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.

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.

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.

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.

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.

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.

Estimate of Refractory Reflux Disease in the United States: Economic Burden and Associated Clinical Characteristics.

GOALS: To update the estimate of the prevalence of refractory gastroesophageal reflux disease (GERD) in the United States, and to assess the clinical and economic differences between patients with and without refractory GERD. BACKGROUND: GERD affects 18% to 28% of the US population, with nearly 40% of GERD patients presenting with refractory symptoms despite ongoing therapy. STUDY: Retrospective analysis of the IBM MarketScan databases between January 2011 and June 2018. Inclusion criteria were prescription fill and subsequent refill of a proton pump inhibitor or H2-receptor antagonist (earliest claim=index date), diagnosis of GERD 60 days preceding and/or following index, continuous insurance enrolment for 12 months preceding/following index, and absence of prior GERD diagnosis or GERD medication. We derived refractory GERD symptom scores for all patients on the basis of a previously published algorithm. Health care costs and comorbidities were assessed for all patients and compared between those with and without refractory GERD. RESULTS: In total, 399,017 GERD patients qualified for the study; 103,654 (26%) met our definition of having indications of refractory GERD symptoms. Patients with refractory GERD symptoms reported significantly higher rates of hiatal hernia (25.1% vs. 5.9%), esophagitis (37.3% vs. 11.8%), esophageal stricture (11.3% vs. 1.5%), and dysphagia (26.8% vs. 7.1%; P<0.01 for each). The refractory GERD symptoms cohort incurred ~$10,000 greater health care costs per patient per year compared with patients without refractory GERD symptoms ($26,057±$58,948 vs. $15,285±$39,307; P<0.01). CONCLUSIONS: Refractory GERD symptoms were associated with a substantial increase in health care costs. Treatments aimed at improving refractory GERD symptoms may mitigate symptom burden, potentially reducing health care expenditure.

Clinical and economic burden of severe asthma among US patients treated with biologic therapies.

BACKGROUND: Patients with severe asthma may remain uncontrolled despite biologic therapy in addition to standard therapy, but this disease burden has not been quantified. OBJECTIVE: To estimate the clinical and economic burden in a US national sample. METHODS: Patients who have severe asthma with indicated biologic treatment (earliest use = index date) were selected from the MarketScan database between January 1, 2013, and June 30, 2018. Inclusion criteria were continuous enrollment for 12 months postindex with a minimum of 2 biologic fills, greater than or equal to 12 years of age, evidence of medium- to high-dose inhaled corticosteroids and long-acting ß-agonist combination before the index, and absence of other respiratory diagnoses and malignancies. Disease exacerbations (used to classify asthma control), health care costs, and treatment characteristics were reported during the 12-month postindex period. RESULTS: The sample included 3262 biologic patients; 88% with anti-immunoglobulin E therapy (omalizumab) and 12% non-anti-immunoglobulin E (reslizumab, mepolizumab, benralizumab). The mean age was 49 (±15) years; 64% were women. Prescriptions included inhaled corticosteroids and long-acting ß-agonist (82%), systemic corticosteroids (76%), and leukotriene receptor antagonists (68%). Notably, 63% of patients presented greater than or equal to 1 asthma exacerbation (mean 1.3 per patient/year). Furthermore, 35% of patients were categorized as having controlled asthma, whereas 28% were suboptimally controlled and 29% were uncontrolled. Patients with uncontrolled disease had higher all-cause and asthma-related costs ($69,206 and $45,693, respectively) than patients with suboptimally controlled ($59,407 and $40,793, respectively) or controlled disease ($53,083 and $38,393, respectively). Furthermore, 62% of newly treated patients were persistent with their index biologic. CONCLUSION: Biologic therapies are effective in reducing exacerbations, but a substantial proportion of patients with severe asthma treated with current biologics continue to experience uncontrolled disease, highlighting a remaining unmet need for patients with severe uncontrolled asthma.

Real-world evidence costs of allergic rhinitis and allergy immunotherapy in the commercially insured United States population.

OBJECTIVE: To assess total and allergic rhinitis (AR)-related healthcare costs among AR patients residing in the United States with a focus on patients persisting with AIT. METHODS: AR patients were identified in the IBM MarketScan database between 1 January 2014 to 31 March 2017. Patients receiving allergy immunotherapy (AIT) were identified with relevant billing codes (earliest AIT claim = index date); non-AIT patients were identified with claims containing a diagnosis code for AR (earliest AR claim = index date). AIT patients reaching 25+ injection claims were analyzed as a separate maintenance cohort. All patients were required to have continuous enrollment for 12 months preceding and following index. RESULTS: A total of 2,334,530 AR patients were included; 103,207 had at least 1 AIT claim, with 45,279 (43.9%) of these patients reaching maintenance, and 24,640 AIT patients (23.9%) never presenting a single injection claim. Compared to non-AIT patients, patients initiating AIT presented higher rates of baseline comorbidities, including asthma (30.1% vs. 7.5%) and conjunctivitis (21.7% vs. 4.4%). During the follow-up period, patients reaching the maintenance phase of AIT incurred lower total costs than the overall AIT cohort ($10,431±$16,606 vs. $11,612±$24,797), and also presented lower follow-up hospitalization costs ($698±$7,248 vs. $1,281±$12,991) and total medical costs ($7950±$13,844 vs. $8989±$22,019). CONCLUSIONS: Continued efforts are needed to increase patient awareness of available options and adherence to AIT, along with reducing wastage. Despite AIT patients presenting fairly progressed disease at the time of treatment initiation, this therapy remains an economical treatment option, as it was not accompanied by substantial increases in overall healthcare expenditure, and may promote positive societal impacts beyond the direct medical costs.What is known on this topicThe prevalence of allergic diseases has increased over the past 50 years and affects between 10-30% of the world population.Allergic rhinitis (AR) poses a significant economic burden in the form of both direct and indirect costsAllergy immunotherapy (AIT) is the only treatment option able to modify the underlying course of the disease.What this study addsSpecific all-cause and AR-related healthcare costs decreased following the initiation of AIT among patients diagnosed with AR, with the largest decreases observed among AIT patients reaching the maintenance phase of treatment, while non-AIT patients showed increases in all categories assessed over a similar follow-up period.Cost decreases among AIT patients were observed despite increased levels of comorbidities compared to non-AIT patients, as the AIT cohort presented elevated rates of atopic dermatitis (7.1% vs. 2.7%), conjunctivitis (21.7% vs. 4.4%), asthma (30.1% vs. 7.5%), and chronic sinusitis (22.6% vs. 4.9%).An analysis of patients' index subcutaneous AIT consultation revealed substantial variability in the initial treatment costs, with nearly 20% of paid amounts exceeding $1,000; given nearly 1 in 4 AIT patients who get AIT mixed never came back for their first injection, this highlights an opportunity to target frontloaded billing practices and the timing of mixing/injection as an area to minimize healthcare waste.

Variations in breast cancer surgical treatment and timing: determinants and disparities.

PURPOSE: To describe clinical and non-clinical factors associated with receipt of breast conserving surgery (BCS) versus mastectomy and time to surgical intervention. METHODS: Cross-sectional retrospective study of January 1, 2012 through March 31, 2018 data from the IBM MarketScan Commercial Claims and Encounter and Medicare Supplemental Databases. Area Health Resource Files provided non-clinical characteristics and sociodemographic data. Eligibility: Female sex, claim(s) with ICD-9-CM or ICD-10-CM diagnosis of non-metastatic invasive breast cancer, > 6 months of continuous insurance pre- and post-diagnosis, evidence of BCS or mastectomy following initial ICD9/10 code diagnosis. Logistic and quantile multivariable regression models assessed the association between clinical and non-clinical factors and the outcome of BCS and time to surgery, respectively. RESULTS: A total of 53,060 women were included in the study. Compared to mastectomy, BCS was significantly associated with older age (ORs: 1.54 to 2.99, 95% CIs 1.45 to 3.38; ps < .0001) and higher community density of medical genetics (OR: 5.88, 95% CIs 1.38 to 25.00; p = 0.02) or obstetrics and gynecology (OR: 1.13, 95% CI 1.02 to 1.25; p = .02) physicians. Shorter time-to-BCS was associated with living in the South (-2.96, 95% CI -4.39 to -1.33; p < .0001). Longer time-to-BCS was associated with residence in more urban (4.18, 95% CI 0.08 to 8.29; p = 0. 05), educated (9.02, 95% CI 0.13 to 17.91; p = 0.05), or plastic-surgeon-dense (4.62, 95% CI 0.50 to 8.73; p = 0.03) communities. CONCLUSIONS: Clinical and non-clinical factors are associated with adoption of BCS and time to treatment, suggesting opportunities to ensure equitable and timely care.

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.

The Effect of Dose Escalation on the Cost-Effectiveness of Etanercept and Adalimumab with Methotrexate Among Patients with Moderate to Severe Rheumatoid Arthritis.

BACKGROUND: Patients with moderate to severe rheumatoid arthritis (RA) occasionally increase their doses of tumor necrosis factor (TNF) inhibitors, especially the monoclonal antibody origin drugs such as adalimumab and infliximab, after inadequate response to the initial dose. Previous studies have evaluated the cost-effectiveness of various sequences of treatment for RA in the United States but have not considered the effect of dose escalation. OBJECTIVE: To assess the cost-effectiveness of etanercept and adalimumab by incorporating the effect of dose escalation in moderate to severe RA patients. METHODS: We adapted the open-source Innovation and Value Initiative - Rheumatoid Arthritis model, version 1.0 to separately simulate the magnitude and time to dose escalation among RA patients taking adalimumab plus methotrexate or etanercept plus methotrexate from a societal perspective and lifetime horizon. An important assumption in the model was that dose escalation would increase treatment costs through its effect on the number of doses but would have no effect on effectiveness. We estimated the dose escalation parameters using the IBM MarketScan Commercial and Medicare Supplemental Databases. We fit competing parametric survival models to model time to dose escalation and used model diagnostics to compare the fit of the competing models. We measured the magnitude of dose escalation as the percentage increase in the number of doses conditional on dose escalation. Finally, we used the parameterized model to simulate treatment sequences beginning with a TNF inhibitor (adalimumab, etanercept) followed by nonbiologic treatment. RESULTS: In baseline models without dose escalation, the incremental cost per quality-adjusted life-year of the etanercept treatment sequence relative to the adalimumab treatment sequence was $85,593. Incorporating dose escalation increased treatment costs for each sequence, but costs increased more with adalimumab, lowering the incremental cost-effectiveness ratio to $9,001. At willingness-to-pay levels of $100,000, the etanercept sequence was more cost-effective compared with the adalimumab sequence, with probability 0.55 and 0.85 in models with and without dose escalation, respectively. CONCLUSIONS: Dose escalation has important effects on cost-effectiveness and should be considered when comparing biologic medications for the treatment of RA. DISCLOSURES: Funding for this study was contributed by Amgen. When this work was conducted, Incerti and Jansen were employees of Precision Health Economics, which received financial support from Amgen. Maksabedian Hernandez, Collier, Gharaibeh, and Stolshek were employees and stockholders of Amgen, and Tkacz and Moore-Schiltz were employees of IBM Watson Health, which received financial support from Amgen. Some of the results of this work were previously presented as a poster at the 2019 AMCP Managed Care & Specialty Pharmacy Annual Meeting, March 25-28, 2019, in San Diego, CA.

Psoriatic arthritis treatment patterns and costs among pharmacologic treatment-naïve patients.

OBJECTIVES: Pharmacologic treatment for psoriatic arthritis (PsA) includes traditional oral small molecules (OSMs), tumor necrosis factor inhibitors (TNFis), and newer oral therapies such as a phosphodiesterase-4 (PDE4) inhibitor and a Janus kinase inhibitor. We aimed to describe treatment patterns and health care costs for treatment-naïve patients with active PsA initiating pharmacologic treatment. STUDY DESIGN: This was an observational, retrospective study. METHODS: We assessed treatment patterns and health care costs from the IBM MarketScan Research databases. We calculated costs during the 12-month follow-up period for inpatient and outpatient medical health care, including outpatient prescription costs. RESULTS: A total of 3491 patients were identified for the study. Incident therapies included OSMs methotrexate (58.3%), sulfasalazine (9.8%), hydroxychloroquine (2.3%), and other OSMs (1.9%); TNFis adalimumab (12.3%), etanercept (8.6%), infliximab (1.9%), and other TNFis (1.4%); and the PDE4 inhibitor apremilast (2.6%). Persistence ranged from 15.2% to 34.6% with OSM monotherapy and from 42.9% to 58.2% with TNFi monotherapy. Percentage of patients with a gap of at least 60 days in therapy ranged from 42.9% to 48.5% with OSMs and from 17.9% to 29.9% with TNFis. Mean first-line unadjusted per-patient per-month total health care costs for OSMs ranged from $1029 to $1456 and mean total health care costs ranged from $19,173 to $25,013. Mean unadjusted per-patient per-month total health care costs for TNFis ranged from $4203 to $7063 and mean total health care costs ranged from $45,635 to $60,933. CONCLUSIONS: Although patients using OSMs had generally lower total health care costs, they also had the highest rates of treatment modifications such as low persistence and medication gaps of at least 60 days.

Systemic Corticosteroid-Related Complications and Costs in Adults with Persistent Asthma.

BACKGROUND: Systemic corticosteroids (SCS) may cause complications for patients with asthma. OBJECTIVE: We sought to better understand the burden of SCS use in persistent asthma, including health care costs. METHODS: Adult patients with persistent asthma were identified in the IBM MarketScan Databases from January 2003 to July 2016. The index date was set as the first SCS prescription for SCS users or an algorithm-matched date for non-SCS users. Patients were required to have ≥1 year of data before and after the index date. Based on the number of SCS claims in the first year after index, patients were categorized into 3 SCS groups: 0 SCS claims, 1 to 3 claims, and 4+ claims. Inverse probability of treatment weights were applied to adjust for differences between SCS and non-SCS users. Analyses included weighted and multivariate modeling to assess SCS-related complications and costs during a 3-year follow-up. RESULTS: A total of 86,786 SCS users (1-3 claims: 76,690; 4+ claims: 10,096) and 91,409 non-SCS users were included; 45% remained 3 years after index. In multivariate analysis, the 3-year risk of developing any chronic complication was 6% greater for those with 1 to 3 claims and 26% greater for those with 4+ claims compared with non-SCS users (P < .001). Multivariate-adjusted health care costs over 3 years were significantly greater as 4+ users incurred $22,311 greater total costs, $4627 greater asthma-related costs, and $2647 greater chronic complication-related costs than non-SCS users (P < .001). CONCLUSIONS: In this study, adults with persistent asthma receiving SCS treatment had greater odds of complications and greater associated costs over 3 years than matched non-SCS asthma patients.

The economic burden to payers of patients with diffuse large B-cell lymphoma during the treatment period by line of therapy.

We retrospectively analyzed treatment patterns and healthcare costs among patients diagnosed with diffuse large B-cell lymphoma (DLBCL) during each line of therapy (LOT) using data from the IBM® MarketScan® Commercial and Medicare Supplemental Databases from January 2011 to May 2017. Patients were included if they had a diagnosis of DLBCL, ≥12 months of disease-free continuous enrollment prediagnosis, and ≥1 month of postdiagnosis follow-up. Of 2066 eligible patients receiving first-line treatment, 17% (n = 340) received second-line treatment; of these, 23% (n = 77) received third-line treatment. Mean healthcare expenditures (treatment duration) for first, second, and third LOTs were $111,314 (124.5 days), $88,472 (80.8 days), and $103,365 (70.9 days), respectively. When adjusted to 30-day period costs, first, second, and third LOT healthcare expenditures increased to $26,825, $32,857, and $43,854, respectively. Patients with newly diagnosed and relapsed/refractory DLBCL incur a significant cost burden (for payers), and such costs increase as patients proceed through subsequent LOTs.

Treatment Patterns and Costs in Biologic DMARD-Naive Patients with Rheumatoid Arthritis Initiating Etanercept or Adalimumab with or Without Methotrexate.

BACKGROUND: Etanercept (ETN) and adalimumab (ADA) are tumor necrosis factor inhibitors indicated for treatment of moderate to severe rheumatoid arthritis (RA) and are used as monotherapy or in combination with conventional disease-modifying antirheumatic drugs (DMARDs) such as methotrexate (MTX). Data on treatment patterns and costs of ETN and ADA as monotherapies or in combination therapy with MTX are lacking in biologic DMARD (bDMARD)-naive patients with RA. OBJECTIVE: To evaluate treatment patterns and costs of ETN and ADA monotherapy and combination therapy in bDMARD-naive patients with RA. METHODS: Data from adult bDMARD-naive patients with RA were evaluated according to index therapy (ADA or ETN as monotherapy or combination therapy with MTX) in a retrospective cohort study using the IBM MarketScan Commercial Claims and Encounters and Medicare Supplemental Databases from January 1, 2010, to June 30, 2017. Participants were bDMARD-naive for ≥ 12 months before initial ETN or ADA pharmacy claim (index date) and had continuous enrollment for ≥ 12 months pre-index and 24 months post-index. Combination therapy cohorts had an MTX claim within 30 days of the index date. Outcomes included persistence (no treatment changes or gap [≥ 60 days]); modifications to index therapy (discontinuation or switching without prior gap, restarting as switch or restart after gap, or MTX initiation/discontinuation); and mean total bDMARD costs for 2 years post-index. RESULTS: Patients on ETN monotherapy (n = 2,064) had higher persistence (26.8% vs. 21.1%, respectively; P < 0.001) on index treatment and received treatment for a longer duration (mean 375.9 days vs. 339.7 days, respectively; P < 0.001) than those on ADA monotherapy (n = 1,528). Regimen changes were more common in patients on ADA monotherapy than patients on ETN monotherapy (38.0% vs. 33.4%, respectively; P = 0.004). More patients on ADA monotherapy added MTX than those on ETN (17.5% vs. 12.6%, respectively; P < 0.001). Overall, 790 patients receiving index monotherapy had a regimen change following a gap (≥ 60 days), with a similar proportion between cohorts. Among these patients, 13.8% restarted index therapy, and 7.9% switched from index therapy. Significantly more patients receiving ETN monotherapy restarted their index regimen after a gap than those receiving ADA monotherapy (14.9% vs. 12.2%, respectively; P = 0.023). The proportion of patients persistent on combination therapy was similar between the ETN and ADA combination therapy cohorts (21.9% vs. 22.2%, respectively; P = 0.818). Treatment pattern rates were similar regardless of index combination therapy. Overall, costs for ADA were consistently higher within the index regimen throughout the follow-up period irrespective of MTX. CONCLUSIONS: ETN monotherapy as first-line treatment was associated with higher persistence, lower rate of MTX supplementation, and lower bDMARD costs than ADA monotherapy. ETN monotherapy may represent a less costly option for achieving treatment targets in bDMARD-naive patients with RA. DISCLOSURES: This study was sponsored by Amgen. Tkacz, Henderson DeYoung, and Wilson are employees of IBM Watson Health, which received funding from Amgen for this study. Collier and Oko-osi are employees and shareholders of Amgen. Gharaibeh was an employee of Amgen at the time of study execution and manuscript drafting. Data pertaining to this study were presented in a poster at AMCP Nexus 2018; October 25-28, 2018; Orlando, FL.

A claims-based algorithm to reduce relapse and cost in schizophrenia.

OBJECTIVES: To refine a payer algorithm identifying patients with schizophrenia at high risk of relapse within a managed Medicaid population and evaluate its effectiveness in a case management (CM) program. STUDY DESIGN: Cross-sectional and longitudinal study design. METHODS: The algorithm used a single payer's Medicaid medical and pharmacy claims (August 1, 2009, to July 31, 2014) for patients with schizophrenia (N = 12,353) to predict those at high risk for hospitalization. The final algorithm was used in a CM program (outbound communication to providers) at 3 payer service centers in 3 states. Based on the algorithm, 60 patients (20 from each site) with the highest risk scores were targeted for CM (CM group) and 60 (those patients ranked 21st-40th most at-risk at each site) comprised the control group. Chi-square tests compared groups on frequency measures (hospitalizations, emergency department [ED] visits). Pre- to postimplementation differences were tested using McNemar's test. A pre-post analysis of variance assessed mean numbers of inpatient admissions, inpatient days, and ED visits for both groups. RESULTS: The algorithm had good positive predictive power (64.0%), negative predictive power (94.7%), sensitivity (40.2%), and specificity (97.9%). Following CM, the proportion of patients with at least 1 inpatient admission in the CM group decreased (23.3% to 13.3%), as did the rate of ED visits per month (by approximately 15%), whereas increases were observed in the control group. CONCLUSIONS: Although not all of these differences were statistically significant, they suggest that the algorithm may be an effective case-finding tool for plans attempting to mitigate hospitalizations among high-risk patients with schizophrenia.