HCPCS Codes Research Articles

All-cause claims analysis of the LATERA absorbable nasal implant vs surgical repair in patients with nasal valve collapse

Aims To compare all-cause claims associated with the LATERA Absorbable Nasal Implant and surgical repair of nasal vestibular stenosis in patients with nasal valve collapse. Methods This retrospective cohort study utilized data from STATinMED RWD Insights. A defined set of HCPCS, ICD-10-CM and CPT codes were used to identify patients with ≥1 claim for a LATERA procedure, and patients with ≥1 claim for surgical repair between June 1, 2015– March 31, 2023. Patients with continuous capture for at least 12 months before and at least 6 months after the index date were selected. The index date was defined as earliest date of encounter for a LATERA or surgical repair procedure. Inverse probability of treatment weighting (IPTW) was used to ensure balance between cohorts. Descriptive analyses were provided for all claims data using standard summary statistics. All-cause claims were assessed during the baseline, index date, and follow-up period. Chi-squared tests and independent sample t-tests were used to assess differences in cohorts for categorical and continuous variables, respectively. Results The study population included 5,032 LATERA patients and 26,553 surgical repair patients. During the baseline and follow-up periods, the matched cohorts exhibited similar all-cause claims. On the index date, LATERA patients incurred lower claims vs. surgical repair, likely due to LATERA’s ability to be implanted in the physician office setting. LATERA patients and surgical repair patients mean (SD) total costs were $9,612 [$14,930] vs $11,846 [$17,037] (p ≤ 0.0001), respectively. Conclusions Treatment with the LATERA Absorbable Nasal Implant is a potentially cost saving option for payers on the index date compared to traditional surgical repair in patients with nasal valve collapse due to the ability to be performed in the office. All-cause claims were similar in the baseline and follow-up periods. When performed with concomitant procedures, all-cause claims during follow-up were similar between groups.

Cardiotoxicity of immune checkpoint inhibitors: A retrospective cohort study of 93,362 patients.

e14529 Background: The advent of immune checkpoint inhibitors (ICI) as therapy for a wide array of cancer types has extended patient survival and propelled the field of oncology into a new era. However, notable immune-related adverse events have been observed that transgress self-tolerance. Among these adverse events, myocarditis is emerging as a serious and often lethal toxicity. This study aims to assess whether a significant association exists between immune checkpoint inhibitors and myocarditis and/or pericarditis. Methods: The TriNetX research network was used for this study. Two patient cohorts were created by using International Classification of Disease 10 (ICD-10) codes and HCPCS codes. Both patient cohorts consisted of patients with malignancy (C00-D49) and no history of myocarditis. One cohort was treated with immunotherapy while the other was excluded from such exposure (HCPCS codes were used for ipilimumab, nivolumab, pembrolizumab, and durvalumab). The cohorts were balanced for age, race, gender, and ethnicity by propensity score matching and the greedy nearest neighbor algorithm, resulting in 46,681 patients in each arm. They were then evaluated for the development of myocarditis or pericarditis (I51.4, I31, I30) over the subsequent 5 years. Results: Cancer patients treated with immunotherapy were significantly more likely to experience myocarditis or pericarditis than those who did not receive those agents (7% vs 1.2%, RR 5.8, 95% CI (5.33,6.36), P value <0.0001). Conclusions: This study suggests a significant association between the use of immunotherapy agents and the development of myocarditis and pericarditis. Further studies are necessary to better delineate the mechanism by which these cardiac toxicities occur, establish guidelines for surveillance of its onset, and discover how to suppress the immune-toxicities while retaining anti-tumor effect.

Abstract PO5-10-10: Disparities in Work RVUs for Breast and Prostate Cancer Operations

Abstract Introduction: In a vast array of different methods used to quantify healthcare processes, the Relative Value Unit (RVUs) has become the federal precedent set by the Centers for Medicare and Medicaid Services (CMS) to assign value to different procedures and processes. The current RVU conversion factor in 2023 is $33.06 per unit. Physician work RVUs, malpractice RVUs (MP RVUs) and practice expense RVUs (PE RVUs) were first implemented in 1992 as a system for assigning payment to physicians while providing administrative budgeting based on clinical and liability expenditures. These values are subject to reevaluation every 5 years at minimum, or as new services become available. The CMS updates it’s RVU model by consulting the American Medical Association’s Specialty Society Relative Value Scale Update Committee (RUC), which controversially sets higher values in certain fields of medicine than others. This article will objectively analyze the RVUs provided by the CMS to surgical oncologists treating breast cancer and compare them to the RVUs compensated to urologists treating prostate cancer, across multiple modalities. Methods: Work RVUs, practice expense RVUs, and malpractice RVUs were obtained from the CMS 2023 physician fee schedule, using the HCPCS codes to identify the services from their database. Estimated pre-evaluation times, intra-procedure times, immediate post service times, and total procedural times were gathered from the CY 2023 Final Rule Physician Work Time database provided by CMS. The HCPCS codes used for mastectomy variations were 19301 for partial mastectomy, 19302 for partial mastectomy with lymph node removal, 19303 for a simple complete mastectomy, 19305 for a radical mastectomy, 19306 for an urban type radical mastectomy, and 19307 for a modified radical mastectomy. The HCPCS codes used for armpit lymph nodes were 38740 and 38745 for axillary lymph node dissections. The HCPCS codes used for prostatectomy variations were 55810 and 55812 for a radical perineal prostatectomy, 55840 and 55845 for a radical retropubic prostatectomy, and 55866 for a laparoscopic retropubic radical prostatectomy. The HCPCS codes used for pelvic lymph nodes were 38571-38573 for laparoscopic lymphadenectomies. Work RVUs were compared between mastectomy and prostatectomy procedures, and axillary node procedures were compared to those of pelvic lymph nodes. To further asses any true disparities in the values assigned to the operations, a second analysis of work RVUs divided by total operation times were compared between their surgical counterparts. Conclusion: Values collected from CMS indicate 59% more RVUs are provided to urologists for prostatectomies than breast surgeons for mastectomies per procedure, and 12% more per hour of total procedure time. Additionally, the CMS indicates on average 29% more work RVUs are provided to urologists for pelvic lymph node removals than breast surgeons for axillary lymph node removals, and 3.4% more per hour of total procedure time (appendix 1). Breast cancer and prostate cancer have similar incidence and mortality rates, but one affects mostly women and the other only men. The decision by the Center of Medicare and Medicaid Services to place a higher value in prostate cancer management is unknown, and elicits future analysis with surveyed procedural data across the nation for statistical significance determination. Appendix 1 allocated work RVUs, practice expense RVUs, malpractice RVUs, and median operative times for prostate cancer and breast cancer operations. Citation Format: Noah Khosrowzadeh, Kyle Chambers, Matthew Gompels, Cyrus Washington, Jessica Meshman. Disparities in Work RVUs for Breast and Prostate Cancer Operations [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO5-10-10.

Abstract PO3-03-07: Patterns of Chemotherapy Utilization among Elderly Patients with Early-Stage Triple-Negative Breast Cancer

Abstract Background: Patterns of adjuvant and neoadjuvant chemotherapy use among patients with breast cancer have changed over time. Historically, adjuvant chemotherapy has been the standard treatment approach for patients with triple-negative breast cancer after surgical resection, aiming to eliminate any remaining cancer cells and reduce the risk of recurrence. Advancements in treatment strategies, research findings, and clinical guidelines have contributed to shifts in cancer care approaches, with an increase in the use of neoadjuvant chemotherapy. In this study, we explore chemotherapy utilization in a large cohort of elderly patients diagnosed with early-stage triple-negative breast cancer (TNBC). Methods: Data were obtained from the SEER- and Texas Cancer Registry (TCR)-linked Medicare databases. We identified female patients aged 66 years or older, diagnosed with early-stage (localized or regional disease) TNBC between 2010 and 2017 with claims until 2019. We identified the use of chemotherapy using HCPCS codes from outpatient and physician’s carrier claims. We used descriptive statistics and analyzed overall chemotherapy utilization and time trends of neoadjuvant versus adjuvant use via the Cochran-Armitage trend test, and evaluated factors associated with chemotherapy use via logistic regression models. This study adhered to the STROBE reporting guidelines for cohort studies. Results: Among 8,848 patients with localized or regional stage TNBC (median age 74) a total of 5,159 (58%) were treated with chemotherapy. The rate of chemotherapy utilization increased yearly from 52% in 2010 to 66% in 2017 (p< 0.001). After multivariable adjustment, any chemotherapy use was associated with recent year of diagnosis (OR=1.77; 95%CI 1.54-2.04), regional stage compared to localized (OR=3.78; 95%CI 3.34-4.27), and Northeastern region compared to South (OR=1.2; 95%CI 1.06-1.37). Conversely, decreased chemotherapy use was associated with age ≥76 (OR=0.24; 95%CI 0.2-0.27), being single (OR=0.76; 95%CI 0.67-0.86), and higher comorbidity score (OR=0.69; 95%CI 0.61-0.78). Among chemotherapy-treated patients, 3,808 (73.8%) received it in the adjuvant setting, 722 (14.0%) received it in the neoadjuvant setting, and 629 (12.2%) received chemotherapy both preoperatively and postoperatively. Among those who were treated with any chemotherapy, the percentage of patients treated with neoadjuvant chemotherapy increased from 15.2% in 2010 to 37.4% in 2017 (p< 0.001). Among patients treated with chemotherapy, neoadjuvant chemotherapy use was associated with recent year of diagnosis (OR=3.38; 95%CI 2.77-4.12), regional stage (OR=3.28; 95%CI 2.86-3.77), and inversely associated with older age (OR=0.77; 95%CI 0.64-0.94), non-White, non-Hispanic, non-Black race or ethnicity (OR=0.64 95%CI 0.45-0.94), non-metro area (OR=0.61; 95%CI 0.5-0.74), and Northeastern region (OR=0.66; 95%CI 0.56-0.78). Conclusion: Our study highlights the significant changes in patterns of adjuvant and neoadjuvant chemotherapy use among elderly patients with early-stage TNBC. We observed an increasing trend in chemotherapy utilization, with a notable shift from adjuvant to neoadjuvant treatment. This transition reflects the evolving landscape of cancer care and the adoption of more personalized approaches to treatment, with increased utilization of neoadjuvant chemotherapy offering opportunities for better risk assessments and tailored treatment strategies. Citation Format: Catalina Malinowski, Xiudong Lei, Sharon Giordano, Marianna Chavez. Patterns of Chemotherapy Utilization among Elderly Patients with Early-Stage Triple-Negative Breast Cancer [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO3-03-07.

Abstract PO3-03-08: Use of adjuvant Capecitabine after neoadjuvant chemotherapy: A Cohort Study among Elderly Patients with Early-Stage Triple-Negative Breast Cancer

Abstract Background: The use of capecitabine in the adjuvant setting in patients with residual disease after neoadjuvant chemotherapy has been incorporated into practice based on the results of the CREATE-X trial. We evaluate utilization patterns of adjuvant capecitabine use, its association with outcomes, and subsequent hospitalizations and emergency room (ER) visits among elderly patients with early-stage triple-negative breast cancer (TNBC). Methods: We identified patients aged ≥66, diagnosed with early-stage TNBC between 2010 and 2017 in the SEER and Texas Cancer Registry (TCR)-linked Medicare databases. All patients were treated with neoadjuvant chemotherapy for localized or regional-stage disease. All patients had continuous enrollment in Medicare Parts A & B without a Health Maintenance Organization enrollment 12 months before cancer diagnosis and 12 months after cancer diagnosis. Chemotherapy administration was identified using HCPCS codes from outpatient and physician’s carrier claims. We analyzed the patterns of capecitabine use, its association with survival outcomes, and the frequency of ER visits and hospitalizations during treatment (between the first capecitabine claim and 30 days after the last claim for capecitabine). Descriptive statistics were used. Primary analyses included logistic regression, Kaplan-Meier estimates, and Cox regression models with propensity score adjustments. This study adhered to the STROBE guidelines for cohort studies. Results: 1,239 patients with localized or regional TNBC treated with neoadjuvant chemotherapy were included (median 72 years). Of them, 96 (7.7%) were prescribed adjuvant capecitabine. Treatment with capecitabine was associated with recent year of diagnosis, regional disease, and residing in non-metropolitan areas. Specifically, the use of capecitabine increased from 1% in 2010 to 10% in 2016 and 21% in 2017. The median duration of capecitabine treatment was 4 cycles. In multivariable logistic regression analyses, older age was associated with decreased odds of receiving ≥4 cycles of capecitabine (OR=0.25; 95% CI: 0.11–0.60; p =0.002). Among capecitabine users, 3-year OS was 46% and 78% for patients who received 1-3 and ≥4cycles of capecitabine, respectively (p< 0.001). The 3-year estimate of BCSS was 43% and 85% respectively (p< 0.001). After multivariable adjustment for comorbidity score, stage, and propensity score, receiving ≥4 cycles of capecitabine was associated with decreased risk of death (HR=0.29; 95%CI 0.13–0.63, p=0.002) and breast cancer-specific death (HR=0.15; 95%CI: 0.05–0.51, p=0.002) compared to receiving 1-3 cycles. Twenty-seven (28%) patients had ER/hospitalization during capecitabine treatment; median time from initial capecitabine claim to ER/hospitalization was 24 days (IQ 13-39). The median number of capecitabine cycles was 3 (IQR 2-5) and 5 (IQR 3-8) for those with and without ER/hospitalization (p=0.02). The most common diagnosis codes associated with ER/hospitalization included pleural effusion, GI symptoms, pneumonia, and acute kidney failure. A higher comorbidity score at diagnosis was associated with an increased risk of ER/hospitalization (HR=2.76; 95%CI 1.05-7.28, p=0.04). Conclusion: We demonstrate an increasing trend in capecitabine utilization among elderly patients with early-stage TNBC. Although the limited sample size hindered a conclusive analysis, more cycles of capecitabine were associated with improved survival outcomes. Notably, a significant proportion of patients undergoing capecitabine treatment experienced ER/hospitalizations. These findings contribute valuable information on the risks and benefits of capecitabine treatment, aiding evidence-based decision-making to prevent serious complications. Citation Format: Marija Sullivan, Xiudong Lei, Catalina Malinowski, Sharon Giordano, Marianna Chavez. Use of adjuvant Capecitabine after neoadjuvant chemotherapy: A Cohort Study among Elderly Patients with Early-Stage Triple-Negative Breast Cancer [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO3-03-08.

Continuous Glucose Monitoring and Reduced Diabetes-Related Hospitalizations in Patients with Type 2 Diabetes and CKD.

There is a heightened risk of glycemic variability in patients with diabetes and chronic kidney disease (CKD). This glycemic variability could lead to hypoglycemic or hyperglycemic crises. We hypothesized that initiation of continuous glucose monitoring (CGM), which provides a glucose measurement every 1-5 minutes, could reduce the incidence of hospitalizations for patients with type 2 diabetes (T2D) and CKD. A retrospective analysis of US administrative claims data from the Optum Clinformatics© Database was conducted. People with T2D, using insulin, not receiving dialysis, and living with stage 3-5 CKD who initiated CGM between 1/1/2016 and 3/31/2022 were identified. NDC and HCPCS codes were used to identify CGM device use and ICD-10 codes were used to identify CKD diagnosis and categorize healthcare encounters. Rates of diabetes-related hospitalizations were obtained, and multivariable logistic regression analyses revealed predictors of hypoglycemic and hyperglycemic encounters. A total of 8,959insulin-using patients with T2D and CKD were identified. Most were White (72.3%), had Medicare insurance coverage (82.2%), were using intensive insulin (91.3%), and had Stage 3 CKD (86.0%). After CGM initiation, rates of hospitalizations for hyperglycemia or hypoglycemia decreased by 18.2% and 17.0%, respectively (p<0.0001 for both). The proportion hospitalized with at least one hypoglycemic or hyperglycemic event also significantly decreased after CGM initiation. Significant predictors of both hypoglycemic and hyperglycemic encounters included a previous encounter of that type, age 30-59 years and depression (for hypoglycemia), and age 30-49 and neuropathy (for hyperglycemia). Use of CGM or glucagon-like peptide-1 receptor agonists was significantly protective against hypoglycemic encounters. Initiation of CGM was associated with significant reductions in diabetes-related hospitalizations among insulin-using individuals with T2D and moderate-to-severe CKD. CGM could help patients with T2D and CKD control their glucose and avoid potentially dangerous glycemic events.

(288) Trends in Penile Prosthesis Placement in Men with Erectile Dysfunction

Abstract Introduction Erectile Dysfunction (ED) is a common problem impacting 20% of all men. Current treatment options include oral medications, vacuum erection devices, intraurethral suppositories, intracavernosal injections, and penile prosthesis placement (PPP). A shared decision-making framework is increasingly utilized for treatment decisions where an appropriate treatment is selected from all options based on the values and priorities of the patient and their partner. Objective Our objective is to identify trends in PPP, including the proportion of patients who pursue PPP as an initial treatment as well as the time from ED diagnosis to PPP. Methods We retrospectively reviewed all men with an ED diagnosis based on ICD9/ICD10 codes using the IBM MarketScan insurance claims database. The initial treatment option processed through an insurance claim following an ED diagnosis was identified and categorized using ICD, HCPCS, NDC, J, and CPT codes. Time from ED diagnosis to PPP was also recorded. Only patients with at least one year of enrollment pre-ED diagnosis and with at least one year of follow-up were included. Linear regressions were performed to investigate the trends of each year based on the time of initial ED diagnosis. Results We identified a total of 670,096 patients diagnosed with ED between 2012-2019. The mean age was 56 years (47-62). Of those patients, 11% were smokers, 29% had diabetes, 24% had cardiovascular disease, 65% had hypertension, and 29% were obese. Among those who received treatment, the most common initial treatment was oral medications in 26% of patients. PPP was an initial treatment in &amp;lt;1% of patients. The proportion of patients who underwent this surgical intervention as an initial treatment significantly decreased from 2012-2019 (P&amp;lt;0.001) as patients utilized other initial treatment modalities more commonly. Over the same period, the time from ED diagnosis to PPP significantly decreased from approximately 500 days in 2012 to &amp;lt;200 days in 2019 (P=0.001). Conclusions Although the proportion of patients who utilize other ED treatment options prior to PPP is higher, patients diagnosed with ED more recently undergo PPP in a significantly shorter timeframe. Utilization of other treatment modalities as an initial treatment option may stem from changes in insurance coverage. Patients moving more quickly from an ED diagnosis to PPP is likely due to several factors, including improvements in the device leading to less mechanical and infectious complications, familiarity with the device due to marketing, and an earlier discussion with the physician about the device based on a shared decision-making model. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Inherent bio, Paterna bio, Firmtech, Turtle health, Maximus, Carrot.

Utilization Patterns and Outcomes from Iron Chelation in Elderly Patients with Low-Risk Myelodysplastic Syndrome

Introduction: Iron overload from red blood cell (RBC) transfusions is a source of morbidity and mortality in patients with myelodysplastic syndromes (MDS). Evidence supporting iron chelation therapy (ICT) in Low-Risk MDS (LR-MDS) is controversial on account of studies conducted in highly selected patients and limited clinical trial data. We conducted a large population analysis aimed at defining real-world ICT utilization in LR-MDS and associated outcomes. Methods: We included patients diagnosed with MDS from 2007 to 2017 in SEER-Medicare using ICD-O-3 codes, aged 66 or older, with continuous Medicare parts A, B, and D. Exclusion criteria included patients with high-risk histology (MDS with excess blasts), less than 2-year survival, without complete follow-up, or enrolled in HMO. ICT eligibility was defined as ICD-9/10 codes for transfusion-related iron overload and/or cumulative ≥20 RBC units within ≤2 years of MDS diagnosis. ICT was identified from HCPCS codes for deferoxamine or prescription records for deferasirox or deferiprone. Explanatory variables included age, sex, race, rurality, socioeconomic quintile, marital status, geographic region, MDS histologic subtype, year of diagnosis, Charlson comorbidity index (CCI), and MDS therapies, including erythropoietin-stimulating agents (ESA), hypomethylating agents (HMA), and lenalidomide, identified from HCPCS codes and prescription records. Outcomes were identified through validated algorithms using ICD-9/10 codes and included overall survival (OS), progression to acute myeloid leukemia (AML), and complications related to iron overload, comprising heart failure, non-ischemic heart disease, atrial fibrillation/flutter, and liver disease/cirrhosis. To control for confounding, we implemented 3 approaches: multivariable Cox-proportional hazards regression, propensity score matching (PSM) by conditional probability of receiving ICT, and cause-specific regression with competing risk of death. Results: We analyzed 2,564 LR-MDS patients who were eligible for ICT. The mean ± SD age was 81 ± 6 years and 56.2% were male. Only 393 (15.3%) of these patients received ICT. The initial agent of choice was deferasirox in 203 (51.7%), deferoxamine in 188 (47.8%), and deferiprone in 2 (0.5%). Median ICT duration was 7 months (IQR 1-20). Chelated patients were younger (median age 79 vs 81, p&amp;lt;0.01), more likely to have histology with ringed sideroblasts [RS] (17.8% vs 7%, p&amp;lt;0.01), had less comorbid burden (median CCI 1 vs 2, p&amp;lt;0.01), and were more frequently treated with ESA (42.8% vs 33%, p&amp;lt;0.01), HMA (59% vs 49.8%), and lenalidomide (27% vs 11.1%, p&amp;lt;0.01), than those not treated with ICT. Their median monthly RBC transfusion density was 4 (IQR 2-6). Factors predicting ICT use were histology with RS (OR=1.9, 95%CI 1.4 - 3.8), RBC transfusion density (OR=1.1 per 4 units/month, 95%CI 1.1-1.2), and therapy with ESA (OR=1.5, 95%CI 1.2-1.9), HMA (OR=1.3, 95%CI 1.1-1.8), or lenalidomide (OR=2.6, 95%CI 1.9-3.5). Among patients who received ICT, 352 (89.6%) were considered transfusion dependent (≥2 RBC units within 8 weeks before starting ICT). Of them, 278 (78.9%) achieved hematologic response (≥50% decrease in RBC units following ICT). ICT was associated with decreased risk of death (HR=0.52, 95%CI 0.46-0.59) in the multivariable model adjusting for all listed covariates. The PSM matched 379 chelated (96.4% case rate) with 729 non-chelated patients and yielded similar results for OS benefit from ICT (HR=0.53, 95%CI 0.46-0.61). Table 1 shows results for other outcomes. Across models, ICT was associated with 43-49% decreased risk of AML transformation and 23-32% reduced risk of adverse cardiac outcomes. Cardiac benefit was predominantly driven by a lower risk of heart failure. No significant association was observed between ICT and hepatic outcomes. Conclusions: Our results suggest that ICT is associated with fewer transfusions, improved OS, lower risk of AML, and less adverse cardiac outcomes in LR-MDS. Our older, unselected cohort better reflects real-world LR-MDS patients and builds upon OS benefit reported in more restricting settings. Given the link between clonal hematopoiesis, cardiovascular disease and LR-MDS, defining ICT's effect on molecular and clonal dynamics could clarify the mechanism behind improved cardiac outcomes.

Metabolic Syndrome Among Patients with Myelodysplastic Syndrome: A Population Analysis

Introduction: Metabolic syndrome (MS) comprises a cluster of cardiovascular risk factors, including central obesity, dysglycemia, elevated blood pressure (BP), increased triglyceride levels (HyperTG), and low HDL cholesterol levels. Epidemiologic and clinical data suggest that MS may be an important etiologic factor in the progression of certain cancer types. These studies have excluded patients with myelodysplastic syndromes (MDS), but MS may be relevant in these patients owing to the link between cardiovascular disease and MDS derived from clonal hematopoiesis. We conducted a population-based analysis to define the prevalence of MS and its components among patients with MDS and explore the effect of MS on MDS outcomes. Methods: We identified patients aged 66 and older diagnosed with MDS between 2007 and 2017 using the SEER-Medicare database. Preexisting MS was identified using ICD-9/10 codes in claims from at least 12 months before MDS diagnosis. MS was defined as the presence of 3 or more of the 5 MS components. MDS histologic risk was defined based on ICD-O-3 morphology codes. Transfusion dependence, defined as 2 or more transfusions within 8 weeks of MDS diagnosis date, and therapy with hypomethylating agents (HMA), lenalidomide and erythropoietin stimulating agents (ESA) were defined from HCPCS codes and prescription records. Other variables defined included age, sex, race/ethnicity, rurality (using RUCC codes), marital status, and socioeconomic status [SES] (using the Yost index). Descriptive statistics were used to define the frequency of MS and its components. MDS outcomes of interest were transformation to acute myeloid leukemia (AML), defined from ICD-9/10 codes for AML, and overall survival (OS), defined as the time between MDS diagnosis and death from any cause. Cox proportional hazards regression was used to determine the association between MS and AML transformation and OS, through adjusted hazard ratios (HR). Results: A total of 15,227 cases diagnosed with MDS between 2007 and 2017 were analyzed, including 3,402 (22.3%) with baseline MS. High BP was present in 72.2%, HyperTG in 47.8%, dysglycemia in 35.5%, central obesity in 4.6% and 0.5% had low HDL cholesterol. The prevalence of MS and the distribution of its components did not significantly differ based on MDS histologic risk (Table 1). The prevalence of hyperTG was notably higher in patients with MDS, especially in the high histologic risk category (50.4%). Compared to other MDS patients, those with preexisting MS were predominantly male (55.5% vs 53.3%, p=0.03) of non-White race (6.7% vs 4.8% non-Hispanic Black, p&amp;lt;0.01, and 2.1% vs 1.5% Hispanic, p&amp;lt;0.01), from urban/metropolitan areas (87.7% vs 86%, p=0.01) and lower SES quintiles 1 and 2 (34.2% vs 31.5%, p&amp;lt;0.01). In a model adjusting for age, sex, race/ethnicity, rurality, marital status, SES, MDS risk, transfusion dependence and MDS therapies (HMA, lenalidomide and ESA), baseline MS at the time of MDS diagnosis was not associated with a significant effect on the risk of AML transformation (HR=1.0, 95%CI 0.9-1.2) or the risk of death from any cause (HR=1.0, 95%CI 0.9-1.1) (Table 2). In models assessing the effect of MS subcomponents on MDS outcomes, high BP (HR=1.0, 95CI% 1.0-1.1) and obesity (HR=1.1, 95CI% 1.0-1.2) were associated with an increased risk of mortality. Obesity was also associated with an increased risk of transformation to AML (HR=1.3, 95CI% 1.0-1.6). Conclusions: The overall prevalence of MS among patients with MDS appears similar to that reported in the general population and does not differ based on the histologic risk category. The observed prevalence of HyperTG was higher than expected, particularly in high-risk MDS patients. Older males of non-White race from urban/metropolitan areas of lower SES are more likely affected across all groups. Though preexisting MS is present in an important proportion of MDS patients, it was not significantly associated with an increased risk of mortality or AML transformation after adjusting for confounders. Obesity was associated with higher mortality and linked to increased transformation to AML. Given recent data suggesting that statins may improve survival and decrease AML transformation in MDS, future studies should investigate the potential association between other metabolic parameters and MDS outcomes.

Bleeding Risk from Anticoagulant Thromboprophylaxis in Patients with Multiple Myeloma

Introduction: Patients with multiple myeloma (MM) have a high risk of venous thromboembolism (VTE) due to unique disease-related (i.e., vascular inflammation, hyperviscosity) and treatment-related factors (i.e., immunomodulatory drugs [IMiDs], high-dose dexamethasone). Thromboprophylaxis is recommended for most patients starting MM therapy. Anticoagulants are preferred over aspirin except in patients at low risk for VTE. However, compliance with prophylaxis guidelines is low. The risk of bleeding from thromboprophylaxis is not well described in these patients so an excessive perceived risk may influence clinicians' practice. We conducted a real-world analysis of bleeding complications from VTE prophylaxis in MM. Methods: The IBM MarketScan Commercial Claims Database was used to identify MM cases between 2013 and 2021. Cases required MM diagnosis from 1 inpatient or 2 outpatient claims, based on ICD-9 or ICD-10 codes, and MM-specific therapy started between 7 days before and 90 days after index diagnosis code, based on HCPCS codes and prescription records. Those with preexisting VTE, atrial fibrillation or stroke were excluded. Thromboprophylaxis was defined as at least 1 prescription for warfarin, low-molecular weight heparin (LMWH) or direct oral anticoagulants (DOAC) within 30 days of diagnosis. Major bleeding was defined as bleeding requiring hospitalization using inpatient ICD codes previously validated (Cunningham algorithm). Patients were followed from end of prophylaxis exposure window (index MM + 30 days) to first major bleeding event, disenrollment (due to death or other reasons) or December 31, 2021. Descriptive statistics were used to calculate rates of bleeding. Cox regression was used to assess the risk of bleeding from thromboprophylaxis and define risk factors associated with major bleeding. Results: We included 6,656 patients diagnosed and treated for MM, with mean age 62.7 years and 55.3% males. Although over 50% of the population would have had a high thrombotic risk based on consensus guidelines, concurrent anticoagulant prophylaxis was prescribed in only 6.6% (436). Prophylaxis agent of choice was warfarin in 23% (102), LMWH in 39% (169), and DOAC in 38% (165), respectively. There was a trend over time favoring DOAC over other agents (25% increase in DOAC use vs. other agents per year on average, p&amp;lt;0.01). Patients on prophylaxis had a higher rate of IMiD-based therapy (63.8% vs. 46.7%, p&amp;lt;0.01) and lower concomitant anti-platelet use (2.1% vs. 4.7%, p=0.01) than those not receiving prophylaxis. There were no differences in age/sex distribution, Charlson comorbidity index (CCI) or history of bleeding between groups. With a median 1.3 years follow-up, the incidence of major bleeding among MM patients receiving VTE prophylaxis was 1.4% or 7.8 bleeding events per 1,000 person-years. This was numerically but not statistically lower than the incident bleeding rate in patients not receiving prophylaxis: 1.8% or 10.1 events per 1,000 person-years. Table 1 shows risk factors for bleeding in this MM population, adjusting for age and sex, including higher age (per 10-year increase, HR 1.38), higher CCI (per SD increment, HR 1.18), history of bleeding (HR 1.54), hypertension (HR 1.87), and renal disease (HR 1.56). IMiD-based MM therapy was associated with decreased risk of bleeding (HR 0.69). Table 2 shows the estimated bleeding risk associated with prophylaxis across several models. No statistically significant association was identified between major bleeding and anticoagulant prophylaxis. Discussion: In a real-world analysis of commercial claims data, the risk of major bleeding associated with VTE prophylaxis in patients with MM undergoing cancer therapy is low and no significant increase in bleeding risk was identified for concurrent anticoagulant use. The rate of major bleeding events appears to be comparable between patients who receive VTE prophylaxis and those who do not. Nevertheless, underutilization of VTE prophylaxis is frequent. Higher CCI, bleeding history, hypertension, and renal disease were clinical factors associated bleeding risk, which may be included in models to help clinicians assess individual patient's risk and guide clinical decisions.

Impact of Hypomethylating Agents on Cardiovascular Disease Risk Among Patients with Myelodysplastic Syndromes

Introduction: The association between clonal hematopoiesis (CH) and cardiovascular disease (CVD) risk has drawn attention to cardiovascular outcomes in myelodysplastic syndromes (MDS). CVD accounts for 25% of deaths in MDS, potentially via CH-mediated accelerated atherosclerosis from inflammatory vascular responses. We previously demonstrated that MDS was independently associated with increased risk of CVD in older adults from SEER-Medicare. We subsequently hypothesized that treatment with hypomethylating agents (HMA) could reduce CVD risk by ameliorating CH clones and reducing the inflammation. In this study, we aimed to define the impact of HMA on incident cardiovascular events among older adults with MDS. Methods: We identified subjects ≥66 years diagnosed with MDS from 2007 to 2017 in SEER-Medicare. Exclusion criteria including lacking continuous Medicare parts A, B, and D, enrolled in HMO, or incomplete follow-up. Demographics included age, sex, race, rurality, socioeconomic quintile, marital status, and geographic region. Baseline CVD risk factors, defined from ICD-9/10 codes, included hypertension, hyperlipidemia, diabetes, atrial fibrillation, pre-existing cardiac disease, obesity, and smoking. MDS factors, defined using HCPCS codes, ICD-O-3 codes and prescription records, included MDS subtype and histologic risk stratification, transfusion dependence and treatment with hypomethylating agents (HMA), lenalidomide, or erythropoietin-stimulating agents (ESA) as time-varying variables. Incident CVD was defined as new myocardial infarction (MI) and/or ischemic stroke occurring after MDS diagnosis, using published ICD-9/10 algorithms. We controlled for confounding using 2 complementary analytic approaches. First, we assessed the association between HMA use and CVD using propensity score adjusted cause-specific competing risk Cox hazard models with death as competing risk, Second, we used a case-crossover design with conditional logistic regression, in which subjects with CVD served as their own controls, using a 3-month HMA treatment window and a control period 6 months prior to the incident event. Results: We identified a cohort of 15,227 eligible patients with MDS. Of these, 1,125 patients had an MI and/or ischemic stroke within 1 year before MDS diagnoses and were excluded. We analyzed 14,102 MDS patients, with median age 82 years (IQR 77 - 86), who were predominantly male (53.8%), non-Hispanic white (88.6%), and from urban/suburban areas (86.2%). MDS was of low, intermediate, and high histologic risk in 14.7%, 72.8%, and 12.5%, respectively, and 28.6% were transfusion dependent. Pre-existing CVD risk factors at time of MDS diagnosis were present in 12,538 patients, with baseline cardiovascular risk defined as low, intermediate, and high in 11.1%, 32.3%, and 56.6% of the cohort. The cumulative incidences of MI, ischemic stroke and composite CVD events were 11.3%, 10.6% and 20.4%, respectively. The propensity score (PS) conditional probability for being treated with HMA included demographic variables, CVD risk factors, MDS histology and transfusion dependence. Our PS model adequately predicted HMA treatment propensity (AUC 0.76). Cause-specific regression with death as competing risk, adjusted for PS and other MDS-specific treatments (ESA and lenalidomide), showed no significant effect of HMA on the risk of composite CVD events, MI, or ischemic stroke (Table 1). Conditional logistic regression in the case-crossover analysis of 1,907 patients with composite CVD events showed no significant effect of HMA. Results were similar for analysis of patients with MI and ischemic stroke (Table 2). Conclusions: No study has previously investigated the effect of HMA therapy on cardiovascular outcomes in patients with MDS. We demonstrate that HMA therapy is not associated with a significant risk reduction in cardiovascular events among patients with MDS patients from the SEER-Medicare database. These results show that HMA therapy is unlikely to reduce cardiovascular mortality and underscore the need for alternative therapeutic strategies targeting cardiovascular health patients with MDS.

Methods for Identification of Blood Product Transfusions in a Cohort of Myelofibrosis Patients: An Assessment of Data Capture Using Insurance Claims and Electronic Health Record Abstraction

Introduction Transfusion data completeness is critical in assessing real-world response and progression in myeloid malignancies. In the real-world setting transfusion data can be collected via insurance claims or by Electronic Health Record (EHR) abstraction. Transfusion events captured from claims have previously been shown to be 71% sensitive and 92% specific compared to EHR abstraction in the community hospital setting, however this has not been evaluated in outpatient community oncology setting (Howard DH, et al. Transfusion Medicine. 2016;26:457-459). Our objective was to assess the completeness of transfusion data from claims in the The Komodo Healthcare Map™(KHM) to EHR abstraction in the Flatiron Health Research Database (FHRD) in a group of patients with myelofibrosis (MF). Methods This study used the nationwide Flatiron Health EHR-derived de-identified database and The Komodo Healthcare Map™, a database of de-identified claim-based healthcare encounters from insured patients in the US (2015-2022).This is a cross-sectional study of a cohort of patients with MF that underwent EHR abstraction (EHRC) (n = 507) from FHRD, capturing transfusion dates, and number of units from date of diagnosis up to data cutoff on 30 November 2022 (observation window). Those patients were linked to KHM to create a Linked Claims Cohort (LCC), and a sub-cohort of patients with any closed claims during the observation window to make a Closed Claims Cohort (CCC), where transfusions were assessed by reviewing transfusion-related HCPCS and ICD codes. Analyses were performed on the matched patients in the LCC and CCC, respectively. To assess the level of concordance between claims and EHR data sources on the number of transfusions per patient the intraclass correlation coefficient (ICC) was used. Also, percent overlap and sensitivity, specificity, and positive and negative predictive values were calculated. Results Out of a total of 507 in the EHRC, 498 were found in KHM and included in the LCC, and 245 had closed claims and comprised the CCC. Demographics are listed below (Table 1) and are similar between groups, however the CCC had a higher percentage of patients with more recent diagnosis. A total of 319 (64%) vs 168 (34%) in the LCC, and 143 (58%) vs 95 (39%) patients in the CCC had at least one transfusion identified by EHR and claims data sources, respectively (Table 2). In the LCC, there was 64.1% agreement of having a transfusion across data sources, with a kappa of 0.34 (p = 0), and in the CCC, there was 72.24% agreement, with a kappa of 0.47 (p = 0). The unweighted kappa for the number of transfusions recorded during the observation period was 0.11 (p = 0) in the LCC and 0.18 (p = 0) in the CCC. Treating the EHR source as the source of truth, the claims data source in LCC had a sensitivity of 48.28%, specificity of 92.18%, PPV of 91.67%, and NPV of 50% to identify transfusion events, while the claims in CCC had a sensitivity of 59.44%, specificity of 90.20%, PPV of 89.47%, and NPV of 61.33% Conclusions There was an observed low agreement between transfusions identified via EHR abstraction and Claims data sources, with the EHR having more transfusions identified, but a moderate agreement when selecting for patients with closed claims. As a source for transfusion data EHR provided more data points during the observation window for this group of patients. Future investigation of transfusions in patients with continuous closed claims during the observation window is warranted to determine if it improves data capture. This study demonstrates that EHR abstraction may have higher utility for identifying transfusions with lower attrition in a cohort of MF patients with long observation periods, and with variable insurance coverage in the outpatient oncology setting.

Comparing Changes in Medicare Reimbursement for Radiation Oncology and Medical Oncology (2010-2020)

A recent study found that radiation oncology (RO) has seen significant declines in Medicare reimbursement (MCR) from 2010-2019. While it is presumed that other cancer subspecialties have seen decreasing MCR, to our knowledge, there are no studies directly comparing changes in MCR between RO and other oncology subspecialties. In this study, we analyze changes in MCR from 2010-2020 for both RO and medical oncology. We hypothesized that the declines in MCR will be similar between the two fields. The publicly available Physician/Supplier Procedure Summary (PSPS) database was used for all years from 2010-2020. All reimbursement for providers with primary provider codes 92 (RO) and 83 and 90 (heme/onc and medical oncology, respectively) were analyzed. For the 150 most highly-reimbursed HCPCS codes for each specialty in 2010, the total allowed charge for each code was corrected for inflation and then divided by the number of submitted claims to calculate average MCR per code for each year. For each code and each specialty, the 2020 billing frequency was multiplied by the calculated average reimbursement per claim in a given year to calculate what the reimbursement would have been in that year using 2020 dollars and utilization rates (projected reimbursement). The projected reimbursement was summed for all HCPCS codes in each year for each specialty to calculate an aggregate MCR for that specialty for that year. This aggregate MCR was then compared with the actual 2020 reimbursement for that basket of codes to calculate the change in MCR over time. Both medical and radiation oncology saw decreases in projected vs. actual MCR from 2010-2020 for this basket of services (Table). Adjusting for inflation and utilization, RO MCR declined by $0.7 billion (B) (-29.0%) from 2010 to 2020 and by $0.2B (-10.5%) from 2015 to 2020 while medical oncology MCR declined by $0.8B (-14.7%) from 2010-2020 and by $0.4B (-6.6%) from 2015-2020. The average decrease per year in projected vs. actual reimbursement for RO was 2.9% (2010 to 2015) and 1.05% (2015 to 2020) and for medical oncology was 1.5% (2010-2015) and 0.7% (2015-2020), respectively. Adjusting for inflation, Medicare reimbursement for a large array of services has declined for both medical oncology and RO from 2010 - 2020. Contrary to our hypothesis, RO reported a 97% greater relative decline in reimbursement compared with medical oncology from 2010 - 2020. Significant decreases in reimbursement to both fields and their potential implications on patient care and access to care should be considered by policymakers while shifting towards an episode-based Alternative Payment Model and when considering further cuts to Medicare reimbursement.

141-LB: Cost-Effectiveness of Real-Time Continuous Glucose Monitoring (rt-CGM) vs. Intermittent-Scanning Continuous Glucose Monitoring (is-CGM) from a U.S. Payer Perspective in Patients with Type 2 Diabetes on Multiple Daily Injections of Insulin (PwT2D on MDI)

Diabetes management for PwT2D on MDI requires access to timely glucose readings to inform treatment decisions and avoid acute events like severe hypoglycemia (SHE) and Diabetic Ketoacidosis (DKA). CGM systems have different features that can impact glycemic outcomes and disease complications and costs. There is a gap in the literature on the cost-effectiveness of rt-CGM vs is-CGM systems. We conducted lifetime projections of disease outcomes and costs from a US payer perspective using the IQVIA Core Diabetes Model v9.5+. Cohort characteristics and clinical inputs were sourced from the DIAMOND T2D and REPLACE RCTs. Applying Bucher's adjusted indirect comparison method resulted in an HbA1c effect of -0.33 favoring rt-CGM, SHE incidence rates of 0.014 and 0 Per Person-Year (PPY) for is-CGM and rt-CGM, respectively, and DKA rates were estimated using Time-Above-Range (0.0313 and 0 PPY, respectively). The cost of both CGM systems is based on Medicare pricing and 80% reimbursement (HCPCS code A4239). A utility for fear of hypoglycemia (FoH) reduction was applied from the ALERTT1 RCT. The model associates rt-CGM use with reduced eye (-5.64%), renal (-7.42%), neural (-4.08%), and cardiovascular (-2.56%) complications compared to is-CGM. It projects rt-CGM users to have higher quality-adjusted life years (QALYs) by 0.454 with cost savings of -$1,355, and an incremental cost-effectiveness ratio of -$2,983/QALY. Rt-CGM remained cost-effective under the $50,000 willingness-to-pay threshold even when its cost was increased by 70% (+$1,713). Scenario analysis with 50% lower FoH utility, SHE, and DKA rates reduced QALYs gained to 0.264. Our analysis suggests that rt-CGM is cost-saving and cost-effective vs is-CGM in PwT2D on MDI in the US and can inform US payers of the economic value of different CGM systems. Disclosure H. Alshannaq: Employee; Dexcom, Inc., Other Relationship; Vertex Pharmaceuticals Incorporated. G. J. Norman: Employee; Dexcom, Inc. P. M. Lynch: Employee; Dexcom, Inc., Stock/Shareholder; Dexcom, Inc.

MP54-14 MENTAL HEALTH ILLNESS IN PATIENTS WITH NON-MUSCLE INVASIVE BLADDER CANCER. DOES BCG PLAY A ROLE?

You have accessJournal of UrologyCME1 Apr 2023MP54-14 MENTAL HEALTH ILLNESS IN PATIENTS WITH NON-MUSCLE INVASIVE BLADDER CANCER. DOES BCG PLAY A ROLE? Valentina Grajales, Zhigang Duan, Wei Shen Tan, Roberto Contieri, Hui Zhao, Sharon Giordano, Stephen B. Williams, and Ashish M. Kamat Valentina GrajalesValentina Grajales More articles by this author , Zhigang DuanZhigang Duan More articles by this author , Wei Shen TanWei Shen Tan More articles by this author , Roberto ContieriRoberto Contieri More articles by this author , Hui ZhaoHui Zhao More articles by this author , Sharon GiordanoSharon Giordano More articles by this author , Stephen B. WilliamsStephen B. Williams More articles by this author , and Ashish M. KamatAshish M. Kamat More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003307.14AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Up to a third of cancer patients experience a mental health condition during their cancer treatment; Bacillus Calmette-Guerin (BCG) has been shown to be neuroprotective. Herein, we assess the incidence of mental health illness (MHI) in non-muscle invasive bladder cancer (NMIBC) patients and the impact of intravesical BCG on the development of non-neurodegenerative MHI. METHODS: Using the Surveillance, Epidemiology, and End Results (SEER)-Medicare data set, we identified 30,991 patients diagnosed with NMIBC between 2005-2017. MHI diagnosis and BCG treatment were identified using ICD9/ICD10 diagnosis codes and HCPCS codes from Medicare inpatient, outpatient, and physician claims. We excluded developmental, organic, and neurodegenerative MHI. Descriptive statistics were done using the Pearson’s chi-square test for categorical variables. RESULTS: A total of 27.0% of patients (N=8,367) received at least an induction course of BCG. Pre-existing MHI was present in 15.9% (N=4,928) of patients 1 year prior to bladder cancer diagnosis. These patients had lower rates of induction BCG (23.0% VS 27.8%, p<0.001). Excluding pre-existing MHI, 43.7% (N=11,377) of patients developed MHI after their bladder cancer diagnosis. Both female and older patients had higher rates of developing MHI (p<0.001), Table 1. Patients without pre-existing MHI treated with at least an induction course of BCG (N=7,233) had a lower MHI development rate than those who did not receive BCG (41.5% VS 44.5%, p<0.001). CONCLUSIONS: Patients with NMIBC are at high risk of developing MHI after diagnosis especially elderly and female patients. Patients who received at least induction BCG treatment had lower rates of developing de novo MHI, however, those with pre-existing MHI were less likely to receive BCG. Source of Funding: This research was supported by the Wayne B. Duddlesten Professorship in Cancer Research © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e759 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Valentina Grajales More articles by this author Zhigang Duan More articles by this author Wei Shen Tan More articles by this author Roberto Contieri More articles by this author Hui Zhao More articles by this author Sharon Giordano More articles by this author Stephen B. Williams More articles by this author Ashish M. Kamat More articles by this author Expand All Advertisement PDF downloadLoading ...

Evaluating bottoming-out of bariatric sized wheelchair cushions

ABSTRACT In the United States, wheelchair cushions are classified using HCPCS codes. Cushions classified as Skin Protection cushions are provided for wheelchair users who are at risk of tissue damage. Cushions designed for bariatric users fall into a category of cushions with width of 22 inches or greater. Current coding procedures require tests that are designed for 41–43-cm-wide cushion so cannot evaluate wider cushions. The objective of this study was to evaluate the performance of heavy-duty or bariatric wheelchair cushions using an anthropometrically appropriate buttock model and loading profile. A rigid buttock model, designed to reflect the anthropometry of persons using cushions over 55 cm in width was loaded onto six bariatric-sized wheelchair cushions. Two applied loads, 75 and 88 kg, represented the 50th and 80th percentile of persons who would be expected to use a 55-cm-wide cushion. None of the cushions indicated a bottomed-out state at the 88 kg load, suggesting that they could adequately support users weighing 135 kg. However, when evaluating cushions at their maximum rated loads, two of the six cushions were approaching or had bottomed-out. This study indicates that a more valid approach to classify Skin Protection bariatric cushions is needed.

Abstract P3-03-13: Long-term heart failure risk of trastuzumab with or without anthracyclines in early stage breast cancer: A SEER-Medicare Database Analysis

Abstract Background: Cardiotoxicity associated with use of trastuzumab (T) in breast cancer has been assessed in multiple studies with short-term follow up. However, long-term risk of clinical heart failure (CHF) with the use of T, either with or without anthracyclines (A), is poorly understood. Since the approval of T for use in early-stage breast cancer (ESBC) in 2006, long-term follow up data is now available in the SEER-Medicare database. Methods: We performed a retrospective cohort study in patients (pts) with ESBC identified in the SEER-Medicare database, diagnosed between 2005-2016, excluding pts with in-situ or metastatic disease at time of diagnosis or a history of CHF prior to diagnosis. Primary exposure variables were identified using HCPCS codes and included receipt of T or A. The reference baseline population used for univariate logistic regression of the primary exposure variables was pts with ESBC who received neither T nor A. For multivariate analyses, to avoid co-linearity in the final model, the exposure variables were categorized as either having or not having the exposure (i.e. with or without T, with or without A). The primary outcome variable was CHF, identified using codes 428.0-9, 402.11, 402.91 (ICD9) and I50.0-9, I110 (ICD10). Covariates used in multivariate logistic regression (MLR) included hypertension (HTN), valve disease, hyperthyroidism, diabetes (DM), emphysema, coronary artery disease (CAD), left sided radiation, age, and race. MLR models were constructed using a stepwise-up approach and confirmed using the stepwise-down method with a cutoff of p&amp;lt; 0.05 for inclusion in the final model. Results: A total of 244,129 pts were identified with a median follow up of 6.7 years (7.7 years in the T cohort). Median age was 68. Other demographics are listed in Table 1. Of these, 10,603 were HER2-positive (HER2+) pts who all received T and all of whom also received some form of chemotherapy. Of the HER2+ pts, 19.1% (2,026) also received A in addition to T as part of their treatment regimen. Pts who received T had significantly higher baseline rates of HTN, valve disease, hyperthyroidism, DM, emphysema, and CAD as compared to pts who did not receive T. Compared to pts who received T without A, pts who received T with A had significantly higher baseline rates of HTN, valve disease, hyperthyroidism, emphysema, and CAD with no difference in baseline rate of DM. Risk of CHF with exposure variables are summarized in Table 2. The overall rate of CHF for the entire 244,129 population was 21.3% with a rate of 20.8% in pts who did not receive any T or A (the baseline population). The rate of CHF in pts who received T without A was 19.1% (OR 0.90, 95% CI 0.85-0.95), and 29.0% for those who received T with A (OR 1.55, 95% CI 1.41-1.71). Associations of covariates of interest with risk of CHF as well as MLR models are summarized in Table 3. After adjusting for all baseline cardiac comorbidities as well as other covariates, receipt of T was associated with a reduced risk of CHF (OR 0.74, 95% CI 0.70-0.79, p&amp;lt; 0.001), and receipt of A remained associated with an increased risk of CHF (OR 1.19, 95% CI 1.15-1.24, p&amp;lt; 0.001). Conclusions: With long-term follow up, the addition of A to T significantly increased the risk of CHF over T without A (from 19.1% to 29.0%) in pts with ESBC. Additionally, pts who received T without A had a similar risk of CHF compared to the baseline population who received neither T nor A. After adjusting for potential confounders in the MLR model, T was associated with a slightly decreased overall risk of CHF, while A remained associated with an increased risk of CHF. Possible explanations for these findings include potential increased cardiac monitoring in the T population which may have led to optimization of cardiac comorbidities, which were higher in the T population at baseline. Taken together, these data indicate concern with use of T plus A in ESBC regarding the long-term development of clinical CHF; especially when non-A regimens with similar efficacy are available. Table 1: Demographics Table 2: Risk of Heart Failure with Primary Exposure Variables Table 3: Univariate and Multivariate Analyses Citation Format: Nicholas P. McAndrew, Karissa Britten, Xiaoyan Wang, Eric Yang, Sara Hurvitz, Dennis Slamon. Long-term heart failure risk of trastuzumab with or without anthracyclines in early stage breast cancer: A SEER-Medicare Database Analysis [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr P3-03-13.

1145. Real-world Effectiveness of Sotrovimab for the Early Treatment of COVID-19 in the US

Abstract Background Sotrovimab, a monoclonal antibody (mAb), received Emergency Use Authorization (EUA) for the treatment of high-risk outpatients with symptomatic COVID-19. The study objective was to evaluate real-world effectiveness of sotrovimab (500 mg intravenous) in reducing the risk of mortality or hospitalization during the SARS-CoV-2 Delta and initial Omicron variant waves in the US. Methods A retrospective analysis was conducted of de-identified patients (pts) diagnosed with COVID-19 (ICD-10: U07.1) from 9/1/2021 to 2/28/2022 in the FAIR Health FH NPIC® claims database. Pts were divided into 2 cohorts based on HCPCS codes: treated with sotrovimab and not treated with any mAb (no mAb). Pts meeting EUA high-risk criteria were identified via pre-specified ICD-10-CM diagnoses in records ≤ 24 months prior to their first COVID-19 diagnosis (index date). Facility-reported mortality (referred to as “mortality”), all cause hospitalizations and intensive care unit (ICU) admissions within 30 days of index were identified. Chi-square test, ANOVA, or t-tests were performed to statistically compare cohorts at a 0.05 level of significance (2-sided). P-values were not adjusted for multiplicity. Multivariable logistic regression was conducted to estimate the risk of mortality or hospitalization within 30 days, adjusting for demographic and clinical factors. Results Of the high-risk COVID-19 pts identified, 13,140 were treated with sotrovimab and 1,283,284 received no mAb therapy. Compared to the no mAb cohort, the sotrovimab cohort was older, had more baseline conditions, and were more likely to be female (all p &amp;lt; 0.0001). In the no mAb cohort, 0.59% died and 5.74% were hospitalized (of whom 30% in ICU). In the sotrovimab cohort, 0.08% died and 2.50% were hospitalized (of whom 15% in ICU). After adjusting for potential confounders, treatment with sotrovimab was associated with 83% reduced odds of 30-day mortality (OR: 0.17, 95% CI: 0.09-0.31) and 61% reduced odds of 30-day hospitalization or mortality (OR: 0.39, 95% CI: 0.35-0.43) among high-risk COVID-19 pts. Conclusion In this US real-world observational study of high-risk COVID-19 pts during the Delta and initial Omicron waves, treatment with sotrovimab was associated with reduced odds of mortality and hospitalization compared to no mAb treatment. Disclosures Mindy M. Cheng, PhD, Vir Biotechnology: Employee, Shareholder Daniel C. Gibbons, PhD, GlaxoSmithKline: Employee, GlaxoSmithKline GSK shareholder Helen Birch, PhD, GlaxoSmithKline: Employee, GlaxoSmithKline GSK shareholder Vishal Patel, MSc, GlaxoSmithKline: Employee, GlaxoSmithKline Christopher F. Bell, n/a, GlaxoSmithKline: Employee, GlaxoSmithKline GSK shareholder Myriam Drysdale, PhD, GlaxoSmithKline: Employee, GlaxoSmithKline GSK shareholder Sacha Satram, PhD, Vir Biotechnology: Employee, Vir Biotechnology Vir shareholder Carolina M. Reyes, PhD, Vir Biotechnology: Employee, Vir Biotechnology Vir shareholder.

Comorbidity Burden in Patients with Covid-19 Treated with Molnupiravir in the United States

Individuals with certain medical conditions, e.g., diabetes, heart, and/or lung disease, are at higher risk of severe COVID-19. Molnupiravir, an oral antiviral drug for treatment of mild-to-moderate COVID-19 in certain adults, was granted US FDA emergency use authorization. Retrospective analyses of US patient-level medical and pharmacy claims, and hospital chargemaster data, aggregated by HealthVerity, was conducted. Adults (≥18 years) were indexed to their first outpatient pharmacy fill for molnupiravir between Dec-24-2021 and May-02-2022. Comorbidities were identified using ICD-10 diagnosis, CPT, and/or HCPCS codes during pre-index period (back to Dec-01-2018) and comedications by generic name (from NDCs) ≤90 days before index. Demographic, comorbidity, and comedication characteristics were reported using descriptive statistics. The analyses included 26,191 patients: mean age 58.7 (SD 16.3) years, 59.0% female and 75.9% resided in the South. Presence of ≥1 comorbidity associated with severe COVID-19 was observed in 87.0%: hypertension (52.5%), overweight/obesity (37.4%), mood disorder (30.7%) and cardiovascular disease (18.9%). Diabetes mellitus was observed in 6,944 (26.5%) patients: mean age 62.5 (SD 14.3) years and 54.4% female. Polypharmacy (≥5 comedications) within the last 90 days was also prevalent in both the overall (49.7%) and patients with diabetes (66.1%). Concomitant use of comedications contraindicated with ritonavir-based COVID-19 treatment was noted in 33.7% of all patients and 45.8% of patients with diabetes. Majority of COVID-19 patients treated with molnupiravir in clinical practice were at high risk of severe COVID-19. Future research needs to assess impact of molnupiravir on clinical outcomes in real-world practice, including in patients with comorbid conditions.

Examination of Disparities in Access to Chimeric Antigen Receptor (CAR) T Cell Therapies in Medicare Patients (Pts) with Relapsed or Refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL) Who Had Failed at Least 2 Prior Lines of Therapy (LOT)

Background: The Medicare population, representing older pts with multiple comorbidities, has been successfully treated with CAR T cell therapy. However, prior research suggests that access to this therapy offering possible durable, long-term responses could be limited and subject to health disparities based on socioeconomic status, age, or other pt characteristics (Ahmed et al. Transplant Cell Ther. 2022). Prior research focused on examining determinants of access to CAR T cell therapy relative to a heterogeneous group of pts with respect to treatment history (ie, 0-3 prior lines, etc) or subsequent management (ie, active or maintenance therapy or no additional treatment). The current study examines and contextualizes determinants of receipt of CAR T cell therapy and disparities in access among pts with R/R DLBCL enrolled in a Medicare plan who failed ≥ 2 prior LOTs and were actively treated with ≥ 3 LOTs. Methods: This retrospective cohort study used the Medicare Limited Data Set (LDS) administrative claims data (from 01/01/2017 to 03/31/2021) containing 100% final action claims submitted for fee-for-service (FFS) Medicare beneficiaries. Claims data were linked to publicly available US census county-level measures of the Area Deprivation Index (ADI) 2019 as well as predisposing, enabling, and need contextual characteristics from the Area Health Resource Files from 2019 to 2020 to measure socioeconomic disadvantage. Pts with newly diagnosed DLBCL (ICD-10-CM: C83.3X) continuously enrolled for ≥ 6 months before diagnosis (baseline period) and who received rituximab (RTX)-based therapy during follow-up were included. DLBCL treatments received by pts were identified using ICD-10 procedure and HCPCS codes; Medicare Part D prescription drug claims were not available. Pts had to have received ≥ 2 prior LOTs after DLBCL diagnosis and initiated a subsequent LOT consistent with NCCN guidelines. Those with prior diagnoses of other non-Hodgkin lymphomas or hematologic cancers were excluded, except for primary mediastinal large B-cell lymphoma, chronic lymphocytic leukemia, and follicular lymphoma. The association between receiving CAR T cell therapy and key patient and county of residence characteristics was assessed using multivariate logistic regression models. Results: A total of 15,472 Medicare pts with DLBCL received RTX at any point during follow-up. Of those, 266 pts had 2 prior LOTs, RTX in combination with another chemotherapy as first line, and a third or later LOT that was an active comparator of interest (104 pts received CAR T cell therapy vs 162 pts who did not). Among pts who did not receive CAR T cell therapy, the distribution of third LOTs included stem cell transplant (27.8%), polatuzumab-based therapy (26.5%), and various salvage combinations of RTX with chemotherapy (45.7%). More CAR T cell therapy recipients were evaluated for clinical trial participation over the study period versus nonrecipients (37.5% vs 11.1%, respectively). In unadjusted analysis, those ≥ 76 y old were numerically associated with lower odds of receiving CAR T cell therapy vs those 66-75 y, but the difference was not statistically significant (OR = 0.501, P = 0.06). In multivariate adjusted analysis restricted to 209 pts excluding those who were evaluated for clinical trial participation (65 pts received CAR T cell therapy vs 144 pts who did not), CAR T cell therapy recipients were less likely to be female (odds ratio [OR] = 0.463, P = 0.04), have Charlson Comorbidity Index (CCI) score ≥ 3 (OR = 0.451, P = 0.04), or be residents of the South (OR = 0.284, P = 0.02) (Table). There was no association of ADI and receipt of CAR T cell therapy. Conclusions: Pts with R/R DLBCL on Medicare FFS who received CAR T cell therapy were less fragile, with a CCI < 3, and more likely to experience advanced LOTs. Despite the small sample size of this study, the findings suggest that access to CAR T cell therapy should be particularly improved in female pts and pts living in the South, possibly due to geographical limitations of CAR T centers and a high population of socioeconomically disadvantaged racial minorities. Given the demonstrated durable benefit in pts with R/R DLBCL, increased adoption of CAR T cell therapy can have a significant impact on pts’ lives and improve their health outcomes. Figure 1View largeDownload PPTFigure 1View largeDownload PPT Close modal