Quan-Charlson Comorbidity Index Research Articles

Total cost of care of Medicare Advantage beneficiaries participating in an appointment-based model in a national pharmacy chain.

The appointment-based model (ABM) is a pharmacy service to improve medication-related health outcomes. ABM involves medication synchronization and medication review, plus other services such as medication reconciliation, medication therapy management, vaccine administration, and multimedication packaging. ABM can improve medication adherence, but the economic impact is unknown. To assess the effect of a national pharmacy chain's ABM program for Medicare Advantage beneficiaries on total cost of care (TCOC). This study analyzed administrative claims data from April 7, 2017, through February 29, 2020, for Medicare Advantage beneficiaries with Part D using a propensity score-matched cohort design. The national pharmacy chain provided a list of ABM participants. Eligibility criteria for the ABM and control (non-ABM) groups included age 65 years or older on the index date (initial participation, ABM; random fill date, control) and continuous enrollment from at least 6 months pre-index (baseline) date through at least 6 months post-index (follow-up) date. Medical inflation-adjusted (2020) TCOC was calculated as the sum of all health care spending from Medicare Advantage beneficiaries with Part D plan and patient paid amounts, standardized to per patient per month (PPPM), during the follow-up period. Secondary outcomes included medication adherence calculated across prevalent maintenance therapeutic classes using proportion of days covered (PDC). Each group contained 5,225 patients with balanced characteristics after matching: 64% female, 73% White, mean age 75 years, mean Quan-Charlson comorbidity index score 0.9, and hypertension and dyslipidemia, each >65%. Median baseline all-cause PPPM health care costs in the ABM and control groups, respectively, were $517 and $548 ($221 and $234 medical, $135 and $164 pharmacy). Baseline PDC of at least 80% was 83% in the ABM group and, similarly, 84% in the control group. The mean (SD) follow-up was 604 (155) days for the ABM group and 598 (151) days for the control group. During the follow-up period, the median PPPM TCOC for the ABM group was $656 and was $723 for the control group (P = 0.011). Median pharmacy costs were also significantly less in the ABM group ($161 vs $193, P < 0.001), whereas median medical costs were $328 in the ABM group and $358 among controls (P = 0.254). More patients in the ABM group were adherent during follow-up, with 84% achieving PDC of at least 80% vs 82% among controls (P = 0.009). The ABM program was associated with significantly lower follow-up median total costs (medical and pharmacy), driven primarily by pharmacy costs. More patients were adherent in the ABM program. Payers and pharmacies can use this evidence to assess ABM programs for their members.

Treatment patterns and hospitalizations following rejection, reversal, or payment of the initial once-monthly paliperidone palmitate long-acting injectable antipsychotic claim among patients with schizophrenia or schizoaffective disorder.

Once-monthly paliperidone palmitate (PP1M) is a long-acting injectable antipsychotic approved for the treatment of schizophrenia and schizoaffective disorder (SCA) in adults. To assess treatment patterns and schizophrenia/SCA-related hospitalization following payer rejection, patient reversal, or payment of an initial PP1M claim. This was a retrospective cohort study using the IQVIA Formulary Impact Analyzer database linked to the Medical Claims, Hospital Charge Detail Master, and Experian consumer databases. Patients with schizophrenia/SCA and ≥1 PP1M pharmacy claim from January 1, 2018, to February 28, 2022, were identified and stratified into 3 cohorts based on the transaction status of the initial PP1M claim (index date): rejected (payer not approved), reversed (payer approved, patient abandoned), and paid (payer approved, patient filled). Patient characteristics during the 12 months before the index date, subsequent treatment patterns, and schizophrenia/SCA-related hospitalization for patients with >6 months of follow-up were assessed by cohort. The rejected, reversed, and paid cohorts included 1,260, 1,046, and 1,686 patients, respectively. Across these cohorts, the mean ages ranged between 39.2 and 44.5 years; more than half were male (50.8%-51.6%) and White (50.6%-58.3%); 19.8%-24.6% of patients had a Quan-Charlson Comorbidity Index score of ≥2. Rates of prior atypical oral and long-acting injectable antipsychotic use ranged between 76.4%-80.3% and 7.8%-12.7%, respectively. Among patients with ≥6 months of follow-up, 52.2% in the rejected and 53.1% in the reversed cohorts had a subsequent paid PP1M claim during the study period; the median (quartile 1-quartile 3) time to the first paid PP1M claim was 22 (5-74) days for rejection and 11 (1-41) days for reversal. In the rejected and reversed cohorts, 10.2% (n = 111) and 9.8% (n = 90) of patients, respectively, did not receive any paid claim for an antipsychotic after the initial PP1M rejection/reversal. The prevalence of schizophrenia/SCA-related hospitalization during follow-up was similar between patients with a paid (7.4%) and rejected PP1M claim (7.0%; P = 0.689) but higher among patients with a reversed claim (10.8%; P = 0.004). After adjusting for confounders, patients in the reversed cohort were 39% more likely to have a schizophrenia/SCA-related hospitalization than those in the paid cohort (odds ratio = 1.39; 95% CI = 1.03-1.87). Payer rejection and patient reversal of initial PP1M claims is a form of primary nonadherence and may influence patient trajectory. Data from this study suggest that patient reversal of PP1M may lead to an increased risk of schizophrenia/SCA-related hospitalizations, potentially caused by missed or delayed treatment. Policy initiatives that remove barriers to primary adherence or fulfillment may help improve patients' clinical outcomes.

Daratumumab Combinations in US Veterans: Patient Characteristics and Outcomes

Background: Daratumumab is an anti-CD38 antibody with efficacy both in relapsed and newly diagnosed multiple myeloma (NDMM).Clinical trials evaluating daratumumab have demonstrated improved outcomes when combined with lenalidomide (DRd) or bortezomib (DVd) and with dexamethasone, as well as using all four drugs (D-VRd). We evaluated characteristics and outcomes of veterans treated with daratumumab combination in NDMM. Methods: This retrospective, cross-sectional study analyzed electronic medical record data from the Veterans Affairs (VA) Corporate Data Warehouse (CDW). We identified veterans by evidence of daratumumab administration in prescription records in combination with a second agent within 30 days and who did not receive any anti-myeloma agents prior to 30 days. Age, race, Quan's Charlson Comorbidity Index (CCI), the time to next treatment (TTNT), and overall survival (OS) were assessed. Patient characteristics were compared using ANOVA or chi-square and overall survival was estimated using Kaplan-Meier. Analyses were conducted using SAS 9.x. Results: There were 428 veterans who received daratumumab containing regimens. Mean age was 69.5 years and 36.2% self-identified as African American. There were 147 patients who received DRd, 190 DVd, and 91 D-VRd. Veterans who received DRd were significantly older than veterans receiving DVd (mean 73.0 vs. 69.1 years) and D-VRd(73.0 vs. 64.9 years, p&amp;lt;0.001). Use of daratumumab combinations has increased yearly since FDA approval (see table). There was no significant difference in use of regimens by race or comorbidity, measured by CCI. TTNT displayed distinct variations among the regimens, with DRd showing the most extended duration at a median of 316 days, followed by D-VRd at 231 days, and DVd at 40 days. These observed differences in TTNT may be attributed to changes in regimen, such as starting lenalidomide after 1-2 cycles of DVd. Median overall survival with DRd at 45 months (95% CI 38-not reached (NR)) and with DVd was 28 months (95% CI 20-39). Median survival in D-VRd was not reached. Conclusion: Daratumumab combinations are increasingly used to treat multiple myeloma in the VHA. DRd is used more commonly in older veterans and D-VRd in younger veterans. DVd is used more frequently than other combinations and veterans may transition or other treatments.

Real-World Study of Adherence to Anticoagulant Treatment Guidelines in Patients with Cancer-Associated Thrombosis (CAT)

Background and Objectives: Clinical guidelines recommend using anticoagulant therapy for 3-6 months to treat cancer-associated thrombosis (CAT). Limited data are available on real-world compliance with these guidelines in the US. This analysis aimed to describe treatment patterns for CAT in the US. Methods: A retrospective cohort study on adult patients with active cancer who developed CAT between January 2018 to December 2019 was conducted using integrated closed medical and pharmacy claims data from HelthVerity PS 20 database. Patients were categorized as treated cohort if they initiated anticoagulant or inferior vena cava filter within 15 days prior or 45 days after the first CAT event. Patients were required to have a continuous enrollment of ≥ 12 months prior and ≥45 days after the first CAT date. Clinical characteristics during the baseline period and treatment patterns during the follow-up period were described. Results: A total of 2,119 patients met the inclusion and exclusion criteria, with 1,536 (72.5%) patients assigned to the treated cohort (Quan-Charlson comorbidity index [QCI] 2.11±2.0; HAS-BLED score 1.91±1.1 and VTE-BLEED risk score 3.65±1.3). Among the treated cohort, 43.9% initiated treatment with a DOAC; the median treatment duration was 164 days. Of the treated patients, 33.8% had &amp;lt;91 days of treatment duration. Relative to patients with ≥91 days of treatment, patients with &amp;lt;91 days of treatment had a higher comorbidity burden [QCI 2.43±2.2 vs. 1.88±1.9; p-value &amp;lt;0.001], a higher HAS-BLED score [2.07±1.1 vs. 1.8±1.0; p-value &amp;lt;0.001], and higher average VTE-BLEED risk score [3.82±1.3 vs. 3.54±1.2; p-value &amp;lt;0.001]. Conclusion: Compliance with clinical guidelines on the use of anticoagulation in CAT is suboptimal. Patients who receive &amp;lt;91 days of treatment are more likely to have higher risk features than those who receive ≥91 days of treatment.

Evolving Real-World Characteristics and Step-up Dosing Among Early Initiators of Teclistamab for Multiple Myeloma - a National All-Payer Claims Database Study

Introduction: Teclistamab, a first-in-class B-cell maturation antigen (BCMA) x CD3 bispecific antibody with a personalized, weight-based dosing schedule, gained United States (US) regulatory approval in October 2022 for the treatment of triple-class exposed relapsed/refractory multiple myeloma (MM). Prior real-world analyses using hospital chargemaster or single-center data (Tan SOHO 2023, Firestone ASCO 2023) found that early initiators of teclistamab were elderly, diverse, frail, heavily pretreated, and had significant comorbidities. The evolving characteristics of patients receiving teclistamab over time and the operationalization of step-up dosing (SUD) nationally have not been characterized. Methods: This is a retrospective, observational, descriptive study using the All-payer Real-world Multiple Myeloma Research-ready Data (ARMMRD) registry, derived from STATinMED RWD Insights all-payer claims data that covers approximately 87% of the nationally insured population in the US, from January 1, 2014 to May 31, 2023. The intake period was October 26, 2022 to May 31, 2023; patients were indexed on the earliest outpatient claim of a teclistamab 30mg/3mL vial or admission date of the earliest hospitalization with teclistamab. A claims-based algorithm was applied to best approximate the SUD period per label which includes the first two step-up doses and the first treatment dose. Patients were included if they had ≥1 MM diagnosis claim on or any time prior to index, age ≥18 years on index, and continuous eligibility for 6 months before index (baseline period). Patients who received teclistamab on or before the approval date were excluded. Patient characteristics and length of SUD were analyzed descriptively across 4 index timing-based cohorts: 1) those indexed through February 2023; 2) in March 2023; 3) in April 2023; and 4) in May 2023. Results: A total of 124 patients were included in the study. Median (interquartile range [IQR]) age was 71.5 (14.5) years; 33.9% were age ≥75 years; 72.6% had Medicare insurance; 49.2% were male. Most were White (62.1%) and non-Hispanic (63.7%), with 12.1% Black. The mean (standard deviation [SD]) Quan-Charlson Comorbidity Index score was 4.2 (3.6) for the overall population; the cohort indexed in March 2023 had the highest score at 5.8 (3.9). Similarly, while the overall comorbidity burden was high in the overall population, the cohort indexed in March 2023 had the highest rates for many comorbidities (Table 1). Among 68 patients with continuous eligibility since the initial MM diagnosis, 16.2% had prior exposure to a commercial BCMA therapy: 10.3% were exposed to BCMA chimeric antigen receptor (CAR)-T therapy and 8.8% to belantamab mafodotin. Among 99 patients who completed SUD by the data cutoff, 87 (87.9%) completed SUD in one inpatient admission, 4 (4.0%) fully outpatient, and 8 (8.1%) in hybrid inpatient/outpatient settings. Among patients with ≥1 teclistamab hospitalization, the median (IQR) length of stay was 8.0 (4.0) days, with mean (SD) of 8.3 (2.9) days after omitting extreme outliers. Over time, the mean (SD) length of the SUD period shortened from 12.1 (9.0) days to 6.7 (1.2) days. However, the percentage of patients who received teclistamab SUD in one hospitalization remained relatively constant (Figure 1). Conclusion: This is the first national real-world study using all-payer claims data of patients initiating teclistamab in the first 7 months of market availability. Like prior reports, early initiators of this first-in-class bispecific represented a diverse and elderly population with substantial comorbidities; yet, across the index time-based cohorts, the average comorbidity index score fell. Teclistamab SUD was generally administered through a single hospitalization, which may reflect logistical considerations with adverse event monitoring and elective hospital readmissions. Nonetheless, the duration of SUD period appeared to shorten over time, and most admitted patients were discharged without delay. Study limitations include the nature of insurance claims data, small sample size per subgroup, and lack of granular data on CRS incidence and management; however, to our knowledge, this is the largest analysis of real-world teclistamab use to date. Additional analyses are warranted to understand evolving trends in teclistamab SUD and establish best practices as the field grows more familiar with bispecific antibodies in MM.

Comparative Effectiveness of Ibrutinib Flexible Dosing Treatment Strategies on Time to Next Treatment in a Largely Community-Based Claims Database: A Target Trial Emulation Study

Introduction: Outside of a clinical trial setting, ibrutinib is the most well-characterized of the covalent Bruton's tyrosine kinase inhibitors used in the treatment of patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) in the first-line (1L) setting. However, the impact of ibrutinib dose adjustment on clinical outcomes remains to be defined. In this real-world effectiveness study, we compared time to next treatment (TTNT) as a proxy for disease progression for dose adjustment and standard dose treatment strategies in patients with CLL/SLL receiving 1L single-agent IBR. Methods: This study utilized the Komodo Health payer-complete dataset, derived from U.S. health insurance claims from &amp;gt;150 private insurers covering &amp;gt;160 million individuals from 2015-2023; 53% of these patients are from community centers. Adult patients with CLL/SLL were included if they initiated 1L single-agent IBR 420 mg/day between March 2016 - April 2023 (IBR initiation date = index date; 1L single-agent IBR was defined as no other CLL/SLL treatment in the 12-month baseline period or within 28 days after index). A target trial emulation (TTE) approach was utilized to compare TTNT, defined as the time between the index date to the initiation of a next line of therapy (LOT), for two treatment strategies: 1) Dose adjustment strategy, defined as a lead-in IBR treatment at 420mg/day for 3-12 months, followed by dose adjustment to &amp;lt;420mg/day until next LOT or IBR discontinuation; 2) Standard dose strategy, defined as a continuous IBR treatment at 420mg/day without any dose adjustment for &amp;gt;12 months until next LOT or IBR discontinuation. The TTE approach minimizes immortal time bias in a naïve observational analysis as patients in the dose adjustment cohort cannot initiate next LOT before dose adjustment occurs [Hernan et al. Am J Epidemiol. 2016]. To explicitly emulate a target trial, two clones were created for each patient, with one clone contributing person-time and event to each treatment strategy of interest, respectively. A clone was artificially censored when the actual treatment path deviated from the assigned treatment strategy. Selection bias due to artificial censoring was corrected using time-varying inverse probability of censoring weights (IPCW), accounting for post-index time-varying clinical factors related to IBR dose adjustment or IBR discontinuation. TTNT hazard ratio (HR; robust 95% confidence interval [CI]) was estimated using an IPCW-weighted pooled logistic regression model. Alternative lead-in periods with IBR standard dosing (3-6 and 3-9 months) were also evaluated. A subgroup analysis was conducted among patients with high cardiovascular (CV) risk, defined as having a preexisting CV comorbidity or a high CHA 2DS 2-Vasc risk score. Results: 3,342 adults initiated 1L single-agent IBR at 420 mg/day. Mean (standard deviation [SD]) age was 67.5 (10.6) years, 62% were male, and mean (SD) Quan-Charlson Comorbidity Index score was 3.0 (1.5). The median (interquartile range) follow-up duration was 19.6 (7.5, 35.0) months. During the study period, 463 patients (14%) initiated a subsequent LOT. The high CV risk subgroup consisted of 2,640 (79%) patients. In the overall study population, 608 (18%) patients experienced a dose adjustment after the index date. Of those, the dose adjustment occurred ≤3 months, ≤6 months, and ≤12 months post-index in 159 (26%), 300 (49%), and 440 (72%) patients, respectively, with dose used at the first reduction of 70 mg, 140 mg, or 280 mg in 4 (1%), 85 (14%), and 519 (85%) patients, respectively. The dose adjustment strategy (420 mg/day for 3-12 months followed by a reduced dose) was not associated with increased risk of initiating next LOT (adjusted HR [95% CI] 0.95 [0.80, 1.14]) compared to the continuous standard dose strategy; results for the alternative lead-in periods and the high CV risk subgroup were consistent with the primary scenario. Conclusions: In this real-world comparative effectiveness study with the majority of patients from community centers, dose adjustment of 1L single-agent IBR treatment for CLL/SLL is not associated with an increased risk of initiating next LOT when compared to continuous standard dose treatment. These findings suggest that a flexible dosing approach with IBR may be an effective option to maintain an optimal balance of clinical therapeutic efficacy and safety for patients with CLL/SLL in the 1L setting.

Comparison of Time to Next Treatment or Death between Front-Line Daratumumab, Lenalidomide, and Dexamethasone (DRd) and Bortezomib, Lenalidomide, and Dexamethasone (VRd) in Transplant Ineligible Patients with Multiple Myeloma

Introduction: Daratumumab, lenalidomide, and dexamethasone (DRd) and bortezomib, lenalidomide, and dexamethasone (VRd) are the only two regimens that are considered as preferred per the National Comprehensive Care Network for transplant ineligible (TIE) patients with newly diagnosed multiple myeloma (NDMM). While there are no head-to-head studies comparing clinical outcomes of DRd and VRd in this population, an indirect comparison (PEGASUS study [Durie et al., 2020]) has shown that DRd was associated with significantly lower risk of disease progression or death compared with VRd and Rd. This study aims at supplementing this information by comparing real-world time-to-next-treatment (TTNT) or death between NDMM TIE patients treated with front-line (FL) DRd or VRd. Methods: A retrospective cohort study was conducted for patients with NDMM who initiated FL DRd or VRd in Acentrus (1/1/2018 - 5/31/2023), an electronic medical record (EMR) database from academic and non-teaching hospitals in the United States. Patients were included if they had ≥2 records with an ICD-10-CM diagnosis code for MM, ≥6 months of data availability prior to first record with MM diagnosis (without use of antineoplastic agent), initiated FL treatment (initiation of DRd or VRd; index date) within 12 months of first record of MM diagnosis, and ≥90 days of data availability post-index. Patients with pre-index diagnosis of amyloidosis or other cancers and those who participated in a clinical trial before or during FL treatment were excluded. To limit the analysis to the TIE population, patients who had a record of a stem-cell transplant (SCT) before or during FL treatment and those who were &amp;lt;65 years old (used as proxy to SCT eligibility) were excluded. Patient characteristics were evaluated up to 12-months pre-index (baseline period). Patients were followed from the index date until earliest of date of initiation of a next line of treatment, death, or end of data availability. Medications received within 60 days from the date of the first MM antineoplastic agent were considered as FL therapy regimen. Next line of treatment was identified as initiation of a new antineoplastic agent (excluding corticosteroids) outside of FL therapy or re-treatment of FL after &amp;gt;90-day gap. Inverse probability of treatment weighting (IPTW) was used to balance baseline characteristics between study cohorts, with variables with standardized differences &amp;lt;10% considered balanced. Weighted Kaplan-Meier (KM) curves and a doubly-robust Cox proportional hazards model adjusting for baseline variables remaining imbalanced after IPTW were used compare TTNT or death between study cohorts. Results: Overall, 149 and 494 patients were identified in the DRd and VRd cohorts, respectively. After weighting (N DRd weighted = 302, N VRd weighted = 341), most baseline characteristics in both cohorts were similar, including mean age (DRd: 75.3, VRd: 74.5), female sex (DRd: 48.9%, VRd: 45.8%), white race (DRd: 55.8%, VRd: 58.7%), black race (DRd: 8.8%, VRd: 11.3%), Medicare insurance coverage (DRd: 62.7%, VRd: 65.9%), and mean Quan-Charlson comorbidity index (DRd: 3.8, VRd: 3.6; Table 1). Some imbalances remained for mean age, race, ethnicity, and index year, thus they were additionally adjusted for in doubly-robust Cox model. The median duration of follow-up was 20.2 months and 21.5 months among DRd and VRd patients, respectively. A total of 98 (32.4%) DRd patients and 175 (51.2%) VRd patients received a subsequent line of therapy or died, with the median TTNT or death being 37.8 and 18.7 months in the DRd and VRd cohorts, respectively (hazard ratio: 0.58, 95% CI: 0.35, 0.81; p&amp;lt;0.001; Figure 1). KM estimates for patients remaining on FL therapy were significantly higher for DRd than VRd at 6 months (93.0% vs. 80.1%), 12 months (80.0% vs. 61.0%), 18 months (64.9% vs. 51.3%), and 24 months (60.2% vs. 42.9%). Conclusion: In this retrospective cohort study using EMR data, TIE NDMM patients who initiated DRd had a significantly longer time to next treatment or death than patients who initiated VRd. Results from this real-world study fills an unmet data gap by providing information on the comparative effectiveness evidence for DRd versus VRd among TIE NDMM patients. These findings support the use of DRd as an effective treatment option in the TIE NDMM patient population.

Ibrutinib Dose Adjustment Does Not Impact Time to Next Treatment in First-Line Patients with Chronic Lymphocytic Leukemia: A Real-World Analysis of Electronic Medical Records from Academic and Non-Teaching Hospitals Using Target Trial Emulation

Introduction: Ibrutinib, a once-daily Bruton's tyrosine kinase inhibitor (BTKi), is recommended as first-line (1L) treatment for patients with chronic lymphocytic leukemia (CLL). Dosing flexibility with ibrutinib allows patients to adjust their daily dose to help prevent recurrence or worsening of adverse events, while maintaining efficacy by allowing patients to stay on treatment and benefit from long-term treatment outcomes. The current study aimed to compare time to next treatment (TTNT) in CLL patients initiating 1L single-agent ibrutinib at 420mg/day and staying on this dose versus those having a dose adjustment (DA) within 3-12 months. Methods: Specialty pharmacy electronic medical records from the Acentrus database, comprised primarily of academic and non-teaching hospital systems in the United States (1/1/2016-4/30/2022), were used to identify adults with CLL who initiated 1L single-agent ibrutinib at a starting dose of 420mg/day (index date) (N = 1,171). A washout period of ≥12 months pre-index (also used to evaluate baseline characteristics) was required to confirm use as 1L therapy. The following treatment strategies were compared: treatment for 3 months post-index at 420mg/day followed by DA to a dose below 420mg/day between 3-12 months post-index versus sustained treatment for ≥12 months post-index at 420mg/day. The first 3 months were required to be at 420mg/day for both strategies, as most DAs occur after this period. TTNT was defined as the time from the index date to the initiation of a next treatment. Administrative censoring included treatment discontinuation (based on treatment gap of ≥365 days), death, participation in a clinical trial, end of data availability, within-class BTKi switch (i.e., switching to another covalent BTKi), anti-CD20 antibody (i.e., obinutuzumab or rituximab), or venetoclax add-on within 180 days post-index. To account for immortal time bias (i.e., patients with DA are required to survive on 1L therapy until DA), as well as overlap between follow-up time and definition of treatment strategies, a target trial emulation approach was used, where all patients were cloned at index date and contributed follow-up to both treatment strategy arms. Hazard ratios (HRs) were approximated from odds ratios obtained from multivariate pooled logistic regression models comparing TTNT between the two treatment strategies. Sensitivity analyses using different time periods to capture DA (3-6, 3-9, and 3-18 months) were also conducted. Results were replicated in the subgroup of patients at high risk for a cardiovascular (CV) event (based on pre-existing CV conditions or a high CV risk score). Results: Among the 1,171 patients who initiated 1L single-agent ibrutinib at a starting dose of 420mg/day, the mean age was 70.4 years, with 34.6% being female. The mean Quan-Charlson Comorbidity Index score was 3.0, and 61.8% were classified as high risk for a CV event. The mean (median) follow-up was 29.8 (30.9) months. Overall, 229 (19.6%) patients had a DA at any time (178 [77.7%] adjusted their dose to 280mg/day), with a mean (median) time to DA of 9.0 (5.5) months. Of these patients, 111 (48.5%) had a DA between 3-12 months post-index date (3-6 months: 66 [28.8%] patients, 3-9 months: 87 [38.0%] patients, 3-18 months: 126 [55.0%] patients). A total of 90 (7.7%) patients initiated a next treatment, out of which 59 (65.6%) patients initiated a venetoclax-based regimen (beyond the first 180 days) as their subsequent therapy. After adjustment in a pooled logistic regression model, DA was not associated with an increased risk of having a next treatment (HR: 1.14, p-value: 0.469) ( Figure 1). In sensitivity analyses evaluating DA over periods of 3-6, 3-9, and 3-18 months, results remained non-significant, with HRs ranging from 1.13 to 1.30 (all p-values &amp;gt;0.05) ( Figure 2). Results were also consistent in the subgroup with high risk for a CV event. Conclusions: This large real-world analysis of CLL patients from academic and non-teaching hospital systems showed that undergoing DA of 1L ibrutinib yielded similar clinical outcomes compared to having no DA, with similar findings for the high CV risk subgroup. These findings, along with those from clinical trials and real-world community oncology practices, suggest that a flexible dosing approach with ibrutinib may be an effective approach in allowing patients to achieve optimal outcomes while remaining on long-term continuous 1L treatment.

Racial disparities in utilization of first-generation versus second-generation long-acting injectable antipsychotics in Medicaid beneficiaries with schizophrenia.

Multiple studies report racial disparities in antipsychotic prescription patterns. This study assessed demographic and clinical factors associated with the utilization of first-generation (FG) versus second-generation (SG) long-acting injectable (LAI) antipsychotics. This retrospective, observational cohort analysis used claims data from the IBM MarketScan® Multi-State Medicaid database. The study included adults with an LAI claim between 01-January-2009 and 31-December-2018, an ICD-9-CM or ICD-10-CM diagnosis of schizophrenia, race recorded as Black or White, and ≥12months of continuous enrollment before the index LAI. Descriptive analysis detailed the relationship between race and FG or SG LAI initiation. Multivariate logistic regression was used to assess potential associations with FG vs. SG LAI initiation, including clinical and demographic factors, comorbidities, and index year. A total of 10,773 patients were included: 6659 (62%) Black and 4114 (38%) White. Black patients had a higher utilization of FG LAIs than White patients (46.8% vs. 38.9%) over the 10years analyzed. Black patients were more likely to utilize FG LAIs than White patients (odds ratio: 1.47; 95% CI: 1.34, 1.62) after controlling for index year and covariates (race, age, gender, insurance plan type, Quan-Charlson Comorbidity index score, comorbidities, prior medications). Significant predictors of FG LAI utilization were older age, type of baseline oral antipsychotic (FG vs SG), type of coverage (managed care vs fee for service), and greater comorbidity burden. The utilization of FG LAIs was greater in Black compared to White Medicaid beneficiaries with schizophrenia over a 10-year period. These findings suggest that racial disparities exist in LAI initiation, with implications for differential quality of schizophrenia treatment.

Examining the Association Between a Modified Quan-Charlson Comorbidity Index and HIV Viral Suppression: A Cross-Sectional Analysis of DC Cohort Participants.

With the advancement of effective antiretroviral therapy, people with HIV live longer, and many are developing non-AIDS comorbidities. It is important to assess how comorbidities are associated with HIV-related health outcomes, such as viral suppression (VS). The aim of this study was to analyze the association between comorbidity burden, measured using a modified Quan-Charlson Comorbidity Index (QCCI), and VS (viral load result of <200 copies/mL). We hypothesized that an increase in QCCI score, indicating a higher risk for mortality, would correlate with lower likelihood of VS because of the burden of comorbidity treatment, possibly leading to worse antiretroviral adherence. Our analysis included participants from the DC Cohort Longitudinal HIV Study in Washington, DC. Eligible participants were aged ≥18 years and enrolled in the cohort as of January 1, 2018 (n = 2,471). A modified QCCI score, which weighs selected comorbidities (not including HIV/AIDS) and predicts mortality, was calculated using International Classification of Disease-9/10 codes from electronic health records. Multivariable logistic regressions were used to characterize the association between QCCI composite scores and VS. Participants were predominantly virally suppressed (89.6%), male (73.9%), non-Hispanic Black (74.7%), and between 18 and 55 years (59.3%). The median QCCI score was 1 (range = 1-12, interquartile range = 0-2), demonstrating predominately low mortality risk. We did not establish a statistically significant association between QCCI score and VS (adjusted odds ratio = 1.06, 95% confidence interval 0.96-1.17). Our findings suggest that a higher QCCI score was not associated with lower VS in this population, which may be partly due to the high retention in care among cohort participants.

Real-world treatment outcomes in patients with chronic lymphocytic leukemia or small lymphocytic lymphoma who were treated with first-line single-agent ibrutinib vs. chemoimmunotherapy.

e19509 Background: Real-world evidence on Bruton Tyrosine Kinase Inhibitor treatment vs chemoimmunotherapy (CIT) for patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) has been limited to certain practice settings; research using a large and more comprehensive data source is warranted. Methods: This retrospective cohort study evaluated treatment outcomes among patients with CLL/SLL treated with first-line (1L) ibrutinib (IBR) or CIT using the US claims data from the Komodo Health payer-complete dataset, derived from &gt;150 private insurers and &gt;140 million insured individuals from 2015 to 2022. This study included adult patients with CLL/SLL who initiated 1L single-agent IBR or CIT (defined as no prior CLL/SLL treatment for ≥12 months in the baseline period) on or after March 2016. Time to next treatment (TTNT) was defined as the time from initiation (index date) of 1L treatment to treatment add-on or switch to a next line of therapy ≥29 days post-index and was compared using Cox proportional hazards models. Cohorts were balanced on baseline characteristics using inverse probability of treatment weights. Results: A total of 3570 1L IBR- and 2391 CIT-treated patients were included, with the mean age 68 vs 64 years, 63% vs 66% male, and mean Quan-Charlson Comorbidity Index score 2.87 vs 3.05, respectively. Median follow-up was 26 vs 31 months, and 13% vs 26% of patients recorded a next treatment during the study period for IBR and CIT, respectively. At 1-, 3-, and 5-year post-index, the probabilities (95% confidence interval [CI]) of not initiating a new treatment were 92% (91%-93%), 83% (81%-84%) and 76% (73%-78%) vs 88% (87%-89%), 70% (68%-73%) and 56% (53%-60%) for the IBR and CIT cohorts, respectively. After controlling for baseline characteristics, 1L IBR patients were significantly less likely to initiate the next line of therapy during the study period (hazard ratio 0.61, 95% CI 0.54-0.69, p&lt;0.001). Conclusions: 1L single-agent IBR was associated with a significantly lower risk of advancing to next line of treatment compared to CIT in this large claims-based data set, reinforcing real-world effectiveness of 1L IBR for CLL in an insured US patient population. [Table: see text]

Predicting Risk of 1-Year Hospitalization Among Patients with Pulmonary Arterial Hypertension.

US claims-based analyses emphasize the substantial hospitalization burden of patients with pulmonary arterial hypertension (PAH) and the significant need for improved monitoring and more timely interventions. A claims-based predictive model may be useful to assist healthcare providers and payers in identifying patients with PAH at increased hospitalization risk. To address this aim, we constructed statistical models using baseline patient variables available in administrative healthcare claims to predict patients' risk for all-cause and PH-related hospitalization within 1year of initiating ≥ 1 PAH indicated medication. Adult patients with PAH who newly initiated ≥ 1 PAH indicated medication were selected from the MarketScan Commercial and Medicare Supplemental databases (January1, 2009-January31, 2019). Cox regression models were built with a randomly selected training set and evaluated using a validation set of remaining patients. Predictive variables for the models were selected in three steps: clinical knowledge, univariate analysis, and backward stepwise selection. Within 1year of initiating ≥ 1 PAH indicated medication, 1502/3872 (38.8%) had an all-cause hospitalization and 950/3872 (24.5%) had a pulmonary hypertension (PH)-related hospitalization. Predictive risk factors for all-cause hospitalization were Quan-Charlson Comorbidity Index (CCI) score 2-3 [hazard ratio (HR) 1.229; P = 0.038] and ≥ 4 (HR 1.531; P < 0.001), claims-based frailty index (CFI) score > 1 (highest frailty level; HR 1.301; P = 0.018), hemoptysis (HR 1.254; P = 0.016), malaise/fatigue (HR 1.150; P = 0.037), history of PH-related hospitalization (HR 1.171; P = 0.011), non-PH-related ER visit (HR 1.713; P = 0.014), and higher non-PH-related outpatient visit cost (HR 1.069; P < 0.001). Predictive risk factors for PH-related hospitalization were female sex (HR 1.264; P = 0.004), Quan-CCI score ≥ 4 (HR 1.408; P = 0.008), portal hypertension (HR 1.565; P = 0.019), CFI score > 1 (HR 1.522; P = 0.002), dyspnea (HR 1.259; P = 0.023), and history of PH-related hospitalization (HR 1.273; P = 0.002). The US claims-based predictive models showed acceptable performance to predict 1-year hospitalization among patients with PAH.

Real-World Comparison of Time to Next Treatment for Patients with CLL Initiated on First-Line Treatment with Ibrutinib Versus Acalabrutinib

Introduction: Treatment guidelines recommend Bruton's tyrosine kinase inhibitors (BTKi) ibrutinib (once-daily) and acalabrutinib (twice-daily) as preferred regimens for chronic lymphocytic leukemia (CLL); however, there are no studies comparing the effectiveness of ibrutinib and acalabrutinib as first-line (1L) therapy in CLL. This study investigated time to next treatment (TTNT) for patients with CLL initiated on 1L ibrutinib or acalabrutinib in real-world (RW) clinical practice in the US. Methods: Specialty pharmacy electronic medical records from academic integrated care networks (11/21/2018-4/30/2022) were used to identify adults with CLL who initiated ibrutinib or acalabrutinib in 1L (index date) on or after the date of acalabrutinib approval for CLL (11/21/2019). A washout period of ≥12 months without antineoplastic agent use pre-index was required to confirm use as 1L therapy. Patients were excluded if there was concomitant use of another antineoplastic agent during the first 28 days post-index. Characteristics evaluated in the 12-month baseline period were compared between ibrutinib and acalabrutinib cohorts using t-tests for continuous variables and chi-square tests for categorical variables. TTNT was defined as the time from the index date to the initiation a next or additional treatment. Patients without a next/additional treatment were censored at death or end of data (4/30/2022). Patients with a within-class BTKi switch at any time post-index were censored at time of switch, as this may have indicated a switch due to tolerability rather than progression. Patients who added an anti-CD20 antibody or venetoclax to the BTKi within 180 days post-index were censored at time of add-on, as these may not have indicated overt disease progression but rather late initiation of a second anti-cancer agent as a 1L combination treatment strategy. Beyond 180 days, anti-CD20 or venetoclax add-ons were considered as a next/additional treatment. TTNT was described using Kaplan Meier curves and compared between ibrutinib and acalabrutinib using a Cox proportional hazards model adjusted for the following baseline variables: age, gender, region, race, year of index date, Quan-Charlson Comorbidity Index (Quan-CCI), chronic pulmonary disease (CPD), peripheral vascular disease, hypertension, atrial fibrillation (AF), metastatic cancer, use of corticosteroids, and use of antiplatelets. Results: Among 710 and 373 patients in the ibrutinib and acalabrutinib cohorts, respectively, mean age was 71.5 and 72.4 years (P=0.159) and 38.5% and 38.3% were female (P=0.971; Table). Mean baseline Quan-CCI score was similar for ibrutinib and acalabrutinib (3.1 vs 3.0; P=0.597); a higher proportion of patients in the ibrutinib cohort had CPD (13.6% vs 8.8%; P=0.024), peripheral vascular disease (7.8% vs 4.1%; P=0.022), and hypertension (41.4% vs 32.2%; P=0.003) at baseline, while AF was similar (7.0% vs 9.9%, P=0.098). Baseline corticosteroid use was lower in the ibrutinib cohort (14.5% vs 20.1%; P=0.018), but antiplatelet use was higher (7.0% vs 3.5%; P=0.017). Mean (median [range]) follow-up was 17.1 (18.1 [1.0-29.3]) months for the ibrutinib cohort and 12.5 (11.9 [1.0-29.1]) months for the acalabrutinib cohort. Four/710 (0.6%) patients in the ibrutinib cohort and 16/373 (4.3%) in the acalabrutinib cohort added an anti-CD20 antibody to the BTKi within 180 days and were censored at that point. Ten/710 (1.4%) and 8/373 (2.1%) patients added venetoclax to ibrutinib or acalabrutinib within 180 days and were censored at that point. The proportion of patients in the ibrutinib cohort who initiated a next or additional treatment was 5.9% relative to 7.5% for acalabrutinib. After adjusting for baseline characteristics, patients treated with acalabrutinib were 89% more likely to start a next or additional treatment than those treated with ibrutinib (hazard ratio = 1.89 [95% confidence interval] = [1.12, 3.13]; P=0.016; Figure). Results were similar when censoring anti-CD20 add-ons at any time (hazard ratio = 1.82 [95% confidence interval] = [1.08, 3.03]; P=0.025). Conclusions: In this large US RW study, patients with CLL treated with 1L acalabrutinib were significantly more likely to start a next treatment or add/intensify therapy than those treated with 1L ibrutinib. RW treatment patterns also suggest a higher propensity to add an anti-CD20 antibody to acalabrutinib versus ibrutinib in 1L CLL. Figure 1View largeDownload PPTFigure 1View largeDownload PPT Close modal

Burden of Hospitalization before and after a Disease Progression Following Triple-Class Exposure in Patients with Relapsed and Refractory Multiple Myeloma

Introduction: Multiple myeloma (MM) is a plasma cell malignancy with various clinical complications. Patients with relapsed and refractory multiple myeloma (RRMM) often suffer from disease progression and cycle through multiple treatments, including those from the same drug classes that they have failed before. Disease progression is usually associated with significant burden, including high health care resource utilization (HCRU) and costs. However, no current known literature quantifies HCRU and costs before and after disease progression in RRMM patients who have been exposed to multiple classes of therapies. This study aims to describe and compare hospitalization use and associated costs before and after disease progression in patients with RRMM who are triple-class exposed (TCE; defined as exposure to a proteosome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody). Methods: This retrospective cohort study used the Optum Clinformatics® Data Mart database from 1/1/2012 to 12/31/2021. Adults with ≥2 diagnosis codes for MM (ICD-10-CM: C90.0x) ≥30 days apart and who received a subsequent line of therapy (LOT) after becoming TCE were included. The start of a subsequent LOT after TCE was used as a surrogate to define disease progression, and the initiation date of the latest of such LOTs was defined as the index date if multiple eligible LOTs were observed for the same patient. Patients were also required to have ≥6-month continuous enrollment (CE) in medical and pharmacy plans before and after index. Patient characteristics were described at index and during the 6-month baseline period. A 2-month pre-post analysis was performed to compare all-cause inpatient admissions, intensive care unit (ICU) stays, hospitalization length of stay, and direct inpatient costs. Categorical variables were compared using McNemar's test, and counts and costs were compared using paired generalized linear models. Subgroup analyses were performed in patients with commercial insurance or Medicare Advantage. Results: A total of 523 patients met the study criteria. The mean age was 70.2 years, 63.1% were White, 51.2% were female, 72.5% had Medicare Advantage, the mean Quan-Charlson comorbidity index was 4.2, and 34.8% had ≥4 prior LOTs within the CE period containing the index date. The proportion of patients who had an all-cause inpatient admission (20.1% vs 12.8%, P = 0.0008) and an ICU stay (6.5% vs 1.9%, P = 0.0004) were significantly higher during the 2-month post- versus pre-index period. During the 2-month post-index period, patients on average had significantly more all-cause inpatient admissions (0.29 vs 0.16, P <0.0001). The mean inpatient length of stay for the cohort was numerically higher during the 2-month post- versus pre-index period (1.67 vs 1.07 days, P = 0.0751). The mean per-month cost of all-cause hospitalization was significantly higher during the 2-month post- versus pre-index period ($3,590.81 vs $1,267.18, P = 0.0008). The majority of the all-cause hospitalization use and costs (>90%) were MM-related. Similar trends were observed among commercial and Medicare Advantage patients. Conclusions: This study found a pronounced increase in hospitalization and costs in the 2 months immediately following disease progression in RRMM patients who are TCE. The data may support economic assessment and value framework for innovative treatments with significant prolonged progression-free survival. In addition, there is a need to focus on multifaceted efforts to improve overall well-being and the total cost of care for patients with RRMM.

A US National View of Prevalent and Newly Diagnosed Multiple Myeloma in 2021: A Retrospective Analysis of National All-Payer Claims Database

Introduction: Multiple myeloma (MM) is a rare and heterogeneous cancer with steadily improving patient survival in recent years due to advancement in therapies. Updates to the prevalence and incidence of MM using the latest nationally representative data are needed to support population health management, resource planning, and health economic assessments. Furthermore, disparities in disease burden, access to care, treatment patterns, and outcomes could exist across patient subpopulations with MM, prompting a need for comprehensive data to understand the population. Currently, there is a gap in such data due to the highly fragmented health care system in the US in which real-world evidence is often siloed and represents only a portion of the population. This study aims to provide a national view of MM by estimating the prevalence and incidence in US adults overall and by state/territory, payer type, race, and ethnicity in 2021. Methods: This is a retrospective study using the All-Payer Real-World Multiple Myeloma Research-Ready Data built using the US national all-payer claims database (APCD), which covers ~87% of the nationally insured population from 1/1/2014 to 1/31/2022. Data included adults with ≥2 claims with MM diagnosis (ICD-9-CM: 203.0x and ICD-10-CM: C90.0x) who had continuous capture with medical and pharmacy benefits for ≥12 months prior to and 30 days after the first MM diagnosis date. To be included in this study, patients also had to have ≥1 claim in 2021. The latest claim date in 2021 was defined as the index date. A subcohort of patients with newly diagnosed MM (NDMM; incident MM cases) were additionally required to have their first MM diagnosis date (the index date for the NDMM cohort) in 2021. Prevalence and incidence of MM were estimated using the number of patients in MM and NDMM cohorts, divided by the total APCD adult population with similar continuous capture eligibility. Prevalence and incidence were calculated for the overall population and stratified by state/territory, payer type, race, and ethnicity. Patient characteristics were captured at the index date and during the baseline period. The proportion of patients with NDMM who initiated their first treatment in 2021 and the time from diagnosis to their first treatment were captured. Results: A total of 63,281 MM and 9,674 NDMM patients met the study criteria. Mean age was 71.1 and 70.0 years, 51.4% and 52.9% were male, and 68.7% and 72.0% were covered by Medicare, respectively. Overall, about two-thirds of the patients had available race (74%), ethnicity (69%), and income data (76%), while 46% had education status. Among those with data, 15.6% of MM and 14.7% of NDMM cohorts were Black, 12.2% and 11.9% were Hispanic, 65.1% and 64.5% had an annual income ≤$50,000, and 67.5% and 67.2% had high school as their highest level of education. The overall prevalence of MM was 73.8 per 100,000 adults in 2021, with the prevalence being the highest among those who were Black (124.8), non-Hispanic (101.3), covered by Medicare (245.2), and residing in the US Virgin Islands (243.6) and Arkansas (126.5). The overall incidence of NDMM was 11.3 per 100,000 adults in 2021, and the incidence was highest among those who were Black (17.8), non-Hispanic (15.3), covered by Medicare (39.3), and those residing in Puerto Rico (24.5), the US Virgin Islands (22.8), and Washington (20.7; Tables 1 and 2). The mean Quan-Charlson comorbidity index (excluding MM diagnosis) was 2.8 for the MM cohort and 2.4 for the NDMM cohort. Commonly observed comorbidities for both cohorts included anemia (44.8% and 47.4%), diabetes with chronic complications (23.9% and 22.4%), peripheral neuropathy (24.8% and 15.2%), renal impairment (22.7% and 20.1%), and infections (21.9% and 14.4%). There were 3,377 (35%) patients with NDMM who initiated their first treatment in 2021, with a mean and median time to treatment of 50.8 (standard deviation = 67.5) and 27 days. Conclusions: While the prevalence and incidence of MM in 2021 estimated in this study were consistent with projected estimates from the literature, variations in rates of MM were observed across race, ethnicity, payer type, and state/territory, indicating potential disparities in the burden of MM. Such a comprehensive view of rates of MM could serve as a foundation for future health policy decisions, quality improvement, resource deployment, and initiatives to address health disparities across subpopulations. Figure 1View largeDownload PPTFigure 1View largeDownload PPT Close modal

Healthcare Resource Utilization and Costs of Relapsed or Refractory Patients with Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Treated with Ibrutinib

Introduction: Chronic lymphocytic leukemia (CLL) is the most common type of leukemia among adults in the United States (US). First-line (1L) treatment includes targeted treatments like the Bruton's tyrosine kinase inhibitor ibrutinib. While treatment with ibrutinib can result in durable responses and improved survival, patients who progress while on ibrutinib have been shown to have a poor prognosis. However, there is currently limited literature describing the economic burden associated with ibrutinib failure. Therefore, this study was conducted to compare the healthcare resource utilization (HRU) and costs between patients with and without relapse/refractoriness (R/R) to ibrutinib in the US. Methods: Data from Optum Clinformatics DataMartTM (01/2007-03/2020) were used to identify adult patients with ≥2 medical encounters with a diagnosis code for CLL or small lymphocytic lymphoma (SLL) on different dates, ≥1 pharmacy claim for ibrutinib therapy as a single-agent or combination therapy (first dispensing was the index date), and ≥12 months of continuous enrollment pre-index date (baseline period). Patients with a diagnosis for mantle cell lymphoma or with evidence of anticancer therapy (antineoplastic, radiation, or cell therapy) during baseline were excluded. Patients were categorized as R/R to ibrutinib if they received treatment with another antineoplastic after switching/discontinuing ibrutinib; all remaining patients were considered not R/R to ibrutinib (i.e., remained on ibrutinib for the whole observation period, restarted ibrutinib, or discontinued ibrutinib treatment without initiating a different antineoplastic). Patients who died on ibrutinib or within 6 months of discontinuation without subsequent antineoplastic therapy were excluded. All-cause and CLL/SLL-related HRU and healthcare costs incurred from the index date to the earliest of death, end of data availability or insurance coverage were evaluated and then compared in the population R/R and not R/R to ibrutinib using adjusted rate ratios for HRU and adjusted cost differences for costs. P-value and 95% confidence interval (CI) were obtained from non-parametric bootstrap procedures. Results: Among 1,126 patients treated with ibrutinib, mean age was 72.5 years and 38.8% were female. Patients had a mean Quan-Charlson Comorbidity index of 3.4. Over 1.8 years of observation, patients treated with ibrutinib had mean (SD) 0.47 (0.80) all-cause inpatient stays, 0.67 (1.50) emergency room (ER) visits, and 28.4 (18.1) outpatient visits, resulting in $148,758 (77,099) per patient-year total all-cause healthcare costs. CLL/SLL-related HRU amounted to 0.37 (0.69) inpatient stays, 0.19 (0.48) ER visits, and 12.0 (10.8) outpatient visits, resulting in $29,079 (51,165) per patient-year CLL/SLL-related medical costs. A total of 207 patients were R/R to ibrutinib (mean age: 73.4 years; 40.1% female) and 919 were not R/R to ibrutinib (mean age: 72.3 years; 38.5% female). Over a mean observation of 2.4 years (R/R) and 1.8 years (not R/R), patients R/R to ibrutinib had significantly more all-cause inpatient stays (rate ratio [95% CI] = 1.92 [1.57, 2.37]; P<0.001), ER visits (1.81 [1.31, 2.61]; P<0.001), and outpatient visits (1.51 [1.38, 1.65]; P<0.001) than patients not R/R to ibrutinib (Table). This led to $16,427 (95% CI: 4,627, 28,103) significantly higher incremental all-cause healthcare costs per patient-year in the R/R cohort versus not R/R (P=0.006). Similarly, rates of CLL/SLL-related inpatient stays (rate ratio [95% CI] =1.91 [1.51, 2.40]; P<0.001), ER visits (1.93 [1.43, 2.66]; P<0.001), and outpatient visits (1.80 [1.62, 2.02]; P<0.001) were significantly higher among patients R/R to ibrutinib versus not R/R (Table). This resulted in $38,252 (95% CI: 30,505, 48,023) significantly higher incremental CLL/SLL-related medical costs per patient-year in the R/R cohort versus not R/R (P<0.001). Conclusions: In this US real-world study, patients with CLL who were treated with ibrutinib incurred substantial HRU and costs. This burden was shown to be even larger for patients who were R/R to ibrutinib, with CLL/SLL-related healthcare resource use being nearly twice higher for R/R compared to non-R/R patients. These findings highlight the unmet treatment need for patients with CLL who are R/R to ibrutinib. Figure 1View largeDownload PPTFigure 1View largeDownload PPT Close modal

S819 Non-Biologic Medication Use Pre- and Post-Ustekinumab Initiation Among Patients With Ulcerative Colitis

Introduction: Among patients with ulcerative colitis (UC), treatment with immunomodulators, 5-ASA (5-aminosalicylic acid), and corticosteroids while receiving biologic agents is common. However, real-world information on non-biologic medication use among UC patients initiated on ustekinumab is limited. This study compared non-biologic medication use pre- and post-ustekinumab initiation among UC patients. Methods: Adults with UC initiated on ustekinumab (index date) between 10/18/2019 (FDA approval of ustekinumab for UC) and 10/31/2020 were selected from the de-identified health insurance claims Symphony Health Solutions’ Patient Transactional Datasets. Patients were excluded if they had a claim for Crohn’s disease anytime or for other autoimmune diseases pre-index. Patients were required to have: ≥1 claim for UC in the 12 months pre-index period (baseline), ≥2 ustekinumab claims within 90 days of the index date, and ≥6 months of follow-up. Non-biologic agent use in the 6 months period before and after the initiation of ustekinumab was compared with a logistic model estimated by generalized estimating equation. Results were reported as odds ratio with 95% confidence interval and p-values. Results: A total of 760 patients with UC were initiated on ustekinumab and selected for the study (age 44.6 years old; 48.9% female; baseline biologic use 52.1% [potentially underestimated given the database open nature]; Quan-Charlson comorbidity index 0.62). The likelihood of immunomodulator and 5-ASA use decreased by 22% and 46%, after ustekinumab initiation (all P< 0.05). Similarly, patients were 52% less likely to use any corticosteroids and 34% less likely to use corticosteroids for ≥60 days (all P< 0.05). Further, there was no significant changes observed for the use of opioids (18.9% vs. 17.4%) or the use of anti-diarrheals (5.9% vs. 6.1%), and patients were 29% less likely to use GI antispasmodics after ustekinumab initiation (P< 0.05; Table). In a descriptive analysis, corticosteroids use numerically decreased at each month post-ustekinumab from 25.4% during the first 30 days following the index date compared to 17.4% within 150-180 days post-ustekinumab (Figure). Conclusion: In this real-world study of patients with UC, initiating ustekinumab was associated with a significant decrease in the use of immunomodulators, 5-ASA, and corticosteroids. Longer-term data are necessary to better understand non-biologic medication use after biologic initiation and inform treatment choice for patients with UC.Figure 1.: Corticosteroid use during the 6 months post-ustekinumab initiation (N=760). Table 1. - Non-biologic medication use in the 6-month period before vs after the initiation of ustekinumab Pre-ustekinumab Post-ustekinumab Odds ratio1 (95% CI), p-value N = 760 Use of immunomodulators 120 (15.8) 97 (12.8) 0.78 (0.64, 0.95), 0.014* Use of 5-ASA 312 (41.1) 208 (27.4) 0.54 (0.47, 0.62), < 0.001* Use of corticosteroids 481 (63.3) 346 (45.5) 0.48 (0.41, 0.57), < 0.001* Cumulative use2 ≥60 days 243 (32.0) 180 (23.7) 0.66 (0.55, 0.79), < 0.001* Cumulative use2 ≥90 days 151 (19.9) 114 (15.0) 0.71 (0.58, 0.87), 0.001* ≥1 episode3 ≥ 60 days 201 (26.4) 156 (20.5) 0.72 (0.59, 0.87), < 0.001* ≥1 episode3 ≥ 90 days 118 (15.5) 89 (11.7) 0.72 (0.56, 0.93), 0.013* Use of opioids 144 (18.9) 132 (17.4) 0.90 (0.74, 1.10), 0.296 Use of antidiarrheals 45 (5.9) 46 (6.1) 1.02 (0.76, 1.38), 0.879 Use of GI antispasmodics 86 (11.3) 63 (8.3) 0.71 (0.54, 0.93), 0.013* Abbreviations: CI: Confidence interval; GI: Gastrointestinal; 5-ASA: 5-aminosalicylic acid Notes: (1) Odds ratio obtained from a logistic model estimated with generalized estimating equation; (2) Non-overlapping days of supply included; (3) A therapy exposure gap of 14 days of supply was used to define continuous use

Occurrence of Thromboembolic Events and Mortality Among Hospitalized Coronavirus 2019 Patients: Large Observational Cohort Study of Electronic Health Records.

Background Most symptoms of coronavirus 2019 (COVID-19) are mild; however, some patients experience cardiovascular complications, including thromboembolic events and death. Data are needed to better inform prevention and treatment of these events. This analysis was designed to describe patient characteristics, medication use, thromboembolic events, and all-cause mortality in hospitalized COVID-19 patients in the United States. Methods This retrospective, observational cohort study identified adults hospitalized with COVID-19 (January 21, 2020-January 07, 2021) in the deidentified Optum COVID-19 Electronic Health Records dataset. Thromboembolic events and all-cause mortality were collected at any time during the variable follow-up period (up to 50 weeks). Results Of 181,995 COVID-19 patients who met eligibility criteria, 40,524 (22.3%) were hospitalized with COVID-19. Hospitalized patients had a mean age of 63 years and a Quan-Charlson comorbidity index of 1.3. Anticoagulants were used in 89.2% of patients during hospitalization and in 18.7% of postdischarge patients. Of hospitalized patients, 17.6% had a thromboembolic event during the entire follow-up period (mean time to the first event of 15 days), of whom 13.4% had an event during hospitalization; of discharged patients, 4.3% had a thromboembolic event (mean time from discharge to event of 43 days). Death during the follow-up period was reported in 15.0% of patients. Conclusions In this large, observational cohort study, patients hospitalized with COVID-19 had high rates of thromboembolic events during hospitalization and in the postdischarge period; mortality was also high in this population. Anticoagulant use was common during hospitalization. These findings support further studies to optimize in-hospital and extended prophylaxis for hospitalized COVID-19 patients.

BURDEN OF ILLNESS IN PATIENTS WITH PULMONARY HYPERTENSION DUE TO COPD IN US ADMINISTRATIVE CLAIMS DATA

BURDEN OF ILLNESS IN PATIENTS WITH PULMONARY HYPERTENSION DUE TO COPD IN US ADMINISTRATIVE CLAIMS DATA

Overall survival by race and ethnicity among men with metastatic castration-resistant prostate cancer (mCRPC) in the U.S. Medicare population.

144 Background: Previous studies reported mixed findings about racial and ethnic disparities in overall survival (OS) in mCRPC. This study describes OS by race and ethnicity among men with mCRPC in the US Medicare population. Methods: Men newly diagnosed with mCRPC were identified in Medicare fee-for-service claims during 1/1/2014–6/30/2019. Adult men were required to have a diagnosis of prostate cancer, metastasis diagnosis, castration-resistance using a published claims-based algorithm, and continuous insurance coverage for ≥1 year before and ≥6 months after index mCRPC diagnosis unless patients died. OS from mCRPC diagnosis and from start of first-line (1L) therapy for mCRPC for White (W), Black (B), Hispanic (H), and Asian (A) men were estimated using Kaplan-Meier analysis and Cox proportional hazards models adjusting for patient characteristics and 1L mCRPC therapy type or no treatment. Results: Among 14,780 men with mCRPC in this study, 75% were W, 14% were B, 6% were H, 3% were A, and 3% were of other or unknown race. Mean age at mCRPC diagnosis was 76 years among W men; B men had similar age while H and A men were slightly older than W men (Table). B, H, and A men had higher Quan-Charlson Comorbidity Index (CCI) than W men. Median follow-up after mCRPC diagnosis was 17 months. Similar proportions of W, H and A men (78%, 78%, and 79%, respectively) and lower proportion of B men (75%) initiated 1L life-prolonging therapy after mCRPC diagnosis. Among treated men, higher proportions of B, H, and A men (71%, 74%, and 73%, respectively) initiated 1L therapy with novel hormonal therapy than W men (64%). Median OS after mCRPC diagnosis was 26.0, 22.3, 22.9, and 24.2 months among W, B, H, and A men, respectively. Median OS after initiation of 1L mCRPC therapy was 23.8, 21.1, 19.9, and 24.1 months among W, B, H, and A men, respectively. After adjusting for patient characteristics and 1L treatment, OS was not different for B and H men relative to W men, while A men had lower risk of death. (Table). Conclusions: This study found no statistically significant differences in overall survival in mCRPC for B and H men and lower risk of death for A men relative to W men after adjusting for patient characteristics and treatment in the US Medicare population.[Table: see text]