12-month Post-index Period Research Articles

EXPOSURE TO SYSTEMIC CORTICOSTEROIDS AMONG US PATIENTS WITH ASTHMA: RISKS ASSOCIATED WITH SHORT-ACTING BETA2-AGONIST USE

EXPOSURE TO SYSTEMIC CORTICOSTEROIDS AMONG US PATIENTS WITH ASTHMA: RISKS ASSOCIATED WITH SHORT-ACTING BETA2-AGONIST USE

CLL-410 Adherence and Discontinuation Among Medicare Beneficiaries Initiating Venetoclax versus BTKis for Relapsed/Refractory Chronic Lymphocytic Leukemia

Compelling clinical trial data for BCL2 (i.e., venetoclax) and BTK inhibitors (BTKis) have led to a paradigm shift in chronic lymphocytic leukemia (CLL) treatment. However, contemporary real-world studies evaluating venetoclax and BTKis remain limited, with real-world adherence and discontinuation in patients treated with venetoclax versus BTKis uncertain. To compare real-world venetoclax versus BTKis treatment patterns in older adults with relapsed/refractory (R/R) CLL. We performed a retrospective claims-based study using 2015-2019 100% Medicare Parts A/B/D, identifying fee-for-service Medicare beneficiaries aged ≥66 years newly initiating venetoclax between 1/1/2016 and 12/31/2018. From the remaining individuals during the same period, we also identified patients newly initiating a BTKi. Treatment outcomes in the 12-month post-index period included adherence (proportion of days covered [PDC] ≥0.80) and discontinuation (evidence of a 90-day consecutive gap in treatment [sensitivity analyses: 60- and 120-day gaps]). Logistic regressions controlling for differences in sociodemographic and clinical characteristics between the two study groups were used to estimate adjusted outcomes. We identified 711 and 1,566 mutually exclusive groups of beneficiaries initiating venetoclax and BTKi, respectively. Compared to BTKi initiators, those initiating venetoclax tended to be slightly younger (mean age 75.6 [SD 6.0] vs. 77.6 [SD 6.9] years, P<0.001) but had poorer clinical characteristics (for example, 39.4% vs. 30.4% with ≥8 comorbidities [P<0.001] and 51.5% vs. 42.5% with any hospitalization in the 12-months pre-index [P<0.001]). Beneficiaries initiating venetoclax had a higher unadjusted rate of adherence (57.9% vs. 47.3%, P<0.001) and a lower unadjusted rate of discontinuation at 12 months compared to BTKi (32.8% vs. 45.1%, P<0.001). Sensitivity analyses using a 60- and 120-day gap showed similar results. After risk adjustment, the venetoclax group had even higher adherence (61.9% vs. 45.4%, P<.0001) and lower discontinuation when compared to the BTKi group (28.5% vs. 47.4%, P<0.001). In this large, real-world study utilizing national Medicare data, older heavily pre-treated adults with R/R CLL initiating venetoclax had higher rates of adherence and lower rates of discontinuation relative to those initiating BTKis, despite poorer clinical characteristics. These favorable real-world venetoclax results are encouraging and support the goal of developing well-tolerated novel combinations for older adults.

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

PurposeNasal 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. MethodsThis 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. FindingsSCS 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). ImplicationsIn 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.

Real-world Medicare Healthcare Costs of Patients with Dupuytren's Contracture Treated with Collagenase or Fasciectomy.

Background:Our study aimed to compare real-world healthcare resource utilization (HRU) and healthcare cost (HC) of Medicare-insured patients (≥65 years old) with Dupuytren’s contracture (DC) treated with Clostridium histolyticum (collagenase) or fasciectomy.Methods:DC patients treated with collagenase or fasciectomy between July 2011 and June 2017 were identified using the IBM MarketScan Medicare Supplemental Database. The index date was the date of the first procedure. Demographic characteristics were captured on the index date, and comorbidities were assessed during the 24-month preindex period. HRU and HC were analyzed throughout the 12-month postindex period. Patients were matched using propensity score weights. Gamma log-linked generalized linear models were used to evaluate HC drivers.Results:Out of 37,374 DC patients, 2911 received collagenase, while 6258 underwent fasciectomy. Postmatching, the total average annual HC was similar between collagenase and fasciectomy ($7271 versus $6220, P = 0.357). When HCs were stratified by the service provider, outpatient facility and physician office costs were lower in the collagenase cohort ($850 versus $1284, P = 0.047 and $546 versus $1001, P < 0.001). The costs of professional services were significantly higher than in the fasciectomy cohort due to the cost of collagenase injection ($1682 versus $629, P < 0.001). The HRU was similar between cohorts, except for more frequent outpatient facility visits in fasciectomy patients (12.3 versus 22.9, P < 0.001). Generalized linear model revealed Charlson comorbidity index, plan type, patients’ residence region, sleep disorder, and hyperlipidemia as significant predictors of total HC.Conclusion:This study found comparable total annual HC and HRU between collagenase- and fasciectomy-treated Medicare patients.

Clinical and economic burden of uncontrolled severe noneosinophilic asthma.

To quantify the clinical and economic burden of patients with severe asthma with low blood eosinophil counts (BECs) untreated with biologics. Retrospective cohort study in IBM MarketScan claims database. 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. 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. 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.

Health Resource Utilization and Associated Health Care Costs of Biologic Disease-Modifying Antirheumatic Drugs in German Patients With Psoriatic Arthritis.

To investigate health care costs associated with biologic disease-modifying antirheumatic drugs (bDMARDs) in a German real-world cohort of adult biologics-naive patients with psoriatic arthritis (PsA). Claims data from the Institute for Applied Health Research Berlin (InGef) research database for patients with a PsA diagnosis and bDMARD claims record (index date) between January 1, 2014, and December 31, 2017, and no bDMARD prescriptions for 365 days before the index date were retrospectively analyzed. Primary outcomes were determination of health care resource utilization and associated annual health care costs for overall and individual bDMARDs in the 12-month pre-index and post-index periods. These outcomes were compared between persistent and nonpersistent groups. Nonpersistence was defined as treatment gap or switch to a bDMARD other than the index therapy. Among 10,954 patients with a PsA diagnosis, 348 were eligible. Although mean ± SD post-index costs were significantly higher in the persistent group than the nonpersistent group (€27,869 ± 8,001 versus €21,897 ± 10,600, P < 0 .001) due to higher bDMARD acquisition costs (€23,996 ± 4,818 versus €16,427 ± 9,033, P < 0.001), persistence reduced inpatient treatment costs (-€760), outpatient treatment costs (-€192), other drug costs (-€724), and sick leave costs (-€601). Although initiation of bDMARDs increased the total health care costs irrespective of persistence status, partial cost offsets were observed in the persistent patient population.

Predictors of nonresponse to dupilumab in patients with atopic dermatitis: A machine learning analysis

BackgroundMany patients with atopic dermatitis (AD) have a suboptimal response to systemic therapy. ObjectiveThis study assessed predictors of nonresponse to dupilumab in patients with AD. MethodsData (April 2017 through June 2019) for patients aged 12 years and above with AD (International Classification of Diseases–9/10-Clinical Modification: 691.8/L20.x) who initiated dupilumab on or after April 1, 2017 (index date) were collected from an electronic health record and insurance claims database. Nonresponse indicators (dupilumab discontinuation, addition of another systemic therapy or phototherapy, addition of a high-potency topical corticosteroid, AD-related hospital visit, AD-related emergency department visit, incident skin infection) were predicted from available demographic and clinical variables using machine learning. ResultsAmong 419 patients (mean age: 45 years), 145 (35%) experienced at least 1 indicator of nonresponse in the 6-month postindex period. In patients with at least 1 indicator, the most common was dupilumab discontinuation (47% [68/145]). Of note, this analysis could not capture nonmedical reasons for dupilumab discontinuation (eg, cost, access). The most common predictors of nonresponse were a claim for ibuprofen (in 69% of patients with a nonresponse indicator) and a Quan-Charlson Comorbidity Index value of 3 to 4 (59%). ConclusionSystemic dupilumab therapy for AD can be associated with a relatively high prevalence of nonresponse indicators. Factors associated with these indicators—that is, predictors of nonresponse—may be used to optimize disease management.

Excess healthcare resource utilization and healthcare costs among privately and publicly insured patients with major depressive disorder and acute suicidal ideation or behavior in the United States

BackgroundThis study assessed the healthcare resource utilization (HRU) and cost burden of patients with major depressive disorder (MDD) and acute suicidal ideation or behavior (SIB; MDSI) versus those with MDD without SIB and those without MDD. MethodsAdults were selected from the MarketScan® Databases (10/2015–02/2020). The MDSI cohort received an MDD diagnosis within 6 months of a claim for acute SIB (index date). The index date was a random MDD claim in the MDD without SIB cohort and a random date in the non-MDD cohort. Patients had continuous eligibility ≥12 months pre- and ≥1 month post-index. HRU and costs were compared during 1- and 12-month post-index periods between MDSI and control cohorts matched 1:1 on demographics. ResultsThe MDSI cohort included 73,242 patients (mean age 35 years, 60.6% female, 37.2% Medicaid coverage). At 1 month post-index, the MDSI cohort versus the MDD without SIB/non-MDD cohorts had 12.8/67.2 times more inpatient admissions and 3.3/8.9 times more emergency department visits; they had 2.9 times more outpatient visits versus the non-MDD cohort (all p < 0.001). The MDSI cohort had incremental mean healthcare costs of $5255 and $6674 per-patient-month versus the MDD without SIB and non-MDD cohorts (all p < 0.001); inpatient costs drove up to 89.5% of incremental costs. At 12 months post-index, HRU and costs remained higher in MDSI versus control cohorts. LimitationsSIB are underreported in claims; unobserved confounders may cause bias. ConclusionsMDSI is associated with substantial excess healthcare costs driven by inpatient costs, concentrated in the first month post-index, and persisting during the following year.

Mirabegron has longer treatment persistence than antimuscarinics:Real-world data from a Korean national cohort database.

To descriptively evaluate treatment persistence among adults who received mirabegron or antimuscarinics in South Korea. This study involved a retrospective analysis of the Health Insurance Review and Assessment (HIRA) database. Patients (≥18 years) who had a new prescription for an overactive bladder (OAB) target medication (mirabegron/antimuscarinic) within an 8-month index period (July 1, 2015-February 29, 2016) were included. The date when the target (index) medication was dispensed was the index date. The 6-month period before the index date was used to assess patient eligibility. A 12-month post-index period was used to assess medication persistence, which was defined as the time to discontinuation. Overall data were analyzed and the results were also stratified by age group (≤65, >65 years), sex, or prior OAB medication experience. Persistence rates were calculated after the 1st, 3rd, 6th, 9th, and 12th months. A data set of 52 722 cases was obtained (mirabegron: 11 424, antimuscarinics: 41 298). The mean age was 60.9 ± 16.1 years and the majority of the patients were female (30 862 [58.5%] patients). Median persistence was longer with mirabegron (51 days) versus antimuscarinics (25 days). The persistence rate with mirabegron was higher throughout the study compared with all the antimuscarinics (12-month data: 13.5% and 4.9%, respectively). Longer treatment persistence was noted in older, male, and treatment-experienced patients. The results from the HIRA database showed that persistence was longer with mirabegron than with antimuscarinics in South Korea. This finding may help inform clinical decision-making within the South Korean healthcare system.

Retrospective Analysis of Disease Severity, Health Care Resource Utilization, and Costs Among Patients Initiating Belimumab for the Treatment of Systemic Lupus Erythematosus

The goal of this study was to evaluate clinical and economic outcomes associated with the initiation of intravenous (IV) belimumab for the treatment of systemic lupus erythematosus (SLE) in clinical practice in the United States. This retrospective study used administrative claims data from the IBM MarketScan Commercial Claims and Encounters Database and the Medicare Supplemental and Coordination of Benefits Database. Data for patients with SLE who initiated (index) IV belimumab were collected for the 12 months before (pre-index) and the 12 months after (post-index) belimumab initiation. Outcomes included SLE disease severity and flares, all-cause health care resource utilization (HCRU) and health care costs, and hospital-based costs and service visits. Post hoc analyses of total hospital-based costs were conducted to further explore drivers of mean post-index costs. Baseline characteristics (N=908) are as follows: female, 93.4%; mean (SD) age, 45.6 (11.9) years; mean Charlson Comorbidity Index score, 0.9 (2.0); and moderate or severe disease, 94.9%. Disease activity (SLE flare episodes) was significantly reduced between the pre-index and post-index periods (severe flares, 16.4% vs 10.1% [P < 0.0001]; moderate flares, 92.1% vs 85.6% [P < 0.0001]; and mild flares, 77.4% vs 71.1%; [P=0.0003]). The proportion of patients receiving oral corticosteroids (OCS) was reduced between the pre-index and post-index periods, especially among patients at higher OCS thresholds (prednisone-equivalent dose: ≥60 mg/d, 7.3% vs 4.2%; >40 mg/d, 14.1% vs 7.9%). From the pre-index to the post-index period, few differences in HCRU were observed, although all-cause physician office visits, outpatient visits, and unique prescriptions filled increased significantly. In the 12-month post-index period, patients had a mean of 12.2 (9.0) encounters (eg, outpatient visit or prescription) associated with IV belimumab. All-cause total, medical, and pharmacy costs increased from the pre-index to the post-index period. Mean all-cause hospital-based costs increased from the pre-index to the post-index period ($7735 [26,603] vs $11,030 [88,086]; P=0.396). However, the 75th, 90th, and 95th percentile costs decreased from the pre-index to the post-index period ($305, $2107, and $3861, respectively). After initiation of IV belimumab, disease activity (number of moderate and severe SLE flares) and use of OCS were significantly reduced. However, HCRU and costs, including hospital-based costs, were generally greater in the post-index period. Further studies will increase understanding of SLE, with the specific goals of incorporating disease activity measures and long-term outcomes in studies of HCRU, costs, and patient outcomes.

Real World Clinical and Economic Burden of Patients with Hodgkin Lymphoma (HL) Who Fail Frontline (FL) Therapy in the US

Introduction: Hodgkin lymphoma (HL) is a hematologic malignancy for which frontline treatment options and outcomes have remained unchanged for several decades. HL is considered to have a favorable prognosis although failure rates after FL therapy range from 10% to 30% depending on stage. Patients who fail go on to bear the burden of additional therapy after FL. Little real-world evidence exists on the burden of disease for patients who fail FL (FLF) therapy for healthcare providers to contextualize the value of novel therapies. This study aimed to identify FLF patients and compare healthcare costs between HL patients with and without FLF.Methods: This retrospective analysis used the MarketScan Commercial and Medicare Supplemental administrative claims databases to select adults aged >18 years with ≥ 1 inpatient or 2 outpatient claims with a HL diagnosis (ICD-9 201.xx excluding Hodgkin paragranuloma, Hodgkin sarcoma and lymphocytic-histiocytic predominance) from 1/1/2010 to 9/30/2015. Eligible patients were required to have continuous plan enrollment for > 6 months prior to the diagnosis, no prior cancer, and initiate a multi-agent regimen indicative of curative intent.Patients were in the FLF cohort if they had one of the following failure events: initiate a new chemotherapy after discontinuing FL (gap >60 days with no chemotherapy), switch to a new treatment, or having a stem cell transplant (SCT). Patients were in FLF+XRT cohort if they also received radiation after completing FL chemotherapy. Index dates for the FLF and FLF+XRT cohorts were the earliest date of the failure events, and were randomly assigned for non-FLF patients based on distribution of intervals between FL start date and index date for the FLF cohort. They had to have > 30-day post-index continuous enrollment and followed until date of disenrollment, death, or end of the study period.Annual healthcare costs were measured at 12-month post-index periods among patients with > 12-months post-index continuous enrollment. Costs were measured during FL and the entire follow-up period (reported as per patient per month [PPPM]).Results: 795 patients met the selection criterion (mean age 38.5 years, 47.5% female). 67.8% of patients 18-44 years old, 26.4% 45-64 years old, and 5.8% ≥65 years old. Most resided in urban areas (81.9%), and the mean pre-index Charlson Comorbidity Index score of study patients was 2.9±1.9. The two most frequent coded comorbidities during FL were symptoms involving the respiratory system (41.3%) and cardiovascular (22.9%) in both cohorts. Of the patients in the FL+XRT cohort, 60.1% received XRT after FL discontinuation, 21.8% discontinued and restarted therapy, 10.4% switched to a new therapy, and 7.8% went on to a SCT directly after FL.The PPPM costs for FLF cohort during the follow up was $12,494 (N=77, Table 1) and the annual all-cause cost of failure was $160,839 (N=33, Table 2) higher than patients who did not fail FL. The PPPM costs in FLF+XRT cohort (N=193) was $11,918 (vs $7,772) (Table 1). The annual all-cause cost in was $68,431 (N=94) higher than patients in non-FLF cohort (Table 2). PPPM costs during FL in FLF+XRT was $21,676 (vs $16,396) (Table 1) driven by outpatient services (50.5%) and inpatient admissions (48.6%). The FLF+XRT (vs non-FLF) cohort had a significantly shorter duration of FL therapy (average of 112 vs 131 days, p<0.05).The economic burden of failure varied by type (Table 3). The annual costs of failure due to restarting, switching, SCT, or radiation were $269,189, $46,951, $231,824, and $55,989, respectively. Similar trends in cost were observed among patients with ≥24 months post-index enrollment (n=200).Conclusions: HL patients who fail FL represent a substantially higher economic burden compared to those without FLF, not accounting for stage at diagnosis. We did not assess the indirect costs or societal impact of FLF for the population and therefore this is an underestimate of the overall burden. More research is needed to determine optimal treatment that could reduce the risk of progression, the need for treatment after completion of FL and enhance long-term clinical and economic outcomes. [Display omitted] DisclosuresStraus:Received consulting fee from Seattle Genetics for involvement in the research: Consultancy. Bonafede:Employee of Truven Health Analytics, an IBM Company, that received a research contract to conduct this study with and on behalf of Seattle Genetics, Inc: Employment. Feliciano:Seattle Genetics: Employment, Equity Ownership. Cai:Truven Health Analytics: Employment, Other: I am an employee of Truven Health Analytics, an IBM company which received funding from Seattle Genetics to conduct this study. Noxon:Truven Health Analytics, an IBM company which received project funding from Global Blood Therapeutics: Employment. Princic:Truven Health Analytics, IBM Company: Employment. Josephson:Seattle Genetics: Employment, Equity Ownership. Richhariya:Seattle Genetics: Employment, Equity Ownership.

PMH9 Economic Burden of Major Depressive Disorder with Acute Suicidal Ideation or Behavior in the United States

This study assessed healthcare resource utilization (HRU) and costs of patients with major depressive disorder (MDD) and acute suicidal ideation or behavior (MDSI) compared to MDD without suicidal ideation (MDD) and without MDD (non-MDD). Adults were identified in the MarketScan® Databases (10/2015-02/2020). The MDSI cohort received an MDD diagnosis on the same day or within 6 months before a claim for acute suicidal ideation or behavior (index date). Index date was a random date with an MDD claim in the MDD cohort, and a random date in the non-MDD cohort. All patients had continuous eligibility ≥12 months pre- and ≥1 month post-index. HRU and costs (2020 US$) were compared during 1- and 12-month post-index periods between the MDSI and control cohorts matched 1:1. The MDSI cohort included 73,242 patients (mean age 35 years, 60.6% female, 37.2% Medicaid coverage) matched to controls in each cohort. During 1 month post-index, the MDSI cohort had 12.8 times more inpatient admissions and 3.3 times more emergency room (ER) visits versus the MDD cohort, as well as 67.2 times more inpatient admissions, 8.9 times more ER visits, and 2.9 times more outpatient visits versus the non-MDD cohort (all p<0.001). During 12 months post-index, HRU remained higher in the MDSI versus control cohorts. During 1 and 12 months post-index, respectively, the MDSI cohort had higher mean healthcare costs per-patient-month ($7,272 and $2,068) vs the MDD ($2,017 and $1,122) and non-MDD ($598 and $696) cohorts (all p<0.001). During 1 and 12 months post-index, inpatient costs drove 89.5% and 77.8% of cost differences versus the MDD cohort, and 81.1% and 63.6% versus the non-MDD cohort, respectively. MDSI is associated with substantial economic burden driven by inpatient costs. The economic burden of MDSI is concentrated in the first month post-index, persisting during the following year.

Characterizing unplanned resource utilization associated with cancer-related diarrhea.

e18625 Background: In clinical oncology practice, diarrhea is a very common and severe side effect of cancer treatments including from radiotherapy, chemotherapy, and targeted therapies. Cancer-related diarrhea (CRD) leads to increased healthcare resource consumption due to unscheduled outpatient visits, and , increased hospital stays requiring intensive supportive care measures. We evaluated CRD patients receiving chemotherapy, targeted therapy, or both, requiring emergency department (ED), physician office visits, hospitalizations, and length of stay (LOS) compared to a matched cohort of non-CRD patients. Methods: We performed a longitudinal study among adult patients ( &gt; 18 yrs) with CRD identified by diagnosis codes or pharmacy claims compared to matched non-CRD patients using claims data derived from the IQVIA PharMetrics Plus database. Index date was the first cancer claim date and patients were re-indexed based on their CRD claim. Each patient had a 6-month pre-index period, a minimum 3-month post-index period and had ≥12 months of continuous enrollment following the CRD index date. To adjust for selection bias and baseline differences, we matched CRD patients to non-CRD patients (1:1) by age, gender, geography and payer type. Patients were stratified by cancer therapy type (chemotherapy, targeted therapy or both treatments). We reported proportion of patients with hospitalizations, average length of stay (LOS), and ED visits. A generalized estimating equation model with log link and binomial distribution adjusted for type of cancer, therapy, and Charlson Comorbidity Index (CCI) was built to estimate the difference in occurrence of hospitalization between CRD and non-CRD cohorts. Results: We evaluated a total of 104,135 matched pairs of CRD and non-CRD adult patients with solid or hematologic cancer with 12-month continuous enrollment. The proportion of patients with ED visits (36.2% vs 18.9%, p &lt; 0.0001) and hospitalizations (29.6% vs 12.8%, p &lt; 0.0001) were significantly higher among CRD versus non-CRD cohort. When compared to non-CRD patients, CRD patients were more likely to be hospitalized (adjusted OR 2.28. 95% CI of 2.23-2.33). Mean CRD-specific office/hospital visits were significantly higher in the CRD cohort compared to the non-CRD cohort over the 12-month post-index period and patients had more CRD-specific visits to ED (7.5% vs 1.8%); physician’s offices (14.7% vs 3.8%); laboratory testing (11.6% vs 3.2%) and outpatient ancillary services (10.9% vs 2.6%) (all p &lt; 0.0001). Mean hospital LOS among patients with CRD was higher than non-CRD patients (6.6±8.9 vs 5.8±10.5 days, p &lt; 0.0001). Conclusions: Patients with CRD used significantly more resources, including outpatient services, ED visits, and hospitalizations. Effective prevention of CRD remains an unmet strategy to reduce the overall cost of cancer care.

The impact of cancer-related diarrhea on changes in cancer therapy patterns.

12111 Background: We studied the impact that cancer related diarrhea (CRD) has on cancer therapy and treatment patterns, including persistence, discontinuation, adherence, and switching of chemotherapy and targeted therapies in patients with and without CRD. Methods: We performed a longitudinal observational study among adult ( &gt; 18 yrs) patients with CRD identified by diagnosis codes or pharmacy claims compared to matched (1:1) non-CRD patients using claims data derived from the IQVIA PharMetrics Plus database. Index date was defined as the date of the first cancer claim, and we re-indexed patients based on CRD claims. Each patient had a 6-month pre-index period and a minimum 3-month follow-up post-index period. To adjust for selection bias and baseline differences, we directly matched the CRD patients to non-CRD patients. Treatment patterns were evaluated and stratified for the first cancer therapy with or without CRD (chemotherapy vs targeted therapy vs both targeted and chemotherapy). Discontinuation was defined as a 30-day gap for chemotherapy and a 14-day gap for targeted therapies from index therapy; switching was a new chemotherapy or targeted therapy prescription within 30 days following discontinuation of index therapy. We computed adherence as the proportion of days covered over the 12-month post-index period and persistence as mean number of days on index therapy. A Cox proportional hazards model was used to estimate the difference in risk of discontinuation of index therapy between CRD and non-CRD cohorts. Results: We evaluated a total of 104,135 matched pairs of CRD and non-CRD adult patients with solid or hematologic cancer; each group further grouped by those receiving either chemotherapy (n = 47,220), targeted therapy (n = 2,427), or both treatments (n = 5,313). Patients with CRD discontinued the index therapy more frequently than non-CRD patients for chemotherapy (81.5% vs 62.3%), targeted therapy (69.2% vs 64.3%) or both (96.0% vs 85.5%) (p &lt; 0.0001). Also, the overall percentage of discontinuation (82.4% vs. 64.6%) was significantly higher among patients with CRD. The mean time to discontinuation (59.6±54.1 vs. 68.3±76.6 days) was significantly lower (p &lt; 0.0001) in patients with CRD. The mean time to switch (72.0±48.6 vs. 96.9±84.0 days), mean persistence (95.1±98.1 vs. 154.3±142.7 days), and mean adherence (25.5%±37.2 vs. 47.9±41%) were significantly lower (all p &lt; 0.0001) among patients with CRD compared to non-CRD. The percentage of patients requiring a dose titration for their index cancer therapy was significantly higher (21.8%) for the CRD cohort versus 8.5% for non-CRD patients (p &lt; 0.0001). Conclusions: Patients with CRD were 40% (adjusted) more likely to discontinue the index therapy than patients without CRD. The persistence of index cancer therapy and time to switch were also lower for patients with CRD. Strategies to control CRD and continue cancer therapy are urgently needed.

Healthcare utilization and costs associated with cancer-related diarrhea.

e18623 Background: Diarrhea is a common toxicity of cancer treatments, including radiotherapy, chemotherapy, and/or targeted therapies. Cancer-related diarrhea (CRD) leads to increased healthcare utilization and cost. This study evaluated the all-cause and CRD-specific healthcare utilization and cost of patients with CRD compared to a matched non-CRD cohort. Methods: We conducted a longitudinal observational study among adult patients ( &gt; 18 years) with CRD using diagnosis codes or pharmacy claims compared to matched non-CRD patients using claims data from the IQVIA PharMetrics Plus database (October 2015 to March 2020). The index date was the date of the first cancer claim, and we re-indexed patients based on their CRD claim. Each patient had a 6-month pre-index period and a minimum 3-month post-index period. Patients were also required to have ≥12 months of continuous enrollment following the CRD index date. We directly matched patients 1:1 from the CRD cohort to the non-CRD cohort to adjust for selection bias and baseline differences. Our aim was to compare all-cause healthcare costs over a fixed 12-month post-index period, converting all costs to 2020 USD using the Consumer Price Index's medical component. We analyzed healthcare utilization for CRD-treated, CRD-inadequately treated, and CRD-untreated sub-cohorts (per Buono et al., J Econ 2017). Secondary endpoints included healthcare cost (proportion of patients, per-patient mean and median) and healthcare utilization (prescription fills and visits to the emergency department [ED], physician office, lab/pathology and outpatient ancillary services). We built one generalized estimating equation model with log link and gamma distribution adjusted for type of cancer, therapy and Charlson Comorbidity Index (CCI) to estimate the difference in total healthcare cost between CRD and non-CRD cohorts. Results: We evaluated a total of 104,135 matched pairs of CRD and non-CRD adult patients with solid or hematologic cancer receiving either targeted or chemotherapy, with 12-month continuous enrollment. Patients with CRD incurred significantly higher mean ($104,880 vs $39,664, p &lt; 0.0001) and median ($59,969 vs $8,914, p &lt; 0.0001) all-cause healthcare cost compared to patients without CRD over the 12-month post-index period. Inadequately treated CRD patients had the mean highest cost ($129,531) vs adequately CRD-treated ($107,050) or untreated CRD patients ($56,350) (all p &lt; 0.0001). Mean pharmacy cost for CRD and non-CRD patients were ($35,190 vs $15,883); visits to the ED ($1,107 vs $431), physician office ($3,457 vs $2,058), lab/pathology ($4,074 vs $1,404), and outpatient ancillary services ($15,805 vs $4,940) (all p-values &lt; 0.0001). Conclusions: Our findings show that patients with CRD had nearly 2.9 times higher all-cause total cost than patients without CRD after adjusting for covariates. Prevention of CRD may result in a significant reduction in cancer-treatment cost.

Healthcare utilization and costs associated with first-line treatment with obinutuzumab- and rituximab-based regimens for follicular lymphoma.

e19536 Background: Current real-world data on healthcare utilization (HCU) and costs of common first-line (1L) follicular lymphoma (FL) regimens, including obinutuzumab (G), remain limited. The aim of this study was to examine real-world HCU and costs for the most common National Comprehensive Cancer Network (NCCN)-recommended 1L FL treatments. Methods: This was a retrospective cohort study using administrative claims data from the IQVIA PharMetrics Plus and IBM MarketScan Commercial and Medicare Supplemental databases. We identified patients (pts) ≥18 years, who had ≥1 inpatient claim or ≥2 outpatient claims, with a diagnosis of FL from February 1, 2015 to March 31, 2020, and had received 1L FL treatment (per NCCN guidelines) between February 1, 2016 and September 30, 2019. The first claim for FL treatment was the index date. All pts had ≥12 months of pre- and ≥6 months of post-index continuous enrollment in medical and pharmacy benefits. Pts with other primary cancers, FL treatment, or stem cell transplant during the pre-index period, and clinical trial participation or end-stage renal disease during the study period were excluded. All-cause HCU and costs (2020 USD) per pt during the 6-month post-index period were reported for the five most common 1L FL regimens (only complete NCCN regimens were considered). Results: Overall, 1991 pts met the eligibility criteria, and 53% were male. The mean (standard deviation [SD]) age and Charlson Comorbidity Index at index were 58 (10.4) years, and 1.7 (1.0), respectively. The most common 1L regimens were rituximab-bendamustine (R-benda; n=818 [41.1%]), R-monotherapy (R-mono; n=592 [29.7%]), R-CHOP (n=461 [23.2%]), G-benda (n=86 [4.3%]), and R-CVP (n=34 [1.7%]). The proportion of pts who had ≥1 hospitalization or an emergency room visit was highest with R-CHOP (26.7% and 33.6%, respectively) and lowest with R-mono (11.3% and 18.1%, respectively). Mean (SD) all-cause total healthcare costs were highest with R-benda and G-benda, followed by R-CHOP, R-CVP, and R-mono (Table). Mean (SD) all-cause medical and FL treatment costs (drug and administration) were highest for R-benda ($174,407 [$110,520]; $135,520 [$96,492]) and lowest for R-mono ($87,368 [$83,910]; $54,271 [$40,433]). Conclusions: This real-world study provides an update on HCU and costs among pts initiating current NCCN-recommended 1L treatment for FL. Unadjusted 6-month total healthcare costs were highest with R-benda, followed by G-benda, while the lowest costs were seen with R-CVP and R-mono. Future studies with adjustment for pt characteristics are needed to compare HCU and costs between FL regimens.[Table: see text]

Effectiveness of erenumab and onabotulinumtoxinA on acute medication usage and health care resource utilization as migraine prevention in the United States.

BACKGROUND: Migraine is a common neurological disease that can have a substantial impact on patients' lives and on society. Erenumab, a fully human monoclonal antibody that targets the calcitonin gene-related peptide receptor, was specifically developed for migraine prevention. The efficacy of erenumab has been established in several clinical trials; however, the real-world comparative effectiveness of erenumab has not been fully investigated. OBJECTIVE: To evaluate the real-world impact of erenumab and onabotulinumtoxinA on acute medication usage and health care resource utilization (HCRU) among patients with migraine in the United States. METHODS: This retrospective US claims analysis (Optum's deidentified Clinformatics Data Mart Database) evaluated patients aged at least 18 years diagnosed with migraine who initiated erenumab or onabotulinumtoxinA between May 1, 2018, and September 30, 2019 (index date: first erenumab/onabotulinumtoxinA claim). Cohorts were matched 1:1 using the propensity score (PS) method (greedy match with caliper = 0.1). Stratification was performed based on gender, chronic migraine without aura diagnosis, onabotulinumtoxinA use, and acute/preventive drug use. The impact of erenumab and onabotulinumtoxinA on acute medication usage and HCRU was assessed in the 6-month post-index period. An exploratory analysis assessed the impact of erenumab and onabotulinumtoxinA on a composite endpoint of: (1) outpatient visit with a migraine diagnosis and associated acute medication claim, (2) hospital admission with a primary migraine diagnosis, or (3) emergency department visit with a primary migraine diagnosis. PS-matched data were used for comparative analyses; logistic regression with covariate adjustment was used for dichotomous variables, and a negative binomial model was used for count variables, with odds ratios or rate ratios (RRs) and 95% CIs calculated. RESULTS: Following stratified PS matching, 1,338 patients were included in both cohorts. At 6 months, the adjusted average number of claims per person for any acute medication was significantly lower in the erenumab cohort (1.13 vs 1.29 in the onabotulinumtoxinA cohort; RR = 0.88; 95% CI = 0.80-0.96; P = 0.0069), although the difference in the number of claims for triptans and barbiturates was statistically nonsignificant. The adjusted average number of all-cause and migraine-specific visits per person to health care providers was generally lower in the erenumab cohort compared with the onabotulinumtoxinA cohort. Patients in the erenumab cohort had a significantly lower number of composite events (0.44 vs 0.69 in the onabotulinumtoxinA cohort; RR = 0.63; 95% CI = 0.56-0.71; P < 0.0001). Similarly, the adjusted proportion of patients with any of the 3 composite events was lower in the erenumab cohort (31.7% vs 44.3% in the onabotulinumtoxinA cohort; OR = 0.59; 95% CI = 0.49-0.70; P < 0.0001). CONCLUSIONS: In this retrospective claims analysis study, erenumab significantly reduced acute medication usage (opioids and nonsteroidal anti-inflammatory drugs; any acute medication when analyzed together) and HCRU to a greater extent than onabotulinumtoxinA. DISCLOSURES: This study was supported by Novartis Pharma AG. Novartis employees contributed to the study design, analysis of the data, and the decision to publish the results. Fang, Abdrabboh, Glassberg, Vo, and Ferraris are employed by Novartis. Zhou and Shen are employed by KMK Consulting, Inc., which received funding from Novartis to conduct the study. Tepper reports grants from Allergan, Amgen, ElectroCore, Eli Lilly, Lundbeck, Neurolief, Novartis, Satsuma, and Zosano, outside the submitted work; personal fees from Dartmouth-Hitchcock Medical Center, American Headache Society, Thomas Jefferson University, Aeon, Align Strategies, Allergan/AbbVie, Alphasights, Amgen, Aperture Venture Partners, Aralez Pharmaceuticals Canada, Axsome Therapeutics, Becker Pharmaceutical Consulting, BioDelivery Sciences International, Biohaven, ClearView Healthcare Partners, CoolTech, CRG, Currax, Decision Resources, DeepBench, DRG, Eli Lilly, Equinox, ExpertConnect, GLG, Guidepoint Global Healthcare Consultancy Group, Health Science Communications, HMP Communications, Impel, InteractiveForums, M3 Global Research, Magellan Rx Management, Medicxi, Navigant Consulting, Neurorelief, Nordic BioTech, Novartis, Pulmatrix, Reckner Healthcare, Relevale, SAI MedPartners, Satsuma, Slingshot Insights, Spherix Global Insights, Sudler and Hennessey, Synapse Medical Communications, System Analytic, Teva, Theranica, Thought Leader Select, Trinity Partners, XOC, Zosano, Krog and Partners, and Lundbeck, outside the submitted work; and CME honoraria from American Academy of Neurology, American Headache Society, Cleveland Clinic Foundation, Diamond Headache Clinic, Elsevier, Forefront Collaborative, Hamilton General Hospital, Ontario, Canada, Headache Cooperative of New England, Henry Ford Hospital, Detroit, Inova, Medical Learning Institute PeerView, Medical Education Speakers Network, Miller Medical Communications, North American Center for CME, Physicians' Education Resource, Rockpointe, ScientiaCME, WebMD/Medscape. The abstract and poster of these results were presented at The Migraine Trust Virtual Symposium (MTIS), October 3-9, 2020.

Impact of erenumab on acute medication usage and health care resource utilization among migraine patients: a US claims database study

BackgroundMigraine is one of the leading causes of disability worldwide. Erenumab is a fully human monoclonal antibody that targets the calcitonin gene-related peptide (CGRP) receptor. This study aimed to evaluate real-world evidence on the impact of erenumab on acute medication usage and health care resource utilization (HCRU) among migraine patients.MethodsThis retrospective effectiveness study utilized the US Optum’s de-identified Clinformatics® Data Mart database to identify migraine patients initiating erenumab between May 1, 2018 and September 30, 2019. Patients had to be at least 18 years old, with a minimum of three doses for erenumab in the 6-month post-index period and continuous medical/pharmacy coverage in the 12-month pre- and 6-month post-index period. The date of the first claim for erenumab served as the index date. Use of acute medications overall and at different drug class level, and HCRU were compared during the 6-month pre- vs. post-index period. Impact of erenumab on a composite endpoint of three possible events: 1) outpatient visit with a diagnosis of migraine and an associated acute medication claim within 7 days of the visit, 2) hospital admission with a primary diagnosis for migraine, or 3) emergency room visit with a primary diagnosis for migraine (any events that occurred ≤3 days apart were counted only once) was also evaluated.ResultsThe analysis included 3171 identified patients. At 6 months, following initiation of erenumab, acute medication use including the number of types of acute medication, number of claims of each medication and % of patients who received acute medication, and HCRU were significantly decreased. For the composite outcome, the mean number of events decreased from 1.03 to 0.77 (rate ratio: 0.75; 95% CI: 0.71 to 0.79; P < 0.0001). A decrease in the proportion of patients with any of the three events was also observed (52.7% vs. 39.5%, P < 0.0001).ConclusionIn this retrospective analysis, erenumab was associated with significantly reduced acute medication use and HCRU in a real-world setting, hence significantly reducing the burden of the disease. A composite endpoint could be used as a proxy to evaluate the burden of migraine attacks; however, further research is needed.

The Incidence and Economic Burden of Extrapyramidal Symptoms in Patients with Schizophrenia Treated with Atypical Antipsychotics

Extrapyramidal symptoms (EPS), including movement disorders, tremors, and muscle contractions are common side effects of atypical antipsychotic (AAP) drugs in patients with schizophrenia. This study examined the incidence and burden of EPS in patients with schizophrenia initiating AAPs. Patients with schizophrenia initiating AAPs with no prior EPS were identified in the MarketScan Multi-state Medicaid database from 1/1/2012-12/31/2018. Incidence of EPS (identified via ICD-9/ICD-10 diagnoses and medications) was assessed during the 12-months following AAP initiation. Cohorts with and without EPS were defined. Demographics, clinical characteristics, and healthcare resource use and costs over 12 months following the first EPS claim (EPS) or randomly assigned index date (Non-EPS) were assessed. A total of 11,642 patients with schizophrenia were identified; 21.2% developed EPS in the 12-months following AAP initiation. EPS and Non-EPS cohorts included 2,295 (mean age 38, 61% male, CCI 0.6) and 5,607 (mean age 39, 57% male, CCI 0.7) patients, respectively. Over the 12-month post-index period, EPS cohort had significantly higher rates of all-cause (30.2% vs. 24.6%, p<0.001) and schizophrenia-related hospitalizations (22.5% vs. 12.9%, p<0.001) and schizophrenia-related emergency room visits (25.5% vs. 16.7%, p<0.001) compared to Non-EPS cohort. All-cause ($25,911 vs. $21,550, p<0.001) and schizophrenia-related healthcare costs ($12,134 vs. $6,230, p<0.001) were significantly higher in EPS vs. Non-EPS cohort. In the 12 months following AAP initiation, over 20% of schizophrenia patients developed EPS, which was associated with increased healthcare resource utilization and costs. Treatment options that minimize EPS may reduce the economic burden of schizophrenia. Sunovion Pharmaceuticals Inc.

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

BackgroundPatients with severe asthma may remain uncontrolled despite biologic therapy in addition to standard therapy, but this disease burden has not been quantified. ObjectiveTo estimate the clinical and economic burden in a US national sample. MethodsPatients 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 β-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. ResultsThe 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 β-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. ConclusionBiologic 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.