) as the index therapy, whereas 23.8% of prescriptions were for tumor necrosis factor inhibitors (adalimumab, 14.2%; etanercept, 7.9%; and infliximab, 1.7%). Compared with other specialists, dermatologists prescribed biologics and other specialty drugs more frequently-adalimumab (32.7%), apremilast (14.3%), etanercept (11.6%), and ustekinumab (8.8%)-and methotrexate less frequently (30.6%). The greatest unadjusted median health care costs were observed among dermatologists ($45,548) compared with rheumatologists ($30,411), primary care physicians ($29,927), rheumatologists/dermatologists ($27,393), and other specialists ($27,774). However, after adjusting for patient-level factors, multivariate regression analyses found that provider specialty was not associated with higher health care costs. CONCLUSIONS: In patients with newly diagnosed psoriatic arthritis, physician specialty was associated with different medication choices but not costs.